Cardiac support device delivery tool with release mechanism

Information

  • Patent Grant
  • 10307252
  • Patent Number
    10,307,252
  • Date Filed
    Monday, August 21, 2017
    6 years ago
  • Date Issued
    Tuesday, June 4, 2019
    5 years ago
Abstract
An apparatus for placing a cardiac support device (CSD) on a heart. The apparatus includes a body, a deployment mechanism on the body for supporting the CSD in an open position for placement on the heart, and a release mechanism coupled to the deployment mechanism for releasably mounting the CSD to the deployment mechanism. The release mechanism includes a release element for releasably engaging the CSD, and a release actuator coupled to the release element for actuating the release element to release the CSD.
Description
FIELD OF THE INVENTION

The present invention pertains to a method and apparatus for treating congestive heart disease and related valvular dysfunction. More particularly, the present invention is directed to an apparatus and method for delivery of a cardiac support device.


BACKGROUND OF THE INVENTION

Various cardiac support devices for treating congestive heart disease are known. One exemplary type of cardiac support device includes a cardiac jacket for reducing tension in the heart wall by constraining or resisting expansion of the heart. Devices and methods for delivering cardiac support devices using minimally invasive surgical procedures are also known. Such cardiac support devices and/or cardiac support device delivery devices are described, for example, in U.S. Pat. Nos. 5,702,343; 6,155,972; 6,193,648; 6,293,906; 6,482,146; 6,682,476;6,902,524; 6,425,856; 6,908,426; 6,572,533; and 6,951,534, all of which are assigned to Acorn Cardiovascular, Inc. and are incorporated herein by reference.


Other embodiments of cardiac support devices and/or cardiac support device delivery devices are disclosed in U.S. Pat. Nos. 6,702,732; 6,723,041; U.S. patent application publication no. US 2006/0009831 A1 published Jan. 12, 2006; U.S. patent application publication no. US 2005/0288715 published Dec. 29, 2005; U.S. patent application publication no. US 2005/0256368 A1 published Nov. 17, 2005; U.S. patent application publication no. US 2005/0171589 published Aug. 4, 2005; U.S. patent application publication no. US 2005/0090707 A1 published Apr. 28, 2005; and U.S. patent application publication no. US 2005/0059855 A1 published Mar. 17, 2005, all of which are incorporated herein by reference.


There remains, however, a continuing need for improved delivery devices for cardiac support devices. In particular, there is a need for a delivery device for efficiently and effectively releasing the cardiac jacket over the heart.


SUMMARY OF THE INVENTION

In one embodiment, the present invention is an apparatus for placing a cardiac support device (CSD) on a heart. The apparatus includes a body, a deployment mechanism on the body for supporting the CSD in an open position for placement on the heart, and a release mechanism coupled to the deployment mechanism for releasably mounting the CSD to the deployment mechanism. The release mechanism includes a release element for releasably engaging the CSD, and a release actuator coupled to the release element for actuating the release element to release the CSD.


In another embodiment, the present invention is an apparatus for placing a cardiac support device (CSD) on a heart. The apparatus includes an elongate body, a deployment mechanism slidably coupled to the body for supporting the CSD, and a release means on the body for releasably coupling the CSD to the deployment mechanism.


In yet another embodiment, the present invention is a method for deploying a cardiac support device (CSD) about a heart of a patient. The method includes releasably coupling the CSD to a deployment mechanism of a delivery apparatus, positioning the CSD in a desired position about the heart using the delivery apparatus, and actuating a release mechanism to de-couple the CSD and the deployment mechanism. The release mechanism includes a release element coupled to the deployment mechanism and a release actuator coupled to the release element.


While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.





BRIEF DESCRIPTION OF THE DRAWINGS


FIG. 1 shows a CSD mounted on an exemplary delivery device that can be used in relation to embodiments of the present invention.



FIG. 2A shows a front view of the delivery device of FIG. 1 in a retracted state.



FIG. 2B shows a front view of the delivery device of FIG. 1 in an extended state.



FIG. 2C shows a perspective view of a portion of a control mechanism and release mechanism of FIG. 1.



FIG. 2D shows a perspective view of the distal ends of the support member and release clement shown in FIG. 1.



FIG. 3A shows a front view of the release element in relation to the support member of FIG. 1.



FIG. 3B shows the release element and support member of FIG. 3A in relation to a portion of the CSD shown in exploded detail.



FIG. 4A shows a front view of a delivery device according to another embodiment of the invention in a retracted state.



FIG. 4B shows a front view of the delivery device of FIG. 4A in an extended state.



FIG. 4C shows a side view of a portion of the control mechanism and release mechanism of FIG. 4A.



FIG. 5A shows a front view of a delivery device according to another embodiment of the invention in a retracted state.



FIG. 5B shows a front view of the delivery device of FIG. 5A in an extended state.



FIG. 5C shows a perspective view of a portion of the release mechanism of FIGS. 5A.



FIG. 5D shows a cross sectional view of a portion of the control mechanism and release mechanism of FIG. 5A.



FIG. 6A shows a front view of a delivery device according to another embodiment of the invention in a retracted state.



FIG. 6B shows a front view of the delivery device of FIG. 6A in an extended state.



FIG. 6C shows a perspective view of a portion of the release mechanism of FIGS. 6A and 6B.



FIG. 7A shows a front view of a delivery device according to another embodiment of the invention in an extended state.



FIG. 7B shows a cross-sectional view of the delivery device of FIG. 7A taken along line 6-6.



FIG. 8A shows a release element and support member according to another embodiment of the present invention coupled to a CSD.



FIG. 8B shows the release element and support member of FIG. 8A released from the CSD.



FIG. 9A shows a release element and support member according to another embodiment of the present invention coupled to a CSD.



FIG. 9B shows the release element and support member of FIG. 9A released from the CSD.



