Patent Grant
8475525
Some applications of the present invention relate in general to valve repair. More specifically, some applications of the present invention relate to repair of a tricuspid valve of a patient.
Functional tricuspid regurgitation (FTR) is governed by several pathophysiologic abnormalities such as tricuspid valve annular dilatation, annular shape, pulmonary hypertension, left or right ventricle dysfunction, right ventricle geometry, and leaflet tethering. Treatment options for FTR are primarily surgical. The current prevalence of moderate-to-severe tricuspid regurgitation is estimated to be 1.6 million in the United States. Of these, only 8,000 patients undergo tricuspid valve surgeries annually, most of them in conjunction with left heart valve surgeries.
U.S. Pat. No. 7,530,995 to Quijano et al. describes a method of protecting an upper and a lower body of a patient from high venous pressures comprising: providing an elongate valve stent, wherein the stent comprises a first stent member with a first tissue valve secured to a first support structure being disposed at a first end of the stent and a second stent member with a second tissue valve secured to a second support structure being disposed at an opposite second end of the stent, wherein both support structures are collapsibly expandable, the second end being connected to the first end with at least one elongate connecting member; passing the elongate valve stent through a blood vessel with the first and second support structures in a collapsed position; and securing the first support structure to an inferior vena cava and the second support structure to a superior vena cava with both support structures in an expanded shape.
U.S. Pat. No. 7,159,593 to McCarthy et al. describes a method of protecting an upper body and a lower body of a patient from high venous pressures comprising implanting a first stented valve at the superior vena cava and a second stented valve at the inferior vena cava, wherein the first and second valves are configured to permit blood flow towards a right atrium of the patient and prevent blood flow in an opposite direction.
PCT Publication WO 05/021063 to Numamoto et al. describes an elongate valve stent and methods for protecting an upper or a lower body of a patient from high venous pressures comprising a stent member, the stent member comprising a support structure and a tissue valve, wherein the tissue valve is configured to permit fluid flow in one direction and prevent fluid flow in an opposite direction, and means for anchoring the stent member onto surrounding tissue of the superior vena cava or inferior vena cava.
U.S. Pat. No. 6,332,893 to Mortier et al. describes a device for heart valve repair including at least one tension member having a first end and second end. A basal anchor is disposed at the first end of the tension member and a secondary anchor at the second end. The method includes the steps of anchoring the basal anchor proximate a heart valve and anchoring the secondary anchor at a location spaced from the valve such that the chamber geometry is altered to reduce heart wall tension and/or stress on the valve leaflets.
The following patents and patent application publications may be of interest:
U.S. Pat. No. 5,450,860 to O'Connor
U.S. Pat. No. 6,626,899 to Houser et al.
U.S. Pat. No. 7,549,983 to Roue et al.
US Patent Application Publication 2005-0216039 to Lederman
US Patent Application Publication 2007-0118151 to Davidson
US Patent Application Publication 2007-0198082 to Kapadia et al.
In some applications of the present invention, apparatus and method are provided for repairing a tricuspid valve of a patient using tension. Typically, apparatus and method for repairing the tricuspid valve facilitate reducing of tricuspid valve regurgitation by altering the geometry of the tricuspid valve and/or by altering the geometry of the wall of the right atrium of the heart of the patient. In some applications of the present invention, a first tissue-engaging element is implanted in a first portion of tissue that is upstream of the tricuspid valve of the patient. A second tissue-engaging element is then implanted in a second portion of tissue that is upstream of the tricuspid valve of the patient. Typically, following implantation of both the first and second tissue-engaging elements, a distance between the leaflets of the tricuspid valve is adjusted by pulling a longitudinal member that connects the first and second tissue-engaging elements or by pulling at least one of the tissue-engaging elements. Alternatively or additionally, the longitudinal member is adjusted prior to implanting the second tissue-engaging element. For some applications, the longitudinal member is coupled at least in part to an adjusting mechanism, and the longitudinal member is pulled or relaxed responsively to actuation of the adjusting mechanism.
In some applications of the present invention, apparatus and method are provided to achieve bicuspidization of the tricuspid valve. For such applications, typically, the anterior leaflet and the septal leaflet are drawn together to enhance coaptation.
For some applications, the first tissue-engaging element comprises a first stent element which is expanded in a portion of an inferior vena cava. The second tissue engaging element comprises a second stent element which is expanded in a portion of a superior vena cava. The distance between the first and second stent elements is then adjusted by pulling the longitudinal member while monitoring regurgitation of the tricuspid valve. Responsively to the pulling of the longitudinal element, the geometry of the right atrium is altered, thereby drawing together the leaflets of the tricuspid valve.
For other applications, the first tissue-engaging element comprises a stent member that is implanted in either the inferior or superior vena cava, and the second tissue-engaging element comprises a tissue anchor which punctures a portion of cardiac tissue of the patient and is implanted at least in part in the portion of cardiac tissue.
For still other applications of the present invention, both the first and second tissue-engaging elements comprise respective first and second tissue anchors. Each tissue anchor punctures a respective portion of cardiac tissue of the patient and is implanted at least in part in the respective portion of cardiac tissue. The tensioning element couples the first and second tissue anchors and is adjusted following implantation of the first and second tissue anchors by pulling or relaxing the tensioning element.
There is therefore provided, in accordance with some applications of the present invention, a method, including:
implanting at least a first tissue-engaging element in a first portion of tissue in a vicinity of a heart valve of a patient;
implanting at least a second tissue-engaging element in a portion of a blood vessel that is in contact with an atrium of a heart of the patient; and
drawing at least a first leaflet of the valve toward at least a second leaflet of the valve by adjusting a distance between the portion of the blood vessel and the first portion of tissue in the vicinity of the heart valve of the patient.
