Suturing needle assemblies and methods of use thereof

Abstract

A suturing needle assembly enables simultaneous passage of suture and introduction of local anesthetic into body tissue. Two suturing needle assembly embodiments are described and methods of using the needle assemblies include cystopexy, cystourethropexy, urethropexy and uteropexy procedures.

What is claimed is:  
     
       1. A suturing needle assembly for enabling simultaneous passage of suture and introduction of local anesthetic into body tissue, said assembly comprising: 
       a hollow needle body defining an interior passageway and further defining first and second ends having first and second openings therein, respectively, in fluid communication with said passageway;  
       said first end further defining a third opening therein for removably receiving a suture;  
       means connected to said second end for removably attaching said needle assembly to a source of local anesthetic;  
       said first end being bevelled with respect to said needle body to form a bevelled end surface; and  
       said third opening extending through said bevelled end surface.  
     
     
       2. An assembly as in  claim 1  further including means attached to said needle body for enhancing a user's grip of said assembly during use. 
     
     
       3. An assembly as in  claim 2  wherein said needle body defines a first substantially straight portion adjacent to said first end and a second substantially straight portion connected to said first straight portion and adjacent to said second end, said first and second straight portions defining an angle of substantially one hundred forty-five degrees therebetween. 
     
     
       4. An assembly as in  claim 3  wherein said angle is from one hundred ten degrees to one hundred eighty degrees. 
     
     
       5. An assembly as in  claim 2  wherein said needle body defines a first substantially straight portion adjacent to said first end; a second substantially straight portion adjacent to said second end; a third substantially straight portion connected to said first straight portion; and a fourth substantially straight portion connected between said second and third straight portions defining first and second angles of substantially one hundred forty-five degrees with each of said second and third straight portions, respectively, and said first and third straight portions defining a third angle of substantially one hundred thirty-five degrees therebetween. 
     
     
       6. An assembly as in  claim 5  wherein said first and second angles are from one hundred fifteen degrees to one hundred seventy-five degrees and wherein said third angle is from one hundred five degrees to one hundred sixty-five degrees. 
     
     
       7. An assembly as in  claim 6  wherein said second straight portion defines an extended imaginary straight centerline there through which intersects said first straight portion. 
     
     
       8. A method of simultaneously passing suture and introducing local anesthetic into body tissue, said method comprising the steps of: 
       providing the suturing needle assembly of  claim 1 ;  
       positioning said suture into and through said third opening;  
       attaching said source of local anesthetic to said needle assembly; and  
       introducing said first end of said needle assembly, said suture and said local anesthetic substantially simultaneously into said body tissue.  
     
     
       9. The method of  claim 8  wherein said step of introducing said local anesthetic into said body tissue further includes the step of: 
       passing said local anesthetic from said source of local anesthetic through said second opening, through said interior passageway of said hollow needle body, and through said first opening into said body tissue.  
     
