Source: https://patents.google.com/patent/WO2006064490A1/en
Timestamp: 2018-07-22 15:23:30
Document Index: 232891361

Matched Legal Cases: ['art.\n42', 'art.\n43', 'art.\n75', 'art.\n16', 'art.\n77', 'art.\n85', 'art.\n99', 'art.\n100', 'art.\n101', 'art.\n122', 'art.\n144', 'art.\n145', 'art.\n190', 'art.\n194', 'art.\n200', 'art. 210', 'art.\n221', 'art.\n263', 'art.\n264']

WO2006064490A1 - A medical device suitable for use in treatment of a valve - Google Patents
WO2006064490A1
WO2006064490A1 PCT/IE2005/000144 IE2005000144W WO2006064490A1 WO 2006064490 A1 WO2006064490 A1 WO 2006064490A1 IE 2005000144 W IE2005000144 W IE 2005000144W WO 2006064490 A1 WO2006064490 A1 WO 2006064490A1
PCT/IE2005/000144
A médical device (1210) comprises a generally cylindrical treatment élément (1220) for location between a pair of valve leaflets (1212) situated between an atrium (1214) and a ventricle (1216) of a heart . The treatment élément (1220) supports the valve leaflets (1212) at the région of co-aptation of the valve leaflets (1212) and occludes the valve opening to resist fluid flow in the rétrograde direction through the valve opening. The device (1210) comprises a support (1222) to support the treatment élément (1210) at the région of co-aptation of the valve leaflets (1212) . The support has an anchor (1224) and a tether (1226) , the tether (1226) being provided at the end of a guide wire (1228) which is initially utilised in the percutaneous insertion of the treatment élément (1220) . The anchor (1224) is secured, in use, to a septal wall (1230) , while the guide wire (1228) exits the atrium (1214) through a vein adjacent a rear wall (1224) thereof .
"A medical device suitable for use in treatment of a valve"
The heart contains four valves, two semilunar, the aortic and pulmonary valves, and two atrioventricular (AV) valves, the mitral and tricuspid valves. The heart fills with blood from the lungs and body when the AV valves are open. When the heart pumps . or contracts, the AV valves close , and prevent the blood from regurgitating backwards. The semilunar valves open when the heart pumps allowing the blood to flow into the aorta and main pulmonary artery.
Dysfunction of the cardiac AV valves is common and can have profound clinical consequences. Failure of the AV valves to prevent regurgitation leads to an increase in the pressure of blood in the lungs or liver and reduces forward blood flow. Valvular dysfunction either results from a defect in the valve leaflet or supporting structure, or dilation of the fibrous ring supporting the valve. These factors lead to a failure of valve leaflets to meet one another, known as coaptation, allowing the blood to travel in the wrong direction.
Conventional treatment of leaking AV valves often involves replacement or operative repair of the valves. These treatments are considerable surgical operations requiring cardiopulmonary bypass and are associated with significant morbidity. In many instances patients are too sick or too frail to undergo these operations and hospital stays and recovery phases after such operations are prolonged. Percutaneous techniques of valve repair have the advantage of being significantly less traumatic for the patient. During such procedures the valve repair is performed from within the heart, accessing the heart through a vein in the neck or the groin. Percutaneous procedures are performed under local anaesthetic and the incisions required to perform the procedures are extremely small. In addition, procedural times and recovery phases are also expected to be significantly less. Current attempts at percutaneous repair of leaking heart valves are based on two techniques, the first being the insertion of a mitral valve support structure into a large cardiac vein known as the coronary sinus, and the second being the insertion of a stitch or clip into the mitral valve leaflets to hold them together.
The treatment element may be movable between a collapsed configuration and an expanded configuration. In the expanded configuration the treatment element may be engageable with a valve leaflet. In the expanded configuration the treatment element may be sealingly engageable with a valve leaflet. In the collapsed configuration the treatment element may be deliverable through a vasculature to a treatment site. In one case the treatment element is engageable with a valve leaflet which is movable between a closed configuration and an open configuration. In the closed configuration the treatment element may be engageable with a valve leaflet. In the closed configuration the treatment element may be sealingly engageable with a valve leaflet. The treatment element may comprise a plug element. In the closed configuration the treatment element may be configured to prevent fluid flow through a valve opening. In the open configuration the treatment element may be spaced-apart from the region of co-aptation of the valve leaflets. In the open configuration the treatment element may be configured to resist fluid flow in the first direction through a valve opening. In the open configuration the treatment element may be configured to facilitate fluid flow in the second direction through a valve opening.
In one case the treatment element is engageable with a valve leaflet at an engagement region spaced substantially from an annulus of the valve. The treatment element may be engageable with a valve leaflet at the region of coaptation of the valve leaflets. The treatment element may be engageable with a valve leaflet at an engagement region in proximity to or within the valve opening.
It will be appreciated that movement of the heart, for example during the cardiac beating cycle, may result in the treatment element moving relative to the valve leaflets. By extending the treatment element at least partially through the valve opening, this arrangement results in a degree of redundancy to ensure that at least part of the treatment element is located at the region of co-aptation of the valve leaflets at all times. .
The support element may be engageable with a wall of body tissue. The support element may be releasably engageable with a wall of body tissue. The support element may be configured to abut a wall of body tissue. The support element may be configured to exert a compressive force on a body tissue wall. The support element may be configured to abut an inner surface of a body tissue wall. In one case the support element is configured to extend substantially laterally relative to a valve opening. The device may comprise a plurality of support elements connected together to form a substantially spherically-shaped support.
In one case the . support element is substantially spherical, and the treatment element is provided on a portion of the spherical surface such that when the treatment element is positioned adjacent the interface between at least a pair of valve leaflets, the treatment element at least partially prevents leakage from said interface.
In one embodiment the device comprises a delivery system to facilitate delivery of the treatment element to the region of co-aptation of the valve leaflets. The delivery system may comprise a percutatneous delivery system to facilitate percutaneous delivery of the treatment element to the region of co-aptation of the valve leaflets. The delivery system may comprise a delivery catheter for housing at least part of the treatment element during delivery. The delivery system may comprise a carrier element over which the treatment element is deliverable. The carrier element comprises a gύidewire. In one case the carrier element comprises an anchor element to anchor the carrier element to a wall of body tissue. The anchor element may be extendable into a body tissue wall. The anchor element may be configured to extend only partially through a body tissue wall. The anchor element may be configured to be extended into a body tissue wall from an interior side of the body tissue wall.
In one case the anchor element is configured to anchor the carrier element to a ventricle of a heart. The anchor element may be configured to, anchor the carrier element to a septal wall of a ventricle of a heart. The anchor element may be configured to anchor the carrier element to the apex of a ventricle of a heart.
In one, embodiment the . treatment element is at least partially comprised of a resiliently deformable material. The configuration of the treatment element may be adjustable in-situ at the region of co-aptation of the valve leaflets. The size of the treatment element may be adjustable in-situ. The radial dimension of the treatment element may be adjustable in-situ. The treatment element may be inflatable in-situ.
In one case the radial dimension of the treatment element is substantially small relative to the overall radial dimension of a valve. In one embodiment the device comprises a repair device for treating a leaking heart valve. The device may comprise a repair device for treating a leaking heart valve having at least a pair of valve leaflets.
