SHUNTING DEVICE

Abstract

An implantable shunting device configured to shunt blood from the left atrium of the heart to the azygous vein through an aperture in the atrial septal wall is provided. The device comprises a flexible tube configured for radial adjustment between a contracted delivery configuration suitable for delivery in a delivery catheter and a deployed radially expanded configuration, the tube having a through lumen, a distal end configured to anchor within the azygous vein, and a proximal end configured to span an aperture in an atrial septal wall and anchor to the wall to provide fluid communication between the left atrium and the azygous vein. Methods of treating heart disease by implanting a shunting device of the invention are also disclosed.

Claims

1-41. (canceled)

42. An implantable shunting device configured to shunt blood from the left atrium of the heart through an aperture in the atrial septal wall, the device comprising a tube configured for radial adjustment between a contracted delivery configuration suitable for delivery in a delivery catheter and a deployed radially expanded configuration, the tube having a through lumen, a distal end, and a proximal end configured to span an aperture in an atrial septal wall and anchor to the wall, characterised in that the distal end of the tube is configured to anchor within the azygos vein and engage the azygos vein in a fluidically tight manner whereby the device is configured to shunt blood from the left atrium of the heart to the azygos vein.

43. An implantable shunting device according to claim 42, in which the distal end of the device is configured for over-expansion in the ostium of the azygos vein, to anchor the distal end of the device in the ostium of the azygos vein and create a fluidically tight connection between the shunting device and the azygos vein.

44. An implantable shunting device according to claim 42, in which the tube is flexible and comprises a structural wire element suitable for maintaining patency of the device and a biocompatible occluding sheath configured to prevent fluid leakage out of the device.

45. An implantable shunting device according to claim 42, in which the device comprises a sensor to detect a parameter of blood within or adjacent to the shunting device.

46. An implantable shunting device according to claim 45, in which the sensor comprises a wireless communication module configured to wirelessly send signals from the sensor to a remote location.

47. An implantable shunting device according to claim 45, comprising a second sensor.

48. An implantable shunting device according to claim 47, in which the sensor is configured to detect a parameter of blood in the left atrium and the second sensor is configured to detect a parameter of blood in the right atrium.

49. An implantable shunting device according to claim 47, in which the sensor is configured to detect blood pressure in the left atrium and the second sensor is configured to detect blood pressure in the right atrium.

50. An implantable shunting device according to claim 42, in which the device comprises a valve, in which the valve is configured to control right to left or left to right blood flow, or passage of thrombus into the left atrium.

51. An implantable shunting device according to claim 50, in which the valve is configured for retro-fitting to the shunting device in-vivo or ex-vivo.

52. An implantable shunting device according to claim 42, in which the proximal end comprises two axially spaced apart expansible retention flange sections configured for expansion on each side of an atrial septal wall to anchor the distal end of the device.

53. (canceled)

54. An implantable shunting device according to claim 42, in which the device is self-expansible.

55. (canceled)

56. An implantable shunting device according to claim 42, in which the device is modular and provided in two or more parts configured for assembly in-situ in the heart.

57. An implantable shunting device according to claim 42, in which the device comprises a first part comprising or consisting essentially of the distal end, and a second part comprising or consisting of the proximal end, wherein free ends of the first and second parts are configured for engagement in-situ in the heart.

58. (canceled)

59. An implantable shunting device according to claim 42, in which the device comprises a structural wire element and a biocompatible occluding sheath disposed on the inside or outside of the structural wire element.

60. An implantable shunting device according to claim 42, in which the device comprises a structural wire element and a biocompatible occluding sheath disposed on the inside or outside of the structural wire element, in which the structural wire element comprises a shape-memory material.

61. An implantable shunting device according to claim 42, in which the device comprises a structural wire element and a biocompatible occluding sheath disposed on the inside or outside of the structural wire element, in which the structural wire element comprises a plurality of circumferential and radially expansible wire struts.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0146] FIG. 1 is an illustration of a human heart in section showing a shunting device of the invention implanted in the heart and providing fluidic communication between the left ventricle of the heart and the azygous vein through an aperture formed in the atrial septal wall.

[0147] FIG. 2A is an illustration of part of the shunting device of FIG. 1 showing the distal end of the shunting device in a constrained configuration (left side) and in a deployed, radially expanded, configuration (right side).

