The present technology is related to systems, devices, and methods for applying treatments within a nasal cavity. More specifically, the disclosed technology relates to providing adequate pain relief to allow interventions related to the nasal cavity (e.g., cryo-ablation, turbinate reduction, thermal ablation, mechanical reconstruction, thermal treatments, and tissue modifying procedure manipulates tissue) to be performed with minimal or no discomfort to patients. The technology is beneficial in allowing for nasal procedures to be performed more safely and with less morbidity, and as such allows for improvements in medical management of nasal and sinus conditions.
Many nasal cavity related medical conditions (e.g., ailments including rhinitis and sinusitis and structural abnormalities such as a deviated septum) may be treated using instruments that are inserted into a nasal cavity. However, the nasal cavity is a highly-innervated region of tissue and as such is particularly sensitive to noxious stimuli. Patient discomfort is typically a consequence of instruments making even relatively mild contact with a wall of the nasal cavity. During interactions between instruments and the nasal or sinus cavities (e.g., during the application of a treatment or procedure to a tissue), discomfort may be significant. As such, it is a standard of care and general practice to apply an anesthetic agent or an analgesic to the nasal cavity prior to instrument insertion. During some procedures, it may be necessary to utilize a number of anesthetics and/or sedatives to achieve a more substantial degree of pain control.
However, there are several shortcomings and challenges associated with achieving pain control within the nasal cavity, particularly with applying anesthesia to the nasal cavity. For example, the nasal cavity is a relatively narrow passageway with limited space to maneuver the instruments. The surfaces of the nasal cavity are also highly-irregular in shape as there are numerous nooks and ridges that are created by the protrusions of turbinate bones and other surfaces in the nasal cavity. The positions of the sensory afferents in the nasal cavity are broadly distributed and may exist across a range of locations, not all of which may be easily accessible from a single conventional approach. These factors make uniform and complete application of anesthetic agents challenging.
There are a number of additional challenges associated with applying anesthetic agents to the nasal cavity. One such challenge is the tendency for a portion of the anesthetic substance to be exposed to the throat, which is a common occurrence associated with the use of liquids and sprays. For example, in some instances, when anesthetics reach the throat, a patient may experience a diminished throat sensation that may result in difficulty breathing and associated patient distress. However, with many anesthetic substances and methods/devices for application, it remains difficult to obtain thorough tissue coverage and thus achieve the desired broad pain-control effect without excess anesthetic reaching the throat.
Additional challenges relate to the business aspects of performing a procedure, particularly for in-office procedures. Within many areas of medicine there is a consistent pressure to reduce costs. Extraneous costs related to wasted anesthetic substances, overly expensive anesthetic delivery mechanisms, or increased time spent by clinicians to perform a procedure are generally viewed as undesirable. To achieve widespread adoption and to impact the most patients, solutions for adequate patient anesthesia should be cost-effective to implement and deliver.
Another challenge is the lack of simple yet effective ways to test and evaluate the thoroughness of anesthesia that is induced in the nasal cavity. Given a lack of options, modern medical practice may not involve testing for anesthetic depth or pain control. Any adjustments to anesthesia are often reactive (e.g., patient complaints or other indicators of pain prompt a practitioner to pause, withdraw instruments, and apply more of an anesthetic agent), which is a process that is considered burdensome from both time and cost perspectives and that results in unnecessary patient discomfort. Improved techniques would allow for proactive testing of anesthesia effectiveness and for any adjustments to be made prior to initiating procedures, allowing for improved patient comfort and reduced costs via a more efficient workflow.
Accordingly, there is a need to provide improved anesthetic delivery to the nasal cavity. Additionally, there is a need to allow for improved testing of the depth or effectiveness of anesthesia applied within the nasal cavity.
In an example, an apparatus for delivering an anesthetic agent to a target tissue in a nasal cavity of a patient is described. The apparatus includes an elongated shaft with a proximal end and a distal end. The apparatus also includes an absorbent plug coupled to the distal end of the elongated shaft, wherein the absorbent plug is configured to occupy a first volume in a compressed state and a second volume in an uncompressed state, wherein the second volume is greater than the first volume, and wherein the absorbent plug is configured to store an anesthetic agent and deliver the anesthetic agent to the target tissue in the nasal cavity by contacting the target tissue in the uncompressed state. The apparatus also includes a sheath at least partially covering the absorbent plug, wherein the sheath retains the absorbent plug in the compressed state when positioned at least partially over the absorbent plug, and wherein removal of the sheath allows for the absorbent plug to expand to the uncompressed state.
In another example, another apparatus for delivering an anesthetic agent to a target tissue in a nasal cavity of a patient is described. The apparatus includes an elongated shaft with a proximal end and a distal end. The apparatus also includes an absorbent plug coupled to the distal end of the elongated shaft, wherein the absorbent plug is configured to store the anesthetic agent and deliver the anesthetic agent to the target tissue in the nasal cavity by contacting the target tissue. The apparatus also includes a lumen extending through the elongated shaft and into the absorbent plug, wherein the lumen comprises one or more ports within the absorbent plug configured to deliver the anesthetic agent into the absorbent plug to be absorbed by the absorbent plug.
In another example, another apparatus for delivering an anesthetic agent to a target tissue in a nasal cavity of a patient is described. The apparatus includes an elongated shaft with a proximal end and a distal end. The apparatus also includes a balloon coupled to the distal end of the elongated shaft. The apparatus also includes an absorbent sheath covering the balloon, wherein the absorbent sheath is configured to store an anesthetic agent and deliver the anesthetic agent to the target tissue in the nasal cavity by contacting the target tissue. The absorbent sheath is configured to be inserted into the nasal cavity proximate to the target tissue with the balloon in a deflated state, and the balloon is configured to expand from the deflated state to an inflated state in order to cause the absorbent sheath to expand and contact the target tissue in the nasal cavity so as to deliver the anesthetic agent to the contacted target tissue.
