MIXER SHEATH FOR A VASCULAR CATHETER

Abstract

The application relates to vascular catheters, in particular to vascular catheter systems (100) which are configured to mix blood. Aspects relate to a mixer sheath (110) for a vascular catheter, a method of manufacturing a mixer sheath, a catheter sheath, a catheter, a method of deploying a vascular catheter, a method of removing a vascular catheter, a method of deploying one or more blood mixing elements, a method of using a catheter system and a method of reversing the deployment of a blood mixing element. The mixer sheath comprises a tube having a wall patterned with a line of weakness (212) which is configured to cause buckling of a portion of the tube wall when a longitudinal compression force is applied to the tube to form a blood mixing element (111) which extends radially outwards with respect to a location of the portion of the tube wall prior to buckling.

Claims

1. A mixer sheath for a vascular catheter, the mixer sheath comprising a tube having a wall patterned with a line of weakness which is configured to cause buckling of a portion of the tube wall when a longitudinal compression force is applied to the tube to form a blood mixing element which extends radially outwards with respect to a location of the portion of the tube wall prior to buckling, wherein, in an unbuckled state, the line of weakness extends for at least some of its length in a direction with a non-zero longitudinal component with respect to an axis of the tube.

2. The mixer sheath of claim 1, wherein the line of weakness is a cut line through the full thickness of the tube wall.

3. (canceled)

4. The mixer sheath of claim 1, wherein the line of weakness is one of a pair of lines of weakness configured to cause buckling of the portion of the tube wall when a longitudinal compression force is applied to the tube such that part of the tube exterior surface extends radially outwards to form the mixing element, the mixing element comprising two diametrically opposed fins.

5. The mixer sheath of claim 4, wherein the lines of weakness forming the pair at least partially overlap in their longitudinal extents.

6. (canceled)

7. The mixer sheath of claim 1, wherein the line of weakness substantially forms a longitudinally extending zigzag.

8. (canceled)

9. The mixer sheath of claim 7, wherein one or more sections of the zigzag are curved such that the mixing element forms with a curved outer edge.

10. (canceled)

11. The mixer sheath of claim 1, comprising one or more further lines of weakness configured to cause buckling of a further portion of the tube wall when a longitudinal compression force is applied to the tube to form a further blood mixing element which extends radially outwards with respect to a location of the further portion of the tube wall prior to buckling.

12. The mixer sheath of claim 11, wherein the two or more mixing elements together form a static mixer.

13. The mixer sheath of claim 11, wherein longitudinally successive lines of weakness are arranged at successive angular positions around a circumference of the tube so that, following buckling of the tube wall, longitudinally successive mixing elements extend at successive angles around the tube circumference.

14. The mixer sheath of claim 13, wherein each successive angular position is at ninety degrees to the last.

15. The mixer sheath of claim 1, wherein the line of weakness varies in thickness along its length.

16. The mixer sheath of claim 1, comprising a catheter connector configured to fix a distal end of the mixer sheath to a distal end of the catheter, such that the longitudinal compression force can be applied by moving a proximal end of the mixer sheath axially with respect to a proximal end of the catheter.

17. The mixer sheath of claim 1, wherein the tube wall varies in thickness between one region of the mixer sheath and another.

18. The mixer sheath of claim 11, wherein the tube wall varies in thickness between one region of the mixer sheath and another, and wherein the thickness of the tube wall at the locations of longitudinally successive lines of weakness is successively greater so that, on application of the longitudinal compression force, longitudinally successive mixing elements form in a sequence corresponding to their longitudinal location.

19. The mixer sheath of claim 1, comprising an inlet port for permitting blood flow through the tube wall.

20.-30. (canceled)

31. A method of using a vascular catheter, the vascular catheter comprising a mixer sheath, the mixer sheath comprising a tube having a wall patterned with a line of weakness that extends for at least some of its length in a direction with a non-zero longitudinal component with respect to an axis of the tube, the method comprising: feeding the catheter through a blood vessel to a desired location; and subsequently pushing on a proximal end of the mixer sheath while holding the catheter substantially stationary with respect to the vessel so as to apply the a longitudinal compression force to the mixer sheath to cause buckling of a portion of the tube wall to form a blood mixing element which deploys radially outwards with respect to a location of the portion of the tube wall prior to buckling, thereby to mix blood in the blood vessel as it flows past the blood mixing element.

