BYPASS CATHETER

Abstract

An innovative medical device that permits rapid, minimally invasive restoration of blood flow across a vascular blockage. A system allowing for lysis or removal of said blockage. Said device creates a temporary bypass using longitudinal structure configured for insertion into the blood vessel and adapted to deliver a side hole to a target area. The side hole defines a distal first segment and a proximal second segment with a lumen to allow blood flow therethrough to at least one distal end hole. Said device includes at least one semi-permeable membrane which may act as a filter that located circumferentially around outer surface of at least one of said device segments. In an alternate embodiment, a slidable outer sheath can cover the side hole to permit reversal of blood flow from the distal end hole to a proximal end hole located outside a patient's body by means of an aspiration controller. Alternate embodiments include an optional anchoring balloon, a macerating stent or wires, perforations for fluid delivery, and a backflow valve.

Claims

1-9. (canceled)

10. A catheter for bypassing a blocked vessel, comprising: (a) an outer wall having a side hole adapted for positioning at a location upstream of a target area; b) a lumen; (c) a proximal hole positioned proximally of the side hole; (d) a distal hole positioned distally of the side hole and in communication with the proximal hole via the lumen, the side hole adapted for passage of blood from upstream of the target area the distal hole, (e) an expandable semi-permeable filter positioned at a distal region of the catheter and configured to block flow of debris; and (e) a macerating element extending from the catheter and rotatable to remove clot, the macerating element positioned distal of the side hole and proximal of the distal hole.

11. The catheter of claim 10 further comprising a valve positioned in the catheter to prevent blood entering the side hole from flowing proximally, the valve positioned proximally of the side hole.

12. The catheter of claim 11, wherein the valve is closable by a user.

13. The catheter of claim 10, wherein the lumen defines a first diameter in a first segment of the catheter and a second diameter in a more proximal second segment of the catheter, wherein the second diameter is less than the first diameter to restrict backflow of blood into said second segment.

14. The apparatus of claim 10, further comprising at least one perforation disposed in the outer wall of the catheter between the side hole and distal hole for injection of fluid to dissolve or alter the composition of the blockage.

15. The apparatus of claim 14, wherein the catheter further comprises a second lumen communicating with the perforation to deliver the fluid to the clot.

16. The apparatus of claim 10, wherein the macerating element comprises at least one macerating loop.

17. The apparatus of claim 10, wherein a portion of the catheter has a sinusoidal shape.

18. The apparatus of claim 10, further comprising an inflatable balloon to block flow during maceration.

19. The apparatus of claim 10, wherein the lumen is in communication with a source of pressurized fluid to inject pressurized fluid through the lumen to prevent backflow of blood which entered the side hole.

20. The catheter of claim 10, wherein the outer wall has a groove formed therein and the filter is positioned within the groove.

21. The catheter of claim 10, wherein the filter is not affixed to the catheter such that rotation of the catheter does not rotate the filter

22. The catheter of claim 10, wherein the filter is affixed to the catheter such that rotation of the catheter rotates the filter.

23. The catheter of claim 10, further comprising a valve to actively close the side hole to enable aspiration solely through the distal hole.

24. The catheter of claim 10, further comprising a second filter positioned proximal of the side hole.

25. The apparatus of claim 10, further comprising a balloon disposed between the side hole and the proximal hole of the catheter, wherein blood enters the side hole distal of the balloon.

26. The apparatus of claim 10, wherein the catheter is configured such that blow flow into the side hole and distally in the lumen exits exclusively through the distal hole such that the distal hole provides a sole exit opening for blood entering the lumen through the side hole.

27. The apparatus of claim 10, further comprising an outer support sheath for covering the side hole to close the side hole, wherein closing of the side hole redirects blood flow proximally through the distal hole out the proximal hole.

28. The apparatus of claim 10, further comprising a second concentric lumen, wherein the at least one perforation communicates with an area between an internal surface of the second concentric lumen and an outer surface of the lumen for blood flow.

