Patent Application
20190059711
The present invention pertains generally to systems and methods that can be used to verify the proper placement of feeding and ventilating tubes in the body of a neonate. More particularly, the present invention pertains to systems and methods that implement optical techniques for visually verifying the proper placement of tubes in a neonate. The present invention is particularly, but not exclusively, useful as a system or method that advances an illuminated optical fiber through a prepositioned tube in the body of a neonate, to transmit light from the optical fiber in the tube and through the translucent body tissue of a neonate to provide visual verification of a proper placement of the tube in the body of the neonate.
It is well known and widely appreciated that neonates have unique medical needs that require special attention. Of continuing importance for all neonates, regardless of whatever else their needs might be, their basic needs for ventilation and nourishment persist and cannot be ignored. Moreover, it happens that these considerations can be of critical importance. For example, it is not uncommon for a neonate to be unable to either eat or breathe. In both instances some form of intervention is required, and most often this intervention requires the placement of a tube in the neonate.
Of crucial importance when tubes are used for a neonate is that they be properly placed. In particular, it is important that the tube be advanced through the esophagus and into the stomach, rather than through the larynx and into the lungs. Verifying proper tube placement, however, can be problematic for a variety of reasons. For the most part, the difficulties here arise from a basic inability to visually verify a proper tube placement. The problem is further exacerbated by the fact that due to the fragility of a neonate, x-ray techniques are preferably avoided.
With the above considerations in mind, the present invention has recognized that the body tissue of a neonate is relatively more translucent than that of more mature tissue. Indeed, it can be demonstrated that interior anatomical organs of a neonate can be visualized with light that has been passed through the body tissue of a neonate. Most importantly, this capability is sufficiently detailed to inspect tube placements in a neonate. With this in mind, the present invention recognizes that when a nasogastric tube is inadvertently inserted into the trachea of a neonate, rather than continuing on through the esophagus and into the stomach, the problem can be visually detected.
Accordingly, it is an object of the present invention to provide a system and method for verifying the placement of a tube in a neonate that implement optical techniques for visually verifying the proper placement of tubes in the neonate. Another object of the present invention is to provide a system or method that advances an illuminated optical fiber through a prepositioned tube in the body of a neonate, and to transmit light from the optical fiber while it is in the tube, through the translucent body tissue of a neonate, to thereby provide visual verification of a proper placement of the tube in the body of the neonate. Still another object of the present invention is to provide a system and method for verifying the placement of a tube in a neonate that is easy to use, is simple to manufacture, and is comparatively cost effective.
In accordance with the present invention a device for verifying the placement of a tube in a neonate essentially includes an optical fiber and a light source. In combination, the light source is connected to the proximal end of the optical fiber. Preferably, this connection is provided by a swivel connector that will allow the light source to be selectively angled relative to the optical fiber, to thereby facilitate an unencumbered manipulation of the optical fiber during its use.
As intended for the present invention, the verification device is used to inspect and verify the placement of an intubation tube such as an endotracheal tube, a nasogastric tube or an orogastric tube (hereinafter each individually referred to simply as a “tube”). In each case the tube will have a length Ltube and it will be formed with a lumen having a diameter Dlumen. For its interaction with the tube, the optical fiber of the device will have a length Lfiber and it will have an outer diameter Dfiber. In their comparison with each other, the length Ltube of the optical fiber is greater than the length Ltube of the tube, and the diameter of the optical fiber Dfiber is less than the lumen diameter Dlumen of the tube (Lfiber>Ltube and Dfiber<Dlumen).
It is an important aspect of the optical fiber for the device of the present invention that it be made of a material having a high light-loss characteristic. Stated differently, it is important for the optical fiber to radiate as much light as possible. In particular, it is important that the distal portion of the optical fiber have a high light radiating capability. To enhance this capability an alternate embodiment of the present invention envisions the possibility of enclosing the proximal portion of the optical fiber in an opaque sheath.
