|Title of Invention||
A DEVICE FOR USE IN PERCUTANEOUS DILATIONAL OSTOMY
|Abstract||A device for use in percutaneous dilational ostomy is disclosed. The device comprises a vertical member of gradually tapering cross section, a horizontal member connected to said vertical member at the end which is larger in cross section, the vertical member and said horizontal member together forming a T-shaped structure and a co-axial tunnel in the center of said horizontal member and extending throughout the length of the said vertical member for the passage of a flexible guidewire.|
|Full Text||Field of Invention
The present invention relates to the field of percutaneous dilational ostomy in a patient. In particular, the present invention relates to a device for creating stoma of desired size, speedily and with more simplicity, accuracy, and minimum risks of procedure related injury. More particularly, the present invention relates to a device for use in percutaneous dilational ostomy, preferably tracheostomy. In a preferred embodiment, the present invention relates to a device for use in percutaneous dilational tracheostomy.
Background of the Invention and prior art
The entire purpose of tracheostomy is to bypass an air passageway obstruction and maintain flow of air to the patient's lungs. A tracheostomy operation however, can be quite complicated. Any injury or collapse of the trachea can result in permanent brain damage and even death. These complications are normally due to the trauma to the surrounding tissue, an unnecessarily large opening of the trachea or puncture of the posterior tracheal wall. Since the entire purpose of the surgery is to restore the patient's air passageway as quickly as possible, a surgeon cannot be sidetracked into unnecessary complications arising out of the surgery itself.
Prior art teaches several approaches for forming an ostomy in trachea. Many of them require making an incision in the neck using a scalpel while the patient is under general anesthesia. Use of scalpels has the disadvantage of the having to make a large opening in the beginning itself causing trauma to the surrounding tissues. To minimise the trauma it is always advantageous to make a small opening in the beginning and gradually enlarge it, but in practice it is not always possible to do so.
Towards achieving the above objective, U.S patent No 4,677,978 teaches a technique of dilating an ostomy by using a wire guide, followed by introduction of one or more dilators to enlarge an opening in the trachea. As disclosed in this patent, a needle and an over-the-needle catheter are inserted into the trachea. The needle is then removed and the catheter is replaced by a wire guide. A tapered elongated tubular dilator or a series of telescopically positionable, tapered dilators are positioned over the wire guide and introduced into the trachea. This technique, however, suffers from a disadvantage that sequential manipulation of several dilators by the surgeon
increases the chances of injury, is time consuming and unnecessarily complicates the entire procedure.
U.S.Patent No. 4,889,112 teaches an improvement in this procedure. This U.S. Patent eliminates the use of the catheter by placing the wire guide through the needle. However, this technique requires maintaining the position of the needle at the point of entry in the trachea while the guide wire is positioned there through. This unduly increases chances of injuring posterior tracheal wall of patient. Tremendous care has to be exercised to ensure that the needle does not advance too far.
Yet another prior technique is use of a tapered, elongated, tubular dilator or a series of telescopically positionable, tapered dilators with increasingly larger diameters. A serious disadvantage of this technique is that each dilator presents a pointed distal end to the posterior wall of trachea when introduced into the trachea. This increases the chance of injury to trachea which because the inherent toughness of its walls naturally resists introduction of dilators. Thus, the dilators have to be introduced with considerable force, yet the surgeons must possess skill to avoid injury to the tracheal wall.
Another prior art method teaches use of a dilator with a handle and a nose with a pair of jaws which extend from the handle. The jaws are capable of spreading apart the tissues. For instance, U.S. Patent No. 4,889,112 discloses a device for introduction into the trachea by positioning the elongated, tapered nose over a wire guide. Unfortunately this device suffers from the disadvantage that the unguarded nose has to be inserted into the trachea with great precision and care and slightest of wrong angle of insertion could result in a serious injury.
U.S. Patent No 4,643 ,188, discloses a device with a handle a laterally extending nose with two sharp jaws. The jaws are tapered and terminate in sharpened, flat, distal blades. A problem with this device is that the jaws expose the sharpened, flat, distal blades to the posterior tracheal wall, again exposing them to a serious risk of injury.
