Device for passively removing a target component from blood or lymph of a vertebrate subject

• US 9,061,094 B2
• Filed: 10/22/2012
• Issued: 06/23/2015
• Est. Priority Date: 02/25/2009
• 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: Hyde, Roderick A., Ishikawa, Muriel Y., Jung, Edward K. Y., Langer, Robert, Leuthardt, Eric C., Myhrvold, Nathan P., Sweeney, Elizabeth A., Wood, Lowell L. Jr.
• Primary Examiner(s): DEAK, LESLIE R
• Application Number:
  US13/656,964
• Publication Number:
  US 20130109934A1
• Time in Patent Office: 974 Days
• Field of Search: 604/4.01, 604/5.01, 604/5.04, 604/6.08, 604/6.09, 604/6.11, 604/500, 604/507, 604/508, 210/645, 210/501, 210/502.1, 210/745
• US Class Current: 1/1
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• 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: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61M 1/362 changing physical properties of target cells by binding them to added particles to facilitate their subsequent separation from other cells, e.g. immunoaffinity
• CPC Class Codes: A61M 1/3679 by absorption A61M1/3675 takes precedence
• CPC Class Codes: A61M 1/3681 by irradiation
• CPC Class Codes: A61M 1/3683 using photoactive agents
• CPC Class Codes: A61M 2202/0405 Lymph
• CPC Class Codes: A61M 2205/04 implanted
• CPC Class Codes: A61M 5/00 Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests vaccination appliances for veterinary use A61D1/025 ; tube connectors, tube couplings, valves or branch units specially adapted for medical use A61M39/00; containers specially adapted for medical or pharmaceutical purposes A61J1/00; combinations of vial and syringe for mixing or transferring their contents A61J1/20; holders for containers for collecting, storing or administering blood or medical fluids A61J1/16
• CPC Class Codes: A61M 5/007 for contrast media
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61N 5/02 using microwaves
• CPC Class Codes: A61N 5/0601 Apparatus for use inside the body
• CPC Class Codes: A61N 5/062 Photodynamic therapy, i.e. excitation of an agent
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092
• CPC Class Codes: A61P 33/06 Antimalarials
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 35/04 specific for metastasis

Abstract

Devices, systems, and methods are described herein for controlling or modulating the levels of one or more target components in the blood and/or lymph of a vertebrate subject. Devices and systems are provided that include a body defining at least one lumen configured for fluid flow; at least one controllable flow barrier to fluid flow into the at least one lumen; at least one first reservoir disposed within the body and configured to include one or more bifunctional tags, wherein the one or more bifunctional tags are configured to selectively bind to one or more target components in one or more of blood fluid or lymph fluid of a vertebrate subject; at least one treatment region disposed within the at least one lumen; and at least one second reservoir disposed in the at least one treatment region and configured to include one or more reactive components, wherein the one or more reactive components are configured to sequester the one or more bifunctional tags when bound to the one or more target components.

Claims

1. A method for treating an inflammatory condition or inflammatory disease in a vertebrate subject comprising:

providing an implantable device including a body defining at least one lumen configured for fluid flow;

at least one first reservoir disposed within the at least one lumen and configured to include one or more bifunctional tags, wherein the one or more bifunctional tags are configured to selectively bind to one or more target components in one or more of blood fluid or lymph fluid of a vertebrate subject;

at least one treatment region disposed within the at least one lumen; and

at least one second reservoir disposed in the at least one treatment region and configured to include one or more reactive components, wherein the one or more reactive components are configured to sequester the one or more bifunctional tags when bound to the one or more target components;

further including providing one or more sensor configured to measure a physiological condition proximate to the device;

wherein the one or more sensor is configured to target the device to a site having an elevated level of the one or more target components.

2. The method of claim 1, wherein the one or more reactive components has an increased affinity for the one or more bifunctional tags bound to the one or more target components compared to an affinity for the one or more bifunctional tags unbound to the one or more reactive components.

3. The method of claim 1, wherein the one or more reactive components is configured to modulate a physiological effect of the one or more target components.

4. The method of claim 1, wherein the one or more bifunctional tags are configured to enter a circulatory system of the mammalian subject at a site different from a site of the one or more reactive components.

5. The method of claim 1, wherein the one or more bifunctional tags includes one or more of a recognition element, recognition molecule, antibody, integrin, selectin, lectin, mimetic polymer, affibody, a label, or virus-like particle.

6. The method of claim 5, wherein the label includes one or more of a QDOT, a nanoparticle, a fluorescent molecule, a magnetic particle, a contrast agent, or a radioisotope.

7. The method of claim 5, wherein the one or more bifunctional tags includes one or more bifunctional antibodies.

8. The method of claim 7, wherein the one or more bifunctional antibodies binds to one or more of the target component and the reactive component.

9. The method of claim 1, wherein the one or more target components include one or more of circulating target cells or circulating target emboli.

10. The method of claim 9, wherein the one or more target components include cancer cells, pre-cancer cells, autoimmune-related cells, B cells, T cells, phagocytes, platelets, lipoproteins, parasites, viruses, bacteria, fungi, or infected cells.

11. The method of claim 9, wherein the one or more reactive components is configured to produce necrosis or apoptosis in one or more target cells.