In some applications of the present invention, adjusting the distance between the portion of the blood vessel and the first portion of tissue in the vicinity of the heart valve of the patient includes pulling a longitudinal member that connects the first and second tissue-engaging elements.
In some applications of the present invention, adjusting the distance between the portion of the blood vessel and the first portion of tissue in the vicinity of the heart valve of the patient includes applying tension to one or more elements selected from the group consisting of the first tissue-engaging element and the second tissue-engaging element.
In some applications of the present invention, the method includes monitoring a level of regurgitation of the heart valve in conjunction with the adjusting the distance between the portion of the blood vessel and the first portion of tissue in the vicinity of the heart valve of the patient.
In some applications of the present invention, adjusting the distance between the portion of the blood vessel and the first portion of tissue in the vicinity of the heart valve of the patient includes pulling the first tissue-engaging element toward the portion of the blood vessel.
In some applications of the present invention, the heart valve includes a tricuspid valve, and adjusting the distance between the portion of the blood vessel and the first portion of tissue in the vicinity of the heart valve of the patient includes achieving bicuspidization of the tricuspid valve of the heart.
In some applications of the present invention, adjusting the distance between the portion of the blood vessel and the first portion of tissue in the vicinity of the heart valve of the patient includes actuating an adjusting mechanism that is coupled to a portion of a longitudinal member that connects the first and second tissue-engaging elements.
In some applications of the present invention, implanting the second tissue-engaging element in the portion of the blood vessel includes expanding a stent in the portion of the blood vessel.
In some applications of the present invention, the method includes:
implanting a third tissue-engaging element in a second portion of tissue of the heart, the third tissue-engaging element bring connected at a proximal end thereof to a distal end of a longitudinal member; and
engaging a proximal end portion of the longitudinal member with the stent.
In some applications of the present invention, the method includes applying tension to the third tissue-engaging element.
In some applications of the present invention, implanting the first tissue-engaging element in the first portion of tissue in the vicinity of the heart valve of the patient includes engaging the first portion of tissue by performing one or more actions selected from the group consisting of: puncturing and squeezing the first portion of tissue and advancing at least a portion of the first tissue-engaging element into the first portion of tissue.
In some applications of the present invention:
the first portion of tissue in the vicinity of the heart valve includes a portion of tissue of that is opposite the portion of the blood vessel of the patient,
engaging the first portion of tissue includes engaging the portion of tissue that is opposite the portion of the blood vessel of the patient, and
drawing the first leaflet of the valve toward the second leaflet of the valve includes adjusting a distance between the portion of the blood vessel of the patient and the portion of tissue that is opposite the portion of the blood vessel of the patient.
In some applications of the present invention, the first portion of tissue in the vicinity of the heart valve includes a portion of tissue of an annulus of the valve, and engaging the first portion of tissue includes engaging the portion of tissue of the annulus of the valve.
In some applications of the present invention, the portion of tissue of the annulus of the valve includes a portion of tissue that is between a middle portion of an anterior leaflet of the valve and a middle portion of a posterior leaflet of the valve.
In some applications of the present invention, the first portion of tissue in the vicinity of the heart valve includes a portion of tissue of a wall of the atrium of the heart above an annulus of the valve, and engaging the first portion of tissue includes engaging the portion of tissue of the wall of the atrium.
There is additionally provided, in accordance with some applications of the present invention, a method, including:
implanting at least a first tissue-engaging element in a first portion of tissue upstream of a tricuspid valve of a patient;
implanting at least a second tissue-engaging element in a second portion of tissue upstream of the tricuspid valve of the patient; and
altering a geometry of a wall of a right atrium of a heart of the patient by adjusting a distance between the first portion of tissue upstream of the tricuspid valve of the patient and the second portion of tissue upstream of the tricuspid valve of the patient.
In some applications of the present invention, adjusting the distance between the first portion of tissue upstream of the tricuspid valve of the patient and the second portion of tissue upstream of the tricuspid valve of the patient includes adjusting a distance between the first tissue-engaging element and the second tissue-engaging element.
In some applications of the present invention, the first portion of tissue includes a first portion of the wall of the right atrium, and implanting the first tissue-engaging element in the first portion of tissue upstream of the tricuspid valve of the patient includes implanting the first tissue-engaging element in the first portion of the wall of the right atrium.
In some applications of the present invention, the second portion of tissue includes a second portion of the wall of the right atrium, and implanting the second tissue-engaging element in the second portion of tissue upstream of the tricuspid valve of the patient includes implanting the second tissue-engaging element in the second portion of the wall of the right atrium.
In some applications of the present invention, the method includes monitoring a level of regurgitation of the tricuspid valve in conjunction with the altering the geometry of the wall of the right atrium.
In some applications of the present invention, adjusting the distance between the first portion of tissue upstream of the tricuspid valve of the patient and the second portion of tissue upstream of the tricuspid valve of the patient includes pulling a longitudinal element that connects the first and second tissue-engaging elements.
In some applications of the present invention, adjusting the distance between the first portion of tissue upstream of the tricuspid valve of the patient and the second portion of tissue upstream of the tricuspid valve of the patient includes actuating an adjusting mechanism that is coupled to a portion of a longitudinal element that connects the first and second tissue-engaging elements.
In some applications of the present invention, altering the geometry of the wall of the right atrium of the heart of the patient includes drawing together at least a first leaflet of the tricuspid valve of the patient and at least a second leaflet of the tricuspid valve of the patient.