In an attempt to overcome the problems associated with the possible injury to posterior tracheal wall, US Patent No. 5,217,007 discloses a device, where a speculum is used not with a wire guide but instead a flexible and curved distal end on one of the members and a cannula sized for extension through that end. The tip of the cannula is exposed and it straightens the curved distal end during the penetration of the tracheal wall. The cannula is retracted as the penetration advances so that only the flexible and
curved distal end meets the posterior tracheal wall when the speculum is used to dilate the ostomy. However, while this patent to some extent avoids injury to the posterior tracheal wall, its use requires application of some strength from the surgeon.
Towards meeting some of the above-mentioned problems, the Ciaglia blue rhino (CBR) a specially designed dilator (Cook Critical Care, Bloomington, IN USA) is used. The CBR is a gradually tapered hollow, cylindrical, rigid plastic structure curved at about 60 degree. Notwithstanding the advantages of the apparatus, the device is associated with number of problems, e.g. slippery grip, trapping of air in the lungs, increase in airway pressure during stoma formation, soft tissue injuries and other life threatening complications. The device is also associated with fracture/rupture of tracheal cartilage rings in about one third of the patients which may have long term anatomical and pathological problems. Further, the presently available CBR is used in all patients irrespective of the size of tracheostomy tube and patient characteristics. Therefore there are other obvious problems.
Accordingly, there is an urgent need for a device for forming and dilating an ostomy with minimum risk of injury to the tracheal wall. Objects of the invention
It is therefore, a main object of the present invention to provide a device for use in percutaneous dilational ostomy, preferably tracheostomy which envisages minimum risk of injury to the posterior tracheal wall.
It is another object of the present invention to provide a device for use in percutaneous dilational ostomy, tracheostomy which is simple to use and is atraumatic, both to the patient and the surgeon.
It is another object of the present invention to provide a device for use in percutaneous dilational ostomy, preferably, tracheostomy which permits enlargement of a formed ostomy speedily without the risk of perforating the rear of trachea,
It is yet another object of the present invention to provide a percutaneous tracheostomy device in which the dilator creates desired size of tracheal stoma without subjecting the patients to increased risks of complications that are common with the prior art. Summary of the invention
The above and other objects of the invention are achieved by percutaneous ostomy device, which comprises in essence a T-shaped device made preferably of some-rigid plastic or any other material, the vertical portion of said T-shaped device
being preferably in the form of a curved shaft. The horizontal portion of said T-shaped structure is conveniently in the form of handle. The device is characterized in that the shaft is tapered from its center to outwards and therefore, the center of the shaft is thicker and periphery of the shaft is thinnest blunt. The device comprises of a co-axial tunnel in the center thereof throughout its length for the passage of a flexible guidewire.
The portion of the device where the horizontal handle meets the vertical shaft is characterized by platform. Said platform represents an enlarged portion or a region of thickness, where the shaft meets the handle. The shaft is tapered towards its rounded tip so that it can be inserted through the anterior tracheal wall or any other body tissue until said platform reaches at skin level and causing the dilation of stoma and the overlying skin to pass a desired size ostomy tube.
Accordingly, the present invention provides a device for use in percutaneous dilational ostomy which comprises a vertical member of gradually tapering cross section, a vertical tunnel extending throughout the length of the said vertical member for the passage of a flexible guidewire, characterized in that a horizontal member is connected to said vertical member, a tunnel passing through the centre of said horizontal member co-axial with the tunnel in said vertical member, said horizontal member being connected to said vertical member at the end which is larger in cross section, the vertical member and said horizontal member together forming a T-shaped structure, and a plurality of holes located on said vertical member so that when the vertical member lies inside the tracheal lumen, there is a communication above and below the vertical member through these holes to avoid the entry of air inside the lungs and therefore prevention of extreme increase in airway pressure.