29. The apparatus of claim 10, wherein the lumen in a proximal segment of the catheter is smaller than the distal hole.

Description

[0038] The invention will be better understood and objects other than those set forth above will become apparent when consideration is given to the following detailed description thereof. Such description makes reference to the annexed drawings+wherein:

[0039] FIG. 1 is a side view of the basic embodiment of the current invention.

[0040] FIG. 2 is a side view of the current invention showing the inner segment with dashed lines.

[0041] FIG. 3 depicts the first segment of the current invention connected to a pressurized fluid column.

[0042] FIG. 4 is a side view of the current invention with perforations allowing infusion of medication from the proximal end.

[0043] FIG. 5 depicts an alternative embodiment of the current invention.

[0044] FIG. 6A depicts a segment with groove

[0045] FIG. 6B depicts the segment of FIG. 6A, with a semi-permeable membrane positioned circumferentially within the groove of said segment.

[0046] FIG. 6C depicts multiple, semi-permeable membranes positioned circumferentially within grooves scored into the first segment and second segment.

[0047] FIG. 7 depicts a side view of an embodiment of the current invention having a branched first segment, and semi-permeable membranes located at each distal end hole.

[0048] FIG. 8A is a perspective view of the semi-permeable filter of the current invention in an expanded state deployed within the vessel wall at the distal end hole.

[0049] FIG. 8B is a perspective view of the semi-permeable filter of the current invention in an undeployed state positioned at the distal end hole.

DETAILED DESCRIPTION OF THE INVENTION

[0050] The present invention combines elements of three prior inventions by Walzman, namely a temporary bypass catheter and balloon, a single lumen support catheter, and the rotating irrigating and aspirating thrombectomy device as well as at least one semi-permeable membrane which may act as a filter that is located and may be circumferentially positioned in a groove scored within, or to the outside of at least one segment of the current invention.

[0051] The current invention is composed of a catheter with at least one distal end hole, at least one bypass window proximal to said end hole and at least one semi-permeable membrane which may act as a filter that located circumferentially within a groove, or around outer surface of at least one segment of the current invention. The present invention is capable of deploying said catheter across a blockage in a vessel.

[0052] The temporary balloon element, when present on the bypass catheter, is composed of a catheter with at least one distal end hole, at least one bypass window proximal to said end hole and a balloon element between said end hole and said bypass window. The present invention is capable of deploying said balloon element, before inflation, across a blockage in a vessel.

[0053] In the present invention, blood flows into the side hole and out one or more distal end hole(s). The present invention introduces a novel combination of either or both of two previously disclosed structures: a branching element and a filtering element. These structures can be used independently or in concert depending upon the specific medical need. In the preferred embodiment, a second segment (6) is attached to a first segment (5) with an optional valve (3) located at or near the point where first segment (5) joins second segment (6). A side hole (2) is located more closely to end hole or holes (4) than the optional valve (3). The branching elements are located closer to the end hole (4) than to side hole (2). Semi-permeable membranes (9), which can take the form of umbrellas, are attached to the outside of the end hole (4) and extend from the outside of end hole (4) circumferentially until they abut the vessel wall into which the device has been inserted. The preferred embodiment also contains perforations (30) on first segment (5), including branches, which allow medication to be expelled in a target area or areas. Said perforations (30) are fed from outside the body through second segment (6) to first segment (5).

[0054] Once the present invention is properly positioned, side hole (2) will be positioned to receive blood flow from a source located upstream from a blockage, and end holes (4) positioned downstream from the target blockage, the perforations (30) positioned upstream, downstream and at the blockage. Once positioned, the present invention would allow blood to flow into the side hole (2), out of the end hole(s) (4), and allow medications introduced through second segment (6) to be delivered through perforations (30) to allow said medications to interact with the target blockage. The present invention alternatively may include a second lumen through second segment (6) which communicates from outside the patient's body through perforations (30).

