Abstract
A method and a kit for the prevention of venous stenosis associated with the use of hemodialysis AV shunts. The kit may use a bifurcated needle for providing access to the shunt or blood vessel. One of the arms is used for returning the blood to the subject after dialysis treatment, while the other arm is used for inserting a device for cleaning the vein, the device being either an autonomous crawling device, or a passive tethered device moved down the vein by the blood flow. The autonomous crawling device may be a series of sequentially inflatable chambers, the stenosis being cleared by pressure from the outer walls of the chambers when inflated and moved. The passive device may be an element having a flexible disc-like structure, whose flexible peripheral edge slides along the inner walls of the blood vessel, compressing or clearing the material attached thereto.
Claims
1. A system for reducing dialysis shunt stenosis in a blood vessel of a subject, said system comprising: a deployable clearing device, adapted to move down said blood vessel; and a needle for insertion of said clearing device into said blood vessel of the subject; wherein said clearing device comprises: at least one cleaning element having a periphery of such a diameter that it contacts the walls of said blood vessel when deployed, said periphery further being adapted to contact said walls of said blood vessel as it moves therealong; and a tether attached proximally to said clearing device for withdrawing said device from said blood vessel, and wherein said clearing device has a stowed diameter sufficiently small that it can pass through the bore of said needle into the blood stream of the subject.
2. A system according to claim 1, wherein said cleaning element comprises at least one passage enabling continued flow of blood through said blood vessel when said device is disposed in said blood vessel.
3. A system according to any of the previous claims, wherein said deployable blood vessel clearing device comprises a locomotive system, by means of which said device moves down said blood vessel.
4. A system according to either of claims 1 and 2, wherein said deployable clearing device comprises at least one element shaped to be swept by the blood flow, such that said device moves down said blood vessel under the influence of said blood flow.
5. A system according to claim 1, wherein said clearing device comprises at least one inflatable chamber whose inflated diameter is such that its periphery applies pressure to said walls of said blood vessel when said at least one chamber is inflated.
6. A system according to claim 5, wherein said at least one inflatable chamber comprises a series of inflatable chambers connected by apertures of a predetermined cross section such that when fluid pressure is applied to the proximal one of said chambers, the chambers sequentially expand radially to the inner wall of the blood vessel and axially along the blood vessel.
7. A system according to claim 6, wherein at least some of said inflatable chambers have at least one region at which the outer surface does not touch said inner wall of said blood vessel when said chamber is inflated.
8. A system according to claim 7, wherein said regions are arranged at different angular locations around the periphery of different ones of said chambers
9. A system according to claim 1, wherein said cleaning element comprises at least one flexible disc-shaped element attached to a body, said flexible disc-shaped element having an outer diameter at least as large as the internal diameter of said blood vessel of said subject in the region where said stenosis is expected.
10. A system according to claim 9, wherein said clearing device further comprises threads attached to outer portions of said at least one flexible disc-shaped element, such that said at least one flexible disc-shaped element can be stowed onto said body by means of tension applied to said threads.
11. A system according to either of claims 9 and 10, where at least one of said flexible disc-shaped elements is constructed of a polymeric material.
12. A system according to any of the previous claims, wherein said cleaning element is drug eluting, said drug being a stenosis retarding drug.
13. A system according to any of the previous claims, wherein said needle is one entry arm of a bifurcated needle, such that the other entry arm is free for flowing blood into said blood vessel.
14. A system according to any of the previous claims, wherein said needle is a single bore needle, said system further comprising a second single bore needle for flowing blood into said blood vessel.
15. A method of reducing dialysis shunt stenosis in a blood vessel of a subject, said method comprising: providing a deployable clearing device, and a needle for insertion of said clearing device into said blood vessel of the subject, said clearing device comprising: at least one cleaning element having a periphery of such a diameter that it contacts the walls of said blood vessel when deployed and a stowed diameter sufficiently small that it can pass through the bore of said needle; and a proximally attached tether; inserting said clearing device into said blood vessel through said needle bore, such that it passes down said blood vessel and such that said periphery of said cleaning element contacts said walls of said blood vessel as it moves therealong; and withdrawing said device from said blood vessel by means of said tether.
