Source: https://patents.google.com/patent/EP3175797A1/en
Timestamp: 2019-05-20 16:10:53
Document Index: 536951095

Matched Legal Cases: ['Application No. 61', 'Application No. 61', 'Application No. 61', 'Application No. 61', 'art.\n4', 'art.\n9', 'art.\n12', 'art.\n15', 'art.\n28', 'art.\n36', 'art.\n42', 'art.\n43']

EP3175797A1 - Trans-catheter ventricular reconstruction structures and systems for treatment of congestive heart failure and other conditions - Google Patents
Trans-catheter ventricular reconstruction structures and systems for treatment of congestive heart failure and other conditions Download PDF
EP3175797A1
EP3175797A1 EP16206824.1A EP16206824A EP3175797A1 EP 3175797 A1 EP3175797 A1 EP 3175797A1 EP 16206824 A EP16206824 A EP 16206824A EP 3175797 A1 EP3175797 A1 EP 3175797A1
EP16206824.1A
2012-09-28 Priority to EP12835954.4A priority patent/EP2760371B1/en
2017-06-07 Publication of EP3175797A1 publication Critical patent/EP3175797A1/en
This application is related to and claims the benefit of U.S. Provisional Patent Application No. 61/541,624 entitled "Trans-Catheter Ventricular Reconstruction Structures, Methods, and Systems for Treatment of Congestive Heart Failure and Other Conditions," filed September 30, 2011. This application is also related to and claims the benefit of U.S. Provisional Patent Application No. 61/541,975 entitled "Remote Pericardial Hemostasis for Ventricular Access and Reconstruction or Other Organ Therapies," filed September 30, 2011; U.S. Provisional Patent Application No. 61/541,980 entitled "Over-The-Wire Cardiac Implant Delivery System for Treatment of CHF and Other Conditions," filed September 30, 2011; and U.S. Provisional Patent Application No. 61/541,978 entitled "Cardiac Implant Migration Inhibiting Systems," filed September 30, 2011; the full disclosures of which are incorporated herein by reference in their entirety.
The subject matter of this application is related to that of US Patent Publication No. US2009/0093670 , as published on April 9, 2009 and entitled "Treating Dysfunctional Cardiac Tissue;" and to that of US Patent Publication No. US2010/0016655 , as published on January 21, 2010 and entitled "Cardiac Anchor Structures, Methods, and Systems for treatment of Congestive Heart Failure and Other Conditions;" the full disclosures of which are incorporated herein by reference in their entirety.
An exemplary method and implant for closing off a lower portion of a heart ventricle is described in U.S. Pat. No. 6,776,754 , the full disclosure of which is incorporated herein by reference. A variety of alternative implant structures and methods have also been proposed for treatment of the heart. U.S. Pat. No. 6,059,715 is directed to a heart wall tension reduction apparatus. U.S. Pat. No. 6,162,168 also describes a heart wall tension reduction apparatus, while U.S. Pat. No. 6,125,852 describes minimally-invasive devices and methods for treatment of congestive heart failure, at least some of which involve reshaping an outer wall of the patient's heart so as to reduce the transverse dimension of the left ventricle. U.S. Pat. No. 6,616,684 describes endovascular splinting devices and methods, while U.S. Pat. No. 6,808,488 describes external stress reduction devices and methods that may create a heart wall shape change. US Patent Publication No. US2009/0093670 describes structures and methods for treating dysfunctional cardiac tissue, while US Patent Publication No. US2010/0016655 describes cardiac anchor structures, methods, and systems for treatment of congestive heart failure and Other Conditions. The full disclosures of all of these references are incorporated herein by reference in their entirety.
Figs 3B and 3C schematically illustrate a needle and guidewire crossing one chamber of a heart and being inserted into another chamber.