In another aspect the invention provides a device for the treatment of a valve defect, the device comprising :-
, , the treatment element having an expanded treatment configuration and a collapsed delivery configuration;
In one embodiment of the invention the proximal segment of the treatment wire is detachable from the distal segment of the treatment wire. The proximal segment of the treatment wire may be configured to be located exterior to a patient. The transition segment may be adjacent a point of detachment of the proximal segment. The transition segment may be adapted to provide an atraumatic tissue implant interface. The atraumatic tissue implant interface may comprise a soft polymeric interface, or a porous interface, or a mechanical stress-distributing element. The device may comprise a locking element for locking the treatment element to the treatment wire.
The invention also provides in a further aspect a device for the treatment of a valve defect, the device comprising:-
In one case the treatment element acts as a support element to at least partially support at least one of the valve leaflets at the region of co-aptation of the valve leaflets. The treatment element may act as an occluder element to at least partially occlude the valve opening. In one embodiment the valve is a unidirectional valve. Fluid flow through the valve opening in a second direction may be facilitated. The second direction may be a forward direction. The first direction may be a retrograde direction.
The method may comprise the step of deploying the support element to secure the treatment element in position. The method may comprise the step of tethering the treatment element via the support element, to a wall of a heart, preferably a wall of a ventricle of the heart.
expanding the treatment element at the desired region; and terminating the proximal end of the wire beneath the skin of the patient.
In one embodiment the anchoring step comprises a relative motion between a core of the treatment wire and an outer tube of trie treatment wire. The anchoring step relative motion may comprise torqueing the core relative to the outer tube to anchor a distal end of the treatment wire. The anchoring step relative motion may comprise advancing the core relative to the outer tube to anchor a distal end of the treatment device.
In one embodiment the method comprises the step of inserting the collapsed treatment element into the procedural catheter. The method may comprise the step of advancing the treatment element over the treatment wire. The step of terminating the proximal end of the treatment wire may comprise the step of removing a proximal segment of the wire. The step of removing a proximal end of the treatment wire may comprise cutting, and/or unscrewing, and/or decoupling, and/or cutting, and/or breaking the proximal end of the wire. The step of terminating the proximal end of the treatment wire may comprise engaging a soft cap with the end of the wire. The step of terminating the proximal end of the treatment wire may comprise closing the puncture site with the proximal end of the treatment wire beneath the skin. In one case the method comprises the step of locking the treatment element to the treatment wire adjacent the valve. The step of collapsing the treatment element may comprise the step of loading the treatment element into a delivery catheter distal end.
[n one case,, the method comprises the step of supporting the medical device in me desired location.
The medical device may be advanced to the desired location at the region of coaptation of valve leaflets of the heart. The medical device may be advanced to the desired location at the region of co-aptation of mitral valve leaflets or tricuspid valve leaflets of the heart.
In a further aspect of the invention there is provided a delivery catheter for delivering at least one medical device through a coronary sinus, the catheter comprising at least one opening through which at least one medical device is advanceable out of the catheter through a sidewall of the coronary sinus. In one embodiment of the invention the catheter comprises a first opening through which a first medical device is advanceable out of the catheter and a second opening through which a second medical device is advanceable out of the catheter. The opening may be provided in sidewall of the catheter. The catheter may comprise an opening forming element for forming an opening in a sidewall of the coronary sinus. The catheter may comprise at least one drawing element for drawing at least one medical device out of the coronary sinus.
Preferably,, the plug is dimensioned when collapsed, to facilitate the percuatneous delivery of the support.
Preferably, the plug is at least partially comprised of a non thrombogenic material. Preferably, the plug has a substantially fluid impermeable contact surface for location adjacent the interface of the leaflets such that the plug at least partially prevents leakage from said interface.
Preferably, the method comprises, in the step of inserting the plug, percutaneously inserting the plug. Preferably, the method comprises, in the step of securing the plug, deploying a support to secure the plug in position.
In one case the invention provides a percutaneous cardiac valve repair device and method. The method may include the step of introducing a support structure through a vein in the neck to buttress the mitral valve or tricuspid valve. The treatment element of the medical device may be delivered percutaneously with a procedure similar to cardiac catheterization. The treatment element of the medical device may be manufactured out of nitinol, "memory metal", metal that can be compressed into small tubes but will return to its original shape once delivered from the tube. In the medical device, the support for the treatment element may be provided by a sheath and a wire attached to the apex of the heart ventricle. The support may be provided by the treatment element engaging the walls of the atrial cavity. The shape, size and position of the medical device may be altered to achieve the desired result. The treatment element of the medical device may be removable and the position of the treatment element may be altered at a later date by movement of the locking system in the neck The design of the treatment element of the medical device is such that it may also form part of the valvular surface in conditions of severe regurgitation. The carrier element/support wire may be inserted through the venous system, through the inferior vena cava or the superior vena cava to the right atrium or across the atrial septum into the left atrium.
The stability of the treatment element within the heart is important for its performance. There are a number of ferees that act on the treatment element; 1) regurgitant flow from the ventricle into the atrium 2) forward flow from the body into the ventricle when the valve is open and 3) gravity and other minor forces such as respiration and body movement. The stability of the treatment element may be maintained either by a wire support anchored in the ventricular wall, or by supports anchored in the walls of the atrium. The shape of the treatment element may be designed to use the regurgitant jet to force it into the correct position.
As used in this patent specification, the term "interface" will be understood to mean an area at which two elements or surfaces meet or approach one another without necessarily touching.
As used in this patent specification, the term "plug" will be understood to mean a component or collection of components which are adapted to at least partially fill or occlude a gap between two or more surfaces or the like, whether using the whole plug or a portion thereof.
As used in this patent specification, the term "repair" will be understood to mean the procedure of resisting retrograde fluid flow through a valve, for example by at least partially supporting at least one of the valve leaflets at the region of coaptation of the valve leaflets and/or by at least partially occluding the valve opening.
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:- Fig. 1 is a schematic illustration of a heart;
Fig. 12 is an end view of the treatment element of Fig. 10, in use; Figs. 13 to 15 are views similar to Figs. 10 to 12 of a treatment element of another medical device according to the invention;
Fig. 21, is a side view of another medical device according to the invention, in use;
Fig. 31 illustrates a schematic representation of another embodiment of a medical device according to the invention, deployed in a final or working configuration in a human heart; Fig. 32 is an isometric view of another medical device according to the invention, in use;
Fig: 53 to 63 are cross-sectional, side views of a further medical device according to the invention, in use;
Fig. 61 is a side view of the device of Fig. 66;
Fig. 69 is an end view of the device of Fig. 66; Fig. 70 illustrates a schematic representation of the first stage of insertion of another embodiment of a medical device according to the invention;
Fig. 73 illustrates the treatment element of the device of Fig. 70 when fully deployed within an atrium of a human heart, with a guide wire of the device remaining in position withm the heart;
Referring in particular to Fig. 2, the treatment element 20 is provided in the form of a plug 20 which is adapted, as will be described in greater detail hereinafter, to be located adjacent the interface of the leaflets 12 such that the plug 20 at least partially prevents leakage from said interface, by partially or completely occluding said interface, and therefore prevent regurgitation of blood therefrom. In order to secure the plug 20 in position, the device 10 is provided with the support element 22 which, in the embodiment illustrated, comprises an anchor 24 which is secured, as will be described in detail hereinafter, to the septal wall of the ventricle 16 or to the apex of the ventricle 16, the support element 22 further comprising a tether 26 extending in use from the anchor 24, between the valve leaflets 12,. into, connection with the plug 20. The support 22 therefore retains the plug 20 in position relative to the leaflets 12, such that each time the valve leaflets 12 close, the plug 20 will at least partially occlude any gap therebetween.