16. A method according to claim 15, wherein said needle is inserted into said shunt upstream of a junction of said shunt with said blood vessel.
17. A method according to claim 15, wherein said needle is inserted into said blood vessel close to a junction of said shunt with said blood vessel.
18. A method according to any of claims 15 to 17, wherein said deployable clearing device comprises a locomotive system, further comprising the step of using said locomotive system to move said clearing device down said blood vessel.
19. A method according to any of claims 15 to 17, wherein said deployable clearing device comprises at least one element shaped to be swept by the blood flow, such that said device moves down said blood vessel under the influence of said blood flow.
20. A method according to any of claims 15 to 19, wherein said step of withdrawing said device from said blood vessel is executed after said clearing device has performed at least one passage down said blood vessel, and further including the step of using said tether to pull back said clearing device proximally after each forward passage.
21. A method according to claim 15, wherein said clearing device comprises at least one inflatable chamber whose inflated diameter is such that its periphery applies pressure to said walls of said blood vessel when said at least one chamber is inflated.
22. A method according to claim 21, wherein said at least one inflatable chamber comprises a series of inflatable chambers connected by apertures of a predetermined cross section, and comprising the further step of applying fluid pressure to the proximal one of said chambers, such that the chambers sequentially expand radially to the inner wall of the blood vessel and axially along the blood vessel.
23. A method according to claim 22, wherein at least some of said inflatable chambers have at least one region at which the outer surface does not touch said inner wall of said blood vessel when said chamber is inflated.
24. A method according to claim 23, wherein said regions are arranged at different angular locations around the periphery of different ones of said chambers
25. A method according to claim 15, wherein said cleaning element comprises at least one flexible disc-shaped element attached to a body, said flexible disc-shaped element having an outer diameter at least as large as the internal diameter of said blood vessel of said subject in the region where said stenosis is expected.
26. A method according to claim 25, wherein said clearing device further comprises threads attached to outer portions of said at least one flexible disc-shaped element, said method further comprising the step of applying tension to said threads such that said at least one flexible disc-shaped element can be stowed onto said body.
27. A method according to either of claims 25 and 26, where at least one of said flexible disc-shaped elements is constructed of a polymeric material.
28. A method according to any of claims 15 to 27, wherein said needle is one entry arm of a bifurcated needle, said method further comprising the step of flowing blood into said blood vessel through the other entry arm of said bifurcated needle.
29. A method according to any of claims 15 to 27, wherein said needle is a single bore needle, said method further comprising the step of flowing blood into said blood vessel through a second single bore needle.
30. A method according to any of claims 16 to 20, further providing the step of enabling the elution of a stenosis retarding drug from the periphery of said cleaning element, at least during passage through said blood vessel.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0039] The presently claimed invention will be understood and appreciated more fully from the following detailed description, taken in conjunction with the drawings in which:
[0040] FIG. 1 illustrates schematically the layout of the vasculature in the forearm of a subject, with an arterial-venous shunt installed;
[0041] FIG. 2 shows schematically illustrates an exemplary system as disclosed in this application, for the prevention of shunt stenosis;
[0042] FIGS. 3A and 3B show schematically a first exemplary implementation of the cleaning device, in the form of a self-propelled locomotion device;
[0043] FIG. 3C is an isometric view of the implementation shown in FIG. 3B, showing offset circumferential blood by-pass passages in successive balloons;
[0044] FIGS. 4A and 4B show schematically a second exemplary implementation of the cleaning device, using a single chamber balloon which is inflated from the trailing fluid inflation tube;
[0045] FIGS. 5A and 5B show schematically a further exemplary implementation of a blood flow transported cleaning device, using a flexible diaphragm disc to slide along the wall of the blood vessel;
[0046] FIG. 6 shows an enlarged view of the insertion point of a Y-needle having a slightly rounded inner edge to assist in withdrawal of the cleaning device; and
[0047] FIGS. 7A and 7B show an implementation of the cleaning device of FIGS. 5A and 5B, incorporating fine retraction threads attached to circumferential points of the discs to assist in withdrawal of the cleaning device.