In another example, another apparatus for delivering an anesthetic agent to a target tissue in a nasal cavity of a patient is described. The apparatus includes an elongated shaft with a proximal end and a distal end. The apparatus also includes an expandable member coupled to the distal end of the elongated shaft, wherein the expandable member comprises an absorbent outer layer, wherein the absorbent outer layer is configured to store an anesthetic agent and deliver the anesthetic agent to the target tissue in the nasal cavity by contacting the target tissue. The apparatus also includes a malleable spine within the expandable member configured to be formable to a plurality of shapes in order to match an anatomy of the nasal cavity. The expandable member is configured to be inserted into the nasal cavity proximate to the target tissue in a deflated stated and then expanded to an inflated state so that the absorbent outer layer contacts the target tissue in the nasal cavity so as to deliver the anesthetic agent to the contacted target tissue.
In yet another example, an apparatus for delivering a liquid anesthetic agent to a target tissue in a nasal cavity of a patient is described. The apparatus includes an elongated shaft with a proximal end and a distal end. The apparatus also includes an air intake port disposed at the proximal end of the elongated shaft configured to receive compressed air to drive the liquid anesthetic agent towards the distal end of the elongated shaft. The apparatus also includes a loading port disposed at the proximal end of the elongated shaft configured to receive the liquid anesthetic agent. The apparatus also includes one or more dispensing ports disposed at the distal end of the elongated shaft and configured to dispense the liquid anesthetic agent onto the target tissue in the nasal cavity.
The features, functions, and advantages that have been discussed can be achieved independently in various examples or may be combined in yet other examples further details of which can be seen with reference to the following description and drawings.
The novel features believed characteristic of the illustrative examples are set forth in the appended claims. The illustrative examples, however, as well as a preferred mode of use, further objectives and descriptions thereof, will best be understood by reference to the following detailed description of an illustrative example of the present disclosure when read in conjunction with the accompanying drawings, wherein:
The present technology is related to systems, devices, and methods for creating an anesthetic effect in a tissue. More specifically, the present technology relates to delivering anesthesia and creating an anesthetic effect in a tissue region including or proximal to a nasal cavity and/or a sinus cavity. This technology can be particularly useful when performing interventional procedures that would otherwise provide relatively moderate or severe patient discomfort, where a lack of adequate anesthesia would lead to patient morbidity, excess costs, and be discouraging to both practitioners and patients alike in terms of willingness to participate in the procedure in the future. Additionally, the technology of the present disclosure can enable time-efficient and cost-efficient implementation, and improve patient care from both clinician and patient perspectives.
In the following description, various examples of the present technology will be described. For purposes of explanation, specific configurations and details are set forth in order to provide a thorough understanding of the examples. However, it will also be apparent to one skilled in the art that the present technology can be practiced without the specific details. Furthermore, well-known features can be omitted or simplified in order not to obscure the example being described.
Various aspects of the technology described herein can be applied to any of the particular applications set forth below or for any other types of pain control systems or methods. The technology can be applied as a standalone system or method, or as part of an integrated medical treatment system.
Within examples, apparatuses for delivery of an anesthetic agent to the nasal cavity are described herein. One example apparatus includes an absorbent plug (also referred to herein as a tamponade), which can be inserted via the nostril and positioned within the nasal cavity (e.g., using a pleget or probe having an elongated shaft). The elongated shaft can be malleable and/or flexible to allow for navigation and placement within the tortuous anatomy of the nasal cavity. The absorbent plug can include a soft and absorbent material (such as, e.g., cotton or gauze), which allows for the absorbent plug to temporarily store and transport the anesthetic agent to an anatomical region for application (e.g., a region in the nasal cavity 100 shown in
As shown in
The proximal end 214 of the elongated shaft 212 can be coupled to a hand piece 218. Within examples, the hand piece 218 can be configured to facilitate gripping and manipulating the apparatus 200. For instance, in a dimension transverse to a longitudinal axis of the apparatus 200, the hand piece 218 can have a size that is relatively larger than a size of the elongated shaft 212 to provide a relatively larger gripping surface, which an operator can use to maneuver the apparatus 200 during insertion of the apparatus 200 in the nasal cavity 100.
As shown in
Within examples, the apparatus 200 can also include a sheath 224 disposed on and translatable relative to the elongated shaft 212 between a first position shown in
To transition the apparatus 200 from the first state shown in
As described above, the absorbent plug 220 is configured to occupy the first volume in the compressed state and the second volume in the uncompressed state, where the second volume is greater than the first volume. In one example, the absorbent plug 220 can have a cross-sectional diameter that is less than approximately 1 mm in the compressed state and a cross-sectional diameter that is greater than approximately 1 mm in the uncompressed state. In other example, the absorbent plug 220 can have a cross-sectional diameter that is less than or equal to a cross-sectional diameter of the elongated shaft 212 when the absorbent plug 220 is in the compressed state, and a cross-sectional diameter that is greater than the cross-sectional diameter of the elongated shaft 212 when the absorbent plug 220 is in the uncompressed state.
In operation, the apparatus 200 initially can be in the first state shown in
Additionally, with the sheath 224 in the first position and the sheath 224 at least partially covering the absorbent plug 220 so that the absorbent plug 220, the sheath 224 can help to reduce (or minimize) contact between the absorbent plug 220 and the anesthetic agent 222 and the nasal cavity 100 during insertion to the target tissue. This can beneficially help to reduce (or minimize) delivering the anesthetic agent 222 to portions of the nasal cavity 100 that are outside of the target tissue.
After the apparatus 200 is inserted in the nasal cavity 100 and positioned at the target tissue, the sheath 224 can be translated relative to the elongated shaft 212 and the absorbent plug 220 in a direction from the distal end 216 of the elongated shaft 212 toward the proximal end 214 of the elongated shaft 212 (i.e., from the first position to the second position).