Figs. 25a-28Z3 illustrate deployment of an embodiment of a remote ventricular reconstruction implant in a pig cadaver heart, as described in the Experimental section;
The present invention generally provides improved medical devices, systems, and methods. Exemplary embodiments of the devices are described for use in reducing the distance between a region along the septum and a region of an external wall of the left ventricle of a heart in a less or minimally invasive manner. Hence, embodiments of the tools and methods described herein may find specific use in the treatment of congestive heart failure and other progressive heart diseases by reconfiguring abnormal heart geometry that may be contributing to heart dysfunction. For congestive heart failure therapies, perforating both the exterior wall and the septum from an epicardial approach can provide significant benefits in control over the locations of implant deployments, thereby effectively enhancing the resulting reshaping of the ventricular chamber. Despite this largely epicardial approach, there are surprising benefits to guiding deployment of the implant from along both the epicardial access path and another access path into and via an access path through the right ventricle. This additional right atrial access path into the heart may be via the superior vena cava, the inferior vena cava, the right atrial appendage, or the like, and the pathways may be joined together by coupling of a snare to a guidewire or the like within the right ventricle, the right atrium, the right pulmonary artery, or the like. While a variety of tools will be described herein for providing access pathways, for joining pathways together within the heart, for deploying implants, for maintaining hemostasis, and the like, it should be recognized that alternative embodiments may employ additional or alternative structures, some of which may be off-the-shelf, and some of which may be new structures configured particularly for use in the advantageous therapies described herein. For example, embodiments of the systems, implants, and techniques described herein may employ components described in US2009/0093670 , as published on April 9, 2009 and entitled "Treating Dysfunctional Cardiac Tissue;" and/or in US Patent Publication No. US2010/0016655 , as published on January 21, 2010 and entitled "Cardiac Anchor Structures, Methods, and Systems for treatment of Congestive Heart Failure and Other Conditions;' the full disclosures of which are incorporated herein by reference in their entirety.
Referring now to Figs. lA and 1B, a series of implants 10 are shown implanted in a heart H so as to decrease a cross-section of a left ventricle LV. Each implant 10 generally includes a first anchor 12, a second anchor 14, and a tension member 16 coupling the anchors together. Tension in the tension member 16 is transferred from the anchors 12, 14 to the septum S and the external wall EW bordering the left ventricle LV so as to bring these structures into engagement, thereby effectively excluding a region of scar tissue ST from the left ventricle. In many embodiments described herein, implant 10 will be deployed by penetrating the external wall EW and septum S via a pericardium P of the heart H, and also by accessing a right ventricle RV via a right atrium. Anchors deployed within a right ventricle and/or in engagement with the septum S may sometimes be referred to herein as septal anchors, while anchors deployed along the external wall EW of the left ventricle LV may be referred to as epicardial anchors.
Referring now to Fig. 3, joining of an access path through the right atrium to an access path through the pericardium and cpicardium by snaring of a guidewire within the right ventricle under thoracoscopic guidance 20 is schematically illustrated. The right atrial access path may extend into the arterial vasculature via the femoral artery FA and inferior vena cava IVC, via the jugular artery JA via the superior vena cava, or the like. As can be understood with reference to Fig. 3A, a selected location for perforation of the external wall EW can be identified using an image from thoracoscope 20, optionally in compination with an image from another imaging modality (such as a prior or contemporaneous image from an ultrasound imaging system, an MRI imaging system, an X-ray or fluoroscopic imaging system, a CT imaging system, or the like. In exemplary embodiments, a rigid or semi-rigid shaft of an access tool 22 having a working lumen therethrough is advanced through the epicardium of the beating heart so that a distal end of the shaft is disposed within the left ventricle LV. Access tool 22 may comprise a relatively simple needle or trocar, an may have a proximal hemostasis valve at its proximal end so as to inhibit bloodflow through the lumen and facilitate insertion and/or removal of a guidewire and the like. In some embodiments, access tool 22 may have a tissue penetrating sharpened distal end to facilitate distal insertion, and/or a stylus may be removably disposed within the lumen. Optional embodiments of access tool 22 may have an energy delivery surface at or near the distal end so as to deliver radiofrequency energy, laser energy, or the like to facilitate penetrating the tissue of the external wall EW. Suitable RF penetrating structures may be commercially available from (or modified from those available from) Baylis Medical of Toronto Canada.
A wide variety of alternative septum perforation approaches might be employed, including using atrial septum perforation structures and techniques (or structures and techniques derived therefrom). For example, mechanical systems may employ a sharpened distal tip and axial penetration (such as using structures commercially available from--or structures derived from--the SafeSept™ transseptal guidewire commercially available from Adaptive Surgical, LLC; the ACross Transseptal Access System commercially available from St Jude, or the like), a rotatable angled blade, the transseptal puncturing structures and methods described by Wittkampf et al. in US2011/0087261 , or the like. RF systems may employ a proprietary tissue penetrating structure or may energize an off-the-shelf transseptal needle with RF energy, as was described by Knecht et al. in an article entitled "Radiofrequency Puncture of the Fossa Ovalis for Resistant Transseptal Access," Circ Arrhythm Electrophysiol 1, 169 (2008). Laser-energy transseptal approaches may also be employed, including structures commercially available from (or derived from those commercially available from) Spectranetics and others.
