Abstract:
The main idea for the tongue debulking stapler is to introduce a new surgical procedure for tongue size reduction in cases of macroglossia and in concern for cases of moderate and sever OSA as a one of the minimally invasive procedures that will have a better outcome and less intraoperative and postoperative complications than the conventional procedures. The tongue debulking stapler did not used before in the field of otolaryngology. The stapler has 3 parts (hand—body—stapling cutting part) and for each parts there specific protection elements. The stapler is supplied by tongue tissue holder to facilitates its work

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    “Not applicable” 
       STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0002]    “Not applicable” 
       SEQUENCE LISTING 
       [0003]    “Not applicable” 
       THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT 
       [0004]    “Not applicable” 
       BACKGROUND OF THE INVENTION 
       [0005]    1. Field of Invention 
         [0006]    This invention described herein relates to devices and associated method for treating macroglossia. More specifically, the invention described herein relate to devices and methods for treating enlarged tongue base in the treatment of cases of obstructive sleep apnea as a minimally invasive technique as the previous conventional tongue base surgeries had a lot of intraoperative and postoperative complications and necessities a temporary preoperative tracheostomy 
         [0007]    2. Description of the Related Art 
         [0008]    Obstructive sleep apnea (osa) is highly prevalent medical problem. One in fifteen adults has moderate to severe osa requiring treatment. Untreated osa results in reduced quality of life and increased risk of disease including hypertension, stroke, heart disease, etc. 
         [0009]    Continuous positive airway pressure (cpap) is the standard treatment for osa. while cpap is non-invasive and highly effective, it is not well tolerated by patients. Patient compliance for CPAP is often reported to be between 40% and 60%. 
         [0010]    Surgical treatment options for OSA are available too. However, they tend to be highly invasive, irreversible, and have poor and/or inconsistent efficacy. Even the more effective surgical procedures are undesirable because they usually require multiple invasive and irreversible operations, they may alter a patient&#39;s appearance (e.g., maxillo-mandibulary advancement), and/or they may be socially stigmatic (e.g., tracheostomy) 
         [0011]    The tongue base reduction surgeries, partial glossectomy operations, are one of the curative, but, it is considered as major surgeries for obstructive sleep apnea patients with a lot of perioperative problems 
         [0012]    The tongue debulking stapler is a design of a new surgical instrument based on the minimally invasive concept that will be of value in the field of OSA; more specifically; tongue base surgery 
         [0000]    The tongue debulking stapler can avoids the drawbacks of partial glossectomy operations mainly the need of preoperative temporary tracheostomy because of the possibility of intraoperative bleeding and postoperative tongue edema 
       BRIEF SUMMARY OF THE INVENTION 
       [0013]    The present invention provides device and method for tongue base reduction for osa patient asone of the minimally invasive procedures with better outcome and less intraoperative and postoperative complications compared to the other conventional surgical methods as described in the following detailed description. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING 
         [0014]    Together with the following detailed description, the drawings illustrate exemplary embodiments and serve to explain certain principles in the drawings: 
           [0015]      FIG. 1 : A schematic diagram showing side view and parts of the shape of the tongue debulking stapler; vertical orientation 
           [0016]      FIG. 2 : A schematic diagram showing another side view and parts of the shape of the tongue debulking stapler; vertical orientation 
           [0017]      FIG. 3 : A schematic diagram showing two views together; one while the handle is open and the other one while the handle is closed 
           [0018]      FIGS. 4 &amp; 5 : Schematic diagrams showing parts the handle with view of the stapler cutting segment while the handle is opened. 
           [0019]      FIGS. 6 &amp; 7 : Schematic diagrams showing the parts handle with view of the stapler cutting segment while the handle closed 
           [0020]      FIGS. 8 ,  9  &amp;  10 : Schematic diagrams showing parts of the staper body and movement of the sliding bar in relation to the stapling cutting segment; resting position and while moving forewords when the handle closed 
           [0021]      FIGS. 11 &amp; 12 : Schematic diagrams showing the stapling cutting segment; opened and closed 
           [0022]      FIGS. 13 &amp; 14 : Schematic diagrams showing front view of the stapling cutting segment; while the stapler is in vertical position 
           [0023]      FIGS. 15 &amp; 16 : Schematic diagrams showing front view of the stapling cutting segment; while the stapler is in horizontal position 
           [0024]      FIGS. 17 &amp; 18 : Schematic diagrams showing the direction of the cut section and the cut section of the stapler while the stapler is in vertical position 
           [0025]      FIGS. 19 &amp; 20 : Schematic diagrams showing the direction of the cut section and the cut section of the stapler while the stapler is in horizontal position 
           [0026]      FIGS. 21 ,  22  &amp;  23 : Schematic diagrams showing projection views of the strut holding the cutter and the pushing arm of the staples 
           [0027]      FIG. 24 : A schematic diagram showing the details of the staples holding segment 
           [0028]      FIG. 25 : A schematic diagram showing the staple 
           [0029]      FIG. 26 : A schematic diagram showing parts of the tongue tissue holder 
       