After translating the sheath 224 from the first position to the second position, the apparatus 200 can be maintained in position for a prescribed period of time to allow for the anesthetic agent 222 to release from the absorbent plug 220 and be delivered to the target tissue (e.g., approximately 5 minutes to approximately 15 minutes). In some implementations, it may be desirable to maintain the absorbent plug 220 in contact with the target tissue for a relatively long period of time. In one example, the apparatus 200 can be configured to enhance patient comfort during the time for delivering the anesthetic agent 222 to the target tissue.
For instance, as shown in
Additionally, for example, decoupling the elongated shaft 212 and the hand piece 218 can facilitate removing the sheath 224. For instance, as shown in
As illustrated in
Within examples, the removal member 226 can be a relatively soft material that has a relatively high tensile strength (e.g., a tensile strength that is sufficient to provide for pulling the absorbent plug 220 out of the nasal cavity 100). The relatively softness of the removal member 226 can improve comfort for the patient while the absorbent plug 220 is at the target tissue for the prescribed time for delivering the anesthetic agent 222 (e.g., several minutes). Additionally, the relatively high tensile strength of the removal member 226 can facilitate pulling on the removal member 226 in manner that can overcome a radial outward force of the absorbent plug 220 without detaching or breaking.
In one example, the removal member 226 can be housed in a lumen or a cavity within the elongated shaft 212 and/or the hand piece 218 when the apparatus 200 is in the first state and/or the second state (e.g., prior to decoupling the elongated shaft 212 from the absorbent plug 220).
In the example shown in
In one implementation, the removable barrier of the sheath 324 can be a dissolvable coating covering the absorbent plug 220. In operation, the absorbent plug 220 at least partially covered by the removable barrier of the sheath 324 can be inserted in the nasal cavity 100 to the target tissue and then held in place at the target tissue until at least one (i) the dissolvable coating of the removable barrier dissolves due to moisture present within the nasal cavity 100, (ii) a liquid introduced by the operator dissolves the removable barrier, or (iii) the anesthetic agent 222 within the absorbent plug 220 dissolves the removable barrier.
In this way, the removable barrier of the sheath 324 can retain the absorbent plug 220 in the compressed state during insertion in the nasal cavity 100 and then, at the target tissue, be removed from the absorbent plug 220 (e.g., by dissolving or unwrapping) to allow for the absorbent plug 220 to expand to the uncompressed state.
In the examples described above, the apparatus 200, 300 includes the absorbent plug 220, which (i) retains the anesthetic agent 222 prior to insertion of the apparatus 200, 300 in the nasal cavity 100, and then (e.g., after translation and/or removal of the sheath 224, 324) (ii) is exposed to contact and deliver the anesthetic agent 222 to the target tissue in the nasal cavity 100. In other examples, the apparatus 200, 300 can retain and/or deliver the anesthetic agent 222 in additional or alternative manners.
The apparatus 400 also includes an absorbent plug 420 coupled to the distal end 416 of the elongated shaft 412. As described above, the absorbent plug 420 is configured to store the anesthetic agent 222 and deliver the anesthetic agent 222 to the target tissue in the nasal cavity 100 by contacting the target tissue.
Additionally, as shown in
As shown in
In use, the elongated shaft 412 of the apparatus 400 can be maneuvered by an operator such that the distal end 416, including the absorbent plug 420, is proximate to the target tissue to which it is desired to apply the anesthetic agent 422. The operator can then deploy the anesthetic agent 422, for example, by injecting the anesthetic agent 422 using a syringe (not shown) into the proximal end 414 of the elongated shaft 412 via the lumen 428. The anesthetic agent 422 flows through the lumen 428 from the proximal end 414 to the distal end 416 and out of the one or more ports 430 into the absorbent plug 420. The anesthetic agent 422 then flows through the absorbent plug 420 from the one or more ports 430 to the external surface of the absorbent plug 420, which contacts the target tissue in the nasal cavity 100. As a result of this contact, the absorbent plug 420 delivers the anesthetic agent to the target tissue in the nasal cavity 100.
In one example, the absorbent plug 420 is adapted for insertion in the nasal cavity 100 in a stable, reduced-size configuration. In such an example, the absorbent plug 420 can be composed of a dry and compressed sponge-like material which allows for a relatively small diameter (e.g., a cross-sectional diameter less than approximately 1 mm) to facilitate navigation within the nasal cavity 100 and positioning of the absorbent plug 420 in a desired region at the target tissue. Once positioned at the target tissue, the absorbent plug 420 can begin to expand as the absorbent plug 420 absorbs moisture (e.g., moisture from mucosal tissues of the nasal cavity 100). Responsive to the anesthetic agent 422 injected in the lumen 428 contacting the absorbent plug 420, the absorbent plug 420 can further expand. After the absorbent plug 420 expands, the absorbent plug 420 can establish a contact pressure with the target tissue in the nasal cavity 100 and thereby deliver the anesthetic agent 422 to the target tissue.
In additional or alternative examples, the apparatus 200, 300, 400 can include one or more removal mechanisms to assist with removing the absorbent plug 220, 420 after the anesthetic agent 222, 422 is applied. For instance, after the absorbent plug 420 has expanded to a full size (e.g., responsive to proximally translating the sheath 224 from the first position to the second position, removing the sheath 324, and/or injecting the anesthetic agent 422 via the lumen 428), the absorbent plug 220, 420 can apply a radial outward force to adjacent tissues in the nasal cavity 100. While this force can assist with effective delivery of the anesthetic agent 222, 422, the radial outward force can make the absorbent plug 220, 420 difficult and/or uncomfortable to remove from the nasal cavity 100.