Referring now to Figs 4A-4C, a distal end of catheter 30 may be advanced to the right ventricle RV through the right atrium RA and associated vasculature using known techniques, so that catheter 30 provides a right ventricle access tool. Optionally, a snare tool has a distal portion configured to engage a distal portion of the guidewire. For example, distal snare 32 may be separated from a proximal end of a snare body by sufficient length of the snare body to allow the snare to be manipulated within the right ventricle from the proximal end of catheter 30. Snare 32 may be biased to open when advanced beyond catheter 30, allowing the catheter to be positioned near the septum around the epicardial path of catheter 24. Advancing guidewire 26 through the opening of snare 30 and withdrawing snare 32 into catheter 32 so that the guidewire is bent as it enters the distal end of catheter 30 axially couples the guidewire to the snare.
Referring now to Figs 5A and 5B, there may be advantages to employing alternative elongate flexible bodies to couple the access paths within the heart. For example, a guidewire-like elongate body with a proximal end and a distal portion formed as a basket 34 may be expanded in the right ventricle so that the basket encompasses a volume within the right ventricle. In some embodiments, the basket may be withdrawn back into catheter 24 or 30 so as to capture a guidewire extending from the other, thereby joining the paths. In other embodiments, a guidwire-like elongate flexible body 36 having short lateral distal protrusion or barb can be advanced a relatively short distance into a target portion of the basket and withdrawn back into the catheter so as to capture a member of basket 34, with the target portion of the basket being separated from sensitive heart tissues (such as valve leaflets or chordae) by the expansion of the basket. Optionally, the basket 34 may be advanced toward or into the right atrium before engaging the basket with the distal portion of flexible body 36. An exemplary basket structure and associated access catheter are shown in Fig. 6.
Referring now to Figs. 10G-10I, and alternative dilation catheter 50' may have a tapered helical distal end 52' that is configured to rotationally advance or screw into and through tissue. Inner and outer concentric shafts extend proximally of distal end 52 toward a proximal hub 51. The shafts are laterally flexible to accommodate curvature of the axis of the dilation catheter, and the hub and tip may be axially coupled to the inner shaft and the inner shaft may be sufficiently axially stiff so that rotation of the hub outside the body induces controlled roation of the tip into and through the tissue while the outer shaft remains rotationally stationary.
Referring now to Figs 9B, 10, 10A, 10F, and 12A, the end of the guidewire extending out from the epicardial access path is threaded through a lumen of an anchor delivery 70 from a distal end of the delivery catheter and out the proximal end. The same guidwire end can then be inserted through an axial anchor lumen 80 through anchor 12 and with the anchor aligned along tether 16, the anchor 12 can be loaded into the proximal end of an anchor delivery catheter 70 over guidewire 26 with tether 16 trailing behind the anchor. A pusher catheter 72 can be positioned proximally of the anchor within delivery catheter 70 to push the anchor distally. The delivery catheter can be advanced along the epicardial access path over guidewire 26 so that the distal end of the delivery catheter extends into the right ventricle. Optionally, a loading cartridge 82 may facilitate insertion of anchor 12 into delivery catheter 70. Anchor 12 can then be advanced out of the distal end of delivery catheter 70 by pushing the anchor distally with pusher 72. Guidewire 26 helps maintain a position and orientation of the anchor within the right ventricle, particularly when the guidewire extends along the coupled access paths.