32. The method of claim 31, further comprising, between the feeding and the pushing steps, withdrawing an outer sheath to expose a region of the mixer sheath in the vicinity of the line of weakness which is configured to buckle to form the mixing element.

33. The method of claim 32, wherein withdrawing the outer sheath only exposes the portion of the tube wall which is configured to buckle to form one mixing element or one cluster of mixing elements, the method further comprising: subsequent to the pushing step, withdrawing the outer sheath further to expose a further portion of the tube wall which is configured to buckle to form a further mixing element; and subsequently pushing on the proximal end of the mixer sheath while holding the catheter substantially stationary with respect to the vessel so as to apply the longitudinal compression force to the mixer sheath again.

34. The method of claim 31, further comprising: pulling on a proximal end of the mixer sheath while holding the catheter substantially stationary with respect to the vessel so as to apply a longitudinal extension force to the mixer sheath, thereby collapsing the mixing element; and withdrawing the catheter through the blood vessel.

35.-42. (canceled)

43. A vascular catheter comprising the mixer sheath of claim 1.

Description

[0050] Aspects of the present disclosure will now be described by way of example with reference to the accompanying figures. In the figures:

[0051] FIG. 1 illustrates an example catheter system;

[0052] FIGS. 2A, 2B and 2C illustrate how an example catheter system like that of FIG. 1 could be deployed in a blood vessel;

[0053] FIGS. 3A to 3E illustrate an example buckling process for the type of catheter system illustrated in FIGS. 1 and 2A to 2C;

[0054] FIGS. 4A and 4B show the pattern of a pair of lines of weakness on a flattened-out portion of an example mixer sheath;

[0055] FIG. 5 shows how the pattern of FIG. 4B could be repeated down the length of a mixer sheath;

[0056] FIG. 6 illustrates an alternative example catheter system;

[0057] FIGS. 7A and 7B are flowcharts showing example methods for manufacturing a mixer sheath;

[0058] FIG. 8A is a flowchart describing a method of deploying a vascular catheter with a mixer sheath; and

[0059] FIG. 8B is a flowchart describing a method 850 of removing a vascular catheter.

[0060] The following description is presented to enable any person skilled in the art to make and use the system, and is provided in the context of a particular application. Various modifications to the disclosed embodiments will be readily apparent to those skilled in the art.

[0061] The terms “top”, “bottom”, “sides” and other terms describing the orientation of features are not intended to be limiting and are purely included in order to facilitate the description of the relative location of these features in the context of the accompanying drawings. In use, or during storage, the features may be disposed in other orientations.

[0062] In order to provide deployable external mixing elements on a vascular catheter, it is proposed to employ a “mixer sheath”. The mixer sheath comprises a tube having a wall patterned with at least one line of weakness such that, when the tube is compressed longitudinally, the tube wall buckles into a configuration in which part of the tube wall extends radially outwards with respect to its prior location to form a blood mixing element. The blood mixing element is of a suitable size and shape to deflect a portion of blood flow which encounters it in use. It may for example be described as a fin, baffle, blade or vane.

[0063] FIG. 1 illustrates an example catheter system 100 having such a mixer sheath 110, with mixing elements 111 deployed in a blood vessel 120. The mixer sheath 110 comprises a tip 113 on its distal end. The tip 113 can comprise a catheter connector (not shown) which affixes the distal end of the mixer sheath 110 to the distal end of the catheter within the mixer sheath (not shown). (As used herein in relation to a catheter system, “distal” shall be taken to mean the free end, which traverses the longest distance through the patient's vasculature. Similarly, as used herein in relation to a catheter system, “proximal” shall be taken to mean the directly controlled end, which traverses the shortest distance through the patient's vasculature, and may not even enter the patient's vasculature at all.) An optional outer sheath 130 is shown, and will be described further in relation to FIGS. 2A to 2C. The catheter system can for example be designed with a central lumen to allow the catheter to be tracked over an interventional guide wire 140 until the required location of the catheter in the blood vessel 120 is achieved. The guide wire could also comprise radiopaque marker bands or fillers to allow precise location to be visualised, e.g. under fluoroscopic imaging.

[0064] In this example, the mixing elements occur in diametrically opposed pairs with a small axial offset between the two elements forming each pair, and a larger axial offset between adjacent pairs. Successive pairs of mixing elements are arranged at successive circumferential locations. In this case, the angular offset between successive pairs is ninety degrees, though other angular offsets could be employed. This type of arrangement creates a static mixer which mixes the blood through flow division (stratification) and radial mixing.