[0148] FIG. 2B is an illustration of part of the shunting device of FIG. 1 showing the proximal end of the shunting device with retention flange sections in a constrained configuration (left side) and in a deployed, radially expanded, configuration (right side).

[0149] FIG. 2C is an illustration of a face pull synch retraction mechanism forming part of the shunting device of the invention.

[0150] FIG. 2D illustrates part of a two-part shunting device according to the invention, having a first part, second part, each having a free end, and tethering elements that are laced between the sinusoidal ring struts at each free end.

[0151] FIG. 3 illustrates a trans-apical method of delivering and anchoring the shunting device of the invention.

[0152] FIG. 4 illustrates a percutaneous method of delivering and anchoring a two-part shunting device of the invention via a combination of a femoral vein/IVC and aorta approach.

[0153] FIG. 5 illustrates a bifurcated delivery device of the invention, and a percutaneous method of delivering and anchoring a two-part shunting device of the invention using the bifurcated delivery device via a femoral vein/IVC approach.

[0154] FIG. 6 is an illustration of the venous architecture showing how the azygous vein can be accessed percutaneously via an approach through the common iliac vein and right ascending lumbar vein.

[0155] FIG. 7 illustrates a modular shunting device according to the invention.

[0156] FIG. 8 illustrates another modular shunting device according to the invention.

[0157] FIG. 9 illustrates anchoring mechanisms of the invention: (A) the anchoring mechanism shown deployed in the azygous vein of the heart; (B) one embodiment of the anchoring mechanism showing the inner and outer tubes and the anchoring barb; (C) showing how axial movement of the inner sleeve relative to the inner sleeve causes the anchoring barb to extend radially outwardly; (D) similar to FIG. 9E, showing the anchoring the barb in the ostium of the azygous vein; (E to G) showing a second embodiment of the anchoring mechanism which is substantially the same as the anchoring system of FIGS. 9B-D with the exception that deployment involves rotational movement of the inner sleeve relative to the outer sleeve.

DETAILED DESCRIPTION OF THE INVENTION

[0158] All publications, patents, patent applications and other references mentioned herein are hereby incorporated by reference in their entireties for all purposes as if each individual publication, patent or patent application were specifically and individually indicated to be incorporated by reference and the content thereof recited in full.

Definitions and General Preferences

[0159] Where used herein and unless specifically indicated otherwise, the following terms are intended to have the following meanings in addition to any broader (or narrower) meanings the terms might enjoy in the art:

[0160] Unless otherwise required by context, the use herein of the singular is to be read to include the plural and vice versa. The term “a” or “an” used in relation to an entity is to be read to refer to one or more of that entity. As such, the terms “a” (or “an”), “one or more,” and “at least one” are used interchangeably herein.

[0161] As used herein, the term “comprise,” or variations thereof such as “comprises” or “comprising,” are to be read to indicate the inclusion of any recited integer (e.g. a feature, element, characteristic, property, method/process step or limitation) or group of integers (e.g. features, element, characteristics, properties, method/process steps or limitations) but not the exclusion of any other integer or group of integers. Thus, as used herein the term “comprising” is inclusive or open-ended and does not exclude additional, unrecited integers or method/process steps.

[0162] As used herein, the term “disease” is used to define any abnormal condition that impairs physiological function and is associated with specific symptoms. The term is used broadly to encompass any disorder, illness, abnormality, pathology, sickness, condition or syndrome in which physiological function is impaired irrespective of the nature of the aetiology (or indeed whether the aetiological basis for the disease is established). It therefore encompasses conditions arising from infection, trauma, injury, surgery, radiological ablation, age, poisoning or nutritional deficiencies.

[0163] As used herein, the term “treatment” or “treating” refers to an intervention (e.g. the administration of an agent to a subject) which cures, ameliorates or lessens the symptoms of a disease or removes (or lessens the impact of) its cause(s) (for example, the reduction in accumulation of pathological levels of lysosomal enzymes). In this case, the term is used synonymously with the term “therapy”.

[0164] Additionally, the terms “treatment” or “treating” refers to an intervention (e.g. the administration of an agent to a subject) which prevents or delays the onset or progression of a disease or reduces (or eradicates) its incidence within a treated population. In this case, the term treatment is used synonymously with the term “prophylaxis”.