[0055] Referring now to FIG. 1, the current invention (1) there is a distal end hole (4) and a side hole (2) disposed upon the outer diameter of the device (1) of the current invention at the juncture of first segment (5) and second segment (6). Side hole (2) defines the end of second segment (6) through proximal end hole (7) from first segment (5) through distal end hole (4). The outer diameter of first segment (5) and second segment (6) are the same in some but not all embodiments. At least one semi-permeable membrane (9) is shown positioned on the first segment (5) between side hole (2) and balloon (8). It should be noted that membrane (9) is positioned on a segment at interface location (91). Interface location (91) may be groove (90) or the outer circumference of either first segment (5) or second segment (6).

[0056] The bypass catheter device (1) of the current invention is introduced through an incision in a patient's vessel and often directed to a target site by means of standard endovascular techniques, with the aid of wires and/or other delivery catheters, often under fluoroscopic guidance.

[0057] Returning to FIG. 1, first segment (5) is used to anchor device (1) so as to position side hole (2) at the desired location. Optionally, first segment (5) may be attached to a balloon (8) which, upon inflation, further anchors device (1) of the current invention in the desired position.

[0058] The present invention is positioned such that side hole (2) is positioned to accept blood flow from the patient and direct the blood through first segment (5) out through distal hole (4), bypassing said blood flow past a blockage. The current invention prevents backflow of blood in three ways, or any combination thereof.

[0059] FIG. 1 illustrates an embodiment employing valve (3) disposed at the juncture of second section (6) with side hole (2). In this embodiment, once the device (1) of the current invention is positioned in the desired position, valve (3) is closed by the user to prevent blood entering side hole (2) from flowing back into said second segment (6). The blood is thereby directed through first segment (5), through and out end hole (4), and allowed to perfuse the at risk tissue.

[0060] In an alternative embodiment better depicted in FIG. 2, the inner diameter (10) of second segment (6) is less than the inner diameter of first segment (5). Inner diameter (10) terminates at inner hole (11). Inner hole (11) is smaller than distal end hole (4). The differential acts to constrict backflow and direct blood through first segment (5) to and out end hole (4).

[0061] In a preferred embodiment, a valve (3) and a reduced inner diameter (10) and inner hole (11) are employed to constrict backflow of blood.

[0062] In a still further embodiment depicted in FIG. 3, pressurized fluid may be introduced into second segment (6) to prevent the backflow of blood. FIG. 3 depicts device (1) of the current invention connected to pressurized fluid bag (12) interfacing with proximal end hole (7). Proximal end hole (7) communicates with second segment (6) through to first segment (5). Said pressurized fluid bag (12) may be connected to a flow regulator which is outside the patient's body to allow the user of the current invention to control flow of fluid through the second segment (6).

[0063] In another embodiment, pressurized fluid may be used in conjunction with valve (3) and/or inner hole (11) to prevent backflow of blood. In a still further embodiment, pressurized fluid, valve (3) and differential inner diameter (10) and inner hole (11) may be used concurrently.

[0064] As shown in FIG. 4, first segment (5) may optionally be perforated with at least one perforation (30). Perforations (30) are end holes for a lumen which extends from said perforations (30) and communicating with a separate irrigation channel (not shown) disposed at proximal end hole (7) and in communication with an additional controller (not shown). The fluid typically introduced into the separate channel exiting perforations (30) is designed to dissolve vessel-clogging material. For example, the fluid may be a lytic such as Alteplase, which dissolves blood clots. Said additional controller is capable of sending medication from said additional controller through communicating lumen and out perforations (30) to facilitate the irrigation of clots near first segment (5). Said medication has the capability of softening and/or changing the chemical makeup of clots proximal to perforations (30) for purposes of dislocating and/or dissolving said clot(s) or other blockage. In an alternate embodiment, the present invention device (1) is composed of co-centric lumens wherein perforations (30) communicate with the area between the internal surface of the outer lumen and the outer surface of the inner lumen, said gap extends from perforations (30) to proximal end hole (7) and communicates with said additional controller, allowing medication to be pumped from said additional controller through the area between the internal surface of the outer lumen and the outer surface of the inner lumen and out perforations (30) to allow the infusion of medication to soften, lyse, or alter the composition of clots or blockages. In the preferred embodiment, the inner channel (or area between the internal surface of the outer lumen and the outer surface of the inner lumen) terminates at the most distal perforation (30). Alternatively, the inner channel may terminate in the first segment at or near the end hole (4).