There is further provided, in accordance with some applications of the present invention, a method, including:
engaging at least a portion of at least a first tissue-engaging element in a portion of tissue of a wall of an inferior vena cava of a patient;
engaging at least a portion of at least a second tissue-engaging element in a portion of tissue of a wall of a superior vena cava of the patient;
drawing at least a first leaflet of a heart valve toward at least a second leaflet of the valve by applying tension to one or more portions of tissue selected from the group consisting of: the portion of tissue of the wall of the inferior vena cava of the patient and the portion of tissue of the wall of the superior vena cava of the patient; and
monitoring a level of regurgitation of a heart valve of the patient in conjunction with the applying of the tension.
In some applications of the present invention, applying the tension includes applying the tension following the engaging of the at least first tissue-engaging element and the engaging of the at least second tissue-engaging element.
In some applications of the present invention, applying the tension includes adjusting a distance between the portion of tissue of the wall of the inferior vena cava of the patient and the portion of tissue of the wall of the superior vena cava of the patient.
In some applications of the present invention, adjusting the distance between the portion of tissue of the wall of the inferior vena cava of the patient and the portion of tissue of the wall of the superior vena cava of the patient includes, by the applying of the tension, adjusting a distance between the first tissue-engaging element and the second tissue-engaging element.
In some applications of the present invention, engaging the portion of the at least first tissue-engaging element in the portion of tissue of the wall of the inferior vena cava of the patient includes expanding a first stent member in the inferior vena cava and contacting at least a portion of the first stent member with the portion of the wall of the inferior vena cava.
In some applications of the present invention, engaging the portion of the at least second tissue-engaging element in the portion of tissue of the wall of the superior vena cava of the patient includes expanding a second stent member in the inferior vena cava and contacting at least a portion of the first stent member with the portion of the wall of the inferior vena cava.
In some applications of the present invention, applying the tension includes altering a geometry of a wall of an atrium of a heart of the patient.
In some applications of the present invention, applying the tension includes pulling a longitudinal member that connects the at least first tissue-engaging element and the at least second tissue-engaging element.
In some applications of the present invention, applying the tension includes actuating an adjusting mechanism that is coupled to a portion of a tensioning element that connects the first and second tissue-engaging elements.
The present invention will be more fully understood from the following detailed description of applications thereof, taken together with the drawings, in which:
Reference is now made to
Typically, first and second tissue-engaging elements 60a and 60b and longitudinal member 42 are fabricated from the same material, e.g., nitinol, from a single piece. That is, first and second tissue-engaging elements 60a and 60b and longitudinal member 42 define a single continuous implant unit. For some applications, at least second tissue-engaging element 60b and longitudinal member 42 are fabricated from a single piece.
For other applications, longitudinal member 42 comprises a flexible and/or superelastic material, e.g., nitinol, polyester, stainless steel, cobalt chrome, PTFE, or ePTFE. In some applications of the present invention, longitudinal member 42 comprises a braided polyester suture (e.g., Ticron). In other applications of the present invention, longitudinal member 42 is coated with polytetrafluoroethylene (PTFE). In some applications of the present invention, longitudinal member 42 comprises a plurality of wires that are intertwined to form a rope structure. For some applications, at least a part of longitudinal member 42 comprises a tension spring and/or a plurality of coils.
Second tissue-engaging element 60b comprises a stent member 50 which advanced toward and expandable in a portion of inferior vena cava 8, i.e., a blood vessel that is in direct contact with a right atrium 6 of heart 2 of the patient. Second tissue-engaging element 60b is implanted at second implantation site 52. As shown, first implantation site 30 comprises a portion of an annulus of tricuspid valve 4. Implantation site 30 typically comprises a portion of the annulus of valve 4 that is between (1) the middle of the junction between the annulus and anterior leaflet 14, and (2) the middle of the junction between the annulus and posterior leaflet 16, e.g., between the middle of the junction between the annulus and anterior leaflet 14 and the commissure between the anterior and posterior leaflets. That is, anchor 40 is screwed in the fibrous tissue of the tricuspid annulus close to the commissure in between anterior leaflet 14 and posterior leaflet 16. Implantation site 30 is typically close to the mural side valve 4. For such applications, the drawing together of first and second implantation sites 30 and 52 cinches valve 4 and creates a bicuspidization of tricuspid valve 4, and thereby achieve stronger coaptation between anterior leaflet 14 and septal leaflet 12.
For some applications, implantation site 30 may include a portion of tissue of a wall defining right atrium 6 of heart 2, typically in a vicinity of the annulus of valve 4. For other applications, first implantation site 30 may include a portion of a wall of a right ventricle of heart 2, a ventricular portion of the annulus of valve 4, or a portion of a papillary muscle of the right ventricle of heart 2, as is shown hereinbelow in
As shown in
Once distal end 23 of catheter 22 is disposed within atrium 6, an anchor-deployment tube 24 extends from within catheter 22 beyond distal end 23 thereof and toward first implantation site 30. Anchor-deployment tube 24 holds tissue anchor 40 and a distal portion of longitudinal member 42. For some applications, tube 24 is steerable, as is known in the catheter art, while for other applications, a separate steerable element may be coupled to anchor-deployment tube 24. Under the aid of imaging guidance, anchor-deployment tube 24 is advanced toward first implantation site 30 until a distal end 26 thereof contacts cardiac tissue of heart 2 at first implantation site 30. Anchor-deployment tube 24 facilitates atraumatic advancement of first tissue-engaging element 60a toward first implantation site 30. For such an application in which anchor-deployment tube 24 is used, stent 50 is compressed within a portion of tube 24.