As shown in
Additionally, as shown in
More particularly, to remove the absorbent plug 420 from the nasal cavity 100, residual fluid in the absorbent plug 420 can be extracted via the one or more second ports 534 and withdrawn through the second lumen 532 into a fluid reservoir (not shown), which is fluidly coupled with the second lumen 532 at the proximal end 414 and/or proximal of the hand piece. As noted above, the residual fluid in the absorbent plug 420 can be removed from the absorbent plug 420 by, for example, applying a negative pressure (e.g., a vacuum and/or a suction force) to the second lumen 532. As the residual fluid is extracted from the absorbent plug 420, the negative pressure can reduce the size of the absorbent plug 420, which can allow for easier withdrawal of the absorbent plug 420 from the nasal cavity 100 compared to withdrawing a fully expanded absorbent plug 420 from the nasal cavity 100.
In some examples, the anesthetic agent 222, 422 can be a fluid-based anesthetic agent. However, in other examples, the anesthetic agent 222, 422 can include one or more foams, gases, mists, and/or gels. Within examples, the lumen 428 and/or the second lumen 532 can be configured to supply and/or withdraw, respectively, the anesthetic agent 222, 422 and/or residual substances in the absorbent plug 220, 520 including one or more fluids, foams, gases, mists, and/or gels.
Additionally, although
Referring now to
As shown in
As shown in
In the examples described above, the absorbent plug 220, 420 provides an applicator that can expand to conform to an irregular shape of the nasal cavity 100 and deliver the anesthetic agent 222, 422 to the target tissue. In some implementations, the absorbent plug 220, 420 can expand passively. In other implementations, an apparatus can include an actively expandable applicator that can be inserted in the nasal cavity 100 with a relatively small size and then actively expanded to conform to the irregular shape of the nasal cavity 100 and deliver the anesthetic agent. For instance, within examples, an outward force from an expanding agent can allow for improved conformability to irregularly shaped surfaces and improved contact with mucosal tissues.
Referring now to
The apparatus 1200 also includes a balloon 1236 coupled to the distal end 1216 of the elongated shaft 1212. The balloon 1236 is configured to be inflated such that the balloon 1236 expands outward from the elongated shaft 1212. As such, the balloon 1236 can have (i) a deflated state in which the balloon 1236 has a first size and (ii) an inflated state in which the balloon 1236 has a second size, which is greater than the first size. As one example, the balloon 1236 can be a compliant latex balloon.
Additionally, the apparatus 1200 includes an absorbent sheath 1238 covering the balloon 1236. The absorbent sheath 1238 is configured to store an anesthetic agent and deliver the anesthetic agent to a target tissue in the nasal cavity 100 by contacting the target tissue. For instance, the absorbent sheath 1238 can retain and release the anesthetic agent in manner similar to the absorbent plug 220 described above.
To inflate and deflate the balloon 1236, the apparatus 1200 includes an air delivery lumen 1240, an air pump 1242, and a release valve 1244. In
In this arrangement, the absorbent sheath 1238 and the balloon 1236 can be inserted into the nasal cavity 100 and positioned adjacent to the target tissue with the balloon 1236 in the deflated state. After the absorbent sheath 1238 and the balloon 1236 are positioned adjacent to the target tissue in the nasal cavity 100, the air pump 1242 can be activated to supply air through the air delivery lumen 1240 in the elongated shaft 1212. Within examples, the air pump 1242 can be manually operated and/or electrically operated.
Responsive to the air pump 1242 supplying the air to the balloon 1236, the balloon 1236 expands from the deflated state to the inflated state and, thus, causes the absorbent sheath 1238 to expand and contact the target tissue in the nasal cavity 100 so as to deliver the anesthetic agent to the contacted target tissue. Until the release valve 1244 is actuated, the release valve 1244 inhibits (or prevents) the air egressing from the balloon 1236 (i.e., the release valve 1244 ensures that air flow is unidirectional toward to the distal end 1216 of the elongated shaft 1212).
After the absorbent sheath 1238 has contacted the target tissue for sufficient to time to deliver the anesthetic agent to the target tissue, the release valve 1244 can be actuated to return the balloon from the inflated state to the deflated state. Responsive to the balloon 1236 reducing in size (e.g., in the deflated state), the balloon 1236 and the absorbent sheath 1238 can be withdrawn from the nasal cavity 100. Thus, by inserting and withdrawing the balloon 1236 and the absorbent sheath 1238 while the balloon is in the deflated state, patient discomfort can be reduced (or minimized).
As described above, the balloon 1236 and the absorbent sheath 1238 can be inserted into the nasal cavity 100 with the balloon 608 in the deflated state such that the balloon 1236 and the absorbent sheath 1238 have a relatively slim profile, as shown in
As shown in
The absorbent sheath 1238 can be held in contact with target tissue via the balloon 1236 in the inflated state for a predetermined period of time to achieve an anesthetic effect, as shown in
In one example, the absorbent sheath 1238 can be mildly adhesive or otherwise have a means to stay in contact with the target tissue even after the balloon 1236 is deflated, as shown in
In one implementation, the balloon 1236 can decouple from the absorbent sheath 1238 responsive to deflation of the balloon 1236. Additionally, within examples, the apparatus 1200 can include a removal member (e.g., the removal member 226) that can facilitate removing the absorbent sheath 1238 from the nasal cavity 100 following application of the anesthetic agent. In one example, the removal member can include a string and/or braided wire coupled to the absorbent sheath 1238, and the removable member can be exposed responsive to the balloon 1236 decoupling from absorbent sheath 1238.
In the example shown in
The delivery cannula 1348 and the expandable member 1350 can have a combined length, L1, (e.g., along a longitudinal axis) between approximately 100 mm and approximately 200 mm. The delivery cannula 1348 is coupled to the expandable member 1350 at an interface 1354. In an example, the delivery cannula 1348 can be constructed of a semi-rigid plastic or metal material, and the delivery cannula 1348 can have an outer surface that is rigid between a proximal end 1356 and the interface 1354 with the expandable member 1350.
