IMPLANTABLE DEVICE FOR DELIVERING FLUID TO INTERNAL TARGET

An at least partially implantable medical device can include a body where at least a first portion of the body configured to be implanted through an ostial opening, and at least a second portion of the body configured to at least temporarily retain the body in the implanted position. The second portion can be more distal than the first portion and including a cross-sectional area larger than a cross-sectional area of the first portion. At least one of the first portion or the second portion can be configured to elute a fluid.

BACKGROUND

An ostia is a small orifice or opening. A sinus cavity, pelvic opening, an ear Eustachian tube, and portions of a gastrointestinal (GI) tract, are examples of ostia. Ostia can he problematic if inflamed, partially blocked, or the like.

Chronic rhinosinusitis (CRS) is inflammation of the paranasal sinuses for a period lasting more than 12 weeks. Typically, symptoms can include, among others, nasal inflammation, anterior or posterior nasal discharge, nasal obstruction or congestion, loss of smell, and facial pain, tenderness, and swelling. CRS can be caused by an infection in the paranasal sinuses, nasal polyps, a deviated nasal septum, chronic inflammation of the sinus ostium, and allergies, among other causes. Current treatments available for treating CRS tend to focus on aerating the sinus cavity and/or applying a one-time fluid directly into the sinus cavity. For example, current treatment for CRS can include nasal, oral, or injected corticosteroids, nasal irrigation with saline, antibiotics, or surgery.

Surgery can include functional endoscopic sinus surgery (FESS). FESS can include placing an endoscope in the sinus and removing affected tissue and/or bone from the sinus and/or surrounding area and/or expanding the ostium. In the case of a deviated nasal septum, surgery can include a procedure to correct a deviated nasal septum. In the case of chronic inflammation of the sinus, surgery can include balloon sinus dilation (BSD) to better open the sinus ostium. BSD can include inserting a balloon catheter into the sinus ostium and dilating the balloon to expand the sinus ostium. A drug eluting stent can also be positioned in the sinus ostium during BSD.

SUMMARY

The present disclosure relates to a medical device positionable inside a target anatomy (e.g., sinus ostia or other portion of the sinus, vagina or other portion of the female reproductive system, or the like), such as for aeration or optional exchange of a medium. The medical device can, for example, treat a chronic condition (e.g., CRS). The medical device can be removably connectable to a delivery system. Such systems and methods can be beneficial for treating patients (e.g., recalcitrant patients) for whom BSD can lead to undesirable side effects (e.g., pain).

According to an embodiment, a medical device insertable within a target anatomical region can include a body, at least a first portion of the body being configured to be insertable within the target anatomical region, and at least a second portion of the body being configured to facilitate retention of the body in the target anatomical region. At least one of the first portion or the second portion being configured to interact with a portion surrounding the target anatomical region and/or configured to exchange a component to effect a change within the target anatomical region.

According to an embodiment, a medical device insertable within a target anatomical region includes a body, at least a first portion of the body being configured to be insertable within a target anatomical region, and at least a second portion of the body being configured to facilitate retention of the body in the target anatomical region. At least one of the first portion or the second portion being configured to receive a medium and permit exchange thereof with the target anatomical region. At least one of the first portion or the second portion being configured to facilitate in situ manipulation of the medium via an external manipulation system.

According to an embodiment, a medical device insertable within a target anatomical region includes a body, at least a first portion of the body being configured to he insertable within a target anatomical region, at least a second portion of the body being configured to facilitate retention of the body in the target anatomical region, and a connecting portion for facilitating a removable connection between the body and a delivery system for delivering a medium.

According to an embodiment, a medical device includes a body extending from a proximal end to a distal end, a connecting portion connected to the body at the proximal end, and a portion formed on the body adjacent to the distal end that can be configured to receive a medium and deliver the medium to a body cavity.

According to an embodiment, a system includes a medical device and a delivery system comprising a connecting portion for removably connecting to a connecting portion of the medical device. The medical device includes a body, at least a first portion of the body being configured to be insertable within a target anatomical region, and at least a second portion of the body being configured to facilitate retention of the body in the target anatomical region. The delivery system facilitates transfer of a medium toward the medical device.

According to an embodiment, a system includes a medical device and a delivery device removably connectable to the medical device, the delivery device being configured to maintain the medical device in an insertion configuration during insertion of the medical device inside the target anatomical region. The medical device includes a body, at least a first portion of the body being configured to be insertable within a target anatomical region, and at least a second portion of the body being configured to facilitate retention of the body in the target anatomical region. The delivery device being further configured to decouple the medical device from the delivery system after insertion of the medical device in the target anatomical region.

According to an embodiment, a system includes a dispenser configured to receive a fluid, a delivery member with a proximal end attached to the dispenser and a distal end that includes a connecting member and a medical device that can be configured to be positioned in a body cavity. The medical device includes a body extending from a proximal end to a distal end, a connecting member connected to the body at the proximal end that can be configured to mate to the coupler of the delivery member, and a portion formed on the body adjacent to the distal end that can be configured to receive the fluid and deliver the fluid into a body cavity.

According to an embodiment, a system includes a medical device that can he configured to be positioned in a body cavity to deliver a medium to the body cavity, and an external device positioned adjacent to the medical device.

According to an embodiment, a method of inserting a medical device into a sinus cavity includes deploying a distal end of a delivery device into a nasal cavity, positioning the distal end of the delivery device near a sinus ostium, advancing a guide wire of the delivery device through the sinus ostium and into the sinus cavity, advancing a medical device over the guide wire into the sinus cavity, wherein the medical device includes a body with a connecting portion at a proximal end and a portion at a distal end, and removing the guide wire from the sinus cavity, wherein the medical device remains in place in the sinus cavity.

A method includes coupling a dispenser to a medical device positioned in a cavity, delivering a fluid to the medical device, wherein the medical device includes a body with a connecting portion at a proximal end and a portion at a distal end, delivering the fluid to the cavity through the medical device, and decoupling the dispenser from the medical device.

DETAILED DESCRIPTION

A medical device for implanting in a body cavity (e.g., a sinus cavity, a vagina or other portion of the female reproductive system, or the like) can be disclosed. The medical device can include a body that can be positioned in the sinus cavity. The medical device can extend through the sinus ostium and into the nasal cavity. A proximal end of the medical device (a portion positioned in the nasal cavity after implantation) can include a connecting portion that can he configured to couple the medical device to a dispenser. In an embodiment, the connecting portion on the medical device can be configured to couple to a connecting portion on the dispenser and/or a delivery member attached to the dispenser. The dispenser and/or delivery member can be magnetically coupled to and decoupled from the medical device. The dispenser and/or delivery member can be coupled to the medical device to dispense a fluid into the medical device. The fluid can flow through the medical device into the sinus cavity, such as to treat the sinus cavity.

A distal portion of the medical device can form a portion of the medical device. The portion of the medical device can include one or more pores through which the fluid can flow. Alternatively or in addition to the pores, the portion of the medical device can include a material that absorbs the fluid. The fluid can elute from the pores and/or the material on the portion of the medical device.

The medical device can provide access to the body cavity (e.g., sinus cavity, ear canal, GI tract, oral cavity, vagina, or other portion of the female reproductive system) through a natural orifice (e.g., the nostril, nasal cavity, vagina, or the like). Accessing the medical device through the natural orifice allows for refilling of the medical device with a fluid as needed. This access can allow for periodic treatment of the body cavity for chronic conditions (for instance, CRS). Further, the medical device can allow a fluid to be eluted from the medical device over a period of time (e.g., seconds, minutes, hours, days, etc.).

Embodiments described below illustrate the exemplary use of the medical device and a delivery device for treating CRS.

Human head100can be shown inFIGS. 1A-1B. Human head100includes nose102positioned in a center of human head100. Nose102has two nostrils104leading to nasal cavity106. Paranasal sinuses108are positioned in human head100and are connected to nasal cavity106. Paranasal sinuses108are a group of air-filled spaces in human head100that are positioned around nasal cavity106.

Paranasal sinuses108include frontal sinuses110, ethmoid sinuses112, maxillary sinuses114, and sphenoid sinuses116. There are two frontal sinuses110positioned above each eye in the forehead region of human head100. One frontal sinus ostium118connects each frontal sinus110to sinus cavity106. There are two ethmoid sinuses112positioned between the eyes of human head100. Ethmoid sinuses112each include several discrete air cells, also called Haller cells. There are two maxillary sinuses114positioned under each eye in the cheek region of human head100. One maxillary sinus ostium120connects each maxillary sinus114to sinus cavity106. There are two sphenoid sinuses116positioned behind each eye of human head110. One sphenoid sinus ostium122connects each sphenoid sinus116to sinus cavity106.

Paranasal sinuses108are noun ally filled with air. However, paranasal sinuses108are susceptible to becoming inflamed, which can block the sinus ostia and cause paranasal sinuses108to fill with fluid. Paranasal sinuses108can become blocked due for a number of different reasons, including infection, nasal polyps, a deviated nasal septum, chronic inflammation of the sinus ostium, and allergies, among others. Symptoms typically include nasal inflammation, anterior or posterior nasal discharge, nasal obstruction or congestion, loss of smell, and facial pain, tenderness, and swelling. These symptoms can persist for a period of time. Chronic rhinosinusitis (CRS) can be inflammation of paranasal sinuses108for a period lasting more than 12 weeks.

Medical device200can be configured to be positioned and retained in a body cavity. In instances in which the medical device200can be configured for treatment of CRS, the body cavity can be a sinus cavity (e.g., maxillary, frontal, ethmoid, and the like). The medical device200can include body202. In the embodiment shown inFIG. 2, the body202can be elongate and includes a proximal end204and distal end206. The lumen208can extend from proximal end204to distal end206through body202. The proximal end204can include the opening210to provide access to the lumen208. The distal end206does, in the illustrated embodiment, does not include a through-flow lumen and can. Alternatively, body202is not be elongate, and can have a non-elongate shape.

In the embodiment shown inFIG. 2, the connecting portion212can be connected to the body202at the proximal end204. The connecting portion212cancan cooperatively connect to a connecting portion of a dispenser (described elsewhere herein). In an embodiment, the connecting portion212on medical device200can include a magnetic material or a material that can be selectively magnetized (e.g., prior to or during one of the following: coupling of the medical device and the dispenser, placement of the medical device in the sinus cavity, delivery of a substance, and the like). Alternatively, other types of connections, such as frictional, mechanical couplers can be included with the medical device200. Still further, the connecting portion212can be integral with the body.

In an embodiment, the retention portion216can be configured (e.g., shape, size, material properties) to retain the medical device200in the body cavity. ReferencingFIG. 2, the retention portion216can be curled distally. In such embodiments, stern214forms a portion of the body202extending from the proximal end204to the retention portion216. Curled retention portion216can extend from the stem214to the distal end206. The curled retention portion216can include portion(s) of the medical device200.

The body202of the medical device200can include a flexible, durable material. The body202of the medical device200can include a polymer material, for example polyurethane. Alternatively, the body202of the medical device200can include any suitable biocompatible material. In some aspects, the body202can include a shape memory material that can be pre-formed into a suitable shape to facilitate retention of the medical device200in the body cavity. In embodiments in which the body202includes a shape memory material, the body202can initially be in a shape suitable for insertion (e.g., elongate), and can return to a shape suitable for retention (e.g., curved with a preformed curve shape) after placement of the medical device200in the body cavity. In such embodiments, the body202can be elongate after a force can be applied or after guided by a guidewire during insertion. After the force or guidewire can be removed, the body202can revert to its preformed shape.

The retention portion216of medical device200, as illustrated inFIG. 2, includes the pores218. A fluid (e.g., a, cleansing, flushing, or other purpose fluid) can be inserted into the lumen208of the medical device200with a dispenser that can be coupled to medical device200at connecting portion212. The fluid can move through the lumen208from the proximal end204to the distal end206and can move out of the pores218into the sinus cavity. Any number of the pores218can be included on the retention portion216. The pores218can have any suitable shape and size, and the pores218can he distributed across the retention portion216in any suitable manner.