    
    
     BRIEF SUMMARY OF THE INVENTION 
       [0030]    The main idea for the tongue debulking stapler is to make surgical procedure for tongue base reduction in cases of moderate and sever OSA one of the minimally invasive procedures with better outcome and less intraoperative and postoperative complications than the conventional procedures. The tongue debulking stapler did not used before in the field of otolaryngology. The stapler has 3 parts (handle—body and stapling cutting part) and for each part there specific protection elements. The stapler is supplied by tongue tissue holder to facilitates its work 
       DETAILED DESCRIPTION OF THE INVENTION 
       [0031]    Partial glossectomy is a surgical procedure to remove part of the tongue tissue. It can be performed for treatment of different causes of tongue enlargement. Enlargement of the back part of tongue (called the tongue base) can lead to significant obstruction of the upper airway during sleep. Partial glossectomy or tongue base reduction involves removing a portion of the back part of tongue. This results in less tissue bulk to fall backwards to block your breathing. The airway in the back of your throat is opened, allowing for more comfortable sleeping at night. 
         [0032]    The tongue debulkinge stapler is a new design of surgical instrument that will be used in the field of tongue base reduction surgeries in cases of moderate to severe and severe cases of OSA 
         [0033]    The idea is to be one of the minimally invasive tongue base surgeries that will avoid the intraoperative and postoperative complications of the traditional tongue base reduction surgeries 
         [0034]    The stapler can be either disposable or reusable, made of plastic or stainless steel. Both types are generally loaded using replaceable disposable cartridges. 
         [0035]    The stapler can be either of child or adult size according to the length and diameter of both body and stapling cutting segment 
         [0036]    The stapler incorporates a knife or cutter, for complete excision and stapling in a single operation. 
         [0037]    The stapler cutter can be a conventional one; working as a cold knife or can be attached to harmonic technology; harmonic scalpel to reduce the tongue tissue bleeding 
         [0038]    The staple line is either straight or slightly cutved 
         [0039]    The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. 
         [0040]    Description of the Tongue Debulking Stapler and the Tissue Holding Forceps 
         [0041]    With reference to  FIG. 1 : the shape and parts of the tongue debulking stapler; side view; vertical orientation. 
         [0000]      1  handle
 
 2  shaft
 
 3  stapling cutting part.
 