[0165] As used herein, an effective amount or a therapeutically effective amount of an agent defines an amount that can be administered to a subject without excessive toxicity, irritation, allergic response, or other problem or complication, commensurate with a reasonable benefit/risk ratio, but one that is sufficient to provide the desired effect, e.g. the treatment or prophylaxis manifested by a permanent or temporary improvement in the subject's condition. The amount will vary from subject to subject, depending on the age and general condition of the individual, mode of administration and other factors. Thus, while it is not possible to specify an exact effective amount, those skilled in the art will be able to determine an appropriate “effective” amount in any individual case using routine experimentation and background general knowledge. A therapeutic result in this context includes eradication or lessening of symptoms, reduced pain or discomfort, prolonged survival, improved mobility and other markers of clinical improvement. A therapeutic result need not be a complete cure. Improvement may be observed in biological/molecular markers, clinical or observational improvements. In a preferred embodiment, the methods of the invention are applicable to humans, large racing animals (horses, camels, dogs), and domestic companion animals (cats and dogs).

[0166] In the context of treatment and effective amounts as defined above, the term subject (which is to be read to include “individual”, “animal”, “patient” or “mammal” where context permits) defines any subject, particularly a mammalian subject, for whom treatment is indicated. Mammalian subjects include, but are not limited to, humans, domestic animals, farm animals, zoo animals, sport animals, pet animals such as dogs, cats, guinea pigs, rabbits, rats, mice, horses, camels, bison, cattle, cows; primates such as apes, monkeys, orangutans, and chimpanzees; canids such as dogs and wolves; felids such as cats, lions, and tigers; equids such as horses, donkeys, and zebras; food animals such as cows, pigs, and sheep; ungulates such as deer and giraffes; and rodents such as mice, rats, hamsters and guinea pigs. In preferred embodiments, the subject is a human. As used herein, the term “equine” refers to mammals of the family Equidae, which includes horses, donkeys, asses, kiang and zebra.

[0167] As used herein, the term “implantable shunting device” means a conduit configured to provide fluidic connection between the left atrium and the azygous vein, via an aperture in the atrial septal wall. The device may be employed to reduce fluid pressure in the left side of the heart, and thereby treat or prevent diseases or conditions characterised by elevated left side pressure. The device has a distal end configured to engage the azygous vein (generally at the ostium of the azygous vein) typically in a fluidically tight manner. In one embodiment, the proximal end of the device is configured for over-expansion in the ostium of the azygous vein, to anchor the end of the device in the vein and create a fluidically tight connection between the shunting device and the vein. The proximal end typically has a “shunt-like” end of the type known in the art configured to anchor to an atrial septal wall (See FIGS. 3A and 3B) having axially spaced-apart expansible retention flanges configured for deployment of each side of the wall to anchor to the wall, although other methods of anchoring to the atrial septal wall and establishing fluid connection with the left atrium via an aperture may be employed. The device is generally flexible and generally self-expansible, although non self-expansible devices that require expansion using a radial expansion device (i.e. a balloon) may be employed. The device (or at least the flexible tube part of the device) generally comprises a structural wire element (suitable for maintaining patency of the device) and a biocompatible occluding sheath (configured to prevent fluid leakage out of the device). The device upon deployment is generally sufficiently flexible to allow it to curve along its length (shown in FIG. 1), but it may also comprise a number of straight sections that are connected at an angle, or are hingedly connected, to provide a route from the aperture in the atrial septal wall to the azygous vein (as shown in FIGS. 7 and 8). The device may be delivered in an assembled form, or it may be delivered in parts and assembled in-situ in the heart.

[0168] As used herein, the term “azygos vein” refers to the part of the pulmonary venous system that transports deoxygenated blood from the posterior walls of the thorax and abdomen into the superior vena cava vein. It is formed by the union of the ascending lumbar veins with the right subcostal veins at the level of the 12th thoracic vertebra, ascending in the posterior mediastinum, and arching over the right main bronchus posteriorly at the root of the right lung to join the superior vena cava. A major tributary is the hemiazygos vein, a similar structure on the opposite side of the vertebral column. Other tributaries include the bronchial veins, pericardial veins, and posterior right intercostal veins. It communicates with the vertebral venous plexuses. Accessing the azygous vein may be achieved by insertion of a catheter into the femoral vein, in a sizable subset of patients, the right ascending lumbar (RAL) vein anastomoses with the right common iliac vein, and in patients with hypervolemic states (i.e. HF), it will be more robustly formed. Advance the catheter into the RAL vein which can be confirmed easily with contrast venography. Advance a wire up the RAL vein in the Azygos and eventually to the Azygous ostium, once through the ostium the catheter will enter the superior vena cava and then the right atrium of the heart.