[0065] FIGS. 2A to 2C illustrate how an example catheter system like that of FIG. 1 could be deployed in a blood vessel 220. First, the catheter system 200 is manoeuvred into position in the blood vessel 220 along a guide wire 240. As shown in FIG. 2A, an outer sheath 230 could enclose some or all of the mixer sheath at this stage. (As shown, the catheter tip 213 is not enclosed by the outer sheath 230.) Next, as shown in FIG. 2B, the outer sheath 230 is withdrawn to reveal the mixer sheath 210, in particular lines of weakness 212. Finally, the proximal end (not shown) of the mixer sheath 210 is pushed on while the central lumen of the catheter (joined to the tip, which in this example acts as a connector between the catheter and mixer sheath) within the mixer sheath is held stationary with respect to the blood vessel 220, causing longitudinal compression of the mixer sheath 210. This results in buckling of a portion of the mixer sheath 210 in the vicinity of each line of weakness 212 to produce mixer elements 211. (This result could be achieved in other ways, by any combination of pushing/pulling on the mixer sheath and/or the catheter that results in relative movement between them at one longitudinal location while they remain fixed relative to one another at another longitudinal location, the relative movement resulting in longitudinal compression of the mixer sheath.)

[0066] An example buckling process for the type of catheter system illustrated in FIGS. 1 and 2A to 2C is illustrated in FIGS. 3A to 3D. The mixer sheath 310 comprises a tube surrounding a catheter 350. Lines of weakness 312 are patterned on its external surface. In this case the lines of weakness 312 are cut lines all the way through the thickness of the tube. FIG. 3A illustrates what this looks like following withdrawal of optional outer sheath 330. As the mixer sheath 310 is longitudinally compressed, the line of weakness 312 gapes to reveal the central tube of the catheter 350 within the mixer sheath 310, as shown in FIG. 3B. With further longitudinal compression of the mixer sheath 310, the portions of the mixer sheath 310 around the gaping line of weakness 312 start to fold in on themselves as shown in FIG. 3C. This folding/wrapping continues with further longitudinal compression of the mixer sheath 310, and the exposed region of the catheter 350 visible through the gaping line of weakness 312 becomes axially shorter as shown in FIG. 3D, as the proximal portion of the mixer sheath 310 is pushed distally. This continues with further longitudinal compression of the mixer sheath 310 until the mixer elements 311 are fully formed as shown in FIG. 3E, leaving only a thin strip of the catheter 350 visible between distal and proximal portions of the mixer sheath 310.

[0067] Although in FIGS. 3A to 3E only one line of weakness 312 is visible, for the buckling to work in the manner shown a pair of lines of weakness 412 in mixer sheath 410 is needed as shown in the examples of FIGS. 4A and 4B. (Alternatively, the pair of lines 412 could form a single line of weakness if they are connected, e.g. at their distal and/or proximal ends, by a portion of fold line, e.g. formed by scoring or perforating the mixer sheath.) FIGS. 4A and 4B show the pattern of this pair of lines of weakness on a flattened-out portion of the mixer sheath 410. Each line of weakness 412 forms a zigzag pattern which changes direction four times. In this flat view, the two lines of weakness 412 are reflections of one another in mirror line M. Thus, when this patterning is present on the mixer sheath in tube form, they are projections onto the tube of symmetrical images across a longitudinal line of symmetry on the tube surface. FIG. 4B shows an example (which corresponds to the examples of FIGS. 1 to 3E) in which the lines of weakness 412 are thicker in some places than others, i.e. with the lines being slits in some parts and cut-outs in others. In particular, the lines are thicker towards the two central points of each zigzag pattern to form cut-outs 412a. This results in a rounded outer edge on the mixing elements, reducing the risk of them damaging the blood vessel wall. Making the lines of weakness thicker in some places, e.g. at their ends to make rounded corners, can also provide stress relief to minimise the risk of tears propagating.

[0068] FIG. 5 shows how the pattern of FIG. 4B could be repeated down the length of a mixer sheath 510 to form a catheter system 500 capable of producing a static mixer that can substantially fully mix blood flow across the entire cross section of a blood vessel.

