# US 12,588,989 B2 · Implant delivery > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,588,989 B2 - Document ID: US12588989B2 - Status: Granted - Kind: B2 - Application number: 19/186,940 - Filed: 2025-04-23 - Published: 2025-09-18 - Granted: 2026-03-31 - Earliest claimed: 2023-03-24 - Assignees: 4C Medical Technologies, Inc. - Applicants: 4C Medical Technologies, Inc. - Inventors: Jason S. Diedering; Jonathan Berndt; Sounthara Khouengboua; Paul Thompson; Shelby Jo Byron - Web page: https://patentgrep.com/patent/US12588989B2 ## CPC - A61F 2/2418: {Scaffolds therefor, e.g. support stents} - A61F 2/2466: {Delivery devices therefor} - A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation} - A61F 2/2439: {Expansion controlled by filaments} - A61F 2/2436: {Deployment by retracting a sheath} - A61F 2230/0069: cylindrical - A61F 2250/0006: for adjusting angular orientation - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) ## Abstract Apparatus and methods for an implant are provided. The implant may have a constrained configuration and a relaxed configuration. The implant may include a strut having an end that may be captured by a hub and may define a reference angle in the relaxed configuration. The implant may include a swivel body that may engage a shaft of a delivery cable and may be rotated through the reference angle. The apparatus may include a pusher catheter to push the implant. The delivery cable may engage the implant. The apparatus may include gauge handle that may include a force gauge to indicate the presence of a force acting on the implant. The apparatus may include a bushing that may be fixed to an end of a pusher catheter. The bushing may move along a delivery catheter lumen and may guide the implant to a keyed position at the bushing. ## Claims ### Claim 1 Apparatus for manipulating an implant, the apparatus comprising: a pusher catheter configured to push the implant into a heart chamber; a delivery cable configured to be engaged with the implant; a main handle; and a gauge handle that includes a force gauge that is configured to indicate a presence of a force acting on the implant other than that of the delivery cable; wherein: the force gauge is further configured to indicate a threshold force that is a predetermined amount less than a failure strength of a predetermined failure region included in the delivery cable. ### Claim 2 (depends on 1) The apparatus of claim 1 wherein: a distal end of the delivery cable is configured to be removably coupled to a hub of the implant; and the delivery cable is configured to be slidable within the pusher catheter. ### Claim 3 (depends on 2) The apparatus of claim 2 wherein the distal end of the delivery cable is configured to threadingly engage the hub. ### Claim 4 (depends on 1) The apparatus of claim 1 wherein the gauge handle includes: a first base that is: spaced apart from a second base; and configured to be coupled to the delivery cable; and the second base that is configured to be coupled to the pusher catheter; wherein the force gauge is coupled to the first base and the second base. ### Claim 5 (depends on 4) The apparatus of claim 4 wherein the force includes a differential force between the delivery cable and the pusher catheter. ### Claim 6 (depends on 5) The apparatus of claim 5 wherein the differential force is a tensile force. ### Claim 7 (depends on 5) The apparatus of claim 5 wherein the differential force is a compressive force. ### Claim 8 (depends on 4) The apparatus of claim 4 wherein: the first base defines a first cannula; the second base defines a second cannula; the delivery cable is positioned within, and terminates inside, the first cannula; the delivery cable extends through the second cannula; and the pusher catheter is positioned within, and terminates inside, the second cannula. ### Claim 9 (depends on 8) The apparatus of claim 8 wherein the main handle is configured to advance and withdraw the pusher catheter. ### Claim 10 (depends on 9) The apparatus of claim 9 wherein, when the pusher catheter and the delivery cable are locked to the first and second bases, respectively, the gauge handle, the pusher catheter and the delivery cable move in unison relative to the main handle. ### Claim 11 (depends on 10) The apparatus of claim 10 wherein, when the pusher catheter and the delivery cable are unlocked from the first and second bases, respectively, the pusher catheter and the delivery cable move separately relative to the main handle. ### Claim 12 (depends on 11) The apparatus of claim 11 wherein a cylindrical boss is positioned at a proximal end of the delivery cable. ### Claim 13 (depends on 12) The apparatus of claim 12 wherein the proximal end of the delivery cable is removably locked to the first base via fasteners inserted through thicknesses of the first base and threaded into holes defined in an outer surface of the cylindrical