Number  1 : refers to the handle in all pictures; number  2  refers to the body in all pictures &amp; number  3  refers to the stapling cutting part in all pictures
 
         [0042]    With reference to  FIG. 2 : showing another side view and parts of the tongue debulking stapler; vertical orientation. 
         [0000]      1  handle
 
 2  shaft
 
 3  stapling cutting part
 
         [0043]    With reference to  FIG. 3 : schematic diagram showing two views together; one while the handle is opened and the other one while the handle is closed. 
         [0000]      1  handle
 
 2  shaft
 
 3  stapling cutting part
 
         [0044]    With reference to  FIGS. 4 &amp; 5 : schematic diagrams showing parts of the handle with view of the stapler cutting segment while the handle opened. 
         [0000]    Wwith reference to  FIG. 4 :
 
 1 / 1  &amp;  2 / 1  Fixed grips
 
 3 / 1  Active grip, working in relation to the fixed grip  2 / 2  through an articulating joint.
 
 4 / 1  Control segment: inner surface of the active grip is attached to a control segment with 2 step movement range; for approximation then complete fixation. This segment is continue anteriorly with a sliding bar
 
 5 / 1  Firing knob: responsible for cutting and stapling as a single function. range of movement is one and half cm in a forward direction. This knob has to 2 step movement mode to insure safe secure cutting
 
 6 / 1  Two ridges on the inner surface of the active grip needed for the 2 step movement range of the control segment with reference to  FIG. 5 :
 
 1 / 2  The stapler shaft
 
 2 / 2  The sliding bar of stapler body
 
 3 / 2  The distal end of the sliding bar
 
 2 / 3  Fixed limb of the stapling segment; anvil
 
 3 / 3  Mobile limb; cartilage holding limb
 
         [0045]    With reference to  FIGS. 6 &amp; 7 : schematic diagrams showing parts of the handle with view of the stapler cutting segment while the handle closed 
         [0000]    With reference to  FIG. 6 :
 
 1 / 1  &amp;  2 / 1  Fixed grips
 
 3 / 1  Active grip
 
Movement of the active grip in inwards direction to close with the fixed part through 2 step movement of the control segment
 
 5 / 1  Firing knob
 
With reference to  FIG. 7 :
 
 1 / 2  The stapler shaft
 
 2 / 2  The sliding bar of stapler shaft
 
 3 / 2  The distal end of the sliding bar
 
 2 / 3  Fixed limb of the stapling segment; anvil
 
 3 / 3  Mobile limb; cartilage holding limb
 
         [0046]    With reference to  FIGS. 8 ,  9  &amp;  10 : Schematic diagrams showing parts of the staper body and movement of the sliding bar in relation to the stapling cutting segment; resting position and while moving forewords when the handle closed with reference to  FIG. 8 : the body and sliding bar: 
         [0000]      1 / 2  The shaft of the stapler
 
 2 / 2  The sliding bar that work between the control segment of the handle and the cartilage holding limb of the stapling cutting part of the stapler.
 
 3 / 2  The distal end of the bar is less in wideth than the rest of the bar
 
 2 / 3  Fixed limb of the stapling segment; anvil
 
 3 / 3  Mobile limb; cartilage holding limb
 
         [0047]    Body length: 12-15 cm; external wideth: 5-8 mm and hight: 5 mm; according to the stapler size (child or adult) 
         [0048]    With reference to  FIG. 9 : stapler cutting segment; open: 
         [0000]      1 / 2  The shaft of the stapler
 
 2 / 2  The sliding bar of stapler shaft
 
 3 / 2  The distal end of the sliding bar
 
With reference to  FIG. 10 : stapler cutting segment; closed
 
 1 / 2  The body of the stapler
 
 2 / 2  The sliding bar of stapler shaft
 
 3 / 2  The distal end of the sliding bar
 
 1 / 3  Cutting blade
 
 2 / 3  Fixed limb of the stapling segment; anvil
 
 3 / 3  Mobile limb; cartilage holding limb
 
         [0049]    With reference to  FIGS. 11 &amp; 12 : schematic diagrams showing the stapling cutting segment; opened and closed with reference to  FIG. 11 : the stapling cutting segment; opened: 
         [0000]      2 / 2  The sliding bar of stapler shaft
 