     
       10. A method of suspending a bladder neck of a patient, comprising the steps of: 
       placing first and second sutures at first and second locations, respectively, at the level of the bladder neck through the entire thickness of the vagina on both sides from the midline of the patient's body;  
       holding the first and second sutures;  
       simultaneously introducing and driving a first said needle body of a first said needle assembly of  claim 3  into a third location, which is a predetermined distance toward a first side from the midline of the patient's body just above the edge of the pubis, and into the retropubic space paravesically along the posterior aspect of the pubic bone and introducing local anesthetic through said first needle body as said first needle body is driven;  
       guiding said first needle body until it emerges through the vagina;  
       disconnecting a first said source of local anesthetic from said first needle assembly;  
       simultaneously introducing and driving a second said needle body of a second said needle assembly of  claim 3  into a fourth location a predetermined distance toward a second side from the midline of the patient's body just above the edge of the pubis and into the retropubic space paravesically along the posterior aspect of the pubic bone and introducing local anesthetic through said second needle body as said second needle body is driven;  
       guiding said second needle body until it emerges through the vagina;  
       disconnecting a second said source of local anesthetic from said second needle assembly;  
       passing said first and second sutures through said third openings in said first and second needle bodies, respectively;  
       pulling said first and second needle bodies back along the posterior aspect of the pubis until said first and second sutures are pulled through the anterior abdominal wall of the patient;  
       removing said first and second needle bodies from said first and second sutures, respectively;  
       grasping said first and second sutures;  
       releasing a first portion of said first suture and threading said first suture portion through said third opening of a first said needle body of a first said needle assembly of  claim 5 ;  
       holding a second portion of said first suture;  
       introducing said first needle body of said first needle assembly of  claim 5  into a third location on the patient's body a predetermined distance laterally from the midline above the edge of the pubis;  
       simultaneously introducing said local anesthetic through said first needle body of said first needle assembly of  claim 5  and driving said first needle body of said first needle assembly of  claim 5  downwardly and then laterally just above the fascia and then upwardly until said last-mentioned needle body emerges through the skin at a fourth location on the patient's body a predetermined distance laterally from the midline above the edge of the pubis;  
       releasing said first suture from said last-mentioned needle body;  
       releasing a first portion of said second suture and threading said last-mentioned first suture portion through said third opening of said first needle body of said first needle assembly of  claim 5 ;  
       holding a second portion of said second suture together with said first portion of said first suture;  
       pulling said last-mentioned needle body backwardly until said second suture emerges through said third location on the patient's body;  
       releasing said second suture from said last-mentioned needle body and holding said second suture;  
       releasing said first and second sutures;  
       applying traction on said first and second sutures and then reholding said first and second sutures;  
       elevating the bladder neck to a normal anatomical position;  
       tieing said first and second sutures into knots when said bladder neck is elevated to a normal anatomical position; and  
       cutting said first and second sutures above said knots.  
     
     
       11. A method as in  claim 10  wherein said first and second locations are each substantially one centimeter laterally from the midline of the patient's body  at the level of the bladder neck. 
     
     
       12. A method of bladder neck and urethral suspension of a patient, comprising the steps of: 
       placing first and second sutures at first and second locations, respectively, at the level of the bladder neck through the entire thickness of the vagina on both sides from the midline of the patient's body;  
       holding the first and second sutures;  
       placing third and fourth sutures at third and fourth locations, respectively, at the level of proximal one-third of the urethra on both sides from the midline of the patient's body through the entire thickness of the vagina;  
       marking ends of said third and fourth sutures for later identification;  
       holding said third and fourth sutures;  
       simultaneously introducing and driving a first said needle body of a first said needle assembly of  claim 5  into a fifth location, which is a predetermined distance toward a first side from the midline of the patient's body just above the edge of the pubis, and into the retropubic space paravesically along the posterior aspect of the pubic bone and introducing local anesthetic through said first needle body as said first needle body is driven;  
       guiding said first needle body until it emerges through the vagina;  
       disconnecting a first said source of local anesthetic from said first needle assembly;  
       simultaneously introducing and driving a second said needle body of a second said needle assembly of  claim 5  into a sixth location a predetermined distance toward a second side from the midline of the patient's body just above the edge of the pubis and into the retropubic space paravesically along the posterior aspect of the pubic bone and introducing local anesthetic through said second needle body as said second needle body is driven;  
       guiding said second needle body until it emerges through the vagina;  
       disconnecting a second said source of local anesthetic from said second needle assembly;  
       passing said first and third sutures through said third opening in said first needle body;  
       passing said second and fourth sutures through said third opening in said second needle body;  
       pulling said first and second needle bodies back along the posterior aspect of the pubis until said first, second, third and fourth sutures are pulled through the anterior abdominal wall of the patient;  
       removing said first needle body from said first and third sutures;  
       removing said second needle body from said second and fourth sutures;  
       grasping said first, second, third and fourth sutures;  
       releasing first portions of said first and third sutures and threading said first and third suture portions through said third opening of a first said needle body of a first said needle assembly of  claim 5 ;  
       holding second portions of said first and third sutures;  
       introducing said first needle body of said first needle assembly of  claim 5  into said fifth location on the patient's body a predetermined distance laterally from the midline above the edge of the pubis;  
       simultaneously introducing said local anesthetic through said first needle body of said first needle assembly of  claim 5  and driving said first needle body of said first needle assembly of  claim 5  downwardly and then laterally just above the fascia and then upwardly until said last-mentioned needle body emerges through the skin at said sixth location on the patient's body a predetermined distance laterally from the midline above the edge of the pubis;  
       releasing said first and third sutures from said last-mentioned needle body;  
       releasing first portions of said second and fourth sutures and threading said last-mentioned first suture portions through said third opening of said first needle body of said first needle assembly of  claim 5 ;  
       holding second portions of said second and fourth sutures together with said first portions of said first and third sutures;  
       pulling said last-mentioned needle body backwardly until said second and fourth sutures emerge through said fifth location on the patient's body;  
       releasing said second and fourth sutures from said last-mentioned needle body and holding said second and fourth sutures;  
       releasing said first, second, third and fourth sutures;  
       applying traction on said first, second, third and fourth sutures and then reholding said first, second, third and fourth sutures;  
       elevating the bladder neck to a normal anatomical position;  
       tieing said first, second, third and fourth sutures into knots when said bladder neck is elevated to a normal anatomical position; and  
       cutting said first, second, third and fourth sutures above said knots.  
     