At the interface 1354, the delivery cannula 1348 is coupled to the expandable member 1350 superficially and inserts into an internal layer 1358 (Layer 3) of the expandable member 1350, as shown in
Within examples, the dispensing tool 1346 can have a design similar to a syringe. For example, the dispensing tool 1346 can include a container body 1366 that defines an internal chamber in which the expanding agent 1352 is contained. Additionally, for example, the dispensing tool 1346 can include a plunger 1368 having a stopper 1370 that is axially movable in the internal chamber to dispense the expanding agent 1352 from a dispense end 1372 of the dispensing tool 1346. The dispense end 1372 is configured to couple with the central lumen 1362 at the mating feature 1364. As examples, the expanding agent 1352 can include saline, a gel, and/or an activating fluid that mixes with a mating fluid and thereby causes the internal layer 1358 to expand.
Within examples, the expandable member 1350 is actuatable between a collapsed state and an expanded state. In one implementation, when the expandable member 1350 is in the collapsed state, the expandable member 1350 can be approximately 30 mm to approximately 100 mm in length (L2) along the longitudinal axis, less than approximately 2 mm in thickness, and approximately 5 mm to approximately 20 mm in height. Also in this implementation, when the expandable member 1350 is in the expanded state, the thickness of the expandable member 1350 can be greater than approximately 3 mm, the height can be at least 20% greater than the height of the expandable member 1350 in the collapsed state, and the length can remain approximately the same as in the collapsed state (i.e., the expandable member 1350 can have a negligible change in the length (L2)).
Within examples, the expandable member 1350 can be constructed of an absorbent outer layer 1374 (Layer 1) that is configured to absorb a therapeutic agent or mixture of agents. As examples, the absorbent outer layer 1374 can include one or more of a cotton, a terrycloth, and/or a sponge-like material. Also, within examples, the absorbent outer layer 1374 can have a thickness of approximately 0.25 mm to approximately 0.5 mm.
The absorbent outer layer 1374 can surround the expandable member 1350 on at least three sides. An intermediate layer 1376 (Layer 2) of the expandable member 1350 can be constructed of a thin film that inhibits (or prevents) fluid from passing through the intermediate layer 1376 to more internal layers (e.g., the internal layer 1358) for a period of time (e.g., several minutes).
Within examples, the intermediate layer 1376 can have a thickness that is less than approximately 0.005 mm and be constructed from a compliant polymer (such as, e.g., latex/urethane) or from a dissolvable substance (such as, e.g., sugar or Kollidon). As shown in
As shown in
As shown in
In examples of a method for use of a system, for example as illustrated in
In additional or alternative examples, a catheter can be used that can spray an anesthetic agent directly into one or more regions of interest. Within examples, the catheter can eject the anesthetic agent with a force to project the anesthetic agent against tissue walls in the nasal cavity 100. Also, within examples, the catheter can reduce (or minimize) an amount of the anesthetic agent that reaches a patient's throat. Accomplishing either of these stated objectives represents a marked improvement over devices and techniques in the prior art, which tend to be deployed by syringes or other low pressure mechanisms, leading to inaccurate placement, drippage, and the eventually migration of the anesthetic agent to the patient's throat.
Within examples, the catheter shaft 1484 can be disposable. Also, within examples, the catheter shaft 1484 can be coupled to the handle region 1418 by a threaded connection 1490 and/or using another connection means known to those skilled in the art.
In examples, the loading port 1480 is configured to receive a liquid anesthetic agent (e.g., via a luer fitting or another configuration known to those skilled in the art). The anesthetic agent can then flow from the loading port 1480 to the one or more output ports 1488 at the distal end of the catheter 1400 via an internal lumen (not shown). The one or more output ports 1488 (and/or one or more channels leading to the one or more output ports 1488) are shaped and configured to convert a liquid anesthetic agent into a fine mist as pressured air released into the air intake port 1482 drives the anesthetic agent out of the catheter 1400 towards the target tissue. This combination of outward spraying pressure and fine mist achieves multiple objectives: (a) allowing for application of the anesthetic agent even to regions in the nasal cavity 100 that the catheter 1400 cannot contact directly; (b) ensuring broad coverage due to the dispersive nature of the mist; and (c) due to the fine nature of the mist and the associated surface tension of the mist particles interacting with the target tissue. The drippage of the anesthetic agent into unwanted regions outside the target tissue (e.g., towards the patient's throat) can be avoided provided that a limited amount of the anesthetic agent is applied in each region.
In examples, the one or more output ports 1488 can be fixed to release the anesthetic agent in a stable set of directions relative to the catheter 1400. In examples, the catheter shaft 1484 and/or the one or more output ports 1488 can move either automatically or manually by the operator to adjust angles and/or directions at which the anesthetic agent is released from the one or more output ports 1488.
In examples, the air intake port 1482 can be configured to interface with a hand-pump or other source of compressed air. In examples, the air intake port 1482 can be replaced by a syringe/plunger mechanism or other suitable mechanism for producing the pressure gradient to drive an anesthetic through the catheter lumen and out of the one or more output ports 1488.
In examples, the catheter 1400 is configured to dispense the anesthetic agent including one or more of a gel, a foam, and/or other forms. In examples, the one or more output ports 1488 may not be configured to produce a mist, but can instead be configured to use the pressure generated by the catheter 1400 to deploy the anesthetic agent to various regions.
Referring now to
Additionally, as shown in
The catheter 1500 can be particularly useful when deploying anesthesia in certain patient anatomical regions. For example, as shown in
The anesthetic agent (e.g., a mist or liquid spray) can be sprayed onto the target tissue via the one or more output ports 1588, and excess anesthetic agent can migrate downstream and be trapped by the occlusion balloon 1594. Once applying the anesthetic agent is complete, the suction port 1596 can be used to remove excess anesthetic agent from a region at the occlusion balloon 1594 and the excess anesthetic agent can be supplied through the catheter 1500 to the waste reservoir 1598. At the waste reservoir 1598, the excess anesthetic agent can be collected by the operator and discarded. The occlusion balloon 1594 can then be deflated, and the thin extension 1592 can then be retracted into the catheter 1400.