In an embodiment of the invention, vertical member has acute increase in width the thickness proximate to the point of connection between said vertical member and said horizontal member to restrict further insertion of the said device in the stoma or lumen.
In another embodiment, the device includes at the widest end of said vertical member, platform for preventing further insertion of the device into the tracheal stoma or body tissue.
In still another embodiment of the invention, the shaft includes a number of elliptical/oval holes so that when the shaft lies inside the tracheal lumen, there is a communication above and below the shaft through these holes to avoid the entry of air in
and out of lungs during inspiration and expiration and therefore prevention of extreme increase in airway pressure and air trapping.
In still another embodiment of the invention, the said shaft beyond the distal tip is catheter shaped 3-5 cm long, elongated, unbreakable made of plastic or Teflon or any other such material and has an annular ridge at the junction with the shaft to avoid injuries to the tracheal wall during stoma dilation.
In the above mentioned embodiments of the invention, the size of the device varies with the dilatation of tracheal stoma required for the particular size of tracheostomy tube to be inserted and is written on the body, between the junction of shaft and the shoulders. Detailed description
A preferred embodiment of the device will now be described in greater detail with reference to the accompanying drawings wherein Fig. 1-a and 1-b shows front view of the apparatus of the present invention. Fig. 2-a and 2-b discloses a perspective view of the apparatus of the present invention Fig. 3 depicts a top view of the apparatus of the present invention. Fig.4 shows a bottom view of the apparatus of the present invention. Fig.5 describes a side view of the apparatus of the present invention. Fig. 6 depicts a cross sectional view at various points of the apparatus of the present invention.
Fig. 7-12 teaches the procedure of percutaneous tracheostomy with the apparatus of present invention.
With reference to Fig. 1-6, the present invention will be described with respect to its application in performing a percutaneous tracheostomy. It must however, be borne in mind that tracheostomy is only an example of the application of the present invention. It will be apparent to a person skilled in the art that the device of the present invention may be used for performing an ostomy anywhere in the body The device of the present invention is a T-shaped device, which has an elongated, flat, gradually tapered shaft (5,6,7) that is co-axially hollow in the midline to pass a guidewire through the two openings (1,2). The shaft (5,6,7) of the dilator is gradually tapered from the base along its length and width. The shaft is thickest in midline and thinnest but blunt on its either side. The tip of the dilator is rounded and gradually tapered in length beyond the distal mark (8). In another embodiment of this device the distal portion beyond mark (8) is more elongated and catheter shaped (14) measuring
3-5 cm in length and the junction with the shaft is an annular ridge (15) is made up of unbreakable plastic or Teflon or any other material. The top of the device is T-shaped with rigid handles (3,4) on either side. The middle portion of the shaft (6) contains number of oval/elliptical holes (11). The shaft of the device joins its body (10) at the point (12) where it becomes acutely thick and bulky. The device may be made of tough plastic or any other material in such a way that when the device is inserted into the trachea and its proximal mark (9) lies in the tracheal lumen or mark 12 at skin level so that it creates a elliptical slit/stoma to pass a desired size of tracheostomy tube. The width of the shaft at proximal mark (9) varies depending on the size of the tracheostomy tube to be inserted and therefore the device would be available in different sizes. The size of the dilator in terms of tracheostomy tube is marked (13) on the base (10) near the handles.
