Device and method for examining a body lumen

• US 20030040685A1
• Filed: 07/11/2002
• Published: 02/27/2003
• Est. Priority Date: 07/12/2001
• Status: Active Grant

• Current Assignee: Given Imaging Limited (Medtronic Plc)
• Original Assignee: Given Imaging Limited (Medtronic Plc)
• Inventors: Gilad, Zvika, Meron, Gavriel, Glukhovsky, Arkady, Lewkowicz, Shlomo, Gat, Daniel, Kraizer, Yehudit, Leuw, David
• Granted Patent: US 7,083,578 B2
• Time in Patent Office: Days
• US Class Current: 600/593
• CPC Class Codes: A61B 1/00029 externally powered, e.g. wireless
• CPC Class Codes: A61B 1/00158 using magnetic field
• CPC Class Codes: A61B 1/041 Capsule endoscopes for imaging
• CPC Class Codes: A61B 2017/00035 pH
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2090/392 Radioactive markers
• CPC Class Codes: A61B 2090/3954 magnetic, e.g. NMR or MRI
• CPC Class Codes: A61B 2560/0219 of externally powered implanted units
• CPC Class Codes: A61B 5/06 Devices, other than using radiation, for detecting or locating foreign bodies for removing same A61B17/50 ; determining position of probes within or on the body of the patient
• CPC Class Codes: A61B 5/062 using magnetic field
• CPC Class Codes: A61B 5/064 using markers A61B5/062 takes precedence
• CPC Class Codes: A61B 5/073 Intestinal transmitters
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61B 90/98 using electromagnetic means, e.g. transponders
• CPC Class Codes: A61K 49/0002 General or multifunctional contrast agents, e.g. chelated agents
• CPC Class Codes: A61K 49/0409 Physical forms of mixtures of two different X-ray contrast-enhancing agents, containing at least one X-ray contrast-enhancing agent which is not a halogenated organic compound
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61K 9/0009 involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis microelectromechanical systems A61K9/0097
• CPC Class Codes: A61K 9/0065 : Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
• 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: A61K 9/4866 : Organic macromolecular compounds
• CPC Class Codes: A61K 9/4891 : Coated capsules; Multilayered drug free capsule shells with drug coating for immediate release A61K9/4808; osmotic devices A61K9/0004

Abstract

An in vivo examining device and method are described. The in vivo examining device has two operational phases; an initial phase in which the device is of initial dimensions and a final phase in which the device is of final dimensions. In the initial phase the device can pass freely through a normally configured body lumen whereas it may not be able to pass freely through an abnormally configured lumen. In the final phase the device can pass freely through a body lumen even if it is abnormally configured.

Claims

1. A method for testing a body lumen, the method comprising the steps of:

introducing into the body lumen a device, said device having initial dimensions for a predetermined period and reduced dimensions after the predetermined period; and

monitoring the device.

2. The method according to claim 1 wherein the body lumen is the GI tract.

3. The method according to claim 2 wherein the step of introducing the device comprises ingesting the device.

4. The method according to claim 1 wherein the predetermined period is a period of approximately one hundred hours or more.

5. The method according to claim 1 wherein the device comprises a permeable coating and a filling disposed within said coating, the filling being capable of absorbing fluid from the body lumen.

6. The method according to claim 5 wherein, after the predetermined period, the filling swells enough to burst the coating.

7. The method according to claim 1 wherein, after the predetermined period, the coating is burst.

8. The method according to claim 1 wherein the coating comprises at least one layer.

9. The method according to claim 1 wherein the coating includes a material or combination of materials selected from the group consisting of:

parylene C, hard gelatin, soft gelatin, vegetable gelatin and a hydrogel.

10. The method according to claim 9 wherein the hydrogel is ethyl cellulose acetate.

11. The method according to claim 1 wherein the filling comprises at least one layer.

12. The method according to claim 1 wherein the filling includes a material or combination of materials selected from the group consisting of:

a filler, a biodegradable polymer, microparticles of a hydrophilic substance and a hydrogel.

13. The method according to claim 12 wherein the biodegradable polymer is a- polymer of lactide and glycollide.

14. The method according to claim 12 wherein the filling further comprises adhesives.

15. The method according to claim 1 wherein the coating is thinner than the filling.

16. The method according to claim 1 wherein the initial dimensions comprise a diameter of approximately 1-12 mm and wherein the reduced dimensions comprise a diameter of approximately 2-10 μ

m.