The plug 20 preferably comprises a substantially fluid impermeable contact surface 34 which is disposed, in use, against or between the gap or interface between the valve leaflets 12, the plug 20 also comprising a base 36 which is connected to the contact surface 34 via a plurality of connecting struts 38. The contact surface 34 and the struts 38 are preferably formed from a resiliently deformable material such as nitinol metal or the like, in order to allow the plug 20 to be displaced into a collapsed state and to self-expand to an expanded state. The plug 20 is also preferably formed from a non-thrombogenic material. The delivery system 211, illustrated in Figs. 3 and 4, comprises a delivery catheter sheath 32 for housing at least part of the treatment element 20 during delivery, and a carrier element 28 over which the treatment element 20 is delivered.
A delivery wire 212 may be advanced to deliver the treatment element 20 from the sheath 32 (Fig. 4). As the treatment, element 20 exits the delivery sheath 32 it re-expands to its natural conformation.
Referring to Fig. 8, the plug 20 is advanced along the guide wire 28 until the contact surface 34 is correctly positioned against the valve leaflets 12. The base 36 may then be clamped against the guide wire 28, by the release of a remotely operable spring loaded clamp or the like contained within the base 36, or on the guide wire 28, at which point the plug 20 is secured against the valve leaflets 12 by means of the tether 26 connected between the septal wall 30 and the plug 20. Fig. 8 illustrates the plug 20 positioned at the desired level within the atrium 14 supporting the valve leaflets 12 and plugging the defect. Referring to Fig. 9, the sheath 32 is then removed back along the guide wire 28 and out of the patient's vein, leaving only the guide wire 28 in position. The opposed end of the guide wire 28, at the point of incision into the patient, may be provided with any suitable subcutaneous plug or the like in order to secure the guide wire 28 in position. The device 10 is thus secured in place and ready for use, with the plug 20, and in particular the contact surface 34, allowing blood to flow therepast from the atrium 14 into the ventricle 16, while at least partially preventing the regurgitation of blood by occluding the gap at the interface of the valve leaflets 12. It should therefore be appreciated that the diameter of at least the contact surface 34 should be sufficiently large to substantially occlude any such gap to the extent that backward leakage is reduced by an effective amount, and preferably entirely, while being sufficiently small to allow the flow of blood around the contact surface 34 and into, the ventricle .16.
Referring to Fig. 11, there is illustrated a front elevation of an alternative embodiment of the plug 20, in which like components have been accorded like reference numerals. The plug 20 comprises the base 26 extending from which are three struts 38. Mounted to the struts 38 is a ring shaped contact surface 34 which, in use, will be seated against the valve leaflets 12 in order to substantially occlude any gap therebetween. The ring shaped contact surface 34 could be used when only a small gap exists between the valve leaflets 12, and presents a significantly smaller impediment to the flow of blood from the atrium 14 into the ventricle 16. Referring to Fig. 14, another embodiment of the plug 20 is illustrated. The plug 20 compries the base 36 extending from which are three struts 38, which connect to a support ring 50. Extending radially inwardly from the support ring 50 are a pair of secondary struts 38', which carry the contact surface 34 at the centre of the support ring 50. In use, the plug 20 is positioned such that the contact surface 34 at least partially occludes any gap between the valve leaflets 12, as hereinbefore described. The contact surface 34 is significantly smaller than the contact surface 34 of the plug 20 of the Figs. 2 to 9, and would thus be used when a small gap exists between the valve leaflets 12. The contact surface 34 will present a significantly smaller impediment to the flow of blood from the atrium 14 into the ventricle 16.
For example, in the medical device of Figs. 29 and 30 four support arms 280 extend radially outwardly from the body portion 271 of the treatment element 20. The arms 280 are engageable with the inner walls of the atrium and with the valve leaflets 12 to support the treatment element 20 in the desired location at the region of co-aptation of the valve leaflets 20 with the treatment element 20 extending partially into the valve opening 210. In this case the arms 280 are curved for atrial support. Referring to Fig. 31 there is illustrated another medical device according to the invention, generally indicated as 1210, which is similar to the medical device 10 of Figs. 2 to 9. The device 1210 comprises a generally cylindrical plug 1220 for location between a pair of valve leaflets 1212 situated between an atrium 1214 and a ventricle 1216 of a heart. The leaflets 1212 are connected to the ventricle 1216 by a respective set of cordae tendinae 1218.
The device 1210 comprises a support 1222 having an anchor 1224 and a tether 1226, the tether 1226 being provided at the end of the guide wire 1228 which is initially utilised in the insertion of the plug 1220 in a manner similar to that as hereinbefore described with reference to Figs. 2 to 9. The anchor 1224 is secured, in use, to a septal wall 1230, while the guide wire 1228 exits the atrium 1214 through a vein adjacent a rear wall 1240 thereof. . .
It will be appreciated that the guide wire lead 1228, the treatment element 1201 and the tether 1226 may be integrally formed. In this case the treatment element 1201 may be formed as an expansion section on the lead 1228, which may be anchored to the ventricle wall be means of the anchor element 1224. This results in a particularly simple form of the medical device, 1200.
In Fig. 33 there is illustrated a further medical device 300 according to the invention, which is similar to the device 1200 of Fig. 32, and similar elements in Fig. 33 are assigned the same reference numerals. The treatment element plug 1201 extends through the valve opening 210 in this case.
A proximal end 301 of the guide wire lead 1228 may be sutured to muscle tissue beneath the outer skin of the patient. A protective sheath may be provided around the proximal end 301. This arrangement maintains the position of the proximal end 301 of the guide wire 1228 fixed. It is possible to access the proximal end 301 of the guide wire 1228 at a later time, for example if it is required to alter the location of the treatment element 1201, or to remove the treatment element 1201, for example if the treatment element , 1201 became infected. Access may be gained by removing the protective sheath, rotating the guide wire 1228 to unscrew the anchor element 1224 from the ventricle wall, and withdrawing the guide wire 1228 and the treatment element 1201 fixed to the guide wire 1228.
An electrode for pacing of the. heart may be provided at the proximal end 301 of the guide wire lead 1228.
It will be appreciated that a variety of possible means may be employed for supporting the treatment element in the desired location at the region of coaptation of the valve leaflets.
One or more of the anchor elements 24 may be provided in the form of a threaded screw element to anchor to the ventricle wall by rotating the tether 26 to screw the anchor element 24 into the ventricle wall (Fig. 36). Alternatively one or more of the anchor elements 24 may be provided in the form of a hook to anchor to the ventricle wall by hooking into the ventricle wall (Fig. 37). Alternatively one or more of , the anchor elements 24 may be provided in the form of a suture loop to anchor to the ventricle wall by suturing to the ventricle wall (Fig. 38).
Referring to Figs. 39 to 52 there is illustrated a further medical device 310 according to the invention, which is similar to the device of Figs. 29 and 30, and similar elements, in Figs. 39 to, 52 are assigned the same reference numerals.