[0169] As used herein, the term “two-part shunting device” refers to a shunting device of the invention that is provided in two parts which are configured to be connected in-situ in the heart to form an assembled shunting device. For example, the device may comprise a first part comprising the flexible tube and the distal end, and a second part comprising or consisting of the proximal end, where free ends of the first and second parts are configured for engagement in-vivo. In this embodiment, the proximal end is generally anchored in the aperture in the atrial septal wall first, and then the second part of deployed and to the azygous vein, and the parts are then connected in the right atrium to form the assembled device. In another embodiment, the device may comprise a first part comprising the proximal end and a proximal section of the flexible tube (conduit) and a second part comprising the distal end and a distal section of the flexible tube (conduit), whereby free ends of the flexible tube sections are configured for engagement in-vivo. Various engagement means for the free ends of the first and second parts may be employed, for example friction fit ends, magnetic connectors, threaded connectors, suture clips, or re-entrant slot connectors. The ends may be configured to reversible or non-reversible engagement.

[0170] As used herein, the term “structural wire element” refers to the structural skeleton of the device, which is generally configured to allow the device be sufficiently flexible to allow it traverse from the atrial septal wall to the azygous vein), yet maintain patency. The wire element may comprise a single wire element, or a plurality of wire elements which may be connected or un-connected. Suitable structural wire elements are described in the cardiac stent prior art, the details of which will be known to a person skilled in the art. Examples include U.S. Pat. No. 6,468,303, US2017/0113026 and US2018/0263766). In one embodiment, the wire element comprises a plurality radially expansible circumferential struts, axially arranged along the tube. The structural wire element may be formed from a metal, for example stainless steel or a shape memory material such as Nitinol, or from a polymer material which may be laser cut.

[0171] As used herein, the term “biocompatible occluding sheath” refers to the cover on the structural wire element that occludes the lumen of the wire element and may be formed on the inside or outside of the wire element. The biocompatible occluding sheath or coating may be formed from polyethylene, TPU, PTFE stent encapsulation, or an electrospun material such as polyurethanes, urethan co-polymers, PET, or resorbable materials such as PLGA, PLLA, and PLA. The fibre size, material thickness, and fibre orientation can be configured as necessary.

[0172] As used herein, the term “Transluminal delivery” means delivery of the shunting device to a target site (for example the heart) heart through a body lumen, for example delivery through an artery or vein. It is generally carried out by an interventional cardiologist. In one embodiment, the device of the invention is advanced through an artery or vein to deliver the device to the right atrium of the hear.

[0173] As used herein, the term “transapical delivery” means delivery through a wall of the heart. This usually requires a cardiac surgeon, and may be performed by means of open-heart surgery, or by means of key-hole surgery with access though the ribcage.

[0174] As used herein, the term “delivery device” refers to a device, generally a delivery catheter, having at least one lumen configured to receive the shunting device (or part of the shunting device) in a contracted configuration, transport the device to the heart either percutaneously or trans-apically, and deliver the device at a target location in the heart. In one embodiment, the delivery device is configured for retraction relative to the contained device to deploy the device out of a distal end of the delivery device.

[0175] “Energy delivering element” refers to a device configured to receive energy and direct the energy to the tissue, and ideally convert the energy to heat to heat the tissue causing collagen denaturation (tissue ablation). Tissue ablation devices are known to the skilled person, and operate on the basis of emitting thermal energy (heat or cold), microwave energy, radiofrequency energy, other types of energy suitable for ablation of tissue, or chemicals configured to ablate tissue. Tissue ablation devices are sold by ANGIODYNAMICS, including the STARBURST radiofrequency ablation systems, and ACCULIS microwave ABLATION SYSTEMS. In one embodiment, the tissue ablation device comprises an array of electrodes or electrical components typically configured to deliver heat to adjacent tissue. In one embodiment, one or more of the electrodes comprises at least one or two thermocouples in electrical communication with the electrode. In one embodiment, one or more of the electrodes are configured to deliver RF or microwave energy.

