Patent Application
20230201506
All patents, patent applications, and publications cited herein are hereby incorporated by reference in their entirety. The disclosures of these publications in their entireties are hereby incorporated by reference into this application in order to more fully describe the state of the art as known to those skilled therein as of the date of the invention described and claimed herein.
This patent disclosure contains material that is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure as it appears in the U.S. Patent and Trademark Office patent file or records, but otherwise reserves any and all copyright rights.
Not applicable.
The present invention is directed to design and functional improvements of the cannula portion of tracheostomy and endotracheal tubes.
Tracheostomy cannulas and endotracheal tubes are commonly used devices for creating or securing a temporary or permanent breathing passage. However current tracheostomy and endotracheal systems exhibit significant inefficiencies including problems with humidification of incoming air, delivery of oxygen, and delivery of pharmaceutical agent.
Aspects of the invention are drawn to a respiratory cannula system.
For example, embodiments can comprise an outer cannula and an inner cannula. In embodiments, the outer cannula comprises an outer cannula body, an outer cannula lumen, and a port in the form of a hole, gap, notch, or channel extending through the outer cannula body. In embodiments, the inner cannula further comprises an inner cannula body and an inner cannula lumen. In embodiments, the outer cannula is configured to receive and hold at least a portion of the inner cannula body within at least a portion of the outer cannula lumen; and a chamber exists in the outer cannula lumen when the inner cannula is disposed therein, the chamber being in fluid communication with a patient's respiratory system.
In embodiments, the outer cannula lumen comprises a diameter that is slightly larger than a diameter of the inner cannula body; and the chamber exists as a space within the outer cannula lumen when at least a portion of the inner cannula body resides therein.
In embodiments, the diameter of the inner cannula body is about 80% of the diameter of the outer cannula lumen.
In embodiments, the outer cannula lumen comprises a diameter of about 10 mm or less. For example, the outer cannula lumen comprises a diameter of about 6 mm, about 7 mm, about 8 mm, about 9 mm, or about 10 mm.
In embodiments, the inner cannula body comprises a diameter of about 8.5 mm or less. For example, the inner cannula body comprises a diameter of about 4.5 mm, about 5.5 mm, about 6.5 mm, about 7.5 mm, or about 8.5 mm.
In embodiments, the outer cannula lumen comprises a diameter of about 10 mm or less and the inner cannula body comprise a diameter of about 8.5 mm or less. For example, the outer cannula lumen comprises a diameter of about 8 mm and inner canula body comprises a diameter of about 6.5 mm.
In embodiments, the port comprises a tubular extension extending from an external surface of the outer cannula body.
In embodiments, the port permits fluid communication between an external source and the chamber.
In embodiments, the port comprises a valve to selectively control fluid communication with the chamber.
In embodiments, the port further comprises a Luer-lock or Luer-taper hub.
In embodiments, the outer cannula comprises at least two ports.
In embodiments, the inner cannula body further comprises at least one vent that is configured to permit fluid communication between the inner cannula lumen and the chamber, the port, or a combination thereof. For example, the at least one vent comprises a plurality of perforations disposed along the inner cannula body.
In embodiments, the external source is configured to introduce oxygen, humidified air, a pharmaceutical agent, or a combination thereof into the chamber. For example, the pharmaceutical agent comprises one or more aerosolized drugs. For example, the pharmaceutical agent comprises albuterol, dexamethasone, tobramycin, any other medication that can be delivered via a nebulizer, or a combination thereof.
In embodiments, the outer cannula, inner cannula, or both comprise a medical grade metal, a medical-grade polymer, or a combination thereof. For example, the medical grade metal comprises stainless steel, titanium, tantalum, gold, platinum, palladium, or a combination thereof. For example, the outer cannula, inner cannula, or both comprise a silicone elastomer, sterilizable plastic, polytetrafluoroethylene, polyether block amide, polyvinyl chloride, or a combination thereof.
In embodiments, the outer cannula, inner cannula, or both are reusable.
In embodiments, the outer cannula, inner cannula, or both are disposable.