One or more fluids can be delivered to the medical device200. The fluid(s) can include a liquid or a gas. The fluid can include any suitable fluid. For example, the fluid can include saline or air, such as for flushing mucus out of the sinus cavity, for aerating the sinus cavity, for cleansing the sinus cavity, for treating inflammation, and/or for lubricating dry sinus passages, or other cavity in which the medical device200can be inserted. The fluid can also be any suitable carrier medium, for example saline, air, or a cooling gas (such as nitrous oxide for mild sedation during treatment). The carrier medium can carry one or more beads, particles, disperse fibers, or suspensions, among others. The particles can include a pharmaceutical compound or can be radio-opaque or fluoresce under UV to aid visualization in addition to having properties. The pharmaceutical compound can include, for example, steroid (mometasone furoate) anti-microbial drugs, anti-inflammatories, or the like. The carrier medium can transport the particles into the sinus cavity for visualization and/or treatment. Further, the fluid can include pledget spheres, for example a gelatin foam coated with a drug or a radiopaque marker.

The pores218on retention portion216of the medical device200can be configured to release the fluid at a predetermined rate. For example, the pores218can be configured to elute the fluid into the sinus cavity over the course of about one to about ten days to treat the sinus cavity over that period of time.

FIG. 3Acan be a schematic view of the medical device200positioned in the sinus cavity234.FIG. 3Bcan be a schematic view of the medical device200positioned in the sinus cavity234with a delivery system coupled to the medical device200. The medical device200, as illustrated, includes the body202, the proximal end204, the distal end206, the lumen208, the opening210, the connecting portion212, the stem214, the retention portion216, and the pores218.FIGS. 3A-39also show nostril230, nasal cavity232, sinus cavity234, and sinus ostium236.FIG. 3Balso shows dispenser240, delivery member242, and connecting portion244.

The medical device200can have the structure and configure as discussed above in reference toFIG. 2.FIGS. 3A-3Bfurther show the nostril230, the nasal cavity232, the sinus cavity234, and the sinus ostium236. The nostril230can be an opening that leads to the nasal cavity232. The sinus cavity234can be connected to the nasal cavity232through the sinus ostium236. The sinus ostium236can be a passage connecting nasal cavity232to sinus cavity234.

The retention portion216of the medical device200can be positioned in the sinus cavity234and can be configured to retain the medical device200in the sinus cavity234. The retention portion216can be illustrated as having a curled shape in the embodiment shown inFIG. 2, but can have any shape and size that retains the medical device200in the sinus cavity234. The stem214can extend away from the sinus cavity234, through the sinus ostium236, and into the nasal cavity238. The connecting portion212of the medical device200can be positioned in the nasal cavity232.

FIG. 3Bshows the dispenser240. The dispense can be positioned outside of the nostril230. The dispenser240can be shown as being a syringe inFIG. 3B, but can be a gas cylinder, squeeze pump, hand-held dispenser with or without triggers, buttons or other actuators, or any other suitable dispenser in alternate embodiments. The delivery member242can be connected to the dispenser240. The delivery member242can be integrally formed with the dispenser240or can be a separate piece that can be attached to the dispenser240. The delivery member242and dispenser240can form a delivery system for delivering a medium (e.g., a fluid) to the medical device200.

The delivery member242can include the connecting portion244positioned at a distal end. The Delivery member242can be configured to extend through the nostril230and into the nasal cavity232, such as to couple with the medical device200. In an embodiment, the connecting portion244on the delivery member242can be configured to magnetically couple with the connecting portion212on the medical device200.

The connecting portion212on the medical device200can include a magnetic material or a magnetized material. The connecting portion244on the delivery member242can include a magnetic material or a magnetized material. If the connecting portion212on the medical device200includes a magnetic material, the connecting portion244on the delivery member242can include a magnetized material, such as to magnetically couple the connecting portion212and the connecting portion244. Vice versa, if the connecting portion244on the delivery member242includes a magnetic material, the connecting portion212on medical device200can include a magnetized material to magnetically couple the connecting portion212and the connecting portion244. One or more of the connecting portion212on the medical device200and the connecting portion244on the delivery member242can include a magnetized material. The connecting portion244and the connecting portion212can be decoupled by pulling them apart with a simple hand pull or separating them with a physical component. in an embodiment, the magnetic coupling of the connecting portion212and the connecting portion244can be strong enough to hold the connecting portion212and the connecting portion244, and thus the medical device200and the delivery member242, together as a fluid can be delivered to medical device200, but weak enough to allow the connecting portion212and the connecting portion244, and thus the medical device200and the delivery member242, to be separated with a hand pull or a physical component without pulling the medical device200out of the sinus cavity234.

The dispenser240can couple to the medical device200, such as to deliver a fluid in the dispenser240to the medical device200through the delivery member242. The connecting portion212on the medical device200and the connecting portion244on the delivery member242can provide for a releasable coupling of the medical device200and the dispenser240. The medical device200can be reloaded with a fluid as often as needed. To reload the medical device200, the connecting portion244on the delivery member242can be coupled with the connecting portion212on the medical device200. A fluid can then be dispensed from the dispenser240. The fluid can flow through the delivery member242into the medical device200. The connecting portion244on the delivery member242can then be decoupled from the connecting portion212on the medical device200and the delivery member242can be removed from the nasal cavity232.

The medical device200can provide a reloadable and reconnectable mechanism for delivering a fluid to the sinus cavity232. The medical device200can be accessed via a natural orifice, such as the nostril230, to be reloaded. After the medical device200has been positioned in the sinus cavity232, the dispenser240can be coupled to the medical device200to refill the medical device200(as often as needed).

FIG. 4can be a flow chart showing an example of a method of inserting the medical device200in the sinus cavity234.FIG. 5Acan be a perspective view of the delivery device280according to an embodiment. FIG. SB can be a schematic view of the delivery device280being positioned in the nasal cavity232. FIG. SC can be a schematic view of a guide wire284of the delivery device280being inserted into the sinus cavity234.FIG. 5Dcan be a schematic view of the medical device200being inserted into the sinus cavity234.FIG. 5Ecan be a schematic view of the guide wire284being removed from the sinus cavity234.FIG. 5Fcan be a schematic view of the delivery device280being removed from the nasal cavity232.FIG. 5Gcan be a schematic view of a delivery system coupled to the medical device200.FIGS. 4-5Gcan be discussed together.FIG. 4includes operations250-274. The medical device200, as illustrated, includes the connecting portion212, the stem214, the retention portion216, and the pores218. The dispenser240, as illustrated, includes the delivery member242and the connecting portion244. The delivery device280, as illustrated, includes the drug reservoir282, the guide wire284, the sheath288, and a sensor290(e.g., a complementary metal oxide semiconductor (CMOS) or another sensor).

Some of the operations ofFIG. 4are optional. Operation250can include visualizing the sinus234. An endoscope can be inserted in the nostril230to visualize the nasal cavity232, the sinus cavity234, and/or the sinus ostium236, or other structure around the medical device200. Alternatively, the sinus cavity234can be visualized externally using any suitable device.

Operation252can include cleansing the sinus cavity234. The sinus cavity234can be cleansed by flushing a cleansing agent (e.g., saline or air) into the sinus cavity234. In an embodiment, the cleansing can be performed by delivering the cleansing agent via a working channel of an endoscope. Additionally, or alternatively, any suitable cleaning device can be used. to flush the cleansing agent into the sinus cavity234. A lumen of the cleaning device can be inserted into the sinus cavity234and a cleansing agent can be applied to the sinus cavity234through the lumen. The cleansing agent can include a saline liquid or a gas that flows across the walls of the sinus cavity234to cleanse the sinus cavity234. The cleansing agent can flow out of the sinus cavity234, through the nasal cavity232, and into a throat or out of a nose. Alternatively, a drain tube can be positioned around the lumen and the cleansing agent can flow out of sinus cavity234through the drain tube.

Operations250and252can be completed prior to inserting the medical device200into the sinus cavity234. The operations250and252can be repeated (e.g., as needed for cleaning of the sinus cavity234).

Operation254can include deploying a distal end of the delivery device280into the nasal cavity232. In the embodiment shown inFIG. 5A, the delivery device280includes a drug reservoir282. In an embodiment, the delivery device280does not include the drug reservoir282. Further, in the embodiment shown inFIG. 5A, a nozzle extending from the drug reservoir282can be centered on the drug reservoir282. In other embodiments, the nozzle can be offset from the center of the drug reservoir282, can be angled with respect to the drug reservoir282, and/or can be on an outside wall of the drug reservoir282, such as for sensor attachment and manipulation during use. The guide wire284can extend from the delivery device280. The medical device200can be positioned over the guide wire284. The medical device200can be held sufficiently elongated for insertion by the guide wire284. In the embodiment shown inFIG. 5A, the delivery device280further includes a sheath288. The embodiment inFIG. 5Afurther includes a sensor290at a distal end of sheath288. In an alternate embodiment, the delivery device280does not include the sheath288or the sensor290. The sheath288can extend adjacent to the guide wire284to allow the sensor290to be more easily manipulated during use. The sensor290can be used to visualize the nasal cavity232, the sinus cavity234, and/or the sinus ostium236, or other structure around the medical device200.

Operation256can include positioning the distal end of the delivery device280near the sinus ostium236, as shown inFIG. 5B. The sensor290can be used to help position the distal end of the delivery device280near sinus the ostium236. Alternatively, external visualization (e.g., using an endoscope) can be used to help position the distal end of the delivery device280near the sinus ostium236.

Operation258can include advancing the guide wire284of the delivery device280through the sinus ostium236and into the sinus cavity234, as shown inFIG. 5C. The wire284can be configured to pass through the sinus ostium236even if the sinus ostium236can be inflamed or blocked.

Operation260can include advancing the medical device200over the guide wire284into the sinus cavity234, as shown inFIG. 5D. The medical device200can be advanced into the sinus cavity234over the guide wire284using the delivery device280. In embodiments, the cross-section of the medical device200can be sufficiently small to permit insertion through the sinus ostium236and into the sinus cavity234, even in instances after the sinus ostium236can be at least partially blocked. Accordingly, the insertion procedure of the medical device200does not involve dilation of the sinus ostium236, thereby reducing the chances of a patient experiencing pain during insertion.

Operation262can include removing the guide wire284from the sinus cavity234, as shown inFIG. 5E. After the guide wire284can be removed from the sinus cavity234, the medical device200cancan remain in the sinus cavity234. The medical device200can he configured to be retained in the cavity upon removal of the guide wire284. As described previously, various embodiments of the medical device200can include suitable materials (e.g., with shape memory alloys, or made of polymer, or another resilient material) and optionally formed with a preformed shape (e.g., curved, enlarged, etc.) upon removal of the guide wire284. In the embodiment shown inFIG. 5E, the medical device200includes the retention portion216that cancan take its curled shape after the guide wire284can be removed, however, other alternatives are contemplated and described further below. After the guide wire284can be removed, the medical device200cancan be retained in the sinus cavity234.

Operation264can include removing the delivery device280from the nasal cavity232, as shown inFIG. 5F. After the delivery device280can be removed from the nasal cavity232, the medical device200can decouple from delivery device280. After the medical device200decouples from delivery device200, the retention portion216of medical device200can remain positioned in the sinus cavity234, and the stem214of the medical device200can extend from the sinus cavity234, through the sinus ostium236, and into the nasal cavity232.

In one embodiment, medical device200can be preloaded with a fluid after it can be inserted into sinus cavity234. In a second embodiment, drug reservoir282of delivery device280can be used to dispense a fluid into medical device200prior to removing guide wire284and delivery device280from sinus cavity234and nasal cavity232. In a third embodiment, delivery device280can be removed from sinus cavity234and nasal cavity232and dispenser240can be coupled to medical device200to deliver a fluid to medical device200.

In some embodiments, operations266-272discussed below can be completed after (e.g., immediately after) insertion of the medical device200into the sinus cavity234, such as to deliver a fluid to the medical device200. Alternatively, operations266-272can be completed a period of time after the medical device200has been inserted into sinus cavity234. Such embodiments can first aerate the sinus cavity234and, if it can be determined that a compound. (e.g., saline, anti-inflammatory substance, etc.) can have to be delivered upon aeration, operations266-272can be completed after a period of time has passed following the placement of medical device200. In other embodiments, operations266-272can be completed after placement of the medical device200to reload the medical device200with a fluid, such as to treat chronic conditions. Operations266-272can be repeated any number of times, (as needed) such as to deliver a fluid to sinus cavity234.