FIG. 10A shows a release element and support member according to another embodiment of the present invention coupled to a CSD.



FIG. 10B shows the release element and support member of FIG. 10A released from the CSD.



FIG. 11A shows a portion of a release mechanism according to another embodiment of the invention.



FIG. 11B shows the release mechanism of FIG. 11A coupled to a portion of a CSD.



FIG. 11C shows the release mechanism of FIG. 11B de-coupled from the CSD.



FIG. 12A shows a CSD having a release structure according to one embodiment of the invention.



FIG. 12B shows a release mechanism according to one embodiment of the present invention in relation to the CSD of FIG. 12A.



FIG. 12C shows a side-sectional view of the CSD of FIG. 12A coupled to the release mechanism.



FIG. 13A shows a CSD having a release structure according to yet another embodiment of the invention.



FIG. 13B shows the release structure of FIG. 13A and a release mechanism according to one embodiment of the invention.



FIG. 13C shows the actuation of the release mechanism within the release structure shown in FIG. 13A.



FIG. 13D shows the release mechanism de-coupled from the release structure of FIG. 13A.



FIG. 14A shows a release structure and release mechanism according to another embodiment of the present invention.



FIG. 14B shows a front view of the release mechanism coupled to the release structure of FIG. 14A.



FIG. 14C shows a front view of the release mechanism de-coupled from the release structure shown in FIG. 14B.



FIG. 15A shows a portion of a release mechanism releasably coupled to a CSD according to another embodiment of the invention.



FIG. 15B shows a side view of the release mechanism and CSD of FIG. 15A.



FIG. 15C shows a side view of the release mechanism of FIG. 15B released from the CSD.



FIG. 16A shows a release structure and release mechanism according to another embodiment of the present invention.



FIG. 16B shows a front view of the release mechanism coupled to the release structure of FIG. 16A.



FIG. 16C shows a front view of the release mechanism de-coupled from the release structure shown in FIG. 16B.



FIG. 17 shows a detailed and partially sectional view of a support member and release element in accordance with another embodiment of the invention, in an engaged state.



FIG. 18 shows a detailed view of a portion of the support member and release element shown in FIG. 17, in a released state.





While the invention is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the invention to the particular embodiments described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims.


DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS


FIG. 1 illustrates a delivery device 100 according to one embodiment of the present invention supporting a cardiac support device (CSD) 104 for deployment over a patient's heart. The CSD 104 may be any type of cardiac support device, including, without limitation, any of the devices disclosed in any of the patents and patent publications referenced and incorporated herein in the Background of the Invention. In the illustrated embodiment, the CSD 104 includes an open base end 108 and an apex portion 112 having an open apex end 116. A hem 117 is formed about the open base end 108 of the CSD 104.


As shown in FIG. 1, the delivery device 100 includes a body 120, a deployment mechanism 124, an actuator or a control mechanism 128 on the body 120 operatively coupled to the deployment mechanism 124, and a release mechanism 132 (see FIG. 2C) on the body 120 for releasably coupling the CSD 104 to the deployment mechanism 124.


The deployment mechanism 124 is operable to move between a first retracted or closed state, as shown in FIG. 2A, and a second extended or open state, as shown in FIG. 1. FIG. 2B shows the deployment mechanism 124 moved to an extended but not opened state. The deployment mechanism 124 is further adapted to releasably support the CSD 104 and to accurately position the CSD 104 at a desired implantation position on the patient's heart. The deployment mechanism 124 includes at least one elongate support member 136. In the illustrated embodiment, the deployment mechanism 124 includes eight support members 136. The invention is not so limited, however, and the deployment mechanism 124 may include a greater or few number of support members 136 in varying configurations.


The control mechanism 128 drives the deployment mechanism 124 between the retracted and extended states for positioning the CSD 104 on the heart. In the illustrated embodiment, the control mechanism 128 is slidable along a portion of the length of the body 104 to move the support members 136 from the retracted state to the extended state. In the illustrated embodiment, the support members 136 are curved so that the support members 136 form a cup shape to receive the CSD 104 when in the extended state. In other embodiments (not shown), the control mechanism 128 also includes means for spreading apart or otherwise shaping the support members 136 when in the extended state.


The release mechanism 132 releasably couples the CSD 104 to the deployment mechanism 124. Thus, once the delivery device 100 has been manipulated to maneuver the CSD 104 into position over or about all or a portion of the heart, the release mechanism 132 is operated to release the CSD 104 from the delivery device 100 onto the heart. The release mechanism 132 includes a release element 140 (see FIG. 2A) for releasably engaging the CSD 104 and an actuator mechanism 144 operatively coupled to the release element 140 to control release of the CSD 104 from the release element 140.


In the illustrated embodiment, the release element 140 is an elongate member positioned adjacent to each of the support members 136. A distal end 148 of the release element 140 is movable from an engaged state in which the release element 140 permits the CSD 104 to be mounted to the deployment mechanism 124 and a released state in which the release element 140 releases the CSD 104 from the deployment mechanism 124. An actuator mechanism 144 is operable to move the release element 140 between the engaged and released states. In the illustrated embodiment, the release elements 140 slide through a channel 156 in the support members 136. The support members 136 are formed with a plurality of slots 158 to provide incremental advancement of the release elements 140 relative to the support members 136.


In the embodiment illustrated in FIGS. 1 and 2A-2D, the control mechanism 128 and the actuator mechanism 144 are integrated into a cylinder 160 positioned about the body 120. The cylinder 160 slides over a first or main travel region T while moving the all of the support members 136 from the retracted state to the extended state. A second control mechanism 138 including a first user interface 164 is provided for moving individual support members 136 from the retracted state to the extended state. The first user interfaces 164 are individually slidable over a second or supplementary travel region t to move the support members 136. The release elements 140 remain in the engaged state while the support members 136 are moved from the retracted state to the extended state.