The sheath 323 is used to access the left or right ventricle. For the left ventricle access, a transeptal puncture is, performed. The wire 322 is removed (Fig. 42), and the fixation support guide wire 28 is fed through the sheath 323 into the ventricle 16 to abut on the ventricular myocardium (Fig. 43). The wire 28 is rotated in order to screw the support wire 28 into the myocardium by means of the screw anchor elements 313 (Fig. 44). A second and third support wire 28 are fixed in the ventricle 16 in different positions (Fig. 45). By anchoring the treatment element 311 to the ventricle using three anchor elements 313, this assists in evenly distributing the forces exerted on the ventricle. The treatment element 311 in its folded form is delivered through a rapid exchange delivery sheath 32 over the support wire 28 (Figs. 46 and 47). The treatment element 311 is delivered in the delivery sheath 32 to the correct position using 2D and 3D echo imaging, for example transesophogeal, or transthoracic, or intracardiac, or x-ray, including CT.
In this case the treatment element 311 is substantially cylindrically shaped. When deployed, the treatment element 3 IT extends through the valve opening 210 (Fig. 63).
The. support element 412 comprises two tether arms 413 which are anchored to the valve leaflets 12 to support the treatment element 411 in the desired location at the region of co-aptation of the valve leaflets 12. In this case each tether arm 413 is sutured to a mitral valve leaflet 12.
Turning to Fig. 71, a sheath or catheter 132 is advanced over the guide wire 128 until the free end of the catheter 132 is in communication with the atrium 114. The plug 120 is then advanced through the catheter 132, in the collapsed state, into the atrium 114, as illustrated in Fig. 72. Once the plug 120 has been advanced fully out of the catheter 132, the plug 120 will automatically displace into the expanded state wherein the catheter 132 can be removed, as illustrated in Fig. 73. The plug 120 is hollow in form, but carries a substantially fluid impermeable contact surface 134 thereon, which in use is positioned against the valve leaflets 112, in order to at least partially support the valve leaflets 112 and/or at least partially occlude the gap therebetween. The plug 120, being hollow, is comprised of a substantially spherical shell 138 which is reticulated in form, and which provides dual functionality to the plug 120. The reticulated nature of the shell 138 enables the plug 120 to be deformable between the collapsed and expanded state, in addition to allowing the free flow of blood into and through the plug 120, other than through the contact surface 134, in order to allow blood to flow between the atrium 114 and the ventricle 116 when the plug 120 is present. The resiliently deformable nature of the plug 120 also allows the slight deformation thereof as the atrium 114 itself deforms during pumping of blood into the ventricle 116.
The plug 120 is dimensioned such that, when deployed in the atrium 114, the plug 120 contacts both the valve leaflets 112 and a back wall 140 of the atrium 114 (Fig. 74), in order to ensure that the plug 12(3 is sufficiently supported in position within the atrium 114. As a result once the plug 120 is located in position, the anchor 124 may be unscrewed from the septal wall 130, and the guide wire 128 withdrawn from the heart, as illustrated in Fig. 74. The plug 120 is left in place within the atrium 114, with the fluid impermeable contact surface 134 seated against the interface between the pair of valve leaflets 112. It will be appreciated that the plug 120, in supporting the contact surface 134 in position, takes the place of the support 22 of the device 10 of Figs. 2 to 9.
It will be appreciated that the plug could be of any other suitable form once the functionality thereof is retained, namely to be capable of being seated between or against the valve leaflets in order to at least partially occlude a gap therebetween, thereby substantially or completely preventing the regurgitation of blood. For example, a plug having a conical or cylindrical contact surface could be employed, which could then be inserted partially or wholly within the gap between the valve leaflets. It will be appreciated that any suitable means may be employed in order to deliver the plug into position, and any suitable means may also be employed to secure the plug in position once delivered.
The looped wire 502 is pulled into the second puncture 509 to deliver the treatment element 501 and fix the treatment element 501 in the desired location across the mitral valve at the region of co-aptation of the valve leaflets 506, 507 (Fig. 78). Fig. 79 illustrates the treatment element 501 pulled into position across the mitral valve. The treatment element 501 is supported in the desired location at the region of co-aptation of the valve leaflets by means of clamping the support wires 502, 510 into position at the coronary sinus 504/left atrium punctures 508, 509 (Fig. 80).
1 A medical device suitable for use in treatment of a valve, the device comprising a treatment element configured to be located at the region at coaptation of leaflets of a valve to resist fluid flow in a first direction through an opening of the valve.
2 A device as claimed in claim 1 wherein the treatment element acts as a support element to at least partially support at least one valve leaflet at the region of co-aptation of the valve leaflets.
3 A device as claimed in claim 1 or 2 wherein the treatment element acts as an occluder element to at least partially occlude a valve opening.
4 A device as claimed in any of claims 1 to 3 wherein the device is configured for use in treatment of a unidirectional valve.
5 A device as claimed in any of claims 1 to 4 wherein the treatment element is configured to facilitate fluid flow in a second direction through a valve opening.
6 A device as claimed in any of claims 1 to 5 wherein the first direction is a retrograde direction.
7 A device as claimed in claim 5 or 6 wherein the second direction is a forward direction.
8 A device as claimed in any of claims 1 to 7 wherein the treatment element when deployed, is shaped and dimensioned to permit unidirectional flow of fluid therepast.
A device as claimed in any of claims 1 to 8 wherein the treatment element is configured to be urged towards a valve opening by fluid flow.
A device as claimed in claim 9 wherein the treatment element is configured to be urged towards a valve opening by fluid flow in the first direction.
A device as claimed in claim 9 or 10 wherein the treatment element is configured to be urged towards a valve opening by fluid flow in the second direction.
A device as claimed in any of claims 9 to 11 wherein the treatment element is shaped to be urged towards a valve opening by fluid flow.
A device as claimed in any of claims 1 to 12 wherein the treatment element is at least partially substantially cylindrically shaped.
A device as claimed in any of claims 1 to 13 wherein the treatment element is at least partially substantially frusto-conically shaped.
A device as claimed in claim 14 wherein the apex end of the frusto-cone is configured to point substantially towards a valve opening.
A device as claimed in any of claims 1 to 15 wherein the treatment element is at least partially substantially diamond shaped.
A device as claimed in any of claims 1 to 16 wherein the treatment element is at least partially substantially crescent shaped.
A device as claimed in claim 17 wherein the concave portion of the crescent is configured to face substantially towards a valve opening.
A device as claimed in any of claims 1 to 18 wherein the treatment element comprises a ring element.
A device as claimed in any of claims 1 to 19 wherein the treatment element comprises a disc element.
A device as claimed in any of claims 1 to 20 wherein the treatment element comprises at least one arm.
A device as claimed in claim 21 wherein the arm is configured to protrude substantially laterally relative to a valve opening.
A device as claimed in claim 22 wherein , the arm tapers inwardly in the lateral direction away from a valve opening.
A device as claimed in any of claims 1 to 23 wherein the treatment element is engageable with at least one leaflet of a valve.
A device as claimed in any of claims 1 to 24 wherein the treatment element is movable between a collapsed configuration and an expanded configuration.
A device as claimed in claim 25 wherein in the expanded configuration the treatment element is engageable with a valve leaflet.
A device as claimed in claim 26 wherein in the expanded configuration the treatment element is sealingly engageable with a valve leaflet.
A device as claimed in any of claims 25 to 27 wherein in the collapsed configuration the treatment element is deliverable through a vasculature to a treatment site.
A device as claimed in any of claims 24 to 28 wherein the treatment element is engageable with a valve leaflet which is movable between a closed configuration and an open configuration.
A device as claimed in claim 29 wherein in the closed configuration the treatment element is engageable with a valve leaflet.
A device as claimed in claim 30 wherein in the closed configuration the treatment element is sealingly engageable with a valve leaflet.
