Self-contained medical applicators for multiple component formulations, and methods of use thereof

• US 8,323,262 B2
• Filed: 07/08/2009
• Issued: 12/04/2012
• Est. Priority Date: 07/08/2008
• Status: Active Grant

• Current Assignee: HyperBranch Medical Technology, Inc. (Stryker Corporation)
• Original Assignee: HyperBranch Medical Technology, Inc. (Stryker Corporation)
• Inventors: D'Alessio, Keith R., Clark, Jeffrey G., Chin, Wai N., Colonna, Robert M., Matusaitis, Tomas, Taylor, Todd J., Yahnker, Christopher R., Attride, Roy R. B.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Anderson, Michael J
• Application Number:
  US12/499,469
• Publication Number:
  US 20100010473A1
• Time in Patent Office: 1,245 Days
• Field of Search: 604 82- 91, 604/520, 604/416, 604/191, 606/213
• US Class Current: 604/520
• 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 2090/0807 Indication means
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• CPC Class Codes: A61M 35/003 Portable hand-held applicators having means for dispensing or spreading integral media hand-held massage devices with liquid delivery A61H7/003
• 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

Abstract

Certain aspects of the invention relate to an applicator, and methods of use thereof, which can house multiple component formulations in separate material receptacles, which can then be easily reconstituted at time of use without any assembly by the user. A device of the invention can be used for, but is not limited to, applying hydrogel formulations to dura mater, abdominal tissue in hernia repair, tissues near the spine, lung tissue, intestinal tissue, and any of the internal tissues. A device of the invention can be configured to apply a spray or a stream of liquid formulation onto a surface to be treated. A device of the invention can be configured to deliver the formulation through an endoscope or laparoscope.

Claims

1. An applicator, comprising a rear housing, a front housing, a mechanical interlock and a nozzle assembly;

wherein

(i) the rear housing comprises;

a first barrel, having a first diameter;

a first end;

a second end;

a first internal chamber;

a first piercer, attached to the second end of the first barrel, having a first fluid passageway; and

a first plunger, having a first end and a second end, located at least partially within the first internal chamber and under pressure moveable therethrough; and

a second barrel having a second diameter;

a first end;

a second end;

a second internal chamber;

a second piercer, located on the second end of the second barrel, having a second fluid passageway; and

a second plunger, having a first end and a second end, located at least partially within the second internal chamber and under pressure moveable therethrough;

(ii) the front housing comprises;

a third barrel, having a third diameter;

a first end;

a second end;

a third internal chamber;

a first piston having a third fluid passageway therethrough, located within the third internal chamber and under pressure moveable therethrough;

a first piercable barrier, located at the first end of the third barrel and suitably positioned to be pierced by the first piercer, thereby allowing fluid communication between the first internal chamber and the second internal chamber via the first fluid passageway and the third fluid passageway; and

a second piercable barrier, located at the second end of the third barrel; and

a fourth barrel, having a fourth diameter;

a first end;

a second end;

a fourth internal chamber;

a second piston having a fourth fluid passageway therethrough, located within the fourth internal chamber and under pressure moveable therethrough;

a third piercable barrier, located at the first end of the fourth barrel and suitably positioned to be pierced by the second piercer, thereby allowing fluid communication between the second internal chamber and the fourth internal chamber via the second fluid passageway and the fourth fluid passageway; and

a fourth piercable barrier, located at the second end of the fourth barrel; and

(iii) the nozzle assembly comprises;

a fifth internal chamber;

having a first inlet with a third piercer affixed thereto, which comprises a fifth fluid passageway, and is suitably positioned at the first inlet to pierce the second piercable barrier and thereby allow fluid communication between the third internal chamber and the fifth internal chamber via the fifth fluid passageway;

a second inlet with a fourth piercer affixed thereto, which comprises a sixth fluid passageway, and is suitably positioned at the second inlet to pierce the fourth piercable barrier and thereby allow fluid communication between the fourth internal chamber and the fifth internal chamber via the sixth fluid passageway; and

an outlet;

wherein the nozzle assembly is connected to the front housing;

the front housing is connected to the rear housing;

the first diameter is less than the third diameter;

the second diameter is less than the fourth diameter;

the first piercer is sized to block the first fluid passageway;

the second piercer is sized to block the second fluid passageway; and

the mechanical interlock is positioned to allow initially the first piercer to pierce the first barrier but not block the first fluid passageway; and

the mechanical interlock is positioned to initially allow the second piercer to pierce the second barrier but not block the second fluid passageway.

2. The applicator of claim 1, wherein the applicator body further comprises a liquid in the first internal chamber.

3. The applicator of claim 1, wherein the applicator body further comprises a liquid in second internal chamber.

4. The applicator of claim 1, wherein the applicator body further comprises a solid in the third internal chamber.

5. The applicator of claim 4, wherein the solid comprises a polyalkyleneimine.

6. The applicator of claim 1, wherein the applicator body further comprises a viscous liquid in the third internal chamber;

and the viscous liquid comprises PEI.

7. The applicator of claim 1, wherein the applicator body further comprises a solid in the fourth internal chamber;

and the solid comprises a PEG(NHS)₂ or a mixture of two or more PEG(NHS)₂.

8. The applicator of claim 1, wherein the applicator body further comprises a solid in the fourth internal chamber;

and the solid comprises

9. The applicator of claim 1, further comprising a check valve between the first fluid passageway and the third fluid passageway;

and further comprising a check valve between the second fluid passageway and the fourth fluid passageway.

10. The applicator of claim 1, wherein the nozzle further comprises two precision orifices;

the fifth fluid passageway pass through one of said orifices; and

the sixth fluid passageway pass through the other of said orifices.

