Delivery System for In Situ Forming Foams and Methods of Using The Same

• US 20140228745A1
• Filed: 03/14/2014
• Published: 08/14/2014
• Est. Priority Date: 08/24/2010
• Status: Active Grant

• Current Assignee: Arsenal Medical, Inc
• Original Assignee: Arsenal Medical, Inc
• Inventors: Sharma, Upma, Busold, Rany, Rago, Adam, Zugates, Gregory T., Freyman, Toby, Miller, Lisette Manrique
• Granted Patent: US 9,579,449 B2
• Time in Patent Office: Days
• US Class Current: 604/82
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/00495 for two-component glue
• CPC Class Codes: A61B 2017/00544 pneumatically
• CPC Class Codes: A61B 2017/00548 Gas cartridges therefor
• CPC Class Codes: A61B 2017/8838 for mixing bone cement or fluid fillers
• CPC Class Codes: A61C 9/0026 Syringes or guns for injecting impression material; Mixing impression material for immediate use
• CPC Class Codes: A61M 13/003 Blowing gases other than for carrying powders, e.g. for inflating, dilating or rinsing
• CPC Class Codes: A61M 2205/103 rotating
• CPC Class Codes: A61M 5/1409 in series, e.g. first substance passing through container holding second substance, e.g. reconstitution systems needle sets A61M5/162
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/16804 Flow controllers
• CPC Class Codes: A61M 5/19 having more than one chamber , e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly surgical glue applicators A61B17/00491
• CPC Class Codes: B01F 23/2351 using driven stirrers
• CPC Class Codes: B01F 25/42 in which the mixing is affected by moving the components jointly in changing directions, e.g. in tubes provided with baffles or obstructions
• CPC Class Codes: B01F 25/422 between stacked plates, e.g. grooved or perforated plates
• CPC Class Codes: B01F 27/118 Stirrers in the form of brushes, sieves, grids, chains or springs
• CPC Class Codes: B01F 27/13 Openwork frame or cage stirrers not provided for in other groups of this subclass
• CPC Class Codes: B01F 33/50112 of the syringe or cartridge type
• CPC Class Codes: B01F 35/2209 Controlling the mixing process as a whole, i.e. involving a complete monitoring and controlling of the mixing process during the whole mixing cycle
• CPC Class Codes: B01F 35/3203 : Gas driven
• CPC Class Codes: B01F 35/754251 : reciprocating in the mixing receptacle
• CPC Class Codes: B05B 7/0037 : including sieves, porous members or the like
• CPC Class Codes: B05B 7/2421 : Gas containers
• CPC Class Codes: B05B 7/2472 : comprising several containers
• CPC Class Codes: B05C 17/00553 : with means allowing the stock of material to consist of at least two different components
• CPC Class Codes: B65D 81/325 : Containers having parallel or coaxial compartments, provided with a piston or a movable bottom for discharging contents

Abstract

Delivery systems for in situ forming foam formulations are provided. The devices may include various actuation mechanisms and may entrain air into fluid formulation components in a variety of ways, including mixing with air and the addition of compressed gas.

Claims

1. A medical device, comprising:

a fluid cartridge comprising at least one chamber and at least one piston, wherein a volume of the chamber is determined by a position of the at least one piston;

at least one impeller located within the at least one chamber

a static mixer in fluid communication with the chamber, the static mixer including a tip configured for insertion into a body of a patient; and

a first actuator adapted to move at least one of the impeller and the piston.

2. The medical device of claim 1, wherein moving the first actuator moves the piston, decreasing a volume of the chamber.

3. The medical device of claim 1, wherein moving the first actuator aerates a fluid in at least one chamber of the cartridge.

4. The medical device of claim 2, wherein the first actuator is one of a squeeze handle, a crank handle, a ratchet, or a piston pump.

5. The medical device of claim 3, wherein the first actuator is configured to reversibly couple to one or more of the at least one piston and the at least one impeller.

6. The medical device of claim 1, further comprising a cylinder loaded with compressed gas, wherein activation of the first actuator causes the evacuation of compressed gas from the cylinder and one of (a) the advancement of the piston within the at least one chamber, thereby expelling the contents of the fluid cartridge, or (b) the movement of the impeller within the at least one chamber, thereby aerating a fluid within the cartridge.

7. The medical device of claim 1, wherein the impeller comprises a mesh.

8. The medical device of claim 1, wherein a rim of the impeller contacts a wall of the chamber.

9. The medical device of claim 1, wherein the static mixer comprises a substantially cylindrical outer shell defining a lumen, the outer shell having a tapered end, the tapered end comprising a plurality of apertures through the outer shell, and a plurality of mixing elements disposed within the lumen.

10. The medical device of claim 9, wherein the mixing elements are selected from the group consisting of X-grids, beads, and mesh.

11. The medical device of claim 1, further comprising a lockout mechanism reversibly coupled to the fluid cartridge, wherein (a) the lockout mechanism is movable between a first configuration which prevents the movement of the at least one piston and a second configuration which permits the movement of the at least one piston and (b) the lockout mechanism moves from the first configuration to the second configuration after the impeller has undergone a predetermined number of rotations within the at least one chamber.

12. The medical device of claim 1, further comprising a movable dose selector which is configured to stop the movement of the at least one piston beyond a position determined by a position of the movable dose selector.

13. A system for treating a hemorrhage, comprising:

a medical device comprising;

a fluid cartridge comprising at least one chamber and at least one piston, wherein a volume of the chamber is determined by a position of the piston;

at least one impeller located within the at least one chamber;

a static mixer adapted to fluidly communicate with the at least one chamber, the static mixer including a tip configured for insertion into a body of a patient; and

a first actuator adapted to move at least one of the impeller and the piston; and

a formulation configured to form, within the body of a patient, a polymer foam, the formulation disposed within the fluid cartridge of the medical device.

14. The system of claim 13, wherein moving the first actuator moves the piston, decreasing a volume of the chamber.

15. The system of claim 13, wherein moving the first actuator moves the impeller, thereby entraining air into the formulation.

16. The system of claim 15, wherein the first actuator is configured to reversibly couple to the at least one impeller and the at least one piston.

17. The system of claim 13, wherein (a) the formulation comprises first and second fluid components, each component in a separate chamber of the fluid cartridge, and (b) the static mixer is fluidly connected to each of the separate chambers such that, when the at least one piston is advanced, the first and second fluid components are expelled from the separate chambers and pass through the static mixer.

18. The system of claim 13, wherein the impeller comprises a mesh.

19. The system of claim 13, wherein a rim of the impeller contacts a wall of the chamber.

20. The system of claim 13, wherein the static mixer comprises a substantially cylindrical outer shell defining a lumen, the outer shell having a tapered end, the tapered end comprising a plurality of apertures through the outer shell, and a plurality of mixing elements disposed within the lumen.

21. The system of claim 13, further comprising a lockout mechanism reversibly coupled to the medical device, wherein (a) the lockout mechanism is movable between a first configuration which prevents the movement of the at least one piston and a second configuration which permits the movement of the at least one piston and (b) the lockout mechanism moves from the first configuration to the second configuration after the impeller has undergone a predetermined number of rotations within the at least one chamber.

22. The system of claim 13, wherein the medical device includes a movable dose selector which is configured to stop the movement of the at least one piston beyond a position determined by a position of the movable dose selector.