An anchor-manipulating tool (not shown for clarity of illustration), that is slidably disposed within anchor-deployment tube 24, is slid distally within tube so as to push distally tissue anchor 40 of first tissue-engaging element 60a and expose tissue anchor 40 from within tube 24. For some applications of the present invention, the anchor-manipulating tool is reversibly coupled to anchor 40 and facilitates implantation of anchor 40 in the cardiac tissue. For applications in which anchor 40 comprises a helical tissue anchor, as shown, the operating physician rotates the anchor-manipulating tool from a site outside the body of the patient in order to rotate anchor 40 and thereby corkscrew at least a portion of anchor 40 in the cardiac tissue.
Alternatively, system 20 is provided independently of the anchor-manipulating tool, and anchor-deployment tube 24 facilitates implantation of anchor 40 in the cardiac tissue. For applications in which anchor 40 comprises a helical tissue anchor, as shown, the operating physician rotates anchor-deployment tube 24 from a site outside the body of the patient in order to rotate anchor 40 and thereby corkscrew at least a portion of anchor 40 in the cardiac tissue.
It is to be noted that for some applications of the present invention, anchor 40 comprises a clip, jaws, or a clamp which grips and squeezes a portion of cardiac tissue and does not puncture the cardiac tissue.
Following the implantation of anchor 40 at first implantation site 30, anchor-deployment tube 24 is retracted within catheter 22 in order to expose longitudinal member 42, as shown in
For some applications, prior to pulling the portion of longitudinal member 42 that is disposed between anchor 40 and distal end 23 of catheter 22, a mechanism that facilitates the application of a pulling force to longitudinal member 42 is fixed in place, as will be described hereinbelow. This fixing in place provides a reference force to system 20 while applying tension to longitudinal member 42 so as to ensure that during the pulling of longitudinal member 42, stent 50 is not pulled from within catheter 22. For some applications, distal end 23 of catheter 22 is fixed in place with respect to longitudinal member 42. Fixing in place catheter 22 stabilizes catheter 22 as longitudinal member 42 is pulled. This enables distal end 23 to remain in place and not slide distally toward implantation site 30 during the adjusting of longitudinal member 42. For some applications of the present invention, a proximal portion of catheter 22 and/or a proximal handle portion coupled to catheter 22 is anchored or otherwise fixed in place at its access location, e.g., by taping or plastering. Alternatively or additionally, a distal portion of catheter 22 comprises an inflatable element coupled to an inflation conduit which runs the length of catheter 22 from the distal portion thereof to a site outside the body of the patient. Prior to the adjusting of longitudinal member 42, the inflatable element is inflated such that it contacts tissue of the vasculature through which catheter 22 is advanced, and thereby catheter 22 is fixed in place. Typically, the inflatable element comprises an annular inflatable element, such that when inflated, the annular inflatable element functions as a seal to hold in place the distal portion of catheter 22.
Following the fixation of the mechanism that facilitates pulling of longitudinal member 42, the physician then pulls longitudinal member 42 and thereby draws together first and second implantation sites 30 and 52.
For some applications, catheter 22 is reversibly coupled to a proximal portion of longitudinal member 42 by being directly coupled to the proximal portion of member 42 and/or catheter 22 is reversibly coupled to second tissue-engaging element 60b. For example, catheter 22 may be reversibly coupled to stent 50 by the stent's application of a radial force against the inner wall of catheter 22 because of the tendency of stent 50 to expand radially. Following implantation of first tissue-engaging element 60a, catheter 22 (or an element disposed therein) is then pulled proximally to apply tension to longitudinal member 42, which, in such an application, functions as a tensioning element. For some applications, catheter 22 pulls on second tissue-engaging element 60b in order to pull longitudinal member 42. For other applications, catheter 22 pulls directly on longitudinal member 42. For yet other applications, a pulling mechanism pulls on longitudinal member 42, as is described hereinbelow with reference to
Pulling longitudinal member 42 pulls taut the portion of longitudinal member 42 that is disposed between anchor 40 and distal end 23 of catheter 22. Additionally, longitudinal member 42 may be pulled or relaxed in order to adjust the distance between first and second implantation sites 30 and 52. Responsively to the pulling of longitudinal member 42, at least the anterior and septal leaflets of tricuspid valve 4 are drawn together because the geometry of the annulus and/or of the wall of atrium 6 is altered in accordance with the pulling of longitudinal member 42 and depending on the positioning of first tissue-engaging element 60a. During the pulling of longitudinal member 42 by catheter 22, a level of regurgitation of tricuspid valve 4 is monitored. Longitudinal member 42 is pulled until the regurgitation ceases.
Once the physician determines that the regurgitation of valve 4 ceases, and valve 4 has been repaired, the physician decouples catheter 22 from second tissue-engaging element 60b disposed therein and/or from longitudinal member 42, and then retracts catheter 22 in order to expose second tissue-engaging element 60b, i.e., stent member 50, as shown. During the advancement of catheter 22 toward atrium 6, stent member 50 is disposed within a distal portion of catheter 22 in a compressed state. Following initial retracting of catheter 22, stent member 50 is exposed and is allowed to expand and contact a wall of inferior vena cava 8, as shown in
Reference is now made to
Reference is again made to
Reference is now made to
Reference is now made to
System 200 comprises an adapter 218, which is shaped so as to define an annular proximal portion and a distal cylindrical portion having a distal end 220. During the manufacture of system 200, distal end 220 of the cylindrical portion of adapter 218 is slid through annular loop 218 at the distal end of longitudinal member 42, thereby coupling adapter 218 to the distal end of longitudinal member 42. Distal end 220 of adapter 218 is then welded or otherwise fixedly coupled to a proximal portion of an inner lumen of anchor 40, as shown in
Delivery tool system 200 comprises a delivery tool overtube 202 having a distal end thereof. Delivery tool overtube 202 is housed within catheter 22 such that a distal portion thereof passes in part through the lumen of stent 50 and a distal end 204 thereof extends toward tissue anchor 40. During delivery of tissue anchor 40 and stent 50 toward their respective implantation sites, deliver tool system 200 assumes the configuration shown in
Reference is again made to
Following rotation of anchor 40, torque-delivering and an anchor-pulling tube 208 is pulled by the physician in order to pull on anchor 40 and thereby on the portion of cardiac tissue to which anchor 40 is implanted at first implantation site 30. Tube 208 is typically coupled at a proximal end thereof to a mechanical element, e.g., a knob, at the handle portion outside the body of the patient. The physician pulls on tube 208 by actuating the mechanical element that is coupled to the proximal end of tube 208. This pulling of tube 208, and thereby of anchor 40 and of cardiac tissue at first implantation site 30, draws first implantation site toward second implantation site 52 and thereby draws at least anterior leaflet 14 toward septal leaflet 12 in order to achieve coaptation of the leaflets and reduce regurgitation through valve 4.