A device as claimed in claim 31 wherein the treatment element comprises a plug element.
A disc as claimed in claim 31 or 32 wherein in the closed configuration the treatment element is configured to prevent fluid flow through a valve opening.
A device as claimed in any of claims 29 to 33 wherein in the open configuration the treatment element is spaced-apart from the region of coaptation of the valve leaflets.
A device as claimed in any of claims 29 to 34 wherein in the open configuration the treatment element is configured to resist fluid flow in the first direction through a valve opening.
A device as claimed in any of claims 29 to 35 wherein in the open configuration the treatment element is configured to facilitate fluid flow in the second direction through a valve opening.
37 A device as claimed in any of claims 24 to 36 wherein the treatment element is engageable with a valve leaflet at an engagement region spaced substantially from an annulus of the valve.
38 A device as claimed in any of claims 24 to 37 wherein the treatment element is engageable with a valve leaflet at the region of co-aptation of the valve leaflets.
39 A device as claimed in any of claims 24 to 38 wherein the treatment element is engageable with a valve leaflet at an engagement region in proximity to or within the valve opening.
40. A device as claimed in any of claims 24 to 39 wherein the treatment element comprises a contact part for engaging with a valve leaflet.
41 A device as claimed in claim 40 wherein the treatment element comprises a base part.
42 A device as claimed in claim 41 wherein the treatment element comprises at least one support part for supporting the contact part relative to the base part.
43 A device as claimed in any of claims 40 to 42 wherein the contact part comprises a membrane, or a mesh, or a weave, or a porous or a micro- porous surface.
44 A device as claimed in any of claims 1 to 43 wherein the treatment element is configured to be located adjacent an interface between at least a pair of valve leaflets.
A device as claimed in claim 44 wherein the treatment element is configured to at least partially prevent leakage from the interface.
A device as claimed in any of claims 1 to 45 wherein the treatment element has a substantially fluid impermeable contact surface for location adjacent the interface between at least a pair of valve leaflets such that the treatment element at least partially prevents leakage from said interface.
A device as claimed in claim 46 wherein the contact surface is substantially circular, or conical, or cylindrical.
A device as claimed in any of claims 1 to 47 wherein the device comprises at least one support element to support the treatment element at the region of co-aptation of the valve leaflets.
A device as claimed in claim 48 wherein the support element is configured to support the treatment element in a location adjacent to a valve opening.
A device as claimed in claim 48 or 49 wherein the support element is configured to support the treatment element in a location externally of a valve opening.
A device as claimed in claim 48 wherein the support element is configured to support the treatment element extending at least partially through a valve opening.
A device as claimed in any of claims 48 to 51 wherein the support element is engageable with a wall of body tissue.
A device as claimed in claim 52 wherein the support element is releasably engageable with a wall of body tissue.
A device as claimed in claim 52 or 53 wherein the support element is configured to abut a wall of body tissue.
A device as claimed in claim 54 wherein the support element is configured to exert a compressive force on a body tissue wall.
A device as claimed in claim 54 or 55 wherein the support element is configured to abut an inner surface of a body tissue wall.
A device as claimed in any of claims 54 to 56 wherein the support element is configured to extend substantially laterally relative to a valve opening.
A device as claimed in any of claims 54 to 56 wherein the device comprises a plurality of support elements connected together to form a substantially spherically-shaped support.
A device as claimed in any of claims 54 to 58 wherein the support element is engageable with a wall of an atrium of a heart.
A device as claimed in any of claims 54 to 58 wherein the support element is engageable with at least one leaflet of a valve.
A device as claimed in any of claims 54 to 60 wherein the treatment element is carried on the support element.
A device as claimed in any of claims 54 to 61 wherein the support element is substantially porous.
A device as claimed in any of claims 54 to 62 wherein the support element is dimensioned, in use, to fit within a chamber of a heart.
A device as claimed in any of claims 54 to 63 wherein the support element is substantially hollow and comprises a reticulated surface.
A device as claimed in any of claims 54 to 64 wherein the support element is substantially spherical, and the treatment element is provided on a portion of the spherical surface such that when the treatment element is positioned adjacent the interface between at least a pair of valve leaflets, the treatment element at least partially prevents leakage from said interface.
A device as claimed in claim 52 or 53 wherein the support element comprises an anchor element to anchor the treatment element to a wall of body tissue. . . . . ,
A device as claimed in claim 66 wherein the anchor element is extendable into a body tissue wall.
A device as claimed in claim 67 wherein the anchor element is configured to extend only partially through a body tissue wall.
A device as claimed in claim 67 or 68 wherein the anchor element is configured to be extended into a body tissue wall from an interior side of the body tissue wall.
A device as claimed in any of claims 66 to 69 wherein the anchor element comprises a hook element.
A device as claimed in any of claims 66 to 69 wherein the anchor element comprises a suture loop.
72 A device as claimed in any of claims 66 to 69 wherein the anchor element comprises a threaded element.
73 A device as claimed in claim 72 wherein the threaded element comprises a screw element.
74 A device as claimed in any of claims 66 to 73 wherein the anchor element is configured to anchor the treatment element to a ventricle of a heart.
75 A device as claimed in claim 74 wherein the anchor element is configured to anchor the treatment element to a septal wall of a ventricle of a heart.
16 A device as. claimed in claim .74 or 75 wherein the anchor element is configured to anchor the treatment element to the apex of a ventricle of a heart.
77 A device as claimed in any of claims 66 to 73 wherein the anchor element is configured to anchor the treatment element to at least one leaflet of a valve.
78 A device as claimed in any of claims 66 to 77 wherein the support element comprises a connector element between the anchor element and the treatment element.
79 A device as claimed in claim 78 wherein the connector element comprises a tether.
80 A device as claimed in claim 78 or 79 wherein the connector element is configured to extend through a valve opening.
81 A device as claimed in any of claims 78 to 80 wherein the connector element is dimensioned to extend, in use, from the anchor element through the interface between at least a pair of valve leaflets, to the treatment element.
82 A device as claimed in any of claims 78 to 81 wherein the position at which the treatment element is located along the connector element may be varied.
83 A device as claimed in any of claims 78 to 82 wherein the connector element comprises at least part of a guide wire, or a treatment wire.
84 A device as claimed in any of claims 78 to 83 wherein the connector element has sufficient torsional rigidity to enable the connector element to be used to screw the anchor element to a wall of a heart.
85 A device as claimed in any of claims 1 to 84 wherein the device comprises a delivery system to facilitate delivery of the treatment element to the region of co-aptation of the valve leaflets .
86 A device as claimed in claim 85 wherein the delivery system comprises a percutatneous delivery system to facilitate percutaneous delivery of the treatment element to the region of co-aptation of the valve leaflets.
87 A device as claimed in claim 85 or 86 wherein the delivery system comprises a delivery catheter for housing at least part of the treatment element during delivery.
88 A device as claimed in any of claims 85 to 87 wherein the delivery system comprises a carrier element over which the treatment element is deliverable.
89 A device as claimed in claim 88 wherein the carrier element comprises a guidewire.
90 A device as claimed in claim 88 or 89 wherein the carrier element comprises an anchor element to anchor the carrier element to a wall of body tissue.
91 A device as claimed in claim 90 wherein the anchor element is extendable into a body tissue wall.
92 A device as claimed in claim 91 wherein the anchor element is configured to extend only partially through a body tissue wall.
