FIELD OF THE INVENTION

This application relates to an apparatus for supplying supplemental oxygen or other gas to a patient via a nasal cannula.

BACKGROUND OF THE INVENTION

Dual prong nasal cannulas are generally used to deliver oxygen to a patient via the patient's nose. The most commonly used arrangement includes a dual prong nosepiece which is centered in a loop of vinyl tubing. The nosepiece openings are inserted in the nostrils with the tubing tucked behind the ears and around to the front of the patient below the chin. A slide adjustment may be used to draw it tight beneath the chin. Usually by the third or fourth day of using a dual prong nasal cannula, irritation of the skin and subcutaneous areas in contact with the cannulas and tubing begins and by the fifth day, the majority of patients have begun to use tissues and the like to relieve the soreness, pressure and irritation under the nose and around the ears. This soreness, pressure and irritation is often due to abrasion and interface pressure which is often caused by movement of the tight fitting tubing and cannulas and to the accumulation of moisture between the skin and the tubing and/or cannulas. As the slide is pulled tighter to keep the cannulas in the nostrils of the patient the irritation is only exacerbated and the subcutaneous layers of the skin are affected.

Thus, the use of a dual prong cannula can become quite uncomfortable for a patient and can lead to pressure ulcers. The comfort of the patient becomes even more critical, both to the patient and to the professionals attending the patient when the patient is also fitted with a naso- gastric or Levine tube. Now the nose becomes a fairly cluttered access route, and adhesive tape is often used, by application to the face, to get all the tubes to remain in place.

In addition to the discomfort and susceptibility to skin deterioration where supplemental oxygen is required, a patient may suffer from "free floating anxiety" as a result of reduced blood oxygen. Such a patient may believe something is wrong but cannot quite identify the problem, and may not be thinking clearly. Often such patients have feelings of claustrophobia and may attempt to remove the cannulas despite the fact that doing so may adversely affect the patient's condition. It is not uncommon to find the tubing disconnected or prongs displaced from the nose due to pulling from movement of the head, especially during sleep. Further, patient non- compliance or lack of cooperation may necessitate the use of some more expensive or aggressive means of oxygen administration, including face masks or catheters.

To an increasing extent, supplemental oxygen is used on an outpatient basis, such as in a home. Under such conditions, the cosmetics of the oxygen delivery apparatus can be important, and the commonly-used dual prong cannula can make a person feel conspicuous and, as previously mentioned, cause irritation from interface pressure.

In addition to the discomfort, skin deterioration, and cosmetic concerns posed by use of the dual prong cannulas, it has been established that single prong nasal, or unilateral, nasal catheters provide a higher inspired oxygen fraction than the dual prong cannulas.

Therefore, a need exists for an oxygen delivery device having a single prong nasal cannula that can be securely affixed to a patient while providing an adequate supply of oxygen to the patient with the least amount of irritation and/or discomfort to the patient possible. The relevant prior art includes the following references:

Patent No. Inventor Issue/Publication Date

(U.S. Patent References)

4,660,555 Payton 04-28-1987

4,685,456 Smart 08- 11-1987

4,736,741 Payton et al. 04- 12-1988

4,742,824 Payton et al. 05- 10-1988

6,804,866 Lemke et al. 10-19-2004

6,807,966 Wright 10-26-2004

WO2005/014080 Wood 02-17-2005

6,913,017 Roberts 07- 05-2005

2008/0223375 Cortez et al. 09- 18-2008

D643,113 Butler 08- 09-2011

SUMMARY OF THE INVENTION

The primary object of the present invention is to provide an oxygen delivery device having a single prong nasal cannula and tubing that can be securely affixed to a patient while providing an adequate supply of oxygen to the patient with the least amount of irritation and/or discomfort to the patient possible.

The present invention fulfills the above and other objects by providing an oxygen delivery device having a single prong nasal cannula for insertion into a patient's right or left nostril to deliver oxygen to the patient. The substantially U-shaped cannula is preferably tubular. The U-shaped cannula may be flexible or non-flexible and may be constructed of bendable or memory materials. The U-shaped nasal cannula has a first end that fits inside the patient's nostril and a second end having a substantially U-shaped portion that extends downward from the patient's nostril, around an outer surface of the patient's nostril, and then upward toward the patient's eye. The U-shaped nasal cannula may have a bendable wire embedded within at least a portion of the cannula wall, with the wire extending substantially axially along the cannula wall. The cannula may retain its shape when bent. Alternatively, the cannula may return to its original shape after bending. The cannula may have a substantially ninety degree bend located between substantially U-shaped portion of the substantially U-shaped nasal cannula and a juncture with a first section of tubing. The bend prevents the formation of kinks that could reduce or restrict the flow of gas and also enhances the placement of cannula and tubing on the patient's face.

