Medical device suitable for location in a body lumen

Abstract

A medical device suitable for location in a body lumen is movable between a first loaded configuration and a second loaded configuration. The device has an unloaded configuration which is intermediate the first loaded configuration and the second loaded configuration. The device can be a stent for deployment in a blood vessel.

Claims

1. A method of employing a medical device in a body lumen, wherein the medical device is a stent, comprising: deploying and expanding the stent in a body lumen, the stent having a diameter, the body lumen being deformable between an unloaded state and a loaded state wherein in the loaded state, the body lumen is more curved than in the unloaded state; wherein the stent is one which, after deployment and expansion, is deformable between a first loaded configuration and a second loaded configuration and has an unloaded configuration intermediate the first loaded configuration and the second loaded configuration; wherein in said unloaded and second loaded configurations at least part of the longitudinal axis of the stent is helically shaped and has an amplitude and wherein in the second loaded configuration the amplitude of the helical longitudinal axis divided by the diameter of the stent is greater than in the unloaded configuration; wherein the deploying comprises deploying the stent in the body lumen so that after deployment and expansion when the body lumen is in the unloaded state the stent is in the first loaded configuration, and when the body lumen is in the loaded state the stent is in the second loaded configuration; wherein in the unloaded configuration the amplitude of the helical longitudinal axis divided by the diameter of the stent is in the range of 0.3 to 0.9; wherein in the first loaded configuration at least part of the longitudinal axis of the stent is one of straight and helical and the amplitude of said part of the longitudinal axis divided by the diameter of the stent is in the range of 0 to 0.5; and wherein in the second loaded configuration the amplitude of the helical longitudinal axis divided by the diameter of the stent is in the range of 0.5 to 2.

2. A method as claimed in claim 1, wherein the pitch of the helical longitudinal axis is less in the second loaded configuration than in the unloaded configuration.

3. A method as claimed in claim 1, wherein in the first loaded configuration at least part of the longitudinal axis of the stent is helically shaped and the amplitude of the helical longitudinal axis divided by the diameter of the stent is less than in the unloaded configuration.

4. A method as claimed in claim 3, wherein the pitch of the helical longitudinal axis is greater in the first loaded configuration than in the unloaded configuration.

5. A method as claimed in claim 1, wherein the stent is bendable between the first loaded configuration and the second loaded configuration.

6. A method as claimed in claim 1, wherein the stent is twistable between the first loaded configuration and the second loaded configuration.

7. A method as claimed in claim 1, wherein the stent is compressible between the first loaded configuration and the second loaded configuration.

8. A method as claimed in claim 1, wherein the unloaded configuration is midway between the first loaded configuration and the second loaded configuration.

9. A method as claimed in claim 1, further comprising aligning the stent relative to the body lumen in which the stent is deployed.

10. A method as claimed in claim 9, wherein aligning the stent comprises aligning a marker or the stent with the body lumen.

11. A method as claimed in claim 1, wherein the body lumen is a blood vessel.

12. A method as claimed in claim 1, wherein the stent has a longitudinal axis with a length of at least 50 mm.

13. A method as claimed in claim 1, wherein the stent is made of Nitinol.

14. A method of employing a medical device in a body lumen, wherein the medical device is a stent, comprising: deploying and expanding the stent in a body lumen such that it is in a deployed, expanded configuration; and when the stent is in the deployed, expanded configuration: deforming the stent to a first loaded configuration, wherein when the stent is in the first loaded configuration, the body lumen is in an unloaded state; deforming the stent to a second loaded configuration, wherein when the stent is in the second loaded configuration, the body lumen is in a loaded state, which is more curved than the unloaded state of the body lumen; wherein the stent has an unloaded configuration intermediate the first and second loaded configurations and wherein in the unloaded and second loaded configurations at least part of the longitudinal axis of the stent is helically shaped, wherein the amplitude of the helical longitudinal axis divided by the diameter of the stent is greater in the second loaded configuration than in the unloaded configuration; and wherein when the stent is axially compressed by 6% from the first loaded configuration to the second loaded configuration, the maximum strain in the stent, at any stage at or between the first and second loaded configurations, is less than or equal to 0.7%.

