Compositions and methods for therapeutic delivery with frozen particles

• US 8,793,075 B2
• Filed: 10/31/2008
• Issued: 07/29/2014
• Est. Priority Date: 10/31/2008
• Status: Expired due to Fees

• Current Assignee: Gearbox LLC (Intellectual Ventures LLC)
• Original Assignee: The Invention Science Fund I, L.L.C. (Intellectual Ventures LLC)
• Inventors: Boyden, Edward S., Hyde, Roderick A., Leuthardt, Eric C., Myhrvold, Nathan P., Sweeney, Elizabeth A., Wood, Lowell L. Jr.
• Primary Examiner(s): HARWARD, SOREN T
• Application Number:
  US12/290,690
• Publication Number:
  US 20100114592A1
• Time in Patent Office: 2,097 Days
• US Class Current: 702/19
• CPC Class Codes: A61K 9/14 Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles microspheres A61K9/16; microcapsules A61K9/50; nanocapsules, nanoparticles of the matrix type A61K9/51
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 37/0069 Devices for implanting pellets, e.g. markers or solid medicaments for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027
• CPC Class Codes: A61M 5/3015 for injecting a dose of particles in form of powdered drug, e.g. mounted on a rupturable membrane and accelerated by a gaseous shock wave or supersonic gas flow cell injection devices C12M3/006
• CPC Class Codes: G16B 20/00 ICT specially adapted for functional genomics or proteomics, e.g. genotype-phenotype associations
• CPC Class Codes: G16B 20/20 Allele or variant detection, e.g. single nucleotide polymorphism [SNP] detection
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

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

1. A method, comprising:

administering at least one solid frozen particle therapeutic composition including at least one tracer agent at high speed to at least one subject, and with use of at least one computing device, comparing information regarding at least one aspect of administering the at least one solid frozen particle therapeutic composition to the at least one subject based on the real-time feedback signal from the at least one tracer agent, and information regarding at least one clinical outcome following receipt by the at least one subject of at least one solid frozen particle therapeutic composition; and

providing output information regarding at least one aspect of the administering the at least one solid frozen particle therapeutic composition to the at least one subject based on the real-time feedback signal from the at least one tracer agent;

wherein the output information is in the form of at least one of a code indicative of at least one vaccination delivered, a code indicative of at least one therapeutic agent delivered, a code indicative of at least one diagnostic agent delivered, a code indicative of at least one interaction of a delivered agent and at least one biological or chemical agent in the subject, a code indicative of at least one detection material delivered, a code indicative of the depth of penetration of a delivered agent, or a code indicative of the condition of at least one location of an administered frozen particle composition.

2. The method of claim 1, further including determining at least one statistical correlation.

3. The method of claim 1, further including counting the occurrence of at least one clinical outcome.

4. The method of claim 1, further including comparing information regarding at least one aspect of administering the at least one solid frozen particle therapeutic composition and the information regarding at least one clinical outcome based on the real-time feedback signal from the at least one tracer agent, before the administration of the at least one solid frozen particle therapeutic composition to another subject.

5. The method of claim 1, wherein the information regarding the at least one aspect of administering the at least one solid frozen particle therapeutic composition includes information regarding the amount of at least one solid frozen particle therapeutic composition or therapeutic agent administered to at least one biological tissue of a subject based on the real-time feedback signal from the at least one tracer agent.

6. The method of claim 1, wherein the information regarding the at least one aspect of administering the at least one solid frozen particle therapeutic composition includes information regarding at least one dimension of biological tissue penetration based on the real-time feedback signal from the at least one tracer agent.

7. The method of claim 6, wherein the information regarding the at least one dimension of biological tissue penetration includes information regarding at least one of depth, width, or breadth of administration of the at least one solid frozen particle therapeutic composition to the at least one biological tissue of at least one subject based on the real-time feedback signal from the at least one tracer agent.