93 A device as claimed in claim 91 or 92 wherein the anchor element is configured to be extended into a body tissue wall from an interior side of the body tissue wall.
94 A device as claimed in any of claims 90 to 93 wherein the anchor element comprises a hook element.
95 A device as claimed in any of claims 90 to 93 wherein the anchor element comprises a suture loop.
96 A device as claimed in any of claims 90 to 93 wherein the anchor element comprises a threaded element.
97 A device as claimed in claim 96 wherein the threaded element comprises a screw element.
98 A device as claimed in any of claims 90 to 97 wherein the anchor element is configured to anchor the carrier element to a ventricle of a heart.
99 A device as claimed in claim 98 wherein the anchor element is configured to anchor the carrier element to a septal wall of a ventricle of a heart.
100 A device as claimed in claim 98 or 99 wherein the anchor element is configured to anchor the carrier element to the apex of a ventricle of a heart.
101 A device as claimed in any of claims 90 to 100 wherein the delivery system comprises a holder element for holding the treatment element fixed relative to the carrier element.
102 A device as claimed in claim 101 wherein the holder element comprises a clamp.
103 A device as claimed in any of claims 1 to 102 wherein the treatment element is movable between a delivery configuration and a deployment configuration.,
104 A device as claimed in claim 103 wherein the treatment element is substantially collapsed in the delivery configuration.
105 A device as claimed in claim 103 or 104 wherein the treatment element is substantially expanded in the deployment configuration.
106 A device as claimed in any of claims 103 to 105 wherein the treatment element is biased towards the deployment configuration.
107 A device as claimed in any of claims 1 to 106 wherein the treatment element at least partially comprises a shape-memory material.
108 A device as claimed in claim 107 wherein the shape-memory material comprises Nitinol.
109 A device as claimed in any of claims 1 to 108 wherein the treatment element is collapsible to facilitate delivery of the treatment element via a sheath or the like.
110 A device as claimed in claim 109 wherein the treatment element is dimensioned when collapsed, to facilitate percutaneous delivery of the support element.
111 A device as claimed in any of claims 1 to 110 wherein the treatment element is at least partially comprised of a resiliently deformable material.
112 A device as claimed in any of claims 1 to 111 wherein the configuration of the treatment element is adjustable in-situ at the region of co-aptation of the valve leaflets.
113 A device as claimed in claim 112 wherein the size of the treatment element is adjustable in-situ.
114 A device as claimed in claim 113 wherein the radial dimension of the treatment element is adjustable in-situ.
115 A device as claimed in claim 113 or 114 wherein the treatment element is inflatable in-situ.
116 A device as claimed in any of claims 1 to 115 wherein the treatment element comprises a non-thrombogenic coating.
117 A device as claimed in claim 116 wherein the coating comprises polytetrafluoroethylene (PTFE).
118 A device as claimed in any of claims 1 to 117 wherein the device is configured for use in treatment of a heart valve.
119 A device as claimed in claim 118 wherein the device is configured for use in treatment of an atrioventricular valve.
120 A device as claimed in claim 119 wherein the device is configured for use in treatment of a mitral valve or a tricuspid valve.
121 A device as claimed in any of claims 1 to 120 wherein the treatment element is configured to be located in an atrium of a heart.
122 A device as claimed in any of claims 1 to 120 wherein the treatment element is configured to be located extending from an atrium of a heart at least partially through a mitral valve or a tricuspid valve.
123 A device as claimed in any of claims 1 to 122 wherein the radial dimension . . of the treatment element is substantially small relative to the overall radial dimension of a valve.
124 A device as claimed in any of claims 1 to 123 wherein the device comprises a repair device for treating a leaking heart valve.
125 A device as claimed in claim 124 wherein the device comprises a repair device for treating a leaking heart valve having at least a pair of valve leaflets.
126 A medical device suitable for use in treatment of a valve substantially as hereinbefore described with reference to the accompanying drawings.
127 A device for the treatment of a valve defect, the device comprising:- a treatment element; and
128 A device as claimed in claim 127 wherein the proximal segment of the treatment wire is detachable from the distal segment of the treatment wire.
129 A device as claimed in claim 127 or 128 wherein the proximal segment of the treatment wire is configured to be located exterior to a patient.
130 A device as claimed in claim 128 wherein the transition segment is adjacent a point of detachment of the proximal segment.
131 A device as claimed in any of claims 127 to 130 wherein the transition segment is adapted to provide an atraumatic tissue implant interface.
132 A device as claimed in claim 131 wherein the atraumatic tissue implant interface comprises a soft polymeric interface, or a porous interface, or a mechanical stress-distributing element.
133 A device as claimed in any of claims 127 to 132 wherein the device comprises a locking element for locking the treatment element to the treatment wire.
134 A device for the treatment of a valve defect, the device comprising:-
. the treatment wire comprising an anchor at the distal end;
135 A device as claimed in claim 134 wherein the treatment element is advanceable through a procedure catheter.
136 A device as claimed in claim 135 wherein the treatment element is advanceable through a procedure catheter having a deflectable tip.
137 A device as claimed in any of claims 134 to 136 wherein the treatment wire is a wire, or a tube, or a combination of a wire and a tube.
138 A device as claimed in any of claims 134 to 137 wherein the treatment wire is at least partially metallic or polymeric.
139 A device as claimed in any of claims 134 to 138 wherein the treatment wire comprises an outer jacket and an inner core.
140 A device as claimed in claim 139 wherein the outer jacket is polymeric and the inner core is metallic.
141 A device as claimed in claim 139 or 140 wherein the core is translatable or rotatable relative to the outer jacket.
142 A device as claimed in any of, claims 139 to ,141 wherein the inner core is engagable with the anchor at the distal end of the treatment wire.
143 A device as claimed in any of claims 139 to 142 wherein relative movement of the core is configured to anchor the anchor in a wall of a heart.
144 A device as claimed in claim 143 wherein the core is movable relative to the outer jacket to anchor the anchor in a wall of a heart.
145 A device as claimed in any of claims 139 to 144 wherein the inner core is removable from the outer jacket.
146 A device as claimed in any of claims 139 to 145 wherein the outer jacket is a non-thrombogenic polymer.
147 A device as claimed in any of claims 139 to 146 wherein the outer jacket is coated or covered with a non-thrombogenic coating, and/or a drug eluting coating, and/or a coating containing an active agent, and/or an active agent and/or a drug.
148 A device as claimed in any of claims 134 to 147 wherein the treatment element is a self-expanding element.
149 A device as claimed in any of claims 134 to 148 wherein the treatment element is expandable by inflation.
150 A device as claimed in any of claims 134 to 149 wherein the treatment wire comprises a multi lumen tubing.
151 A device as claimed in claim 150 wherein at least one lumen is an inflation lumen.
152 A device as claimed in claim 151 wherein the inflation lumen is occludable after inflation.
153 A device as claimed in claim 152 wherein the inflation lumen is occludable using a soft polymeric interface as a proximal plug or valve.
154 A device as claimed in any of claims 134 to 153 wherein the treatment element is expandable by mechanical actuation.
155 A device as claimed in any of claims 139 to 154 wherein the core is a pacing lead.
156 A device as claimed in any of claims 134 to 155 wherein the treatment element is slidable over the treatment wire in the collapsed configuration and is coupled to the wire in the expanded configuration.
157 A method of treating a valve, the method comprising the step of locating a treatment element at the region of co-aptation of leaflets of the valve to resist fluid flow in a first direction through an opening of the valve.
