US-20260124406-A1 - Preparation Kit for Biologic Treatments and Method for Use of Same

Abstract

A preparation kit and method for reconstituting and delivering biologic treatments derived from human umbilical cord and amniotic membrane tissue. The kit includes a vial containing lyophilized biologic material, a removable seal, and a spray nozzle with a removable cap to maintain sterility. A container holds a humectant solution comprising glycerol, hyaluronic acid, or a combination thereof. In use, the humectant solution is added to the vial, the biologic material is mixed, and the spray nozzle is used for aesthetic application to human skin or hair. The vial is made of glass or medical-grade plastic to prevent contamination. The spray nozzle delivers a measured dose ranging from 0.5 mL to 5 mL. The method involves removing the seal, adding the humectant solution, attaching the spray nozzle, mixing the components, and applying the biologic via spray.

Inventors

• Sagar Nepal

Assignees

• Quintessence Biologics Inc.

Dates

Publication Date

20260507

Application Date

20241106

Claims (14)

1. 1 . A preparation kit for biologic treatments, comprising: a vial containing at least one lyophilized biologic material derived from at least one of human umbilical cord and amniotic membrane tissue; a removable seal configured to close the vial; a spray nozzle attachable to the vial; a container holding a humectant solution, the humectant solution being one of a glycerol-based material and a hyaluronic acid-based material; wherein, in use, the removable seal is removed, the liquid material is added to the vial, the spray nozzle is attached, and the lyophilized biologic material and the humectant solution are mixed to reconstitute a biologic for aesthetic application by way of the spray nozzle to one of human skin and human hair.
2. 2 . The preparation kit as recited in claim 1 , wherein the spray nozzle further comprises a removable cap for maintaining sterility prior to use.
3. 3 . The preparation kit as recited in claim 1 , wherein the humectant solution added to the vial is a combination of glycerol and hyaluronic acid.
4. 4 . The preparation kit as recited in claim 1 , wherein the vial is made of a material selected from the group consisting of glass and medical-grade plastic to ensure compatibility with the biologic and prevent contamination.
5. 5 . The preparation kit as recited in claim 1 , wherein the vial is made of borosilicate glass to ensure compatibility with the biologic material and prevent contamination
6. 6 . The preparation kit as recited in claim 1 , wherein the spray nozzle is configured to deliver a measured dose of the biologic material, wherein the dose ranges from 0.5 mL to 5 mL per spray.
7. 7 . The preparation kit as recited in claim 1 , wherein the biologic material is configured for post-treatment applications in aesthetic procedures, including CO 2 laser resurfacing, microneedling, microdermabrasion, and chemical peels, to reduce downtime and enhance procedural outcomes.
8. 8 . The preparation kit as recited in claim 1 , wherein the humectant solution, comprising glycerol or hyaluronic acid, enhances the hydrophilic properties and penetration of the biologic material for improved absorption upon application.
9. 9 . A preparation kit for biologic treatments, comprising: a vial containing at least one lyophilized biologic material derived from at least one of human umbilical cord and amniotic membrane tissue; a removable seal configured to close the vial; a spray nozzle attachable to the vial, the spray nozzle further comprising a removable cap for maintaining sterility prior to use; a container holding a humectant solution, the humectant solution being one of a glycerol-based material, a hyaluronic acid-based material, and a combination of glycerol and hyaluronic acid; wherein the vial is made of a material selected from the group consisting of glass and medical-grade plastic to ensure compatibility with the biologic and prevent contamination; wherein, in use, the removable seal is removed, the humectant solution is added to the vial, the spray nozzle is attached, and the lyophilized biologic material and the humectant solution are mixed to reconstitute a biologic for aesthetic application by way of the spray nozzle to one of human skin and human hair; wherein the spray nozzle is configured to deliver a measured dose of the biologic material, wherein the dose ranges from 0.5 mL to 5 mL per spray; and wherein the vial containing the lyophilized biologic material and the container holding the humectant solution are stored at room temperature before use, and wherein, after reconstitution, the biologic solution is ideally applied immediately or refrigerated at 2°C to 8°C and used within 72 hours.
10. 10 . A method for preparing a biologic treatment for aesthetic application to one of human skin and human hair, the method comprising: providing a vial containing at least one lyophilized biologic material derived from at least one of human umbilical cord and amniotic membrane tissue; removing a removable seal from the vial; adding a humectant solution to the vial, the humectant solution being one of a glycerol-based material, a hyaluronic acid-based material, or a combination of glycerol and hyaluronic acid; attaching a spray nozzle to the vial; mixing the lyophilized biologic material and the humectant solution to reconstitute the biologic material; and spraying the reconstituted biologic material through the spray nozzle for aesthetic application to one of human skin and human hair.
11. 11 . The method as recited in claim 10 , further comprising the step of placing a removable cap over the spray nozzle to maintain sterility prior to use.
12. 12 . The method as recited in claim 10 , wherein the humectant solution is a combination of glycerol and hyaluronic acid to improve moisture retention and extend the effective application time of the biologic material.
13. 13 . The method as recited in claim 10 , wherein the vial is made of a material selected from the group consisting of glass and medical-grade plastic to ensure compatibility with the biologic material and prevent contamination.
14. 14 . The method as recited in claim 10 , wherein the spray nozzle is configured to deliver a measured dose of the biologic material, wherein the dose ranges from 0.5 mL to 5 mL per spray.

