Method and apparatus for extending a tube

• US 9,661,992 B2
• Filed: 04/04/2013
• Issued: 05/30/2017
• Est. Priority Date: 04/28/2010
• Status: Active Grant

• Current Assignee: Torus Medical Ltd.
• Original Assignee: Torus Medical Ltd.
• Inventors: Levin, Boris, Lerner, Vlad, Ulanovsky, Levy
• Primary Examiner(s): NEAL, TIMOTHY JAY
• Application Number:
  US13/856,695
• Publication Number:
  US 20130289350A1
• Time in Patent Office: 1,517 Days
• Field of Search: 600109, 600114, 600116, 600127, 600139, 600144, 600155, 600156, 60410101, 60410102, 60410103, 60410305, 604104
• CPC Class Codes: A61B 1/00151 using everted tubes
• CPC Class Codes: A61B 1/005 Flexible endoscopes
• CPC Class Codes: A61B 1/015 Control of fluid supply or evacuation
• 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 25/0119 Eversible catheters
• CPC Class Codes: A61M 3/0241 the liquid being supplied by gravity
• CPC Class Codes: A61M 3/0279 Cannula; Nozzles; Tips; their connection means
• 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
• CPC Class Codes: A61M 3/0295 with inflatable balloon

Abstract

Apparatus and methods for extending a tube, the apparatus including a foldable tube having a folded portion inside an unfolded portion of the tube, and a source of fluid coupled to the unfolded portion for providing fluid into the unfolded portion to unfold and extend the folded portion out of the unfolded portion to become an extension of the unfolded portion. The apparatus and methods are useful, inter alia, for cleansing the colon in the normal direction, that is, from the cecum to the anus, using an apparatus that is introduced via the anus. A washing liquid is supplied deep into the colon via the soft feed tube that is inserted via the anus and is extended into the colon by inflation. The washing liquid is then drained out via the anus through a drainage channel.

Claims

1. An endoscopic apparatus reversibly insertable into a curved lumen of a patient, said apparatus comprising:

a flexible sleeve having a length, a proximal end, a distal end, and a longitudinal axis;

said distal end of said flexible sleeve comprising;

a folded sleeve portion having a length L_fold;

a compact folded portion enclosed within said folded sleeve portion such that a single topologically cylindrical sleeve is provided;

said compact folded portion comprising a spiral structure in which at least a part of said flexible sleeve portion has been rolled from said distal end about an axis of rotation and rotated so that said axis of rotation is parallel to said longitudinal axis, such that when said sleeve is inflated by fluid, said compact folded portion partially unfolds and everts radially from said folded sleeve portion; and

an unfolded sleeve portion connecting said compact folded portion to said folded sleeve portion;

said unfolded sleeve portion having a length L_unfold that increases as at least a portion of said compact folded portion unfolds and everts when said sleeve is inflated by fluid;

wherein;

when in use, said folded sleeve portion extends distally when at least a portion of said compact folded portion unfolds and everts;

said eversion is provided so as to increase said unfolded sleeve portion length L_unfold and such that when in use said folded sleeve portion self-navigates within said curved lumen when said sleeve is inflated by fluid; and

said unfolded sleeve portion substantially stays stationary when said sleeve is inflated by fluid.

2. The endoscopic apparatus according to claim 1, wherein said length L_fold remains substantially the same when fluid is introduced into said folded sleeve part so as to evert and unfold at least a portion of said compact folded portion as said compact folded portion advances within said curved lumen, such that longitudinal shearing forces between (a) at least one selected from a group consisting of (i) said folded sleeve portion, (ii) said unfolded sleeve portion, and (iii) any combination thereof;

and (b) said curved lumen is mitigated so as to enable advancement of said folded sleeve part within said curved lumen.

3. The endoscopic apparatus according to claim 1, wherein at least one of the following is true:

said length L_fold remains substantially the same when fluid is introduced into said folded sleeve portion and said compact folded portion unfolds and everts;

said length L_unfold increases as at least a portion of compact folded portion unfolds and everts,

such that longitudinal shearing forces between (a) at least one selected from a group consisting of (i) said folded sleeve, (ii) said unfolded sleeve portion, and (iii) any combination thereof; and

(b) said curved lumen is mitigated.

4. The endoscopic apparatus according to claim 1, wherein said unfolding of at least a portion of said compact folded portion is configured to have an unfolding function Y calculated as a ratio L_unfold/L_fold as a function of time t, Y(t) represented by at least 2 regions:

at least one first region 0<

t<

x1;

in which said Y(t) substantially equals 1;

at least one second region t>

x1;

in which said Y(t) is greater than 1.

