# US 9,040,087 B2 · Frozen compositions and methods for piercing a substrate

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- Number: US 9,040,087 B2
- Document ID: US9040087B2
- Status: Granted
- Kind: B2
- Application number: 12/586,074
- Filed: 2009-09-15
- Published: 2010-05-06
- Granted: 2015-05-26
- Earliest claimed: 2008-10-31
- Assignees: The Invention Science Fund I, LLC
- Applicants: Edward S. Boyden; Daniel B. Cook; Roderick A. Hyde; Eric C. Leuthardt; Nathan P. Myhrvold; Elizabeth A. Sweeney; Lowell L. Wood, Jr.
- Inventors: Edward S. Boyden; Daniel B. Cook; Roderick A. Hyde; Eric C. Leuthardt; Nathan P. Myhrvold; Elizabeth A. Sweeney; Lowell L. Wood, Jr.
- Web page: https://patentgrep.com/patent/US9040087B2

## CPC

- G16H 30/40: for processing medical images, e.g. editing
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 9/0021: {Intradermal administration, e.g. through microneedle arrays or needleless injectors}
- A61K 9/007: {Pulmonary tract; Aromatherapy}
- A61K 9/08: Solutions {(composition of solutions A61K47/00)}
- A61K 9/12: Aerosols; Foams {(A61K9/0043, A61K9/0056, A61K9/006, A61K9/0073 take precedence; spray-films A61K9/7015)}
- A61K 9/143: {with inorganic compounds}
- A61K 9/1611: {Inorganic compounds}
- A61K 9/1641: {obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers}
- A61K 9/1664: {Compounds of unknown constitution, e.g. material from plants or animals (oils, fats, waxes, shellac A61K9/1617)}
- A61K 9/1688: {resulting in pure drug agglomerate optionally containing up to 5% of excipient}
- A61K 9/19: lyophilised {, i.e. freeze-dried, solutions or dispersions (lyophilised products with subsequent particle size reduction A61K9/14; granules or pellets made by lyphilisation A61K9/1682; solid oral dosage forms made by lyophilisation A61K9/2095; lyophilisation additives A61K47/00)}
- A61K 9/209: {containing drug in at least two layers or in the core and in at least one outer layer}
- A61K 9/2095: {Tabletting processes}
- A61K 9/2866: {Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose}
- A61K 31/00: Medicinal preparations containing organic active ingredients
- A61K 31/337: having four-membered rings, e.g. taxol
- A61K 31/70: Carbohydrates; Sugars; Derivatives thereof (sorbitol A61K31/047)
- A61K 31/7088: Compounds having three or more nucleosides or nucleotides
- A61K 31/74: Synthetic polymeric materials
- A61K 33/00: Medicinal preparations containing inorganic active ingredients
- A61K 38/38: Albumins
- A61K 38/4833: {Thrombin (3.4.21.5)}
- A61K 39/12: Viral antigens
- A61K 39/145: Orthomyxoviridae, e.g. influenza virus
- A61K 41/0004: {Homeopathy; Vitalisation; Resonance; Dynamisation, e.g. esoteric applications; Oxygenation of blood}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61M 37/0015: {by using microneedles}
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 31/16: for influenza or rhinoviruses
- A61P 35/00: Antineoplastic agents
- C07K 16/22: against growth factors {; against growth regulators}
- C07K 16/283: {against Fc-receptors, e.g. CD16, CD32, CD64 (CD23 C07K16/2851)}
- C07K 16/2842: {against integrin beta1-subunit-containing molecules, e.g. CD29, CD49}
- C07K 16/2878: {against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95}
- C07K 16/30: from tumour cells
- G16H 50/20: for computer-aided diagnosis, e.g. based on medical expert systems
- G16H 50/50: for simulation or modelling of medical disorders
- A61K 31/505: Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K 31/519: ortho- or peri-condensed with heterocyclic rings
- A61K 31/59: Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
- A61K 38/4886: {Metalloendopeptidases (3.4.24), e.g. collagenase}
- A61K 39/00: Medicinal preparations containing antigens or antibodies (materials for immunoassay G01N33/53)
- A61K 2039/505: {comprising antibodies}
- A61K 2039/54: {characterised by the route of administration}
- A61M 2037/0023: {Drug applicators using microneedles}
- A61M 2037/003: {having a lumen}
- A61M 2205/02: characterised by a particular materials
- B33Y 80/00: Products made by additive manufacturing
- C12N 2760/16034: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- G16H 20/10: relating to drugs or medications, e.g. for ensuring correct administration to patients
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- Y02A 90/10: Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
- Y10T 83/222: With receptacle or support for cut product
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- B33Y: ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