     
       13. A method as in  claim 12  wherein said first and second locations are each substantially one centimeter laterally from the midline of the patient's body  at the level of the bladder neck. 
     
     
       14. A method of urethral suspension of a patient, comprising the steps of: 
       placing first and second sutures at first and second locations, respectively, at the level of proximal one-third of the urethra through the entire thickness of the vagina on both sides from the midline of the patient's body;  
       holding the first and second sutures;  
       simultaneously introducing and driving a first said needle body of a first said needle assembly of  claim 3  into a third location, which is a predetermined distance toward a first side from the midline of the patient's body just above the edge of the pubis, and into the retropubic space paravesically along the posterior aspect of the pubic bone and introducing local anesthetic through said first needle body as said first needle body is driven;  
       guiding said first needle body until it emerges through the vagina;  
       disconnecting a first said source of local anesthetic from said first needle assembly;  
       simultaneously introducing and driving a second said needle body of a second said needle assembly of  claim 5  into a fourth location a predetermined distance toward a second side from the midline of the patient's body just above the edge of the pubis and into the retropubic space paravesically along the posterior aspect of the pubic bone and introducing local anesthetic through said second needle body as said second needle body is driven;  
       guiding said second needle body until it emerges through the vagina;  
       disconnecting a second said source of local anesthetic from said second needle assembly;  
       passing said first and second sutures through said third openings in said first and second needle bodies, respectively;  
       pulling said first and second needle bodies back along the posterior aspect of the pubis until said first and second sutures are pulled through the anterior abdominal wall of the patient;  
       removing said first and second needle bodies from said first and second sutures, respectively;  
       grasping said first and second sutures;  
       releasing a first portion of said first suture and threading said first suture portion through said third opening of a first said needle body of a first said needle assembly of  claim 5 ;  
       holding a second portion of said first suture;  
       introducing said first needle body of said first needle assembly of  claim 5  into a third location on the patient's body a predetermined distance laterally from the midline above the edge of the pubis;  
       simultaneously introducing said local anesthetic through said first needle body of said first needle assembly of  claim 5  and driving said first needle body of said first needle assembly of  claim 5  downwardly and then laterally just above the fascia and then upwardly until said last-mentioned needle body emerges through the skin at a fourth location on the patient's body a predetermined distance laterally from the midline above the edge of the pubis;  
       releasing said first suture from said last-mentioned needle body;  
       releasing a first portion of said second suture and threading said last-mentioned first suture portion through said third opening of said first needle body of said first needle assembly of  claim 5 ;  
       holding a second portion of said second suture together with said first portion of said first suture;  
       pulling said last-mentioned needle body backwardly until said second suture emerges through said third location on the patient's body;  
       releasing said second suture from said last-mentioned needle body and holding said second suture;  
       releasing said first and second sutures;  
       applying traction on said first and second sutures and then reholding said first and second sutures;  
       elevating the distal urethra to a normal anatomical position;  
       tieing said first and second sutures into knots when said distal urethra is elevated to a normal anatomical position; and  
       cutting said first and second sutures above said knots.  
     
