Endoluminal drug delivery device

Abstract

Endoluminal drug delivery device (10) for delivering medicament to a target site in an anatomical lumen. The device (10) includes an elongate body (20), a plurality of microneedles (30) arranged along the body (20), and an actuator (40). The body (20) defines a medicament lumen (22) configured to couple to convey medicament through the body (20). The microneedles (30) are arranged along the body (20) and each in fluid communication with the lumen (22) to allow expelling the medicament therefrom. The body (20) is deformable, by operating the actuator (40), between a first configuration, where the body (20) is shaped to pass through the anatomical lumen, and a second configuration, where the body (20) is shaped to press the microneedles (30) against the wall of the anatomical lumen such that the microneedles 30 are arranged circumferentially about a portion of the wall.

Description

" Endoluminal Drug Delivery Device "Technical Field

[0001] The present disclosure relates generally to an endo luminal drug delivery device and method for delivering medicament to an anatomical lumen, such as to the intima and sub-intima of a blood vessel. In particular, although not necessarily exclusively, the disclosure relates to an endoluminal drug delivery device and method for delivering medicament to a target site in an anatomical lumen such as a fibroatheroma in a wall of a blood vessel.Background

[0002] Atherosclerosis is the pathophysiology underlying Cardiovascular Disease, including Coronary Heart Disease, and Cerebrovascular Disease, which can be lifethreatening. Atherosclerosis is a disease of the intimal layer of arteries, involving lipid deposition and inflammation, which can lead to the formation of plaques within the blood vessel wall. The plaques may cause occlusion, stenosis, and wall weakness, and may ultimately result in infarction, ischaemia, or aneurysm formation.

[0003] Early pathological indications of the disease include isolated foam cells and morphologies of fatty streaks, which can be found in children in the first decade of life. The intermediate form of the disease includes the formation of fibroatheromas that contain both soft lipid (atheroma) and fibrous tissue. As the inflammatory process becomes chronic and there is increased deposition of extracellular connective tissue and calcification, fibrotic and fibrocalcific plaque types are predominant. These plaque types are termed stable plaques.

[0004] Complicated plaques are characteristic of late stage atherosclerosis and can cause clinical events such as sudden death, or heart attacks. Complicated plaques have a defect in their intimal surface that exposes platelets and clotting factors in the blood to the plaque contents and tissues of the vessel media. This leads to thrombusformation which can result in vessel occlusion or stenosis. This process is dynamic. If thrombus formation does not lead to vessel occlusion or stenosis, healing of the surface defect can occur without clinical consequence. Healed plaques commonly progress into thick-capped fibroatheroma and fibrocalcific plaque types which are stable.

[0005] A particular subtype of fibroatheroma, the thin-capped fibroatheroma, is the plaque type found to precede complicated plaques. The lipid pool or necrotic core in these plaques has a thin (<65um) cap of fibrous tissue between it and the blood flowing inside the artery. Rupture of this cap of fibrous tissue typically leads to the development of a complicated plaque.

[0006] Over the last decade, a number of technologies have emerged to allow identification of vulnerable coronary plaques. These include both non-invasive technologies, such as computed tomography coronary angiography, and invasive technologies performed during invasive coronary angiography, such as near infrared spectroscopy. Current treatment options being trialled for vulnerable coronary plaques include permanent implant of drug-eluting stents, or the use of a cryoballoon system.

[0007] There is a clinical need to harness the pathophysiology of atherosclerosis and to specifically target and treat thin-capped fibro atheromas to evolve into stable plaque types for the prevention of clinical cardiovascular events, or otherwise debulk, reduce or reverse complex plaque formation for the prevent of clinical cardiovascular events.

[0008] Any discussion of documents, acts, materials, devices, articles or the like which has been included in the present specification is not to be taken as an admission that any or all of these matters were common general knowledge in the field relevant to the present disclosure as it existed before the priority date of each of the appended claims.Summary

[0009] According to some disclosed aspects, there is provided an endoluminal drug delivery device for delivering medicament to a target site at a wall of an anatomical lumen, the device including: an elongate body defining a medicament lumen having an inlet configured to couple to a supply of the medicament, the medicament lumen arranged to convey the medicament through the body, a plurality of microneedles arranged along the body, each microneedle being in fluid communication with the medicament lumen to allow expelling the medicament from the microneedle, and an actuator, the body being deformable by operating the actuator to transition between a first configuration, where the body is shaped to allow passing through the anatomical lumen, and a second configuration, where the body is shaped to define a notional cylinder to allow pressing the microneedles against the wall of the anatomical lumen such that the microneedles are arranged circumferentially about a portion of the wall.

