# US 2014/0193907 A1 · Particle based biologically active molecule delivery systems > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2014/0193907 A1 - Document ID: US20140193907A1 - Status: Published application - Kind: A1 - Application number: 14/104,804 - Filed: 2013-12-12 - Published: 2014-07-10 - Earliest claimed: 2012-12-14 - Assignees: Bay Genomics, LLC - Applicants: Bay Genomics, LLC - Inventors: Kenneth GREENBERG; Scott GELLER - Web page: https://patentgrep.com/patent/US20140193907A1 ## CPC - A61M 5/2046: {Media being expelled from injector by gas generation, e.g. explosive charge} - A61M 5/3015: {for injecting a dose of particles in form of powdered drug, e.g. mounted on a rupturable membrane and accelerated by a gaseous shock wave or supersonic gas flow (cell injection devices C12M3/006)} - A61M 37/00: Other apparatus for introducing media into the body (for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30); Percutany, i.e. introducing medicines into the body by diffusion through the skin (salt baths A61H33/04) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} ## Abstract Described here are devices and methods for the delivery of molecules, including biologically active molecules, into tissues. The devices and methods are generally particle based, and devised to deploy the molecules into a target tissue in a controlled manner to minimize tissue damage. The devices and methods may further be devised to tailor molecule delivery parameters to a variety of tissue types. Kits including various device components are also described. ## Claims ### Claim 1 A device for delivering molecules comprising: a source of pressurized gas for acceleration of a molecule; a handpiece having a body, the body comprising a proximal end, a distal end, and an acceleration lumen therebetween in fluid communication with the pressurized gas source; a device interface configured to receive input from a user, where the input defines one or more operating parameters of a plurality of device systems; and a control module linked to the device interface, and configured to execute the one or more operating parameters of the systems according to the user input to generate a pulse pattern. ### Claim 2 (depends on 1) The device of claim 1, wherein the device interface comprises a touch screen LCD display. ### Claim 3 (depends on 1) The device of claim 1, wherein the plurality of device systems comprises a pressure relief system. ### Claim 4 (depends on 3) The device of claim 3, wherein the pressure relief system comprises at least one pressure relief valve for reducing gas pressure within a portion of the acceleration lumen. ### Claim 5 (depends on 1) The device of claim 1, wherein the plurality of device systems comprises a vacuum system. ### Claim 6 (depends on 5) The device of claim 5, wherein the one or more operating parameters of the vacuum system are vacuum pulse frequency, vacuum pulse duration, and vacuum pulse amplitude. ### Claim 7 (depends on 1) The device of claim 1, further comprising a delivery conduit having a proximal end and a distal end, and removably attached to, and extending from, the distal end of the handpiece. ### Claim 8 (depends on 7) The device of claim 7, wherein the delivery conduit comprises a needle, a cannula, or a catheter. ### Claim 9 (depends on 7) The device of claim 7, wherein the delivery conduit comprises a first delivery lumen, the first delivery lumen comprising a wall having an inner surface, and a second vacuum lumen. ### Claim 10 (depends on 9) The device of claim 9, wherein the first delivery lumen and the second vacuum lumen have different outer diameters. ### Claim 11 (depends on 9) The device of claim 9, wherein the first delivery lumen is eccentrically disposed within the second vacuum lumen. ### Claim 12 (depends on 9) The device of claim 9, wherein the first delivery lumen is concentrically disposed within the second vacuum lumen. ### Claim 13 (depends on 9) The device of claim 9, wherein the second vacuum lumen is disposed within the wall of the first delivery lumen. ### Claim 14 (depends on 9) The device of claim 9, wherein the inner surface of the wall of the delivery lumen is charged or uncharged. ### Claim 15 (depends on 14) The device of claim 14, wherein the charged inner surface comprises a material having a charge at steady state. ### Claim 16 (depends on 14) The device of claim 