Referring now to Figs. 10, 10D, 10E, and 16A-21, epicardial anchor 14 has a spring cam structure as more fully described in US Patent Publication No. US2010/0016655 , as published on January 21, 2010 and entitled "Cardiac Anchor Structures, Methods, and Systems for treatment of Congestive Heart Failure and Other Conditions;" the full disclosures of which are incorporated herein by reference. The spring cam allows anchor 14 to slide along tether 16 toward anchor 12, but inhibits sliding of anchor 14 away from anchor 12, so that the spring cam can effective maintains a tissue engagement force between the anchors. This set-force interaction between the tether and anchor 14 is advantageous once the proper force is applied, but it can be challenging to apply the desired force when the heart is beating. To more accurately apply septal/external wall engagement forces within a desired range, an anchor set tool 110 can engage the cam spring mechanism of anchor 14 so as to allow the anchor to slide both axial directions along tether 16, thereby configuring anchor 14 into a variable force mode. This allows a controlled force to be applied between the tether 16 and epicardial anchor 14 despite beating of the heart, with the force preferably being applied by a force application tool 112 having an elongate shaft 114. Force application tool 14 may be a relatively simple structure similar to a scale, typically having a force spring and an indicator showing when a force in a desired range is being applied such as by showing deflection of the spring to a position within a desired range. By sliding the shaft of the force application tool over tether 16, engaging the surface of anchor 14 with a compression surface of the shaft, and applying force between the tether and the force application tool till the desired deflection is identified the desired force may be applied between anchors 12 and 14. While that force is applied, anchor set tool 110 may disengage the cam lock of epicardial anchor 14, thereby reconfiguring the anchor from the variable-force mode to the set-force mode. The force application tool 112 and anchor set tool 112 can then be removed, the tether 16 extending away from the heart from epicardial anchor can be cut and removed. Pressure by epicardial anchor 14 against external wall 14 inhibits blood flow out of the left ventricle along the epicardial access path, while pressure of septal anchor 12 against the septum inhibits blood flow from the left ventricle to the right ventricle. Known techniques can be used for closure of the vascular access of catheter 30 and the minimally invasive access to the epicardium.
Referring now to Figs 22A-22D, an epicardial access tool may facilitate both access to the epicardium and hemostasis of the epicardial access path. A shaft of the epicardial access tool extends from a proximal handle to a circumferatial series of distal radial compression features. A working lumen of the access tool shaft allows the various access tools to be advanced along a tissue tract from outside the patient to an epicardial surface region encompassing the epicardial access path. The compression features are oriented to engage tissue of the external wall and urge the engaged tissue radially inwardly when the handle is actuated. In the exemplary embodiment, filaments extend axially from the handle along the shaft to each compression feature, and then turn laterally from that compression feature to another compression feature. Actuation of the handle pulls the filaments, thereby pulling the compression features radially inwardly. Alternative epicardial access tools may employ suction to grip and stabilize the epicardial surface of the heart, somewhat analogous to the engagement between known heart stabilization tools and the heart as used for beating-heart coronary arterial bypass grafting and the like.
As shown in Figs. 25a-c, basket configured to retrieve a wire from the apex of the right ventricular septum, from the mid-portion of the right ventricular septum, and from the infundibulum (pulmonary outflow tract) of the right ventricular septum were provided, respectively.
As shown in Fig. 26a the apical basket is placed in the apex of the RV and visualized via fluoroscopy. In Fig. 26b, a needle is passed into the epicardial surface of the L V and in Fig. 26c is aimed toward the basket. Following positioning of the needle, a guide wire is passed through the needle and into the basket via fluoroscopic control. The wire position is confirmed in bi-planar views and the needle is withdrawn. In Figs. 27a and 27b, the guide wire has been passed through the needle and appeared to be within the basket in bi-planar fluoroscopic views, and in 27c the needle is withdrawn leaving the guide wire in the basket. The guide wire is then grasped by closing the basket into the guiding catheter and pulling, the guide wire along with the catheter and closed basket out of the right atrium (see Figs. 28a-28c).
In Figs. 28a and b, as the guiding sheath is pushed over the basket, the basket grasps the guide wire and pulls it into the catheter. In Fig. 28c the catheter is withdrawn from the right atrium with the attached guide wire.
This same procedure was then repeated using different baskets and needles to pass and retrieve guide wires from the mid-portion and the infundibular portion of the RV septum. Passing and retrieving a guidewire at the mid-RV septal level is shown in Figs. 28D and 28E, and passing a retrieving a guide wire at the distal-RV septal (infundibular) level is shown in Figs 28F and 28G.
As shown in Figs. 29A, a needle is passed into the epicardial surface of the LV and a guide wire is aimed toward the basket. As shown in Figs. 29B, the basket grasps the guide wire and pulls it into the catheter. As shown in Figs. 29C the catheter is withdrawn from the right atrium with the attached guide wire.
As shown in Figs. 30A, the tether has been passed through the sheath, the guide wire has been passed through the anchor and the anchor is pushed through the sheath into the RV. As shown in Figs. 30B, the anchor has been released from the sheath in the RV. Upon removing the guide wire, the anchor can pivot and is properly aligned along the septum with the tether. As shown in Figs. 30C, the first anchor pair is deployed.