Operation266can include coupling the dispenser240to the medical device200, as shown inFIG. 5G. The dispenser240can include the delivery member242with the connecting portion244on a distal end of the delivery member242. The delivery member242can be passed through the nostril230and into the nasal cavity232towards the medical device200. The connecting portion244on the delivery member242can be magnetically coupled to the connecting portion212of the medical device200, such as to couple the dispenser240to the medical device200.

Operation268can include delivering a fluid to the medical device200using the dispenser240. The dispenser240is shown as being a syringe inFIG. 5G, bu5G but any suitable dispenser in alternate embodiments. The fluid can be a cleansing agent used to cleanse the sinus cavity234, including a saline or gas. The fluid can also be a therapeutic fluid, for example a therapeutic fluid including a therapeutic drug.

Operation270can include delivering the fluid in the medical device200to the sinus cavity234. As discussed above in reference toFIG. 2, the medical device200can include the pores218through which the fluid can move to enter the sinus cavity234. The medical device200can include any suitable number of the pores218. The pores218can have any shape and size, and the pores218can positioned in any manner on the medical device200.

Operation272can include decoupling the dispenser240from the medical device200. The dispenser240can be decoupled from the medical device200by decoupling the connecting portion244of the delivery member242from the connecting portion212of the medical device200. The connecting portion244and the connecting portion212can be decoupled by pulling them apart with a simple hand pull or separating them with a physical component.

Operation274can include applying an external field or a light source to the fluid. Operation274can be completed in conjunction with operation270while the fluid can be dispensed into the medical device200from the dispenser240, or operation274can be completed. after operation272after the dispenser240has been decoupled from the medical device200. Operation274can include, for example, applying a magnetic field to the fluid as it can be delivered to medical device200to magnetize the fluid. Operation274can also include, for example, applying a UV light source to the fluid.

The medical device200can be removed from the sinus cavity234. To remove the medical device200from the sinus cavity234, a removal device with a connecting portion can he inserted into the nasal cavity232. The removal device can couple to the connecting portion212on the medical device200. For example, if the connecting portion212on the medical device200can be magnetic, the connecting portion on the removal device can be magnetic to couple to the connecting portion212on the medical device200. The strength of the magnetic coupling can be strong enough to cause the medical device200to pull through the sinus ostium236, the nasal cavity232, and out of the nostril230. Alternatively, a removal device with a wire could be inserted into the sinus cavity234to pull the medical device200out with the wire.

In embodiments, a patient interface can be provided, via software, such as for monitoring and tracking of symptoms prior to or after placement of the medical device200. The patient can download a patient interface software, such as an app, to a mobile device that allows the patient and a medical provider to communicate. For example, a patient can log his/her symptoms in the app, such as pain level, inflammation, drainage, etc. Further, the app can prompt the patient to enter his/her symptoms. The interface can also prompt (either based on the recorded symptoms, predetermined visit schedule, or upon determination by a medical provider) the patient to visit in person with a medical provider. The medical provider can also ask questions to the patient through the app to follow up on the patient's symptoms and care.

Operations250-274discussed above are merely examples. Additional operations can be included, some operations can be excluded, and operations can be performed in different sequences. Further, the process for inserting the medical device200into each of the different paranasal sinuses can vary due to the placement of each of the paranasal sinuses.

The following discloses various embodiments of the medical device200, the dispenser240, and the delivery member242. The following embodiments of the medical device200can be implanted and loaded with a fluid using the process described above. Further, any combinations of the medical devices, dispensers, and delivery members can be used. Further yet, the following discloses external fields that can be applied to any of the medical devices, dispensers, or delivery members.

Next, embodiments of medical devices are discussed. The medical devices can be used alternatively or in combination with embodiments ofFIGS. 1-5G.

FIG. 6can be a front view of a medical device300with a retention portion316. The medical device300includes a body302, a proximal end304, a distal end306, a lumen308, an opening310, a connecting portion312, a stem314, a retention portion316, and pores318.

The medical device300includes the body302having the proximal end304and the distal end306. The lumen308can extend from the proximal end304to the distal end306through the body302. The proximal end304can include the opening310. The opening310can provide access to the lumen308. The distal end306, in some embodiments, does not include an opening that provides a through-flow for the lumen308. The connecting portion312can be connected to the body302at the proximal end304. The connecting portion312can be configured to connect to a connecting portion of a dispenser, such as to couple the medical device300to the dispenser, as discussed above in reference toFIGS. 2-5G. The stem314can form a portion of the body302extending from the proximal end304to the retention portion316. The retention portion316can extend from the stem314to the distal end306. The retention portion316can include portion(s) of the medical device300. The retention portion316can be a widened portion in the embodiment shown inFIG. 6. The retention portion316can increase in cross-sectional area after placement in the cavity, such as to facilitate ease of insertion and retention of medical device300. The increased cross-section of medical device300can be larger than the opening(s) in the sinus ostium.

After the medical device300can be positioned in a sinus cavity, the retention portion316can be positioned in the sinus cavity and the stem314can extend from the sinus cavity, through the sinus ostium, and into the nasal cavity. The retention portion316can be sized larger than the sinus ostium, such as to retain the medical device300in the sinus cavity. After a dispenser that has been magnetically coupled to medical device300(e.g., at the connecting portion312) can be decoupled from medical device300, the retention portion316can help retain the medical device300in the sinus cavity. Prior to placement of the medical device300, the medical device300can have a cross-sectional area less than an opening size of a sinus ostium (e.g., with or without inflammation or blockage). Upon insertion into the sinus cavity (e.g., after removal of guide wire284as described above in reference toFIGS. 5A-5G), one or more portions of the medical device300can become larger than the opening size of the sinus ostium for retention of the medical device300in the sinus cavity. With reference toFIG. 6, the retention portion316can enlarge (e.g., become wider and/or thicker), such that the cross-section at the distal end306can be greater than the opening size of the sinus ostium. In some such embodiments, the cross-section at the distal end306can be greater than the cross-section at the proximal end304.

The retention portion316of the medical device300can include the pores318. A fluid can be delivered into the lumen308of the medical device300with a dispenser that can be coupled to the medical device300. The fluid can move through the lumen308from the proximal end304toward the distal end306and can elute via the pores318into the sinus cavity. The pores318can also aerate the sinus cavity after no fluid can be delivered to the medical device300. Any number of the pores318can be included on the retention portion316. The pores318can have any suitable shape and size, and the pores318can be distributed across the retention portion316in any suitable manner.

The medical device300can be an alternate embodiment of the medical device200discussed above in reference toFIGS. 2-5G. The medical device300can be inserted into a sinus cavity using a similar process to the process discussed above in reference toFIGS. 4-5G. Further, any suitable dispenser can be coupled to the medical device300, and any suitable fluid can be delivered to the medical device300.

FIG. 7can be a perspective view of medical device350with retention portion366. The medical device350includes a body352, a proximal end354, a distal end356, a lumen358, an opening360, a connecting portion362, a stem364, the retention portion366, and pores368.

The medical device350includes the body352having the proximal end354and. the distal end356. The lumen358can extend from the proximal end354to the distal end356through the body352. The proximal end354can include the opening360to provide access to the lumen358. The distal end356, in some embodiments, does not include an opening that provides a through-flow for the lumen358. The connecting portion362can be connected to the body352at the proximal end354. The connecting portion362can be configured to connect to a connecting portion of a dispenser, such as to couple the medical device350to the dispenser, as discussed above in reference toFIGS. 2-5G. The stem364can form a portion of the body352extending from the proximal end354to the retention portion366. The retention portion366can extend from the stem364to the distal end356. The retention portion366can be a portion of the medical device350.

The retention portion366can be wave-shaped in the embodiment shown inFIG. 7. The wave-shape includes a series of peaks and valleys. The retention portion366can have the same or similar cross-sectional area as a cross-sectional area of the stem364. The retention portion366can be oriented at an angle to the proximal end354, such as to retain the medical device350in the sinus cavity. After the medical device350can be positioned in a sinus cavity, the retention portion366can be positioned in the sinus cavity and the stem364can extend from the sinus cavity, through the sinus ostium, and into the nasal cavity. The retention portion366can he shaped to retain the medical device350in the sinus cavity. After a dispenser that has been magnetically coupled to the medical device350at the connecting portion362can be decoupled from the medical device350, the retention portion366can help retain the medical device350in the sinus cavity. The retention portion366can be shown as having three peaks and two valleys in the embodiment shown inFIG. 7but can include any number of peaks and valleys in alternate embodiments. The retention portion366can include a shape memory material, such as a polymer, that can be elongated while it can be being inserted into the sinus cavity and then resume its shape in the sinus cavity.

The retention portion366of the medical device350can include pores368. In the embodiment shown inFIG. 7, the pores368can be positioned adjacent to the distal end356and on the two valleys. A fluid can be inserted into the lumen358of the medical device350with a dispenser that can be coupled to the medical device350. The fluid can move through the lumen358from the proximal end354to the distal end356and can move out of the pores368into the sinus cavity. The pores368are positioned so that gravity can pull the fluid out of the pores368. The pores368can aerate the sinus cavity after no fluid can be delivered to the medical device350. Any number of pores368can be included on the retention portion366. The pores368can have any suitable shape and size. The pores368can be distributed across the retention portion366in any suitable manner.

The medical device350can be an alternate embodiment of the medical device200discussed above in reference toFIGS. 2-5G. The medical device350can be inserted into a sinus cavity using a similar process to the process discussed above in reference toFIGS. 4-5G. Further, any suitable dispenser can be coupled to the medical device350, and any suitable fluid can be delivered to the medical device350.

FIG. 8can be a perspective view of a medical device400with a retention portion516. The medical device400, as illustrated, includes a body402, a proximal end404, a distal end406, a lumen408, an opening410, a connecting portion412, a stem414, the retention portion516, and pores418.

The medical device400includes the body402having the proximal end404and the distal end406. The lumen408can extend from the proximal end404to the distal end406through the body402. The proximal end404can include the opening410, such as to provide access to the lumen408. The distal end406, in some embodiments, does not include an opening that provides a through-flow for the lumen408. The connecting portion412can be connected to the body402at the proximal end404. The connecting portion412can be configured to connect to a connecting portion of a dispenser, such as to couple the medical device400to the dispenser, as discussed above in reference toFIGS. 2-5G. The stem414can form a portion of the body402, The stem414can extend from the proximal end404to the retention portion516. The retention portion516can extend from the stem414to the distal end406. The retention portion516can be a portion of medical device400.

The retention portion516has a coiled shape in the embodiment shown inFIG. 8. The coiled shape can be a spiral shape or a series of circles inside of one another and progressively getting smaller. After the medical device400is positioned in a sinus cavity, retention portion516can be positioned in the sinus cavity and the stem414can extend from the sinus cavity, through the sinus ostium, and into the nasal cavity. The retention portion516can be shaped to retain the medical device400in the sinus cavity. After a dispenser that has been magnetically coupled to medical device400at connecting portion412is decoupled from the medical device400, the retention portion516can help retain the medical device400in the sinus cavity. The retention portion516is shown as being in a single plane in the embodiment shown inFIG. 8. In alternative embodiments, retention portion516can be shaped similarly to a spring. The retention portion516can include a shape memory material, such as a polymer, that can be held elongated while being inserted into the sinus cavity and then resume its shape in the sinus cavity.

The retention portion516of the medical device400can include the pores418. A fluid can be inserted into the lumen408of the medical device400with a dispenser that can be coupled to the medical device400. The fluid can move through the lumen408from the proximal end404to the distal end406and can move out of the pores418into the sinus cavity. The pores408can also aerate the sinus cavity after no fluid can be delivered to the medical device400. Any number of the pores418can be included on enlarged portion416. The pores418can have any suitable shape and size. The pores418can be distributed across the enlarged portion416in any suitable manner.

The retention portion516can contact walls of the sinus cavity after being positioned in the sinus cavity. A fluid can be absorbed directly into the walls of the sinus cavity through the pores418, such as to directly treat the walls of the sinus cavity or the mucus membrane on the walls of the sinus cavity.

