Methods and devices for soft palate tissue elevation procedures

Abstract

A self-retaining suture having particular application for treating obstructive sleep apnea and use thereof. The suture includes rising an elongated suture body having a periphery and first and second tissue-penetrating ends each with a bi-curve needle, and a plurality of first retainers on a first segment and oriented to the first end, and a plurality of second retainers a second segment and oriented to the second end, and a retainer-free transition segment disposed between the pluralities of first and second retainers.

What is claimed is: 
     
         1 . A method of approximating soft palate tissue using a bidirectional self-retaining suture having first and second tissue-penetrating ends, first and second pluralities of tissue retainers oriented towards the first and second ends, respectively, and separated by a retainer-free transition segment, the method comprising:
 a. inserting the first end of a suture into the soft palate at an insertion point to one side of the palate midline and between the junction of the hard and soft palates and the posterior end of the soft palate;   b. deploying the first end through the soft palate across the palate midline to a first exit point to the other side of the palate midline and between the junction of the hard and soft palates and the posterior end of the soft palate;   c. urging the first end out of the soft palate at the first exit point and drawing the suture through the soft palate until the second plurality of tissue retainers engage the tissue;   d. re-inserting the first end into the first exit point and deploying the first end through the soft palate posteriorly and away from the palate midline to a second exit point;   e. urging the first end out of the soft palate at the second exit point and drawing the suture out through the second exit point;   f. inserting the second end into the insertion point and deploying the second end through the soft palate posteriorly and away from the palate midline to a third exit point; and   g. urging the second end out of the soft palate at the third exit point and drawing the suture out through the third exit point.   
     
     
         2 . The method according to  claim 1 , further comprising trimming the suture flush with the second and third exit points. 
     
     
         3 . The method according to  claim 1 , further comprising drawing the suture anteriorly and cranially in step “g” to increase elevation of the soft palate. 
     
     
         4 . The method according to  claim 1 , whereby the drawing of the suture results in a volumetric increase in the airway of a patient. 
     
     
         5 . The method according to  claim 1 , wherein the first and second tissue penetrating ends of the suture further comprise first and second bi-curved needles attached to first and second ends of the suture respectively. 
     
     
         6 . The method according to  claim 5 , wherein the bi-curved needle has a length of approximately 28-32 mm. 
     
     
         7 . A surgical kit for soft palate elevation procedures, the kit comprising a suture package including:
 a suture assembly including an elongated suture body having a periphery and first and second tissue-penetrating ends, each of the first and second ends being provided with a needle having a curvature, a plurality of first retainers disposed on a first segment of the elongated body and oriented to the first end, the first plurality of retainers yielding toward the suture body during movement of the suture through tissue in a direction of deployment of the first end, and resisting movement of the suture, when in tissue, in a direction substantially opposite to the direction of deployment of the first end, a plurality of second retainers disposed on a second segment of the elongated body and oriented to the second end, the plurality of second retainers yielding toward the suture body during movement of the suture through tissue in a direction of deployment of the second end, and resisting movement, when in tissue, in a direction substantially opposite the direction of deployment of the second end, and a retainer-free transition segment disposed between the pluralities of first and second retainers, the transition segment having a length of up to 10 mm;   a needle driver;   forceps;   scissors; and   a tongue depressor.   
     
     
         8 . The surgical kit according to  claim 7 , wherein the suture body of the suture assembly is comprised of a bio-absorbable material. 
     
     
         9 . The surgical kit according to  claim 7 , wherein the suture body of the suture assembly is comprised of a non-absorbable material. 
     
     
         10 . The surgical kit according to  claim 7 , wherein the length of the transition segment is between 0.5 and 5 mm. 
     
     
         11 . The surgical kit according to  claim 10 , wherein the length of the transition segment is between 0.5 and 1.5 mm. 
     
     
         12 . The surgical kit according to  claim 11 , wherein the length of the transition segment is approximately 1 mm. 
     
     
         13 . The surgical kit according to  claim 7 , wherein the first and second segments have a length less than 70 mm. 
     
     
         14 . The surgical kit according to  claim 13 , wherein the first and second segments have a length less than 50 mm. 
     
     
         15 . The surgical kit according to  claim 7 , wherein the first and second retainers are arranged in a helical pattern. 
     
     
         16 . The surgical kit according to  claim 15 , wherein the helical pattern is a double helix. 
     
     
         17 . The surgical kit according to  claim 16 , wherein the helical pattern further comprises a retainer density of at least 250 per centimeter. 
     
     
         18 . The surgical kit according to  claim 15 , wherein the helical pattern is a quada-helix. 
     
     
         19 . The surgical kit according to  claim 18 , wherein the helical pattern further comprises a retainer density of at least 250 per centimeter. 
     
     
         20 . A self-retaining suture comprising:
 a. an elongated suture body having a periphery and first and second tissue-penetrating ends, each of the first and second ends being provided with a bi-curve needle;   b. a plurality of first retainers disposed on a first segment of the elongated body and oriented to the first end, the first plurality of retainers yielding toward the suture body during movement of the suture through tissue in a direction of deployment of the first end, and resisting movement of the suture, when in tissue, in a direction substantially opposite to the direction of deployment of the first end;   c. a plurality of second retainers disposed on a second segment of the elongated body and oriented to the second end, the plurality of second retainers yielding toward the suture body during movement of the suture through tissue in a direction of deployment of the second end, and resisting movement, when in tissue, in a direction substantially opposite the direction of deployment of the second end; and   d. a retainer-free transition segment disposed between the pluralities of first and second retainers.   
     
     
         21 . The self-retaining suture according to  claim 20 , wherein the plurality of first and second retainers are arranged in a helical pattern. 
     
     
         22 . The self-retaining suture according to  claim 21 , wherein the first and second retainers have a retainer density of at least 250 per centimeter. 
     
     
         23 . The self-retaining suture according to  claim 21 , wherein the helical pattern in a double helix. 
     
     
         24 . The self retaining suture according to  claim 21 , wherein the helical pattern is a quadra-helix. 
     
     
         25 . The self-retaining suture according to  claim 21 , wherein the length of the transition segment is between approximately 0.5 and 5 mm, and a length of the first and second segments is less than or equal to approximately 70 mm. 
     
     
         26 . The self-retaining suture according to  claim 25 , wherein the length of the first and second segments is less than or equal to approximately 50 mm. 
     
     
         27 . The self retaining suture according to  claim 25 , wherein the length of the transition segment is approximately 1 mm.