The device may be used for elective as well as emergency percutaneous tracheostomy procedures. Though the procedure can be done under sedation and local anesthesia, in majority of the patients the procedure requires endotracheal intubation and general anesthesia. The patient is positioned supine and a sandbag or pillow is placed under the shoulders to moderately extend the neck unless contraindicated. Under direct laryngoscopy the endotracheal tube is withdrawn until the tip of the endotracheal tube lay in the larynx. Cricoid cartilage is identified. Below the cricoid cartilage and at the level of tracheal rings one and two or two and three, 1% solution of lignocaine with 1:200000 adrenaline (3-5ml) is infiltrated subcutaneously. About 2-2.5 cm long horizontal/vertical skin incision is made at this point. The pretracheal subcutaneous tissues may be separated with hemostat forceps and trachea is palpated with the little finger. Keeping larynx and trachea steady in central position with one hand, the anterior wall of the trachea is punctured with a cannula on needle. The entry of cannula in the tracheal lumen is confirmed by the free flow of air bubbles into the saline filled syringe, on aspiration. Once free flow of air is obtained the needle is withdrawn leaving the cannula in situ. Through the cannula a 'J' tip guidewire is inserted into the tracheal lumen. Over the guidewire an initial dilator of 14-French gauze is inserted into the tracheal lumen to form a small stoma. Alternatively, a specially designed cannula on needle-cum-initial dilator may be used which serves the dual purpose of cannula on needle and the initial dilator. If cannula on needle-cum~ initial dilator is used then following its tracheal placement it is advanced further over the guidewire to form the initial stoma. Following creation of a small stoma the T
dilator is loaded over the guidewire and inserted into the tracheal stoma at about 70-80° till the distal mark (8) is inside the trachea (Fig. 10). Now, the handles of the T-Dilator is changed to cephalad between 45-60° and the shaft is inserted through the tracheal stoma by pushing the handles, preferably with both the hands (Fig. 11) till the proximal mark (9) on the dilator is at or inside the tracheal lumen and safety platform (12) at the skin level. Use of the lubricating jelly on the dilator facilitates its insertion into the trachea and creation of tracheal stoma. The T-Dilator is now removed and tracheostomy tube preloaded on its obturator/introducer is threaded over the guidewire (Fig. 12) and inserted through the tracheal stoma until its flange. The obturator is removed and cuff of the tracheostomy tube is inflated with air to prevent air leak around the tube.
The device of the present invention has several other applications and the above illustrates only a preferred embodiment. It will be appreciated by a person skilled in the art that various modifications of the device of the present invention are possible without departing from the scope of the present invention.
1. A device for use in percutaneous dilational ostomy, which comprises a vertical
member of gradually tapering cross section, a vertical tunnel extending throughout the
length of the said vertical member for the passage of a flexible guidewire,
characterized in that a horizontal member is connected to said vertical member, a
tunnel passing through the centre of said horizontal member co-axial with the tunnel
in said vertical member, said horizontal member being connected to said vertical
member at the end which is larger in cross section, the vertical member and said
horizontal member together forming a T-shaped structure, and a plurality of holes
located on said vertical member so that when the vertical member lies inside the
tracheal lumen, there is a communication above and below the vertical member
through these holes to avoid the entry of air inside the lungs and therefore, prevention
of extreme increase in airway pressure.
2. A device as claimed in claim 1 wherein said vertical member has a portion of
increased width and thickness proximate to the point of connection between said
vertical member and said horizontal member to restrict further insertion of the said
device in the stoma or lumen.
3. A device as claimed in claim 2 wherein said portion of increased width comprises a
platform or stop member for preventing further insertion of the device into the
tracheal stoma or body tissue.
4 A device as claimed in any preceding claim wherein said vertical member is in the
form of a shaft and said horizontal member is in the form of a handle with two handle bars for use in holding of the device with two hands and to push the shaft inside the tracheal stoma/body tissues till the platform reaches at skin
5. A device as claimed in any preceding claim wherein said shaft beyond the distal tip is catheter shaped and the junction of the shaft and the catheter is an annular ridge to prevent injuries to the tracheal wall and is made of a flexible and unbreakable plastic or Teflon or any soft material.
6. A device for use in percutaneous dilational ostomy substantially as herein described with reference to and as illustrated in the accompanying drawings.
|Indian Patent Application Number||704/DEL/2002|
|PG Journal Number||40/2008|
|Date of Filing||01-Jul-2002|
|Name of Patentee||SUSHIL PRAKASH AMBESH|
|Applicant Address||TYPE IV/38, SGPGI CAMPUS, LUCKNOW 226 014, UTTAR PRADESH, INDIA.|
|PCT International Classification Number||A61F 005/44|
|PCT International Application Number||N/A|
|PCT International Filing date|