Following the pulling of anchor 40, stent 50 is positioned at second implantation site 52. Catheter 22 is then retracted slightly along tube 202 so as to pull taut longitudinal member 42 and to ensure that tension is maintained at first implantation site 30 and along longitudinal member 42. Stent 50 is then deployed when the physician holds torque-delivering and anchor-pulling tool 208 and then retracts proximally either (1) catheter 22 or (2) a sheath (i.e., that disposed within catheter 22 and surrounds stent 50), around stent 50 so as to deploy stent 50 from within either (1) catheter 22 or (2) the sheath disposed within catheter 22.
It is to be noted that stent 50 is retrievable following at least partial deployment thereof, e.g., following deployment of up to ½ or up to ⅓ of stent 50. In such an application, following the initial retraction proximally of catheter 22 from around stent 50 in order to deploy at least a distal portion of stent 50, catheter 22 is advanceable distally so as to compress and retrieve the at least partially-deployed stent back into the distal end portion of catheter 22. Alternatively, catheter 22 houses a sheath which compresses stent 50 during delivery of stent to second implantation site 52. During the initial retracting of catheter 22 proximally, the sheath surrounding stent 50 is also retracted in conjunction with the retracting of catheter 22. Following the at least partial deployment of stent 50 in order to deploy at least a distal portion of stent 50, the sheath is advanceable distally (while catheter 22 remains in place) so as to compress and retrieve the at least partially-deployed stent back into the distal end portion of the sheath. The sheath is then retracted into catheter 22. For such applications of the present invention in which stent 50 is retrievable following at least partial deployment thereof, anchor 40 can then be unscrewed from first implantation site 30 and the entire implant system may be extracted from the body, or repositioned in the heart, depending on the need of a given patient.
For applications in which stent 50 is retrievable, in order to retrieve stent 50 (i.e., prior to the decoupling of manipulator 206 from adapter 218 and thereby from anchor 40), the physician holds torque-delivering and anchor-pulling tool 208 and then advances distally either (1) catheter 22 or (2) the sheath disposed within catheter 22, around stent 50 so as to compress stent 50 within either (1) catheter 22 or (2) the sheath disposed within catheter 22. Torque-delivering and anchor-pulling tool 208 may then be rotated in order to unscrew anchor 40 from the tissue, and the entire system may be extracted from the body, or repositioned in the heart, depending on the need of a given patient.
Reference is now made to
As shown in
Reference is again made to
Following the implantation of first and second tissue-engaging elements 60a and 60b, catheter 22 is retracted from the body of the patient. Outside the body of the patient, catheter 22 is reloaded with third and fourth tissue-engaging elements 60c and 60d. Catheter 22 is then reintroduced within the body of the patient and is advanced toward right atrium 6, as shown in
Subsequently, a second tissue anchor 40b (i.e., an anchor that is similar to tissue anchor 40a, as described hereinabove) is implanted at a second portion of cardiac tissue at a third implantation site 32. Third implantation site 32 includes a portion of cardiac tissue in the vicinity of tricuspid valve 4 (e.g., a second portion of tissue of the annulus of tricuspid valve 4, as shown). Third implantation site 32, as shown, comprises a portion of tissue that is between (1) the middle of the junction between the annulus and anterior leaflet 14, and (2) the middle of the junction between the annulus and posterior leaflet 16. For some applications, third implantation site 32 may comprise a second portion of the wall that defines right atrium 6. For other applications, third implantation site 32 may comprise a portion of cardiac tissue in the right ventricle, e.g., a portion of the wall that defines the right ventricle, a ventricular portion of the annulus of valve 4, or a portion of a papillary muscle of the right ventricle.
Following implantation of third tissue-engaging element 60c, catheter 22 is retracted and tension is applied to third tissue-engaging element 60c in a manner as described hereinabove with reference to
Additionally, responsively to the pulling of tissue at first and third implantation sites 30 and 32 toward second implantation site 52, anterior leaflet 14 is drawn toward septal leaflet 12, and bicuspidization is achieved. Also, responsively to the pulling, a portion of tissue that is between first and third implantation sites 30 and 32 is cinched.
Reference is now made to
It is to be noted that second stent member 50b is implanted within the lumen of first stent member 50a by way of illustration and not limitation, and that for some applications of the present invention, first and second stent members 50a and 50b may be implanted coaxially at second implantation site 52.
It is to be noted that third and fourth tissue-engaging elements 60c and 60d and second longitudinal member 42b are fabricated from the same material, e.g., nitinol, from a single piece. That is, third and fourth tissue-engaging elements 60c and 60d and second longitudinal member 42b define a single continuous implant unit.