The medical device400can be an alternate embodiment of the medical device200discussed above in reference toFIGS. 2-5G. The medical device400can be inserted into a sinus cavity using a similar process to the process discussed above in reference toFIGS. 4-5G. Further, any suitable dispenser can be coupled to the medical device400, and any suitable fluid can be delivered to the medical device400.

FIG. 9Ais a perspective view of the medical device450including the retention portion466.FIG. 9Bis a perspective view of the medical device400showing the retention portion466with an enlarged shape. The medical device450can include a body452, a proximal end454, a distal end456, a lumen458, an opening460, a connecting portion462, a stem464, the retention portion466, and pores468.

The medical device450can include the body452. The body452can include the proximal end454and the distal end456. The lumen458can extend from the proximal end454to the distal end456through the body452. The proximal end454can include the opening460, such as to provide access to the lumen458. The distal end456, in some embodiments, does not include an opening that provides a through-flow for the lumen458. The connecting portion462can be connected to the body452at the proximal end454. The connecting portion462can be configured to connect to a connecting portion of a dispenser, such as to couple the medical device450to the dispenser, as discussed above in reference toFIGS. 2-5G. The stem464can form a portion of the body452extending from the proximal end454to the retention portion466. The retention portion466can extends from the stem464to the distal end456. The retention portion466can include a portion of the medical device450.

The retention portion466includes a weeping balloon in the embodiment shown inFIGS. 9A-9B. The weeping balloon can move between an original shape, as shown inFIG. 9A, and an enlarged shape, as shown inFIG. 9B. The retention portion466, including the weeping balloon, of the medical device450can include pores468. A fluid can be delivered to the medical device450through a dispenser that can be coupled to the medical device450at the connecting portion462. The fluid can cause the retention portion466(e.g., the weeping balloon) to enlarge from its original shape, shown inFIG. 9A, to its enlarged shape, shown inFIG. 9B. After the retention portion466(e.g., the weeping balloon) can be enlarged, it can hold medical device450in position in the sinus cavity. The fluid can weep out of pores468into the sinus cavity. The pores468can be configured to allow the fluid to weep out over time. The pores468can aerate the sinus cavity after no fluid is being delivered to the medical device450. Any number of pores468can be included on the retention portion466. The pores468can have any suitable shape and size. The pores568can be distributed across the retention portion466in any suitable manner that allows the fluid to weep out of the retention portion466. As the fluid weeps out of the pores468, the retention portion466can deflate to its original position. The medical device450can be configured such that after the retention portion466(e.g., the weeping balloon) deflates to its original position, it can fall out of the sinus cavity.

The medical device450can be an alternate embodiment of the medical device200discussed above in reference toFIGS. 2-5G. The medical device450can be inserted into a sinus cavity using a similar process to the process discussed above in reference toFIGS. 4-5G. Further, any suitable dispenser can be coupled to the medical device450, and any suitable fluid can be delivered to the medical device450.

FIG. 10is a perspective view of a medical device500with a hydrophilic coating520on a retention portion516. The medical device500as illustrated includes a body502, a proximal end504, a distal end506, a lumen508, an opening510, a connecting portion512, a stem514, the retention portion516, pores518, and the hydrophilic coating520.

The medical device500as illustrated includes the body502having the proximal end504and the distal end506. The lumen508can extend from the proximal end504to the distal end506through the body502. The proximal end504can include the opening510. The opening510can provide access to the lumen508. The distal end506, in some embodiments, does not include an opening that provides a through-flow for the lumen508. The connecting portion512can be connected to the body502at the proximal end504. The connecting portion512can be configured to connect to a connecting portion of a dispenser to couple the medical device500to the dispenser, as discussed above in reference toFIGS. 2-5G. The stem514can form a portion of the body502extending from the proximal end504to the retention portion516. The retention portion516can extend from the stem514to the distal end506. The retention portion516can include a therapeutic portion of medical device500.

The retention portion516is shown as being substantially cylindrical in the embodiment shown inFIG. 10, but it can have any suitable shape in alternate embodiments. The retention portion516can help retain the medical device500in the sinus cavity. The retention portion516of the medical device500include pores518. The medical device500as illustrated further includes the hydrophilic coating520positioned on the retention portion516. The pores518can extend through the hydrophilic coating520. After a fluid is delivered to the medical device500, the fluid can flow through the pores518and be absorbed by the hydrophilic coating520. The hydrophilic coating520can swell with the fluid. Hydrophilic coating520and fluid can be designed so that the hydrophilic coating520elutes the fluid at a predetermined rate. This can allow an agent suspended in the fluid to be administered to the sinus cavity over a period of time. The pores518can aerate the sinus cavity after fluid is eluted from the medical device500. Any number of pores518can be included on the retention portion516. The pores518can have any suitable shape and size. The pores518can be distributed across the retention portion516in any suitable manner.

The medical device500can be an alternate embodiment of the medical device200discussed above in reference toFIGS. 2-5G. The medical device500can be inserted into a sinus cavity using a similar process to the process discussed above in reference toFIGS. 4-5G. Further, any suitable dispenser can be coupled to the medical device500, and any suitable fluid can be delivered to the medical device500.

FIG. 11is a perspective view of a medical device550with a hydrophobic coating572and a hydrophilic coating570on a retention portion566. The medical device550as illustrated includes a body552, a proximal end554, a distal end556, a lumen558, an opening560, a connecting portion562, a stern564, the retention portion566, pores568, the hydrophilic coating570, and the hydrophobic coating572.

The medical device550includes the body552having the proximal end554and the distal end556. The lumen558extends from the proximal end554to the distal end556through the body552. The proximal end554includes the opening560, such as to provide access to the lumen558. The distal end556does not include an opening that provides a through-flow for the lumen558. The connecting portion562can be connected to the body552at the proximal end554. The connecting portion562can be configured to connect to a connecting portion of a dispenser to couple the medical device550to the dispenser, as discussed above in reference toFIGS. 2-5G. The stem564can form a portion of the body552. The stem564can extend from the proximal end554to the retention portion566. The retention portion566can extend from the stem564to the distal end556. The retention portion566can include a therapeutic portion of medical device550.

The retention portion566is shown as being substantially cylindrical in the embodiment ofFIG. 11, but it can have any suitable shape in alternate embodiments. The retention portion566can help retain the medical device550in the sinus cavity. The retention portion566of the medical device550can include the pores568. The medical device550can further include the hydrophilic coating570positioned on the retention portion566. The hydrophobic coating572can be positioned on the hydrophilic coating570. The pores568can extend through the hydrophilic coating570and the hydrophobic coating572. After a fluid is delivered to medical device550, the fluid can flow through the pores568and be absorbed by hydrophilic coating570. The hydrophilic coating570can swell with the fluid. The hydrophilic coating570and the fluid can be designed so that hydrophilic coating520elutes the fluid at a predetermined rate. This allows a therapeutic agent suspended in the fluid to be administered to the sinus cavity over a period of time. The hydrophobic coating574can be positioned over hydrophilic coating572to prevent hydrophilic coating572from absorbing fluids in the sinus cavity, such as the mucus in the sinus cavity. The pores568can aerate the sinus cavity fluid has been eluted by the medical device550. Any number of pores568can be included on the retention portion566. The pores568can have any suitable shape and size. The pores568can be distributed across retention portion566in any suitable manner.

The medical device550can be an alternate embodiment of the medical device200discussed above in reference toFIGS. 2-5G. The medical device550can be inserted into a sinus cavity using a similar process to the process discussed above in reference toFIGS. 4-5G. Further, any suitable dispenser can be coupled to the medical device550, and any suitable fluid can he delivered to the medical device550.

FIG. 12Ais a perspective view of medical device600including a biodegradable foam620on a retention portion616.FIG. 12Bis a perspective view of the medical device600showing the biodegradable foam620enlarged. The medical device600as illustrated includes a body602, a proximal end604, a distal end606, a lumen608, an opening610, a connecting portion612, a stem614, the retention portion616, pores618, and the biodegradable foam620.

The medical device600includes the body602having the proximal end604and the distal end606. The lumen608can extend from the proximal end604to the distal end606through the body602. The proximal end604as illustrated includes the opening610, such as to provide access to the lumen608. The distal end606, as illustrated, does not include an opening that provides a through-flow for the lumen608. The connecting portion612can be connected to the body602at the proximal end604. The connecting portion612can be configured to connect to a connecting portion of a dispenser, such as to couple medical device600to the dispenser, as discussed above in reference toFIGS. 2-5G. The stem614can form a portion of the body602that extends from the proximal end604to the retention portion616. The retention portion616can extend from the stem614to the distal end606. The retention portion616can include a therapeutic portion of medical device600.

The retention portion616is shown as being substantially cylindrical in the embodiment shown inFIG. 12A, but it can have any suitable shape in alternate embodiments. The retention portion616can help retain the medical device600in the sinus cavity. The retention portion616of the medical device600can include the pores618. The medical device600can include the biodegradable foam620positioned on the retention portion616. After a fluid is delivered to medical device600, the fluid can flow through the pores618and be absorbed by the biodegradable foam620. The biodegradable foam620can swell from its original state, shown inFIG. 12A, to its enlarged state, shown inFIG. 12B, as it absorbs the fluid. The biodegradable foam620can then elute the agent over a period of time. The pores618can also aerate the sinus cavity after fluid delivered to the medical device600. Any number of pores618can be included on the retention portion616. The pores618can have any suitable shape and size. The pores618can be distributed across the retention portion616in any suitable manner.

The medical device600can be an alternate embodiment of the medical device200discussed above in reference toFIGS. 2-5G. The medical device600can he inserted into a sinus cavity using a similar process to the process discussed above in reference toFIGS. 4-5G. Further, any suitable dispenser can be coupled to the medical device600, and any suitable fluid can be delivered to the medical device600.

FIG. 13is a perspective view of a medical device650including magnetic pores668. The medical device650as illustrated includes a body652, a proximal end654, a distal end656, a lumen658, an opening660, a connecting portion662, a stem664, a retention portion666, and magnetic pores668.

The medical device650includes the body652having the proximal end654and. the distal end656. The lumen658can extend from the proximal end654to the distal end656through the body652. The proximal end654can include the opening660to provide access to lumen658. The distal end656, in some embodiments, does not includes an opening that provides a through-flow for the lumen658. The connecting portion662can be connected to the body652at the proximal end654. The connecting portion662can be configured to connect to a connecting portion of a dispenser, such as to couple the medical device650to the dispenser, as discussed above in reference toFIGS. 2-5G. The stem664can form a portion of the body652. The stem664can extend from the proximal end654to the retention portion666. The retention portion666can extend from the stern664to the distal end656. The retention portion666can include a therapeutic portion of the medical device650.

After the medical device650is positioned in a sinus cavity, the retention portion666can be positioned in the sinus cavity and the stem664extends from the sinus cavity, through the sinus ostium, and into the nasal cavity. The retention portion666is shown as having a curled shape in the embodiment shown inFIG. 13but can have any suitable shape in alternate embodiments. The retention portion666can help retain the medical device650in the sinus cavity.

The retention portion666of the medical device650can include the magnetic pores668. The magnetic pores668can include openings extending through the retention portion666. The magnetic pores668can include a ring of magnetic material or magnetized material surrounding the opening. A fluid including magnetic spheres, which includes either a magnetic material or a magnetized material, can be inserted into the lumen658of the medical device650, such as with a dispenser that can be coupled to the medical device650. One or both of the magnetic pores668and/or magnetic spheres can include a magnetized material. The fluid can move through the lumen658from the proximal end654to the distal end656and can elute through the magnetic pores668into the sinus cavity. The magnetic spheres in the fluid can magnetically adhere to and hold in place on the magnetic pores668. The pores668can aerate the sinus cavity before or after fluid eluted through the medical device650. Any number of the magnetic pores668can be included on retention portion666. The magnetic pores668can have any suitable shape and size. The magnetic pores668can be distributed across the retention portion666in any suitable manner.

