Drug delivery device for providing local analgesia, local anesthesia or nerve blockage

Abstract

The invention relates to a drug delivery device for providing local analgesia, local anesthesia or nerve blockade at a site in a human or animal in need thereof, the device comprising a fibrillar collagen matrix; and at least one drug substance selected from the group consisting of amino amide anesthetics, amino ester anesthetics and mixtures thereof, the at least one drug substance being substantially homogeneously dispersed in the collagen matrix, and the at least one drug substance being present in an amount sufficient to provide a duration of local analgesia, local anesthesia or nerve blockade which lasts for at least about one day after administration.

What is claimed is: 
     
       1. A drug delivery device for providing local analgesia, local anesthesia or nerve blockade at a site in a human or animal in need thereof, the device comprising a fibrillar collagen matrix; and at least one drug substance selected from the group consisting of amino amide anesthetics, amino ester anesthetics and mixtures thereof, the at least one drug substance being substantially homogeneously dispersed in the collagen matrix, and the at least one drug substance being present in an amount sufficient to provide a duration of local analgesia, local anesthesia or nerve blockade which lasts for at least about one day after administration. 
     
     
       2. The drug delivery device of  claim 1 , wherein the at least one drug substance is present in an amount sufficient to provide a duration of local analgesia, local anesthesia or nerve blockade which lasts for at least about two days after administration. 
     
     
       3. The drug delivery device of  claim 1 , wherein the at least one drug substance is present in an amount sufficient to provide a duration of local analgesia, local anesthesia or nerve blockade which lasts for at least about three days after administration. 
     
     
       4. The drug delivery device of  claim 1 , wherein the at least one drug substance is an amino amide anesthetic selected from the group comprising Bupivacaine, Levobupiyacaine, Lidocaine, Mepivacaine, Prilocaine, Ropivacaine, Articaine, Trimecaine and their salts and prodrugs. 
     
     
       5. The drug delivery device of  claim 1 , wherein the at least one drug substance is an amino amide anesthetic selected from bupivacaine and salts and pro drugs thereof. 
     
     
       6. The drug delivery device of  claim 1 , wherein the fibrillar collagen matrix is a Type I collagen matrix. 
     
     
       7. The drug delivery device of  claim 1 , wherein the fibrillar collagen matrix is a Type I collagen matrix and the at least one drug substance is an amino amide anesthetic selected from bupivacaine and salts and prodrugs thereof. 
     
     
       8. The drug delivery device of  claim 7 , wherein the drug delivery device comprises a plurality of collagen sponges, each collagen sponge containing about 3.6 to about 8.0 mg/cm 3  type I collagen and about 2.0 to about 6.0 mg/cm 3  bupivacaine hydrochloride. 
     
     
       9. The drug delivery device of  claim 7 , wherein the drug delivery device comprises a plurality of collagen sponges, each collagen sponge containing about 5.6 mg/cm 3  type I collagen and about 4.0 mg/cm 3  bupivacaine hydrochloride. 
     
     
       10. A method for providing local analgesia, local anesthesia or nerve blockade in a human or animal in need thereof, the method comprising administering at a site in a human or animal in need thereof a drug delivery device comprising a fibrillar collagen matrix; and at least one drug substance selected from the group consisting of amino amide anesthetics, amino ester anesthetics and mixtures thereof, the at least one drug substance being substantially homogeneously dispersed in the collagen matrix, and the at least one drug substance being present in an amount sufficient to provide a duration of local analgesia, local anesthesia or nerve blockade which lasts for at least about one day after administration. 
     
     
       11. The method of  claim 10 , wherein the at least one drug substance is present in an amount sufficient to provide a duration of local analgesia, local anesthesia or nerve blockade which lasts for at least about two days after administration. 
     
     
       12. The method of  claim 10 , wherein the at least one drug substance is present in an amount sufficient to provide a duration of local analgesia, local anesthesia or nerve blockade which lasts for at least about three days after administration. 
     
     
       13. The method of  claim 10 , wherein the at least one drug substance is an amino amide anesthetic selected from the group comprising Bupivacaine, Levobupivacaine, Lidocaine, Mepivacaine, Prilocaine, Ropivacaine, Articaine, Trimecaine and their salts and prodrugs. 
     
     
       14. The method of  claim 10 , wherein the at least one drug substance is an amino amide anesthetic selected from bupivacaine and salts and prodrugs thereof. 
     
     
       15. The method of  claim 10 , wherein the fibrillar collagen matrix is a Type I collagen matrix. 
     
     
       16. The method of  claim 10 , wherein the fibrillar collagen matrix is a Type  1  collagen matrix and the at least one drug substance is an amino anode anesthetic selected from bupivacaine and salts and prodrugs thereof. 
     
     
       17. The method of  claim 16 , wherein the drug delivery device comprises a plurality of collagen sponges, each collagen sponge containing about 3.6 to about 8.0 mg/cm 3  type I collagen and about 2.0 to about 6.0 mg/cm 3  bupivacaine hydrochloride. 
     