[0010] The body may be in an expanded state in the first configuration and a compressed or contracted state in the second configuration.

[0011] The body may be configured as a helical coil configured to expand or contract to transition between the first and second configurations.

[0012] The body may be at least partially formed from a shape memory material to facilitate deformation between the first configuration and the second configuration. For example, the body may be formed from a shape memory alloy such as nitinol. The body may be biased to move from the first configuration to the second configuration, e.g. by virtue of it being formed of the shape memory material.

[0013] In some embodiments, the actuator may be mechanically coupled to the body to cause or trigger the deformation of the body.

[0014] The actuator may include a balloon carrying the body such that inflating or deflating the balloon causes deformation of the body to transition between the first configuration and the second configuration.

[0015] The actuator may include a sheath dimensioned to at least partially receive the body, the sheath arrangeable about the body such that removal of the sheath causes deformation of the body to transition from the first configuration to the second configuration. The body may be biased to transition from the first configuration to the second configuration upon removal of the sheath, e.g. as a result of the body being formed of a shape memory material.

[0016] The actuator may include a guide wire movable relative to all or part of the body such that movement of the guidewire causes deformation of the body to transition between the first configuration and the second configuration. For example, in some embodiments, the guidewire may be configured to be received within the medicament lumen, the guidewire being moveable within the medicament lumen between an inserted position and a retracted position. In the retracted position, the guidewire may be withdrawn from the medicament lumen whereupon the body may deform between the first configuration and the second configuration, e.g., as a result of the body being formed of a shape memory material. As another example, the guidewire may be fixed to a first end of the body and movement of the guidewire (e.g. by pulling or pushing) may force the body to transition between the first and second configurations by forcing the first end of the body to move relative to an opposite second end of the body.

[0017] The body may define a longitudinal axis, and each of the plurality of microneedles may be arranged to extend radially outwardly from the body at an orthogonal or non-orthogonal (oblique) angle relative to the longitudinal axis.

[0018] The body may define an operative front end that leads insertion of the body into the anatomical lumen, and each of the plurality of microneedles may be configured to extend from the body at an oblique angle, in a direction away from the front end ofthe body. The angling of the microneedles may facilitate insertion of the body into the anatomical lumen and / or reduce the possibility of dissection of the anatomical lumen.

[0019] According to some disclosed aspects, there is also provided a drug delivery device assembly for delivering medicament to a target site at a wall of an anatomical lumen, the assembly including the endoluminal drug delivery device described above and a scope configured to carry one or more of: an imaging or sensing device configured for insertion into the anatomical lumen to detect, image and / or analyse the target site at the wall of the anatomical lumen; or a delivery guidewire configured to carry the body to facilitate insertion of the endoluminal drug delivery device to the target site in the anatomical lumen.

[0020] The one or more imaging or sensing devices may include one or more of an imaging catheter, camera, temperature sensor, pressure sensor or force sensor and / or any other sensor suitable for insertion into the anatomical lumen and detection, imaging and / or analysing of the target site at the wall of the anatomical lumen.

[0021] According to some disclosed aspects, there is also provided a method for delivery of a medicament to a target site at a wall of an anatomical lumen, the method including: inserting an endoluminal drug delivery device into the anatomical lumen, the endoluminal drug delivery device having an elongate body defining a medicament lumen having an inlet for coupling to a supply of medicament, and a plurality of microneedles arranged along the body, each microneedle in fluid communication with the medicament lumen; operating an actuator to transition the body between a first configuration, where the body is shaped to allow passing through the anatomical lumen, and a second configuration, where the body is shaped to define a notional cylinder to press the microneedles against the wall of the anatomical lumen such that the microneedles are arranged circumferentially about a portion of the wall; andconveying the medicament through the medicament lumen to be expelled from the microneedles and into the wall of the portion of the anatomical lumen.

[0022] The actuator may be configured according to one or more of the actuators described above.

[0023] For example, when the actuator includes an inflatable balloon, operating the actuator may include inflating the balloon to transition the body between the first configuration and the second configuration.

[0024] In some instances, the method may include transitioning the body between the second configuration and the first configuration. In some instances, transitioning the body between the second configuration and the first configuration may include reoperating the actuator.