As shown in Fig. 31a, the median basket is placed more apical than the first anchor pair. As shown in Fig. 3 1b, a second guide wire is passed through the LV, across the septum and is (see Fig. 31c) grasped by the basket. As shown in Fig. 31d, the guide wire is brought through the sheath. As shown in Fig. 31e, after the tether is 3 passed retrograde through the sheath and the septal anchor released, (see Fig. 31f) and external anchor is placed. The final view shows alignment of the two anchor pairs.
In Fig. 33a, the heart is exposed through a mid-sternotomy and pericardiotomy. The LAD and apex are labeled, and (see Fig. 33b) a tourniquet is place on the RA. A sheath (blue) is passed and under fluoroscopy and (see Fig. 33c) positioned in the RV (in circle).
In Fig. 34a, an apical basket was used to place lowest anchor. In Fig. 34b, the guide wire was grasped by the basket and drawn through the RA sheath. In Fig. 34c, the external appearance of the RA sheath with the guide wire exiting the L V epicardium is shown.
In Fig. 35a, the dilating catheter was passed through the sheath and follows the guide wire across the ventricular septum and exits on the epicardial surface of LV. In Fig. 35b, the dilator was removed and an anchor tether was passed through the sheath, The end of the tether exits on the epicardial surface. In Fig. 35c, as the anchor approaches the sheath, the guide wire is placed through the hole in the anchor for alignment and entry into the sheath
In Fig. 36a, the anchor within the hypotube is being placed into the sheath. In Fig. 36b, after the guide wire was removed, the anchor was released and manipulated into proper alignment. In Fig. 36c, an external anchor was placed on the tether and secured in place on the epicardium.
Following placement of the first anchor pair, the process was repeated for placing a second anchor pair in the mid-portion of the septum. A lasso type basket snare was used to capture the guidewire. Following this the second wire was captured as it was passed into the RV. Figs 37a-37f show the sequence of events for placement of the second anchor pair: (a) the guide wire is captured by the "lasso' snare and (b) brought out the RA sheath. (c) Shows the guide wire entry site into the LV. (d) A dilator was passed through the sheath over the guide wire and exits the LV (note the absence of bleeding). The anchor tether was passed through the sheath and with the pusher, the anchor was pushed through the sheath. (e) After removing the guide wire, the tether was manipulated to refine the anchor alignment under fluoroscopy. (f) An external anchor was then placed over the tether and slid to the epicardial surface and secured in place.
A third set of anchor pairs was then placed more toward the heart base (RV infundibulum). The same "lasso" snare was used for the second anchor pair and grasped the guide wire near the pulmonary outflow tract. The animal was then sacrificed. Figs. 38A-39B show the final anchor positions in situ and following sacrifice and heart explantation.
The claims of the parent application are reproduced below on pages 28-36. These clauses define preferred embodiments. The applicant reserves the right to pursue protection for the combinations of features set out in these clauses, and/or for any other subject-matter contained in the parent application as filed, either in the present divisional application or in a further application divided from the present divisional application. The claims of the parent application are not the claims of this divisional application.
2. The method of clause 1 , wherein the first anchor and the tension member are advanced into the heart while the heart is beating and with the first anchor axially affixed to the tension member in a low profile configuration, and wherein the first anchor is deployed laterally relative to the tension member within the first chamber.
3. The method of clause 2, wherein the tension member and the first anchor are advanced into the first chamber of the heart along the first path, wherein the tension member is advanced from the first chamber along the second path by pulling an end of the tension member along the second path through the second chamber so that the end of the tension member extends outside the heart.
4. The method of clause 2, wherein the tension member and the first anchor are advanced into the heart along the second path, and wherein the tension member trails from the advancing first anchor so as to extend through the second chamber when the first anchor is advanced into the first chamber.
5. The method of clause 4, wherein a distal portion of the tension member and the first anchor are advanced within a dilating catheter having a dilating distal tip, and further comprising laterally releasing the anchor from the dilating catheter by retracting a sheath of the dilating catheter proximally from the dilating tip.
6. The method of clause 1, wherein the second elongate shaft comprises an at least semi-rigid curved needle, the curved needle having a sharp tissue penetrating tip at the distal end of the second shaft and a lumen extending axially toward the tip.