The substantially U-shaped cannula attaches to a flexible and preferably formable or bendable first section of tubing, which may be constructed of memory material. The tubing then extends upward from the second end of the cannula and toward the patient's eye or ear, across the patient's cheek around the side of the face, and over the patient's ear. This section of tubing may have a wire embedded within at least a portion of the tubing wall, with the wire extending substantially axially along and within the wall. This tubing section may be contoured over the ear and bent slightly inward against the patient's scalp behind the ear to lock the tubing in place around the ear like a temple tip of a conventional pair of eye glasses.

A secondary coiled section of flexible tubing may then extend downward to the patient's shoulder. The coiled section of tubing allows the patient to move his or her head without affecting the placement of the U-shaped cannula in the nostril. Finally, a flexible piece of tubing extends directly to a supply source for supplying oxygen to the patient and preferably around the back of the patient's neck over the opposite shoulder where a clip located on the coiled tubing may be used to attach the tubing to the patient's clothing and then to the supply source for supplying oxygen.

An additional feature of the present invention is a clip with planar stabilization patch that further secures the tubing to the cheek of the patient. The clip is a semi-rigid substantially C- shaped clip located on an upper surface of the planar stabilization patch having adhesive located on a rear surface to attach the patch to the patient's cheek. After the patch is secured to the patient's cheek, the tubing may be pressed into the C-shaped clip and held in place by a pressure fit. The planar stabilization patch may also have other means of holding the tubing to the cheek such as an adhesive and so forth.

An additional feature of the present invention is a flexible stabilization patch made of flexible, breathable and non-irritating material. The flexible stabilization patch has two patch sections that are separated and connected by a tubing securement area. The flexible stabilization patch may be secured to the patient's cheek and/or to the skin behind the patient's ear by an adhesive located on one side of a patch section. The flexible stabilization patch secures the tubing to the face and over and behind the ear by placing the tubing along and perpendicularly across the tube securement area of the stabilization patch, folding the stabilization patch over the tubing to mate the first patch section to the second patch section with an adhesive, and then affixing the stabilization patch on the skin using the adhesive located on the exposed side of a patch section.

An additional feature of the present invention is a nasal cannula tip made of pliable or formable materials, which may be affixed to the end of the cannula. The cannula tip has two ends and secures the cannula within the nostril and enhances the inspired oxygen by reducing the backflow of oxygen out of the nostril. The width of the second end of the cannula tip that is placed within the patient's nostril may be larger than the width of the first end of the cannula tip that is affixed to the end of the cannula.

The above and other objects, features and advantages of the present invention should become even more readily apparent to those skilled in the art upon a reading of the following detailed description in conjunction with the drawings wherein there is shown and described illustrative embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

In the following detailed description, reference will be made to the attached drawings in which:

FIG. 1 is a front view of an oxygen delivery device of the present invention being worn by a patient;

FIG. 2 is a rear view of an oxygen delivery device of the present invention being worn by a patient;

FIG. 3 is a side view of a U-shaped cannula of the present invention constructed of a non- flexible material;

FIG. 4 is a side view of a U-shaped cannula of the present invention constructed of a flexible, formable, or memory material;

FIG. 5 is a front view of a semi-rigid stabilization patch of the present invention;

FIG. 6 is a side view of a semi-rigid stabilization patch of the present invention;

FIG. 7 is an open view of a flexible stabilization patch of the present invention;

FIG. 8 is a closed view of a flexible stabilization patch of the present invention;

FIG. 9 is a side view of a U-shaped cannula with a cannula tip of the present invention attached and constructed of pliable material; FIG. 10 is a perspective of a cannula tip; and

FIG. 11 is a perspective of a first section of tubing of the present invention, showing a tubing wall in which a bendable wire may be embedded.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

For purposes of describing the preferred embodiment, the terminology used in reference to the numbered accessories in the drawings is as follows:

1. oxygen delivery device, generally

2. patient

3. U-shaped nasal cannula

4. first end of U-shaped nasal cannula placed in nostril interior

5. ninety degree bend in cannula

6. second end of U-shaped nasal cannula exterior to nostril

7. juncture of cannula to first section of tubing

8. first section of tubing

9. juncture of first section of tubing to second section of tubing

10. second section of tubing

11. juncture of second section of tubing to third section of tubing

12. third section of tubing

13. juncture of third section of tubing to fourth section of tubing

14. fourth section of tubing

15. clip attaching fourth section of tubing to clothing

16. oxygen supply connector 17. semi-rigid stabilization patch

18. flexible stabilization patch

19. bendable wire

20. cannula wall

21. C-shaped clip

22. upper surface of semi-rigid stabilization patch

23. adhesive

24. rear surface of semi-rigid stabilization patch

25. open view of flexible stabilization patch

26. rear adhesive surface of flexible stabilization patch

27. tubing securement area of flexible stabilization patch

28. upper adhesive surface of flexible stabilization patch

29. closed view of flexible stabilization patch

30. outer non-adhesive surface of closed flexible stabilization patch

31. cannula tip

32. bendable wire

33. tubing wall

34. first end of cannula

35. second end of cannula

36. substantially U-shaped portion of cannula second end

37. gas passageway of cannula

38. first patch section of the flexible stabilization patch

39. second patch section of the flexible stabilization patch 40. folding adhesive side of the first patch section

41. first end of the cannula tip

42. second end of the cannula tip

43. width of the first end of the cannula tip

44. width of the second end of the cannula tip

45. gas passageway of tubing

46. duct of tubing for embedded bendable wire

With reference to FIGS, land 2, a front view and a rear view, respectively, of an oxygen delivery device 1 of the present invention being worn by a patient 2 is illustrated. The oxygen delivery device 1 comprises a substantially U-shaped nasal cannula 3 that may be non- flexible or flexible. The substantially U-shaped nasal cannula 3 is preferably constructed from formable or memory material.

In a preferred embodiment, the cannula 3 is tubular. As further described herein, the substantially U-shaped nasal cannula 3 may have a bendable wire 19 embedded within at least a portion of the cannula wall 20, with the wire 19 extending substantially axially along the cannula wall 20. With the use of a wire 19 in a cannula (and with the tubing 8, described below), softer and more flexible materials, which in turn are more comfortable and less irritating to the patient, may be used. Such materials may include a vinyl polymer or a silicone polymer.

The substantially U-shaped cannula 3 has a first end 4 that fits inside the patient's nostril and a second end 6 that is exterior to the nostril and extends downward from the patient's nostril, around an outer surface of the patient's nostril, and upward toward the patient's eye. The substantially U-shaped cannula 3 attaches to flexible and preferably formable or bendable tubing 8. The tubing 8 then extends upward from the second end 6 of the cannula 3 and toward the patient's eye or ear. The substantially U-shaped cannula 3 has a first end 4 that fits inside the nostril from which oxygen or other gasses are delivered to the patient.

The second end 6 of the U-shaped cannula 3 may further comprise a substantially ninety degree bend 5 preferably constructed from the same material as the rest of the substantially U- shaped cannula 3 to prevent formation of kinks which could reduce or restrict the flow of oxygen and to enhance placement of the cannula and tubing on the patient's face. The substantially U- shaped cannula second end 6 is joined at the juncture 7 of cannula 3 to the first section of tubing 8.

In a preferred embodiment, the first section of tubing 8, that is preferably flexible, formable or bendable, and which may have a bendable wire 32 (not shown) embedded in the tubing wall 33, extends from a second end 6 of the U-shaped cannula across the patient's cheek, around the side of the face and toward the top of the patient's ear. The first section of tubing 8 may be contoured over the patient's ear and bent slightly inward against the patient's scalp behind the ear to secure the tubing placement. This configuration allows the tubing 8 to be positioned and worn slightly above the ear, thereby preventing interface pressure and friction behind the ear and allowing a patient to wear eye glasses without interference from the tubing.