     
       18. The method of  claim 16 , wherein the drug delivery device comprises a plurality of collagen sponges, each collagen sponge containing about 5.6 mg/cm 3  type I collagen and about 4.0 mg/cm 3  bupivacaine hydrochloride. 
     
     
       19. The method of  claim 10 , wherein the method is for providing local analgesia, local anesthesia or nerve blockade in a human following laparotomy. 
     
     
       20. The method of  claim 10 , wherein the method is for providing local analgesia, local anesthesia or nerve blockade in a human following orthopedic, abdominal, gynecological or thoracic surgical procedures. 
     
     
       21. The method of  claim 17 , wherein the method is for providing local analgesia, local anesthesia or nerve blockade in a human following orthopedic, abdominal, gynecological or thoracic surgical procedures. 
     
     
       22. The method of  claim 18 , wherein the method is for providing local analgesia, local anesthesia or nerve blockade in a human following orthopedic, abdominal, gynecological or thoracic surgical procedures. 
     
     
       23. The method of  claim 10 , wherein the drug delivery device comprises a plurality of collagen sponges and wherein at least one sponge is placed adjacent the surgical site, at least one sponge is placed across the incision in the wall of the body cavity and at least one sponge is placed between the sheath and skin around the incision. 
     
     
       24. A method for inducing a post-surgical analgesia-sparing effect in a subject in need thereof with a surgical site, the method comprising:
 implanting at the surgical site a collagen sponge consisting of
 (a) a porous matrix of about 3.6 to about 8.0 mg/cm 3  fibrillar Type I collagen, and 
 (b) bupivacaine, or a pharmaceutically acceptable salt thereof, wherein the bupivacaine or pharmaceutically acceptable salt thereof is substantially homogeneously dispersed in the collagen sponge; 
   wherein
 the collagen sponge provides a duration of local anesthesia of at least about one day following implantation; and 
 the method induces the post-surgical analgesia-sparing effect in the subject.  
   
     
     
       25. The method of claim 24, wherein the collagen sponge consists of
 (a) a porous matrix of about 3.6 to about 8.0 mg/cm 3  fibrillar Type I collagen, and   (b) about 2.0 to about 6.0 mg/cm 3  bupivacaine, or a pharmaceutically acceptable salt thereof, wherein the bupivacaine hydrochloride is substantially homogeneously dispersed in the collagen sponge.    
     
     
       26. The method of claim 24, wherein the collagen sponge consists of
 (a) a porous matrix of about 3.6 to about 8.0 mg/cm 3  fibrillar Type I collagen, and   (b) about 2.0 to about 6.0 mg/cm 3  bupivacaine hydrochloride, wherein the bupivacaine hydrochloride is substantially homogeneously dispersed in the collagen sponge.    
     
     
       27. The method of claim 24, wherein the collagen sponge consists of
 (a) a porous matrix of about 5.6 mg/cm 3  fibrillar Type I collagen, and   (b) about 4.0 mg/cm 3  bupivacaine hydrochloride, wherein the bupivacaine hydrochloride is substantially homogeneously dispersed in the collagen sponge.    
     
     
       28. The method of claim 24, wherein the collagen sponge has a surface area of about 25 cm 2 .  
     
     
       29. The method of claim 24, wherein the collagen sponge has dimensions of about 5 cm×5 cm.  
     
     
       30. The method of claim 24, wherein the collagen sponge has a depth or thickness of about 0.5 cm.  
     
     
       31. The method of claim 24, wherein the collagen sponge has dimensions of about 5 cm×5 cm×0.5 cm.  
     
     
       32. The method of claim 24, wherein the subject has undergone a laparotomy, orthopedic surgery, abdominal surgery, gynecological surgery, or thoracic surgery.  
     
     
       33. The method of claim 25, wherein the collagen sponge has a surface area of about 25 cm 2 .  
     
     
       34. The method of claim 25, wherein the collagen sponge has dimensions of about 5 cm×5 cm.  
     
     
       35. The method of claim 25, wherein the collagen sponge has a depth or thickness of about 0.5 cm.  
     
     
       36. The method of claim 25, wherein the collagen sponge has dimensions of about 5 cm×5 cm×0.5 cm.  
     
     
       37. The method of claim 25, wherein the subject has undergone a laparotomy, orthopedic surgery, abdominal surgery, gynecological surgery, or thoracic surgery.  
     
     
       38. The method of claim 26, wherein the collagen sponge has a surface area of about 25 cm 2 .  
     
     
       39. The method of claim 26, wherein the collagen sponge has dimensions of about 5 cm×5 cm.  
     
     
       40. The method of claim 26, wherein the collagen sponge has a depth or thickness of about 0.5 cm.  
     
     
       41. The method of claim 26, wherein the collagen sponge has dimensions of about 5 cm×5 cm×0.5 cm.  
     
     
       42. The method of claim 26, wherein the subject has undergone a laparotomy, orthopedic surgery, abdominal surgery, gynecological surgery, or thoracic surgery.