7. The method of clause 1, wherein the second shaft comprises a steerable catheter having a tissue penetrating tip.
8. The method of any of clauses 1-7, further comprising advancing a first flexible body through the first elongate shaft so that an end portion of the first flexible body is disposed in the first chamber, and advancing a second flexible body through the second elongate shaft so that an end portion of the second flexible body is disposed in the first chamber, wherein the coupling of the distal end of the first elongate shaft with the distal end of the second elongate shaft comprises axially coupling the flexible bodies together within the first chamber of the heart.
9. The method of clause 8, wherein the axial coupling of the flexible bodies comprises capturing one of the end portions of one of the flexible bodies within an opening in the end portion of the other flexible body.
10. The method of clause 9, wherein the end portion of the other flexible body comprises a snare, and further comprising expanding the snare in the first chamber of the heart so as to expand the opening.
11. The method of clause 10, wherein the snare comprises a basket snare, and further comprising expanding the basket snare by releasing the basket snare from a lumen of the first elongate shaft so that the basket snare expands from a low profile insertion configuration to an expanded configuration encompassing a volume of the first chamber of the heart.
12. The method of clause 10, wherein the axial coupling of the flexible bodies further comprises shrinking the opening by withdrawing the opening into the first elongate shaft.
13. The method of clause 12, further comprising pulling the end portion of the second flexible body from the first chamber through the first elongate shaft and out of the patient, the second flexible body comprising a guidewire having an opposed end and the pulled guidewire extending from the end portion, into the first chamber, through the septum, through the second chamber, through the external wall, and out of the patient to the opposed end.
14. The method of clause 1, wherein the first anchor is advanced over a guidewire, wherein the first anchor comprising an elongate shaft having an axial lumen and is pivotably coupled to the tension member, the guidewire maintaining an axial orientation of the anchor extending along the tension member while the anchor is advanced axially into and within the first chamber of the heart.
15. The method of clause 1, further comprising accessing the first chamber so as to define at least one of the first or second path using an access tool, advancing a guide body from outside the patient to the first chamber using the access tool, and guiding the distal end of at least one of the first or second elongate bodies to the first chamber using the guide body.
16. The method of clause 1, further comprising orienting a working lumen of an epicardial hemostasis tool toward an epicardial surface region of the heart, the epicardial region encompassing the second path through the exterior wall, compressing the exterior wall of the heart inwardly around the second path with the hemostasis tool so as to inhibit bloodflow from the second chamber along the second path, and advancing the second anchor toward the epicardial region through the working lumen.
17. The method of clause 1, further comprising inhibiting migration of the anchors by applying a desired anchor force between the tension member and the second anchor while the second anchor is in a variable force mode, the second anchor in the variable force mode sliding axially proximally and distally along the tension member, and by reconfiguring the second anchor from the variable force mode to a set force mode while the desired anchor force is applied, the second anchor in the set force mode inhibiting movement of the second anchor along the tension member away from the first anchor.
18. The method of clause 17, wherein the desired anchor force is applied to the second anchor by engaging the second anchor, through a working lumen of a minimally invasive access tool, with a compression shaft, and wherein the second anchor is reconfigured from outside the patient body through the working lumen.
19. The method of clause 1, wherein the first elongate shaft comprises a flexible coronary catheter and the distal end of the first shaft is advanced to the right ventricle through the right atrium and blood vessels in fluid communication therewith.
20. The method of clause 1, wherein the first elongate shaft comprises a shaft and the distal end of the first elongate shaft is advanced to the right ventricle through a right atrial appendage of the heart.
an implant configured to be advanced along the joined paths, the implant including: a first anchor having a low profile configuration for advancement of the first anchor along the joined paths;
24. The system of clauses 23, wherein the first flexible body is axially advanceable along the first shaft so that the end portion of the first flexible body is disposed in the first chamber, and further comprising a second flexible body advanceable along the second shaft so that an end portion of the second flexible body is disposed in the first chamber, the end portion of the second flexible body comprising the corresponding end portion.
25. The system of clause 24, wherein the end portion of the first flexible body has an opening configured for capturing the end portions of the second flexible body therein.
26. The system of clause 23, wherein the end portion of the first flexible body comprises a snare, the snare biased to expand from a low profile configuration when released in the first chamber of the heart so as to expand the opening.