[0176] “Sensor” means an electrical sensor configured to detect an environmental parameter within or adjacent to the shunting device, for example blood flow, electrical signal activity, pressure, impedance, moisture or the like. The sensor may be configured to detect a parameter of blood or tissue in the left atrium or right atrium, or both. The sensor may include an emission sensor and a detection sensor that are suitably spaced apart. In one embodiment, the sensor is an electrode. In one embodiment, the sensor is configured to detect fluid flow. In one embodiment, the sensor is configured to detect electrical conductivity. In one embodiment, the sensor is configured to detect electrical impedance. In one embodiment, the sensor is configured to detect an acoustic signal. In one embodiment, the sensor is configured to detect an optical signal typically indicative of changes in blood flow in the surrounding tissue. In one embodiment, the sensor is configured to detect stretch. In one embodiment, the sensor is configured to detect moisture. In one embodiment, the sensor is configured for wireless transmission of a detected signal to a processor. Examples suitable sensor include optical sensors, radio frequency sensors, microwave sensors, sensors based on lower frequency electromagnetic waves (i.e. from DC to RF), radiofrequency waves (from RF to MVV) and microwave sensors (GHz). In one embodiment, the device has two sensors, one to detect a parameter of the left atrium and one to detect a parameter of the right atrium

[0177] “Optical sensor” means a sensor configured to direct light at the tissue and measure reflected/transmitted light. These sensors are particularly sensitive for detecting changes in blood flow in adjacent tissue, and therefore suitable for detecting devascularisation of tissue such as the LAA. Examples include optical probes using pulse oximetry, photoplasmography, near-infrared spectroscopy, Contrast enhanced ultrasonography, diffuse correlation spectroscopy (DCS), transmittance or reflectance sensors, LED RGB, laser doppler flowometry, diffuse reflectance, fluorescence/autofluoresence, Near Infrared (NIR) imaging, diffuse correlation spectroscopy, and optical coherence tomography. An example of a photopeasmography sensor is a device that passes two wavelengths of light through the tissue to a photodetector which measures the changing absorbance at each of the wavelengths, allowing it to determine the absorbances due to the pulsing arterial blood alone, excluding venous blood, muscle, fat etc). Photoplesmography measures change in volume of a tissue caused by a heart beat which is detected by illuminating the tissue with the light from a single LED and then measuring the amount of light either reflected to a photodiode.

Exemplification

[0178] The invention will now be described with reference to specific Examples. These are merely exemplary and for illustrative purposes only: they are not intended to be limiting in any way to the scope of the monopoly claimed or to the invention described. These examples constitute the best mode currently contemplated for practicing the invention.

[0179] Referring to the drawings, and initially to FIGS. 1 to 2, there is illustrated a human heart having a right atrium A, right ventricle B, left atrium C and left ventricle D, inferior vena cava E, superior vena cava F, azygous vein G, and atrial septal wall H. A shunting device of the invention, indicated generally by the reference numeral 1, is shown implanted in the heart A providing fluid communication between the left atrium C and azygous vein G though an aperture J formed in the atrial septal wall.

[0180] The shunting device 1 comprising a flexible tube 2 configured for radial adjustment between a contracted delivery configuration suitable for delivery in a delivery catheter and a deployed radially expanded configuration, the tube having a through lumen, a distal end 3 configured to anchor within the azygous vein G, and a proximal end 4 configured to span an aperture in an atrial septal wall and anchor to the wall. The deice has length of about X cm and diameter (along the flexible tube) of approximately Y cm, when deployed. The distal end 3 has an over-expansion section 3A to anchor within the ostium of the azygous vein having a diameter when expanded of about Z cm. The proximal end 4 comprises two axially spaced apart expansible retention flange sections 5 configured for expansion on each side of an atrial septal wall H to a diameter of approximately X cm to anchor the distal end of the device to the wall and establish fluidic connection between the device 1 and left atrium C via the aperture J.

[0181] As illustrated in FIGS. 2A and 2B, the device illustrated is self-expansible, and is formed from a structural wire element comprising a plurality of sinusoidal ring elements 10 configured for radial expansion from the constrained configuration shown in FIG. 2A (left) to the unconstrained (deployed) configuration shown in FIG. 2A (right). The wire elements comprise a shape memory metal, such as NITI. The device also includes an occluding sheath covering the structural wire element and formed of polyethylene.