8. The method of claim 1, wherein the information regarding at least one aspect of administering the at least one solid frozen particle therapeutic composition includes information regarding two or more subjects with one or more common attributes.

9. The method of claim 8, wherein the one or more common attributes include genetic attributes, mental attributes, or psychological attributes.

10. The method of claim 8, wherein the one or more common attributes include genotype attributes or phenotype attributes.

11. The method of claim 10, wherein the one or more common attributes include at least one of height;

weight;

medical diagnosis;

familial background;

results on one or more medical tests;

ethnic background;

body mass index;

age;

presence or absence of at least one disease or condition;

species;

ethnicity;

race;

allergies;

gender;

thickness of epidermis;

thickness of dermis;

thickness of stratum corneum;

keratin deposition;

collagen deposition;

blood vessel condition;

skin condition;

hair or fur condition;

muscle condition;

tissue condition;

organ condition;

nerve condition;

brain condition;

presence or absence of at least one biological, chemical, or therapeutic agent in the subject;

pregnancy status;

lactation status;

genetic profile;

proteomic profile;

partial or whole genetic sequence;

partial or whole proteomic sequence;

medical history;

or blood condition.

12. The method of claim 1, wherein the output information includes at least one of a response signal, a comparison code, a comparison plot, a diagnostic code, a treatment code, a test code, a code indicative of at least one treatment received, a code indicative of at least one prescribed treatment step, a code indicative of at least one vaccination administered;

a code indicative of at least one therapeutic agent administered;

a code indicative of at least one diagnostic agent administered;

a code indicative of at least one interaction of a administered agent and at least one biological or chemical agent in the subject;

a code indicative of at least one dispersion or location of at least one administered agent;

a code indicative of at least one detection material administered;

a code indicative of the depth of penetration of an administered agent;

or a code indicative of the condition of at least one location of an administered solid frozen particle composition.

13. The method of claim 1, wherein the information regarding at least one aspect of administering the at least one solid frozen particle therapeutic composition includes information regarding at least one cellular or tissue source.

14. The method of claim 13, wherein the information regarding at least one cellular or tissue source includes information regarding at least one abnormal cellular or tissue source.

15. The method of claim 13, wherein the information regarding at least one cellular or tissue source includes information regarding at least one type of cell or tissue.

16. The method of claim 1, wherein the at least one solid frozen particle therapeutic composition includes at least one of nitrogen, carbon dioxide, hydrogen oxide, helium, neon, xenon, krypton, air, oxygen, chlorine, bromine, argon, polyethylene glycol, acetone, ethyl acetate, dimethyl sulfoxide, dimethyl formamide, dioxane, hexamethylphosphorotriamide, perfluorohydrocarbon, methanol, ethanol, tert-butyl alcohol, formic acid, hydrogen fluoride, ammonia, acetic acid, benzene, carbon tetrachloride, acetonitrile, hexane, methylene chloride, carboxylic acid, saline, Ringer'"'"'s solution, lactated Ringer'"'"'s solution, Hartmann'"'"'s solution, acetated Ringer'"'"'s solution, phosphate buffered solution, TRIS-buffered saline solution, Hank'"'"'s balanced salt solution, Earle'"'"'s balanced salt solution, standard saline citrate, HEPES-buffered saline, dextrose, glucose, or diethyl ether.

17. The method of claim 1, wherein the at least one solid frozen particle composition includes at least one major dimension of approximately one centimeter or less, approximately one millimeter or less, approximately one micrometer or less, approximately one nanometer or less, or any value therebetween.

18. The method of claim 1, wherein the at least one solid frozen particle therapeutic composition includes one or more reinforcement agents.

19. The method of claim 1, wherein the at least one solid frozen particle therapeutic composition includes one or more explosive materials.

20. The method of claim 1, wherein the receipt by the at least one subject of the at least one solid frozen particle therapeutic composition is pursuant to at least one clinical trial.