5. The endoscopic apparatus according to claim 1, additionally comprising fluid input means, in fluid communication with said folded sleeve portion, for introducing fluid into said folded sleeve portion so as to unfold at least part of said compact folded portion;

further wherein said fluid is selected from a group consisting of gas, liquid and any combination thereof.

6. The endoscopic apparatus according to claim 1, additionally comprising an inflating tube, coupled to said unfolded sleeve portion, adapted to inflate at least a portion of said compact folded portion;

further wherein said tube is adapted to deflate said flexible sleeve for withdrawal of the same from said curved lumen.

7. The endoscopic apparatus according to claim 1, wherein said apparatus is adapted for cleansing a colon of a patient, such that said curved lumen is the gastrointestinal tract.

8. The endoscopic apparatus according to claim 1, wherein at least one of the following is true

said folded sleeve portion has a constant cross section along a length of the folded sleeve portion;

said folded sleeve portion has a cross section that is variable along a length of the folded sleeve portion;

at least a part of said folded sleeve portion has a cross-section that is quasi-periodically variable along the length of folded sleeve portion;

at least a part of said folded sleeve portion has a shape selected from the group consisting of a sausage-chain, a bead-string and any combination thereof; and

any combination thereof.

9. The endoscopic apparatus according to claim 1, wherein said flexible sleeve additionally comprises at least one aperture configured to allow exit and outflow of cleansing fluids.

10. The endoscopic apparatus according to claim 1, additionally comprising a removable cap adapted to ease the insertion of said flexible sleeve into said lumen;

further wherein said removable cap is filled with water, made of a material that will melt, soften, dissolve or any combination thereof upon being inserted into said lumen and comprises several segments, each of which is small enough to be pulled back through said flexible sleeve with a flow of liquid.

11. The endoscopic apparatus according to claim 1, wherein at least one of the following is true:

said flexible sleeve is made of materials selected from the group consisting of polyethylene, low density polyethylene, polypropylene, polyurethane and any combination thereof; and

said flexible sleeve is designed and constructed so as to enable the insertion of an object selected from the group consisting of an endoscope, a camera, a detachable capsule, a source of radiation, a source of light, a source of X-rays, a source of positrons, a source of other radioactivity, and any combination thereof into said flexible sleeve.

12. The endoscopic apparatus according to claim 11, wherein at least one of the following is true:

said object is coupled directly to said flexible sleeve;

said object is introduced into said flexible sleeve after the same has been fully extended within said lumen; and

said object is configured to be introduced into said flexible sleeve while the flexible sleeve is not fully extended within said lumen, such that said object advances with said flexible sleeve.

13. The endoscopic apparatus according to claim 1, wherein at least one of the following is true:

said flexible sleeve has at least one wider section adapted to spread the wall of said lumen so as to enable visual examination of the said lumen;

a plurality of cameras are coupled to at least one location of said flexible sleeve;

a plurality of cameras are interdisposed within said flexible sleeve;

said flexible sleeve is configured to admit at least one contrast agent adapted for medical imaging of said lumen, said at least one contrast agent being selected from the group consisting of barium sulfate, water soluble contrast agents and any combination thereof;

said flexible sleeve is configured to introduce at least one medication into said lumen; and

said flexible sleeve is adapted to massage at least a part of the wall of said lumen.

14. The endoscopic apparatus according claim 1, wherein at least one selected from a group consisting of said folded sleeve portion, said unfolded sleeve portion and any combination thereof additionally comprises at least one element selected from the group consisting of at least one camera adapted to provide either 2D or 3D real time images, an ultrasound sensor, a source of ultrasound, a radiation sensor, a source of radiation and any combination thereof.

15. The endoscopic apparatus according to claim 1, comprising a piston disposed within said flexible sleeve and configured to be propelled inside said flexible sleeve by pressure of a fluid being pumped thereinto.

16. The endoscopic apparatus according to claim 15, wherein at least one of the following is true:

said piston is coupled to an object; and

said piston is in communication with an object.

17. The endoscopic apparatus according to claim 16, wherein at least one of the following is true:

said object is selected from the group consisting of at least one endoscope, a camera adapted to provide either 2D or 3D real time images, an ultrasound sensor, a source of ultrasound, a radiation sensor, a source of radiation and any combination thereof;

said object is a camera adapted to take images for visual inspection of space around said camera either upon recording said image or in real time while said flexible sleeve is being withdrawn from said lumen, and said flexible sleeve comprises at least one opening through which said camera has a view unobstructed by said flexible sleeve.