 3 / 2  The distal end of the sliding bar
 
 2 / 3  Fixed limb of the stapling segment; anvil
 
 3 / 3  Mobile limb; cartilage holding limb. Staples applied in a side-to-side fashion
 
With reference to  FIG. 12 : The stapling cutting segment; closed:
 
 2 / 2  The sliding bar of stapler shaft
 
 3 / 2  The distal end of the sliding bar
 
 1 / 3  Cutting blade: running immediately above the stapling part
 
       Stapling Segmentt: 
     Parts: 
       [0050]      2 / 3  Fixed limb of the stapling segment; anvil: width 3 mm
 
 3 / 3  Mobile limb; cartilage holding limb; to which staples cartilage is attached. Width 6 mm
 
         [0051]    Each cartilage contains 2 lines of staples; each one consists of 3-4 staples. This part move in relation to the side of distal end of the shaft through a joint 
       Length: 15-20 mm 
       [0052]    Movement of the movable part of the active grip of the handle leads to a forwards movement of the sliding bar that will push and close the movable part of the stapler working segment. The sliding bar is moving on the external surface of the side of the stapler shaft. 
         [0053]    With reference to  FIGS. 13 &amp; 14 : Schematic diagrams showing front view of the stapling cutting segment; while the stapler is in a vertical position 
         [0000]    With reference to  FIG. 13 :
 
 1 / 3  Cutting blade
 
 2 / 3  Fixed limb of the stapling segment; anvil
 
 3 / 3  Mobile limb; cartilage holding limb
 
With reference to  FIG. 14 :
 
 2 / 2  The sliding bar of stapler shaft
 
 3 / 2  The distal end of the sliding bar
 
 1 / 3  Cutting blade
 
 2 / 3  Fixed limb of the stapling segment; anvil
 
 3 / 3  Mobile limb; cartilage holding limb
 
         [0054]    With reference to  FIGS. 15 &amp; 16 : schematic diagrams showing front view of the stapling cutting segment; while the stapler is in horizontal L position 
         [0000]    With reference to  FIG. 15 :
 
 1 / 3  Cutting blade
 
 2 / 3  Fixed limb of the stapling segment; anvil
 
 3 / 3  Mobile limb; cartilage holding limb
 
With reference to  FIG. 16 :
 
 1 / 2  The sliding bar of stapler shaft
 
 2 / 2  The distal end of the sliding bar
 
 1 / 3  Cutting blade
 
 2 / 3  Fixed limb of the stapling segment; anvil
 
 3 / 3  Mobile limb; cartilage holding limb
 
         [0055]    With reference to  FIGS. 17 &amp; 18 : schematic diagrams showing the direction of the cut section and the cut section of the stapler while the stapler is in vertical position with reference to  FIG. 17 : the stapler with broken arrows to show the direction of the cut section, vertical orintation of the stapler.  1  handle,  2  shaft and  3  stapling cutting part 
         [0000]    With reference to  FIG. 18 : the cut section
 
 1 / 1  &amp;  2 / 1  Fixed grips
 
 3 / 1  Active grip
 
 4 / 1  Control segment
 
 5 / 1  Firing knob
 
 6 / 1  Two ridges on the inner surface of the active grip
 
 7 / 1  Acting as contol guide for movement of the contol segment &amp; articulating joint between the 2 nd  fixed grip and the active grip
 
 1 / 2  Shaft of stapler
 
         2 / 2  Sliding bar 
       [0056]      3 / 2  Cutting blade
 
 4 / 2  Distal end of the sliding bar
 
 1 / 3  Joint for movement of the cartiolage holding limb
 
 2 / 3  Cartiolage holding limb
 
         3 / 3  Cartilage 
       4 / 3  Anvil 
       [0057]    With reference to  FIGS. 19 &amp; 20 : schematic diagrams showing the direction of the cut section and the cut section of the stapler while the stapler is in horizontal position with reference to  FIG. 19 : the stapler with broken arrows to show the direction of the cut section, horizontal orintation of the stapler.  1  handle,  2  body and  3  stapling cutting part 
         [0000]    With reference to  FIG. 20 : the cut section
 