14, wherein the charged inner surface is generated by an active potential difference. ### Claim 17 (depends on 14) The device of claim 14, wherein the charged inner surface is generated by coating the surface with a charged molecule. ### Claim 18 (depends on 1) The device of claim 1, further comprising a removably attachable molecule holder, the molecule holder comprising a molecule for delivery to a target tissue. ### Claim 19 (depends on 18) The device of claim 18, wherein the molecule comprises a biologically active molecule. ### Claim 20 (depends on 19) The device of claim 19, wherein the biologically active molecule comprises a deoxyribonucleic acid (DNA), a ribonucleic acid (RNA), a carbohydrate, a protein, a synthetic polymeric construct, a recombinant nucleic acid, a physiological reporter probe, a drug, a dendrimer, a vaccine, or combinations and mixtures thereof. ### Claim 21 (depends on 18) The device of claim 18, wherein the molecule comprises a diagnostic marker. ### Claim 22 (depends on 18) The device of claim 18, wherein the molecule is coupled to a particle. ### Claim 23 (depends on 22) The device of claim 22, wherein the particle comprises gold, silver, or tungsten. ### Claim 24 (depends on 22) The device of claim 22, wherein the particle comprises a non-metallic polymer. ### Claim 25 (depends on 18) The device of claim 18, wherein the molecule holder comprises a plurality of lumens having a polygonal cross-sectional shape. ### Claim 26 (depends on 1) The device of claim 1, wherein the molecule is a biologically active molecule. ### Claim 27 (depends on 26) The device of claim 26, wherein the biologically active molecule comprises a deoxyribonucleic acid (DNA), a ribonucleic acid (RNA), a carbohydrate, a protein, a synthetic polymeric construct, a recombinant nucleic acid, a physiological reporter probe, a drug, a dendrimer, a vaccine, or combinations and mixtures thereof. ### Claim 28 (depends on 1) The device of claim 1, wherein the molecule comprises a diagnostic marker. ### Claim 29 (depends on 1) The device of claim 1, wherein the molecule is coupled to a particle. ### Claim 30 (depends on 29) The device of claim 29, wherein the particle comprises gold, silver, or tungsten. ### Claim 31 (depends on 29) The device of claim 29, wherein the particle comprises a non-metallic polymer. ### Claim 32 (depends on 1) The device of claim 1, wherein the source of pressurized gas comprises nitrogen, argon, xenon, carbon, dioxide, air, helium, or mixtures thereof. ### Claim 33 (depends on 1) The device of claim 1, wherein the plurality of device systems comprises a gas propellant system having one or more operating parameters, wherein the device interface is configured to receive input from a user that defines the one or more operating parameters. ### Claim 34 (depends on 33) The device of claim 33, wherein the one or more operating parameters of the gas propellant system are gas pulse frequency, gas pulse duration, and gas pulse amplitude. ### Claim 35 (depends on 1) The device of claim 1, wherein the pulse pattern comprises one or more gas pulses and one or more vacuum pulses. ### Claim 36 (depends on 1) The device of claim 1, wherein the plurality of device systems comprises a constant positive pressure mechanism having an operating parameter, wherein the device interface is configured to receive input from a user that defines the operating parameter. ### Claim 37 (depends on 36) The device of claim 36, wherein the operating parameter of the constant positive pressure mechanism is positive pressure amplitude. ### Claim 38 A method for controlled delivery of molecules comprising: selecting one or more operating parameters of a plurality of device systems of a delivery device via a user interface of the device to generate a pulse pattern, the device comprising: a handpiece having a body, the body comprising a proximal end, a distal end, and an acceleration lumen therebetween in fluid communication with a pressurized gas source; a device interface configured to receive input from a user, where the input defines one or more operating parameters of the plurality of device systems; and a control module linked to the device interface, and configured to execute the one or more operating parameters of the systems according to the user input; loading a plurality of molecules into the device; positioning the device or a portion thereof