[0065] Referring now to FIG. 5, an alternate embodiment of the device (1) of the present invention further includes rotating, macerating and irrigating elements, more particularly, an slidable outer support sheath (60), macerating elements or loops (70), and/or perforations (30) used as irrigating elements. Said slidable outer support sheath (60) is capable of snugly closing side hole (2) when first segment (5) is withdrawn inside of said sheath (60). This action of withdrawing side hole (2) into outer support sheath (60) results in changing the blood-flow bypass from side hole (2) through distal end hole (4), redirecting the blood flow from distal end hole (4) out proximal end hole (7) due to an aspiration controller communicating with proximal end hole (7). Also shown in this embodiment are optional backflow valve (3) and optional anchoring balloon (50). If the operator chooses to aspirate from distal end hole (4), the bypass catheter (1) can be pulled back so that the side hole (2) is temporarily positioned within sheath (60), which is sized for a snug fit around bypass catheter (1), and aspiration force applied at proximal hole (7) will be transmitted to end hole (4), provided valve (3), when present, is open during said aspiration. It should be noted that for optimal use of this embodiment of the present invention, first segment (5) must fit snugly inside slidable outer support sheath (60).

[0066] Now referring to FIG. 6A, in the preferred embodiment of device (1) of the present invention further includes groove (90). Groove (90) is helpful for the positioning of semi-permeable membrane (9) at groove (90). Said location is referred to as interface location (91), as shown in FIG. 6B. Interface location (91) may also be located on the outside surface of a segment, and not associated with a groove. Interface location (91) may be located in multiple positions on either first segment (5) or second segment (6), or on both first segment (5) and second segment (6), depending upon the surgical procedure involved. Semi-permeable membrane (9) is shown in its expanded state with ribs (95) extending out to the circumference of outer edge (93).

[0067] Referring now to FIG. 6C, one alternative embodiment of the present invention is shown which incorporates multiple semi-permeable membranes (9) disposed at interface locations (91), a side hole (2), a first segment (5) and second segment (6), valve (3), macerating elements or loops (70), and perforations (30) used as irrigating elements. FIG. 6C further shows membrane (9) having ribs (95), and an outer edge or circumference (93) that a radially abut a vessel wall (not shown) when deployed.

[0068] Referring now to FIG. 7, an embodiment of the current invention has a branched first segment (5) forming a Y-shape distal to side hole (2). Each branch includes perforations (30), and semi-permeable membranes (9) located at interface locations (91) at each distal end hole (4).

[0069] Referring now to FIG. 8A, the semi-permeable membrane or filter (9) of the current invention in an expanded state deployed at distal end hole (4) of first segment (5). Outer edge (93) of membrane (9) abuts vessel wall (100). In the deployed state, semi-permeable membrane (9) captures emboli or debris released by the medical procedure.

[0070] Referring now to FIG. 8B shows the semi-permeable membrane or filter (9 (of the current invention in an undeployed state at the distal end hole (4) of first segment (5), to facilitate insertion of device (1) through the vasculature to the desired target area. Following treatment, semi-permeable membrane (9) is retracted to this state for removal.

[0071] It will be understood that the above particular embodiments are shown and described by way of illustration only. The principles and the features of the present disclosure may be employed in various and numerous embodiments thereof without departing from the scope and spirit of the disclosure as claimed. The above-described embodiments illustrate the scope of the disclosure but do not restrict the scope of the disclosure.