Abstract:
An apparatus and method for implanting a surgical apparatus including a first flange having an opening, a substantially X-shaped second flange having an opening, and a shaft having a lumen connecting the first and second flange openings. The surgical apparatus is inserted into a stoma formed in the trachea of a patient. The surgical apparatus receives and secures an oxygen supply line for patients who have difficulty breathing.

Description:
CROSS-REFERENCE TO RELATED APPLICATION  
       [0001]     This application is a continuation-in-part of U.S. patent application Ser. No. 10/752,936 filed Jan. 7, 2004 entitled “Transtracheal Oxygen Stent”, the disclosure of which is incorporated herein by reference. 
     
    
     BACKGROUND OF THE INVENTION  
       [0002]     1. Field of the Invention  
         [0003]     The present invention relates to devices for securing oxygen supplies to a patient. Specifically, the present invention is directed to a transtracheal stent that accepts the insertion of standard oxygen tubing for use with patients suffering from emphysema or other breathing disorders.  
         [0004]     2. Description of the Prior Art  
         [0005]     There are a wide variety of products and devices which have been described for supplying oxygen to patients. Traditionally, this has been accomplished through the use of an oxygen supply which is adapted to fit over the patients ears and supply oxygen to the patient through the nose. For a variety of reasons this type of application is not desirable. These devices are quite inconvenient and obtrusive into the life of the patient and can become uncomfortable for the wearer. Accordingly, one aspect of the present invention is directed at an oxygen supply device and system which provides for greater comfort and convenience for the user.  
         [0006]     Other devices have been developed for implantation into the trachea of a patient. In particular, attention is directed at tracheotomy tubes. These tubes are inserted into the trachea of the patient for a variety of reasons including to promote healing in the patient, permit speaking and breathing following a laryngectomy, provide an access point for forced ventilation of a patient, and a variety of other uses including supplying oxygen to augment normal breathing.  
         [0007]     In one example described in U.S. Pat. No. 5,957,978, the tracheotomy tube is equipped with an outer port for permitting air to flow into and out of the tracheotomy tube, an inner port that permits air to flow to and from the lungs once inside the trachea of the patient, and a fenestration with valve to permit the flow of air through the larynx to permit the wearer to speak. The user must occlude the outer port and exhale to force air through the fenestration to permit speaking, and then release the outer port occluder to breath again. As described in the &#39;978 patent the trachea itself is blocked by a balloon which extends laterally off of the tracheotomy tube to prevent objects from entering the lungs and to force the air flow through the tracheotomy tube itself.  
         [0008]     Another apparatus in the prior art is the tracheostoma device depicted in U.S. Pat. No. 5,738,095. The device is intended to be manually controlled and has a valve which is use to prevent the egress of air out of a stoma in which it is implanted when it is desired that air should flow through a voice prosthesis which is implanted in a fistula connecting the trachea and the esophagus to enable the user to talk. The device also has air filtration and moisture and heat exchanging functionality. This device is placed in a holder which covers the stoma formed in the patients trachea.  
         [0009]     A further example of a tracheostomy tube can be seen in U.S. Pat. No. 6,135,110. The device comprises a tracheostomy tube which can allow for either forced ventilation or the ingress and egress of air by the patient&#39;s normal breathing. One aspect of the apparatus described in the &#39;110 patent is the use of both an inner and outer cannula. This enables the inner cannula to be removed from the patient, cleaned, and re-inserted without the need to disturb the outer cannula, which could be uncomfortable for the patient. Further this allows for the use of several types of inner cannula depending upon the application and desired usage. To secure the inner cannula to the outer cannula a twist lock mechanism is described.  
         [0010]     Still further examples of the prior art are directed at methods and devices for securing a tracheotomy tube to prevent its inadvertent removal from the stoma formed in the patient&#39;s trachea. Examples include U.S. Pat. Nos. 5,819,734, 5,782,236, and 6,105,577. In each of these examples there are described methods for securing the tracheotomy tube using straps which extend around the neck of the patient and attach to a flange section covering the stoma opening in the patients trachea. The purpose of these devices is to hold the tracheotomy tube in place and allow for breathing or assisted ventilation without fear that the tracheotomy tube will be disturbed or in the case of assisted ventilation without fear that the supply line will be pulled out.  
         [0011]     However, all of these devices suffer from several draw backs. Initially, in instances where the larynx has not been removed, the use of these tracheotomy tubes in conjunction with inflatable balloons adds to the complexity and difficulty for patients to talk. Further, many of these devices allow for forced respiration, but do not accommodate oxygenation in combination with normal breathing. Still further, the attachment means for these devices are cumbersome, prone to catching on clothing or disturbed while sleeping, and generally do not provide a neat solution to the oxygen supply problem. Accordingly, the present invention is directed at solving these and other problems associated with the known devices.  
       SUMMARY OF THE INVENTION  
       [0012]     The present invention is directed to an implantable surgical apparatus including a first flange having an opening, a second flange having an opening, and a shaft having a lumen theretrough connecting the first and second flange openings, and for receiving and securing an oxygen supply line.  