21. The method of claim 1, further including creating at least one inclusion criterion and at least one exclusion criterion for a clinical trial involving the at least one solid frozen particle therapeutic composition.

22. The method of claim 1, wherein comparing the information further includes suggesting the inclusion of one or more of the at least one subject in at least one clinical trial.

23. The method of claim 1, wherein comparing the information further includes suggesting the exclusion of one or more of the at least one subject in at least one clinical trial.

24. The method of claim 1, further including using one or more comparisons to predict at least one clinical outcome regarding at least one second subject.

25. The method of claim 24, wherein the at least one second subject has not received the at least one solid frozen particle therapeutic composition.

26. The method of claim 24, further including predicting at least one clinical outcome involving the at least one second subject, wherein the at least one second subject is a plurality of people;

and segregating subject identifiers associated with the plurality of people in reference to the predicted at least one clinical outcome.

27. The method of claim 24, further including determining the eligibility of the at least one second subject for at least one clinical trial.

28. A method of predicting a clinical outcome of administering at least one solid frozen particle therapeutic composition to at least one biological tissue of at least one first subject, comprising:

administering at high speed at least one solid frozen particle therapeutic composition including at least one tracer agent, to at least one biological tissue of at least one first subject and to at least one biological tissue of at least one second subject, and with the use of at least one computing device, determining a similarity or a dissimilarity in information regarding at least one aspect of administering the at least one solid frozen particle therapeutic composition to the at least one biological tissue of the at least one first subject to information regarding at least one aspect of administering at least one solid frozen particle therapeutic composition to the at least one biological tissue of the at least one second subject based on real-time feedback of the detected at least one tracer agent, wherein the at least one second subject attained a clinical outcome following receipt of the at least one solid frozen particle therapeutic composition; and

providing output information regarding at least one aspect of the administering the at least one solid frozen particle therapeutic composition to the at least one biological tissue of at least one subject based on the real-time feedback signal from the at least one tracer agent.

29. The method of claim 28, wherein the information regarding at least one aspect of administering the at least one solid frozen particle therapeutic composition includes information regarding amount of at least one solid frozen particle therapeutic composition or therapeutic agent administered to at least one biological tissue of at least one subject based on the real-time feedback signal from the at least one tracer agent.

30. The method of claim 28, wherein the output information is based on the determination.

31. The method of claim 28, wherein the information regarding at least one aspect of administering the at least one solid frozen particle therapeutic composition includes information regarding at least one dimension of biological tissue penetration based on the real-time feedback signal from the at least one tracer agent.

32. The method of claim 31, wherein the information regarding at least one dimension of biological tissue penetration includes information regarding at least one of depth, width, or breadth of administration of at least one solid frozen particle therapeutic composition to at least one biological tissue of at least one subject based on the real-time feedback signal from the at least one tracer agent.

33. The method of claim 28, wherein the information regarding at least one aspect of administering the at least one solid frozen particle therapeutic composition includes information regarding two or more subjects with one or more common attributes.

34. The method of claim 33, wherein the one or more common attributes include genetic attributes, mental attributes, or psychological attributes.

35. The method of claim 33, wherein the one or more common attributes include genotype attributes or phenotype attributes.

36. The method of claim 35, wherein the one or more common attributes include at least one of height;

weight;

medical diagnosis;

familial background;

medical history;

results on one or more medical tests;

ethnic background;

body mass index;

age;

presence or absence of at least one disease or condition;

species;

ethnicity;

race;

allergies;

gender;

thickness of epidermis;

thickness of dermis;

thickness of stratum corneum;

keratin deposition;

collagen deposition;

lymph condition;

blood vessel condition;

skin condition;

hair or fur condition;

muscle condition;

tissue condition;

organ condition;

nerve condition;

brain condition;

presence or absence of at least one biological, chemical, or therapeutic agent in the subject;

pregnancy status;

lactation status;

genetic profile;

proteomic profile;

partial or whole genetic sequence;

partial or whole proteomic sequence;

or blood condition.