[0025] When the actuator includes an inflatable balloon, for example, re-operating the actuator may include deflating the balloon to transition the body between the second configuration and the first configuration.

[0026] The method may include removing the endoluminal drug delivery device from the anatomical lumen.

[0027] Throughout this specification the word “comprise”, or variations such as “comprises” or “comprising”, will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps.

[0028] It will be appreciated embodiments may comprise steps, features and / or integers disclosed herein or indicated in the specification of this application individually or collectively, and any and all combinations of two or more of said steps or features.Brief Description of Drawings

[0029] Embodiments will now be described by way of example only with reference to the accompany drawings in which:

[0030] Figures 1 and 2 shows an isometric and side view, respectively, of an endoluminal drug delivery device;

[0031] Figure 3 shows a side view of an elongate body of the endoluminal drug delivery device of Figures 1 and 2;

[0032] Figure 4 is a detail view of the endoluminal drug delivery device of Figures 1 and 2;

[0033] Figure 5 is an end view of the elongate body of Figure 3;

[0034] Figures 6A and 6B are further detail views of the endoluminal drug delivery device of Figures 1 and 2, these figures illustrating a microneedle of the elongate body;

[0035] Figure 7 shows microscopic views of microneedles of the endoluminal drug delivery device of Figures 1 and 2; and

[0036] Figure 8 is a flow chart illustrating use of an endoluminal drug delivery device.Description of Embodiments

[0037] In the drawings, reference numeral 10 generally designates an endoluminal drug delivery device 10 for delivering medicament to a target site at a wall of an anatomical lumen. The wall may contain diseased or damaged tissue, such as a fibroatheroma, for example. The device 10 includes an elongate body 20, a plurality of microneedles 30 arranged along the body 20, and an actuator 40. The elongate body 20, defines a medicament lumen 22 having an inlet 24 configured to couple to a supply of the medicament, the medicament lumen 22 being arranged to convey the medicament through the body 20. The plurality of microneedles 30 are arranged along the body 20, each microneedle 30 being in fluid communication with the medicament lumen 22 to allow expelling of the medicament from the microneedle 30. The body 20 is deformable by operating the actuator 40 to transition the body 20 between a first configuration, where the body 20 is shaped to allow passing through the anatomicallumen, and a second configuration, where the body 20 is shaped to define a notional cylinder to allow pressing the microneedles 30 against the wall of the anatomical lumen such that the microneedles 30 are arranged circumferentially about a portion of the wall.

[0038] The disclosed device 10 is described with reference to delivering medicament to treat fibroatheroma in a wall of a blood vessel. It will be appreciated that the device 10 is not limited to this application and may be used as a medicament delivery platform for treatment of other diseases, such as transplant vasculopathy, or for other applications requiring delivery of a fluid to a target site circumferentially about a wall of an anatomical lumen.

[0039] Figures 1 to 7 illustrate an embodiment of the drug delivery device 10. In the illustrated embodiment, the body 20 defines a helical coil portion 21 configured to change in shape to expand or contract, such as by the coil being shortened or elongated, to transition between the first and second configurations.

[0040] Figs. 1 to 6B show the body 20 in the second configuration where the coil portion 21 defines the notional cylinder. In this embodiment, best shown in Figs. 3 and 5, the plurality of microneedles 30 are arranged along an outer surface 26 of the helical coil 21 so that the microneedles face outwardly. This arrangement means that, in use, in the second configuration, the microneedles 30 may penetrate surrounding tissue to allow delivering of medicament about the periphery of the portion of the wall of the anatomical lumen. This arrangement of the microneedles 30 by deforming the body 20 into its expanded (second) configuration forms a three-dimensional (non-planar) array of the microneedles 30 which can usefully optimise surface area, which may be penetrated by the microneedles 30 and, as a result, increase the likelihood of delivering medicament to the target site in the wall of the anatomical lumen.

[0041] The first configuration of the illustrated embodiment of the device 10 corresponds to a compressed and / or contracted configuration of the body 20. In the compressed and / or contracted configuration, the body 20 is shaped to define amaximum diameter dimensioned to be less than the cross-sectional area of the anatomical lumen within which the device 10 is intended to be inserted. The first configuration therefore facilitates insertion and passing of the body 20 through the anatomical lumen without colliding with or otherwise damaging the wall of the anatomical lumen.