Alternatively, the first section of tubing 8 may be joined at juncture 9 to a second section of tubing 10. The second section of tubing 10 extends over and behind the ear and may be flexible, formable or bendable so that it may be contoured over the ear and bent slightly inward against the patient's scalp behind the ear to secure the tubing placement. This configuration of the second section of tubing 10 allows the tubing to be worn slightly above the ear, thereby preventing interface pressure and friction behind the ear and allowing a patient to wear eye glasses without interference from the tubing. A second section of tubing 10 is affixed to a third section of tubing 12 at a juncture 11. The third section of tubing 12 preferably consists of coiled flexible tubing which allows the patient to move his or her head without affecting the placement of the U-shaped cannula 3 in the nostril. A third section of tubing 12 is joined at juncture 13 to a fourth section of tubing 14. A fourth section of tubing 14 extends directly to the oxygen supply source and is preferably draped across the back of the patient's neck and crossing to the opposite shoulder of the nostril into which the cannula 3 is inserted and thence to the oxygen supply source. A clip 15 may be used to attach the fourth section of tubing 14 to the patient's clothing, further securing the cannula 3 placement. A fourth section of tubing 14 is attached to the oxygen supply at connector 16. Also illustrated in FIG 1 is a semi-rigid stabilization patch 17 on the patient's face that further secures the tubing 8 to the cheek of the patient and is discussed in greater detail below. Alternatively, a flexible stabilization patch 18 may be used to secure the first section of tubing 8 in place. In an alternate embodiment, the first section of tubing 8 is joined to the third section of tubing 12 at juncture 11.

In another preferred embodiment, the substantially U-shaped nasal cannula 3 is tubular and includes a bendable wire 19 that is embedded within at least a portion of the cannula wall 20 and extends substantially axially along the cannula wall 20, a first end 4 that fits inside the patient's nostril and a second end 6 that is exterior to the nostril. The second end 6 of the cannula 3 extends downward from the patient's nostril, around an outer surface of the patient's nostril, upward toward the patient's eye to a substantially 90 degree bend 5 across the patient's cheek, around the side of the face, toward the top of and over the patient's ear. With this alternative embodiment, there is no juncture with a first section of tubing 8 proximate the patient's cheek, which eliminates a potential source of irritation for the patient. With reference to FIG 2, a rear view of an oxygen delivery device of the present invention being worn by a patient, a flexible stabilization patch 18 affixed behind the patient's ear is illustrated. This flexible stabilization patch 18 functions to additionally secure the tubing placed over the ear and reduce the movement of the tubing in the vicinity of the ear, reducing the interface pressure and friction of the tubing against the skin.

With reference to FIG. 3, a side view of a U-shaped cannula 3 of the present invention constructed out of a non-flexible tubing is illustrated, which is self-explanatory when viewed in conjunction with the description above. In another preferred embodiment, the cannula 3 is tubing that is flexible and constructed out formable or memory material.

The cannula 3 has a first end 34, which is adapted to fit inside the patient's nostril, and a second end 35 having a substantially U-shaped portion 36, which that is adapted to extend downward from the patient's nostril, around an outer surface of the patient's nostril, and then upward toward the patient's eye. A cannula wall 20 surrounds the gas passageway 37. Also shown in FIG. 3 is a substantially ninety degree bend 5 in the second end 35. Also shown is the location of the juncture 7 of the U-shaped cannula 3 to first section of tubing (not shown). The cannula length extends from the first end 34 to the location of the juncture 7.

With reference to FIG. 4, a side view of a substantially U-shaped cannula 3 of the present invention is illustrated. The cannula 3 is a flexible tubing that is constructed out of a formable or memory material. The cannula 3 has a first end 34, which is adapted to fit inside the patient's nostril, and a second end 35 having a substantially U-shaped portion 36, which that is adapted to extend downward from the patient's nostril, around an outer surface of the patient's nostril, and then upward toward the patient's eye. A cannula wall 20 surrounds the gas passageway 37. Also shown in FIG. 3 is a substantially ninety degree bend 5 in the second end 35. Also shown is the location of the juncture 7 of the U-shaped cannula 3 to first section of tubing (not shown). The cannula length extends from the first end 34 to the location of the juncture 7. As illustrated here, there is a flexible or bendable wire 19 embedded in a wall 20 or proximal to the wall 20 of the U- shaped cannula 3. The wire 19 extends substantially axially along the cannula wall. The length of the wire 19 is typically less than the length of the cannula 3 so that the wire does not protrude into the patient's nostril.

In one embodiment, the substantially U-shaped cannula 3 retains its shape when bent and in another embodiment the substantially U-shaped cannula 3 returns to its original shape after bending. The material used to form the flexible, formable or memory tubing of the cannula 3 may also be a semi-rigid plastic, polyurethane, elastomer or other material that retains its shape when bent without the assistance of the embedded flexible wire 19. Such tubing may also be applied to the section of tubing 10 that fits over the ear of the patient.