 1 / 1  Fixed grip
 
 2 / 1  Firing knob
 
 3 / 1  Cutting blade
 
 4 / 1  Meatal limb that puch the staples out when entering the cartilage
 
 1 / 2  Shaft of the stapler
 
 2 / 2  A plastic strut to which attached the cutter, in its upper anterior end, and the pushinglimb of the staples out when entering the cartilage, in its lower anterior end. The upper surface of the strut is fixed to the inner surface of the stapler body
 
 1 / 3  Stapling segment
 
         [0058]    With reference to  FIGS. 21 ,  22  &amp;  23 : schematic diagrams showing projection views of the strut holding the cutter and the pushing arm of the staples 
         [0000]    With reference to  FIG. 21 : cut section with projection of strut holding the cutter and the pushing arm of the staples
 
With reference to  FIGS. 22 &amp; 23 : projection views of the strut holding the cutter and the pushing arm of the staples
 
 1  Shaft of the stapler
 
 2  Cutting blade
 
 3  The pushing arm of the staples
 
 4  The plastic strut
 
 5  The cartilage holding part of the stapling segment
 
         [0059]    With reference to  FIG. 24 : a schematic diagram showings the details of the staples holding segment 
         [0000]      1  Cutting blade
 
 2  Staples contaner
 
 3  Staples pocket
 
         4  Staples 
       [0060]      5  The cartilage holding part of the stapling segment
 
 6  The cover protection plastic piece; guide aganst stapler firing
 
         [0061]    With reference to  FIG. 25 : a schematic diagram showing of the staples
       Made from absorbable material   Diminutions:
           Crown: 4 mm   Legs: open stapler height 5 mm, closed stapler height 2 mm   Wire diameter: 1 mm   
           Release of 3-4 staples at a time       
 
         [0068]    With reference to  FIG. 26 : a schematic diagram showing of the parts of the tongue tissue holder. This tissue holding will make the stapler work easier and can control the amount of tongue tissue to be excised 
         [0000]      1  TIP: Curved in a way to be able to visualise the tongue tissue needed to be excised; with two sharp teeth for holding the tongue tissue. Height in relation to the shaft: 3 mm
 
 2  Shaft: 12-15 cm in length and 4 mm in diameter and more slopping and less in diameter towards the holding tip
 
         3  Handle 
       [0069]    The following is detailed description of the steps of tongue tissue debulking or partial glossectomy using the tongue debulking stapler 
         [0070]    The procedure under taken under general anesthesia 
         [0071]    A retraction suture is placed through the anterior midline tongue tip. Mark the boundaries of the lingual artery. A handpiece ultrasound probe can be used to delineate and marks thelingual arteries bilaterally. It is documented in several previous studies that the lingual artery runs laterally along the tongue base and that it is at a relatively consistent distance away from the foramen cecum in an inferior and lateral direction. The lingual artery is consistently medial to both the hypoglossal and lingual nerves 
         [0072]    The tongue tissue holder is applied to the area of the tongue needed to be excised. The tongue tissue is pulled upwards and the jaws of the stapler working segment is applied on both sides and closed aganist tongue tissue to be resected. The firing knob is pushed in a forwards direction to cut the tongue tissue and apply staples immediately inferior to the cut line 
         [0073]    A layer of surgical glue is applied the cut edge of the tongue to cover the raw area and help in haemostasis 
         [0074]    The same is applied to the other side of the tongue. It can be one stage operation or a staged operation, one side of tongue in each session to avoid bilateral tongue oedema which may affect the upper airway especially in infants and children 
         [0075]    This technique provides minimal tissue handling with less postoperative tongue edema and short postoperative hospital stay; minimally invasive technique