158 A method as claimed in claim 157 wherein the treatment element acts as a support element to at least partially support at least one of the valve leaflets at the region of co-aptation of the valve leaflets.
159 A method as claimed in claim 157 or 158 wherein the treatment element acts as an occluder element to at least partially occlude the valve opening.
160 A method as claimed in any of claims 157 to 159 wherein the valve is a unidirectional valve. ,
161 A method as claimed in any of claims 157 to 160 wherein fluid flow through the valve opening in a second direction is facilitated.
162 A method as claimed in claim 161 wherein the second direction is a forward direction.
163 A method as claimed in any of claims 157 to 162 wherein the first direction is a retrograde direction.
164 A method as claimed in any of claims 157 to 163 wherein fluid flow through the valve opening urges the treatment element towards the valve opening.
165 A method as claimed in claim 164 wherein fluid flow through the valve opening in the first direction urges the treatment element towards the valve opening.
166 A method as claimed in claim 164 or 165 wherein fluid flow through the valve opening in the second direction urges the treatment element towards the valve opening.
167 A method as claimed in any of claims 157 to 166 wherein the treatment element is engaged with at least one leaflet of the valve.
168 A method as claimed in claim 167 wherein the valve leaflet is movable between a closed configuration and an open configuration.
169 A method as claimed in claim 168 wherein in the closed configuration the treatment element engages with the valve leaflet.
170 A method as claimed in claim 169 wherein in the closed configuration the treatment element sealingly engages with the valve leaflet.
171 A method as claimed in claim 170 wherein in the closed configuration the treatment element prevents fluid flow through the valve opening.
172 A method as claimed in any of claims 168 to 171 wherein in the open configuration the treatment element is spaced-apart from the region of coaptation of the valve leaflets.
173 A method as claimed in any of claims 168 to 172 wherein in the open configuration the treatment resists fluid flow in the first direction through the valve opening.
174 A method as claimed in any of claims 168 to 173 wherein in the open configuration the treatment element facilitates fluid flow in the second direction through the valve opening.
175 A method as claimed in any of claims 167 to 174 wherein the treatment element engages the valve leaflet at an engagement region spaced substantially from an annulus of the valve.
176 A method as claimed in any of claims 167 to 175 wherein the treatment element engages the valve leaflet at the region of co-aptation of the valve leaflets.
177 A method as claimed in any of claims 167 to 176 wherein the treatment element engages the valve leaflet at an engagement region in proximity to or within the valve opening.
178 A method as claimed in any of, claims 157 to 177 wherein the treatment element is inserted into a position adjacent an interface of the valve leaflets such that the treatment element at least partially prevents leakage from said interface.
179 A method as claimed in claim 178 wherein the method comprises, in the step of inserting the treatment element, percutaneously inserting the treatment element.
180 A method as claimed in any of claims 157 to 179 wherein the method comprises the step of supporting the treatment at the region of co-aptation of the valve leaflets.
181 A method as claimed in claim 180 wherein the treatment element is supported adjacent to the valve opening.
182 A method as claimed in claim 180 or 181 wherein the treatment element is supported externally of the valve opening.
183 A method as claimed in claim 180 wherein the treatment element is supported extending at least partially through the valve opening.
184 A method as claimed in any of claims 180 to 183 wherein the treatment element is supported using a support element.
185 A method as claimed in claim 184 wherein the method comprises the step of engaging the support element with a wall of body tissue.
186 A method as claimed in claim 185 wherein the support element abuts the body tissue wall.
187. A method as claimed in claim 186 wherein the support element exerts a compressive force on the body tissue wall.
188 A method as claimed in claim 185 or 186 wherein the support element abuts an inner surface of the body tissue wall.
189 A method as claimed in any of claims 186 to 188 wherein the support element engages a wall of an atrium of a heart.
190 A method as claimed in any of claims 186 to 188 wherein the support element engages at least one leaflet of the valve.
191 A method as claimed in claim 185 wherein the treatment element is anchored to the body tissue wall.
192 A method as claimed in claim 191 wherein the treatment element is anchored to the body tissue wall from an interior side of the body tissue wall. 193 A method as claimed in claim 191 or 192 wherein the treatment element is anchored to a ventricle of a heart.
194 A method as claimed in claim 193 wherein the treatment element is anchored to a septal wall of the heart ventricle.
195 A method as claimed in claim 193 or 194 wherein the treatment element is anchored to the apex of the heart ventricle.
196 A method as claimed in claim 191 or 192 wherein the treatment element is anchored to at least one leaflet of the valve.
197 A1 method as claimed in any of claims 184 to 196 wherein at least part of the support element is extended through the valve opening.
198 A method as claimed in any of claims 184 to 197 wherein the method comprises the step of deploying the support element to secure the treatment element in position.
199 A method as claimed in any of claims 184 to 198 wherein the method comprises the step of tethering the treatment element via the support element, to a wall of a heart, preferably a wall of a ventricle of the heart.
200 A method as claimed in any of claims 184 to 198 wherein the method comprises the step of providing the treatment element on the support element, the support element being porous, and lodging the support element within the atrium such that the treatment element is located adjacent the interface of the valve leaflets in order to at least partially prevent leakage from said interface. 201 A method as claimed in any of claims 154 to 200 wherein the method comprises the step of delivering the treatment element to the region of coaptation of the valve leaflets.
202 A method as claimed in claim 201 wherein the treatment element is percutaneously delivered.
203 A method as claimed in claim 201 or 202 wherein the method comprises the step of housing at least part of the treatment element in a delivery catheter before delivering the treatment element.
204 A method as claimed in any of claims 201 to 203 wherein the treatment element is delivered over a carrier element.
205 A method as claimed in claim 204 wherein the method comprises the step of locating the carrier element in a desired location relative to the valve before delivering the treatment element over the carrier element.
206 A method as claimed in claim 205 wherein the carrier element is located extending through the valve opening.
207 A method as claimed in claim 205 or 206 wherein the method comprises the step of anchoring the carrier element to a wall of body tissue.
208 A method as claimed in claim 207 wherein the carrier element is anchored to the body tissue wall from an interior side of the body tissue wall.
209 A method as claimed in claim 207 or 208 wherein the carrier element is anchored to a ventricle of a heart. 210 A method as claimed in claim 209 wherein the carrier element is anchored to a septal wall of the heart ventricle.
211 A method as claimed in claim 209 or 210 wherein the carrier element is anchored to the apex of the heart ventricle.
212 A method as claimed in any of claims 204 to 211 wherein the method comprises the step of, after delivering the treatment element over the carrier element, holding the treatment element fixed relative to the carrier element.
213 A method as claimed in any of claims 157 to 212 wherein the treatment element moves from a delivery configuration to a deployment configuration.
214 A method as claimed in any of claims 157 to 213 wherein the method comprises the step of collapsing the treatment element, percutaneously passing the treatment element into the atrium, and expanding the treatment element.
215 A method as claimed in any of claims 157 to 214 wherein the method comprises the step of performing imaging to assist in locating the treatment element at the region of co-aptation of the valve leaflets.
216 A method as claimed in claim 215 wherein x-ray and/or ultrasound imaging is performed.
217 A method of treating a heart valve as claimed in any of claims 157 to 216.
218 A method of treating an atrioventricular valve as claimed in claim 217.
219 A method of treating a mitral valve or a tricuspid valve as claimed in claim 218. 220 A method as claimed in any of claims 157 to 219 wherein the method comprises the step of locating the treatment element in an atrium of a heart.