adjacent to or into a target tissue; flowing a pressurized gas through the acceleration lumen; and controllably delivering the particles into the target tissue according to the selected operating parameters. ### Claim 39 (depends on 38) The method of claim 38, wherein the pulse pattern comprises one or more gas pulses and one or more vacuum pulses. ### Claim 40 (depends on 39) The method of claim 39, wherein the pulse pattern comprises a single gas pulse and a plurality of vacuum pulses. ### Claim 41 (depends on 39) The method of claim 39, wherein the pulse pattern comprises a single vacuum pulse and a plurality of gas pulses. ### Claim 42 (depends on 39) The method of claim 39, wherein the gas pulse comprises helium. ### Claim 43 (depends on 39) The method of claim 39, wherein the duration of the gas pulse ranges from about 50 to about 500 milliseconds. ### Claim 44 (depends on 39) The method of claim 39, wherein the duration of the vacuum pulse ranges from about 25 to about 650 milliseconds. ### Claim 45 (depends on 39) The method of claim 39, wherein the vacuum pulse precedes the gas pulse by about 25 to about 150 milliseconds. ### Claim 46 (depends on 38) The method of claim 38, wherein the one or more operating parameters of the vacuum system are vacuum pulse frequency, vacuum pulse duration, and vacuum pulse amplitude. ### Claim 47 (depends on 38) The method of claim 38, wherein the plurality of device systems comprises a gas propellant system having one or more operating parameters. ### Claim 48 (depends on 47) The method of claim 47, wherein the one or more operating parameters of the gas propellant system are gas pulse frequency, gas pulse duration, and gas pulse amplitude. ### Claim 49 (depends on 38) The method of claim 38, wherein the plurality of device systems comprises a constant positive pressure mechanism having an operating parameter. ### Claim 50 (depends on 49) The method of claim 49, wherein the operating parameter is positive pressure amplitude. ### Claim 51 (depends on 38) The method of claim 38, wherein the plurality of molecules comprises a biologically active molecule. ### Claim 52 (depends on 51) The method of claim 51, wherein the biologically active molecule comprises a deoxyribonucleic acid (DNA), a ribonucleic acid (RNA), a carbohydrate, a protein, a synthetic polymeric construct, a recombinant nucleic acid, a physiological reporter probe, a drug, a dendrimer, a vaccine, or combinations and mixtures thereof. ### Claim 53 (depends on 38) The method of claim 38, wherein the plurality of molecules comprises a diagnostic marker. ### Claim 54 (depends on 38) The method of claim 38, wherein the target tissue is muscle, connective tissue, skin, nervous tissue, ocular tissue, or a combination thereof. ### Claim 55 (depends on 54) The method of claim 54, wherein the ocular tissue comprises retinal tissue. ### Claim 56 (depends on 54) The method of claim 54, wherein the nervous tissue comprises brain tissue. ### Claim 57 (depends on 1) A kit for delivering particles into tissue comprising the device of claim 1, and one or more molecule holders. ### Claim 58 (depends on 57) The kit of claim 57, further comprising one or more needles and one or more needle adapters. ### Claim 59 (depends on 8) The device of claim 8, wherein the delivery conduit comprises a needle having a needle lumen. ### Claim 60 (depends on 59) The device of claim 59, further comprising a needle adapter for releasably securing the needle to the handpiece, the needle adapter having a proximal end and a distal end. ### Claim 61 (depends on 60) The device of claim 60, wherein the needle adapter comprises an inner barrel in fluid communication with the needle lumen. ### Claim 62 (depends on 61) The device of claim 61, wherein the inner barrel of the needle adapter extends past the distal end of the adapter. ### Claim 63 (depends on 62) The device of claim 62, wherein the inner barrel of the needle adapter is a particle delivery lumen. ### Claim 64 (depends on 62) The device of claim 62, wherein the inner barrel of the needle adapter is a vacuum delivery lumen. ### Claim 65 (depends on 61) The device of claim 61, wherein the inner barrel of the needle adapter comprises a single central lumen having a constant diameter. ### Claim 66 (depends on 61) The device of claim 61, wherein the inner barrel of the needle adapter comprises a tapered lumen.