With reference to FIGS. 5 and 6, a front view and a side view, respectively, of a semirigid stabilization patch 17 is illustrated. The semi-rigid stabilization patch 17 comprises a preferably semi-rigid substantially C-shaped clip 21 located on an upper surface 22 of a stabilization patch 17 having adhesive 23 located on a rear surface 24 to attach the stabilization patch 17 to a patient's cheek, as illustrated in FIG. 1. The first section of tubing 8 may be pressed into the C-shaped clip 21 and held in place by a pressure fit, as illustrated in FIG. 1. One or more stabilization patches 17 or 18 (as described below) may be placed on a patient's cheek to stabilize the tubing. The placement of the tubing is over areas of the face that have minimum hair growth and oil secretion, thereby ensuring the one or more stabilization patches 17 or 18 adhere to the patient's skin. With reference to FIG. 7, a flexible stabilization patch 18 in an open configuration 25 is illustrated. The flexible stabilization patch 18 may be affixed to the face as shown in FIG 1 in replacement of the semi-rigid stabilization patch 17 or behind the patient's ear 18 as shown in FIG 2. The flexible stabilization patch 18 preferably should be made of flexible, breathable and non-irritating material. The flexible stabilization patch 18 has two patch sections, a first patch section 38 and a second patch section 39, that are separated and connected by a tubing securement area 27. The first patch section 38 includes a skin adhesive side 26, which has adhesive on the surface for attaching the stabilization patch to the skin, and an opposing folding adhesive side 40. The second patch section 39 includes a folding adhesive side 28 and an opposing non-adhesive side 30.

With reference to FIG. 8, a fiexible stabilization patch 25 in a closed configuration 29 is illustrated. To achieve the closed configuration 29, the tubing 10 to be secured is placed perpendicularly across the tubing securement area 27. Then the flexible stabilization patch is folded over the tubing 10 so that the folding adhesive side 40 of the first patch section 38 is mated to the folding adhesive side 28 of the second patch section using an adhesive. The adhesive, which is used to mate the folding adhesive side 40 of the first patch section 38 to the folding adhesive side 28 of the second patch section 39, is located on the surface of either the first patch section 38 folding adhesive side 40 or the second patch section 39 folding adhesive side 28, or both. In a closed configuration, the flexible stabilization patch 25 secures the tubing 10 in the tubing securement area 27. Furthermore, the flexible stabilization patch is affixed to the patient's cheek or to the skin behind the patient's ear by placing the skin adhesive side 26 of the first patch section 38 onto the cheek or the skin behind the ear, respectively. In one embodiment, when the flexible stabilization patch 18 is a closed configuration as illustrated in FIG. 8 , the secured tubing 10 is free to move relative to the flexible stabilization patch and shift in an axial direction relative to the tubing. In another embodiment, all movement of the secured tubing 10 relative to the flexible stabilization patch 18 is prevented. In the closed configuration 25, the non-adhesive upper surface 30 of the flexible stabilization patch 29 is exposed.

With reference to FIG. 9, a side view of U-shaped cannula 3 with a cannula tip 31 affixed. The cannula tip 31 is preferably made of pliable or formable materials which may be affixed to the end of the cannula 4. The cannula tip 31 secures the cannula 4 within the nostril and enhances the inspired oxygen by reducing the backflow of oxygen out of the nostril.

With reference to FIG.10, a perspective of a cannula tip 31 is illustrated. The cannula tip 31 has a first end 41 and a second end 42. The first end 41 of the cannula tip 31 has a width 43 and is attached to the first end of a cannula 3 (not shown). The second end 42 of the cannula tip 31 has a width 44 and is adapted to be placed in a patient's nostril. The second end 42 typically has a width 44 is larger than the width 43 of the first end 41 of the cannula tip 31. Accordingly, the specific size of the cannula tip 31 to be used for a specific patient may be selected according to the size of the patient's nostril (not shown) to comfortably secure the cannula in the nostril while mitigating any irritation and /or discomfort to the patient. For some patients, a cannula tip 31 will be selected so that the width 44 of the second end 42 of the cannula tip 31 is greater than the width 43 of the first end 41.

With reference to FIG. 11, a perspective of a first section of tubing 8 of the present invention is illustrated, showing a tubing wall 33, the gas passageway 45, and a separate duct or passage 46 in the tubing wall 33 into which a bendable wire 32 (not shown) may be inserted and/or embedded. A plug (not shown) may be inserted into the end of the duct 46 and used to prevent protrusion of the bendable wire 32 from the tubing 8.

It is to be understood that while a preferred embodiment of the invention is illustrated, it is not to be limited to the specific form or arrangement of parts herein described and shown. It will be apparent to those skilled in the art that various changes may be made without departing from the scope of the invention and the invention is not to be considered limited to what is shown and described in the specification and drawings.