The actuator mechanism 144 is actuated by sliding a second user interface 168 coupled to the support elements 140 over a third or individual travel region Ito move the release elements 140 between engaged and released states. In the illustrated embodiment, the actuator mechanism 144 is operable to actuate the release elements 140 individually. In other embodiments, however, two or more, or all, of the release elements 140 may be actuated as a group.


As illustrated generally in FIG. 3A, the CSD 104 includes a release structure 170 releasably engaged by one or both of the deployment mechanism 124 and the release element 140. The release structure 170 is adapted for coupling to the deployment mechanism 124 for facilitating release of the CSD 104 from the deployment mechanism 124. In addition, some embodiments of the CSD 104 includes a lubricious element 174. Lubricious element 174 can also be releasably coupled to the CSD 104 by the release mechanism 132. Specifically, the release mechanism 132 is operable to de-couple at least a portion of the lubricious element 174 from the CSD 104.



FIG. 3B illustrates the release element 140 in more detail. The release element 140 is in the form of a hook. A release structure 170 in the form of a loop of cord or suture is coupled to the hem 117 of the CSD 104. In the engaged state, the release structure 170 is coupled to the release element 140 through a hole 157 in the lubricious element 174.


The CSD 104 is placed over a patient's heart with the device 100 as follows. The CSD 104 is mounted to the deployment mechanism 124 with the release elements 140 in the engaged state. The deployment mechanism 124 is put into the retracted state as shown in FIG. 2A. The delivery device body 120 is manipulated to position the CSD 104 near the heart. The user slides the cylinder 160 distally over the body 120, advancing the support members 136 from the retracted state to the extended state while the release elements 140 remain in the engaged state. The user may actuate the first user interfaces 164 to move the support members 136 between the retracted and extended states individually to more precisely position the CSD 104 about the heart.


Once the CSD 104 is maneuvered into the desired position, the actuator mechanisms 144 are actuated by sliding the second user interfaces 168 to move the release elements 140 from the engaged state to the released state to release the CSD 104 from the delivery device 100. In the engaged state, the release element 140 is retracted within the channel 156 such that the release structure 170 coupled to the release element 140. Upon movement of the release element 140 to the released state, shown in dashed lines, the release structure 170 is released from the support member 136.



FIGS. 4A-4C, 5A-5D, 6A-6C and 7A-7B illustrate various additional embodiments of the control mechanism 128 and actuator mechanism 144. FIGS. 8A-8B, 9A-9B, 10A-10B, 11A-11C, 12A-12C, 13A-13D and 14A-14C illustrate various additional embodiments of the release element 140 and release stricture 170. The various embodiments of the control mechanism 128 and actuator mechanism 140 described with respect to FIGS. 1, 2A-2D, 3A-3B, 4A-4C, 5A-5D, 6A-6C and 7A-7B may be used in an combination with the various embodiments of the release element 140 and release structure 170 described with respect to FIGS. a, 2A-2D, 3A-3B, 8A-8B, 9A-9B, 10A-10B, 11A-11C, 12A-12C, 13A-13D and 14A-14C.



FIGS. 4A-4C illustrate a delivery device 200 according to another embodiment of the invention showing an alternate release mechanism. As shown in FIG. 2A, the delivery device 200 includes a body 220, a deployment mechanism 224, a control mechanism 228 on the body 220 operatively coupled to the deployment mechanism 224, and a release mechanism 232 on the body 220 for releasably coupling a CSD (not shown) to the deployment mechanism 224.


Similar to previously described embodiments, advancing a cylinder 260 actuates the control mechanism 228, moving the deployment mechanism 224 from a retracted state as shown in FIG. 4A to an extended state as shown in FIG. 4B. In the illustrated embodiment, the control mechanism 228 is further provided with a locking feature 274 for locking individual advancement of the support members 236. The locking feature 274 includes protrusions 278 and keyways 282 formed in the cylinder 260. Rotation of the cylinder 260, as indicated by arrow 284, captures the protrusions 278 in the keyways 282, preventing individual advancement of the support members 236.


The release mechanism 232 includes a release element 240 and an actuator mechanism 244. The actuator mechanism 244 includes a tilting lever arm 286 coupled to a mechanical linkage 290. Tilting the lever arm 286 forward, as indicated by arrow 292, pulls the linkage 290 proximally to move the release elements 240 from an engaged state to a released state. The lever arm 286 is also part of the control mechanism 228 and functions as a user interface for advancing the support members 236 individually.



FIGS. 5A-5D illustrate a delivery device 300 according to another embodiment of the invention showing an alternate release mechanism. As shown in FIG. 5A, the delivery device 300 includes a body 320, a deployment mechanism 324, a control mechanism 328 on the body 320 operatively coupled to the deployment mechanism 324, and a release mechanism 332 on the body 320 for releasably coupling a CSD (not shown) to the deployment mechanism 324.


Similar to previously described embodiments, advancing a cylinder 360 actuates the control mechanism 328, moving the deployment mechanism 324 from a retracted state as shown in FIG. 5A to an extended (but not opened) state as shown in FIG. 5B. The control mechanism 324 further includes user interface buttons 364 for individually advancing the support members 336 and release elements 340.


The release mechanism 332 includes a release element 340 and an actuator mechanism 344. The actuator mechanism 344 includes a rotating actuator cylinder 391 that is coupled to all of the release elements 340. The actuator mechanism 344 is operable to move all of the release elements 340 from an engaged state to a release state in unison upon rotation of the actuator cylinder 391. The release elements 340 each have an engagement pin 392 that is synchronized with axial teeth 393 in the actuator cylinder 391. Rotational movement of the actuator cylinder 391 captures the engagement pins 392 at various positions of individual adjustment of the support members 336. A keyway 394 in the cylinder 360 controls rotation and forward movement of the actuator cylinder 391.



