COLONIC CLEANSING DEVICE

• US 20120253284A1
• Filed: 04/04/2012
• Published: 10/04/2012
• Est. Priority Date: 01/31/2007
• Status: Active Grant

• Current Assignee: Jet Prep Ltd.
• Original Assignee: Jet Prep Ltd.
• Inventors: DUBI, Shay, NITSAN, David
• Granted Patent: US 8,652,102 B2
• Time in Patent Office: Days
• US Class Current: 604/150
• CPC Class Codes: A61B 1/31 for the rectum, e.g. proctoscopes, sigmoidoscopes , colonoscopes
• CPC Class Codes: A61M 1/77 Suction-irrigation systems aspiration tips supplying fluids A61M1/85; specific for negative pressure wound therapy A61M1/92; combined with tracheal tubes A61M16/0463
• CPC Class Codes: A61M 3/0283 with at least two inner passageways, a first one for irrigating and a second for evacuating suction-irrigation systems A61M1/77; aspiration tips with fluid supply means A61M1/85; for negative pressure wound therapy A61M1/92

Abstract

The present invention may provide devices suitable for insertion into a body passage. The devices may include a conduit and a distal head region located at the distal end of said conduit. A plurality of apertures on the surface of said head region and conduit may be used to direct a liquid spray outwards from said device. The apertures may be designed and spatially arranged such that when the device is inserted into a body passage, the liquid spray emitted from said apertures may be capable of both reducing the frictional contact between the device and the walls of said passage and of cleansing said passage of undesired solid and other particulate matter.

Claims

1. A device suitable for insertion into a body passage, comprising a conduit and a distal head region located at the distal end of said conduit,

wherein said conduit and said distal head region comprise at least one common internal lumen,

wherein said at least one common internal lumen is in fluid communication with a plurality of apertures that are located on the external surface of both the conduit and distal head region,

wherein at least some of the apertures in the conduit and distal head region are adapted such that a fluid pumped through said at least one lumen in a proximal-to-distal direction would exit said apertures in the form of a jet spray.

2. The device according to claim 1, wherein said jet spray apertures are spatially arranged such that if the device were to be placed in a body passage and a jet spray caused to exit said jet spray apertures, said device would be caused to have minimal contact with the walls of said body passage.

3. The device according to claim 2, wherein the jet spray apertures are arranged in a symmetrical manner around the circumference of an imaginary transverse section of said device.

4. The device according to claim 2, wherein the jet spray apertures are arranged such that at least one of said apertures is to be found in each of the four quadrants of the circumference of an imaginary transverse section of said device.

5. The device according to claim 1, wherein at least some of the apertures in the conduit and distal head region are capable of aspirating a liquid situated external to said device upon connection of a negative pressure source to the one or more lumens connected to said apertures.

6. The device according to claim 1, further comprising mechanical cleaning elements attached to the conduit and/or distal head region.

7. The device according to claim 6, wherein the mechanical cleaning elements are selected from the group consisting of discs, brushes, disc brushes, bristles and fabric strips.

8. The device according to claim 1, further comprising guiding means for changing the spatial location of the distal head region.

9. The device according to claim 8, wherein the guiding means comprises one or more wires attached to the distal head region.

10. The device according to claim 1, wherein said device comprises two internal lumens.

11. The device according to claim 1, further comprising one or more cameras attached to its external surface.

12. The device according to claim 1, further comprising an internal lumen containing an optical fiber bundle.

13. The device according to claim 1, further comprising a working channel.

14. The device according to claim 1, wherein the apertures are located in the distal head region and along the entire length of the conduit.

15. The device according to claim 1, wherein the apertures are located in the distal head region and at least 20% of the length of the conduit.

16. A method for cleansing the lumen of a body passage in a mammalian subject, comprising the steps of:

a) introducing a device according to any of the previous claims into said body passage;

b) connecting a pressurized cleaning fluid supply and negative pressure source to the proximal end of the conduit of said device, such that fluid jet spray exiting the jet spray apertures cause the distal head region and at least part of said conduit to hover within the body passage lumen with minimal contact with the walls therefore, and such that said fluid jet spray causes displacement, dislodgement, disintegration and/or dissolution of solid matter present within said body passage, and such that the jet spray liquid and solid and particulate matter within said body passage is removed from the lumen thereof by aspiration through at least some of the apertures in said device;

c) applying manual pushing and pulling forces to the proximal end of the conduit such that said device advances distally within said body passage;

d) optionally performing further procedures within the body cavity,

e) removing said device from said body passage.

17. The method according to claim 16, wherein the optionally-performed procedures are selected from the group consisting of tissue biopsy, surgical removal of polyps and other lesions, capture of video and still images of the colonic wall and lumen, and guiding the distal head region towards selected portions of the colonic wall in order to increase cleansing efficiency.

18. A method for cleansing the lumen of a body passage in a mammalian subject, comprising the steps of:

a) inserting an endoscope into said body passage;

b) inserting a device according to claim 1, into the working channel of the colonoscope;

c) advancing said device through said working channel until the distal head thereof exits the distal end of said working channel, by means of manual pushing and pulling, and optionally by means of connecting the pressurized cleaning fluid supply and negative (suction) pressure source to the conduit of the device, such that the head region and at least part of the conduit are caused to float or hover within the working channel of the colonoscope, thereby significantly reducing frictional contact between the device and the walls of said working channel during the advancement of the device;

d) cleaning the region of the colon that is adjacent to the distal head region and portion of the conduit that has exited the distal end of the working channel of the colonoscope, using the fluid jets and suction created by that region of the device;

e) advancing the colonoscope distally to a new region of interest;

f) repeating steps (c) to (e), as required;

g) removing said device from said body passage.

19. The method according to claim 16, wherein the body passage is the colon.

20. The method according to claim 16, wherein said method is used prior to a colonoscopic procedure.

21. A system for colonic cleansing comprising:

a) a device according to claim 1,

b) a pump suitable for causing said cleaning fluid to pass distally through one or more lumens of said device and to exit through a plurality of jet spray apertures;

c) a negative pressure source; and

d) optionally further comprising a user interface for controlling the operation of said device, said pump and said negative pressure source.