boss. ### Claim 14 (depends on 13) The apparatus of claim 13 wherein, when the delivery cable is locked to the first base, removal of the fasteners unlocks the delivery cable from the first base. ### Claim 15 (depends on 11) The apparatus of claim 11 wherein the pusher catheter is removably locked to the second base via a lock disposed in the second base and operable from outside the gauge handle. ### Claim 16 (depends on 15) The apparatus of claim 15 wherein engagement of the lock with the pusher catheter occurs inside the second cannula. ### Claim 17 (depends on 15) The apparatus of claim 15 wherein a spring is disposed between a top of the lock and the second base for biasing the lock in a non-depressed state. ### Claim 18 (depends on 17) The apparatus of claim 17 wherein when the pusher catheter is locked to the second base: the lock is configured to engage grooves defined on an outer surface of an encasement member of the pusher catheter; and depressing the lock disengages the lock from the grooves to unlock the pusher catheter from the second base. ### Claim 19 (depends on 18) The apparatus of claim 18 wherein the lock defines first, second and third cutouts. ### Claim 20 (depends on 19) The apparatus of claim 19 wherein: the first and second cutouts are configured to receive pins; and the pins are configured to prevent removal of the lock from the second base. ### Claim 21 (depends on 19) The apparatus of claim 19 wherein: the third cutout defines a circular section and an elongated section; the circular section is shaped to receive the encasement member; and the elongated section is shaped to engage the grooves. ### Claim 22 (depends on 4) The apparatus of claim 4 further comprising a pin that: includes a first end disposed in the first base; includes a second end disposed in the second base; and prevents the first base from rotating relative to the second base. ### Claim 23 (depends on 22) The apparatus of claim 22 wherein: the first base and the second base are spaced apart from each other to define a gap; the pin traverses the gap; and the force gauge extends across the gap between the first base and the second base. ### Claim 24 (depends on 23) The apparatus of claim 23 wherein: an outer surface of the first and second bases together define a recess; and the force gauge is disposed in the recess. ### Claim 25 (depends on 24) The apparatus of claim 24 wherein: bosses extend from the first and second bases; and the bosses support the force gauge across the gap. ### Claim 26 (depends on 25) The apparatus of claim 25 wherein the bosses extend into the recess. ### Claim 27 (depends on 24) The apparatus of claim 24 wherein the first and second bases are cylindrical. ### Claim 28 (depends on 1) The apparatus of claim 1 further including an implant loading device, wherein: the implant loading device is configured to receive the implant during loading of the implant; and the implant loading device, acting on the implant during the loading, contributes to the force. ### Claim 29 (depends on 28) The apparatus of claim 28 wherein the implant loading device includes a funnel. ### Claim 30 Apparatus for manipulating an implant, the apparatus comprising: a pusher catheter configured to push the implant into a heart chamber; a delivery cable configured to be engaged with the implant; a main handle; and a gauge handle that includes: a force gauge that is: configured to indicate a presence of a force acting on the implant other than that of the delivery cable; and is coupled to a first base and a second base; the first base that: is spaced apart from the second base; is configured to be coupled to the delivery cable; and defines a first cannula; and the second base that is: configured to be coupled to the pusher catheter; and defines a second cannula; wherein: the delivery cable: is positioned within, and terminates inside, the first cannula; and extends through the second cannula; the pusher catheter is positioned within, and terminates inside, the second cannula; the main handle is configured to advance and withdraw the pusher catheter; and when the pusher catheter and the delivery cable are locked to the first and second bases, respectively, the gauge handle, the pusher catheter and the delivery cable move in unison relative to the main handle. ### Claim 31 (depends on 30) The apparatus of claim 30 wherein: a distal end of the delivery cable is configured to be removably coupled to a hub of the implant; and the delivery cable is configured to be slidable within the pusher catheter. ### Claim 32 (depends on 31) The apparatus of claim 31 wherein the distal end of the delivery cable is configured to threadingly engage the hub. ### Claim 33 (depends on 30) The apparatus of claim 30 wherein the force includes a differential force between the delivery cable and the pusher catheter. ### Claim 34 (depends on 33) The apparatus of claim 