Reference is now made to
It is to be noted that third tissue-engaging element 60c, second longitudinal member 42b, and engaging elements 114 and proximal end portion 112 of second longitudinal member 42b are fabricated from the same material, e.g., nitinol, from a single piece. That is, third tissue-engaging element 60c, second longitudinal member 42b, and engaging elements 114 and proximal end portion 112 of second longitudinal member 42b define a single continuous implant unit.
Reference is now made to
In
Catheter 122 is then retracted so as to pull and apply tension to longitudinal member 42. Longitudinal member 42 is pulled directly by catheter 122 and/or indirectly by pulling stent member 132 disposed within catheter 122. During the pulling, a level of regurgitation of tricuspid valve 4 is monitored, because responsively to the pulling, the geometry of the wall of atrium 6 is altered and the leaflets of tricuspid valve 4 are drawn together so as to reduce and eliminate regurgitation of valve 4.
Once the physician determines that the regurgitation of valve 4 ceases, and valve 4 has been repaired, the physician decouples catheter 122 from second stent member 132 disposed therein and/or from longitudinal member 42, and then retracts catheter 122 in order to expose second tissue-engaging element 60b, i.e., second stent member 132, as shown. Following initial retracting of catheter 122, second stent member 132 is exposed and is allowed to expand and contact a wall of inferior vena cava 8, as shown in
Reference is again made to
It is to be noted that first and second stent members 130 and 132 and longitudinal member 42 are fabricated from the same material, e.g., nitinol, from a single piece. That is, first and second stent members 130 and 132 and longitudinal member 42 define a single continuous implant unit.
Reference is yet again made to
Reference is now made to
Catheter 142 is advanced through vasculature of the patient, in manner as described hereinabove with regard to catheter 22 with reference to
Catheter 142 is then advanced toward second implantation site 52 and facilitates implantation of second tissue anchor 40b in the cardiac tissue. For some applications, as catheter 142 is advanced toward second implantation site, longitudinal member 42 is pulled to draw together the leaflets of valve 4, while a level of regurgitation of valve 4 is monitored. As shown, second implantation site 52 includes a second portion of tissue of the annulus of valve 4 at the septal side of valve 4, by way of illustration and not limitation. For some applications, second implantation site 52 may include a second portion of the wall of atrium 6 of heart 2. As shown by way of illustration and not limitation, second implantation site 52 includes a portion of tissue of the annulus inferior of the middle of septal leaflet 12. It is to be noted that first implantation site 30 may be implanted at any suitable location along and in the vicinity of the annulus of valve 4, e.g., at the commissure between posterior leaflet 16 and septal leaflet 12.
For such an application, by applying tension to longitudinal member 42, anterior leaflet 14 and septal leaflet 12 are drawn together, and bicuspidization of valve 4 is achieved. For some applications, during the adjusting of mechanism 150, a retrievable stent may be deployed in inferior vena cava 8 so as to stabilize system 140 during the adjusting of adjusting mechanism 150. It is to be further noted that tissue-engaging elements 60a and 60b and catheter 142 may be advanced toward atrium 6 through superior vena cava, mutatis mutandis.
For some applications of the present invention, system 140 comprises one or more anchor-manipulating tools (not shown for clarity of illustration), that is slidably disposed within catheter 142. The anchor-manipulating tool is slid distally with within catheter 142 so as to push distally tissue anchors 40a and 40b and expose tissue anchors 40a and 40b from within catheter 142. For some applications of the present invention, the anchor-manipulating tool(s) is(/are) reversibly couplable to anchors 40a and 40b, and facilitate(s) implantation of anchors 40a and 40b in the cardiac tissue. For applications in which anchors 40a and 40b comprises respective helical tissue anchor, as shown, the operating physician rotates the anchor-manipulating tool(s) from a site outside the body of the patient in order to rotate anchors 40a and 40b, and thereby corkscrew at least respective distal portions of anchors 40a and 40b in the cardiac tissue.
Reference is again made to
Typically, following implantation of first and second tissue anchors 40a and 40b, a length of longitudinal member 42, that is disposed between first and second tissue anchors 40a and 40b, is adjusted by adjusting mechanism 150. Adjusting mechanism 150 typically comprises a mechanical element which shortens a distance of longitudinal member 42 between first and second tissue-engaging elements 60a and 60b. For some applications, adjustable mechanism 150 may be permanently coupled to longitudinal member 42 (as shown in
For other applications, adjusting mechanism 150 comprises only adjusting tool 144, as shown in
In either application, a level of regurgitation of valve 4 is monitored during the adjusting of the distance between first and second tissue-engaging elements 60a and 60b by adjusting mechanism 150.
Following the adjusting of the distance between first and second implantation sites 30 and 52, adjusting tool 144 and catheter 142 are decoupled from longitudinal member 42 and are extracted from the body of the patient.
Reference is now made to
Reference is now made to
Reference is now made to
Reference is again made to
For some applications, following the deploying of first, second, third, and fourth tissue-engaging elements 60a-d (i.e., first and second anchors 40a and 40b, and first and second stents 50a and 50b), (1) a distance between first and second tissue-engaging elements 60a and 60b is adjustable by first adjustable mechanism, and (2) a distance between third and fourth tissue-engaging elements 60c and 60d is adjustable by a second adjustable mechanism, as described hereinbelow with reference to
Reference is now made to
Reference is again made to
Reference is yet again made to
For some applications, techniques described herein are practiced in combination with techniques described in one or more of the references cited in the Background section of the present patent application.