12. The method of claim 1, wherein the one or more target components includes one or more of tumor cells, emboli, misfolded proteins, aggregated proteins, antibodies, autoimmune antibodies, infectious agents, or infected cells.

13. The method of claim 1, further including providing two or more parallel lumen configured to receive the one or more target components.

14. The method of claim 13, wherein a diameter of each of the two or more lumen is approximately less than two cell diameters.

15. The method of claim 13, wherein a diameter of each of the two or more lumen is approximately less than 10 μ

m.

16. The method of claim 1, wherein the one or more reactive components is configured to alter, arrest, or destroy the one or more target components.

17. The method of claim 1, wherein the one or more reactive components is configured to be placed relative to a tumor or an organ in the mammalian subject.

18. The method of claim 1, wherein the one or more reactive components includes one or more of an adhesion molecule, antibody, binding mimetic, polymer, lectin, integrin, or selectin.

19. The method of claim 1, wherein the one or more reactive components include one or more of a denaturing agent, degradative agent, or binding agent.

20. The method of claim 19, wherein the one or more reactive components include a cytotoxic agent, a cytostatic agent, a programmed cell death-inducing agent, a chemotherapeutic agent, or an antibody-toxin agent.

21. The method of claim 19, wherein the one or more binding agents include one or more of antibodies, receptors, or cognates configured to bind to one or more target components.

22. The method of claim 19, wherein the one or more binding agents include one or more of lectin, binding protein, catalytic antibody, catalytic aptamer, protease conjugate, or photoactivatable conjugate.

23. The method of claim 19, wherein the one second reservoirs include a matrix configured to present one or more reactive components.

24. The method of claim 1, further including providing one or more energy sources configured to supply energy to the at least one treatment region.

25. The method of claim 24, wherein the energy source is coupled to one or more sensor configured to selectively direct energy to the target component.

26. The method of claim 1, wherein the one or more sensor is configured to detect one or more of unbound bifunctional tags or bifunctional tags bound to target components in the one or more of blood fluid or lymph fluid of the vertebrate subject.

27. The method of claim 1, wherein the one or more sensor is configured to detect sequestration by the at least one reactive component.

28. The method of claim 1, further including providing a transmitter to report data from the one or more sensor.

29. The method of claim 1, wherein the one or more sensor is configured to report to an outside source or to a computing device.

30. The method of claim 1, wherein the one or more sensor is configured to function in, or proximal to, the one or more blood vessel or lymph vessel.

31. The method of claim 1, wherein the one or more sensor is external to the at least one lumen.

32. The method of claim 1, wherein the one or more sensor is internal to the at least one lumen.

33. The method of claim 1, further including providing at least one controller in communication with the one or more sensor.

34. The method of claim 33, further including providing at least one controllable flow barrier to fluid flow into the at least one lumen.

35. The method of claim 34, wherein the at least one controller in communication with the one or more sensor is configured to control the at least one controllable flow barrier to the at least one lumen.

36. The method of claim 35, wherein the one or more sensor is configured to detect the one or more bifunctional tags complexed with the one or more target components and is configured to communicate with the controller to divert flow of the one or more of blood fluid or lymph fluid to the at least one lumen of the device.

37. The method of claim 33, wherein the one or more sensor is configured to detect the one or more target components and configured to communicate with the at least one controller to release the one or more bifunctional tags in response to the one or more detected target components.

38. The method of claim 33, wherein the one or more sensor is configured to detect the one or more bifunctional tags complexed with the one or more target components and is configured to communicate with the controller to activate the one or more reactive components in response to the complex of the one or more bifunctional tags to the one or more target components.

39. The method of claim 33, wherein the one or more sensor and the at least one controller are configured to achieve a target level of the one or more target components in the vertebrate subject.

40. The method of claim 39, wherein the one or more sensor and the at least one controller are configured to control the at least one controllable flow barrier, to activate the one or more reactive components, to release the one or more bifunctional tags, or to activate one or more energy sources.

41. The method of claim 39, wherein the one or more sensor and the at least one controller are configured to control levels of the detected one or more target components to limit a deviation from the target level.

42. The method of claim 41, wherein the deviation is determined by a weighted least squares fit.

43. The method of claim 39, wherein the target level includes a desired concentration of the one or more target components in the one or more of blood fluid or lymph fluid.

44. The method of claim 39, wherein the target level includes a desired range of concentrations of the one or more target components in the one or more of blood fluid or lymph fluid.

45. The method of claim 39, wherein the target level includes a desired ratio of concentrations of two or more target components in the one or more of blood fluid or lymph fluid.

46. The method of claim 39, wherein the target level includes a desired ratio of levels of two or more target components in the one or more of blood fluid or lymph fluid.

47. The method of claim 33, wherein the at least one first reservoir configured to provide one or more bifunctional tags is responsive to the controller.

48. The method of claim 33, wherein the at least one second reservoir configured to provide one or more reactive components is responsive to the controller.

49. The method of claim 1, wherein the one or more reactive components are configured to attach to the at least one lumen.

50. The method of claim 1, wherein the one or more sensor includes a biosensor, chemical sensor, physical sensor, or optical sensor.

51. The method of claim 50, wherein the one or more sensor includes one or more target recognition elements.

52. The method of claim 1, wherein the one second reservoirs include a source for producing the one or more reactive components, the source including at least one reservoir and at least one producer.