COAXIAL NEEDLE CANNULA WITH DISTAL SPIRAL MIXER AND SIDE PORTS FOR FLUID INJECTION

• US 20170035653A1
• Filed: 10/20/2016
• Published: 02/09/2017
• Est. Priority Date: 10/29/2009
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: BoseI, Christopher D., Osborne, Thomas A., Melsheimer, Jeffry S.
• Granted Patent: US 10,596,067 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/8816 characterised by the conduit, e.g. tube, along which fluid flows into the body or by conduit connections
• CPC Class Codes: A61B 17/8822 characterised by means facilitating expulsion of fluid from the introducer, e.g. a screw pump plunger, hydraulic force transmissions, application of vibrations or a vacuum
• CPC Class Codes: A61B 18/06 caused by chemical reaction , e.g. moxaburners
• CPC Class Codes: A61B 2017/8838 for mixing bone cement or fluid fillers
• CPC Class Codes: A61J 1/20 Arrangements for transferring or mixing fluids, e.g. from vial to syringe
• 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: A61M 5/31581 performed by rotationally moving or pivoting actuator operated by user, e.g. an injection lever or handle
• CPC Class Codes: B01F 2101/20 Mixing of ingredients for bone cement
• CPC Class Codes: B01F 25/3141 with additional mixing means other than injector mixers
• CPC Class Codes: B01F 25/4314 with helical baffles
• CPC Class Codes: B01F 25/43141 composed of consecutive sections of helical formed elements

Abstract

Disclosed is a multi-lumen mixing device that includes a first and second lumen constructed and arranged to separately pass a first and second reagent to a mixing chamber in the device, where the mixing chamber includes a mixing feature that mixes the first and second reagents. The disclosed multi-lumen mixing device may also include a port in fluid communication with the reaction mixing to permit the product of the combined reagents to be injected into a patent.

Claims

1. A mixing injection device for use with a patient, the device comprising;

a needle having a tissue penetrating tip on a distal end and a first hub on a proximal end, the needle defining a first lumen fluidly coupling a needle side port to the first hub, wherein the first lumen is adapted to pass a first reagent between the first hub and the needle side port, wherein the needle is constructed from a rigid material having sufficient rigidity to open a path through tissue and wherein the distal end of the first lumen is either closed or substantially narrowed;

a cannula defining a second lumen, the cannula including a second hub and a cannula side port, wherein the second lumen is adapted to pass a second reagent between the second hub and the cannula side port, wherein the cannula is co-axially positioned inside the first lumen, and wherein the second lumen is occluded distally from the cannula side port;

a mixing element on the cannula positioned distally from the cannula side port and inside the first lumen, wherein the second reagent mixes with the first reagent after passing through the cannula side port into the first lumen and traversing along the mixing element and wherein the mixed first and second reagents are injected into the patient through the needle side port.

2. The mixing injection device of claim 1, wherein the mixing element and the cannula are unitarily composed of a single piece.

3. The mixing injection device of claim 1, wherein the second lumen terminates into the first lumen and wherein the mixing element is located distally from where the second lumen terminates into the first lumen.

4. The mixing injection device of claim 1, wherein the mixing element is shaped from a distal portion of the cannula.

5. The mixing injection device of claim 1, wherein a distal end of the cannula is substantially flattened to a generally planar condition along a longitudinal axis of the cannula and is twisted along the longitudinal axis of the cannula.

6. The mixing injection device of claim 1, wherein the tissue penetrating needle tip is selected from the group comprising:

a beveled cutting edge tip, a saw-toothed cutting edge tip, a pointed end tip, a trocar tip, and a pencil point tip.

7. The mixing injection device of claim 1, wherein the needle is constructed of a metal.

8. The mixing injection device of claim 1, wherein the cannula passes through the first hub and is rotatable relative to the needle and the first hub.

9. A method of mixing a first and second reagent while injecting the first and second reagent into a target tissue in a patient'"'"'s body, the method comprising:

penetrating the target tissue by cutting or burrowing through the target tissue with a tissue penetrating tip on a needle thereby creating a passage into the target issue;

after the needle has penetrated the target tissue and while the needle is in the target tissue, injecting a first reagent through a first lumen of the needle and a second reagent through a second lumen of a cannula that is co-axially positioned inside the first lumen to a cannula side port that passes the second reagent into the first lumen, wherein the first and second reagents traverse along a mixing element positioned inside the first lumen distally from the cannula side port thereby mixing the first and second reagents and forming a combined reagent, wherein the second reagent is fluidly isolated from the first reagent when the second reagent is in the second lumen; and

after the second reagent passes through the cannula side port and is mixed with the first reagent in the first lumen, ejecting the combined reagent out of a needle side port into the target tissue.

10. The method of claim 9, wherein the mixing element is a generally planar structure that has a twisted pattern along its longitudinal axis.

11. The method of claim 9, further comprising ablating tissue by inserting the needle into the target tissue to be ablated, wherein the combined reagent generates an exothermic chemical reaction sufficient to ablate the target tissue.

12. The method of claim 9, further comprising stabilizing a vertebra by inserting the needle into the vertebra, wherein the combined reagent is a bone cement.

13. The method of claim 9, further comprising rotating the cannula relative to the needle while injecting the first and second reagents.

14. The method of claim 9, wherein a distal end of the first lumen is either closed or substantially narrowed

15. A system for mixing reagents during injection into a patient, the system comprising:

a first reservoir containing a first reagent;

a second reservoir containing a second reagent; and

a mixing injection device comprising;

a needle having a tissue penetrating tip on a distal end and a first hub on a proximal end fluidly coupled to the first reservoir, the needle defining a first lumen fluidly coupling a needle side port to the first hub, wherein the first lumen is adapted to pass the first reagent between the first hub and the needle side port, wherein the needle is constructed from a rigid material having sufficiently rigidity to open a path through patient tissue and wherein the distal end of the first lumen is either closed or substantially narrowed;

a cannula defining a second lumen, the cannula including a second hub fluidly coupled to the second reservoir and a cannula side port, wherein the second lumen is adapted to pass the second reagent between the second hub and the cannula side port, wherein the cannula is co-axially positioned inside the first lumen, and wherein the second lumen is occluded distally from the cannula side port; and

a mixing element on the cannula positioned distally from the cannula side port and inside the first lumen, wherein the second reagent mixes with the first reagent after passing through the cannula side port into the first lumen and traversing along the mixing element and wherein the mixed first and second reagents are injected into the patient through the needle side port.

16. The system of claim 15, wherein the first lumen defines a third reservoir longitudinally positioned between the mixing element and the second port.

17. The system of claim 15, wherein the mixing element is a generally planar structure that has a twisted pattern along its longitudinal axis.

18. The system of claim 15, wherein the mixing element is shaped from a distal portion of the cannula.

19. The system of claim 15, wherein the cannula passes through the first hub and the cannula is rotatable relative to the first hub and the needle.

20. The system of claim 15, wherein the tissue penetrating tip is selected from a group comprising:

a beveled cutting edge tip, a saw-toothed cutting edge tip, a pointed end tip, a trocar tip, and a pencil point tip.