FIGS. 6A-6C illustrate another embodiment of a delivery device 400 showing an alternative release mechanism. As shown in FIG. 6A, the delivery device 400 includes a body 420, a deployment mechanism 424, a control mechanism 428 on the body 420 operatively coupled to the deployment mechanism 424, and a release mechanism 432 on the body 420 for releasably coupling a CSD (not shown) to the deployment mechanism 424.


The release mechanism 432 includes a release element 440 and an actuator mechanism 444. Similar to previously described embodiments, advancing a cylinder 460 actuates the control mechanism 424, moving the deployment mechanism 424 from a retracted state as shown in FIG. 6A to an extended state as shown in FIG. 6B.



FIGS. 7A and 7B illustrate another embodiment of a delivery device 500 showing an alternative release mechanism. As shown in FIG. 7A, the delivery device 500 includes a body 520, a deployment mechanism 524, a control mechanism 528 on the body 520 operatively coupled to the deployment mechanism 524, and a release mechanism 532 on the body 520 for releasably coupling a CSD (not shown) to the deployment mechanism 524. A suction cup 525 for releasably engaging a patient's heart is connected to a vacuum source (not shown) though tube 527. Actuator mechanism 544 is operated in a manner similar to that of the above-described embodiments to move the deployment mechanism 524 from a retracted position (not shown) to the extended and open position shown in FIGS. 7A and 7B. The support members 536 can be formed resilient members, and can be guided at least in part from their retracted positions to the extended and open positions shown in FIGS. 7A and 7B by the suction cup 525.



FIGS. 8A and 8B illustrate a support member 736, release element 740 and release structure 770 according to another embodiment of the invention. The release element 740 includes an opening 741. The release structure 770 is in the form of a loop of cord or suture that is threaded through a portion of the CSD 104, with a first end 771 coupled to the delivery device 100 and a second end 772 that is free. When the release element 740 is in the engaged state, as shown in FIG. 8A, the free end 772 of the release structure 770 is inserted through the hole 741 and the release element 740 is retracted within the support member 736. The free end 772 of the release structure 770 is thus captured between the release element 740 and the support member 736, coupling the CSD 104 to the support member 736. When the release element 740 is moved to the released state, shown in FIG. 8B, the release element 740 is advanced distally relative to the support member 736, releasing the release structure 770. The release structure 770 is easily pulled through the hole 741 and the CSD 104 as the support member 736 is withdrawn.



FIGS. 9A and 9B illustrate a release element 840 and release structure 870 according to another embodiment of the present invention. The release element 840 is in the form of a hook. The release structure 870 is in the form of a loop of cord or suture having ends 871, 872 coupled to the CSD 104. The release structure 870 is captured by the hook of the release element 840 and coupled to the support member 836 when the release element 840 is in the engaged state, as shown in FIG. 9A. When the release element 840 is moved to the released state, as shown in FIG. 9B, the release structure 870 is released to de-couple the support member 836 and the CSD 104.



FIGS. 10A and 10B illustrate a release element 940 and release structure 970 according to another embodiment of the present invention. The release element 940 is in the form of a pair of pincers 943, while the release structure 970 is in the form of a loop of cord or suture having a portion 773 coupled to the CSD 104. When the release element 932 is in the engaged state, the release element 932 is retracted within the support member 936, causing the pincers 943 to be pinched together, thus capturing the release structure 970, as shown in FIG. 10A. When the release element 940 is moved to the released state, as shown in FIG. 10B, the release structure 970 is advanced distally relative to the support member 936 and the pincers 943 spread apart to release the release structure 970.



FIGS. 11A-11C illustrate a support member 1036, release element 1040 and release structure 1070 configuration according to another embodiment of the present invention. The release element 1040 is in the form of a flat rod received within a channel 1056 formed by the support member 1036. A distal end of the support member 1036 includes an opening 1037. The release structure 1070 is in the form of a flexible band formed around at least a portion of the CSD 104. In the engaged state, the release structure 1070 is received in the opening 1037 and held in place by the release element 1040 which is positioned at the opening 1037 (see FIG. 11B). Upon movement of the release element 1040 from the engaged state, shown in FIG. 11B, to the release state, shown in FIG. 11C, the release element 1040 is moved proximally within the channel 1057 to release the release structure 1070 from the support member 1036.



FIGS. 12A-12C illustrate a support member 1136, release element 1140 and release structure 1170 according to another embodiment of the invention. The release structure 1170 is in the form of protrusions on the hem 117 of the CSD 104 and each has an opening 1171 therethrough (see FIG. 12A). As shown in FIG. 12C, the support member 1136 has a distal recess 1137 sized and shaped to receive the release structure 1170. The release element 1140 is in the form of a slender rod sized to be received in the opening 1171. In the engaged state, shown in FIG. 12B, the release structures 1170 are positioned within the recesses 1137 and the release elements 1140 are inserted into the openings 1171 to hold the release structures 1170 in place. Upon movement of the release element 1140 from the engaged state, to the release state, shown in dashed lines in FIG. 12C, the release element 1140 is withdrawn proximally out of the opening 1171 to release the release structure 1170 from the recesses 1137.



FIGS. 13A-D illustrate a release element 1240, support member 1236 and release structure 1270 according to another embodiment of the invention. The release structure 1270 is in the form of a lock housing positioned on the hem 117 of the CSD 104. A hook 1272 is formed within the release structure 1270. The release structure 1270 further has a passageway 1271 for receiving the release element 1240. In the engaged state, shown in FIG. 13B (release structure shown opened for clarity), the release element 1240 is captured on the hook 1272. Upon movement of the release element 1240 from the engaged state, shown in solid lines in FIG. 13C, to a release state, shown in dashed lines, the release element 1240 disengages from the hook 1272, allowing the release element 1240 to be withdrawn proximally through the passageway 1271 (see FIG. 13D).