[0069] FIG. 6 shows an alternative example catheter system 600 wherein the mixer sheath is reinforced in portions 610a not having lines of weakness 612 patterned thereon, relative to those portions 610b which do have the lines of weakness 612 patterned thereon, to encourage preferential buckling of the correct portions 610b, without allowing the system as a whole to become too flexible or weak. This could be achieved for example by forming the mixer sheath tube in laminated layers, and stripping one or more layers in the portions 610b having lines of weakness 612 patterned thereon. Alternatively the tube could be formed of a single layer, then etched/filed away in the portions 610b to have lines of weakness 612 patterned thereon. As another option, portions 610a not having lines of weakness 612 patterned thereon could be formed by sliding collars over a mixer sheath of the type shown in FIGS. 1 to 5, and optionally heat shrinking those collars or otherwise clamping them in position. Such collars could alternatively be formed by wrapping strips of tape around a mixer sheath of the type shown in FIGS. 1 to 5.

[0070] The thickness of the tube could be varied in any way desired to result in preferential buckling in some locations with respect to others. For example, a plurality of mixing elements could be configured to deploy in a particular sequence by making the tube thinnest in the region to buckle to form the first mixing element to be deployed, a little thicker in the region to buckle to form the second mixing element to be deployed, and so on to the final mixing element to be deployed which is formed in the thickest region of the tube (or the thickest buckling region, if other regions are made thicker for additional strength as described in relation to FIG. 6.) If the sequence is defined according to longitudinal location, the tube wall could taper from one end to the other.

[0071] Although only a few examples have been described above in relation to FIGS. 1 to 6, a buckling mixer sheath for a vascular catheter could take many forms. In general, it comprises a tube, which may be an entirely uniform open-ended cylinder, or may vary in composition and/or thickness and/or diameter and/or cross-sectional shape along its axial extent and/or around its cross-sectional perimeter (circumference). One or both of its ends may be closed.

[0072] The tube has a wall patterned with at least one line of weakness configured to cause buckling under the influence of a longitudinal (e.g. axial) compression force so as to produce at least one external blood mixing element. The line of weakness could be a continuous slit or cut-out through the entire thickness of the tube wall. The line could be formed of a train of slits or cut-outs, i.e. perforations. Alternatively it could be a continuous score line, i.e. a line along which the tube wall is thinner than the tube wall surrounding the line, whether this is achieved through moulding, additive manufacture processes, partial co-extrusion/lamination or by removing material along the score line by e.g. mechanical or chemical methods. A non-continuous score line formed of a train of indentations could alternatively be used. The line of weakness could be formed of a combination of any two or more of the above types of lines, or in any other way that results in preferential buckling of a particular portion of the tube under longitudinal compression to produce a blood mixing element.

[0073] The line of weakness could extend substantially longitudinally when unbuckled, though as illustrated in FIGS. 4A and 4B the line need not be straight and can change direction one or more times.

[0074] Multiple mixing elements can be produced in clusters if multiple lines of weakness are located in a group, for example with at least some longitudinal overlap. For example, diametrically opposed mixing element “fins” can be produced as shown in FIGS. 3A to 3E if a pair of lines of weakness as illustrated in FIGS. 4A and 4B are employed. Other cluster configurations can be envisaged with different patterning of the lines of weakness, for example a tri- or quad-fin propeller type grouping. Fins of ach cluster could be arranged evenly around the circumference of the tube, or in an irregular formation. Alternatively, the patterning could be configured to produce single mixing elements rather than clusters.

[0075] As illustrated in FIGS. 4A and 4B, a zigzag pattern can be used to induce buckling. In that example the zigzag changes direction four times, but if the zigzag extended further, with additional changes of direction, the mixing elements formed would be thicker, and thus stronger.

[0076] The points of the zigzag could be rounded to give the mixing element a curved outer edge.

[0077] In the paired zigzag pattern illustrated in FIGS. 4A and 4B, the width of the stem of the mixing element is determined by the minimum circumferential distance between the two zigzags. This should be wide enough that the mixing elements cannot be torn off under the influence of the kinds of forces typically experienced by vessel wall contacting components of vascular catheter systems. The appropriate minimum width will thus depend on the material, construction and thickness of the mixer sheath. For example, for a mixer sheath formed of a single 0.5 mm thick sheet of polyether ether ketone (PEEK), a suitable minimum stem width is 0.3 mm. A suitable radial extent of the mixing element in this example could be up to 3 mm.

[0078] Other suitable materials for the mixer sheath include polyethylene terephthalate (PET), polyamide, polyimide and polytetrafluoroethylene (PTFE). The mixer sheath could be made of a single material, or could comprise components of multiple different materials, e.g. in a laminated structure.

