Blood-flow tubing

Abstract

An artificial or modified natural blood flow tubing has a helical-flow inducer to induce helical flow in such a fashion as to eliminate or reduce turbulence. One inducer is a tubular stent of expansible mesh having a helical vane.

Claims

1. An intravascular stent comprising: a tubular member having an internal surface and an external surface, wherein the tubular member has an internal helical formation to induce spiral-flow therethrough, and wherein the internal helical formation is provided on a portion of the internal surface and the internal surface extends beyond said portion, wherein the internal helical formation has a helix angle between 5 and 50 degrees relative to a longitudinal axis of the stent, and wherein the tubular member is selected from the group consisting of: (a) a tubular mesh member; (b) a tubular member formed from a wire; or (c) a tubular member of a mesh material that is formed from expanded sheet.

2. The stent according to claim 1, wherein the tubular member is expansible and is inserted by catheterization in collapsed form and which becomes expanded on release from the catheter, the internal helical formation being attached to the portion of the internal surface of the tubular member.

3. The stent according to claim 1, wherein the tubular mesh member is formed from a wire and comprises crisscrossed wires extending helically around the periphery of the stent, and the internal helical formation comprises a helical vane member attached to such wires.

4. The stent according to claim 1, wherein the tubular mesh member, the wire or the expanded sheet is made from metal.

5. The stent according to claim 1, wherein the wire is a wire spring.

6. The intravascular stent according to claim 1, wherein the helix angle is between 5 and 16 degrees relative to the longitudinal axis of the tubular member.

7. The intravascular stent according to claim 6, wherein the helix angle is about 16 degrees relative to the longitudinal axis of the tubular member.

8. The intravascular stent according to claim 1, wherein the helix angle of the internal helical formation is adjustable.

9. The intravascular stent according to claim 1, wherein the internal helical formation is a ridge.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) Some of the features and benefits of the present invention having been stated, others will become apparent as the description proceeds when taken in conjunction with the accompanying drawings, in which:

(2) FIG. 1 is a perspective view of a short length of tubing of a first embodiment suitable for prosthetic implant in a cardio-vascular system;

(3) FIG. 2 is a cross-section of a second embodiment of tubing;

(4) FIG. 3 is a perspective view of a third embodiment;

(5) FIG. 4 is a view of the inside of an example of a length of tubing, opened out;

(6) FIG. 5 in an elevation of an example of a mandrel for use in casting tubing according to the invention;

(7) FIG. 6 is a view of an example of a vaned device in a tube;

(8) FIG. 7 is a view of a second example of a vaned device in a tube;

(9) FIG. 8 is a view of an example of a branched tube according to the invention;

(10) FIG. 9 is a view of an example of a mesh material stent from the side, in its expanded condition;

(11) FIG. 10 is an end-on view of the stent of FIG. 9;

(12) FIG. 11 is an opened-out view of the stent of FIG. 10;

(13) FIG. 12 is an end-on view, to a larger scale, of the stent of FIG. 11 in its collapsed condition, before release from the catheter;

(14) FIG. 13 is a view of an example of a pipeline, with active helical-flow inducing means; and

(15) FIG. 14 is a section through the pipeline of FIG. 13.

(16) While the invention will be described in connection with the preferred embodiments, it will be understood that it is not intended to limit the invention to that embodiment. On the contrary, it is intended to cover all alternatives, modifications, and equivalents, as may be included within the spirit and scope of the invention as defined by the appended claims.

DETAILED DESCRIPTION OF THE INVENTION

(17) The drawings illustrate an example of blood-flow tubing 11 having helical-flow inducing means 12 adapted to induce helical flow in such fashion as to eliminate or reduce turbulence. The tubing 11 may be artificial, for example woven or knitted synthetic polymer fibre, in which the helical-flow inducing means may be knitted or woven structure as by three dimensional knitted or woven formation, or extruded or cast tubing, or modified natural, e.g. autograft material with an insert or with grooving made e.g. by a laser.

(18) The helical-flow inducing means 12 may include grooving 14 and/or ridging 15, which may be multi-start grooving and/or ridging as seen in FIGS. 1, 2 and 4. Square-section ridging, as seen in FIG. 1, or grooving, or semi-circular section ridging and/or grooving, as seen in FIG. 2, can be used, but other cross-sections will serve as well, for example, triangular.

(19) However, as seen in FIG. 3, a non-circular section tube 11 can have a twist, and may also have internal ridging and/or grooving. A twisted tube may be cast as such on a twisted mandrel or, if, for example, of thermoplastic material, may be twisted and heat-set in that state. Even a circular-section tube, bent into a corkscrew shape, can, if the dimensions are appropriate for the density, velocity and viscosity of the liquid flowing through it, give rise to a circulation in the flow.

(20) The helical-flow inducing means 12 may extend over the whole length of the tubing 11. In an example, the helical-flow inducing means 12 is provided where turbulence is likely to occur, for example at the inlet or outlet from the tubing 11, or in branched tubing as seen in FIG. 9, where turbulence can be occasioned in the branch region and can be controlled by ridging and/or grooving 12 at the inlets to the two minor branches 11b where they join the main branch 11a, and/or in the main branch 11a itself. Optionally, different ridging and/or grooving can be in the two minor branches, where, for example, they run at different angles to the main branch.