DETAILED DESCRIPTION
[0048] Reference is now made to FIG. 1, which illustrates schematically the layout of the vasculature in the forearm of the subject, with an arterial-venous shunt 10 installed between an artery 12 and a vein 14, as is customarily done for a subject undergoing a course of hemodialysis treatment. The arrows in the blood vessels and in the shunt show the direction of blood flow. The needle for withdrawing blood for sending to the dialysis machine can either be inserted into the shunt 10 itself, or into the vein immediately after the point at which the shunt joins the vein 15. In FIG. 1 there are shown a deposit of unwanted lesion tissue 16 in the vein, downstream from the shunt-vein joining point, resulting from stenosis of the vein supposedly associated with the presence of the dialysis shunt. In many cases, this plaque deposits extends for a distance of 1 to 2 cm from the shunt-vein junction 15.
[0049] Reference is now made to FIG. 2, which illustrates schematically an exemplary kit for the prevention of shunt stenosis, as described in the present disclosure. The system comprises a Y-needle 20 having a needle cannula leg 21 with a sharp point for puncturing and inserting into a blood vessel, and two arms 22, 23 for input to the needle cannula leg. The Y-needle is adapted to be inserted into the shunt as shown in FIG. 2, though in certain cases it may be inserted into the vein close to the shunt junction. One free arm 22 of the Y-needle is used for attachment to the dialysis machine, for transferring cleaned blood from the machine to the patient. The other free arm 23 of the Y needle 20 is used for inserting the second component of the kit which is the cleaning device, to be shown in FIGS. 3A or 3B and 4A or 4B, used for ensuring that no unwanted tissue growth 16 builds up within the vein, or for removing plaque that has already built up there. The cleaning device is sent through the arm 23 of the Y needle 20, through the needle cannula leg 21, into the shunt and from there into the vein where the stenosis tissue buildup exists, or where the potential buildup is expected. The cleaning device has a tether lead attached to its rear (proximal) end, so that it can be removed back through the Y needle arm once the cleaning procedure has been completed, by pulling on the tether lead. This action can be done either manually, or by means of an automated winch (not shown) to enable the system to be automated for use by non-technical personnel, such as the patient him/herself.
[0050] Reference is now made to FIGS. 3A and 3B, which show a first exemplary implementation of the cleaning device, in the form of a self-propelled locomotion device 30 for passage through the needle and blood vessels, using a series of sequentially inflating balloons 32 connected by passages 33 having a predetermined flow rate for the fluid. The device is powered by an inflation line 34 trailing out behind the device which causes the balloons to inflate sequentially. Such a device has been previously described in the above referenced WO 2007-017876 International Patent Publication, herewith incorporated by reference in its entirety. In FIG. 3A, there is shown how the cleaning device 30 in its non-inflated form, has a diameter sufficiently small that it can pass through the bore of the Y-needle to gain access to the blood vessel 14 to be treated. By this means, a Y-needle of acceptable diameter, significantly less than that of the shunt or the blood vessels, can be used.