Examples can include various combinations of the approaches described above. As one illustrative example, a balloon or tamponade (e.g., an absorbent plug) approach can be first implemented to achieve bulk anesthetic effect. This can be followed by a mist or spray or gel/foam application to fine-tune the anesthetic effect and ensure coverage of particularly irregularly-shaped regions of tissue.
In examples, devices can include temperature-sensitive components that assist with deployment. In examples, a tamponade structure is condensed within a temperature-sensitive polymer casing. After placement in the nasal cavity in contact with the mucosal tissue, the polymer begins to warm as it absorbs heat from the body. Once it reaches a pre-determined temperature, the polymer begins to break-down, and the tamponade can move from its condensed size to a larger size that better conforms with the region of interest.
In examples, vacuum suction can be used. For example, a tamponade structure at the distal end of an insertion probe can include small openings in one or more locations, said openings being connected to an airflow lumen that traverses the length of the insertion probe and connects to a negative pressure source, for example a mild suction unit. In alternative examples, this lumen connects to a manual air pump and valve system that allows a user to create and maintain a negative pressure until a valve is adjusted to release this negative pressure. Negative pressure created at the openings in the tamponade structure will create a mild vacuum effect that draws the tamponade surface and the tissue surface closer to one another. This process can improve contact of the tamponade to the tissue surface, particularly in tissue regions that have irregular shape. The mild negative pressure/vacuum applied to soft tissues can stretch tissue membranes in such a way that it improves the penetration of anesthetics or other therapeutic agents. This latter feature can allow for shorter procedure time during the application of anesthesia.
Examples of systems and methods can include the application of cold air to the nasal cavity prior to and/or during procedures. Studies have demonstrated that some pain sensations driven by afferents in the nasal cavity, for example the sensation commonly referred to as the “ice cream headache,” are inhibited in cold weather. During some procedures, for example cryoblation procedures that involve the application of cold temperatures to tissues, a possible side effect is patient discomfort similar to that of the ice cream headache. Applying cold temperature air to the nasal cavity can minimize or eliminate the potential manifestation of these types of discomfort. In examples, thin nasal cannula commonly used in clinical practice can be inserted into the nasal cavity to provide chilled low-flow oxygen for the patient to breath.
In examples, a therapeutic agent such as an anesthetic can be combined with a carrier molecule substance, for example a chemical compound similar to or with similar properties to dimethyl sulfoxide (DMSO). This combination allows for more rapid and/or more complete absorption of the agent by tissue, further increasing the utility of the technology described herein.
In examples, delivery of an anesthetic or other substance can be enhanced via energy delivery methods such as ultrasound, iontophoresis, or electrophoresis. These energy methods can use mild pressure waves or electrical currents to help widen tissue pores, increase local blood flow, allow for vasodilation, drive ions across membranes, or cause other effects that can aid in the more rapid or complete absorption of therapeutic agents into tissue.
In examples, a nasal cavity tool configured for the delivery of an anesthetic also includes an ultrasound transducer. Upon insertion, the ultrasound transducer is configured to transmit ultrasound energy into tissues targeted for treatment with an anesthetic. In examples, ultrasound frequencies of 5-15 MHz will be used in conjunction with local spatial peak, temporal average intensities of 0.1-100 W/cm2. Ultrasound energy can be applied to tissue prior to, during, or following the application of a substance to tissue (or in any combination of these time periods) in order to enhance the delivery of the substance.
In examples, devices can be used to insulate the nasal cavity from noxious stimuli induced from contact with various tools. This can be accomplished with or without the use of anesthetic agents in combination. In examples, a small catheter contains a detachable and expandable foam tube at its distal end. This foam tube is initially held in a small diameter (1-5 mm) collapsed state by an introducer sheath. After insertion into the nasal cavity, the operator can remove the introducer sheath, allowing the foam tube to expand and make contact with nasal cavity walls. The insertion tool can then be removed to allow different tools to enter the nasal cavity. In examples, the foam tube has a thin wall of approximately 1 mm in diameter and a wider open central lumen of approximately 5 mm in diameter to allow the passage of tools through this lumen. In examples, the foam material has a consistency that is not irritating to the nasal cavity walls yet robust enough to insulate the walls from the sensation of a nasal tool or device making incidental contact with the foam. With the foam bumper in place, tools can be inserted into the nasal cavity with less patient discomfort as incidental contact with the sides of the nasal cavity will no longer produce an irritating sensation. Upon completion of a procedure, the foam bumper can be removed from the nasal cavity. In examples, the foam bumper is comprised of a bioabsorbable material that is naturally absorbed or otherwise flushed out by the body at a time following the procedure.
In examples, the foam bumper is manually expanded using for example a balloon catheter which can be inflated to expand the bumper and then removed from the nasal cavity once the bumper is in place. In examples, the bumper can be comprised of other soft, mechanically-insulating materials aside from foam—for example, a cotton or terrycloth material.
Further, the disclosure comprises examples according to the following clauses:
Clause 1. An apparatus for delivering an anesthetic agent to a target tissue in a nasal cavity of a patient, the apparatus comprising: an elongated shaft with a proximal end and a distal end; an absorbent plug coupled to the distal end of the elongated shaft, wherein the absorbent plug is configured to occupy a first volume in a compressed state and a second volume in an uncompressed state, wherein the second volume is greater than the first volume, and wherein the absorbent plug is configured to store an anesthetic agent and deliver the anesthetic agent to the target tissue in the nasal cavity by contacting the target tissue in the uncompressed state; and a sheath at least partially covering the absorbent plug, wherein the sheath retains the absorbent plug in the compressed state when positioned at least partially over the absorbent plug, and wherein removal of the sheath allows for the absorbent plug to expand to the uncompressed state.
