Systems and devices for selective cell lysis and methods of using same

• US 9,272,124 B2
• Filed: 11/07/2014
• Issued: 03/01/2016
• Est. Priority Date: 12/02/2005
• Status: Active Grant

• Current Assignee: Ulthera Inc. (Merz Pharma GmbH & Company Kgaa)
• Original Assignee: Ulthera Inc. (Merz Pharma GmbH & Company Kgaa)
• Inventors: Merchant, Adnan I., Deem, Mark E.
• Primary Examiner(s): PHAN, THAI Q
• Application Number:
  US14/536,375
• Publication Number:
  US 20150112245A1
• Time in Patent Office: 480 Days
• Field of Search: 703/5, 703/6, 703/7, 601/2, 604/24
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/006 for gases, e.g. CO2
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/1655 Filter with fibers, e.g. filtering element in form of hollow fibers
• CPC Class Codes: 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
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/165 Filtering accessories, e.g. blood filters, filters for infusion liquids A61M1/14 , A61M1/34, A61M1/3627, A61M1/3679, A61M1/3687 take precedence; needle sets with incorporated air inlet filters A61M5/162
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: A61M 5/445 the media being heated in the reservoir, e.g. warming bloodbags
• CPC Class Codes: G06Q 10/02 Reservations, e.g. for tickets, services or events
• CPC Class Codes: G06Q 10/06 Resources, workflows, human or project management; Enterprise or organisation planning; Enterprise or organisation modelling

Abstract

A device for generating microbubbles in a gas and liquid mixture and injection device, the device comprising: a housing defining a mixing chamber; means for mixing solution contained in the mixing chamber to generate microbubbles in the solution; a needle array removably attached to the housing and in fluid connection with the mixing chamber, the needle array including at least one needle; and at least one pressure sensor for measuring tissue apposition pressure, the pressure sensor being mounted on one of the housing and the needle array.

Claims

1. A system for the generation and delivery of microbubbles, comprising:

a liquid reservoir configured to contain a fluid;

a gas reservoir configured to contain a gas or vapor;

a bubble generator,

wherein the bubble generator is in fluidic communication with the liquid reservoir and the gas reservoir,

wherein the bubble generator is configured to receive liquid from the liquid reservoir and gas from the gas reservoir and combine the received liquid and gas to create a solution comprising microbubbles;

a fluid injection device,

wherein the fluid injection device comprises a needle array comprising one or more needles; and

wherein the fluid injection device is in fluidic communication with the bubble generator and is configured to receive the solution comprising microbubbles and to inject the solution comprising microbubbles into a region of target tissue.

2. The system of claim 1, further comprising, a fluid metering device configured to control the amount of fluid dispensed from the liquid reservoir to the bubble generator.

3. The system of claim 1, further comprising, a gas metering device configured to control the amount of gas or vapor dispensed from the gas reservoir to the bubble generator.

4. The system of claim 1, wherein the needle array comprises a plurality of needles, wherein the system further comprising a needle deployment mechanism, wherein the needle deployment mechanism deploys the needles of the needle array from a first position to a desired injection depth, wherein the desired injection depth is optionally adjustable to depths between 6 mm and 10 mm below the dermis.

5. The system of claim 1, wherein the needle array is configured to inject the solution comprising microbubbles at a plurality of injection depths in the target tissue.

6. The system of claim 1, wherein the needle array comprises a plurality of needles having a first length, and wherein the needle array can be removed from the fluid injection device and replaced with a different needle array comprising a plurality of needles having a second length.

7. The system of claim 1, wherein the one or more needles of the needle array each comprise a single injection orifice linearly aligned with a shaft of the one or more needles.

8. The system of claim 1, wherein the one or more needles of the needle array each comprise one or more side-firing orifices positions orthogonally to a shaft of the one or more needles.

9. The system of claim 1, wherein the microbubble generator comprises a rotor, a blade, a paddle, a whisk, or a semi-permeable membrane to generate the microbubbles.

10. The system of claim 1, wherein the microbubble generator is configured to generate a solution containing microbubbles that is biocompatible by adjusting one or more of the ratio of gas to liquid in the solution, the size of the microbubbles and the biocompatibility of the fluid and the gas or vapor.

11. A system for the generation and delivery of microbubbles, comprising:

a gas source;

a solution container comprising a solution;

a solution agitator in fluidic communication with the solution container and the gas source,

wherein the solution agitator is configured to receive gas from the gas source and solution from the solution container and mix the gas and the solution to form a solution comprising microbubbles; and

an injection member comprising at least one needle,

wherein the injection member is in fluidic communication with the solution agitator and is configured to receive the solution comprising microbubbles and to inject the solution comprising microbubbles into a region of target tissue.

12. The system of claim 11, wherein the solution agitator comprises a cartridge and the agitator agitates or shakes the cartridge to generate the microbubbles, and wherein the cartridge is configured to receive measured amounts of liquid and gas.

13. The system of claim 11, wherein the solution comprises hypotonic saline and the gas source comprises air.

14. The system of claim 11, further comprising a cooling element to maintain the solution comprising microbubbles at a pre-determined temperature to further enhance solubility/saturation of the gas in the solution.

15. The system of claim 14, wherein the filter element comprises a HEPA filter.

16. The system of claim 14, wherein the bubble generator is configured to be pressurized to enhance the saturation of the gas in the solution.

17. The system of claim 14, wherein the system further comprises a fluid pressurization mechanism configured to maintain the fluid at a desired pressurization.

18. The system of claim 14, further comprising a cooling element configured to maintain the solution comprising microbubbles at a pre-determined temperature to further enhance solubility/saturation of the gas in the solution.

19. The system of claim 14, further comprising at least one regulatory element configured to regulate one or more of the volume, pressure, and rate at which the solution comprising microbubbles is injected into the target tissue.

20. A system for the generation and delivery of microbubbles, comprising:

a liquid reservoir configured to contain a fluid;

a bubble generator;

a filter element configured to filter a gas or vapor prior to the gas or vapor being passed to the bubble generator,

wherein the bubble generator is in fluidic communication with the liquid reservoir and the filter element,

wherein the bubble generator is configured to receive liquid from the liquid reservoir and gas or vapor filtered through the filter element and combine the received liquid and gas or vapor to create a solution comprising microbubbles;

a fluid injection device,

wherein the fluid injection device comprises a needle array comprising one or more needles; and

wherein the fluid injection device is in fluidic communication with the bubble generator and is configured to receive the solution comprising microbubbles and to inject the solution comprising microbubbles into a region of target tissue.