[0042] The second configuration of the illustrated embodiment of the device 10 corresponds to an expanded configuration of the body 20. In the expanded configuration, the body 20 is shaped to define a maximum diameter dimensioned to be equivalent to or greater than the cross-sectional area of the anatomical lumen, such that the microneedles 30, when arranged within the anatomical lumen, are pressed against, and may penetrate, the wall of the anatomical lumen.

[0043] In other embodiments, the body 20 is configured to define other suitable structures which arrange the microneedles 30 in a three-dimensional array to facilitate delivery of medicament circumferentially about the wall of the anatomical lumen. For example, in some embodiments (not illustrated), the body 20 is configured as a deformable framework of interconnected members, such as including an array of spaced hoops, and / or wires which transition between the first, compact configuration, and second, expanded configuration to define the notional cylinder or cylindrical portion. Such embodiments may be configured so that the body 20 is biased to return to one or other of the configurations, such as by including a spring or similar resiliently deformable structure. Similar to the embodiment described above, in such embodiments, the plurality of microneedles 30 are arranged along an outer surface of the framework to allow pressing circumferentially about the wall of the anatomical lumen when in the second configuration. To transfer medicament to the plurality of microneedles 30, each frame member and / or wire carrying the microneedles 30 are in fluid communication with the medicament lumen 22 of the body 20.

[0044] In some embodiments, the body 20 of the device 10 is at least partially formed from a shape memory alloy, such as nitinol, to facilitate deformation between the first configuration and the second configuration. For example, in some embodiments (notillustrated), the body 20 may comprise a spine of shape memory alloy joined to another elastically deformable material, such as silicone. In the illustrated embodiment, the entire body 20, including the microneedles 30, is a unitary structure formed from nitinol. In other embodiments, the body 20 may be formed of any other suitable material having elastic and / or resiliently deformable properties capable of deformation to allow transition between the first and second configurations. In some embodiments, the body 20 may be formed of a biodegradable and / or dissolvable material, such as magnesium, that is capable of degrading and / or dissolving in the anatomical lumen after a period of time, for example one to two weeks, following delivery of the medicament. In some embodiments (not illustrated), the microneedles 30 may be formed separately from and joined to the body 20, such that the microneedles 30 are formed from an alternative suitable material. For example, the microneedles 30 may be formed from Polydimethylsiloxane (PMDS) and mounted to the body 20, such as by being secured within one or more slots defined by and spaced along the body 20.

[0045] Operation of the actuator 40 transitions the body 20 between the first configuration and the second configuration. In some embodiments, the actuator is mechanically coupled to the body 20. In other embodiments, the actuator is electrically coupled to the body 20. Coupling of the actuator with the body may involve direct coupling, where the actuator 40 is directly connected to the body 20, or indirect coupling where the actuator 40 and the body 20 are coupled by an intermediary component. Operation of the actuator 40 is desired when the body 20 has reached the target site within the anatomical lumen, e.g., adjacent a portion of the anatomical lumen wall containing diseased or damaged tissue such as a fibroatheroma, to cause deforming the body 20 to the second configuration before delivering medicament through the microneedles 30. Advantageously, the actuator 40 may be deactivated, or operated again, to cause transitioning of the body 20 to the first configuration to allow moving the device 10 away from the target site, such as to remove the device 10 after treatment. In some embodiments, where the device 10 is made of a biodegradable and / or dissolvable material, the body 20 may be configured to be plastically deformable such that the body 20 is deformable permanently to the second configuration, for example, to be arranged against or engaged with surrounding tissue. Additionally oralternatively, the actuator 40 may be configured to be detachable from the body 20 so that the actuator 40 is removable from the anatomical lumen without causing the body 20 to transition between the second configuration and the first configuration, such that the body 20 remains within the anatomical lumen to dissolve over time.

[0046] In the illustrated embodiment, the actuator includes a balloon 42 carrying the body 20. The balloon 42 is coupled to the body 20 such that inflating the balloon 42 causes the balloon to press against an interior of the coil portion 21 of the body 20 to cause deformation of the body 20 to transition to the second configuration. Deflating the balloon 42 may allow the body 20 to transition back to the first configuration naturally, e.g. due to shape memory of the body 20, or may result in the balloon 42 actively pulling on the interior of the coil portion 21 of the body 20 to cause deformation of the body 20 to transition to the first configuration.