Clause 2. The apparatus of Clause 1, wherein the absorbent plug is pre-infused with the anesthetic agent prior to an insertion into the nasal cavity to deliver the anesthetic agent.
Clause 3. The apparatus of any one of Clauses 1 or 2, wherein the sheath is translatable relative to the elongated shaft and the absorbent plug, wherein the sheath is translatable in a direction from the distal end toward the proximal end from a first position to a second position, wherein, in the first position, the sheath covers at least a portion of the absorbent plug so that the absorbent plug is in the compressed state, and wherein, in the second position, the sheath does not cover the absorbent plug and the absorbent plug is in the uncompressed state.
Clause 4. The apparatus of any one of Clauses 1-3, the sheath comprises a dissolvable coating at least partially covering the absorbent plug in the compressed state.
Clause 5. An apparatus for delivering an anesthetic agent to a target tissue in a nasal cavity of a patient, the apparatus comprising: an elongated shaft with a proximal end and a distal end; an absorbent plug coupled to the distal end of the elongated shaft, wherein the absorbent plug is configured to store the anesthetic agent and deliver the anesthetic agent to the target tissue in the nasal cavity by contacting the target tissue; and a lumen extending through the elongated shaft and into the absorbent plug, wherein the lumen comprises a one or more ports within the absorbent plug configured to deliver the anesthetic agent into the absorbent plug to be absorbed by the absorbent plug.
Clause 6. The apparatus of Clause 5, wherein the absorbent plug is configured to expand responsive to the anesthetic agent being absorbed by the absorbent plug.
Clause 7. The apparatus of any one of Clauses 5 or 6, further comprising: a second lumen extending through the elongated shaft and into the absorbent plug, wherein the second lumen comprises one or more second ports within the absorbent plug configured to apply suction to remove the anesthetic agent from the absorbent plug and shrink the absorbent plug from an uncompressed state to a compressed state.
Clause 8. An apparatus for delivering an anesthetic agent to a target tissue in a nasal cavity of a patient, the apparatus comprising: an elongated shaft with a proximal end and a distal end; a balloon coupled to the distal end of the elongated shaft; and an absorbent sheath covering the balloon, wherein the absorbent sheath is configured to store an anesthetic agent and deliver the anesthetic agent to the target tissue in the nasal cavity by the target tissue contacted by the absorbent sheath, wherein the absorbent sheath is configured to be inserted into the nasal cavity proximate to the target tissue with the balloon in a deflated state, and wherein the balloon is configured to expand from the deflated state to an inflated state to cause the absorbent sheath to expand and contact the target tissue in the nasal cavity so as to deliver the anesthetic agent to the target tissue contacted by the absorbent sheath.
Clause 9. The apparatus of Clause 8, wherein the absorbent sheath and the balloon are configured so that the balloon is removable from the absorbent sheath after the absorbent sheath contacts the target tissue in the nasal cavity.
Clause 10. The apparatus of any one of Clauses 8 or 9, further comprising an air delivery lumen having a first end coupled to the balloon and a second end configured to couple to an air pump.
Clause 11. The apparatus of any one of Clauses 8-10, further comprising a release valve coupled to the second end of the air delivery lumen, wherein the release valve is configured to inhibit air from egressing from the balloon, and wherein the release valve is configured to be actuated to release the air from the balloon.
Clause 12. An apparatus for delivering an anesthetic agent to a target tissue in a nasal cavity of a patient, the apparatus comprising: an elongated shaft with a proximal end and a distal end; an expandable member coupled to the distal end of the elongated shaft, wherein the expandable member comprises an absorbent outer layer, wherein the absorbent outer layer is configured to store an anesthetic agent and deliver the anesthetic agent to the target tissue in the nasal cavity by contacting the target tissue; and a malleable spine within the expandable member configured to be formable to a plurality of shapes in order to match an anatomy of the nasal cavity, wherein the expandable member is configured to be inserted into the nasal cavity proximate to the target tissue in a deflated stated and then expanded to an inflated state so that the absorbent outer layer contacts the target tissue in the nasal cavity so as to deliver the anesthetic agent to the target tissue contacted by the absorbent outer layer.
Clause 13. The apparatus of Clause 12, further comprising: a dispensing tool comprising: a container body that defines an internal chamber, and a dispensing end configured to dispense an expanding agent from the internal chamber; and a delivery cannula coupled to the dispensing end of the dispensing tool and the expandable member.
Clause 14. The apparatus of Clause 13, wherein the expandable member comprises an internal layer coupled to the delivery cannula, wherein the expandable member is configured to expand responsive to the dispensing tool supplying, via the delivery cannula, the expanding agent to the internal layer.
Clause 15. The apparatus of Clause 13 or Clause 14, wherein the expandable member further comprises an intermediate layer that encapsulates the internal layer, and wherein the intermediate layer is configured to inhibit fluid from passing through the intermediate layer to the internal layer.
Clause 16. An apparatus for delivering a liquid anesthetic agent to a target tissue in a nasal cavity of a patient, the apparatus comprising: an elongated shaft with a proximal end and a distal end; an air intake port disposed at the proximal end of the elongated shaft configured to receive compressed air to drive the liquid anesthetic agent towards the distal end of the elongated shaft; a loading port disposed at the proximal end of the elongated shaft configured to receive the liquid anesthetic agent; and one or more dispensing ports disposed at the distal end of the elongated shaft and configured to dispense the liquid anesthetic agent onto the target tissue in the nasal cavity.