15. A method as claimed in claim 14, wherein the maximum strain is less than or equal to 0.5%.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The invention will be more clearly understood from the following description of some embodiments thereof, given by way of example only, with reference to the accompanying drawings, in which:

(2) FIG. 1 is a side view of a medical device according to the invention in a first loaded configuration located in a body lumen;

(3) FIG. 2 is a side view of the device of FIG. 1 in a second loaded configuration located in the body lumen;

(4) FIG. 3 is a side view of the device of FIG. 1 in an unloaded configuration;

(5) FIG. 4 is a side view of another medical device according to the invention in a first loaded configuration located in a body lumen;

(6) FIG. 5 is a side view of the device of FIG. 4 in a second loaded configuration located in the body lumen;

(7) FIG. 6 is a side view of the device of FIG. 4 in an unloaded configuration;

(8) FIG. 7 is an isometric view of another medical device according to the invention in a first loaded configuration;

(9) FIG. 8 is an isometric view of the device of FIG. 7 in a second loaded configuration;

(10) FIG. 9 is an isometric view of the device of FIG. 7 in an unloaded configuration;

(11) FIG. 10 shows three configurations of the stent of FIGS. 1 to 3 and a graph showing the maximum principal strains in the stent at different angles of deformation;

(12) FIG. 11 shows a comparative example of a conventional stent at two configurations and a graph showing the maximum principal strains in the stent at different angles of deformation;

(13) FIG. 12 shows three configurations of a stent with a helical longitudinal axis and a graph showing the maximum principal strains in the stent at different axial compressions;

(14) FIG. 13 shows a comparative example of a conventional stent at two configurations and a graph showing the maximum principal strains in the stent at different axial compressions; and

(15) FIG. 14 shows part of a helical stent.

DETAILED DESCRIPTION

(16) Referring to the drawings, and initially to FIGS. 1 to 3 thereof, there is illustrated a medical device 1 according to the invention suitable for location in a body lumen. The medical device 1 is movable between a first loaded configuration (FIG. 1) and a second loaded configuration (FIG. 2).

(17) In this case the medical device 1 comprises a stent suitable for deployment in a blood vessel which is movable between an unloaded straight cylindrical state (FIG. 1) and a loaded curved state (FIG. 2). The stent 1 supports at least part of an internal wall of the blood vessel. The stent 1 is in the first loaded configuration when the blood vessel is in the unloaded state (FIG. 1), and the stent 1 is in the second loaded configuration when the blood vessel is in the loaded state (FIG. 2).

(18) The stent 1 is bendable through a single bend between the first loaded configuration (FIG. 1) and the second loaded configuration (FIG. 2).

(19) The stent 1 has an unloaded configuration (FIG. 3) which is intermediate the first loaded configuration and the second loaded configuration. In the unloaded configuration the stent 1 is in a rest state. In this case the unloaded configuration is approximately midway between the first loaded configuration and the second loaded configuration. In the unloaded configuration the longitudinal axis of the stent 1 is curved through a single bend in a two-dimensional plane. In this case no shape change occurs upon delivery of the stent 1 to the blood vessel. The stent 1 has the same unloaded configuration outside of the blood vessel prior to delivery and after deployment in the blood vessel.

(20) The stent 1 may be balloon expandable or self-expanding.

(21) The stent 1 is suitable for use in the blood vessel which is subject to tortuous loading, such as bending. The stent 1 has the pre-set curved geometry in the unloaded configuration, as shown in FIG. 3. The choice of pre-set curve is determined by the extremes of deformation which occur in the blood vessel in which the stent 1 will be implanted. The unloaded configuration of the stent 1 represents a configuration between two opposing extremes of deformation of the blood vessel, such as those shown in FIGS. 1 and 2.

(22) Because of physiological movements within the body, the blood vessel may be forced to adopt tortuous configurations. Large degrees of bending may occur, for example with bends in excess of 90°, for example up to 140°. A bend between limb parts at a joint means the angle between the limb parts measured at the joint, for example the angle between the lower leg and the upper leg at the knee. Such a bend at the joint corresponds to a smaller “curve angle” of the stent as defined above, for example a bend at the joint of 90° may result in a curve angle of the stent of 45°, whilst a bend at the joint of 140° may result in a curve angle of the stent of 70°.