It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.
| Number | Name | Date | Kind |
|---|---|---|---|
| 4493329 | Crawford et al. | Jan 1985 | A |
| 4625727 | Leiboff | Dec 1986 | A |
| 4778468 | Hunt et al. | Oct 1988 | A |
| 5108420 | Marks | Apr 1992 | A |
| 5330521 | Cohen | Jul 1994 | A |
| 5450860 | O'Connor | Sep 1995 | A |
| 5473812 | Morris et al. | Dec 1995 | A |
| 5776178 | Pohndorf et al. | Jul 1998 | A |
| 5843120 | Israel et al. | Dec 1998 | A |
| 6027523 | Schmieding | Feb 2000 | A |
| 6298272 | Peterfeso et al. | Oct 2001 | B1 |
| 6299635 | Frantzen | Oct 2001 | B1 |
| 6332893 | Mortier et al. | Dec 2001 | B1 |
| 6575976 | Grafton | Jun 2003 | B2 |
| 6613078 | Barone | Sep 2003 | B1 |
| 6613079 | Wolinsky et al. | Sep 2003 | B1 |
| 6616684 | Vidlund et al. | Sep 2003 | B1 |
| 6626899 | Houser et al. | Sep 2003 | B2 |
| 6626930 | Allen et al. | Sep 2003 | B1 |
| 6629921 | Schweich, Jr. et al. | Oct 2003 | B1 |
| 6641597 | Burkhart et al. | Nov 2003 | B2 |
| 6702846 | Mikus et al. | Mar 2004 | B2 |
| 6723038 | Schroeder et al. | Apr 2004 | B1 |
| 6730118 | Spenser et al. | May 2004 | B2 |
| 6884250 | Monassevitch et al. | Apr 2005 | B2 |
| 7101395 | Tremulis et al. | Sep 2006 | B2 |
| 7125421 | Tremulis et al. | Oct 2006 | B2 |
| 7144363 | Pai et al. | Dec 2006 | B2 |
| 7159593 | McCarthy et al. | Jan 2007 | B2 |
| 7169187 | Datta et al. | Jan 2007 | B2 |
| 7175625 | Culbert | Feb 2007 | B2 |
| 7186262 | Saadat | Mar 2007 | B2 |
| 7201772 | Schwammenthal et al. | Apr 2007 | B2 |
| 7311728 | Solem et al. | Dec 2007 | B2 |
| 7316706 | Bloom et al. | Jan 2008 | B2 |
| 7316710 | Cheng et al. | Jan 2008 | B1 |
| 7338506 | Caro | Mar 2008 | B2 |
| 7390329 | Westra et al. | Jun 2008 | B2 |
| 7530995 | Quijano et al. | May 2009 | B2 |
| 7547321 | Silvestri et al. | Jun 2009 | B2 |
| 7549983 | Roue et al. | Jun 2009 | B2 |
| 7618449 | Tremulis et al. | Nov 2009 | B2 |
| 7628797 | Tieu et al. | Dec 2009 | B2 |
| 7632303 | Stalker et al. | Dec 2009 | B1 |
| 7771467 | Svensson | Aug 2010 | B2 |
| 7780726 | Seguin | Aug 2010 | B2 |
| 7803187 | Hauser | Sep 2010 | B2 |
| 7988725 | Gross et al. | Aug 2011 | B2 |
| 7991484 | Sengupta et al. | Aug 2011 | B1 |
| 7993368 | Gambale et al. | Aug 2011 | B2 |
| 8010207 | Smits et al. | Aug 2011 | B2 |
| 8108054 | Helland | Jan 2012 | B2 |
| 8236013 | Chu | Aug 2012 | B2 |
| 8262725 | Subramanian | Sep 2012 | B2 |
| 8267981 | Boock et al. | Sep 2012 | B2 |
| 8332051 | Sommer et al. | Dec 2012 | B2 |
| 20020177904 | Huxel et al. | Nov 2002 | A1 |
| 20030236568 | Hojeibane et al. | Dec 2003 | A1 |
| 20040181287 | Gellman | Sep 2004 | A1 |
| 20040186566 | Hindrichs et al. | Sep 2004 | A1 |
| 20040193092 | Deal | Sep 2004 | A1 |
| 20040236419 | Milo | Nov 2004 | A1 |
| 20040260389 | Case et al. | Dec 2004 | A1 |
| 20050016560 | Voughlohn | Jan 2005 | A1 |
| 20050107812 | Starksen et al. | May 2005 | A1 |
| 20050177228 | Solem et al. | Aug 2005 | A1 |
| 20050203606 | VanCamp | Sep 2005 | A1 |
| 20050216039 | Lederman | Sep 2005 | A1 |
| 20060129166 | Lavelle | Jun 2006 | A1 |
| 20060161265 | Levine et al. | Jul 2006 | A1 |
| 20060229708 | Powell et al. | Oct 2006 | A1 |
| 20060241748 | Lee et al. | Oct 2006 | A1 |
| 20060282161 | Huynh et al. | Dec 2006 | A1 |
| 20070016287 | Cartledge et al. | Jan 2007 | A1 |
| 20070049942 | Hindrichs et al. | Mar 2007 | A1 |
| 20070049970 | Belef et al. | Mar 2007 | A1 |
| 20070061010 | Hauser et al. | Mar 2007 | A1 |
| 20070066863 | Rafiee et al. | Mar 2007 | A1 |
| 20070093869 | Bloom et al. | Apr 2007 | A1 |
| 20070118151 | Davidson | May 2007 | A1 |
| 20070162107 | Haug et al. | Jul 2007 | A1 |
| 20070198082 | Kapadia et al. | Aug 2007 | A1 |
| 20070203391 | Bloom et al. | Aug 2007 | A1 |
| 20070250160 | Rafiee | Oct 2007 | A1 |
| 20070282375 | Hindrichs et al. | Dec 2007 | A1 |
| 20080003539 | Lundgren | Jan 2008 | A1 |