The medical device650can be an alternate embodiment of the medical device200discussed above in reference toFIGS. 2-5G. The medical device650can be inserted into a sinus cavity using a similar process to the process discussed above in reference toFIGS. 4-5G. Further, any suitable dispenser can be coupled to the medical device650, and any suitable fluid can be delivered to the medical device650.

FIG. 14Ais a schematic view of a medical device708positioned in a sinus cavity704.FIG. 14Bis a schematic view of a fluid being delivered to the medical device708.FIG. 14Cis a schematic view of the medical device708enlarged.FIGS. 14A-14Cshow a nostril700, a nasal cavity702, the sinus cavity704, a sinus ostium706, and the medical device708. The medical device708can include a connecting portion710.FIGS. 14A-14Bfurther show a dispenser720, a delivery member722, and a connecting portion724.

The nostril700is an opening that leads to nasal cavity702. The sinus cavity704is connected to the nasal cavity702through the sinus ostium706. The sinus ostium706is a narrow passage connecting nasal cavity702to sinus cavity704.1001431The medical device708can include a pledget that can be positioned in the sinus cavity704. A pledget can be a wad of absorbent material, such as a gelatin foam. The medical device708can include the connecting portion710. In a first embodiment, the medical device708can be preloaded with a drug and/or radiopaque marker prior to being positioned in the sinus cavity704. In an alternate embodiment, the medical device708can be positioned in the sinus cavity704and a fluid including a drug and/or radiopaque marker can be delivered to the medical device708. As shown inFIG. 14A, the medical device708can be positioned in the sinus cavity704prior to being loaded with a drug and/or radiopaque marker. The dispenser720, including the delivery member722, can be positioned through the nasal cavity702to the medical device708in the sinus cavity704. The delivery member722can include the connecting portion724that can magnetically couple to the connecting portion710on the medical device708. As shown inFIG. 14B, a fluid in the dispenser720can be delivered to the medical device708through the delivery member722. The medical device708can enlarge as it absorbs the fluid, as shown inFIG. 14C. After at least some of the fluid has been delivered to the medical device708, the delivery member722can be removed.

As the medical device708expands, it can conform to the wall of the sinus cavity704. The expanded medical device708can have a width that can be larger than the width of the sinus ostium706. The expanded medical device708can be held in position in the sinus cavity704. The medical device708can release the drug and/or radiopaque marker from the fluid at a predetermined rate based on the properties of the medical device708and the fluid.

The medical device708can be an alternate embodiment of the medical device200discussed above in reference toFIGS. 2-5G. The medical device708can be inserted into a sinus cavity using a similar process to the process discussed above in reference toFIGS. 4-5G. Further, any suitable dispenser can be coupled to the medical device708, and any suitable fluid can be delivered to the medical device708.

FIG. 15Ais a perspective view of a medical device750.FIG. 15Bis a schematic view of the medical device750positioned in an ethmoid sinus770. The medical device750as illustrated includes a body752, a proximal end754, a distal end756, a lumen758, an opening760, a connecting portion762, a tip764, and openings766.FIG. 15Balso shows the ethmoid sinus770.

The medical device750can include the body752having the proximal end754and the distal end756. The medical device750can include a metallic material or a polymer material. The body752can be substantially rigid. The medical device750can be bioabsorbable. The lumen758can extend through the body752from the proximal end754to the distal end756. The proximal end754can include the opening750, such as to provide access to the lumen758. The connecting portion762can be connected to the body752at the proximal end754. The connecting portion762can be configured to connect to a connecting portion of a dispenser, such as to couple medical device750to the dispenser, as discussed above in reference toFIGS. 2-5G. The distal end756can include the tip764. The tip764can include an atraumatic tip that can be used to push through tissue. The medical device750can include openings766extending through the body752to provide access to the lumen758.

The medical device750can be inserted into the ethmoid sinus770. The Ethmoid sinus770can be formed of air cells that are thin-walled cavities. The air cells of the ethmoid sinus770are formed of an air permeable membrane. After the ethmoid sinus770is infected, the air permeable membrane can clog. After the medical device750is inserted into the ethmoid sinus770, the tip774can puncture through the air permeable membrane of numerous air cells forming the ethmoid sinus770. Puncturing the air cells can help the air cells to drain. The openings766can help aerate the air cells. Further, a dispenser can then be coupled to the connecting portion762of the medical device750. A fluid from the dispenser can flow through the opening760into the lumen758and then out through the openings766into the air cells. The fluid can include air that optionally includes a drug.

The medical device750can be an alternate embodiment of the medical device200discussed above in reference toFIGS. 2-5G. The medical device750can be inserted into a sinus cavity using a similar process to the process discussed above in reference toFIGS. 4-5G. Further, any suitable dispenser can be coupled to the medical device750, and any suitable fluid can be delivered to the medical device750.

Next, embodiments of delivery members are discussed. The delivery members can be used alternatively or in combination with embodiments ofFIGS. 1-15.

FIG. 16is a schematic view of a delivery member802.FIG. 16shows a dispenser800and the delivery member802. The delivery member802includes a body804, a distal end806, a lumen808, and a connecting portion810.

In the embodiment shown inFIG. 16, the dispenser800and the delivery member802are integrally formed. The delivery member802can be configured to extend between the dispenser800and a medical device that can be positioned in a sinus cavity or other cavity. The medical device can include any of the medical devices200,300,350,400,450,500,550,600,650,708, or750discussed above in reference toFIGS. 2-15Bbut can be any other suitable medical device in alternate embodiments.

The delivery member802can include the body804extending from the dispenser800to the distal end806. The lumen808can be an opening that extends from the dispenser800to the distal end806. The delivery member802can include the connecting portion810at the distal end806that can be configured to magnetically couple to a medical device. A fluid can flow from the dispenser800, through the lumen808of the delivery member802, and into the medical device.

The dispenser800and the delivery member802can include a resilient, flexible material. For example, the dispenser800and the delivery member802can be formed out of silicone or a rubber material. The dispenser800can be squeezed to dispense a fluid from the dispenser800through the delivery member802and into a medical device. The delivery member802can enlarge (e.g., temporarily) during delivery of the fluid to the medical device. The enlarged delivery member802can be positioned outside of the nasal cavity or in the nasal cavity. The enlarged delivery member802can be configured to not dilate a sinus ostium, the nasal cavity, or surrounding structures. The delivery member802can be configured to enlarge to allow for pressure control of the fluid in the delivery member802and to allow for better distribution of particles for periodic pressurization and delivery.

FIG. 17Ais a schematic view of a delivery member850with outflow controls860in a closed position.FIG. 17Bis a schematic view of the delivery member850with the outflow controls860in an open position. The delivery member850includes a body852, a distal end854, a lumen856, a connecting portion858, and outflow controls860.FIG. 17Balso shows a pressure sensor870.

The delivery member850can be configured to extend between a dispenser and a medical device that can be positioned in a sinus cavity. The medical device can include any of the medical devices200,300,350,400,450,500,550,600,650,708, or750discussed above in reference toFIGS. 2-15B, but can be any other suitable medical devices in alternate embodiments.

The delivery member850can include the body852and can extend from a proximal end (not shown) to the distal end854. The lumen856is an opening that can extend from the proximal end to distal end854. The proximal end of delivery member850can be attached to a dispenser in any suitable manner. Alternatively, the delivery member850can be integrally formed with a dispenser. The delivery member850can include the connecting portion858at the distal end854. The connecting portion858can be configured to magnetically couple to a medical device. A fluid can flow from a dispenser, through the lumen856of the delivery member850, and into the medical device.

The outflow controls860can be positioned on the delivery member850. The outflow controls860are flaps in the embodiment shown inFIGS. 17A-17Bbut can be any suitable mechanism in alternate embodiments. After the delivery member850is positioned in a nasal cavity, the outflow controls860can remain outside of the nasal cavity. In an unpressurized state, outflow controls860can be flush with delivery member850, as shown inFIG. 17A. After the pressure in delivery member850rises above a threshold pressure level, the outflow controls860can move to an open position, as shown inFIG. 179. The outflow controls860can open above a threshold pressure level, such as to relieve the pressure in the delivery member850. The fluid in the delivery member850can leak out of the outflow controls860after outflow controls860are in an open position. The outflow can lower the pressure of the pressure in the delivery member850. After the pressure has lowered below the threshold pressure level, the outflow controls860can close.

As shown inFIG. 17B, the pressure sensor870can be connected to the delivery member850, such as to measure the pressure in the delivery member850. The pressure in the delivery member850can indicate the pressure in the nasal cavity in which the delivery member850can be positioned. The nasal cavity can be very sensitive, so monitoring the pressure level in the nasal cavity can help to eliminate pain and discomfort during the procedure.

Next, embodiments of fluid dispensers are discussed. The dispensers can be used alternatively or in combination with embodiments ofFIGS. 1-17B.

FIG. 18Ais a side view of a syringe900.FIG. 18Bis a perspective view of a gas cylinder950.FIG. 18Cis a side view of a squeeze bottle1000.FIG. 18Dis a cross-sectional view of a dispenser1050with a solenoid valve1060.FIG. 18Ashows the syringe900, which includes a body902, a cavity904, a plunger906, and a coupler908.FIG. 18Bshows the gas cylinder950, which includes a canister952, a nozzle954, and a coupler956, and a delivery member960.FIG. 18Cshows the squeeze bottle1000, which includes a bottle1002, a cap1004, and a delivery member1010.FIG. 18Dshows the hand-held dispenser1050having a body1052, a trigger1054, a reservoir1056, a delivery member1058, a solenoid valve1060, and a sensor1062.

The syringe900is shown inFIG. 18A. The syringe900can be any syringe known in the art. The syringe900can include the body902with the cavity904. The cavity904can be configured to receive (via another component) a fluid. The plunger906can be positioned in the cavity904. The coupler908can be positioned at a proximal end of the body902. The body can include an opening extending from the cavity904and through the body902. The coupler908can be configured to couple the syringe900to another device. For instance, the coupler908can be coupled to a delivery member, including any of the delivery members800or850discussed above in reference toFIGS. 16-17B, or to a medical device, including any of the medical devices200,300,350,400,450,500,550,600,650,708, or750discussed above in reference toFIGS. 2-15B. The plunger906can be configured to be pushed through the cavity904to push the fluid in the cavity904of out the syringe900through the opening at the coupler908.

The gas cylinder950is shown inFIG. 18B. The gas cylinder950can be any gas cylinder known in the art. The gas cylinder950can include the canister952. The canister can be configured to receive a gas. The nozzle954can be attached to the canister952and can include the coupler956. The coupler956can be coupled to the delivery member960. The delivery member960can be a rigid shaft. In alternative embodiments, the coupler956can be coupled to any delivery member, including any of the delivery members800or850discussed above in reference toFIGS. 16-17B, or to a medical device, including any of the medical devices200,300,350,400,450,500,550,600,650,708, or750discussed above in reference toFIGS. 2-15B. The nozzle954can be pressed downwards, such as to cause the gas in the canister952to flow through the nozzle954and the coupler952and out of the gas cylinder950. The gas in the gas cylinder950can be pressurized prior to being loaded into the gas cylinder950. Alternatively, the gas in the gas cylinder950can be pressurized with the nozzle954.

The squeeze bottle1000is shown inFIG. 18C. The squeeze bottle1000can be any squeeze bottle known in the art. The squeeze bottle1000includes the bottle1002that can be configured to receive a fluid. The cap1004can be attached to the bottle1002and can be coupled to the delivery member1010. The delivery member1010can be a rigid shaft. In alternative embodiments, the cap1004can be coupled to any delivery member, including any of the delivery members800or850discussed above in reference toFIGS. 16-17B, or to a medical device, including any of the medical devices200,300,350,400,450,500,550,600,650,708, or750discussed above in reference toFIGS. 2-15B. The bottle1002can be squeezed to push the fluid in the squeeze bottle900out of the squeeze bottle1000through the cap1004.