[0051] FIG. 3B now shows schematically how, once the cleaning device 30 has traversed the Y-needle cannula leg 21, it can then be actuated by application of fluid pressure to the inflation line 34, resulting in sequential inflation of the balloons of the device, such that they expand and contact the inner walls of the shunt or blood vessel, which generally have an inner diameter substantially larger than that of the Y-needle, and in addition, move in the forward direction as the balloons expand axially as well as radially. In the example shown in FIG. 3B, three 36 of the four balloons have inflated, and the most distal one 38 is about to inflate. Although the blood flow may tend to sweep the cleaning device into the vein by virtue of its high flow rate, it is more advantageous that the device proceed by means of the sequential balloon inflating technology, such that the outer skin of the inflated balloons reach the inner walls of the blood vessel, and exert pressure on the plaque 16, forcing it against the inner wall of the vein. The pointed probe 35 at the front of the clearing device can assist in opening up a passage in the case of severe plaque accumulation. In cases where no plaque yet exists, which, if the device is used at sufficiently close intervals, should generally be the case, then the very passage of the inflated balloons along the inner walls of the vein should prevent growth of the plaque tissue at an early stage. Once the device has proceeded beyond the point at which the plaque needs to be cleared, it can be retracted from the vein by pulling backwards on the inflation line 34, or on a separate tether line (not shown) attached to the rear of the device. Before passage back through the Y-needle, the inflation pressure must be released so that the balloons deflate and the small diameter deflated device can be withdrawn through the Y-needle passages. If the withdrawal of the cleaning device up to the needle is performed with at least one of the balloons inflated, then the sliding passage of the inflated balloon or balloons on the inner wall of the blood vessel may enhance the cleaning process that was performed during the stage when the cleaning device was crawling forward in the blood vessel. Alternatively, the cleaning device can be caused to crawl forwards and be pulled backwards several times to increase the efficiency of the clearing process.
[0052] Once the cleaning procedure has been completed, the cleaning device arm of the Y needle can be closed to prevent loss of blood, while dialysis continues through the other arm of the Y needle. In the isometric view of this implementation shown in FIG. 3C, circumferential blood by-pass passages 39 are shown in successive inflated balloons 36, to enable blood flow to continue even while the cleaning device is performing its function, with the outer surfaces of the balloon in contact with the inner walls of the blood vessel, except at the depressed by-pass channel regions 39. As shown in FIG. 3C, the passages may be disposed at different angular positions in different balloons such that the entire circumference of the inner wall of the blood vessel will be treated by pressure from one or other of the balloons.
[0053] Reference is now made to FIGS. 4A and 4B, which show an alternative exemplary implementation of the cleaning device 40, comprising one or more inflatable balloons 42, 44. In FIGS. 4A and 4B, unlike the previous implementations of FIGS. 3A and 3B, the cleaning device 40 is illustrated being inserted into the shunt and vein by means of a single needle 45, instead of a Y-needle, while another single needle 46 is used for returning the blood after dialysis. This is an alternative to the use of a Y-needle, and is applicable also to any of the exemplary implementations shown in this disclosure. The extraction of blood to the dialysis machine is performed through another needle, not shown in FIGS. 3A and 3B. As in FIGS. 3A and 3B, FIG. 4A shows the cleaning device being inserted undeployed through the needle, while FIG. 4B shows the cleaning device in its deployed form after inflation within the blood vessel to be cleared.
[0054] However this implementation differs from that of FIGS. 3A and 3B in that the cleaning device is a passive device which relies on the blood flow for transporting it to the region of the vein which is to be kept free of obstruction. The cleaning device of FIGS. 4A and 4B may comprise a single balloon (this implementation not being shown in the drawings) which is inflated from the trailing fluid inflation tube 34, or a series of two or more balloons 42, 44, linked by openings sufficiently large that the balloons inflate essentially simultaneously, and may be considered as a single double chambered balloon. The advantage of using more than one balloon is that if a surface blood by-pass channel is used, as shown in FIG. 3C, then two successive balloons can have their channels positioned in different circumferential positions, to ensure that every region of the inner wall of the vein is treated. As shown in FIG. 4A, the cleaning device 40 is inserted through the arm of the needle 45 while it is in a deflated configuration. Once it is out of the needle bore and in the shunt or vein region, the balloons 42, 44, can be inflated by means of the fluid inflation tube 34, as shown in FIG. 4B and the inflation tube can be paid out to allow the inflated balloon device 40 to be swept downstream by the blood flow. It can then be pulled backwards and allowed to be swept forward over the region where plaque formation is to be found, or is expected to be formed, with or without repeated inflation and deflation in that region, thereby cleaning or maintaining the region free of obstruction. When the cleaning device is to be removed from the blood vessel, it is deflated, or even has suction applied to the inflation tube 34 to collapse the balloon or balloons completely such that they can withdrawn through the needle bore again.