37. The method of claim 28, wherein the output information includes at least one of a response signal, a comparison code, a comparison plot, a diagnostic code, a treatment code, a test code, a code indicative of at least one treatment received, a code indicative of at least one prescribed treatment step, a code indicative of at least one vaccination administered;

a code indicative of at least one therapeutic agent administered;

a code indicative of at least one diagnostic agent administered;

a code indicative of at least one interaction of a administered agent and at least one biological or chemical agent in the subject;

a code indicative of at least one dispersion or location of at least one administered agent;

a code indicative of at least one detection material administered;

a code indicative of the depth of penetration of an administered agent;

or a code indicative of the condition of at least one location of an administered solid frozen particle therapeutic composition.

38. The method of claim 28, wherein the information regarding at least one aspect of administering at least one solid frozen particle therapeutic composition includes information regarding at least one cellular or tissue source.

39. The method of claim 38, wherein the information regarding at least one cellular or tissue source includes information regarding at least one abnormal cellular or tissue source.

40. The method of claim 38, wherein the information regarding at least one cellular or tissue source includes information regarding at least one type of cell or tissue.

41. The method of claim 28, wherein the at least one solid frozen particle therapeutic composition includes at least one of nitrogen, carbon dioxide, hydrogen oxide, helium, neon, xenon, krypton, air, oxygen, chlorine, bromine, argon, polyethylene glycol, acetone, ethyl acetate, dimethyl sulfoxide, dimethyl formamide, dioxane, hexamethylphosphorotriamide, perfluorohydrocarbon, methanol, ethanol, tert-butyl alcohol, formic acid, hydrogen fluoride, ammonia, acetic acid, benzene, carbon tetrachloride, acetonitrile, hexane, methylene chloride, carboxylic acid, saline, Ringer'"'"'s solution, lactated Ringer'"'"'s solution, Hartmann'"'"'s solution, acetated Ringer'"'"'s solution, phosphate buffered solution, TRIS-buffered saline solution, Hank'"'"'s balanced salt solution, Earle'"'"'s balanced salt solution, standard saline citrate, HEPES-buffered saline, dextrose, glucose, or diethyl ether.

42. The method of claim 28, wherein the at least one solid frozen particle therapeutic composition includes at least one major dimension of approximately one centimeter or less, approximately one millimeter or less, approximately one micrometer or less, approximately one nanometer or less, or any value therebetween.

43. The method of claim 28, wherein the at least one solid frozen particle therapeutic composition includes one or more reinforcement agents.

44. The method of claim 28, wherein the at least one solid frozen particle therapeutic composition includes one or more explosive agents.

45. The method of claim 28, wherein the receipt by the at least one subject of at least one solid frozen particle therapeutic composition is pursuant to at least one clinical trial.

46. The method of claim 28, further including determining at least one correlation before the administration of the at least one solid frozen particle therapeutic composition.

47. The method of claim 28, further including creating at least one inclusion criterion and at least one exclusion criterion for a clinical trial involving the at least one solid frozen particle therapeutic composition.

48. The method of claim 28, further including suggesting the inclusion of one or more of the at least one subject in at least one clinical trial.

49. The method of claim 28, further including suggesting the exclusion of one or more of the at least one subject in at least one clinical trial.

50. The method of claim 28, further including using one or more of the at least one determination to predict at least one clinical outcome regarding at least one second subject.

51. The method of claim 50, wherein the at least one second subject has not received the at least one solid frozen particle therapeutic composition.

52. The method of claim 50, wherein using one or more of the at least one comparison further includes predicting at least one clinical outcome involving the at least one second subject, wherein the at least one second subject is a plurality of people;

and segregating subject identifiers associated with the plurality of people in reference to the predicted at least one clinical outcome.

53. The method of claim 51, further including determining the eligibility of the at least one second subject for at least one clinical trial.