(23) The location for the stent 1 may be in the blood vessel in the leg behind the knee which is subject to frequent bending as the patient bends the leg. Because the unloaded configuration of the stent 1 is non-straight, the degrees of deformation which the stent 1 undergoes are minimised leading to minimised strains, increased fatigue life, and reduced risk of fracture. The configuration of FIGS. 1 to 3 results in the stent 1 bending by a maximum of φ degrees, that is from φ degrees to 0 degrees (FIG. 3 to FIG. 1), or from φ degrees to a degrees (FIG. 3 to FIG. 2). In this case α=2φ. This contrasts with the conventional approach of bending a stent by α degrees each time, that is from 0 degrees to α degrees (FIG. 1 to FIG. 2).

(24) Each of the angles α degrees and φ degrees through which the device is curved is a “curve angle”, i.e. the angle between the longitudinal axis of the device at one end thereof and a line from a point on the longitudinal axis at that end to a point on the longitudinal axis at the other end of the device.

(25) FIGS. 1 to 3 illustrate a single bend in one plane. FIG. 1 illustrates the stent 1 deployed in the unloaded vessel, FIG. 2 illustrates the stent 1 deployed in the loaded vessel, and FIG. 3 illustrates the stent 1 in the unloaded configuration.

(26) Since some of the deformation of the blood vessel is already incorporated in the stent 1 in the unloaded configuration (FIG. 3), the strains induced through further deformation of the stent 1 to achieve the fully loaded configuration (FIG. 2) are less than those which would be induced if the stent 1 had to go from the straight (FIG. 1) to the fully loaded configuration of the blood vessel (FIG. 2).

(27) For example, as shown in FIGS. 1 to 3, in a blood vessel which bends between 0 degrees and α degrees in one plane, the curved stent 1 in the unloaded configuration already accommodates the angle of φ degrees. Therefore in order to bend from 0 degrees to α degrees, the stent 1 bends from (−φ) degrees to (α−φ) degrees. Improved mechanical performance is achieved since the induced strains at angles of (−φ) degrees and (α−φ) degrees are less than those induced by bending a straight stent from 0 degrees to α degrees. The stent 1 comprises visualisation means to align the stent 1 relative to the blood vessel. In this case the alignment means comprises one or more markers 2 on the stent 1. A pair of markers 2 are provided in this embodiment, both at one end of the stent 1 and positioned diametrically opposite each other. The stent 1 may be oriented at the implantation site, for example using the radiopaque markers or other visualisation means. The rotational position of the stent may be adjusted during implantation whilst using the markers to visualise the rotational position. The stent 1 may be aligned with the axis of bending of the knee of a patient during deployment.

(28) In use, the stent 1 is delivered into the blood vessel and deployed at a desired treatment site in the blood vessel. The stent 1 may be oriented at the desired treatment site.

(29) As the blood vessel moves from the unloaded straight cylindrical state (FIG. 1) to the loaded curved state (FIG. 2), the stent 1 bends from the first loaded configuration to the second loaded configuration.

(30) The operation of the stent of FIGS. 1 to 3 when inserted in a leg will be described with reference to FIG. 10.

(31) FIG. 10 shows three configurations of the stent, at three leg positions A, B and C.

(32) The leg is substantially straight in position A and at this time the stent is in a first loaded configuration corresponding to FIG. 1. The leg is in a partially bent condition in position B and the stent is then in the unloaded configuration corresponding to FIG. 3, bent at an angle of φ degrees. The leg is in a more bent condition at position C, corresponding to FIG. 2, when the stent is bent at an angle of α degrees.

(33) Finite element analysis was used to evaluate the strains which occur during bending of the leg from the straight condition shown as position A to the sitting condition shown as position C. The results are shown in the graph of FIG. 10. When the leg is straight, the stent has been bent through an angle of −φ degrees and the maximum principle strain in the stent is approximately 0.27%. When the leg is partially bent, and the stent has a bend angle of φ degrees it is in the unloaded configuration. Therefore, at this angle, because the stent is unloaded, the strains in the stent are zero. As the leg is bent further, to an angle of α degrees, the maximum principal strain increases again to approximately 0.27%.