The hand-held dispenser1050is shown inFIG. 18D. The hand-held dispenser1050can be any hand-held dispenser known in the art. The hand-held dispenser1050as illustrated includes the body1052that can be grasped by a user. The trigger1054can be positioned on the body1052so that a user's finger can rest on the trigger1054after holding the hand-held dispenser1050. The reservoir1056can be positioned in the body1052and can be configured to hold a fluid. The delivery member1058has a proximal end that can be fluidly connected to the reservoir1056. The delivery member1058can have a distal end positioned outside of the body1052. The solenoid valve1060can he positioned in the delivery member1058. The solenoid valve1060can be electrically connected to the trigger1054. After a user presses trigger1054, the solenoid valve1060can open, such as to allow the fluid in the reservoir1056to flow through the delivery member1058and outside of the hand-held dispenser1050. After the trigger1054is released, the solenoid valve1060can block the delivery member1058, such as to prevent the fluid from flowing out of the hand-held dispenser1050. The solenoid valve1060can be any suitable actuator in alternate embodiments. The sensor1062can be positioned on the distal end of delivery member1058. The sensor1062can he positioned outside of the body1052. In alternate embodiments, the sensor1062can be positioned on the delivery member1058inside of the body1052. The sensor1062can be a pressure or flow sensor to measure the pressure or flow of the fluid in the delivery member1058.

The delivery member1058can be a rigid shaft. In alternate embodiments, the delivery member1058can have any suitable configuration, including any of the delivery members800or850discussed above in reference toFIGS. 16-17B. The distal end of the delivery member1058can optionally include a connecting portion to couple to a medical device, including any of the medical devices200,300,350,400,450,500,550,600,650,708, or750discussed above in reference toFIGS. 2-15B. Further, the distal end of the delivery member1058can be configured to connected to a second delivery member that can be configured to couple to a medical device.

The embodiments of the dispensers discussed above, including the syringe900, the gas cylinder950, the squeeze bottle1000, and the hand-held dispenser1050, are examples of dispensers and are not intended to be limiting. Any dispenser that can be capable of being coupled to a delivery member or a medical device can be suitable for use with any of medical devices200,300,350,400,450,500,550,600,650,708, or750discussed above in reference toFIGS. 2-15B.

Next, embodiments of external field systems are discussed. The external field systems can be used alternatively or in combination with embodiments ofFIGS. 1-18D.

FIG. 19Ais a schematic view of a gel liquid and/or a gel foam1100in a sinus cavity1104.FIG. 19Bis a schematic view of a scaffold1120in a sinus cavity1104.FIGS. 19A-19Bshow a nostril1100, a nasal cavity1102, a sinus cavity1104, a sinus ostium1106, and a force transducer1108.FIG. 19Afurther shows the gel liquid and/or the gel foam1110, a delivery member1112, and a dispenser1114.FIG. 19Bfurther shows the scaffold1120.

The nostril1100is an opening that leads to nasal cavity1102. The sinus cavity1104is connected to the nasal cavity1102through the sinus ostium1106. The sinus ostium1106is a passage connecting the nasal cavity1102to the sinus cavity1104.

FIGS. 19A-19Bshow an external manipulation system, including a force transducer1108positioned outside of and adjacent to the sinus cavity1104. The force transducer1108can be positioned on the skin external to the nostril1100. The force transducer1108can be an ultrasonic transducer, or other transducer. The gel liquid and/or the gel foam1110can be injected into the sinus cavity1104through the delivery member1112. The gel liquid and/or the gel foam1110can include, for example, an open cell foam. The gel liquid and/or the gel foam1110can he a non-Newtonian fluid that can undergo shear thickening or shear thinning upon application of a force. A distal end of the delivery member1112can be positioned in the sinus cavity1114. A proximal end of the delivery member1112can he connected to the dispenser1114. The dispenser1114can inject the gel liquid and/or the gel foam1110into the sinus cavity1104through the delivery member1102, as shown inFIG. 19A. After the gel liquid and/or the gel foam1110has been injected into the sinus cavity1104, the delivery member1112and the dispenser1114can be removed from the sinus cavity1104and the nasal cavity1102. The force transducer1108can be used to aid in the injection of the gel liquid and/or the gel foam1110into the sinus cavity1104, such as by applying an external force field to the gel liquid and/or the gel foam1110to liquefy the gel liquid and/or the gel foam1110for transportation.

Force transducer1108can then apply a force field to gel liquid and/or gel foam1110, which can undergo a transformation to scaffold1120. Scaffold1120can have a semi-solid or solid state. As the gel liquid and/or the gel foam1110undergoes the transformation to the scaffold1120, it can expand to fill the sinus cavity1104.

The gel liquid and/or the gel foam1110can include a drug suspended in it. The gel liquid and/or the gel foam1110can be injected in the sinus cavity1104. After it undergoes the transformation to the scaffold1120, it can start to elute the drug. Alternatively, a drug can be injected into the sinus cavity1104to be absorbed into the scaffold1120after the gel liquid and/or the gel foam1110has undergone the transformation.

The scaffold1120can contact one or more of the walls of the sinus cavity1104, such as to help relieve sinus pressure. The scaffold1120can have a consistency that is about the same as the consistency of cartilage. The scaffold1120can biodegrade at a predetermined rate. Alternatively, the scaffold1120can contract as the drug is eluted. The scaffold1120can eventually fall out of the nostril1100. The scaffold1120can be removed from the sinus cavity1104, such as by using a vacuum removal tool that can be positioned in the nasal cavity1102and/or the sinus cavity1104.

FIG. 20Ais a schematic view of a delivery member1150including particles1160.FIG. 20Bis a schematic view of the delivery member1150adjacent to an external magnet1170.FIG. 20Cis a schematic view of the delivery member1150with a magnetic wire1180extending through the delivery member1150. The delivery member1150as illustrated includes a body1152, a distal end1154, a lumen1156, and a connecting portion1158.FIGS. 20A-20Cfurther show the particles1160.FIG. 20Balso shows the external magnet1170.FIG. 20Calso shows the magnetic wire1180.

The delivery member1150can he configured to extend between a dispenser and a medical device that can be positioned in a sinus cavity. The medical device can include any of medical devices200,300,350,400,450,500,550,600,650,708, or750discussed above in reference toFIGS. 2-15Bbut can be any other suitable medical devices in alternate embodiments. The dispenser can include any dispenser, including the syringe900, the gas cylinder950, the squeeze bottle1000, or the hand-held dispenser1050discussed above in reference toFIGS. 18A-18D.

The delivery member1150includes the body1152. The body1152can extend from a proximal end (not shown) to the distal end1154. The lumen1156can be an opening that extends from the proximal end to the distal end1154. The proximal end of the delivery member1150can be attached to a dispenser in any suitable manner. Alternatively, the delivery member1150can be integrally formed with a dispenser. The delivery member1150can include the connecting portion1158at the distal end1154. The connecting portion can be configured to magnetically couple to a connecting portion on a medical device. A fluid can flow from a dispenser, through the lumen1156of the delivery member1150, and into the medical device.

The particles1160can be positioned in the delivery member1160. The particles1160can include a magnetic material. As shown inFIG. 20A, the particles1160can be irregular with no magnetic field can be being applied thereto. As shown inFIGS. 20B-20C, the particles1160can align after an external manipulation system applies a magnetic field.FIG. 20Bshows the external magnet1170positioned externally to delivery member1150and applying a magnetic field to the particles1160. The magnet1170can magnetize the particles1160.FIG. 20Cshows the magnetic wire1180extending through the lumen1156of the delivery member1150and applying a magnetic field to the particles1160, such as to magnetize the particles1160.

The particles1160can include a drug with magnetic material attached to the drug. Some drugs are difficult to inject due to the composition and/or state of the drug. After a magnetic material is attached to the drug, a magnetic field can be applied to the particles1160, as shown inFIGS. 20B-20C, such as to magnetize and align the particles1160. Alignment between the particles can make it easier to inject the drug. After the particles1160are injected into a cavity, the magnetic field can be removed. Then the particles1160can be resume an irregular state in the sinus cavity. The drug can be retained in the sinus cavity in its irregular state.

Alternatively, the particles1160can be magnetized particles1160after they are held in a dispenser or the delivery member1150. The particles1160can then be demagnetized prior to or after they are injected into the sinus cavity. For example, the particles1160can be magnetized particles that are attached to the magnetic wire1180. If the magnetic wire1180can be demagnetized, the particles1160can be released from the magnetic wire1180and can be injected into the sinus cavity. The magnetic wire1180can also be magnetized again to attach more magnetized particles1160to it.

Next, embodiments of a connecting portion are discussed. The connecting portion can be used alternatively or in combination with embodiments ofFIGS. 1-20B.FIG. 21Ais a schematic view of a connecting portion1208on a medical device1200coupled to a connecting portion1220on a delivery member1218.FIG. 21Bis a schematic view of the connecting portion1208on the medical device1200being decoupled from the connection portion1220on the delivery member1218. The medical device1200as illustrated includes a body1202, a proximal end1204, a lumen1205, and a connecting portion1208. The delivery system1210as illustrated includes a dispenser1212, a plunger1214, a member1216, the delivery member1218, and the connecting portion1220.

The medical device1200as illustrated includes the body1202extending from the proximal end1204to a distal end (not shown inFIGS. 21A-21B). The lumen1206can extend through the body1202of the medical device1200from the proximal end1204to the distal end. The connecting portion1208can be connected to the body1202at the proximal end1204of the medical device1200.

The delivery system1210can include the dispenser1212, which includes the plunger1214and the member1216. The plunger1214can be positioned in the dispenser1212. The member1216, which can be a telescoping rod, can extend through the plunger1214. The delivery system1210can include the delivery member1218. The delivery member can extend. from the dispenser1212. The connecting member1220can be connected to a distal end of the delivery member1218.

The connecting portion1208of the medical device1200and the connecting portion1220of the delivery member1218can include magnetic materials and can magnetically couple the medical device1200to the delivery member1218, as shown inFIG. 21A. To decouple the medical device1200and the delivery member1218, the member1216can telescope through the plunger1214and extend into the delivery member1218. The member1216can be wider than an opening extending through the connecting portion1208of the medical device1200, such as to push against the connecting portion1208. This can decouple the connecting portion1208of the medical device1200and the connecting portion1220of the delivery member1218, as shown inFIG. 21B.

The following are non-exclusive descriptions of possible embodiments of the present disclosure.

A medical device insertable within a target anatomical region includes a body, at least a first portion of the body being configured to be insertable within the target anatomical region, and at least a second portion of the body being configured to facilitate retention of the body in the target anatomical region. At least one of the first portion or the second portion being configured to interact with a portion surrounding the target anatomical region and/or configured to exchange a component to effect a change within the target anatomical region.

The body can, in some embodiments, be elongate and includes a proximal end and a distal end opposite to the proximal end. Alternatively, the body can include a non-elongate shape.

The first portion can be adjacent to the proximal end and the second portion can be adjacent to the distal end.

The body can include a connecting portion for facilitating connection to any of the following: delivery system, a dispenser, or one or more external actuators. In an embodiment, the connecting portion can be at the proximal end. Alternatively, the connecting portion can be positioned anywhere along the body, including at a distal end of the body.

In an embodiment, the connecting portion can advantageously permit ease of connection to a connector (e.g., a complementary connector) of an external component, including any of the following: delivery system, a dispenser, or one or more external actuators. The connecting portion can, advantageously self-seat, self-center, self-guide the connector of the external component positioned outside the body cavity. In an aspect, the connecting portion can connect to the connector of the external portion once the medical device has been inserted. Such embodiments can advantageously permit ease of connection, and/or repeated connection in the absence of visualization of the body cavity.

In an embodiment, the connecting portion can advantageously permit ease of removal of the connection to a connector (e.g., a complementary connector) of an external component. The connecting portion can include a removal mechanism that can facilitate removal of the connection between the connecting portion and the connector of the external component. Alternatively, the removal mechanism can be provided as a part of the external component.

In some embodiments, the connecting portion can include a magnetic component (e.g., permanent magnets, electromagnetic components, components that can selectively magnetize upon introduction of an external electric or magnetic field). Correspondingly, the external component can also include a magnetic component to facilitate ease of connection (e.g., in the absence of a visual feedback of the body cavity).

The magnetic connecting portion can be configured to couple to a magnetic connecting portion on a delivery system.