[0047] In the illustrated embodiment, the entire body 20 is arranged around, and carried by the balloon 42. It will be appreciated that, in other embodiments (not illustrated), only a portion of the body 20 may be carried by the balloon 42, such as the coil portion 21 of the body 20. In some embodiments, the balloon 42 includes at least one opening 44 configured to be attached to a fluid source to allow introducing or removing fluid from within the balloon to cause inflation / deflation.

[0048] Figures 1 and 2 show the balloon 42 in an inflated state in which it has caused the body 20 to transition to the second, expanded configuration. In this configuration, in use, the body 20 is shaped to be in contact with the wall of the anatomical lumen such that the array of microneedles 30 are pressed into and pierce the surrounding wall to deliver the medicament at the target site. Best shown in Fig. 5, the arrangement of the microneedles 30 along the coil portion 21 means that, in use, the microneedles 30 are arranged circumferentially about a portion of the wall to allow delivering medicament circumferentially about that portion. While Fig. 5 shows the microneedles 30 spaced at 90 degree intervals about the axis A of the body 20 in the second configuration, it will be appreciated that the body 20 may be configured to have more, or less microneedles 30, such that the angular spacing is less, or more than, thearrangement shown in this figure. Deflation of the balloon 42 can trigger the transition of the body 20 from the second configuration to the first configuration for removal of the device 10 from the anatomical lumen, or allow moving through the anatomical lumen to a second treatment site.

[0049] In other embodiments (not illustrated), the actuator 40 includes a sheath dimensioned to at least partially receive the body 20. In some embodiments, the entire body 20 is received within the sheath. The sheath is arrangeable about the body such that removal of the sheath causes deformation of the body to transition from the first configuration to the second configuration. For example, the body 20 may be compressed or otherwise contracted, in the first configuration, to be at least partially received within the sheath, to allow insertion into, and passing through, the anatomical lumen to the target site. When the sheath is removed from the body 20, this allows the body to expand, unfurl, or stretch, to transition to the second configuration, e.g., by virtue of the body 20 being formed of a shape-memory material. The sheath is typically configured to be re-advanced onto the body 20, such as to cause compression or restriction of the body 20, after delivery of the medicament to transition deformation of the body 20 from the second configuration to the first configuration to facilitate moving the device 10 through the anatomical lumen to remove the device.

[0050] In another embodiment (not illustrated), the actuator 40 includes a guidewire that is movable relative to all or part of the body 20 such that movement of the guidewire causes deformation of the body 20 to transition between the first configuration and the second configuration. In such embodiments, the guidewire may be configured to be received within the medicament lumen 22 and attached to the body at or towards a front end 28. In this embodiment, the guidewire may extend within the medicament lumen 22 along the length of the body 20 to carry the body 20, or may extend only through the coil portion 21, should the body 20 be configured to define this portion 21. In this arrangement, drawing the guidewire through the medicament lumen 22 towards a rear end 27 of the body 20 may cause the front and rear ends 28, 27 of the body 20 to move closer together and therefore cause the body expand outwardly to form the coil portion 21 to define the notional cylinder in the second configuration and,conversely, drawing the guidewire through the medicament lumen 22 towards the front end 28 of the body 20 may cause the front and rear ends 28, 27 of the body 20 to move further apart and therefore cause the body 20 to contract inwardly to transition to the first configuration.

[0051] In some embodiments, particularly where the body 20 defines the coil portion 21, the guidewire is configurable as a stiff wire so that when inserted in the medicament lumen 22 this causes the helical coil 21 to straighten over a length of the guidewire to transition to the first configuration facilitating insertion and delivery of the device through the anatomical lumen to the target site. In this arrangement, the guidewire may be withdrawn from the medicament lumen 22 to allow the body 20 to return to the second configuration, such that the body 20 defines the coil portion 21 and may press against the wall of the anatomical lumen.