Aspects of the invention are also drawn towards a method of delivering humidified air to a patient with a tracheostomy. For example, the method comprises obtaining a respiratory cannula system as described herein, inserting the outer cannula through a stoma and into the trachea of a patient; inserting the inner cannula into the outer cannula lumen; attaching an external source of humidified air to the port of the outer cannula; starting the flow of humidified air through the port, into the chamber, and into the respiratory system of the patient.
Aspects of the invention are still further drawn towards a method of delivering oxygen to a patient with a tracheostomy. For example, the method comprises obtaining a respiratory cannula system as described herein; inserting the outer cannula through a stoma and into the trachea of a patient; inserting the inner cannula into the outer cannula lumen; attaching an external source of oxygen to the port of the outer cannula; starting the flow of oxygen through the port, into the chamber, and into the respiratory system of the patient.
Still further, aspects of the invention are drawn towards a method of delivering a pharmaceutical agent to a patient with a tracheostomy. For example, the method comprises obtaining a respiratory cannula system as described herein; inserting the outer cannula through a stoma and into the trachea of a patient; inserting the inner cannula into the outer cannula lumen; attaching an external source of the pharmaceutical agent to the port of the outer cannula; starting the flow of the pharmaceutical agent through the port, into the chamber, and into the respiratory system of the patient.
Aspects of the invention are also drawn towards an outer cannula for use in a respiratory cannula system. For example, embodiments comprise an outer cannula body, an outer cannula lumen, and a port in the form of a hole, gap, notch, or channel extending through the outer cannula body; the outer cannula being configured to receive and hold at least a portion of an inner cannula body within at least a portion of the outer cannula lumen; the outer cannula lumen comprising a diameter that is slightly larger than a diameter of the inner cannula body such that a chamber exists within the outer cannula lumen when an inner cannula body resides therein; the port being in fluid communication with the chamber; and the chamber being in fluid communication with a patient's respiratory system.
In embodiments, the port comprises a tubular extension extending from an external surface of the outer cannula body.
Aspects of the invention are also drawn towards an inner cannula for use in a respiratory cannula system. For example, embodiments comprise an inner cannula body and an inner cannula lumen; at least a portion of the inner cannula body being configured to reside within an outer cannula lumen comprising a diameter that is slightly larger than a diameter of the inner cannula body such that a chamber exists within the outer cannula lumen when at least a portion of the inner cannula body is disposed therein.
In embodiments, the inner cannula body further comprises at least one vent that is configured to permit fluid communication between the inner cannula lumen and the chamber.
In embodiments, the at least one vent comprises a plurality of perforations disposed along the inner cannula body.
Further, aspects of the invention are drawn towards a kit for use in a respiratory cannula system. For example, embodiments comprise an outer cannula further comprising (1) an outer cannula body, (2) an outer cannula lumen, and (3) a port in the form of a hole, gap, notch, or channel extending through a portion of the outer cannula body; an inner cannula further comprising an inner cannula body and an inner cannula lumen; wherein the outer cannula is configured to receive and hold at least a portion of the inner cannula body within at least a portion of the outer cannula lumen; and a chamber exists in the outer cannula lumen when the inner cannula is disposed therein, the chamber being in fluid communication with a patient's respiratory system. Embodiments can comprise instructions for use of the kit. Embodiments can further comprise a pharmacological agent for distribution into the respiratory system of the patient through the port of the outer cannula.
Other objects and advantages of this invention will become readily apparent from the ensuing description.
Certain illustrations, charts, or flow charts are provided to allow for a better understanding for the present invention. It is to be noted, however, that the drawings illustrate only selected embodiments of the inventions and are therefore not to be considered limiting of scope. Additional and equally effective embodiments and applications of the present invention exist.
Detailed descriptions of one or more embodiments are provided herein. It is to be understood, however, that the present invention can be embodied in various forms. Therefore, specific details disclosed herein are not to be interpreted as limiting, but rather as a basis for the claims and as a representative basis for teaching one skilled in the art to employ the present invention in any appropriate manner.