18. The endoscopic apparatus according to claim 1, additionally comprising:

a drainage channel adapted for insertion into said lumen and configured to drain washing fluid out of said lumen through said drainage channel, said flexible sleeve being disposed inside and extending through said drainage channel and said lumen; and

optionally, at least one inflatable balloon inflated inside said lumen and coupled to said drainage channel;

wherein said inflated balloon together with said drainage channel are configured to maintain said drainage channel in position and prevent any unwanted movements.

19. The endoscopic apparatus according to claim 1, additionally comprising a delivery tube having a distal end and a proximal end interconnected to one another by a hollow bore, said delivery tube fluidly connectable at its distal end to said proximal end of said flexible sleeve;

wherein said delivery tube is removably attachable to said proximal end of flexible sleeve.

20. The endoscopic apparatus according to claim 19, additionally comprising at said distal end of said delivery tube, an attachment means for attaching said distal end of said delivery tube to said proximal end of said flexible sleeve;

said attachment means being selected from the group consisting of;

an elastic band, an elastic tie, a ribbon, a tape, a catch, a clip and any combination thereof.

21. The endoscopic apparatus according to claim 20, additionally comprising a flange located at said distal end of said delivery tube, said flange is unitary with said distal end of said delivery tube, said distal end wider than said proximal end.

22. The endoscopic apparatus according to claim 21, wherein the shape of said flange is selected from the group consisting of substantially conical, substantially spherical, substantially ellipsoidal, substantially ovoid, substantially hyperboloid, and any combination thereof.

23. The endoscopic apparatus according to claim 22, wherein the diameter of said flange is in the range of approximately 2 times the diameter of said delivery tube to approximately 5 times said diameter of said delivery tube;

further wherein said hollow bore is adapted to deliver at least one fluid to unfold and evert at least a portion of said compact folded portion.

24. The endoscopic apparatus according to claim 23, wherein said fluid is selected from the group consisting of:

a liquid selected from the group consisting of saline, water, washing liquid, sodium phosphate, baking soda solution, solutions of barium compounds, mineral oil, glycerin, laxatives, medicaments, and any combination thereof;

a gas being selected from the group consisting of air, nitrogen, oxygen, CO₂, xenon and any combination thereof; and

any combination thereof.

25. A method of extending a tube within a curved lumen, the method comprising steps of:

obtaining an apparatus comprising a flexible sleeve having a length, a proximal end, a distal end, and a longitudinal axis;

said distal end of said flexible sleeve comprising;

a folded sleeve portion having a length L_fold;

a compact folded portion enclosed within said folded sleeve portion such that a single topologically cylindrical sleeve is provided;

said compact folded portion comprising a spiral structure in which at least a part of said flexible sleeve portion has been rolled from said distal end about an axis of rotation and rotated by 90°

so that said axis of rotation is parallel to said longitudinal axis, such that when said sleeve is inflated by fluid, said compact folded portion partially unfolds and everts radially from said folded sleeve portion; and

an unfolded sleeve portion connecting said compact folded portion to said folded sleeve portion;

said unfolded sleeve portion having a length L_unfold that increases as at least a portion of said compact folded portion unfolds and everts when said sleeve is inflated by fluid;

inserting said flexible sleeve into said lumen;

introducing a fluid into said folded sleeve portion, thereby unfolding and everting said at least a portion of said compact folded portion; and

extending said flexible sleeve within said curved lumen.

26. The method according to claim 25, wherein said length L_fold remains substantially the same when fluid is introduced into said folded sleeve part so as to evert and unfold at least a portion of said compact folded portion as the same advances within said curved lumen, such that longitudinal shearing forces between (a) at least one selected from a group consisting of (i) said folded sleeve part, (ii) said unfolded sleeve portion, and (iii) any combination thereof;

and (b) said curved lumen is mitigated so as to enable advancement of said folded sleeve part within said curved lumen.

27. The method according to claim 25 wherein at least one of the following is true:

said length L_fold remains substantially the same when fluid is introduced into said flexible folded sleeve part casing and said compact folded portion unfolds and everts;

said length L_unfold increases as at least a portion of compact folded portion unfolds and everts,

such that longitudinal shearing forces between (a) at least one selected from a group consisting of (i) said folded sleeve casing, (ii) said unfolded sleeve portion, and (iii) any combination thereof; and

(b) said curved lumen is mitigated.

28. The method according to claim 25, additionally comprising providing a delivery tube removably attachable to said proximal end of flexible sleeve, having a distal end and a proximal end interconnected to one another by a hollow bore, said delivery tube fluidly connectable at its distal end to said proximal end of said flexible sleeve.