(34) By way of comparison, FIG. 11 shows the case of an initially straight stent subject to the same loading. The strains are zero when the leg is not bent, but the maximum principal strain increases to 0.46% when the leg is bent to an angle of α degrees. Thus for the same loading, the straight stent will exhibit higher strains than the stent with geometry which is intermediate loaded and unloaded configurations.

(35) During bending of the leg, the popliteal artery, which is the artery behind the knee, exhibits large degrees of bending, as seen in FIGS. 10 and 11. The lower superficial femoral artery, which is above the popliteal artery, exhibits bending and also experiences shortening. Conversely, when the leg moves from a sitting condition to a straight condition the arteries must extend over an increased distance. This can be seen in FIGS. 10 and 11.

(36) The strains calculated and shown in FIGS. 10 and 11 relate to examples of stents. It will be appreciated that with different stent patterns (i.e. the pattern of struts or wires forming the stent) the equivalent calculations can be made and will show the same trends in strains when the stents are loaded in a similar manner.

(37) In FIGS. 4 to 6 there is illustrated another medical device 10 according to the invention, which is similar to the medical device 1 of FIGS. 1 to 3. In this case the stent 10 is bendable through two bends between the first loaded configuration (FIG. 4) and the second loaded configuration (FIG. 5).

(38) In the unloaded configuration the longitudinal axis of the stent 10 is curved through two bends in a two-dimensional plane (FIG. 6).

(39) FIGS. 4 to 6 illustrate multiple bends in one plane. FIG. 4 illustrates the stent 10 deployed in the unloaded vessel, FIG. 5 illustrates the stent 10 deployed in the loaded vessel, and FIG. 6 illustrates the stent 10 in the unloaded configuration.

(40) The curve embodied represents a configuration between the two opposing extremes of deformation of the blood vessel, such as those shown in FIGS. 4 and 5. In this case, the stent geometry, as shown in FIG. 6, represents a deformed state in between the straight unloaded state (FIG. 4) and the loaded state (FIG. 5).

(41) FIGS. 7 to 9 illustrate a further medical device 20 according to the invention, which is similar to the medical device 1 of FIGS. 1 to 3.

(42) In this case the stent 20 is bendable and twistable through multiple bends between the first loaded configuration (FIG. 7) and the second loaded configuration (FIG. 8).

(43) In the unloaded configuration the longitudinal axis of the stent 20 is curved through multiple bends in three-dimensional space (FIG. 9). In this case in the unloaded configuration the stent 20 is helically shaped.

(44) When the stent 20 is deployed in the blood vessel, the stent 20 exerts force on the blood vessel causing the blood vessel to adopt a helical configuration. In this manner the stent 20 acts to support at least part of the internal wall of the blood vessel in the helical configuration. Blood flowing through the helically shaped blood vessel then undergoes a swirling action. The swirling flow of blood has been found to minimise thrombosis and platelet adhesion, and to minimise or prevent coverage of the stent 20 by ingrowth of intima. The flow pattern in the blood vessel including the swirling pattern induced by the non-planar geometry of the blood vessel operates to inhibit the development of vascular diseases such as thrombosis/atherosclerosis and intimal hyperplasia.

(45) FIGS. 7 to 9 illustrate multiple bends of the blood vessel in two planes allowing the stent 20 to shorten in a controlled fashion and under lower strains. FIG. 7 illustrates the unloaded vessel, FIG. 8 illustrates the loaded vessel, and FIG. 9 illustrates the stent 20 in the unloaded configuration.

(46) FIG. 12 shows an example of a stent 30 having a helical longitudinal axis. In position A shown in FIG. 12, the helical stent is in a first loaded configuration, when the leg is straight. When the leg is partially bent, the stent is in an unloaded configuration shown at position B. When the leg is more bent, to a sitting position, the stent 30 is in a second loaded configuration. In position C the stent is axially compressed.