[0182] In more detail, and as illustrated in FIG. 2A, the distal end of the device is configured for engagement with the azygous vein, and in this embodiment comprise a self-expansible over-expansion section 3A having a diameter when deployed that is greater than the diameter of the ostium of the azygous vein. Referring to FIG. 2B, the proximal end of the device takes the form of a “shunt” and has two radially expansible retention flange sections axially separated by a distance of about X cm, and shown in a constrained configuration (left side) and deployed, radially expanded, configuration (right side). The flanges are dimensioned such that on deployment, they abut opposite sides of the atrial septal wall in an apposing relationship, anchoring the proximal end of the device to the wall.

[0183] As illustrated in FIG. 2C, the end of the device may incorporate a face pull synch retraction mechanism that can be actuated to retract the device to a constrained configuration, prior to retraction of the device into a removal catheter and removal of the body. In the embodiment shown, the end of the device includes a series of loops 12 and a tether 13 threaded through the loops and configured such that pulling the tether causes the end of the device to radially contract.

[0184] FIG. 2D illustrates part of a two-part shunting device according to the invention, having a first part 15, second part 16, each having a free end 17, and tethering elements 18 that are laced between the sinusoidal ring struts 10 at each free end. When the tethering elements 18 are pulled, the free ends 17 are pulled towards each other and laced together to form a continuous tube.

[0185] FIG. 3 illustrates a trans-apical method of delivery and implantation of a shunting device of the invention in the heart. In a first step, shown in 3A, the wall of the left ventricle D is punctured using a suitable puncturing device, and a catheter 20 is advanced through the hole and into the left atrium C via the left ventricle. A puncturing device (not shown) is then advanced through the catheter and actuated to form an aperture J in the atrial septal wall H. A guide sheath 21 containing a guidewire 22 is then advanced through the catheter 20, through the aperture J, the right atrium B, superior vena cava E, and into the azygous vein G. The guidewire is then deployed, and the guide sheath is retracted leaving the guidewire 22 in-situ. As shown in FIG. 3B, a delivery catheter 25 is then advanced along the same route over the guidewire 22 into the azygous vein, where the distal end 3 of the shunting device is deployed in the ostium of the azygous vein, where it expands into contact with the ostium of the azygous vein anchoring the distal end of the device in the vein. Deployment of the shunting device continues by retraction of the catheter 25 relative to the device 1, until the proximal end of the device is deployed as shown in FIG. 3C. This is generally performed using a cardiac imaging technique, such as fluoroscopy.

[0186] FIG. 4 illustrates a fully percutaneous method of delivery and implantation of a two-part shunting device of the invention in the heart, in which steps described with reference to the previous embodiments are assigned the same reference numerals. In a first step, shown in FIG. 4A, a delivery catheter 30 containing the first part of the shunting device (the proximal end 4 with retention flange sections 5) is advanced percutaneously via a femoral vein/IVC approach into the right atrium A and towards and across the atrial septal wall H (where an aperture has previously been formed using the techniques described previously). The proximal end 4 is then deployed across the aperture, such that the retention flanges self-expand upon deployment on each side of the wall, anchoring the proximal end 4 to the wall. FIG. 4B illustrates the delivery of the second part of the two-part device (which in this embodiment comprises the distal end 3 and flexible tube 2) percutaneously to the left ventricle via the aorta. The delivery steps are substantially the same as that described with reference to FIGS. 3A to 3C, with the exception that the delivery catheter is advanced into the right atrium through the lumen in the anchored proximal end 4, and that once deployed, the free end 15 of the tube 2 is connected to the anchored proximal end 4 as described previously with reference to FIG. 2D.