     
       15. A method as in  claim 14  wherein said first and second locations are each substantially one centimeter laterally from the midline of the patient's body  at the level of proximal one-third of the urethra. 
     
     
       16. A method of uterine suspension for uterine prolapse of a patient, comprising the steps of: 
       placing first and second submucosal sutures at first and second locations, respectively, around a predetermined ligament;  
       passing said first and second sutures underneath the mucosa from said ligament to the urethrovesical angle;  
       holding the first and second sutures;  
       simultaneously introducing and driving a first said needle body of a first said needle assembly of  claim 5  into a third location, which is a predetermined distance toward a first side from the midline of the patient's body just above the edge of the pubis, and into the retropubic space paravesically along the posterior aspect of the pubic bone and introducing local anesthetic through said first needle body as said first needle body is driven;  
       guiding said first needle body until it emerges through the vagina;  
       disconnecting a first said source of local anesthetic from said first needle assembly;  
       simultaneously introducing and driving a second said needle body of a second said needle assembly of  claim 3  into a fourth location a predetermined distance toward a second side from the midline of the patient's body just above the edge of the pubis and into the retropubic space paravesically along the posterior aspect of the pubic bone and introducing local anesthetic through said second needle body as said second needle body is driven;  
       guiding said second needle body until it emerges through the vagina;  
       disconnecting a second said source of local anesthetic from said second needle assembly;  
       passing said first and second sutures through said third openings in said first and second needle bodies, respectively;  
       pulling said first and second needle bodies back along the posterior aspect of the pubis until said first and second sutures are pulled through the anterior abdominal wall of the patient;  
       removing said first and second needle bodies from said first and second sutures, respectively;  
       grasping said first and second sutures;  
       releasing a first portion of said first suture and threading said first suture portion through said third opening of a first said needle body of a first said needle assembly of  claim 5 ;  
       holding a second portion of said first suture;  
       introducing said first needle body of said first needle assembly of  claim 5  into a third location on the patient's body a predetermined distance laterally from the midline above the edge of the pubis;  
       simultaneously introducing said local anesthetic through said first needle body of said first needle assembly of  claim 5  and driving said first needle body of said first needle assembly of  claim 5  downwardly and then laterally just above the fascia and then upwardly until said last-mentioned needle body emerges through the skin at a fourth location on the patient's body a predetermined distance laterally from the midline above the edge of the pubis;  
       releasing said first suture from said last-mentioned needle body;  
       releasing a first portion of said second suture and threading said last-mentioned first suture portion through said third opening of said first needle body of said first needle assembly of  claim 5 ;  
       holding a second portion of said second suture together with said first portion of said first suture;  
       pulling said last-mentioned needle body backwardly until said second suture emerges through said third location on the patient's body;  
       releasing said second suture from said last-mentioned needle body and holding said second suture;  
       releasing said first and second sutures;  
       applying traction on said first and second sutures and then reholding said first and second sutures;  
       elevating the uterus to a normal anatomical position;  
       tieing said first and second sutures into knots when said uterus is elevated to a normal anatomical position; and  
       cutting said first and second sutures above said knots.