(47) When the stent is in position B, in its unloaded configuration, it has a certain relative amplitude and helical pitch. In position A when the stent is in its elongated first loaded configuration, the relative amplitude is decreased and the pitch is increased. In position C, when the stent is axially compressed, the relative amplitude is increased and the pitch is decreased.

(48) The strains which are induced in stent 30 were investigated using finite element analysis and the results are shown in the graph of FIG. 12. When the stent is first deployed in the straight leg, the stent is elongated due to the radial constraint of the artery. This induces a maximum principal strain of approximately 0.26%. Upon bending of the leg, the stented artery shortens into the helical geometry shown at position B. The stented artery has an axial compression of zero when the leg is straight and at position B it has approximately 3% compression. At that stage, the stent is in its unloaded configuration and strains in the stent are zero. Upon further bending of the leg, more axial compression of the stented artery is induced causing the stent to become more helical (increased relative amplitude and decreased pitch) and the maximum principal strain in the stent to increase to approximately 0.4% at 9% stented artery axial compression. This is shown at position C.

(49) FIG. 13 shows an example of a straight stent for comparison purposes. Such known stents are not designed to take up a helical geometry naturally. Position D shows the straight stent when the leg is straight. As the leg bends, finite element analysis predicts that the stent will buckle and kink causing strains in excess of 1.6%, as shown at position E in FIG. 13. This level of strain may cause a fracture of the stent.

(50) Thus for the same loading, the straight stent will exhibit higher strains than the stent with geometry which is intermediate the loaded and unloaded configurations.

(51) The strains calculated and shown in FIGS. 12 and 13 relate to examples of stents. It will be appreciated that with different stent patterns (i.e. the pattern of struts or wires forming the stent) the equivalent calculations can be made and will show the same trends in strains when the stents are loaded in a similar manner.

(52) The helical longitudinal axis of a helical stent may follow a circular path when viewed from an end of the stent. The longitudinal axis may rotate around a central axis which is at the geometrical centre of an envelope in which the helical stent is contained. The central axis may be straight or may itself be curved, for example curved in a two-dimensional plane. The helical longitudinal axis of the stent may not necessarily be circular when viewed along the central axis, i.e. from an end of the stent. For example, the longitudinal axis could be elliptical to form an elliptical helix, or other curve in three-dimensional space. If the longitudinal axis is elliptical, then preferably the major axis of the ellipse is aligned with the plane in which the body part, such as a knee or elbow, bends.

(53) FIGS. 10 and 11 show how an improved result can be obtained with a stent having a bend in one plane, whilst FIGS. 12 and 13 show how an improved result can be obtained with a stent having a longitudinal axis curved in three-dimensional space, e.g. helical. An improved result can similarly be obtained during compressive loading by a stent with multiple bends in one plane, for example having a sinusoidal or serpentine longitudinal axis. Such a stent is shown for example in FIGS. 4-6.

(54) The geometries described, which are intermediate to the loaded and unloaded configurations, could also be manifested in a piecewise fashion, i.e. a series of straight sections along the stent, whose orientation varies with respect to one another, to achieve an overall curvature or series of bends along the stent. Thus the longitudinal axis of the stent overall could have a zig-zag shape or a saw tooth shape.

(55) FIG. 14 shows part of a helical stent and explains some of the parameters used in this specification.

(56) The stent shown in FIG. 14 has a circular cross-section, an internal diameter D and a wall thickness (not shown). The stent is shaped in a helix and has a longitudinal helical axis 40 which follows a helical path about a central longitudinal axis 50. The longitudinal helical axis 40 has an amplitude A (as measured from mean to extreme) and a pitch P. The stent is contained in an imaginary envelope 60 which extends longitudinally and has a width equal to the swept width of the stent. The central longitudinal axis 50 is at the centre of the envelope 60 and may also be referred to as an axis of helical rotation.

(57) It will be appreciated that the stent may be moved between the first loaded configuration and the second loaded configuration under the action of any loading mode. For example the device may be deformed between the first loaded configuration and the second loaded configuration, and/or the device may be compressed between the first loaded configuration and the second loaded configuration.

(58) The invention is not limited to the embodiments hereinbefore described, with reference to the accompanying drawings, which may be varied in construction and detail.