FIGS. 14A-14C illustrate a release element 1340, support member 1336 and release structure 1370 according to another embodiment of the invention. The support member 1336 includes a U-shaped yoke 1338 defining an opening 1339. The release element 1340 is movable from an engaged state, in which the release element 1340 is proximal to the opening 1339 (see FIG. 14B), to a release state, in which the release element 1340 is positioned within the opening 1339 (see FIG. 14C). The release structure 1370 is in the form of a projection sized and shaped to be snugly received within the yoke 1338. Movement of the release element 1340 from the engaged state, shown in FIG. 14B, to the release state, shown in FIG. 14C, ejects the release structure 1370 from the yoke 1338.



FIGS. 15A-15C illustrate a portion of a release element 1440, support member 1436 and release structure 1470 according to another embodiment of the invention. The release structure 1470 is in the form of a length of cord or suture that is threaded through the CSD 104. The support member 1436 includes a pair of distal openings 1437 divided by a support bridge 1438. The release element 1440 includes a cutting surface 1441. In the engaged state, shown in FIGS. 15A and 15B, the release element 1440 is positioned proximally to the openings 1437. The release structure 1470 is threaded through the openings 1437 and tied over the bridge 1438 to couple the CSD 104 to the support member 1436. Upon movement of the release element 1440 to the release state, shown in FIG. 15C, the release element 1440 is moved distally over the release structure 1470 to cut the release structure 1470, thus releasing the CSD 104 from the support member 1436.



FIGS. 16A-16C illustrate a support member 1336′ and release structure 1370′ according to another embodiment of the invention. The support member 1336′ and release structure 1370′ can be substantially the same or similar to support member 1336 and release structure 1370 described above in connection with FIGS. 14A-14C, and similar features are identified by similar reference numbers. Unlike the embodiment of the invention shown in FIGS. 14A-14C, the embodiment shown in FIGS. 16A-16C does not include a release element 1340. Instead and as described in greater detail below, support member 1336′ is passively disengaged from the release structure 1370′. The support member 1336′ includes a C- or U-shaped yoke 1338′ defining an opening 1339′. The release structure 1370′ is in the form of a projection sized and shaped to be snugly received within the yoke 1338′. Yoke 1338′ is formed of resilient material that enables the yoke to sufficiently deform and “snap” onto the release structure 1370′ (e.g., to diametrically expand and then return to its original shape). The characteristics of the yoke 1338′ in cooperation with the release structure 1370′ provides sufficient strength to enable the yoke to remain attached to the release structure while CSD 104 is positioned on the patient's heart. Following positioning of the CSD 104, movement of the support member 1336′ in a direction opposite the opening in the yoke 1338′ causes the yoke to deform and disengage from the release structure 1370′. The support member 1336′ is thereby passively released from the CSD 104 since it was the motion of the support member itself, rather than another structure, that causes the release action.



FIGS. 17 and 18 illustrate a support member 1536 and release element 1540 according to another embodiment of the invention. The support member 1536 is a tubular structure having an opening 1556 on its distal end. The release element 1540 is an elongate member movable within the support member 1536 between retracted and extended positions. A finger on the distal end 1548 of the release element 1540 has a tang 1551 and an inner element 1553 that cooperate to provide a functional engagement portion. The distal end 1548 is formed with the tang 1551 and inner element 1553 separated and spaced from one another when the release element 1540 is in its released state shown in FIG. 18 with the distal end 1548 extending from the opening 1556 of the support member 1536. The tang 1551 is formed of flexible and resilient material, enabling the tang to be deformed from its free or native state into the hook shape of the capture position shown in FIG. 17. When release element 1540 is in the engaged state shown in FIG. 17, the tang 1551 is retained in the capture position adjacent to inner element 1553.


The tang 1551 of release element 1540 can engage a release structure such a suture loop (not shown) on a CSD (also not shown) when the release element is in the engaged state. When moved to the released state shown in FIG. 18, the tang 1551 will return to its native state to release the release structure. Locating the tang 1551 and inner element 1553 at the opening 1556 on the distal end of the support member 1536 can enhance the accuracy by which the CSD can be positioning on the patient's heart.


Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present invention. For example, while the embodiments described above refer to particular features, the scope of this invention also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Accordingly, the scope of the present invention is intended to embrace all such alternatives, modifications, and variations as fall within the scope of the claims, together with all equivalents thereof.