17. The method according to claim 1 wherein the step of monitoring the device comprises detecting a signal emanated from a monitoring device, said device including at least the monitoring device.

18. The method according to claim 17 wherein the monitoring device is of smaller dimensions than the device initial dimensions.

19. The method according to claim 17 wherein the monitoring device is a passive device.

20. The method according to claim 19 wherein the monitoring device is selected from the group consisting of:

an electronic ID tag, a magnetized device or an acoustic device.

21. The method according to claim 19 wherein the step of detecting a signal emanated from a monitoring device comprises the steps of:

inducing the monitoring device to emanate a signal; and

detecting the emanated signal.

22. The method according to claim 21 wherein the step of inducing the monitoring device comprises generating an electromagnetic field to induce an induction power field having a first frequency and wherein the step of detecting the emanated signal comprises receiving a signal having a second frequency from the monitoring unit.

23. The method according to claim 22 wherein the signal having a second frequency is an electromagnetic signal or an acoustic signal.

24. The method according to claim 17 wherein the monitoring device actively emits signals.

25. The method according to claim 24 wherein the signals are electromagnetic or acoustic signals.

26. The method according to claim 1 further comprising the step of sensing at least one parameter of the body lumen.

27. The method according to claim 26 further comprising the step of transmitting data of the sensed parameter.

28. The method according to claim 26 wherein the sensed parameters are selected from the group consisting of:

pH, pressure and temperature.

29. The method according to claim 1 wherein the step of monitoring the device comprises detecting a tag contained in the device.

30. The method according to claim 29 wherein the tag is selected from the group consisting of:

radioactive material, magnetized particles or a radio opaque material.

31. The method according to claim 30 wherein the step of detecting the tag comprises using a radioactive emission detector, a magnometer or an x-ray machine.

32. The method according to claim 1 wherein the step of monitoring the device comprises

releasing a marker from the device;

and

detecting the marker.

33. The method according to claim 32 wherein the marker is a dye.

34. The method according to claim 1 wherein the device comprises

a dissolvable body;

a dissolvable plug affixed to the body, said body and plug defining a closed receptacle;

an essentially impermeable outer coating enclosing the plug and body, said coating covering less than the entire plug.

35. The method according to claim 34 wherein the device further comprises a tag enclosed within the closed receptacle.

36. The method according to claim 34 wherein the body includes gelatin.

37. The method according to claim 34 wherein the plug includes a material selected from the group consisting of:

wax, lipophilic material of plant origin or hydrocarbons.

38. The method according to claim 34 wherein the outer coating includes parylene C.

39. The method according to claim 34 wherein the device further comprises a filler.

40. The method according to claim 34 wherein after the predetermined period the body and plug are dissolved and the outer coating is depleted.

41. The method according to claim 34 wherein the device further comprises an RFID tag.

42. A method for sensing a subject'"'"'s GI tract the method comprising the step of:

ingesting an in vivo sensing device, said device comprising a sensor, a transmitter for transmitting sensed data and an electronic ID tag.

43. The method according to claim 42 wherein the sensor is an image sensor.

44. The method according to claim 42 wherein the electronic ID tag is an RFID.

45. The method according to claim 42 wherein the device further comprises an internal power source.

46. A method for controlled release of at least one substance in a configurationally or clinically abnormal GI tract, the method comprising the step of:

ingesting a device, said device including the substance and the device comprising

a dissolvable body;

a dissolvable plug affixed to the body, said body and plug defining a closed receptacle; and

an essentially impermeable outer coating enclosing the plug and body, said coating covering less than the entire plug.

47. The method according to claim 46 wherein the substance is an active agent or a marker.

48. An in vivo imaging device comprising an image sensor, an illumination source, an internal power source and an electronic ID tag.

49. The imaging device according to claim 48 further comprising a transmitter for transmitting image data to an external receiving system.

50. An in vivo device for controlled release of at least one substance in a configurationally or clinically abnormal GI tract, the device comprising

the substance;

a dissolvable body;

a dissolvable plug affixed to the body, said body and plug defining a closed receptacle; and

an essentially impermeable outer coating enclosing the plug and body, said coating covering less than the entire plug.

51. The in vivo device according to claim 50 wherein the substance is enclosed in the receptacle.

52. The device according to claim 50 wherein at least a first substance is dispersed within the plug and at least a second substance is enclosed in the receptacle.

53. The device according to claim 50 wherein the substance is an active agent or a marker.

54. The device according to claim 50 further comprising an electronic ID tag.