[0187] FIG. 5 illustrates a delivery catheter according to the invention, indicated generally by the reference numeral 40, and for use in delivering and implanting, a two-part shunting device of the invention, to the heart of a subject. The delivery catheter 40 comprises an outer sheath 41, and two inner delivery sheath 42A, 42B, that are axially movable relative to the outer sheath 41, and configured such that on deployment the inner sheaths 42A and 42B assume a bifurcated configuration shown in FIG. 5A. The inner sheath 42A is longer that the sheath 42B, and is configured upon deployment and advancement to project into the superior vena cava F and into the azygous vein G. The inner sheath 42B is configured upon deployment to project towards the atrial septal wall H. In use, the catheter 40 is advanced into the heart via a femoral vein/IVC approach and into the right atrium B where the inner sheaths are deployed and assume the bifurcated configuration shown in FIG. 5A. An ablation catheter (not shown) may then be advanced along inner sheath 42B and actuated to form an aperture in the wall H, before being retracted. The first part of the device (including the proximal end 4) is then advanced along inner sheath 42B and deployed across the atrial septal wall H, as described previously. The second part (including the distal end 3) is then advanced along inner sheath 42A into the ostium of the azygous vein and deployed as described previously. The free ends 17 of the two parts are then meshed together using tethering elements 18 as described previously to form the assembled and implanted shunting device that provides fluidic connection between the left atrium and azygous vein.

[0188] FIG. 6 is an illustration of the venous architecture showing how the azygous vein can be accessed percutaneously via an approach through the common iliac vein and right ascending lumbar vein.

[0189] Referring to FIGS. 7 and 8, a modular device of the invention is illustrated, in which parts identified with reference to the previous embodiments are assigned the same reference numerals. In the embodiment of FIG. 7, the device 50 comprises a first tube 51 with a proximal end 52 configured to engage the atrial septal wall H at the aperture H, and a second tube 53 having a distal end 54 configured to anchor in the azygous vein G. The proximal end of the second tube 53 has an aperture 55 configured to receive a distal end 56 of the first tube 51 during deployment of the first tube, whereby radial expansion of the distal end of the first tube in the aperture 55 locks the two tubes together. The embodiment of FIG. 8 is similar to that of FIG. 7, with the exception that the distal end of the first tube comprises through apertures 58 configured to receive a distal end of the second tube 53. Both embodiments are configured for assembly in-situ in the heart to provide a conduit for blood flow from the left atrium to the azygous vein through the assembled device.

[0190] Referring to FIG. 9, an additional anchoring means for the device, typically the distal end of the device is illustrated. The device of both embodiments comprises anchoring means (hooks or barbs) that are deployable by actuation of the distal end of the device. FIG. 9A shows the device anchored to an ostium of the azygous vein after the deployable anchoring elements have been deployed. In both embodiments, the distal end of the device includes an outer sleeve element 61 and an inner sleeve element 62, that are operatively coupled together and configured for relative axial movement (FIGS. 9B and 9C) or relative rotational movement (FIGS. 9E and 9F). A curved anchoring barb 63 is attached to a distal end of the inner sleeve element 62 and is threaded through an aperture in the outer sleeve element 61 such that axial movement of the inner sleeve relative to the outer sleeve causes the barb to project outwardly into the ostium of the azygous vein (FIGS. 9B to 9D), or rotational movement of the inner sleeve relative to the outer sleeve causes the barb to project outwardly into the ostium of the azygous vein (FIGS. 9E to 9G).

[0191] The shunting device of the invention may be configured to detect blood pressure in the heart, for example in the left atrium and/or right atrium. Providing one or more sensors on the shunting device enables atrial pressures to be monitored which provides information of the effectiveness of the shunting device as well as early and accurate detection of pressure imbalances in the heart (for example early detection of left atrial pressure drop or right atrial hypertension). In one embodiment, the device has a first blood pressure sensor disposed on the left atrial side of the device and positioned to monitor left atrial blood pressure, and a second blood pressure sensor disposed on the right atrial side of the device and positioned to measure right atrial blood pressure. The sensors may be CardioMEMS HF System from CardioMEMS (Atlanta, Ga.) that consists of a battery-free sensor that can continuously measure systolic, diastolic, and mean pressures. The sensors are configured to transmit blood pressure data wirelessly to a remote monitoring device having a wireless receiver and a display for displaying the blood pressure. The data may be transmitted to an online portal where the patient's cardiologist can check the readings collected by the sensors. The monitoring device can have a processor configured to process the data by comparing the data with reference data and providing an output relating to the effectiveness of the shunting treatment and/or diagnostic information relating the heart, or the design of a patient-specific retro-fittable valve for the shunting device which can be retro-fitted to the shunting device in-vivo or ex-vivo.

EQUIVALENTS

[0192] The foregoing description details presently preferred embodiments of the present invention. Numerous modifications and variations in practice thereof are expected to occur to those skilled in the art upon consideration of these descriptions. Those modifications and variations are intended to be encompassed within the claims appended hereto.