Claims
  • 1. A delivery system for delivering an implantable cardiac device around an exterior of a heart, the delivery system comprising: an elongate body;a plurality of elongate support members configured to extend along the elongate body and to extend in a distal direction from the elongate body, each elongate support member being individually extendable and retractable with respect to the elongate body and comprising a distal end for attachment to the implantable cardiac device, each elongate support member including a respective release element that is movable in relation to its corresponding elongate support member;multiple protrusions for engaging the implantable cardiac device extending from each release element, wherein the multiple protrusions longitudinally extend along the distal direction; anda control mechanism configured to distally extend and proximally retract the plurality of elongate members relative to the elongate body.
  • 2. The delivery system of claim 1, wherein the elongate body further comprises an internal tube having a proximal end configured to be in fluid communication with a vacuum source and a distal end with a suction cup for engaging with an apex of the heart.
  • 3. The delivery system of claim 2, wherein the plurality of elongate support members are not inherently radially outwardly biased, and wherein the suction cup deflects the plurality of elongate support members radially outward as the plurality of elongate support members are moved distally relative to the elongate body.
  • 4. The delivery system of claim 1, wherein the control mechanism comprises a respective actuator for each of the elongate support members.
  • 5. A cardiac treatment system, comprising: a delivery system comprising: an elongate body;a plurality of elongate support members configured to extend along the elongate body and to extend in a distal direction from the elongate body, each elongate support member being individually extendable and retractable with respect to the elongate body and comprising a distal end for attachment to an implantable cardiac device, each elongate support member including a respective release element that is movable in relation to its corresponding elongate support member;multiple protrusions for engaging the implantable cardiac device extending from each release element, wherein the multiple protrusions longitudinally extend along the distal direction; anda control mechanism configured to distally extend and proximally retract the plurality of elongate members relative to the elongate body; andthe implantable cardiac device releasably mounted to the delivery system, the implantable cardiac device comprising: a mesh implant body configured for implantation around external portions of a heart and comprising a leading end portion defining an open leading end configured to advance over an apex of the heart, the leading end portion detachably attached to the elongate support members using the multiple protrusions of the release elements.
  • 6. The cardiac treatment system of claim 5, wherein the elongate body further comprises an internal tube having a proximal end configured to be in fluid communication with a vacuum source and a distal end with a suction cup for engaging with the apex of the heart.
  • 7. The cardiac treatment system of claim 6, wherein the plurality of elongate support members are not inherently radially outwardly biased, and wherein the suction cup deflects the plurality of elongate support members radially outward as the plurality of elongate support members are moved distally relative to the elongate body.
  • 8. The cardiac treatment system of claim 5, wherein the control mechanism comprises a respective actuator for each of the elongate support members.
CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of application Ser. No. 14/086,804, filed on Nov. 21, 2013, now U.S. Pat. No. 9,737,404, which is a continuation of application Ser. No. 13/524,093, filed on Jun. 15, 2012, now U.S. Pat. No. 8,617,051, which is a continuation of application Ser. No. 12/638,059, filed on Dec. 15, 2009, now U.S. Pat. No. 8,202,212, which is a continuation of application Ser. No. 11/487,953, filed on Jul. 17, 2006, now U.S. Pat. No. 7,651,462. The prior applications are hereby incorporated by reference in their entireties for all purposes.