27. The system of clause 26, wherein the snare comprises a basket snare configured to expand by releasing the basket snare from a lumen of the first or second shaft so that the basket snare expands from a low profile insertion configuration to an expanded configuration encompassing a volume of the first chamber of the heart.
28. The system of clause 26, wherein the first or second shaft has a lumen, the snare configured to capture the corresponding end portion by withdrawing the snare into the lumen when the corresponding end portion extends through the lumen.
29. The system of clause 28, wherein the lumen extends along the second shaft, and wherein the corresponding end portion comprises a distal length of the tension member so that the tension member and first anchor are configured to be advanced to the first chamber along the first path by pulling the second end of the tension member with the first flexible body through the septum and through the external wall.
30. The system of clause 28, wherein the corresponding end portion comprises a length of a guidewire, the guidewire having first and second opposed ends and configured so that the guidewire can extend from the first end portion outside the patient, into the first chamber along the first path, and through the septum, through the second chamber, through the external wall, and out of the patient to the opposed end along the second path.
31. The system of clause 23, wherein the first anchor is axially affixed and pivotably coupled to the tension member, the first anchor pivoting from the low-profile configuration to a deployed configuration.
32. The system of clause 23, further comprising a dilating catheter having a catheter body with a proximal end and a distal end, a dilating distal tip disposed near the distal end, a sheath slidably disposed over the catheter body proximally of the dilating tip, and an anchor receptacle configured to removably receive the first anchor therein, the anchor laterally releasable from the receptacle of the dilating catheter by retracting the sheath proximally.
33. The system of clause 23, wherein the second shaft comprises an at least semi-rigid curved needle, the curved needle having a sharp tissue penetrating tip at the distal end of the second shaft and a lumen extending axially toward the tip, the curved needle configured for forming the second path through the external wall and the septum.
34. The system of clause 23, wherein the second shaft comprises a steerable catheter having a tissue penetrating tip, the steerable catheter configured for forming the second path through the septum.
35. The system of clause 23, wherein the first anchor comprises an elongate body having an axial guidewire lumen configured for slidably advancing the first anchor into the first chamber over a guidewire so that the guidewire maintains an axial orientation of the anchor extending along the tension member while the anchor is advanced axially into and within the first chamber of the heart.
36. The system of clause 23, further comprising an access tool configured for accessing the first chamber so as to define at least one of the first or second path, and a guide body advanceable from outside the patient to the first chamber along the access tool, the distal end of at least one of the first or second elongate bodies configured to be advanced to the first chamber using the guide body.
37. The system of clause 23, further comprising an epicardial hemostasis tool having an access shaft with a proximal end and a distal end and a working lumen extending therebetween, the epicardial hemostasis tool having a plurality of compression features disposed radially about the distal end of the access shaft, the access shaft configured for insertion through a tissue tract encompassing the second path through the exterior wall, an actuator disposed at the proximal end of the access shaft and operatively coupled to the compression features so as to move the compression features radially inwardly and compress the exterior wall of the heart inwardly so as to inhibit bloodflow from the second chamber along the second path when the working lumen is oriented toward the epicardial surface along the second path and the compression features engage the epicardial surface about the second path.
38. The system of clause 1, further comprising an axial force-application tool configured for applying a desired anchor migration inhibiting force between the anchors;
39. The system of clause 38, wherein the force-application tool has a compression shaft configured to engage the second anchor through a working lumen of a minimally invasive access tool, and wherein the second anchor is configured to be reconfigured between the modes from outside the patient body through the working lumen.
40. The system of clause 23, wherein the first elongate shaft comprises a flexible coronary catheter and the distal end of the first elongate shaft is configured to be advanced to the right ventricle through the right atrium and blood vessels in fluid communication therewith.
41. The system of clause 23, wherein the first elongate shaft comprises an at least semi-rigid shaft and the distal end of the first elongate shaft comprises a tissue-penetrating tip configured to be advanced to the right ventricle through a right atrial appendage of the heart.
42. The system of clause 23, wherein the tension member and the first anchor are configured to be advanced into the first chamber of the heart along the first path with the tension member advanced from the first chamber along the second path by pulling an end of the tension member along the second path through the second chamber so that the end of the tension member extends outside the heart.
43. The system of clause 23, wherein the tension member and the first anchor are configured to be advanced into the heart along the second path with the tension member trailing from the advancing first anchor so as to extend through the second chamber when the first anchor reaches the first chamber.