For purposes of the present invention, the lengthwise extent of the light radiating capability that is required for the distal portion of the optical fiber is determined by the length of the tube to be inspected. Preferably, the illuminated distal portion of the optical fiber will be longer than a predetermined intubation length. Specifically, for the present invention, an intubation length is equal to the length of the tube to be inspected, when the tube is positioned in the neonate for its particular purpose.
For an operation of the present invention, once a tube has been inserted into the neonate, the optical fiber of the device is illuminated by the light source. For this purpose, the light source is preferably a Light Emitting Diode (LED). The illuminated optical fiber is thereafter advanced into the tube. As the tube is being advanced, light that is radiated from the distal portion of the optical fiber passes from the optical fiber and through the tube. The light then continues to radiate from the tube through the body tissue of the neonate. As noted above, the passage of light through the body tissue of the neonate is due to the translucent nature of this tissue. The result is that the tube and the anatomical features of the neonate around the tube are both illuminated by the optical fiber. Thus, they can be visually observed together. Based on this observation a clinician will determine whether the tube has been properly placed. Once the inspection/verification of tube placement has been completed, the optical fiber is withdrawn from the tube, and the tube is repositioned, if necessary.
As an additional feature of the present invention, a cylindrical shaped supply container can be provided for holding a plurality of optical fibers. Structurally, the container will include a cylindrical shaped body portion that is formed with a plurality of tubular shaped cavities. Further, each cavity is aligned parallel to the axis of the cylindrical container, and each cavity is open at its top end and is closed at its bottom end in the container. Additionally, a cap is mounted for axial rotation on the top end of the container. For this combination, the cap is formed with a hole. Thus, as the cap is rotated, the hole is selectively position over a cavity in the body portion of the container for removing an optical fiber from the cavity.
The novel features of this invention, as well as the invention itself, both as to its structure and its operation, will be best understood from the accompanying drawings, taken in conjunction with the accompanying description, in which similar reference characters refer to similar parts, and in which:
Referring initially to
For the present invention, the light source 20 is preferably a source of light from a Light Emitting Diode of a type well known in the pertinent art. Further, the light source 20 can include a dimmer switch (not shown). It is also preferred that the optical fiber 12 be made of a high light-loss material, such as a clear plastic, so that the greatest amount of light will be radiated radially outwardly from the optical fiber 12 through a length of the optical fiber 12 with a predetermined distance from the distal end 14 of the optical fiber 12. Additionally, an opaque sheath 22 can be optionally provided on a portion of the optical fiber 12 that is proximal to this predetermined distance.
In accordance with the present invention, the predetermined distance along the optical fiber 12 where maximum light is to be radiated from the device 10 will be at least equal to the length Ltube of the tube 24 that is shown in
With cross reference between
For a successful use of the device 10 when the tube 24 is either a nasogastric (NG) tube or an orogastric (OG) tube,
During a use of the device 10, the tube 24 is first advanced through the esophagus 42 until its distal end 30 is inserted into the stomach 32 of the neonate 34. The optical fiber 12 is then advanced through the lumen 28 of the tube 24. At this time, the light source 20 is activated to radiate light from the optical fiber 12. It then happens that, due to the translucent nature of tissue in the neonate 34, internal organs of the neonate 34 (e.g. the larynx 34, the esophagus 42, the lungs 40 and the stomach 32) are recognizable to the clinical personnel using the device 10. Of particular importance is the ability to visually determine whether the tube 24 has been properly advanced into the stomach 32 rather than into the lungs 40, or vice versa. After a proper placement of the tube 24 has been verified, the optical fiber 12 can be withdrawn.
As an accessory for the device 10, the present invention envisions the use of a supply container which is generally designated 44 in
While the particular Device for Verifying Placement of Endotracheal, Nasogastric, Orogastric Tubes as herein shown and disclosed in detail is fully capable of obtaining the objects and providing the advantages herein before stated, it is to be understood that it is merely illustrative of the presently preferred embodiments of the invention and that no limitations are intended to the details of construction or design herein shown other than as described in the appended claims.