[0052] Referring to Figure 3, the body 20 defines opposed ends 27, 28 and a longitudinal axis A between the ends 27, 28. In the illustrated embodiment, each of the plurality of microneedles 30 are arranged to extend from the body 20 at an orthogonal angle (perpendicular) relative to the longitudinal axis A. In other embodiments, at least some, or each, of the plurality of microneedles 30 are arranged to extend from the body 20 at a non-orthogonal angle relative to the longitudinal axis A. For example, each microneedle 30 may be arranged at an oblique angle ranging e.g. between 90 and 180 degrees, or 100 and 160 degrees, or 100 and 140 degrees, from the longitudinal axis A. The body 20 defines an operative front end 28 intended to lead insertion of the body into the anatomical lumen, and each of the plurality of microneedles 30 are typically shaped such that the angle extends in a direction away from the front end 28. This angled arrangement of the microneedles 30 may facilitate puncture of the wall of the anatomical lumen in an upstream direction relative to the flow of bodily fluids, for example the flow of blood in a blood vessel, when the body 20 is moved to the second configuration. This angled arrangement of the microneedles 30 may also inhibit the microneedles 30 colliding with, and potentially dissecting, tissue during insertion of the device 10 to the anatomical lumen e.g. in the (downstream) direction of flow of bodily fluids, for example the flow of blood in a blood vessel. Additionally, this arrangementmay also reduce the risk of a clinically problematic tissue damage or dissection occurring within the anatomical lumen during withdrawal of the device 10, as the flow of bodily fluid may correct any minor tissue abrasions caused by the microneedles during withdrawal in a counter, upstream direction. The flow of bodily fluid may align the tissue back towards the wall of the anatomical lumen. Nevertheless, in other embodiments (not illustrated), the microneedles 30 may be arranged at an oblique angle in a direction towards the front end 28 which may inhibit the microneedles 30 colliding with, and potentially dissecting, tissue during withdrawal of the device 10 from the anatomical lumen.

[0053] Microneedles 30 according to an embodiment of the present disclosure are shown in more detail in Figure 7, which includes three views of the microneedles 30, captured with a microscope. The microneedles are arranged at an oblique angle relative to the axis A of the body 20. These images illustrate the directional configuration of the microneedles 30, specifically shaped to facilitate puncture of the wall of the anatomical lumen in an upstream direction. In this embodiment, the microneedles each have an oblique triangular prism shape and an outlet 31 of each microneedle is located at or adjacent to a tip 32 of the oblique triangular prism shape. However, a variety of different shapes and configurations of microneedles may be employed such as cylindrical or conical shapes.

[0054] The endoluminal drug delivery device 10 as described above may form a component of an endoluminal drug delivery assembly (not illustrated). In some embodiments, the drug delivery assembly includes a scope configured to carry one or more of: an imaging or sensing device to detect, image and / or analyse the target site at the wall of the anatomical lumen (e.g. diseased tissue, such as fibroatheroma) and / or a delivery guidewire configured to carry, or be arranged alongside, the body 20 to facilitate insertion of the endoluminal drug delivery device to the target site at the anatomical lumen. In some embodiments, the delivery guidewire may also act as an actuator as previously described. The imaging or sensing device may include one or more of an imaging catheter, camera, temperature sensor, pressure sensor or force sensor and / or any other sensor suitable for insertion into the anatomical lumen anddetection, imaging and / or analysing of the target site at the wall of the anatomical lumen. In such embodiments, the body 20 of the device 10 may be arranged about an end, or over, a scope or delivery guidewire or within a lumen of the scope, and be configured for advancing through the anatomical lumen. The assembly including both the device 10 and an imaging or sensing device may allow detection of the target site within the wall of the anatomical lumen, and actuation of the device to deliver treatment with the medicament may occur in series without the need to remove and reinsert multiple varying devices, limiting the risk of damaging and dissecting tissue during the procedure.

[0055] A method for delivery of a medicament to a target site containing diseased or damaged tissue, such as a fibroatheroma, at a wall of an anatomical lumen, according to one embodiment is shown as flowchart 100 in Figure 8. The illustrated method 100 includes, initially at step 110, inserting an endoluminal drug delivery device into the anatomical lumen. The endoluminal drug delivery device may be the device 10 described above, having an elongate body 20 defining a medicament lumen 22 having an inlet 24 for coupling to a supply of medicament, and a plurality of microneedles 30 arranged along the body 20, each microneedle in fluid communication with the medicament lumen 22. The method 100 also includes, at step 120, operating an actuator to transition the body 20 of the device 10 between a first configuration, where the body 20 is shaped to allow passing through the anatomical lumen, and a second configuration, where the body is shaped to define a notional cylinder to press the microneedles 30 against the wall of the anatomical lumen such that the microneedles are arranged circumferentially about a portion of the wall. The method 100 then involves, at step 130, conveying the medicament through the medicament lumen 22 to be expelled from the microneedles 30 and into the wall of the portion of the anatomical lumen 130.

[0056] The method may also include, at step 140, transitioning the body 20 between the second configuration and the first configuration, e.g. by a re-operation of the actuator, and at step 150, removing the endoluminal drug delivery device 10 from the anatomical lumen.