In certain embodiments, the body can include a lumen. In some such embodiments, the lumen can extend at least partially along portions of the body. In further embodiments, the lumen can extend from the proximal end of the body toward the distal end. In one aspect, the lumen does not extend through the entirety of the body. Accordingly, the distal end and the proximal end may not be in fluid communication with each other. Such embodiments can permit exchange of media with portions surrounding the body cavity. For example, in one instance, such an embodiment can facilitate aeration and/or gaseous exchange (e.g., via nasal cavity) to the exterior of the body. In another instance such an embodiment can facilitate transport and/or exchange of a medium (e.g., anti-inflammatory substance, mucus drainage, etc.) between the body cavity and an exterior of the body cavity. However, alternatives are contemplated, including the use of a lumen that runs substantially through the body (including through the distal end).

The body can include an opening. The lumen and the opening can in fluid communication with each other. Accordingly, the lumen can be configured to receive a medium through the opening.

The body can include pore(s) for facilitating exchange between the body cavity, via the medical device placed within the body cavity, and an exterior of the body cavity. In an embodiment, the pore(s) can be provided at least on the second portion of the body. The pore(s) can be distributed in accordance with desired rate of exchange of media (e.g., air, carbon dioxide, liquids, suspensions, particles, fibers, open or closed cell foams, etc.). For instance, if aeration can be desired, the pore(s) can facilitate exchange of air or carbon dioxide via the sinus ostia, nasal cavity, nostril(s) and to the exterior of the body. Alternatively, the pore(s) can transport, exchange, and/or elute component(s).

The pores are surrounded by a magnetic material.

As described previously, at least the second portion can be configured as a retention portion, to facilitate retention of the medical device inside the body cavity. For instance, in an embodiment, the second portion can have a cross-sectional area larger than an opening of the target anatomical region/body cavity. Alternatively, at least the second portion can pierce or anchor to portions of the target anatomical region/body cavity to facilitate retention of the medical device in the target anatomical region/body cavity.

In some embodiments, the second portion can have a cross-sectional area that can be larger than a cross-sectional area of the first portion.

The second portion has a cross-sectional area that can be larger than a cross-sectional area of an opening of the target anatomical region.

The second portion can be angled with respect to the first portion.

The second portion has a curled shape, a widened shape, a coiled shape, or a wave shape.

At least a portion of the body can be coated with a hydrophilic coating.

The hydrophilic coating on a portion of the body can be coated with a hydrophobic coating.

The second portion includes a weeping balloon.

The weeping balloon can be configured to enlarge after filled with the fluid.

The second portion includes a foam and/or a pledget that can be configured to enlarge upon absorption of a medium.

The second portion can be a rigid member.

The second portion can be configured such that the medical device can anchor or pierce the Haller cells (ethmoid air cells). The second portion can be configured to be positioned in a frontal sinus, a maxillary sinus, or a sphenoid sinus.

A medical device insertable within a target anatomical region includes a body, at least a first portion of the body being configured to be insertable within a target anatomical region, and at least a second portion of the body being configured to facilitate retention of the body in the target anatomical region. At least one of the first portion or the second portion being configured to receive a medium and permit exchange thereof with the target anatomical region. At least one of the first portion or the second portion being configured to facilitate in situ manipulation of the medium via an external manipulation system.

The body can, in some embodiments, be elongate and includes a proximal end and a distal end opposite to the proximal end. Alternatively, the body can include a non-elongate shape.

The first portion can be adjacent to the proximal end and the second portion can be adjacent to the distal end.

The body can include a connecting portion for facilitating connection to any of the following: delivery system, a dispenser, and/or one or more external actuators. In an embodiment, the connecting portion can be at the proximal end. Alternatively, the connecting portion can be positioned anywhere along the body, including at a distal end of the body.

In an embodiment, the connecting portion can advantageously permit ease of connection to a connector (e.g., a complementary connector) of an external component, including any of the following: delivery system, a dispenser, and/or one or more external actuators. The connecting portion can, advantageously self-seat, self-center, self-guide the connector of the external component positioned outside the body cavity. In an aspect, the connecting portion can connect to the connector of the external portion once the medical device has been inserted. Such embodiments can advantageously permit ease of connection, and/or repeated connection in the absence of visualization of the body cavity.

In an embodiment, the connecting portion can advantageously permit ease of removal of the connection to a connector (e.g., a complementary connector) of an external component. The connecting portion can include a removal mechanism that can facilitate removal of the connection between the connecting portion and the connector of the external component. Alternatively, the removal mechanism can be provided as a part of the external component.

In some embodiments, the connecting portion can include a magnetic component (e.g., permanent magnets, electromagnetic components, components that can selectively magnetize upon introduction of an external electric or magnetic field). Correspondingly, the external component can also include a magnetic component to facilitate ease of connection (e.g., in the absence of a visual feedback of the body cavity).

The magnetic connecting portion can be configured to couple to a magnetic connecting portion on a delivery system.

In certain embodiments, the body can include a lumen. In some such embodiments, the lumen can extend at least partially along portions of the body. In further embodiments, the lumen can extend from the proximal end of the body toward the distal end. in one aspect, the lumen does not extend through the entirety of the body. Accordingly, the distal end and the proximal end may not be in fluid communication with each other. Such embodiments can permit exchange of media with portions surrounding the body cavity. For example, in one instance, such an embodiment can facilitate aeration and/or gaseous exchange (e.g., via nasal cavity) to the exterior of the body. In another instance such an embodiment can facilitate transport and/or exchange of a medium (e.g., anti-inflammatory substance, mucus drainage, etc.) between the body cavity and an exterior of the body cavity. However, alternatives are contemplated, including the use of a lumen that runs substantially through the body (including through the distal end).

The body can include an opening. The lumen and the opening can in fluid communication with each other. Accordingly, the lumen can be configured to receive a medium through the opening.

The body can include pore(s) for facilitating exchange between the body cavity, via the medical device placed within the body cavity, and an exterior of the body cavity. In an embodiment, the pore(s) can be provided at least on the second portion of the body. The pore(s) can be distributed in accordance with desired rate of exchange of media (e.g., air, carbon dioxide, liquids, suspensions, particles, fibers, open or closed cell foams, etc.).For instance, if aeration can be desired, the pore(s) can facilitate exchange of air or carbon dioxide via the sinus ostia, nasal cavity, nostril(s) and to the exterior of the body. Alternatively, the pore(s) can transport, exchange, and/or elute component(s).

The pores are surrounded by a magnetic material.

As described previously, at least the second portion can be configured as a retention portion, to facilitate retention of the medical device inside the body cavity. For instance, in an embodiment, the second portion can have a cross-sectional area larger than an opening of the target anatomical region/body cavity. Alternatively, at least the second portion can pierce or anchor to portions of the target anatomical region/body cavity to facilitate retention of the medical device in the target anatomical region/body cavity.

In some embodiments, the second portion can have a cross-sectional area that can be larger than a cross-sectional area of the first portion. The pores are surrounded by a magnetic material. The second portion can be configured to be positioned in a frontal sinus, a maxillary sinus, or a sphenoid sinus.

A medical device insertable within a target anatomical region includes a body, at least a first portion of the body being configured to be insertable within a target anatomical region, at least a second portion of the body being configured to facilitate retention of the body in the target anatomical region, and a connecting portion for facilitating a removable connection between the body and a delivery system for delivering a medium.

The body can, in some embodiments, be elongate and includes a proximal end and a distal end opposite to the proximal end. Alternatively, the body can include a non-elongate shape.

The first portion can be adjacent to the proximal end and the second portion can be adjacent to the distal end.

The body can include a connecting portion for facilitating connection to any of the following: delivery system, a dispenser, and/or one or more external actuators. In an embodiment, the connecting portion can be at the proximal end. Alternatively, the connecting portion can be positioned anywhere along the body, including at a distal end of the body.

In an embodiment, the connecting portion can advantageously permit ease of connection to a connector (e.g., a complementary connector) of an external component, including any of the following: delivery system, a dispenser, and/or one or more external actuators. The connecting portion can, advantageously self-seat, self-center, self-guide the connector of the external component positioned outside the body cavity. In an aspect, the connecting portion can connect to the connector of the external portion once the medical device has been inserted. Such embodiments can advantageously permit ease of connection, and/or repeated connection in the absence of visualization of the body cavity.

In an embodiment, the connecting portion can advantageously permit ease of removal of the connection to a connector (e.g., a complementary connector) of an external component. The connecting portion can include a removal mechanism that can facilitate removal of the connection between the connecting portion and the connector of the external component. Alternatively, the removal mechanism can be provided as a part of the external component.

In some embodiments, the connecting portion can include a magnetic component (e.g., permanent magnets, electromagnetic components, components that can selectively magnetize upon introduction of an external electric or magnetic field). Correspondingly, the external component can also include a magnetic component to facilitate ease of connection (e.g., in the absence of a visual feedback of the body cavity).

The magnetic connecting portion can be configured to couple to a magnetic connecting portion on a delivery system.

In certain embodiments, the body can include a lumen. In some such embodiments, the lumen can extend at least partially along portions of the body. In further embodiments, the lumen can extend from the proximal end of the body toward the distal end. In one aspect, the lumen does not extend through the entirety of the body. Accordingly, the distal end and the proximal end may not be in fluid communication with each other. Such embodiments can permit exchange of media with portions surrounding the body cavity. For example, in one instance, such an embodiment can facilitate aeration and/or gaseous exchange (e.g., via nasal cavity) to the exterior of the body. In another instance such an embodiment can facilitate transport and/or exchange of a medium (e.g., anti-inflammatory substance, mucus drainage, etc.) between the body cavity and an exterior of the body cavity. However, alternatives are contemplated, including the use of a lumen that runs substantially through the body (including through the distal end).

The body can include an opening. The lumen and the opening can in fluid communication with each other. Accordingly, the lumen can be configured to receive a medium through the opening.

The body can include pore(s) for facilitating exchange between the body cavity, via the medical device placed within the body cavity, and an exterior of the body cavity. In an embodiment, the pore(s) can be provided at least on the second portion of the body. The pore(s) can be distributed in accordance with desired rate of exchange of media (e.g., air, carbon dioxide, liquids, suspensions, particles, fibers, open or closed cell foams, etc.).For instance, if aeration can be desired, the pore(s) can facilitate exchange of air or carbon dioxide via the sinus ostia, nasal cavity, nostril(s) and to the exterior of the body. Alternatively, the pore(s) can transport, exchange, and/or elute component(s).

The pores are surrounded by a magnetic material.

As described previously, at least the second portion can be configured as a retention portion, to facilitate retention of the medical device inside the body cavity. For instance, in an embodiment, the second portion can have a cross-sectional area larger than an opening of the target anatomical region/body cavity. Alternatively, at least the second portion can pierce or anchor to portions of the target anatomical region/body cavity to facilitate retention of the medical device in the target anatomical region/body cavity.

In some embodiments, the second portion can have a cross-sectional area that can be larger than a cross-sectional area of the first portion. The pores are surrounded by a magnetic material.

A medical device insertable within a target anatomical region includes a body, at least a first portion of the body being configured to be insertable within the target anatomical region, and at least a second portion of the body being configured to facilitate retention of the body in the target anatomical region. At least one of the first portion or the second portion being configured to interact with a portion surrounding the target anatomical region and/or configured to exchange a component to effect a change within the target anatomical region.

The body includes a proximal end and a distal end.

The first portion can be adjacent to the proximal end and the second portion can be adjacent to the distal end.

Further including a connecting portion at a distal end of the body.

The connecting portion can be a magnetic connecting portion.

The magnetic connecting portion can be configured to couple to a magnetic connecting portion on a delivery system.

Further including a lumen extending through the body from a proximal end to a distal end; and an opening extending through the proximal end of the body to the lumen.

The lumen can be configured to receive a medium through the opening.

Further including pores on the second portion extending through the body.

The pores are magnetic pores.

The second portion has a cross-sectional area that can be larger than a cross-sectional area of the first portion.

The second portion has a cross-sectional area that can be larger than a cross-sectional area of an opening of the target anatomical region.

The second portion can be angled with respect to the first portion.

The second portion has a curled shape, a widened shape, a coiled shape, or a wave shape.

At least a portion of the body can be coated with a hydrophilic coating.

The hydrophilic coating on a portion of the body can be coated with a hydrophobic coating.