33 wherein the differential force is a tensile force. ### Claim 35 (depends on 33) The apparatus of claim 33 wherein the differential force is a compressive force. ### Claim 36 (depends on 30) The apparatus of claim 30 further including an implant loading device, wherein: the implant loading device is configured to receive the implant during loading of the implant; and the implant loading device, acting on the implant during the loading, contributes to the force. ### Claim 37 (depends on 36) The apparatus of claim 36 wherein the implant loading device includes a funnel. ### Claim 38 (depends on 30) The apparatus of claim 30 wherein, when the pusher catheter and the delivery cable are unlocked from the first and second bases, respectively, the pusher catheter and the delivery cable move separately relative to the main handle. ### Claim 39 (depends on 38) The apparatus of claim 38 wherein a cylindrical boss is positioned at a proximal end of the delivery cable. ### Claim 40 (depends on 39) The apparatus of claim 39 wherein the proximal end of the delivery cable is removably locked to the first base via fasteners inserted through thicknesses of the first base and threaded into holes defined in an outer surface of the cylindrical boss. ### Claim 41 (depends on 40) The apparatus of claim 40 wherein, when the delivery cable is locked to the first base, removal of the fasteners unlocks the delivery cable from the first base. ### Claim 42 (depends on 38) The apparatus of claim 38 wherein the pusher catheter is removably locked to the second base via a lock disposed in the second base and operable from outside the gauge handle. ### Claim 43 (depends on 42) The apparatus of claim 42 wherein engagement of the lock with the pusher catheter occurs inside the second cannula. ### Claim 44 (depends on 42) The apparatus of claim 42 wherein a spring is disposed between a top of the lock and the second base for biasing the lock in a non-depressed state. ### Claim 45 (depends on 44) The apparatus of claim 44 wherein when the pusher catheter is locked to the second base: the lock is configured to engage grooves defined on an outer surface of an encasement member of the pusher catheter; and depressing the lock disengages the lock from the grooves to unlock the pusher catheter from the second base. ### Claim 46 (depends on 45) The apparatus of claim 45 wherein the lock defines first, second and third cutouts. ### Claim 47 (depends on 46) The apparatus of claim 46 wherein: the first and second cutouts are configured to receive pins; and the pins are configured to prevent removal of the lock from the second base. ### Claim 48 (depends on 46) The apparatus of claim 46 wherein: the third cutout defines a circular section and an elongated section; the circular section is shaped to receive the encasement member; and the elongated section is shaped to engage the grooves. ### Claim 49 (depends on 30) The apparatus of claim 30 further comprising a pin that: includes a first end disposed in the first base; includes a second end disposed in the second base; and prevents the first base from rotating relative to the second base. ### Claim 50 (depends on 49) The apparatus of claim 49 wherein: the first base and the second base are spaced apart from each other to define a gap; the pin traverses the gap; and the force gauge extends across the gap between the first base and the second base. ### Claim 51 (depends on 50) The apparatus of claim 50 wherein: an outer surface of the first and second bases together define a recess; and the force gauge is disposed in the recess. ### Claim 52 (depends on 51) The apparatus of claim 51 wherein: bosses extend from the first and second bases; and the bosses support the force gauge across the gap. ### Claim 53 (depends on 52) The apparatus of claim 52 wherein the bosses extend into the recess. ### Claim 54 (depends on 51) The apparatus of claim 51 wherein the first and second bases are cylindrical. ### Claim 55 Apparatus for manipulating an implant, the apparatus comprising: a pusher catheter configured to push the implant into a heart chamber; a delivery cable configured to be engaged with the implant; a main handle; a gauge handle that includes: a force gauge that is: configured to indicate a presence of a force acting on the implant other than that of the delivery cable; and is coupled to a first base and a second base; the first base that is: spaced apart from the second base; and configured to be coupled to the delivery cable; the second base that is configured to be coupled to the pusher catheter; and a pin that: includes a first end disposed in the first base; includes a second end disposed in the second base; and prevents the first base from rotating relative to the second base. ### Claim 56 (depends on 55) The apparatus of claim 55 wherein: a distal end of the delivery cable is configured to be removably coupled to a hub