Certain embodiments disclosed herein relate to compositions, methods, devices, systems, and products regarding frozen particles. In certain embodiments, the frozen particles include materials at low temperatures. In certain embodiments, the frozen particles provide vehicles for delivery of particular agents. In certain embodiments, the frozen particles are administered to at least one biological tissue.

## Claims

### Claim 1

A frozen piercing implement, comprising:
at least one sterile frozen ice microneedle approximately one centimeter or less, extending substantially outward from a planar support structure and including at least one vaccine;
wherein the frozen ice microneedle is configured for piercing at least part of at least one substrate, and is coated in at least one of a therapeutic agent, reinforcement agent, abrasive, biological remodeling agent, or explosive material.

### Claim 2 (depends on 1)

The frozen piercing implement of claim 1, wherein the sterile frozen ice microneedle further includes at least one detection material.

### Claim 3 (depends on 2)

The frozen piercing implement of claim 2, wherein the at least one detection material includes at least one of a contrast agent, sensor, or electronic identification device.

### Claim 4 (depends on 3)

The frozen piercing implement of claim 3, wherein the at least one electronic identification device includes at least one radio frequency identification device.

### Claim 5 (depends on 2)

The frozen piercing implement of claim 2, wherein the at least one detection material includes at least one temperature-sensitive substance.

### Claim 6 (depends on 2)

The frozen piercing implement of claim 2, wherein the at least one detection material includes at least one of a radioactive, luminescent, colorimetric or odorous substance.

### Claim 7 (depends on 6)

The frozen piercing implement of claim 6, wherein the at least one radioactive, luminescent, colorimetric or odorous substance includes at least one temperature-sensitive substance.

### Claim 8 (depends on 1)

The frozen piercing implement of claim 1, wherein the at least one frozen piercing implement includes at least one channel.

### Claim 9 (depends on 8)

The frozen piercing implement of claim 8, wherein at least one surface of the at least one channel is substantially hydrophobic.

### Claim 10 (depends on 8)

The frozen piercing implement of claim 8, wherein at least one surface of the at least one channel is substantially hydrophilic.

### Claim 11 (depends on 1)

The frozen piercing implement of claim 1, wherein the frozen piercing implement approximates the shape of at least one of a sphere, bullet, flechette, cone, frustrum, needle, arrow, spear, diamond, pyramid, cylinder, minie ball, shuttlecock, spiral, bell, pear, crystal, cube, spheroid, tetrahedron, crescent, possesses a high aspect ratio shape, or any combination thereof.

### Claim 12 (depends on 1)

The frozen piercing implement of claim 1, further including an implement holding device operably connected to the support structure.

### Claim 13 (depends on 12)

The frozen piercing implement of claim 12, wherein the implement holding device includes at least one handle, robotic arm, or surgical device.

### Claim 14 (depends on 1)

The frozen piercing implement of claim 1, wherein the frozen piercing implement includes at least one substantially tapered end.

### Claim 15 (depends on 1)

The frozen piercing implement of claim 1, wherein the frozen piercing implement includes at least one port.

### Claim 16 (depends on 15)

The frozen piercing implement of claim 15, wherein the at least one port includes at least one side port.

### Claim 17 (depends on 15)

The frozen piercing implement of claim 15, wherein the at least one port includes at least one end port.