[0079] If the catheter is a blood sampling catheter, then the mixer sheath can have one or more inlet ports so that blood can flow through the tube wall to the catheter. Each inlet pot could be in fluid communication with a lumen for removal of blood samples. The inlet ports could be configured such that the sliding of the mixer sheath with respect to the catheter to form the mixing elements could result in the ports aligning with corresponding lumen inlets, so that blood sampling only begins once the mixing elements are deployed. (The ports and lumen inlets could be configured so that they all align at the same instant, in a similar manner to the mechanism described in European patent number EP 1 912 556 B1.) Inlet ports on the mixer sheath could be shaped to exactly correspond to their respective lumen inlets, or could have a longer longitudinal extent to allow for slight variation in the extent of deployment of the mixing elements, for example if full deployment is prevented by an obstacle within the blood vessel such as a bend or constriction.

[0080] FIGS. 7A and 7B are flowcharts showing respective example methods 700a and 700b for manufacturing a mixer sheath such as the example mixer sheaths described above. Both methods use laser micromachining to form the line(s) of weakness precisely.

[0081] The method 700a of FIG. 7A is to produce a mixer sheath having a pair of lines of weakness, for example as illustrated by FIGS. 4A and 4B. At step 720a the tube is formed by any suitable method. For example it could be extruded, produced by additive manufacturing technique (such as 3D printing) or constructed by connecting the long edges of a rectangular sheet together, e.g. by seam welding, with adhesive and/or by encircling the rolled sheet with collars in two or more locations along its length. If collars are used, they could also serve to strengthen the tube in regions in which buckling is not desired, as explained above in relation to FIG. 6. A collar for holding the tube together could for example consist of a ring of elastic material, a ring of heat shrink which is slid into position and then shrunk to fit the tube, or a belt/strap which is tied around the tube with its two ends affixed together. At step 730, subsequent to forming the tube, a laser is aimed at the side of the tube and used to micromachine through the tube wall on the sides both near and far with respect to the laser at once. The laser could be aimed such that it describes a diameter of the tube's cross-section, or could be located off-centre, depending on the design of the mixing elements.

[0082] The method 700b of FIG. 7B can be used for producing a mixer sheath with any configuration of one or more lines of weakness. At step 710 a line of weakness is patterned by laser micromachining a rectangular sheet of sheath material. Then, at step 720b the tube is formed from the sheet by connecting together the long edges of the sheet in any of the ways suggested above.

[0083] FIG. 8A is a flowchart describing a method 810 of deploying a vascular catheter with a mixer sheath. At step 820, a catheter system is fed through a blood vessel to a desired location. Then, at step 830, the proximal end of the mixer sheath is pushed on while the catheter within is held substantially stationary, in order to deploy one or more mixing elements. The method 810 ends at 840.

[0084] If an outer sheath is used, then this must be withdrawn between steps 820 and 830 to allow room for formation of the mixing elements. For example, if a staged deployment is desired then at step 825 the outer sheath is withdrawn to expose a region of the mixer sheath configured to form one mixing element, or one mixing element cluster. Following step 830, if the result of querying at 835 whether any mixing elements or mixing element clusters remain to be deployed is positive, the flow returns to step 825. Otherwise, the method ends at 840.

[0085] FIG. 8B is a flowchart describing a method 850 of removing a vascular catheter. At step 860 the proximal end of the mixer sheath is pulled while the catheter within is held stationary with respect to the blood vessel, in order to collapse the mixer elements. Then, at step 870 the catheter system is withdrawn from the vessel. The method ends at 880. If an outer sheath is used then this can be deployed between steps 860 and 880 by sliding it over the collapsed mixer sheath towards the distal end at 865.

[0086] Other embodiments will be apparent to those skilled in the art from consideration of the specification and practice of the embodiments disclosed herein. It is intended that the specification and examples be considered as exemplary only.

[0087] In addition, where this application has listed the steps of a method or procedure in a specific order, it could be possible, or even expedient in certain circumstances, to change the order in which some steps are performed, and it is intended that the particular steps of the method or procedure claims set forth herein not be construed as being order-specific unless such order specificity is expressly stated in the claim. That is, the operations/steps may be performed in any order, unless otherwise specified, and embodiments may include additional or fewer operations/steps than those disclosed herein. It is further contemplated that executing or performing a particular operation/step before, contemporaneously with, or after another operation is in accordance with the described embodiments.