[0055] Another implementation which relies on the blood flow for transporting it to the region of the vein to be cleared is shown in FIGS. 5A and 5B. This implementation utilizes a cleaning device body 50 having one or more flexible flaps shaped in the form of discs 52 attached to the body 50, and which can slide against the inner wall of the blood vessel, ensuring that no stenotic tissue can grow there, and removing any which has already deposited there. As is shown in FIG. 5A, the cleaning device can advantageously be inserted through the Y-needle with the flexible discs 52 folded inwards and rearwards, such that they can traverse the comparatively small bore of the Y-needle. As now shown schematically in FIG. 5B, once through the Y-needle and in the wider diameter shunt or blood vessel, the flexible disc or discs 52 can open to their deployed size, making contact with the inner wall of the blood vessel. One advantageous implementation involves a circular disc structure, with the disc or discs of slightly larger diameter than the inner diameter of the blood vessel, such that they cannot open to a direction normal to the device axis, but form an umbrella or a parachute like structure. The inner volume formed by the angled discs are angled in the direction such that the flow of blood fills that volume and sweeps the device in the direction of the flow by filling the hollow disc structure and applying a hydraulic locomotive force to the cleaning device. The cleaning action itself may be more effective when the cleaning device is retracted in the reverse direction by means of its tether line 54, since during such a backward motion, the circular disc structure tends to be pushed open and to slide along the walls of the vein through which it is being pulled. The disc structure should be constructed of a sufficiently flexible and soft material, such as a pliable polymer material, such that it can fold up compactly when being inserted through the Y-needle or removed, and also so that it does not do any damage to the walls of the vein while it is sliding along the walls. Although the implementation of FIGS. 5A to 7B show only a single diaphragm disc attached to the body 50, it is to be understood that the invention can also be performed using a body with multiple serially disposed diaphragm discs on it.
[0056] As in the case of the inflated balloon implementation shown in FIGS. 3A and 3B, it may be advantageous to have openings made in the discs so that the blood flow can continue even when the cleaning device is operating in the vein. Because of the simpler structure of this implementation, the opening may be made anywhere in the disc, and advantageously away from the edges, such that the edges slide along the inner wall of the vein around the whole circumference of the disc. Alternatively a number of discs may be used each with a circumferential passageway angularly rotated relative to its neighboring discs, so that the cleaning efficiency is not reduced.
[0057] When withdrawing the device, once the pointed tip of the needle cannula leg 21 of the Y-needle is reached, the discs need to be folded inwards again in order to enter the smaller bore of the Y-needle. If the disc can be made sufficiently strong and sufficiently thick that the sharp edge of the needle point does not cut it off, then the cleaning device can simply be pulled back through the needle, and will fold over in the reverse direction to its deployed direction in the vein. A slightly rounded inner edge 60 to the insertion leg 21 of the needle may assist in this process, as shown in FIG. 6. Alternatively, as shown in FIGS. 7A showing the cleaning device deployed in a vein 14, and FIG. 7B, showing the cleaning device stowed in the needle leg 21, fine retraction threads 70 could be attached to circumferential points of the discs, like parachute cords, in order to pull the circumferential lips of the discs inward to the size of the needle bore, so that the cleaning device can be stowed at a size sufficiently small for extraction through the needle.
[0058] In any of the above described implementations, the cleaning device can be equipped with a drug eluting component, designed to retard or even prevent the stenosis growth in the blood vessel. The drug elution may advantageously be performed from the peripheral regions of the cleaning device, so that the drug has intimate contact with any stenosis tissue growth along the walls of the blood vessel.
[0059] It is appreciated by persons skilled in the art that the present invention is not limited by what has been particularly shown and described hereinabove. Rather the scope of the present invention includes both combinations and subcombinations of various features described hereinabove as well as variations and modifications thereto which would occur to a person of skill in the art upon reading the above description and which are not in the prior art.