Description

TECHNICAL FIELD OF THE INVENTION This invention pertains to preparation kits and methods for reconstituting and delivering biologic treatments and, in particular, this invention pertains to kits used for aesthetic applications of biologics derived from human umbilical cord and amniotic membrane tissue. BACKGROUND OF THE INVENTION Biologic treatments have revolutionized the medical field by offering targeted therapies for a variety of conditions. These treatments are typically composed of large, complex molecules derived from living organisms. However, biologics often have a very limited effective life, ranging from thirty (30) minutes to two (2) hours due to their fragile nature and rapid degradation once administered or exposed to certain conditions. This short time frame presents significant challenges in ensuring these therapies are delivered effectively to patients. One of the primary concerns with biologic treatments is maintaining their stability during transportation and storage, and then efficiently delivering the product in a timely manner to the patient. Current methods often require strict temperature controls, continuous monitoring, and immediate administration upon preparation, placing burdens on healthcare facilities and limiting access for patients who need these therapies in less controlled environments, such as at home or in remote locations. There is a clear need for improvements in the methods and systems used to deliver biologic treatments. Advancements should aim to extend the effective life of biologics, improve delivery mechanisms to ensure timely and efficient patient use, and reduce the logistical challenges currently faced by healthcare providers and patients alike. SUMMARY OF THE INVENTION It would be advantageous to develop a preparation kit and method for its use that significantly improves the stability and delivery of biologic treatments for aesthetic purposes. It would be desirable to enable a biochemical-based solution that provides enhanced performance, improved usability, and extended shelf life for the biologic material. It would be further desirable to enable a convenient and effective solution that provides sterile, precise, and easily administrable doses of the biologic material, ensuring optimal results for aesthetic treatments. Accordingly, a preparation kit and method are disclosed for reconstituting and delivering biologic treatments derived from human umbilical cord and amniotic membrane tissue. The preparation kit includes a vial containing lyophilized biologic material, a removable seal, and a spray nozzle with a removable cap to maintain sterility. A container holds a humectant solution comprising glycerol, hyaluronic acid, or a combination thereof. In use, the humectant solution is added to the vial, the biologic material is mixed, and the spray nozzle is used for aesthetic application of a biologic treatment to human skin or hair. The vial is made of glass or medical-grade plastic to prevent contamination. The spray nozzle delivers a measured dose ranging from 0.5 mL to 5 mL. In another aspect, in one embodiment, the method involves removing the seal, adding the humectant solution, attaching the spray nozzle, mixing the components, and applying the biologic treatment via spray. These and other aspects of the invention will be apparent from and elucidated with reference to the embodiments described hereinafter. BRIEF DESCRIPTION OF THE DRAWINGS For a more complete understanding of the features and advantages of the present invention, reference is now made to the detailed description of the invention along with the accompanying figures in which corresponding numerals in the different figures refer to corresponding parts and in which: FIG. 1 is an exploded view of one embodiment of a preparation kit for biologic treatments, illustrating key components including a vial containing lyophilized biologic material, a removable seal, a spray nozzle, and a container holding a humectant solution; FIG. 2 is a perspective view of the fully assembled preparation kit, showing the spray nozzle attached to the vial after reconstitution of the biologic material as a biologic treatment, ready for application; FIG. 3 is a flowchart detailing one embodiment of a method of using a preparation kit, including steps of removing a seal, adding a humectant solution, attaching a spray nozzle, mixing the components, and applying the biologic treatment; and FIG. 4 illustrates some embodiments of an application of a reconstituted biologic material, a biologic treatment, via the spray nozzle to a target area, such as human skin or hair, for aesthetic treatments. DETAILED DESCRIPTION OF THE INVENTION While the making and using of various embodiments of the present invention are discussed in detail below, it should be appreciated that the present invention provides many applicable inventive concepts, which can be embodied in a wide variety of specific contexts. The specific embodiments discuss