         [0013]     The present invention is also directed to an oxygen supply system including a first flange having an opening, a second flange having an opening, and a shaft having a lumen theretrough connecting the first and second flange openings and for receiving and securing an oxygen supply line. The oxygen supply system further includes a catheter inserted into the lumen of the shaft.  
         [0014]     The present invention is also directed to a method of implanting a transtracheal stent. The method includes the steps of forming a stoma in the trachea of a patient and inserting the transtracheal stent into the stoma. The stent may also be secured to the patient through the use of sutures or other securing means. The implantation can be eased by a step of folding a first flange along the length of the stent, and a catheter can be inserted into the stent for supplying oxygen to the patient.  
         [0015]     The various features of novelty which characterize the invention are pointed out in particularity in the claims annexed to and forming a part of this disclosure. For a better understanding of the invention, its operating advantages and specific objects attained by its uses, reference is made to the accompanying descriptive matter in which preferred embodiments of the invention are illustrated. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0016]     For a more complete understanding of the invention, reference is made to the following description and accompanying drawings, in which:  
         [0017]      FIG. 1  is a top view of a transtracheal stent according to an embodiment of the present invention;  
         [0018]      FIG. 2  is an end view of a transtracheal stent according to an embodiment of the present invention;  
         [0019]      FIG. 3  is a side view of transtracheal stent and catheter according to the present invention;  
         [0020]      FIG. 4  is a side view of a catheter for use with a transtracheal stent according to the present invention; and  
         [0021]      FIG. 5  is a cross sectional view of a transtracheal stent according to an embodiment of the present invention.  
         [0022]      FIG. 6  is a top view of another embodiment of a transtracheal stent according to the present invention;  
         [0023]      FIG. 7  is an end view of another embodiment of a transtracheal stent according to the present invention;  
         [0024]      FIG. 8  is a cross sectional view of another embodiment of a transtracheal stent according to the present invention.  
     
    
     DETAILED DESCRIPTION  
       [0025]     The following detailed description, given by way of example and not intended to limit the present invention solely thereto, will best be appreciated in conjunction with the accompanying drawings, wherein like reference numerals denote like elements and parts.  
         [0026]     In  FIG. 1 , the transtracheal stent  10  is shown with a first flange  12 , a second flange  14 , and a connection tube  16 . The tube  16  connects the two flanges and has a lumen  20  extending therethrough allowing for fluid communication from the first flange  12  to the second flange  14 .  
         [0027]     As shown in  FIG. 1  both the first and second flanges have a curved shape. This curved shape opposes movement of the transtracheal stent after it has been implanted in a patient. The shape of the first flange  12  approximates the curvature of the patients neck, this has the benefit of avoiding unnecessary obtrusion from the patient&#39;s neck and providing for a relatively comfortable resting point of the device. The first flange may also be equipped with holes  18  for securing the stent  10  to the patient through the use of sutures or other surgical securing means. The curvature of the second flange  14  acts against the interior of the trachea to prevent the inadvertent removal of the stent  10  from the patient.  
         [0028]     Further, the second flange  14  as shown in  FIGS. 2 and 3  can be formed of two different thicknesses. As shown in  FIG. 3 , the distal ends of the second flange  14  can be formed with a lesser thickness  22  than that portion of the flange in the immediate vicinity of the tube  16 . This difference in thickness allows for the distal ends of the device to be more easily folded along the tube  16  for implantation into the patient. Because of the curvature of the second flange  14 , and the formation of the thinner distal ends, the second flange  14  resists being pulled in the direction of the first flange  12  or being ejected from the patient by coughing. Despite having a lesser thickness  22  than that portion of the second flange  14  in the immediate vicinity of the tube  14 , the curvature of the flange and the formation of the distal ends help to prevent the second flange  14  from folding in the direction away from the first flange, and thereby assists in the securing of the tracheal stent in the patient.  
         [0029]     The first and second flange  12 ,  14  may be so oriented that they are 90 degrees apart in relation to the tube  16 . That is, in one embodiment of the present invention, the two flanges form an X when viewed from either end. This orientation is believed to further assist in securing the stent in the trachea of the patient.  
         [0030]     A further advantage of the flanges is that they have a relatively low profile. The first flange is in one embodiment approximately 2.4 mm in thickness, while the second flange has a thickness of approximately 1.7 mm and where the distal ends of the second flange have a thickness of approximately 1 mm. Of course the flanges can be made to other thicknesses as desired to accommodate ease in implantation, and security once implanted in the patient as well as the materials used to form the device.  
         [0031]     A second embodiment of the present invention can be seen in  FIGS. 6-8 . This embodiment is similar in all respects to the embodiment described above, except that, as best seen in  FIG. 7 , second flange  15  is generally star-shaped or plus-shaped or X-shaped with a length approximately equal to or shorter than the width of the first flange  12 . In this embodiment, second flange  15  is generally smaller than the second flange embodiment described above. The star-shape folds easily to aid in positioning into the tracheal stoma and allows for minimal intrusion into the trachea. The second flange  15  resists being pulled in the direction of the first flange  12  or being ejected from the patient by coughing. Similar to the previous embodiment, second flange  15  may be curved to facilitate comfort and can be formed of two different thicknesses to further aid insertion. Second flange  15  has a relatively low profile having a thickness of approximately 2.0 mm. In other embodiments, of course, the second flange can be made to other thicknesses as desired to accommodate ease in implantation, security once implanted in the patient, and the materials used to form the device.  