The singular forms “a,” “an,” and “the” include plural reference unless the context clearly dictates otherwise. The use of the word “a” or “an” when used in conjunction with the term “comprising” in the claims and/or the specification can mean “one,” but it is also consistent with the meaning of “one or more,” “at least one,” and “one or more than one.”
Wherever any of the phrases “for example,” “such as,” “including” and the like are used herein, the phrase “and without limitation” is understood to follow unless explicitly stated otherwise. Similarly, “an example,” “exemplary” and the like are understood to be nonlimiting.
The term “substantially” allows for deviations from the descriptor that do not negatively impact the intended purpose. Descriptive terms are understood to be modified by the term “substantially” even if the word “substantially” is not explicitly recited. Therefore, for example, the phrase “wherein the lever extends vertically” means “wherein the lever extends substantially vertically” so long as a precise vertical arrangement is not necessary for the lever to perform its function.
The terms “comprising” and “including” and “having” and “involving” (and similarly “comprises,” “includes,” “has,” and “involves”) and the like are used interchangeably and have the same meaning. Specifically, each of the terms is defined consistent with the common United States patent law definition of “comprising” and is therefore interpreted to be an open term meaning “at least the following,” and is also interpreted not to exclude additional features, limitations, aspects, etc. Thus, for example, “a process involving steps a, b, and c” means that the process includes at least steps a, b and c. Wherever the terms “a” or “an” are used, “one or more” is understood, unless such interpretation is nonsensical in context.
As used herein the term “about” is used herein to mean approximately, roughly, around, or in the region of When the term “about” is used in conjunction with a numerical range, it modifies that range by extending the boundaries above and below the numerical values set forth. In general, the term “about” is used herein to modify a numerical value above and below the stated value by a variance of 20 percent up or down (higher or lower).
For purposes of the present disclosure, it is noted that spatially relative terms, such as “up,” “down,” “right,” “left,” “beneath,” “below,” “lower,” “above,” “upper” and the like, can be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over or rotated, elements described as “below” or “beneath” other elements or features would then be oriented “above” the other elements or features. Thus, the exemplary term “below” can encompass both an orientation of above and below. The device can be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
The terms “subject” and “patient” as used herein include all members of the animal kingdom including, but not limited to, mammals, animals (e.g., cats, dogs, horses, swine, etc.) and humans.
The term “caretaker” as used herein refers to any person, group, or entity who has assumed responsibility to care for the subject or patient or to prepare the therapeutic device for use. By way of non-limiting example, a caretaker can include a physician, a nurse, a clinician, a pharmacist, a physician's assistant, any employee of a clinical facility, a family member of the subject, a friend or acquaintance of the subject, an employee of the subject, or any other person, group, or entity who assumes responsibility to care for the subject. In certain instances, the subject can act as a caretaker, such as when tending to his or her own wounds.
Disclosed herein is an improved cannula system for tracheostomies and endotracheal tubes. In various exemplary embodiments, the present invention provides significant improvements including oxygen and drug delivery capabilities. The disclosed embodiments further improve the utility, efficiency and capabilities of these indwelling cannulas while also reducing potential complications including mucous plugging.
The outer cannula further comprises a lumen (more clearly seen at 321 of
In embodiments, the port 313 is in fluid communication with the lumen 321 of the outer cannula 300 such that the port 313 is in fluid communication with the chamber 421 when the body of the inner cannula 210 is disposed within the lumen of the outer cannula 321.
In embodiments, the tubular extension 312 of the port 313 extends at about a 45° angle from the wall 350 of the outer cannula 300. The tubular extension 212 can extend at any angle that provides convenient attachment/detachment of an external source thereto. The tubular extension 312 can be substantially perpendicular to the wall 350 of the outer cannula 300. In certain embodiments, the tubular extension 312 extends from the wall 350 at an angle of between about 15° to about 90°, inclusive. In embodiments, the tubular extension 312 extends at an angle of between about 30° and about 70°, inclusive. The tubular extension 312 can extend at an angle of between about 40° to about 60°, inclusive. In embodiments, the tubular extension 312 extends from the wall 350 at an angle that ranges from about 45° to about 55°. The tubular extension 312 can extend at an angle of about 20°, about 30°, about 40°, about 50°, about 60°, about 70°, about 80°, or about 90°.
