Vacuum-assisted drug delivery device and method

Abstract

This invention relates to a device and method for the vacuum-assisted delivery of drugs through an intact surface membrane of an organ.

1 . A drug delivery device, comprising:
 a vacuum source; and   a drug reservoir operatively coupled to the vacuum source; wherein:
 the drug reservoir is for contacting with a target surface membrane of an organ to form an air-tight contact between the drug reservoir and the target surface membrane and wherein 
 when a fluid comprising a drug is within the drug reservoir, the fluid is in fluid communication with the target surface membrane when the drug reservoir is in contact with the target surface membrane. 
   
     
     
         2 . The drug delivery device in  claim 1 , wherein the drug reservoir has a surface that is conformed or conformable to the target surface membrane. 
     
     
         3 . The drug delivery device in  claim 1 , wherein a portion of the drug reservoir for contacting with the target surface membrane is open which allows direct contact with the fluid in the drug reservoir with the target surface membrane. 
     
     
         4 . The drug delivery device in  claim 1 , wherein a portion of the drug reservoir is a tube-like structure, wherein one end of the tube-like structure is open to the target surface membrane and a perimeter of the open end of the tube-like structure in for contacting with the target surface membrane for creating a seal when a vacuum is pulled within the drug reservoir. 
     
     
         5 . The drug delivery device of  claim 1 , wherein the vacuum source is selected from the group consisting of a manual pump, an electric pump and a digitally programmable pump. 
     
     
         6 . The drug delivery device of  claim 1 , wherein a vacuum is created by a single-use vacuum source. 
     
     
         7 . The drug delivery device of  claim 6 , wherein the single-use vacuum source is a pressurized canister. 
     
     
         8 . The drug delivery device of  claim 1 , wherein the vacuum source is operatively coupled to the drug reservoir via a rigid or flexible tube. 
     
     
         9 . The drug delivery device of  claim 1 , wherein the device is manufactured such that the drug is located within the device or drug reservoir. 
     
     
         10 . The drug delivery device of  claim 1 , wherein the drug is introduced into the device or drug reservoir at a time of use or treatment. 
     
     
         11 . The drug delivery device of  claim 1 , wherein the device includes a modular and/or interchangeable drug cartridge or removable/replaceable compartment containing the drug for insertion into the device. 
     
     
         12 . The drug delivery device of  claim 11 , wherein the drug cartridge is custom designed. 
     
     
         13 . The drug delivery device of  claim 11 , wherein the drug cartridge is off-the-shelf. 
     
     
         14 . The drug delivery device of  claim 11 , wherein the drug cartridge compartment may serve as a main drug reservoir or an ancillary drug reservoir 
     
     
         15 . The drug delivery device of  claim 10 , wherein the drug is introduced into the device or reservoir with a syringe, needle, or other method of introduction. 
     
     
         16 . The drug delivery device of  claim 1 , further comprising one or more injection sites. 
     
     
         17 . The drug delivery device of  claim 16 , wherein the injection site is coupled to the drug reservoir or to a rigid or flexible tube that operatively couples the drug reservoir to the vacuum source. 
     
     
         18 . The drug delivery system of  claim 1 , wherein when the fluid is in the drug reservoir, the fluid is in fluid communication with the target surface membrane via a plurality of pores in a drug reservoir surface that is in contact with the target surface membrane. 
     
     
         19 . The drug delivery device of  claim 1 , wherein when the fluid is in the drug reservoir, the fluid is in fluid communication with the target surface membrane via an interconnected or open cell foam material or a porous material, either of which comprises a plurality of channels that extend from a surface of the foam or nanoporous material that is in contact with the fluid in the drug reservoir to the surface of the foam or porous material that is in contact with the target surface membrane. 
     
     
         20 . The drug delivery device of  claim 1 , wherein the drug reservoir is detachable from the device while maintaining a vacuum and the drug reservoir remains in contact with the target surface membrane for a prolonged period of time after detachment. 
     
     
         21 . The drug delivery device of  claim 1 , further comprising a proximal flow inhibitor to prevent or reduce the fluid in the drug reservoir from being withdrawn from the drug reservoir when a vacuum is being created by the vacuum source. 
     
     
         22 . The drug delivery device of  claim 18 , wherein the plurality of pores have a diameter of from about 0.001 mm to about 10 mm. 
     
     
         23 . The drug delivery device of  claim 18 , wherein the plurality of pores number from 100 to about 1,000,000 pores. 
     
     
         24 . The drug delivery device of  claim 1 , wherein the vacuum source is capable of creating a vacuum down to about 1 to 300 torr. 
     
     
         25 . The drug delivery device of  claim 1 , further comprising a controller configured to provide pulsing of the vacuum source to create and release a vacuum in the drug reservoir when the drug reservoir surface is conformed to and in contact with the target surface membrane. 
     
     
         26 . The drug delivery device of  claim 25 , wherein the controller is configured to pulse the vacuum source between about 1 torr to about 760 torr. 
     
     
         28 . The drug delivery device of  claim 26 , wherein the controller is configured to pulse the vacuum source at a cyclic rate from about 5 seconds to about 5 minutes. 
     
     
         29 - 33 . (canceled) 
     
     
         34 . A device for vacuum-assisted delivery of drug to a target surface membrane of a patient in need of treatment of a disease or condition, comprising:
 a device body comprising a proximal end and a distal end having fluid communication between the proximal and distal end to allow for creation of a vacuum within the device body;   a diffusive membrane at or near the proximal end for contacting with the target surface membrane through which a fluid comprising drug for treating the disease or condition permeates from the device to the target surface membrane when a vacuum is applied to the device,   wherein the diffusive membrane provides support to the target surface membrane during application of the vacuum which reduces or prevents damage to the target surface membrane during application of the vacuum,   wherein the diffusive membrane is porous to allow permeation of the fluid from the device to the target surface membrane;   a proximal flow inhibitor mechanism that reduces or prevents proximal flow of the fluid away from the diffusive membrane during application of the vacuum; and   a fluid distributer proximal to the diffusive membrane having a distal surface which provides for uniform distribution and delivery of fluid over an area of the diffusive membrane.   
     
     
         35 - 40 . (canceled)