Clause 17. The apparatus of Clause 16, further comprising: an occlusion balloon coupled to the distal end of the elongated shaft, wherein the occlusion balloon is configured to be inflated within the nasal cavity to prevent excess anesthetic delivered to the target tissue from dripping into a throat of the patient.
Clause 18. A method for delivering an anesthetic agent to a target tissue in a nasal cavity of a patient, the method comprising: inserting an apparatus including an absorbent plug into the nasal cavity; positioning the absorbent plug adjacent to the target tissue in the nasal cavity; and deploying the anesthetic agent via the absorbent plug to the target tissue.
Clause 19. The method of Clause 18, wherein inserting the apparatus including the absorbent plug into the nasal cavity comprises inserting the apparatus into the nasal cavity while the absorbent plug is in a compressed state and has a first size.
Clause 20. The method of Clause 19, further comprising: after positioning the absorbent plug adjacent to the target tissue in the nasal cavity, expanding the absorbent plug to an uncompressed state in which the absorbent plug has a second size, wherein the second size of the absorbent plug in the uncompressed state is greater than the first size of the absorbent plug in the compressed state.
Clause 21. The method of any one of Clauses 18-20, wherein deploying the anesthetic agent comprises contacting the target tissue with the absorbent plug.
Clause 22. The method of any one of Clauses 18-21, wherein positioning the absorbent plug adjacent to the target tissue comprises removing a sheath to expose and expand a size of the absorbent plug.
Clause 23. The method of any one of Clauses 18-22, further comprising: reducing a size of the absorbent plug; and after reducing the size of the absorbent plug, removing the absorbent plug from the nasal cavity.
Clause 24. The method of any one of Clauses 18-23, further comprising: prior to inserting the apparatus into the nasal cavity, broadly applying an anesthetic agent in the nasal cavity.
Clause 25. The method of Clause 24, wherein broadly applying the anesthetic agent in the nasal cavity comprises applying the anesthetic agent via a nasal spray or a pleget swab.
Clause 26. The method of any one of Clauses 18-25, further comprising: after positioning the absorbent plug adjacent to the target tissue in the nasal cavity, decoupling an elongated shaft of the apparatus from the absorbent plug.
Clause 27. A method for delivering an anesthetic agent to a target tissue in a nasal cavity of a patient, the method comprising: inserting the apparatus of any one of Clauses 1-4 into the nasal cavity; positioning the absorbent plug adjacent to the target tissue in the nasal cavity; and deploying the anesthetic agent via the absorbent plug to the target tissue.
Clause 28. A method for delivering an anesthetic agent to a target tissue in a nasal cavity of a patient, the method comprising: inserting the apparatus of any one of Clauses 5-7 into the nasal cavity; positioning the absorbent plug adjacent to the target tissue in the nasal cavity; and deploying the anesthetic agent via the absorbent plug to the target tissue.
Clause 29. A method for delivering an anesthetic agent to a target tissue in a nasal cavity of a patient, the method comprising: inserting the apparatus of any one of Clauses 8-11 into the nasal cavity; positioning the balloon and the absorbent sheath adjacent to the target tissue in the nasal cavity; and deploying the anesthetic agent via the balloon and the absorbent sheath to the target tissue.
Clause 30. A method for delivering an anesthetic agent to a target tissue in a nasal cavity of a patient, the method comprising: inserting the apparatus of any one of Clauses 9-15 into the nasal cavity; positioning the expandable member adjacent to the target tissue in the nasal cavity; and deploying the anesthetic agent via the absorbent outer layer of the expandable member to the target tissue.
Clause 31. A method for delivering an anesthetic agent to a target tissue in a nasal cavity of a patient, the method comprising: inserting the apparatus of any one of Clauses 16-17 into the nasal cavity; positioning the one or more dispensing ports adjacent to the target tissue in the nasal cavity; and deploying the anesthetic agent via the one or more dispensing ports to the target tissue.
From the foregoing, it will be appreciated that specific examples of the technology have been described herein for purposes of illustration, but that various modifications can be made without deviating from the spirit and scope of the various examples of the technology. Further, while various advantages associated with certain examples of the technology have been described above in the context of those examples, other examples can also exhibit such advantages, and not all examples need necessarily exhibit such advantages to fall within the scope of the invention. Accordingly, the invention is not limited, except as by the appended claims.
The teachings of the technology provided herein can be applied to other systems, not necessarily the system described above. The elements and acts of the various examples described above can be combined to provide further implementations of the technology. Some alternative implementations of the technology can include not only additional elements to those implementations noted above, but also can include fewer elements. Further any specific numbers noted herein are only examples; alternative implementations can employ differing values or ranges, and can accommodate various increments and gradients of values within and at the boundaries of such ranges. Furthermore, the described features, advantages, and characteristics of the present technology can be combined in any suitable manner in one or more examples. One skilled in the relevant art will recognize that the present technology can be practiced without one or more of the specific features or advantages of a particular example. In other instances, additional features and advantages can be recognized in certain examples that cannot be present in all examples of the present technology.
The description of the different advantageous arrangements has been presented for purposes of illustration and description, and is not intended to be exhaustive or limited to the examples in the form disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art. Further, different advantageous examples may describe different advantages as compared to other advantageous examples. The example or examples selected are chosen and described in order to explain the principles of the examples, the practical application, and to enable others of ordinary skill in the art to understand the disclosure for various examples with various modifications as are suited to the particular use contemplated.
This application claims the benefit of priority to U.S. Provisional Application No. 62/644,137 entitled “SYSTEMS AND METHODS FOR TREATING THE NASAL CAVITY,” filed on Mar. 16, 2018 and U.S. Provisional Application No. 62/652,706 entitled “SYSTEMS AND METHODS FOR TREATING THE NASAL CAVITY,” filed on Apr. 4, 2018, the contents of which are hereby incorporated by reference in their entirety.
Number | Date | Country | |
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62644137 | Mar 2018 | US | |
62652706 | Apr 2018 | US |