A system for treating a heart, the heart having first and second chambers with a septum there between, the system comprising:
a first elongate shaft having a proximal end and a distal end, the distal end of the first shaft being advanceable within a body to the heart, the first elongate shaft being employed to deliver a first implant to a wall of the heart, the first implant being a component of a heart anchor system that is used to apply tension to the wall of the heart and thereby reduce a volume of the first chamber or the second chamber of the heart.
The system of claim 1, further comprising a second elongate shaft having a proximal end and a distal end, the distal end of the second shaft being advanceable within the body, the second elongate shaft being employed to deliver the first implant or a second implant of the heart anchor system.
The system of claim 1, wherein the heart anchor system further comprises a second implant and a tension member that operably couples the first implant and the second implant, wherein the first implant and the second implant are configured to be positioned on opposite sides of the first chamber or the second chamber and are further configured to be tensioned via the tension member in order to apply tension to opposing walls of the first chamber or the second chamber and thereby reduce the volume of said chamber.
The system of claim 3, wherein the tension member extends across the first chamber or the second chamber and through the opposing walls of the first chamber or the second chamber.
The system of claim 3, wherein the first implant or the second implant are pivotably coupled with the tension member.
The system of claim 3, wherein the first implant or the second implant are advanceable over a guidewire that is insertable within the body.
The system of claim 3, further comprising a force-application tool that is configured for applying a desired force between the first implant and the second implant, the desired force corresponding to the tension applied to the opposing walls of the first chamber or the second chamber to reduce the volume of said chamber.
The system of claim 7, wherein the force-application tool is operably coupleable with the second implant and is configured to switch the second implant between a variable-force mode and a set-force mode, wherein the variable force mode allows the second implant to axial slide along the tension member toward the first implant and away from the first implant, and wherein the set-force mode inhibits sliding of the second implant away from the first implant.
The system of claim 2, wherein the first elongate shaft is configured to be advanced from outside the patient into the first chamber or the second chamber of the heart along a first path and the second elongate shaft is configured to be advanced along a second path from outside the patient into the first chamber or the second chamber of the heart, and wherein the first elongate shaft is configured to in-situ couple with the second elongate shaft in order to join the first path with the second path for delivery of the first implant to the wall of the heart.
The system of claim 9, wherein the first elongate shaft comprises a snare device that is used for in-situ coupling of the first elongate shaft and the second elongate shaft, the snare being biased to expand from a low profile configuration.
The system of claim 1, further comprising a hemostasis tool having a plurality of compression features disposed radially about the distal end of an elongate shaft and an actuator that is disposed at a proximal end of the elongate shaft, the actuator being operatively coupled to the compression features so as to move the compression features radially inwardly and compress an exterior wall of the heart inwardly so as to inhibit bloodflow there from.
The system of claim 1, further comprising a curved needle that is configured to penetrate through one or more walls of the heart.
The system of claim 1, wherein the first elongate shaft comprises a flexible coronary catheter and the distal end of the first elongate shaft is configured to be advanced to the right ventricle through the right atrium and blood vessels in fluid communication therewith or through a right atrial appendage of the heart.
The system of claim 1, wherein the first implant is pivotably coupled at the end of a tension member, and wherein the tension member and the first implant are configured to be advanced into the first chamber of the heart along the first path with the tension member advanced distally of the first implant.
The system of claim 14, wherein the second implant is configured to be advanced over the tension member after the first implant is positioned against the wall of the heart.
EP16206824.1A 2011-09-30 2012-09-28 Trans-catheter ventricular reconstruction structures and systems for treatment of congestive heart failure and other conditions Pending EP3175797A1 (en)
EP12835954.4A EP2760371B1 (en) 2011-09-30 2012-09-28 Trans-catheter ventricular reconstruction structures and systems for treatment of congestive heart failure and other conditions
EP12835954.4A Division EP2760371B1 (en) 2011-09-30 2012-09-28 Trans-catheter ventricular reconstruction structures and systems for treatment of congestive heart failure and other conditions
EP12835954.4A Division-Into EP2760371B1 (en) 2011-09-30 2012-09-28 Trans-catheter ventricular reconstruction structures and systems for treatment of congestive heart failure and other conditions
EP3175797A1 true EP3175797A1 (en) 2017-06-07
EP1100378A1 (en) * 1998-07-29 2001-05-23 Myocor, Inc. Transventricular implant tools and devices
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