221 A method as claimed in any of claims 157 to 219 wherein the method comprises the step of locating the treatment element extending from an atrium of a heart at least partially through a mitral valve, or a tricuspid valve.
222 A method of treating a leaking human or animal heart valve having at least a pair of valve leaflets as claimed in any of claims 157 to 221.
223 A method of treating a valve using a treatment device, the treatment device comprising a treatment element, a treatment wire and an anchor element, the method comprising the steps of:
224 A method as claimed in claim 223 wherein the method comprises the step of steering the procedural catheter to allow ease of advancement of the treatment device. 225 A method as claimed in claim 224 wherein the steering step comprises torqueing a shaped procedural catheter.
226 A method as claimed in claim 224 or 225 wherein the steering step comprises actuating a pull cable to deflect a soft distal segment of the procedural catheter.
227 A method as claimed in any of claims 223 to 226 wherein the method comprises the step of collapsing the treatment element.
228 A method as claimed in any of claims 223 to 227 wherein the anchoring step comprises, a relative motion between a core of the treatment wire and an outer tube of the treatment wire.
229 A method as claimed in claim 228 wherein the anchoring step relative motion comprises torqueing the core relative to the outer tube to anchor a distal end of the treatment wire.
230 A method as claimed in claim 228 or 229 wherein the anchoring step relative motion comprises advancing the core relative to the outer tube to anchor a distal end of the treatment device.
231 A method as claimed in any of claims 223 to 230 wherein the method comprises the step of inserting the collapsed treatment element into the procedural catheter.
232 A method as claimed in any of claims 223 to 231 wherein the method comprises the step of advancing the treatment element over the treatment wire. 233 A method as claimed in any of claims 223 to 232 wherein the step of terminating the proximal end of the treatment wire comprises the step of removing a proximal segment of the wire.
234 A method as claimed in claim 233 wherein the step of removing a proximal end of the treatment wire comprises cutting, and/or unscrewing, and/or decoupling, and/or cutting, and/or breaking the proximal end of the wire.
235 A method as claimed in claim 233 or 234 wherein the step of terminating the proximal end of the treatment wire comprises engaging a soft cap with the end of the wire.
236 A method as claimed in any of claims 233 to 235 wherein the step of terminating the proximal end of the treatment wire comprises closing the puncture site with the proximal end of the treatment wire beneath the skin.
237 A method as claimed in any of claims 223 to 236 wherein the method comprises the step of locking the treatment element to the treatment wire adjacent the valve.
238 A method as claimed in claim 227 the step of collapsing the treatment element comprises the step of loading the treatment element into a delivery catheter distal end.
239 A method as claimed in claim 238 wherein the method comprises the step of advancing the treatment element and the delivery catheter over the treatment wire.
240 A method as claimed in claim 238 or 239 where the method of advancing the catheter comprises a rapid exchange technique. 241 A method as claimed in any of claims 238 to 240 wherein the step of expanding the treatment element comprises retraction of the sheath relative to a fixing abutment.
242 A method as claimed in any of claims 223 to 241 wherein the method comprises the step of adjusting the position of the treatment device relative to the valve.
243 A method as claimed in claim 242 wherein the position adjusting step comprises visualising the treatment device under fluoroscopy using radiopaque markers on the treatment device.
,244, A method as, claimed in . claim 242 or 243 wherein the position adjusting step comprising visualising the treatment device using an ultrasound probe and ultrasound visible markers positioned on the treatment device.
245 A method of treating a valve substantially as hereinbefore described with reference to the accompanying drawings.
246 A method of delivering a medical device to a desired location in a heart, the method comprising the step of advancing the medical device through a coronary sinus to the desired location.
247 A method as claimed in claim 246 wherein the method comprises the step of advancing the medical device out of the coronary sinus to the desired location.
248 A method as claimed in claim 247 wherein the method comprises the step of forming a first opening in the sidewall of the coronary sinus. 249 A method as claimed in claim 248 wherein the medical device is advanced out of the coronary sinus through the first opening.
250 A method as claimed in any of claims 247 to 249 wherein the medical device is drawn out of the coronary sinus.
251 A method as claimed in any of claims 246 to 250 wherein the medical device is advanced over a carrier element.
252 A method as claimed in claim 251 wherein the carrier element is advanced through the coronary sinus.
, 253 A method as claimed, in claim 252 wherein the carrier element is advanced out of the coronary sinus.
254 A method as claimed in claim 255 wherein the carrier element is advanced out of the coronary sinus through the first opening.
255 A method as claimed in claim 253 or 254 wherein the carrier element is drawn out of the coronary sinus.
256 A method as claimed in claim 250 or 255 wherein the method comprises the step of advancing a drawing element, for drawing the medical device and/or the carrier element out of the coronary sinus, through the coronary sinus.
257 A method as claimed in claim 256 wherein the method comprises the step of advancing the drawing element out of the coronary sinus.
258 A method as claimed in claim 257 wherein the method comprises the step of forming a second opening in the sidewall of the coronary sinus. 259 A method as claimed in claim 258 wherein the drawing element is advanced out of the coronary sinus through the second opening.
260 A method as claimed in claim 258 or 259 wherein the medical device and/or the carrier element is drawn towards the second opening.
261 A method as claimed in any of claims 246 to 260 wherein the method comprises the step of supporting the medical device in the desired location.
262 A method as claimed in any of claims 246 to 261 wherein the medical device is advanced to the desired location at the region of co-aptation of valve leaflets of the heart.
263 A method as claimed in claim 262 wherein the medical device is advanced to the desired location at the region of co-aptation of mitral valve leaflets or tricuspid valve leaflets of the heart.
264 A method of delivering a treatment element as claimed in any of claims 246 to 263.
265 A method of delivering a medical device to a desired location in a heart substantially as hereinbefore described with reference to the accompanying drawings.
266 A method of treating a valve, the method comprising the step of delivering a medical device to a desired location in a heart as claimed in any of claims 246 to 265.
267 A delivery catheter for delivering at least one medical device through a coronary sinus, the catheter comprising at least one opening through which at least one medical device is advanceable out of the catheter through a sidewall of the coronary sinus.
268 A catheter as claimed in claim 267 wherein the catheter comprises a first opening through which a first medical device is advanceable out of the catheter and a second opening through which a second medical device is advanceable out of the catheter.
269 A catheter as claimed in claim 267 or 268 wherein the opening is provided in sidewall of the catheter.
270 A catheter as claimed in any of claims 267 to 269 wherein the catheter comprises, an opening forming element for forming an opening in a sidewall of the coronary sinus.
271 A catheter as claimed in any of claims 267 to 270 wherein the catheter comprises at least one drawing element for drawing at least one medical
. device out of the coronary sinus.
272 A delivery catheter for delivering at least one medical device though a coronary sinus substantially as hereinbefore described with reference to the accompanying drawings.
PCT/IE2005/000144 2004-12-15 2005-12-15 A medical device suitable for use in treatment of a valve WO2006064490A1 (en)
EP20050816156 EP1841383A1 (en) 2004-12-15 2005-12-15 A medical device suitable for use in treatment of a valve
WO2006064490A1 true true WO2006064490A1 (en) 2006-06-22
PCT/IE2005/000144 WO2006064490A1 (en) 2004-12-15 2005-12-15 A medical device suitable for use in treatment of a valve
WO2016050751A1 (en) * 2014-09-29 2016-04-07 Martin Quinn A heart valve treatment device and method
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