(21) It may be arranged that the ridging and/or grooving 12 has a reducing helix angle in the flow direction over at least part of its lengthan example of which is illustrated in FIG. 4, where the grooving 12 is also tapered so as to extend only over an inlet region L, but the tapering and reducing angle could extend over longer lengths of tubing. The opposite-helix angle increasing and/or depth of grooving or height of ridging increasing in the flow direction may also be appropriate in some circumstances.

(22) A designated helix angle, or range of helix angles, where increasing or decreasing angles are used, can depend on a number of factors, such as but not limited to, dimensions of the tubing 11, the density and viscosity of the liquid flowing through the tubing 11, and the velocity of the liquid flow. Examples exist where helix angles from about 5 to about 50, including about 16, induce a helical flow pattern in the fluid. Angles up to around 5 and greater than 50 can also induce helical flow patterns in the fluid.

(23) FIG. 5 is an elevation of an example of mandrel 51 such as may be used in a coagulation casting process to make prosthesis of polyetherurethane or other biocompatible polymer. Grooves 52 are provided on the mandrel 51 which then forms a tube with internal ridging.

(24) FIGS. 6 and 7 illustrate embodiments of helical vane devices 71 which can be inserted in tubing to cause helical flow of fluid flowing inside the tubing 11 and across the vane devices 71. In the example of FIG. 7 the helical flow effect can be increased by a probe 81, such as one used in angiography. The vanes 82 as shown are on a sleeve 83 and sufficiently flexible to be compressed on a rigid support 84 by a sleeve 85 of the probe 81 being advanced relative to a core 86, the core 86 engaging the support 84 while the sleeve 85 is advanced against the sleeve 83, the sleeve 83 being held in the compressed state by a ratchet arrangement 89 between support 84 and sleeve 83. Such a device may be adjusted during angiography while observing the rotational flow induced, thereby, e.g. by MRI. The adjustment may be effected in any other fashion, e.g. by the application of torque to one end while holding the other end fixed.

(25) FIGS. 9 to 12 illustrate examples of an expansible mesh material stent 101 which is inserted by catheterisation. Such stents are sometimes made of a metal with a shape memory and are presented on a catheter in collapsed form, expanding on release from the catheter as they reach body temperature, others expand elastically as they are pushed from a captive surround. In one example of an expanded condition, as shown in FIGS. 9 and 10, the stent 101 is formed from a mesh cylinder formed, for example, of welded wires 102 with joined segments 103 extending helically around the periphery of the stent 101, though some stents are of expanded metal sheet, in which case the segments would be integral strips. Attached to some of the segments 102, on the inside of the stent 101, are examples of vane members 104. In a welded wire construction, these could be plates welded to segments, while in an expanded sheet construction, the vane members 104 could be parts of the sheet, leaving corresponding holes in the mesh. FIG. 11 shows an opened-out version of the stent 101, as if cut along a generator of the cylinder and laid flat, with the inside face uppermost. FIG. 12, which is to a larger scale, shows the stent 101 in collapsed form around a catheter wire 105, without, however, the associated surround which contains them for insertion and out from which they are pushed once maneuvered into position.

(26) Aside from blood flow tubing for implantation, or devices for use in improving circulation, such as bypasses and stents, blood flow tubing is found in various items of medical equipment such as heart-lung machines, dialysis machines and blood transfusion equipment. Inasmuch as, in such equipment, blood flows much as it does in the body, it could be at least as important to fashion such tubing to give the best possible flow characteristics, in particular, the avoidance of thromboses being generated during prolonged use of the equipment, as in heart surgery and dialysis, and the principles set out above in relation to natural and artificial grafts can also be applied to such external blood flow tubing. Even in giving sets, where flow rate is likely to be low, helical flow may well be found to have advantages, especially at the interfaces between tubing and cannulae and flow regulators.

(27) FIGS. 13 and 14 illustrate, by way of example, the application of the notion of helical flow to an oil pipeline 141. The pipeline 141 is itself made up from pipe sections 142, which may themselves have internal helical grooving and/or ridging 143. In an optional embodiment, active flow rotating means 144 are provided at intervals along the pipeline 141, at junctions between pipe sections 142. The active flow rotating means include, as seen in FIG. 13, rotary vanes 145 mounted in connecting rings 146. Depending on circumstances, it may be desirable to drive the vanes by external means, such, for example, as a motor, which can be, for example, solar powered, or it may be preferred to derive power for rotating the vanes from the flow itself, the general idea being to refresh any swirl component that might have attenuated over the preceding pipe section.

(28) In addition to pipelines, the idea of helical flow will clearly be of benefit in plant in which slurries and suspensions of solids in liquids are transported between reactors and storage tanks, for instance. Examples of such plants are food producing plants, where soups, sauces and like products are manufactured.

(29) It is noted that the mere provision of helical flow induction will not necessarily reduce or eliminate turbulence. It will be important to select the most appropriate configuration, which may well be done by trial and error. It may, of course, be found, especially where sharp bends or corners are encountered in the tubing, that there is a limit to the stability of rotational flowit may be desirable, if possible, to refashion the tubing to eliminate sharp bends or corners before helical flow will have the effect of inducing or maintaining non-turbulent flow.

(30) Designs for the tubing and methods for making the same other than those already discussed can of course be envisioned, all falling within the scope of the invention.