In one particular embodiment, the head 216 comprise a length of about 15 mm and a width of about 15 mm. In alternate embodiments, the head 216 comprise a length of less than about 5 mm. The head 216 can comprise a length of greater than 15 mm. In embodiments, the length of the head 216 ranges from about 5 mm to about 25 mm. The head 216 can comprise a length of between about 10 mm to about 20 mm. In embodiments, the head 216 comprises a length of about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm.
In one embodiment, the head 216 comprise a cross-sectional diameter of about 15 mm. In alternate embodiments, the head 216 comprise a diameter of less than about 5 mm. The head 216 can comprise a diameter of greater than 15 mm. In embodiments, the diameter of the head 216 ranges from about 5 mm to about 25 mm. The head 216 can comprise a diameter of between about 10 mm to about 20 mm. In embodiments, the head 216 comprises a diameter of about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm.
In one particular embodiment, the neck 214 comprise a length of about 12 mm and a width of about 8 mm. In alternate embodiments, the neck 214 comprise a length of less than about 1 mm. The neck 214 can comprise a length of greater than 12 mm. In embodiments, the length of the neck 214 ranges from about 1 mm to about 25 mm. The neck 214 can comprise a length of between about 7 mm to about 17 mm. In embodiments, the neck 214 comprises a length of about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm.
In one embodiment, the neck 214 comprise a cross-sectional diameter of about 8 mm. In alternate embodiments, the neck 214 comprise a diameter of less than about 1 mm. The neck 214 can comprise a diameter of greater than 8 mm. In embodiments, the diameter of the neck 214 ranges from about 1 mm to about 20 mm. The neck 214 can comprise a diameter of between about 2 mm to about 16 mm. In embodiments, the neck 214 comprises a diameter of about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 6 mm, about 7 mm, about 8mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm.
In one embodiment, the cross sectional diameter of the body 210 of the internal cannula is about 6.5 mm. In alternate embodiments, the body 210 comprise a diameter of less than about 1 mm. The body 210 can comprise a diameter of greater than 6.5 mm. In embodiments, the diameter of the body 210 ranges from about 1 mm to about 15 mm. The body 210 can comprise a diameter of between about 1 mm to about 12 mm. In embodiments, the body 210 comprises a diameter of about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm.
The body 210 of the inner cannula 200 is shown with an exemplary radius of curvature of about 58.5°. In certain embodiments, the radius of curvature is about the same as that of traditional, off-the-shelf cannulas. The radius of curvature can range from about 45° to about 75°. In embodiments, the radius of curvature of the outer cannula body is about 50°, about 51°, about 52°, about 53°, about 54°, about 55°, about 56°, about 57°, about 58°, about 59°, about 60°, about 61°, about 62°, about 63°, about 64°, or about 65°.
The lumen 221 within the lowest portion of the head 216 can comprise a diameter of about 6 mm. In embodiments, the lumen 221 within the lowest portion of the head 216 comprises a diameter of greater than 6 mm. The diameter of the lumen 221 within the lowest portion of the head 216 can be less than 6 mm. In certain embodiments, the diameter of the lumen 221 within the lowest portion of the head 216 ranges from between about 0.5 mm to about 20 mm. The diameter of the lumen 221 within the lowest portion of the head 216 can be between about 1 mm and about 15 mm. In embodiments, the lumen 221 within the lowest portion of the head 216 comprises a diameter of about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, or about 15 mm. The lumen 221 within the lowest portion of the head 216 can comprises a diameter that is equal to that the diameter of the lumen 221 within the body 210 of the internal cannula.
In an embodiment, the diameter of the lumen 221 within the body 210 of the internal cannula is about 6 mm. In embodiments, the lumen 221 within the body 210 comprises a diameter of greater than 6 mm. The diameter of the lumen 221 within body 210 can be less than 6 mm. In certain embodiments, the diameter of the lumen 221 within the body 210 ranges from between about 0.5 mm to about 20 mm. The diameter of the lumen 221 within the body 210 can be between about 1 mm and about 15 mm. In embodiments, the lumen 221 within the body 210 comprises a diameter of about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, or about 15 mm.