[0057] Operating the actuator 40 may involve inflating a balloon carrying the body 20 to transition the body 20 between the first configuration and the second configuration, such as by causing expansion of the structure of the body 20, or other deformation. If transitioning the body 20 between the second configuration and the first configuration, the method may also include re-operating the actuator. In this instance, re-operating the actuator may involve deflating the balloon to transition the body 20 between the second configuration and the first configuration, such as by causing compression, or by removing force to allow the body 20 to resiliently return to its original (compact) shape.

[0058] Operating the actuator 40 may include removing or at least partially withdrawing a sheath wrapped around the body 20 to cause deformation of the body 20 to transition from the first configuration to the second configuration, such as by allowing the body 20 to resiliently return to its original (expanded) shape. If transitioning the body 20 between the second configuration and the first configuration, the method may also include re-operating the actuator. In this embodiment, reoperating the actuator may include advancing the sheath over the body 20.

[0059] Operating the actuator 40 may include moving a guidewire relative to the body 20 of the device 10 typically being through the medicament lumen 22 of the body 20. Moving the guidewire may involve retracting the guidewire from the body 20, or inserting the guidewire into the body 20. If transitioning the body 20 between the second configuration and the first configuration, the method may also include reoperating the actuator. In this scenario, re-operating the actuator includes the inverse relative movement, being inserting or retracting the guidewire from the body 20.

[0060] In embodiments where the body 20 of the device 10 is made from a biodegradable and / or dissolvable material, such as magnesium, the method may involve configuring the actuator 40 to be removable from the anatomical lumen without causing the body 20 to transition between the second configuration and the first configuration, such that the body 20 remains within the anatomical lumen. In this instance, the method may involve removing the actuator 40 from the anatomical lumen while leaving the body 20 of the device 10 at the target site within the anatomicallumen to degrade and / or dissolve after a period of time, for example one to two weeks, following delivery of the medicament.

[0061] The device 10 is configured to be readily passed through an anatomical lumen, in the first configuration, to be adjacent a target site, and then actuated to transition to the second configuration to define the notional cylinder to urge the microneedles 30 against the site and deliver medicament to the site. The arrangement of the microneedles 30 along the body 20, and consequently along the notional cylinder, forms a three-dimensional array of microneedles 30 able to deliver medicament circumferentially about a portion or section of the anatomical lumen. This enhances the likelihood that medicament will be delivered to the target site, for example, into the fibroatheroma, or other target area, which can enhance effectiveness and / or efficiency of the treatment procedure.

[0062] The device 10 provides a tool for invasive treatment of diseased or damaged tissue, for example, fibroatheroma, at a wall of an anatomical lumen, for example, a blood vessel, or otherwise delivering medicament into the wall of the anatomical lumen, which is only temporarily present and is configured to inhibit or otherwise minimise causing damage to tissue during use.

[0063] The device 10 provides a tool for circumferential treatment of a wall of an anatomical lumen. This may be advantageous over single or linear endoluminal microneedle devices as the circumferential wall treatment may avoid manipulation of the device 10 or associated assembly, for example, rotation of the device 10, to appropriately treat the target site. The disclosed embodiments with non-orthogonal microneedle 30 alignment have the potential to reduce the risk of tissue dissection of the anatomical lumen following use of the device 10.

[0064] It will be appreciated by persons skilled in the art that numerous variations and / or modifications may be made to the above-described embodiments, without departing from the broad general scope of the present disclosure. The presentembodiments are, therefore, to be considered in all respects as illustrative and not restrictive.

Claims

CLAIMS:

1. An endoluminal drug delivery device for delivering medicament to a target site at a wall of an anatomical lumen, the device including: an elongate body defining a medicament lumen having an inlet configured to couple to a supply of the medicament, the medicament lumen arranged to convey the medicament through the body, a plurality of microneedles arranged along the body, each microneedle being in fluid communication with the medicament lumen to allow expelling the medicament from the microneedle, and an actuator, the body being deformable by operating the actuator to transition between a first configuration, where the body is shaped to allow passing through the anatomical lumen, and a second configuration, where the body is shaped to define a notional cylinder to allow pressing the microneedles against the wall of the anatomical lumen such that the microneedles are arranged circumferentially about a portion of the wall.

