Ingestible device with pharmaceutical product

• US 9,107,806 B2
• Filed: 11/18/2011
• Issued: 08/18/2015
• Est. Priority Date: 11/22/2010
• Status: Active Grant

• Current Assignee: Proteus Digital Health, Inc. (Otsuka Holdings Company Limited)
• Original Assignee: Proteus Digital Health, Inc. (Otsuka Holdings Company Limited)
• Inventors: Hafezi, Hooman, Schmidt, Raymond
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Hall, Deanna K
• Application Number:
  US13/521,993
• Publication Number:
  US 20120302999A1
• Time in Patent Office: 1,369 Days
• Field of Search: 604/891.1, 604/502, 604/93.01
• US Class Current: 1/1
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: A61J 3/071 into the form of telescopically engaged two-piece capsules
• CPC Class Codes: A61K 9/0097 Micromachined devices; Microelectromechanical systems [MEMS]; Devices obtained by lithographic treatment of silicon; Devices comprising chips intradermal microneedle arrays A61K9/0021; MEMS in general B81B7/02
• CPC Class Codes: A61K 9/4808 characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release capsules filled with granules or microparticles A61K9/16; filled with microcapsules or coated microparticles A61K9/50; with mixture of different granules, microcapsules, (coated) microparticles A61K9/5084
• CPC Class Codes: A61M 2205/0238 the material being a coating or protective layer
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/82 Internal energy supply devices
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A system and a manufacturing process are disclosed in accordance with the present invention that protect an electronic device and allows for placement or combination of the device within a pharmaceutical product or capsule. The system includes circuitry and components that can be placed within certain environments. The device includes an assembly including an electronic unit, a flexible membrane secured to the unit, and a protective coating.

Claims

1. A process for creating a pharmaceutical product, the process comprising the steps of:

creating a device sheet including a plurality of devices;

securing an upper sheet to one side of the device sheet to produce a partially coated device sheet;

securing a lower sheet to another side of the partially coated device sheet, to produce a protected device sheet, wherein the upper sheet and the lower sheet form a protective layer;

separating a protected device from the protected device sheet; and

combining the protected device with a pharmaceutical agent to produce the pharmaceutical product.

2. The process of claim 1, wherein the device sheet defines a plurality of holes surrounding each device.

3. The process of claim 2, wherein the step of securing the lower sheet to another side of the partially coated device sheet includes the step of heating the lower sheet and the upper sheet such that the lower sheet comes into contact with the upper sheet through the holes, the lower sheet surrounding each device and the upper sheet and the lower sheet are secured to one another at the point of the contact.

4. The process of claim 1, wherein the step of separating includes the steps of:

aligning the protected device sheet with an opening defined within a die such that the protected device is aligned with the opening of the die; and

punching the protected device using a punch through the opening and into a capsule placed within a capsule holder.

5. The process of claim 1, wherein the step of separating includes the steps of:

aligning the protected device sheet with an opening defined by a tray such that the protected device of the protected device sheet is aligned with the opening of the tray;

separating the protected device from the protected device sheet using a punch; and

placing the protected device into the opening of the tray.

6. The process of claim 5 further comprising the step of aligning the opening of the tray that includes the protected device with a capsule holder that defines a plurality of cavities that hold a first end of a capsule, wherein the capsule comprises the first end and a second end.

7. The process of claim 6 further comprising the step of pushing the protected device out of the opening of the tray and into the first end of the capsule placed within the cavity of the capsule holder.

8. The process of claim 7, wherein the step of combining includes the steps of:

filling the first end of the capsule that includes the protected device with a pharmaceutical product; and

securing the second end of the capsule to the first end of the capsule.