IP Library › Granted Patent US 11,452,474
Granted Patent B1
US 11,452,474 · App. 17/412,213 · Granted Sep 27, 2022

Dual lever dermal patch system

Inventors: Namai Nawana (Weston, MA); Ziad Tarik Al-Shamsie (San Diego, CA)
Assignee: Satio, Inc.
A61B5/150969A61B5/151A61B5/150236
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Quick Facts
Patent No.
US 11,452,474
App. No.
17/412,213
Granted
Sep 27, 2022
Kind
B1
Abstract

A system includes an applicator and a dermal patch coupled to the applicator. The applicator includes a needle configured to puncture a subject's skin to draw a physiological sample, a first actuating lever configured to move form an undeployed position to a deployed position, and a second actuating lever configured to move form an undeployed position to a deployed position. The dermal patch includes a fluid reservoir configured to store a processing fluid, a sample collection chamber configured to receive the processing fluid and the physiological sample, wherein the applicator is configured to cause the needle to puncture the subject's skin to draw the physiological sample when the first actuating lever is moved from the undeployed lever position to the deployed lever position and cause the processing fluid to release from the fluid reservoir when the second actuating lever is moved from the undeployed position to the deployed position.

Claims (43)

1. A system comprising:

an applicator including:

a needle configured to puncture a subject's skin to draw a physiological sample;

a first actuating lever configured to move from an undeployed position to a deployed position, and

a second actuating lever configured to move from an undeployed position to a deployed position,

a latch configured to maintain the second actuating lever in a locked position so as to inhibit movement thereof when the first actuating lever is in the undeployed position and configured to be released upon actuation of the first actuating lever so as to allow actuation of the second actuating lever and;

a dermal patch configured for coupling to the applicator and including:

a fluid reservoir configured to store a processing fluid,

a sample collection chamber configured to receive the processing fluid and the physiological sample,

wherein the applicator is configured to:

cause the needle to puncture the subject's skin to draw the physiological sample when the first actuating lever is moved from the undeployed lever position to the deployed lever position and cause the processing fluid to be released from the fluid reservoir when the second actuating lever is moved from the undeployed position to the deployed position.

2. The system of claim 1 , wherein the dermal patch is removably coupled to the applicator.

3. The system of claim 1 , wherein the dermal patch is integrally coupled to the applicator.

4. The system of claim 1 , wherein the physiological sample includes blood.

5. The system of claim 1 , wherein the processing fluid includes an anti-coagulant.

6. The system of claim 5 , wherein the processing fluid includes heparin or a protease inhibitor.

7. The system of claim 1 , further comprising:

an adhesive layer coupled to the dermal patch, wherein the adhesive layer is configured to attach to skin of the subject.

8. The system of claim 1 , wherein the latch is coupled to the second actuating lever, is maintained within a recess of the first actuating lever, and is configured to move to a released position within the recess when the first actuating lever is moved to the deployed position.

9. The system of claim 1 , wherein the applicator further comprises:

a syringe configured to create a vacuum within the dermal patch when the first actuating lever is moved from the deployed position to the undeployed position, wherein the vacuum draws the physiological sample and the released processing fluid to flow to the sample collection chamber.

10. A system comprising:

an applicator including:

a needle configured to puncture a subject's skin to draw a physiological sample;

a first actuating lever configured to move from an undeployed position to a deployed position, and

a second actuating lever configured to move from an undeployed position to a deployed position,

a latch configured to maintain the second actuating lever in a locked position so as to inhibit movement thereof when the first actuating lever is in the undeployed position and configured to be released upon actuation of the first actuating lever so as to allow actuation of the second actuating lever and;

a dermal patch configured for coupling to the applicator and including:

a fluid reservoir configured to store a processing fluid,

a detector configured to detect a target analyte in a processed physiological sample resulting from processing the physiological sample by the processing fluid,

wherein the applicator is configured to:

cause the needle to puncture the subject's skin to draw the physiological sample when the first actuating lever is moved from the undeployed lever position to the deployed lever position and cause the processing fluid to release from the fluid reservoir when the second actuating lever is moved from the undeployed position to the deployed position.

11. The system of claim 10 , wherein the detector is configured to detect the target analyte when the target analyte is present in the processed physiological sample at a concentration level equal to or greater than a threshold amount.

12. The system of claim 10 , wherein the processing fluid includes a reagent for isothermal amplification of the target analyte.

13. The system of claim 10 , wherein the target analyte includes a biomarker.

14. The system of claim 13 , wherein the biomarker is troponin, brain natriuretic peptide (BnP), myelin basic protein (MBP), ubiquitin carboxyl-terminal hydrolase isoenzyme L1 (UCHL-1), neuron-specific enolase (NSE), glial fibrillary acidic protein (GFAP), S100-B, Cardiac troponin I protein (cTnl), Cardiac troponin T protein (cTnT), C-reactive protein (CRP), B-type natriuretic peptide (BNP), Myeloperoxidase, Creatine kinase MB, Myoglobin, Hemoglobin, or HbA1C.

15. The system of claim 10 , wherein the detector is an immunoassay detector, an isothermal amplification detection system, a graphene-based detector, an electrochemical detector, and chemical detector.

16. The system of claim 10 , wherein the second actuating lever is in locked state when the first actuating lever is in the undeployed position.

17. The system of claim 16 , wherein the applicator further comprises:

wherein the latch is coupled to the second actuating lever, is maintained within a recess of the first actuating lever and is configured to move to a released position within the recess when the first actuating lever is moved to the deployed position and wherein the latch is configured to allow actuating of the second actuating lever when in the released position.

18. The system of claim 10 , wherein the applicator further comprises:

a syringe configured to create a vacuum within the dermal patch when the first actuating lever is moved from the deployed position to the undeployed position, wherein the vacuum draws the physiological sample and the released processing fluid to flow to the sample collection chamber.

19. The system of claim 10 , wherein the applicator is removably coupled to the dermal patch.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 16, 2021
From: NEOENTA LLC
To: SATIO, INC.
Reel/Frame 058523/0361 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 18, 2021
From: NAWANA, NAMAL; AL-SHAMSIE, ZIAD TARIK
To: NEOENTA LLC
Reel/Frame 058154/0810 →
Continuity (2)
Provisional Application 63190700 · May 19, 2021
Provisional Application 63174956 · Apr 14, 2021
Cited By (4)
US 1,130,752 US 12,214,346 US 12,440,133 US 12,446,810