US Referenced Citations (205)
Number Name Date Kind
1682119 Field Aug 1928 A
1965542 Colvin, Jr. Nov 1933 A
1982207 Furniss Nov 1934 A
2138603 Johnson Nov 1938 A
2278926 Hartwell Apr 1942 A
2376442 Mehler May 1945 A
2992550 Frith Jul 1961 A
3384530 Mercer et al. May 1968 A
3452742 Muller Jul 1969 A
3551543 Mercer et al. Dec 1970 A
3587567 Schiff Jun 1971 A
3732662 Paxton May 1973 A
3768643 Bruno Oct 1973 A
3983863 Janke et al. Oct 1976 A
4048990 Goetz Sep 1977 A
4196534 Shibamoto Apr 1980 A
4403604 Wilkinson et al. Sep 1983 A
4428375 Ellman Jan 1984 A
4466331 Matheson Aug 1984 A
4536893 Parravicini Aug 1985 A
4567900 Moore Feb 1986 A
4598039 Fischer et al. Jul 1986 A
4630597 Kantrowitz et al. Dec 1986 A
4637377 Loop Jan 1987 A
4690134 Snyders Sep 1987 A
4790850 Dunn et al. Dec 1988 A
4821723 Baker et al. Apr 1989 A
4827932 Ideker et al. May 1989 A
4834707 Evans May 1989 A
4840626 Linsky et al. Jun 1989 A
4878890 Bilweis Nov 1989 A
4932972 Dunn et al. Jun 1990 A
4936857 Kulik Jun 1990 A
4957477 Lundback Sep 1990 A
4973300 Wright Nov 1990 A
4976730 Kwan-Gett Dec 1990 A
4995857 Arnold Feb 1991 A
5042463 Lekholm Aug 1991 A
5057117 Atweh Oct 1991 A
5074129 Matthew Dec 1991 A
5087243 Avitall Feb 1992 A
5131905 Grooters Jul 1992 A
5150706 Cox et al. Sep 1992 A
5186711 Epstein Feb 1993 A
5188813 Fairey et al. Feb 1993 A
5192314 Daskalakis Mar 1993 A
5207725 Pinkerton May 1993 A
5224363 Sutton Jul 1993 A
5256132 Snyders Oct 1993 A
5279539 Bohan et al. Jan 1994 A
5290217 Campos Mar 1994 A
5336253 Gordon et al. Aug 1994 A
5339657 McMurray Aug 1994 A
5341815 Cofone et al. Aug 1994 A
5356432 Rutkow et al. Oct 1994 A
5366460 Eberbach Nov 1994 A
5383840 Heilman et al. Jan 1995 A
5385156 Oliva Jan 1995 A
5405360 Tovey Apr 1995 A
5409703 McAnalley et al. Apr 1995 A
5429584 Chiu Jul 1995 A
5507779 Altman Apr 1996 A
5524633 Heaven et al. Jun 1996 A
5533958 Wilk Jul 1996 A
5558617 Heilman et al. Sep 1996 A
5593441 Lichtenstein et al. Jan 1997 A
5603337 Jarvik Feb 1997 A
5611515 Benderev et al. Mar 1997 A
5634931 Kugel Jun 1997 A
5647380 Campbell et al. Jul 1997 A
5695525 Mulhauser et al. Dec 1997 A
5702343 Alferness Dec 1997 A
5713954 Rosenberg et al. Feb 1998 A
5735290 Sterman et al. Apr 1998 A
5766216 Gangal et al. Jun 1998 A
5782746 Wright Jul 1998 A
5800334 Wilk Sep 1998 A
5800528 Lederman et al. Sep 1998 A
5839842 Wanat et al. Nov 1998 A
5853422 Huebsch et al. Dec 1998 A
5928250 Kolke et al. Jul 1999 A
5931810 Grabek Aug 1999 A
5961440 Schweich et al. Oct 1999 A
5972013 Schmidt Oct 1999 A
5984932 Yoon Nov 1999 A
5990378 Ellis Nov 1999 A
6045497 Schweich et al. Apr 2000 A
6050936 Schweich et al. Apr 2000 A
6059715 Schweich et al. May 2000 A
6076013 Brennan et al. Jun 2000 A
6077214 Mortier et al. Jun 2000 A
6077218 Alferness Jun 2000 A
6085754 Alferness et al. Jul 2000 A
6089051 Gorywoda et al. Jul 2000 A
6095968 Snyders Aug 2000 A
6123662 Alferness et al. Sep 2000 A
6126590 Alferness Oct 2000 A
6155968 Wilk Dec 2000 A
6155972 Nauertz et al. Dec 2000 A
6165121 Alferness Dec 2000 A
6165122 Alferness Dec 2000 A
6169922 Alferness et al. Jan 2001 B1
6174279 Girard Jan 2001 B1
6179791 Krueger Jan 2001 B1
6193648 Krueger Feb 2001 B1
6205747 Paniagua Olaechea Mar 2001 B1
6206004 Schmidt et al. Mar 2001 B1
6224540 Lederman et al. May 2001 B1
6230714 Alferness et al. May 2001 B1
6241654 Alferness Jun 2001 B1
6293906 Vanden Hoek et al. Sep 2001 B1
6360749 Jayaraman Mar 2002 B1
6370429 Alferness et al. Apr 2002 B1
6375608 Alferness Apr 2002 B1
6402680 Mortier et al. Jun 2002 B2
6416459 Haindl Jul 2002 B1
6425856 Shapland et al. Jul 2002 B1
6432039 Wardle Aug 2002 B1
6482146 Alferness et al. Nov 2002 B1
6508756 Kung et al. Jan 2003 B1
6517570 Lau et al. Feb 2003 B1
6537203 Alferness et al. Mar 2003 B1
6541678 Klein Apr 2003 B2
6544168 Alferness Apr 2003 B2
6564094 Alferness et al. May 2003 B2
6567699 Alferness et al. May 2003 B2
6569082 Chin May 2003 B1
6572533 Shapland et al. Jun 2003 B1
6579226 Vanden Hoek et al. Jun 2003 B2
6582355 Alferness et al. Jun 2003 B2
6587734 Okuzumi Jul 2003 B2
6602184 Lau et al. Aug 2003 B2
6612978 Lau et al. Sep 2003 B2
6612979 Lau et al. Sep 2003 B2
6620095 Taheri Sep 2003 B2
6645139 Haindl Nov 2003 B2
6663558 Lau et al. Dec 2003 B2
6673009 Vanden Hoek et al. Jan 2004 B1
6682474 Lau et al. Jan 2004 B2
6682475 Cox et al. Jan 2004 B2
6682476 Alferness et al. Jan 2004 B2
6689048 Vanden Hoek et al. Feb 2004 B2
6695769 French et al. Feb 2004 B2
6702732 Lau et al. Mar 2004 B1
6723041 Lau et al. Apr 2004 B2
6727316 Bremser Apr 2004 B1
6730016 Cox et al. May 2004 B1
6755779 Vanden Hoek et al. Jun 2004 B2
6881185 Vanden Hoek et al. Apr 2005 B2
6893392 Getzow May 2005 B2
6902522 Walsh et al. Jun 2005 B1
6902524 Alferness et al. Jun 2005 B2
6908426 Shapland et al. Jun 2005 B2
6951534 Girard Oct 2005 B2
7060023 French et al. Jun 2006 B2
7081086 Lau et al. Jul 2006 B2
7155295 Lau et al. Dec 2006 B2
7163507 Alferness et al. Jan 2007 B2
7189203 Lau et al. Mar 2007 B2
7229405 Lau et al. Jun 2007 B2
7235042 Vanden Hoek et al. Jun 2007 B2
7252632 Shapland et al. Aug 2007 B2
7297104 Vanden Hoek et al. Nov 2007 B2
7361139 Lau et al. Apr 2008 B2
7366659 Girard et al. Apr 2008 B2
7404793 Lau et al. Jul 2008 B2
7412274 Mejia Aug 2008 B2
7572219 Lau et al. Aug 2009 B2
7621866 Dietz et al. Nov 2009 B2
7651462 Hjelle et al. Jan 2010 B2
7727142 Hjelle et al. Jun 2010 B2
7736299 Klenk et al. Jun 2010 B2
7819797 Vanden Hoek et al. Oct 2010 B2
8202212 Hjelle et al. Jun 2012 B2