of the implant; and the delivery cable is configured to be slidable within the pusher catheter. ### Claim 57 (depends on 56) The apparatus of claim 56 wherein the distal end of the delivery cable is configured to threadingly engage the hub. ### Claim 58 (depends on 55) The apparatus of claim 55 wherein the force includes a differential force between the delivery cable and the pusher catheter. ### Claim 59 (depends on 58) The apparatus of claim 58 wherein the differential force is a tensile force. ### Claim 60 (depends on 58) The apparatus of claim 58 wherein the differential force is a compressive force. ### Claim 61 (depends on 55) The apparatus of claim 55 further including an implant loading device, wherein: the implant loading device is configured to receive the implant during loading of the implant; and the implant loading device, acting on the implant during the loading, contributes to the force. ### Claim 62 (depends on 61) The apparatus of claim 61 wherein the implant loading device includes a funnel. ### Claim 63 (depends on 55) The apparatus of claim 55 wherein: the first base defines a first cannula; the second base defines a second cannula; the delivery cable is positioned within, and terminates inside, the first cannula; the delivery cable extends through the second cannula; and the pusher catheter is positioned within, and terminates inside, the second cannula. ### Claim 64 (depends on 63) The apparatus of claim 63 wherein the main handle is configured to advance and withdraw the pusher catheter. ### Claim 65 (depends on 64) The apparatus of claim 64 wherein: when the pusher catheter and the delivery cable are locked to the first and second bases, respectively, the gauge handle, the pusher catheter and the delivery cable move in unison relative to the main handle; and when the pusher catheter and the delivery cable are unlocked from the first and second bases, respectively, the pusher catheter and the delivery cable move separately relative to the main handle. ### Claim 66 (depends on 65) The apparatus of claim 65 wherein a cylindrical boss is positioned at a proximal end of the delivery cable. ### Claim 67 (depends on 66) The apparatus of claim 66 wherein the proximal end of the delivery cable is removably locked to the first base via fasteners inserted through thicknesses of the first base and threaded into holes defined in an outer surface of the cylindrical boss. ### Claim 68 (depends on 67) The apparatus of claim 67 wherein, when the delivery cable is locked to the first base, removal of the fasteners unlocks the delivery cable from the first base. ### Claim 69 (depends on 65) The apparatus of claim 65 wherein the pusher catheter is removably locked to the second base via a lock disposed in the second base and operable from outside the gauge handle. ### Claim 70 (depends on 69) The apparatus of claim 69 wherein engagement of the lock with the pusher catheter occurs inside the second cannula. ### Claim 71 (depends on 69) The apparatus of claim 69 wherein a spring is disposed between a top of the lock and the second base for biasing the lock in a non-depressed state. ### Claim 72 (depends on 71) The apparatus of claim 71 wherein when the pusher catheter is locked to the second base: the lock is configured to engage grooves defined on an outer surface of an encasement member of the pusher catheter; and depressing the lock disengages the lock from the grooves to unlock the pusher catheter from the second base. ### Claim 73 (depends on 72) The apparatus of claim 72 wherein the lock defines first, second and third cutouts. ### Claim 74 (depends on 73) The apparatus of claim 73 wherein: the pin is a first pin; the first and second cutouts are configured to receive second pins; and the second pins are configured to prevent removal of the lock from the second base. ### Claim 75 (depends on 73) The apparatus of claim 73 wherein: the third cutout defines a circular section and an elongated section; the circular section is shaped to receive the encasement member; and the elongated section is shaped to engage the grooves. ### Claim 76 (depends on 55) The apparatus of claim 55 wherein: the first base and the second base are spaced apart from each other to define a gap; the pin traverses the gap; and the force gauge extends across the gap between the first base and the second base. ### Claim 77 (depends on 76) The apparatus of claim 76 wherein: an outer surface of the first and second bases together define a recess; and the force gauge is disposed in the recess. ### Claim 78 (depends on 77) The apparatus of claim 77 wherein: bosses extend from the first and second bases; and the bosses support the force gauge across the gap. ### Claim 79 (depends on 78) The apparatus of claim 78 wherein the bosses extend into the recess. ### Claim 80 (depends on 77) The apparatus of claim 77 wherein the first and second bases are cylindrical.