The second portion includes a weeping balloon.

The weeping balloon can be configured to enlarge after filled with the fluid.

The second portion includes a foam and/or a pledget that can be configured to enlarge upon absorption of a medium.

The second portion a rigid member.

The second portion can be configured such that the medical device can anchor or pierce the Haller cells (ethmoid air cells).

The second portion can be configured to be positioned in a frontal sinus, a maxillary sinus, or a sphenoid sinus.

A medical device insertable within a target anatomical region includes a body, at least a first portion of the body being configured to be insertable within a target anatomical region, and at least a second portion of the body being configured to facilitate retention of the body in the target anatomical region. At least one of the first portion or the second portion being configured to receive a medium and permit exchange thereof with the target anatomical region. At least one of the first portion or the second portion being configured to facilitate in situ manipulation of the medium via an external manipulation system.

The body includes a proximal end and a distal end.

The first portion can be adjacent to the proximal end and the second portion can be adjacent to the distal end.

Further including a connecting portion at a distal end of the body.

The connecting portion can be a magnetic connecting portion.

The magnetic connecting portion can be configured to couple to a magnetic connecting portion on a delivery system.

Further including a lumen extending through the body from a proximal end to a distal end; and an opening extending through the proximal end of the body to the lumen.

The lumen can be configured to receive the medium through the opening.

Further including pores on the second portion extending through the body.

The pores are magnetic pores.

The second portion has a cross-sectional area that can he larger than a cross-sectional area of the first portion.

The second portion has a cross-sectional area that can be larger than a cross-sectional area of an opening of the target anatomical region.

The second portion can be angled with respect to the first portion.

The second portion has a curled shape, a widened shape, a coiled shape, or a wave shape.

At least a portion of the body can be coated with a hydrophilic coating.

The hydrophilic coating on a portion of the body can be coated with a hydrophobic coating.

The second portion includes a weeping balloon.

The weeping balloon can be configured to enlarge after filled with the fluid.

The second portion includes a foam and/or a pledget that can be configured to enlarge upon absorption of the medium.

The second portion a rigid member.

The second portion can be configured such that the medical device can anchor or pierce the Haller cells (ethmoid air cells).

The second portion can be configured to be positioned in a frontal sinus, a maxillary sinus, or a sphenoid sinus.

A medical device insertable within a target anatomical region includes a body, at least a first portion of the body being configured to be insertable within a target anatomical region, at least a second portion of the body being configured to facilitate retention of the body in the target anatomical region, and a connecting portion for facilitating a removable connection between the body and a delivery system for delivering a medium.

The body includes a proximal end and a distal end.

The first portion can be adjacent to the proximal end and the second portion can be adjacent to the distal end.

The connecting portion can be a magnetic connecting portion.

The magnetic connecting portion can be configured to couple to a magnetic connecting portion on the delivery system.

Further including a lumen extending through the body from a proximal end to a distal end; and an opening extending through the proximal end of the body to the lumen.

The lumen can be configured to receive the medium through the opening.

Further including pores on the second portion extending through the body.

The pores are magnetic pores.

The second portion has a cross-sectional area that can be larger than a cross-sectional area of the first portion.

The second portion has a cross-sectional area that can be larger than a cross-sectional area of an opening of the target anatomical region.

The second portion can be angled with respect to the first portion.

The second portion has a curled shape, a widened shape, a coiled shape, or a wave shape.

At least a portion of the body can be coated with a hydrophilic coating.

The hydrophilic coating on a portion of the body can be coated with a hydrophobic coating.

The second portion includes a weeping balloon.

The weeping balloon can be configured to enlarge after filled with the fluid.

The second portion includes a foam and/or a pledget that can be configured to enlarge upon absorption of the medium.

The second portion a rigid member.

The second portion can be configured such that the medical device can anchor or pierce the Haller cells (ethmoid air cells).

The second portion can be configured to be positioned in a frontal sinus, a maxillary sinus, or a sphenoid sinus.

A medical device includes a body extending from a proximal end to a distal end, a connecting portion connected to the body at the proximal end, and a portion formed on the body adjacent to the distal end that can be configured to receive a medium and deliver the medium to a body cavity.

The connecting portion can be a magnetic connecting portion.

The magnetic connecting portion can be configured to couple to a magnetic connecting portion on the delivery system.

Further including a lumen extending through the body from the proximal end to the distal end; and an opening extending through the proximal end of the body to the lumen.

The lumen can be configured to receive the medium through the opening.

Further including a stem extending from the proximal end to the portion.

Further including pores on the portion extending through the body.

The pores are surrounded by a magnetic material.

The portion has a cross-sectional area that can be larger than a cross-sectional area of a stem of the medical device.

The portion has a cross-sectional area that can be larger than a cross-sectional area of an opening of the body cavity.

The portion can be angled with respect to a stem of the medical device.

The portion has a curled shape, a widened shape, a coiled shape, or a wave shape.

The portion can be coated with a hydrophilic coating.

The hydrophilic coating on a portion of the body can be coated with a hydrophobic coating.

The portion can be a weeping balloon.

The weeping balloon can be configured to enlarge after filled with the medium.

The portion includes a biodegradable foam.

The portion includes a foam and/or a pledget that can be configured to enlarge upon absorption of the medium.

The portion can be rigid.

The portion can be configured such that the medical device can anchor or pierce the Haller cells (ethmoid air cells).

The portion can be configured to be positioned in a frontal sinus, a maxillary sinus, or a sphenoid sinus.

A system includes a medical device and a delivery system comprising a connecting portion for removably connecting to a connecting portion of the medical device. The medical device includes a body, at least a first portion of the body being configured to be insertable within a target anatomical region, and at least a second portion of the body being configured to facilitate retention of the body in the target anatomical region. The delivery system facilitates transfer of a medium toward the medical device.

At least one of the first portion or the second portion of the medical device being configured to interact with a portion surrounding the target anatomical region and/or configured to exchange a component to effect a change within the target anatomical region.

At least one of the first portion or the second portion of the medical device being configured to receive a medium and permit exchange thereof with the target anatomical region, and wherein at least one of the first portion or the second portion of the medical device being configured to facilitate in situ manipulation of the medium via an external manipulation system.

Further including an external device positioned adjacent to the delivery system and/or the medical device.

The external device can be a force transducer.

The external device can be a magnet.

Further including an internal device positioned in the delivery system.

The internal device can be a magnetic wire that extends through the delivery system.

The medical device further including a connecting portion for facilitating a removable connection between the body and the delivery system for delivering the medium.

The connecting portion on the delivery system can be a magnetic connecting portion, and wherein the connecting portion on the medical device can be a magnetic connecting portion.

The magnetic connecting portion on the delivery system can be configured to releasably couple to the magnetic connecting portion on the medical device.

The delivery system further including a dispenser configured to receive the medium; and a delivery member with a proximal end attached to the dispenser; wherein the connecting portion of the delivery system can be connected to a distal end of the delivery member.

The delivery member includes flaps that are configured to open after a pressure in the delivery member exceeds a threshold pressure.

Further including a pressure sensor connected to the delivery member that can he configured to measure a pressure inside of the delivery member.

The delivery member and the dispenser are integrally formed out of flexible material and the delivery member can be configured to expand.

The dispenser can be a syringe, a gas cylinder, a squeeze bottle, or a hand-held dispenser, with or without a trigger.

A system includes a medical device and a delivery device removably connectable to the medical device, the delivery device being configured to maintain the medical device in an insertion configuration during insertion of the medical device inside the target anatomical region. The medical device includes a body, at least a first portion of the body being configured to he insertable within a target anatomical region, and at least a second portion of the body being configured to facilitate retention of the body in the target anatomical region. The delivery device being further configured to decouple the medical device from the delivery system after insertion of the medical device in the target anatomical region.

At least one of the first portion or the second portion of the medical device being configured to interact with a portion surrounding the target anatomical region and/or configured to exchange a component to effect a change within the target anatomical region.

At least one of the first portion or the second portion of the medical device being configured to receive a medium and permit exchange thereof with the target anatomical region, and wherein at least one of the first portion or the second portion of the medical device being configured to facilitate in situ manipulation of the medium via an external manipulation system.

The medical device further including a connecting portion for facilitating a removable connection between the body and a delivery system for delivering the medium.

A system includes a dispenser configured to receive a fluid, a delivery member with a proximal end attached to the dispenser and a distal end that includes a connecting member and a medical device that can be configured to be positioned in a body cavity. The medical device includes a body extending from a proximal end to a distal end, a connecting member connected to the body at the proximal end that can be configured to mate to the coupler of the delivery member, and a portion formed on the body adjacent to the distal end that can be configured to receive the fluid and deliver the fluid into a body cavity.

The connecting member on the delivery member includes a magnetic connecting member, and wherein the connecting member on the medical device includes a magnetic connecting member.

The magnetic connecting member on the delivery member can be configured to releasably couple to the magnetic connecting member on the medical device.

The delivery member includes flaps that are configured to open after a pressure in the delivery member exceeds a threshold pressure.

Further including a pressure sensor connected to the delivery member that can be configured to measure a pressure inside of the delivery member.

The delivery member and the dispenser are integrally formed out of flexible material and the delivery member can be configured to expand.

The dispenser includes a syringe, a gas cylinder, a squeeze bottle, or a hand-held dispenser, with or without a trigger.

Further including an external device positioned adjacent to the delivery member and/or the medical device.

The external device can be a force transducer.

The external device can be a magnet.

Further including an internal device positioned in the delivery member.

The internal device can be a magnetic wire that extends through the delivery member.

A system includes a medical device that can be configured to be positioned in a body cavity to deliver a medium to the body cavity, and an external device positioned adjacent to the medical device.

The medical device can be a fluid that undergoes a transformation to a scaffold upon application of a force.

The external device can be a force transducer.

A method of inserting a medical device into a sinus cavity includes deploying a distal end of a delivery device into a nasal cavity, positioning the distal end of the delivery device near a sinus ostium, advancing a guide wire of the delivery device through the sinus ostium and into the sinus cavity, advancing a medical device over the guide wire into the sinus cavity, wherein the medical device includes a body with a connecting portion at a proximal end and a portion at a distal end, and removing the guide wire from the sinus cavity, wherein the medical device remains in place in the sinus cavity.

Further including visualizing the sinus cavity; and cleansing the sinus cavity.

Further including removing the delivery device from the nasal cavity.

Further including coupling a dispenser to the medical device; delivering a fluid to the medical device; delivering the fluid to the sinus cavity through the medical device; and decoupling the dispenser from the medical device.

The connecting portion on the medical device can be a magnetic connecting portion, and wherein coupling a dispenser to the medical device includes coupling a magnetic connecting portion on the dispenser to the magnetic connecting portion on the medical device.

The fluid can be a therapeutic fluid.

The fluid can be a cleansing agent.

Delivering the fluid to the sinus cavity through the medical device including delivering the fluid to the sinus cavity through pores on the medical device.

Delivering the fluid to the sinus cavity through the medical device includes eluting the fluid from the medical device into the sinus cavity.

Further including applying an external field to the fluid.

Applying an external field to the fluid includes applying a magnetic field to the fluid.

Applying an external field to the fluid includes applying a force field to the fluid.

Further including applying a light source to the fluid.

A method includes coupling a dispenser to a medical device positioned in a cavity, delivering a fluid to the medical device, wherein the medical device includes a body with a connecting portion at a proximal end and a portion at a distal end, delivering the fluid to the cavity through the medical device, and decoupling the dispenser from the medical device.

The connecting portion on the medical device can be a magnetic connecting portion, and wherein coupling a dispenser to the medical device includes coupling a magnetic connecting portion on the dispenser to the magnetic connecting portion on the medical device.

The fluid can be a fluid.

The fluid can be a cleansing agent.

Delivering the fluid to the cavity through the medical device including delivering the fluid to the cavity through pores on the medical device.

Delivering the fluid to the cavity through the medical device includes eluting the fluid from the medical device into the cavity.

Further including applying an external field to the fluid.

Applying an external field to the fluid includes applying a magnetic field to the fluid.

Applying an external field to the fluid includes applying a force field to the fluid.

Further including applying a light source to the fluid.