As shown in the various exemplary embodiments disclosed herein, the cannula system 100 permits simple and effective delivery of an external substance or compound into the respiratory system of a patient in need thereof The presently disclosed cannula system 100 allows for such delivery without the need for bulky, cumbersome, or uncomfortable adapters or attachments that are presently available on the market (see, for example
In use, the cannula system 100 can be implanted within a patient's trachea such that the lumen 221 of the internal cannula 200 and the chamber 421 are in fluid communication with the patient's respiratory system. In addition, the port 313 of the outer cannula 300 permits fluid communication between an external source and the chamber 421. As such, the port 313 permits the introduction of a substance or compound into the respiratory system of a patient while obviating the need to remove the inner cannula or otherwise interfere with the flow within the inner cannula.
In operation, the tubular extension 312 can be connected to an external source such that the external source delivers a substance or compound through the port 313, into the chamber 421, and ultimately into the respiratory system of the patient.
In various exemplary embodiments, the external source can be configured to introduce any substance or compound that can be useful in treating a patient. By way of non-limiting example, the external source can be configured to introduce oxygen, humidified air, a pharmaceutical agent, or a combination thereof into the chamber 421. Exemplary pharmaceutical agents include, but are not limited to albuterol, dexamethasone, tobramycin, any other medication that can be delivered via a nebulizer, or a combination thereof
In certain embodiments, the inner cannula can be provided with one or more vents, wherein each vent extends through the wall of the inner cannula body 210. Such vents permit any substance or compound delivered from the external source to enter into the lumen 221 of the internal cannula 200 before passing into the respiratory system of the patient.
Another aspect of the present invention includes a method of delivering an external compound or substance using the cannula system 100 in accordance with any embodiment disclosed within this specification or otherwise apparent from the descriptions herein. In embodiments, an outer cannula 300 is inserted into a stoma opening and in to the trachea of a patient. An internal cannula 200 can then be inserted within the lumen of the outer cannula 300. An external source can be secured to the port 313 of the outer cannula 300 and the external source can be engaged such that a substance or compound is introduced into the respiratory system of the patient.
In embodiments, the external source is attached to the port 313 via a Luer-lock hub or any other mechanism known to produce a reversible connection therebetween. In alternative embodiments, the external source is attached to the port 313 via a frictional connect, such as through the sliding of tubing over the tubular extension 312.
Also disclosed is a kit that includes a canula system 100 in accordance with any embodiment disclosed within this specification or otherwise apparent from the descriptions herein. In embodiments, the kit comprises an internal cannula 200, an outer cannula 300, and instructions for use or assembly of the cannula system 100. The instructions can be physically provided with the kit or accessible separately from the kit, such as via the retailer's or manufacturer's website.
Examples are provided below to facilitate a more complete understanding of the invention. The following examples illustrate the exemplary modes of making and practicing the invention. However, the scope of the invention is not limited to specific embodiments disclosed in these Examples, which are for purposes of illustration only, since alternative methods can be utilized to obtain similar results.
The disclosed technology centers around design and functional improvements of the cannula portion of tracheostomy and endotracheal tubes. Tracheostomy and endotracheal tubes are commonly used devices for creating or securing a temporary or permanent breathing passage. The commercial applications of tracheostomy and endotracheal tubes are well documented. The presently disclosed design improvements provide additional capabilities including oxygen and drug delivery capabilities. The design improves the utility, efficiency and capabilities of these indwelling cannulas while also reducing possible complications including mucous plugging.
These presently disclosed technology innovations help resolve existing problems with the use of tracheostomy and endotracheal tubes.
Those skilled in the art will recognize, or be able to ascertain, using no more than routine experimentation, numerous equivalents to the specific substances and procedures described herein. Such equivalents are considered to be within the scope of this invention, and are covered by the following claims.
This application claims priority from U.S. Provisional Application No. 63/028,107 filed on May 21, 2020, the entire contents of which are incorporated herein by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2021/033428 | 5/20/2021 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63028107 | May 2020 | US |
