Predilution sets for distributing antigens

• US 10,695,423 B2
• Filed: 10/16/2019
• Issued: 06/30/2020
• Est. Priority Date: 06/02/2015
• Status: Active Grant

• Current Assignee: Avrio Genetics LLC Formerly Procreative LLC
• Original Assignee: Roca Medical Ltd.
• Inventors: Strader, James, Pulitzer, Jovan
• Primary Examiner(s): Ortiz, Rafael A
• Application Number:
  US16/654,887
• Publication Number:
  US 20200038507A1
• Time in Patent Office: 258 Days
• Field of Search: 206569, 206570, 206223, 2064591, 206363, 206364
• CPC Class Codes: A61K 39/00 Medicinal preparations containing antigens or antibodies materials for immunoassay G01N33/53
• CPC Class Codes: A61K 39/35 Allergens

Abstract

A method for delivering allergens to a pharmacist in a pre-diluted kit form, comprising providing a bulk container of base concentrate antigen containing at least one antigen at a predetermined concentrated level, creating a sequential and more diluted sequence of antigens, providing a plurality of end-use sealable containers that can receive a finite end amount of diluted antigens, dispensing from each of sequential bulk containers a finite end amount of diluted antigens into one of the plurality of end-use sealable containers, wherein the end-use seal containers filled from each of the sequential bulk containers comprises a group of end-use sealable containers associated with each of the sequential bulk containers, sealing each of the end-use containers after diluted antigens are disposed therein, and disposing a select number of the sealed end-use sealable containers from each of the groups of end-use sealable containers into a container comprising a kit.

Claims

1. A prediluted kit including a range of prediluted doses of allergens for dispensing to a patient, comprising:

a container having a plurality of receiving pockets, each being associated with one of a plurality of sequential diluted allergen levels all based on a base concentrate antigen wherein the base concentrate antigen includes at least one specific antigen;

a plurality of end-use sealable containers of prediluted antigens,

wherein the plurality of end-use sealable containers are sterile,

wherein each one of the plurality of end-use sealable containers is at a defined level and disposed in one of the plurality of receiving pockets,

wherein each one of the plurality of end-use sealable containers is prepackaged as already including the base concentrate antigen at a sequential dilution level diluted in accordance with a predetermined sequential dilution process to provide sequentially lower dilution levels for use in an allergy desensitization regimen prescribed by a medical professional, and

wherein each one of the plurality of end-use sealable containers includes at least one insert operable to;

provide an elongated interior in the end-use sealable container, the elongated interior having a volume corresponding to at least a dose; and

fill space within the end-use sealable container to dispose a prediluted antigen at an elevated level in the end-use sealable container for extraction; and

an indicator disposed in association with each of the plurality of receiving pockets indicating the dilution level of the associated one of the end-use sealable containers included therein.

2. The kit of claim 1, wherein each of the plurality of end-use sealable containers includes more than one diluted antigen.

3. The kit of claim 1, wherein each of the plurality of end-use sealable containers includes only a single diluted antigen.

4. The kit of claim 1, wherein a National Drug Code (NDC) of the base concentrate antigen is indicated on the container.

5. The kit of claim 1, wherein the indicator comprises a color code, there being a separate color code associated with each dilution level and wherein each of the end-use sealable containers associated with each of the dilution levels has a corresponding color code disposed there on.

6. The kit of claim 1, wherein each of the end-use sealable containers contains only a single dose of diluted allergen, as defined by the medical professional.

7. The kit of claim 2, wherein a plurality of National Drug Codes (NDC) is indicated on the container, wherein each of the plurality of NDCs is associated with a base concentrate antigen of each of the more than one diluted antigen.