2. The endoluminal drug delivery device of claim 1, wherein the body is configured to expand or contract to transition between the first and second configurations3. The endoluminal drug delivery device of claim 1 or claim 2, wherein the body is configured as a helical coil configured to expand or contract to transition between the first and second configurations.

4. The endoluminal drug delivery device of any one of the preceding claims, wherein the body is at least partially formed from a shape memory material to facilitate deformation between the first configuration and the second configuration.

5. The endoluminal drug delivery device of claim 4, wherein the body is formed from nitinol.

6. The endoluminal drug delivery device of any one of the preceding claims, wherein the actuator is mechanically coupled to the body to cause deformation of the body to transition between the first configuration and the second configuration.

7. The endoluminal drug delivery device of claim 6, wherein the actuator includes a balloon carrying the body such that inflating or deflating the balloon causes deformation of the body to transition between the first configuration and the second configuration.

8. The endoluminal drug delivery device of claim 6, wherein the actuator includes a sheath dimensioned to at least partially receive the body, the sheath arrangeable about the body such that removal of the sheath causes deformation of the body to transition from the first configuration to the second configuration.

9. The endoluminal drug delivery device of claim 6, wherein the actuator includes a guidewire movable relative to the body such that movement of the guidewire causes deformation of the body to transition between the first configuration and the second configuration.

10. The endoluminal drug delivery device of claim 9, wherein the guidewire is configured to be received within the medicament lumen, the guidewire being moveable within the medicament lumen between an inserted position and a retracted position.

11. The endoluminal drug delivery device of claim 9 or 10, wherein the guidewire extends within the medicament lumen along the length of the body to carry the body.

12. The endoluminal drug delivery device of claim 10 or claim 11, wherein, in the retracted position, the guidewire is withdrawn from the medicament lumen to facilitate deformation of the body between the first configuration and the second configuration.

13. The endoluminal drug delivery device of any one of the preceding claims, wherein the body defines a longitudinal axis, and each of the plurality of microneedles are arranged to extend from the body at an orthogonal angle relative to the longitudinal axis.

14. The endoluminal drug delivery device of any one of claims 1 to 12, wherein the body defines a longitudinal axis, and each of the plurality of microneedles are arranged to extend from the body at a non-orthogonal angle relative to the longitudinal axis.

15. The endoluminal drug delivery device of any of the preceding claims, wherein the body defines an operative front end to lead insertion of the body into the anatomical lumen, and each of the plurality of microneedles are shaped such that the angle extends in an oblique angle relative to, and away from, the front end to facilitate passing the body through the anatomical lumen and / or to reduce dissection of the wall of the anatomical lumen.

16. A drug delivery device assembly for delivering medicament to a target site at a wall of an anatomical lumen, the assembly including the endoluminal drug delivery device of any one of claims 1 to 15; and a scope configured to carry one or more of: an imaging or sensing device configured for insertion into the anatomical lumen to detect, image and / or analyse the target site at the wall of the anatomical lumen; or a delivery guidewire configured to carry the body to facilitate insertion of the endoluminal drug delivery device to the target site in the anatomical lumen.

17. A method for delivery of a medicament to a target site at a wall of an anatomical lumen, the method including:inserting an endoluminal drug delivery device into the anatomical lumen, the endoluminal drug delivery device having an elongate body defining a medicament lumen having an inlet for coupling to a supply of medicament, and a plurality of microneedles arranged along the body, each microneedle in fluid communication with the medicament lumen; operating an actuator to transition the body between a first configuration, where the body is shaped to allow passing through the anatomical lumen, and a second configuration, where the body is shaped to define a notional cylinder to press the microneedles against the wall of the anatomical lumen such that the microneedles are arranged circumferentially about a portion of the wall; and conveying the medicament through the medicament lumen to be expelled from the tips of the microneedle and into the wall of the portion of the anatomical lumen.

18. The method for delivery of a medicament of claim 17, wherein operating the actuator includes inflating a balloon carrying the body to transition the body between the first configuration and the second configuration.

19. The method for delivery of a medicament of claim 17 or 18, including transitioning the body between the second configuration and the first configuration.

20. The method for delivery of a medicament of claim 19, including re-operating the actuator to transition the body between the second configuration and the first configuration.

21. The method for delivery of a medicament of claim 18, including transitioning the body between the second configuration and the first configuration by re-operating the actuator, and wherein re-operating the actuator includes deflating the balloon.

22. The method for delivery of a medicament of any one of claims 19 to 21, including removing the endoluminal drug delivery device from the anatomical lumen.

Images