         [0032]     The transtracheal stent  10  is preferably made from medical grade silicone, but other materials could also be used without departing from the scope of the present invention. The medical grade silicone preferably has a hardness of 70 durometer for the first flange and 50 durometer for the remaining parts of the stent  10 . By having the hardness of the first flange  12  be greater than that of the second flange, the stent is easier to implant into the patient. Further, having a harder first flange provides for a more robust stent that is less likely to be affected by the rigors of daily use, whereas a softer material would be more likely to flex and get caught in clothing and the like. Similarly, having a softer material for the second flange improves the feel of the stent  10  after implantation into the patient. The softer material allows the device to conform to the contours of the patient and provide a comfortable fit. Further, the use of a softer material on the second flange allows for easier insertion and reduced insertion trauma for the patient because it is more flexible. It would be understood by those of skill in the art that the use of materials for the second flange that are too soft would not be advantageous as this may allow the stent  10  to be pulled from the patients trachea or inadvertently ejected by coughing.  
         [0033]     Another aspect of the present invention is the oxygen delivery catheter  24  shown in  FIGS. 3 and 4 . The catheter  24  is generally tubing which connects the stent  10  to an oxygen supply source  28 . On the end which will be inserted into the stent  10 , at a distance from the end approximately equal to the length of the stent  10  is a bushing  26 . The bushing  26  prevents the catheter  24  from being inserted into the stent  10  beyond the desired distance. Another feature of the present invention is the lip  30  on the tube  16  side of the second flange  14  as shown in  FIG. 5 . The lip  30  also assists in preventing the catheter  24  from extending beyond the second flange  14  more than the desired distance. Yet another feature of the catheter is the bevel  32  on the end of the catheter  24  to be inserted into the stent  10 . The bevel  32  helps to ease the insertion and retraction of the catheter  24  into and out of the stent  10 . Extending from the end of the catheter  24  to be inserted into the stent  10  is a hood  36 . The hood  36  assists in guiding the airflow of the oxygen away from the tracheal wall and down into the trachea of the patient. The hood  36  substantially eliminates the forcing of air against the tracheal wall and provides a more direct airflow route into the lungs of the patient.  
         [0034]     A further feature of the catheter of the present invention is a pre-formed bend  34 . The pre-formed bend  34  allows the wearer to have greater comfort when employing the device. By pre-forming the bend  34 , there is less likelihood that the catheter  24  will kink and shut off the oxygen supply to the wearer. Similarly, the pre-formed bend  34  assists the wearer in allowing the supply lines to be run underneath of the clothing of the wearer and connect to the catheter at a convenient angle of attachment.  
         [0035]     In one embodiment of the invention it is advantageous to insert the catheter  24  into the stent  10  so that the end of the catheter  24  extends approximately 1 mm beyond the surface of the second flange of the stent  10 . This distance serves two related purposes, initially, the 1 mm extension is not so great that large amounts of mucous and other debris collect on the stent  10  or catheter  24 , and secondly, this distance allows for sloughing off of any mucous that does collect there. The mucous is sloughed off by the removal of the catheter  24  from the stent  10 .  
         [0036]     On the opposite end of the catheter  24  is a universal connector for insertion of standard oxygen tubing from the oxygen supply source. Accordingly, following implantation of the stent  10  in the patient, the catheter  24  can be inserted into the stent  10  until the bushing  26  rests against the end of the stent  10  and the oxygen supply can be started. To clean the stent  10  or the catheter  24 , the catheter  24  can be removed from the stent  10 . This removal action will have a cleaning effect on the end catheter  24 , and the catheter can be further cleaned to ensure a good flow of oxygen to the patient.  
         [0037]     A medical professional seeking to implant the stent  10  of the present invention will initially have to form a stoma in the trachea of the patient. Once the stoma is formed, the stent  10  can be inserted into the stoma. To ease insertion the second flange is folded back along the tube  16  to minimize the profile of the stent  10 . The stent  10  is inserted into the stoma of the patient and after reaching a certain point the second flange will assume its original shape. At this point the stent  10  is secured in the stoma of the patient by the force applied by the curvature of the first and second flanges. If it is desirable, the medical professional can suture the first flange to the patient through the holes  18 , or affix the flange through other means known to those skilled in the art. While the forgoing describe surgical implantation, the stent  10  may also lend itself to percutaneous implantation. This could be accomplished by using an apparatus such as the Cook percutaneous tracheostomy introducer, known to those of skill in the art, and which could be modified for use with the present invention.  
         [0038]     While the present invention has been particularly shown and described in conjunction with preferred embodiments thereof, it will be readily appreciated by those of ordinary skill in the art that various changes may be made without departing from the spirit and scope of the invention. Therefore, it is intended that the appended claims be interpreted as including the embodiments described herein as well as all equivalents thereto.