### Claim 18 (depends on 15)

The frozen piercing implement of claim 15, wherein the at least one port includes at least one inlet port or outlet port.

### Claim 19 (depends on 18)

The frozen piercing implement of claim 18, wherein the at least one inlet port or outlet port is in fluid communication with at least one channel.

### Claim 20 (depends on 1)

The frozen piercing implement of claim 1, wherein the at least one frozen piercing implement includes at least one sensor.

### Claim 21 (depends on 20)

The frozen piercing implement of claim 20, wherein the at least one sensor includes at least one sensor configured for detecting at least one of a biochemical, electrical, optical, functional, physical, chemical, biological, or structural characteristic of the at least one material.

### Claim 22 (depends on 1)

The frozen piercing implement of claim 1, wherein the at least one frozen piercing implement is configured to extract at least one material from the at least one substrate.

### Claim 23 (depends on 1)

The frozen piercing implement of claim 1, wherein the frozen piercing implement is included in at least one frozen piercing implement device, the at least one frozen piercing implement device includes at least one of a frozen piercing implement array device, frozen piercing implement fluidic device, or frozen piercing implement injection device.

### Claim 24 (depends on 1)

The frozen piercing implement of claim 1, wherein the frozen piercing implement is substantially in the form of at least one blade.

### Claim 25 (depends on 1)

The frozen piercing implement of claim 1, configured as a tweezers, fork, scriber, graver, spade, screw, needle or pin.

### Claim 26 (depends on 25)

The frozen piercing implement of claim 25, wherein the needle or pin include at least one macroneedle, macropin, microneedle, micropin, nanoneedle, or nanopin.

### Claim 27 (depends on 1)

The frozen piercing implement of claim 1, wherein the support surface further includes the sterile frozen ice composition as the microneedle.

### Claim 28 (depends on 1)

The frozen piercing implement of claim 1, wherein the external coating includes at least one of an anti-inflammatory agent, pigment, anesthetic, vasoconstrictor, or antimicrobial agent.

### Claim 29 (depends on 1)

The frozen piercing implement of claim 1, wherein the external coating includes at least one reinforcement agent including one or more of polyaramid, vinylester matrix, ceramic, fiberglass, cellulose, broad carbide, aromatic polyamide, nylon, silk, rayon, acetate, modacrylic, olefin, acrylic polymer or copolymer, acrylamide polymer or copolymer, polyester, aromatic polyester, poly-lactic acid, vinyon, saran, spandex, vinalon, aromatic nylon, vinylidene chloride, modal, polybenzimidazole, sulfur, lyocell, orlon, zylon, high-performance polyethylene, polypyridobenzimidazole, vectran, acrylonitrile rubber, corundum, zirconia alumina, silicon, or silica.

### Claim 30

A frozen piercing implement, comprising:
at least one sterile frozen ice microneedle approximately one centimeter or less, extending substantially outward from a planar support structure and including a glucose sensor located within the sterile frozen ice microneedle;
wherein the frozen ice microneedle is configured for piercing a substrate, and is externally coated in at least one of a therapeutic agent, abrasive, reinforcement agent, biological remodeling agent or explosive material.

### Claim 31 (depends on 30)

The frozen piercing implement of claim 30, wherein the sterile frozen ice microneedle further includes insulin.

### Claim 32 (depends on 31)

The frozen piercing implement of claim 31, wherein the insulin is located within a cavity of the sterile frozen ice microneedle.

### Claim 33 (depends on 31)

The frozen piercing implement of claim 31, wherein the insulin is coated on the sterile frozen ice microneedle.

### Claim 34 (depends on 30)

The frozen piercing implement of claim 30, wherein the substrate includes skin, blood, or interstitial fluid.

### Claim 35 (depends on 30)

The frozen piercing implement of claim 30, wherein the glucose sensor includes glucose oxidase.

### Claim 36 (depends on 35)

The frozen piercing implement of claim 35, wherein the sterile frozen ice microneedle is coated with glucose oxidase.