| 20080035160 | Woodson et al. | Feb 2008 | A1 |
| 20080077231 | Heringes et al. | Mar 2008 | A1 |
| 20080262609 | Gross et al. | Oct 2008 | A1 |
| 20080288044 | Osborne | Nov 2008 | A1 |
| 20080288062 | Andrieu et al. | Nov 2008 | A1 |
| 20090084386 | McClellan et al. | Apr 2009 | A1 |
| 20090118776 | Kelsch et al. | May 2009 | A1 |
| 20090149872 | Gross et al. | Jun 2009 | A1 |
| 20090171439 | Nissl | Jul 2009 | A1 |
| 20090216265 | DeVries et al. | Aug 2009 | A1 |
| 20090259307 | Gross et al. | Oct 2009 | A1 |
| 20090264995 | Subramanian | Oct 2009 | A1 |
| 20090326648 | Machold et al. | Dec 2009 | A1 |
| 20100130992 | Machold et al. | May 2010 | A1 |
| 20100161041 | Maisano et al. | Jun 2010 | A1 |
| 20100161042 | Maisano et al. | Jun 2010 | A1 |
| 20100161043 | Maisano et al. | Jun 2010 | A1 |
| 20100161047 | Cabiri | Jun 2010 | A1 |
| 20100168791 | Kassab et al. | Jul 2010 | A1 |
| 20100174358 | Rabkin et al. | Jul 2010 | A1 |
| 20100185278 | Schankereli | Jul 2010 | A1 |
| 20100211166 | Miller et al. | Aug 2010 | A1 |
| 20100217382 | Chau et al. | Aug 2010 | A1 |
| 20100234935 | Bashiri et al. | Sep 2010 | A1 |
| 20100249908 | Chau et al. | Sep 2010 | A1 |
| 20100280603 | Maisano et al. | Nov 2010 | A1 |
| 20100280604 | Zipory et al. | Nov 2010 | A1 |
| 20100280605 | Hammer et al. | Nov 2010 | A1 |
| 20100286628 | Gross | Nov 2010 | A1 |
| 20100286767 | Zipory et al. | Nov 2010 | A1 |
| 20100324598 | Anderson | Dec 2010 | A1 |
| 20110022164 | Quinn et al. | Jan 2011 | A1 |
| 20110029066 | Gilad et al. | Feb 2011 | A1 |
| 20110082538 | Dahlgren et al. | Apr 2011 | A1 |
| 20110087146 | Ryan et al. | Apr 2011 | A1 |
| 20110093002 | Rucker et al. | Apr 2011 | A1 |
| 20110106245 | Miller et al. | May 2011 | A1 |
| 20110106247 | Miller et al. | May 2011 | A1 |
| 20110112632 | Chau et al. | May 2011 | A1 |
| 20110184510 | Maisano et al. | Jul 2011 | A1 |
| 20110238112 | Kim et al. | Sep 2011 | A1 |
| 20120022640 | Gross et al. | Jan 2012 | A1 |
| 20120035712 | Maisano et al. | Feb 2012 | A1 |
| 20120232373 | Hallander et al. | Sep 2012 | A1 |
| 20130030522 | Rowe et al. | Jan 2013 | A1 |
| Number | Date | Country |
|---|---|---|
| 9205093 | Apr 1992 | WO |
| 2005021063 | Mar 2005 | WO |
| 2005102194 | Nov 2005 | WO |
| 2006097931 | Sep 2006 | WO |
| 2008068756 | Jun 2008 | WO |
| 2010004546 | Jan 2010 | WO |
| 2010073246 | Jul 2010 | WO |
| 201028502 | Nov 2010 | WO |
| 2010128503 | Nov 2010 | WO |
| 2011051942 | May 2011 | WO |
| 2011089601 | Jul 2011 | WO |
| 2011143263 | Nov 2011 | WO |
| Entry |
|---|
| Shikhar Agarwal, et al; “Interventional Cardiology Perspective of Functional Tricuspid Regurgitation” Circulation: Cardiovascular Interventions, pp. 565-573; Dec. 2009; vol. 2, Issue 6. |
| Amplatzer Cardiac Plug Brochure (English Pages), AGA Medical Corporation Plymouth MN, Copyright 2008-2010, downloaded Jan. 11, 2011. |
| U.S. Appl. No. 60/902,146, filed Feb. 16, 2007. |
| An International Search Report and A Written Opinion, both dated May 19, 2011, which issued during the prosecution of Applicant's PCT/IL11/00064. |
| Francesco Maisano, et al; “The double-orifice technique as a standardized approach to treat mitral regurgitation due to severe myxomatous disease: surgical technique”, European Journal of Cardio-thoracic Surgery, vol. 17, Issue 3, pp. 201-205; Mar. 2000. |
| Ottavio Alfieri, et al; “Novel Suture Device for Beating-Heart Mitral Leaflet Approximation”, Ann Thorac Surg, vol. 74, Issue 5, Nov. 2002, pp. 1488-1493. |
| Smith & Nephew MINITAC™ TI 2.0 Suture Anchor Product Description, downloaded on Dec. 9, 2012 from http://global.smith-nephew.com/us/MINITAC—TI—2—SUTURE—ANCHR—3127.htm. |
| International Search Report and Written Opinion of the International Searching Authority; dated Jan. 22, 2013; International Appln. No. PCT/IL2012/000282. |
| Number | Date | Country | |
|---|---|---|---|
| 20110184510 A1 | Jul 2011 | US |