8617051 Hjelle Dec 2013 B2
8870744 Hjelle Oct 2014 B2
9737404 Hjelle Aug 2017 B2
20020019580 Lau et al. Feb 2002 A1
20020072662 Hall et al. Jun 2002 A1
20030208220 Worley et al. Nov 2003 A1
20030229265 Girard et al. Dec 2003 A1
20040059181 Alferness Mar 2004 A1
20040138521 Grabek et al. Jul 2004 A1
20040210104 Lau Oct 2004 A1
20050033109 Lau et al. Feb 2005 A1
20050059854 Hoek et al. Mar 2005 A1
20050059855 Lau et al. Mar 2005 A1
20050090707 Lau et al. Apr 2005 A1
20050171589 Lau et al. Aug 2005 A1
20050192474 Vanden Hoek et al. Sep 2005 A1
20050256368 Klenk et al. Nov 2005 A1
20050283042 Meyer et al. Dec 2005 A1
20050288715 Lau et al. Dec 2005 A1
20060009831 Lau et al. Jan 2006 A1
20060129026 Wallin et al. Jun 2006 A1
20060155165 Vanden Hoek et al. Jul 2006 A1
20060229490 Chin Oct 2006 A1
20060270896 Dietz et al. Nov 2006 A1
20070208211 Alferness et al. Sep 2007 A1
20070208214 Hjelle Sep 2007 A1
20070219407 Vanden Hoek et al. Sep 2007 A1
20070225547 Alferness et al. Sep 2007 A1
20080033234 Hjelle et al. Feb 2008 A1
20090048480 Klenk et al. Feb 2009 A1
20100094080 Hjelle et al. Apr 2010 A1
Foreign Referenced Citations (28)
Number Date Country
3 24 524 Aug 1920 DE
38 31 540 Apr 1989 DE
295 17 393 Mar 1996 DE
0 280 564 Aug 1988 EP
0 303 719 Feb 1989 EP
0 557 964 Sep 1993 EP
2 209 678 May 1989 GB
60-203250 Oct 1985 JP
01-145066 Jun 1989 JP
2-271829 Nov 1990 JP
1009457 Apr 1983 SU
WO 9303685 Mar 1993 WO
WO 9616601 Jun 1996 WO
WO 9631175 Oct 1996 WO
WO 9814136 Apr 1998 WO
WO 9829041 Jul 1998 WO
WO 9835632 Aug 1998 WO
WO 9858598 Dec 1998 WO
WO 9944534 Sep 1999 WO
WO 0001306 Jan 2000 WO
WO 0002500 Jan 2000 WO
WO 0006026 Feb 2000 WO
WO 0006027 Feb 2000 WO
WO 0006028 Feb 2000 WO
WO 0016700 Mar 2000 WO
WO 0102500 Jan 2001 WO
WO 0167985 Sep 2001 WO
WO 0623580 Mar 2006 WO
Non-Patent Literature Citations (20)
Entry
Abstracts From the 68th Scientific Sessions, Anaheim Convention Center, Anaheim, California, Nov. 13-16, 1995, American Heart Association Supplement to Circulation, vol. 92, No. 8, Abstracts 1810-1813(Oct. 15, 1995).
Capomolla et al., “Dobutamine and nitroprusside infusion in patients with severe congestive heart failure: Hemodynamic improvement by discordant effects on mitral regurgitation, left atrial function, and ventricular function”, American Heart Journal, pp. 1089-1098 (Dec. 1997).
Capouya et al., “Girdling Effect of Nonstimulated Cardiomyoplasty on Left Ventricular Function”, The Society of Thoracic Surgeons, vol. 56, pp. 867-871 (1993).
Cohn, “The Management of Chronic Heart Failure”, The New England Journal of Medicine, vol. 335, No. 7, pp. 490-498 (Aug. 15, 1996).
Colleta et al., “Prognostic value of left ventricular volume response during dobutamine stress echocardiography”, European Heart Journal, vol. 18, pp. 1599-1605 (Oct. 1997).
deVries, G. et al., “A Novel Technique for Measurement of Pericardia! Balloon,” Am. J. Physiol Heart Circ Physiol, vol. 280, No. 6, pp. H2815-H2822 (Jan. 2001).
Guasp, “Una protesis contentiva para el tratamiento de la miocardiopatia dilatada” Revista Espanola de Cardiologia, vol. 51, No. 7, pp. 521-528 (1998). (Includes the English translation).
Hamilton, D. et al., “Static and Dynamic Operating Characteristics of a Pericardia! Balloon,” J. Appl. Physiol., vol. 90, No. 4, pp. 1481-1488 (Apr. 2001).
International Search Report and Written Opinion from international application No. PCT/US2007/072345, dated Jul. 3, 2008, 11 pages.
Kass et al., “Reverse Remodeling From Cardiomyoplasty in Human Heart Failure”, Circulation, vol. 91, No. 9, pp. 2314-2318 (May 1, 1995).
Labrousse, Louis et al., “Implantation of a Cardiac Support Device by the ‘Parachute-Like’ Technique Through Sternal and Trans-Abdominal Approach”, Abstract, 94 Programme of the 4th EACTS/ESTS Joint Meeting, Wednesday Sep. 28, 2005, Barcelona, Spain.
Levin et al., “Reversal of Chronic Ventricular Dilation in Patients With End-Stage Cardiomyopathy by Prolonged Mechanical Unloading”, Circulation, vol. 91, No. 11, pp. 2717-2720 (Jun. 1, 1995).
Oh et al., “The Effects of Prosthetic Cardiac Binding and Adynamic Cardiomyoplasty in a Model of Dilated Cardiomyopathy”, The Journal of Thoracic and Cardiovascular Surgery, vol. 116, No. 1, pp. 148-153 (Jul. 1998).
Paling, “Two-Bar Fabrics (Part-Set Threading)”, Watp Knitting Technology, Columbine Press (Publishers) Ltd., Buxton, Great Britain, p. 111 (1970).
PCT International Search Report and Written Report, International Application No. PCT/US0783689, dated Aug. 25, 2008, 13 pages.
U.S. Appl. No. 60/148, 130 entitled, “Apparatus and Method for Endoscopic Pericardia! Access”, filed Aug. 10, 1999.
U.S. Appl. No. 60/150,737 entitled, “Longitudinal Mechanical Dilator for Vessel Harvesting”, filed Aug. 25, 1999.
U.S. Appl. No. 09/635,345 entitled, “Apparatus and Methods for Subxiphoid Endoscopic Access”, filed Aug. 9, 2000.
Vaynblat et al., Cardiac Binding in Experimental Heart Failure⋅, Ann Thorac Surg, vol. 64 (1997).
Vinereanu, et al., Worsening Global Diastolic Dysfunction of the Left Ventricle is Associated with a Progressive Decline in Longitudinal Systolic Function, European Journal of Heart Failure, Aug. 7(5): 820-8 (2005).
Related Publications (1)
Number Date Country
20170348103 A1 Dec 2017 US
Continuations (4)
Number Date Country
Parent 14086804 Nov 2013 US
Child 15682111 US
Parent 13524093 Jun 2012 US
Child 14086804 US
Parent 12638059 Dec 2009 US
Child 13524093 US
Parent 11487953 Jul 2006 US
Child 12638059 US