11. The applicator of claim 1, wherein the nozzle further comprises a brush, a sponge, a foam swab, a porous plastic component, a duck bill tip, a textile mitt or a spray tip affixed to the outlet.

12. The applicator of claim 1, wherein the nozzle further comprises a tubular fitment having two open ends;

one open end of the tubular fitment is affixed to the outlet and the other open end of the fitment comprises a protruding spatula-like piece.

13. The applicator of claim 1, further comprising an atomization fluid pathway;

wherein said atomization fluid pathway is configured to expel any material in the fifth internal chamber out of the nozzle through the outlet.

14. The applicator of claim 1, wherein said applicator further comprises a trigger mechanism which controls the movement of one or more plungers or pistons.

15. The applicator of claim 1, further comprising a power source;

wherein said power source is contained within the applicator.

16. The applicator of claim 15, wherein said power source is selected from the group consisting of compressed gas, mechanical power, chemical power, and electrical power.

17. The applicator of claim 1, wherein the first barrel and the second barrel are mechanically locked such that their ability to advance through the third barrel and the fourth barrel, respectively, is constrained to be substantially simultaneous.

18. The applicator of claim 1, wherein the applicator body further comprises a buffer in the first internal chamber;

a buffer in the second internal chamber;

PEI in the third internal chamber; and

PEG(NHS)₂ in the fourth internal chamber.

19. A method of using an applicator to apply a composition to a surface;

wherein the applicator comprises a rear housing, a front housing, a mechanical interlock and a nozzle assembly;

wherein

(i) the rear housing comprises;

a first barrel, having a first diameter;

a first end;

a second end;

a first internal chamber containing a first liquid;

a first piercer, attached to the second end of the first barrel, having a first fluid passageway; and

a first plunger, having a first end and a second end, located at least partially within the first internal chamber and under pressure moveable therethrough; and

a second barrel having a second diameter;

a first end;

a second end;

a second internal chamber containing a second liquid;

a second piercer, located on the second end of the second barrel, having a second fluid passageway; and

a second plunger, having a first end and a second end, located at least partially within the second internal chamber and under pressure moveable therethrough;

(ii) the front housing comprises;

a third barrel, having a third diameter;

a first end;

a second end;

a third internal chamber containing a first solid;

a first piston having a third fluid passageway therethrough, located within the third internal chamber and under pressure moveable therethrough;

a first piercable barrier, located at the first end of the third barrel and suitably positioned to be pierced by the first piercer, thereby allowing fluid communication between the first internal chamber and the second internal chamber via the first fluid passageway and the third fluid passageway; and

a second piercable barrier, located at the second end of the third barrel; and

a fourth barrel, having a fourth diameter;

a first end;

a second end;

a fourth internal chamber containing a second solid;

a second piston having a fourth fluid passageway therethrough, located within the fourth internal chamber and under pressure moveable therethrough;

a third piercable barrier, located at the first end of the fourth barrel and suitably positioned to be pierced by the second piercer, thereby allowing fluid communication between the second internal chamber and the fourth internal chamber via the second fluid passageway and the fourth fluid passageway; and

a fourth piercable barrier, located at the second end of the fourth barrel; and

(iii) the nozzle assembly comprises;

a fifth internal chamber;

having a first inlet with a third piercer affixed thereto, which comprises a fifth fluid passageway, and is suitably positioned at the first inlet to pierce the second piercable barrier and thereby allow fluid communication between the third internal chamber and the fifth internal chamber via the fifth fluid passageway;

a second inlet with a fourth piercer affixed thereto, which comprises a sixth fluid passageway, and is suitably positioned at the second inlet to pierce the fourth piercable barrier and thereby allow fluid communication between the fourth internal chamber and the fifth internal chamber via the sixth fluid passageway; and

an outlet;

wherein the nozzle assembly is connected to the front housing;

the front housing is connected to the rear housing;

the first diameter is less than the third diameter;

the second diameter is less than the fourth diameter;

the first piercer is sized to block the first fluid passageway;

the second piercer is sized to block the second fluid passageway; and

the mechanical interlock is positioned to allow initially the first piercer to pierce the first barrier but not block the first fluid passageway; and

the mechanical interlock is positioned to initially allow the second piercer to pierce the second barrier but not block the second fluid passageway;

comprising the steps of;

advancing the first barrel towards the nozzle and into the third barrel, thereby piercing the first barrier, placing the first internal chamber in fluid communication with the third internal chamber;

advancing the first plunger towards the nozzle, thereby expelling the first liquid into the third internal chamber, forming a first mixture of the first liquid and the first solid;

advancing the second barrel towards the nozzle and into the fourth barrel, thereby piercing the second barrier, placing the second internal chamber in fluid communication with the fourth internal chamber;

advancing the second plunger towards the nozzle, thereby expelling the second liquid into the fourth internal chamber, forming a second mixture of the first liquid and the first solid;

advancing the third barrel towards the nozzle, thereby piercing the third barrier and placing the third internal chamber in fluid communication with the fifth internal chamber;

advancing the fourth barrel towards the nozzle, thereby piercing the fourth barrier, placing the fourth internal chamber in fluid communication with the fifth internal chamber;

advancing the first piston and the second piston towards the nozzle, thereby causing the first mixture to mix with the second mixture in the fifth internal chamber, forming a pre-composition mixture;

applying the pre-composition mixture to the surface, wherein the mixture gels to form the composition on the surface.

20. The method of claim 19, wherein the surface is dura matter, abdominal tissue, tissue adjacent to a spine, internal tissue, lung tissue, intestinal tissue, a cornea, or any internal surface.