Medical Transplant Systems

Abstract

The medical implantation system (1) comprises an access sheath (2) having a lumen (3), an implant (6) disposed within the lumen (3) of the access sheath (2) and axially adjustable relative thereto, radially adjustable from a contracted delivery configuration to a radially expanded deployed configuration, and removably coupled to an implant delivery shaft (4) having a lumen (5), an anchor (8) mountable within the lumen (5) of the implant delivery shaft (4) and axially adjustable relative thereto, radially adjustable from a anchor delivery configuration to a radially expanded implant anchoring configuration, and removably coupled to the anchor delivery shaft (7), and a handle (9) operably coupled to the implant delivery shaft (4) and the access sheath (2) and including an axial actuator for adjusting the axial position of the implant delivery shaft (4) relative to the access sheath (2). The axial actuator includes an outer actuator sleeve (23) rotatably mounted to a body (20) of the handle (9) for rotation about a longitudinal axis (21) of the handle (9). A method of using the medical implant system (1) is also described.

Description

[Technical Field]

[0001] The present invention relates to a medical implant system and a method for implanting and securing a medical implant in a body cavity, such as the left atrial appendage of the heart. [Background technology]

[0002] Systems for occluding body cavities are described in the literature, for example, U.S. Patent Nos. 5,629,999, 5,729,963, 5,729,973, 5,729,983, 5,729,993, and 5,729,983. These systems generally include a nitinol cage implant that is radially adjustable from a contracted delivery configuration to a radially deployed deployment configuration, an implant delivery catheter removably attached to the implant, an access catheter having a lumen for receiving the delivery catheter for delivering the implant to the target body cavity, and a handle to which the access catheter and implant delivery catheter are coupled. The implant is typically detachable from the delivery catheter, allowing the catheter to be withdrawn while leaving the implant in place. The implant often includes electrodes for tissue ablation and an electrical coupling system for electrically coupling and decoupling the implant and delivery catheter. Furthermore, prior art describes fixation systems that include fixators that secure the implant within the body cavity. Controlling all parts of such an occlusion system using a handle is difficult because it requires separate axial and rotational movement of the delivery catheter and fixator delivery shaft. Additionally, because deployment of the implant into the contact tissue is a critical part of the process, controllable axial actuation of the implant is required.

[0003] An object of the present invention is to solve at least one of the above problems. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] U.S. Patent Publication No. 2020 / 0121324 [Patent Document 2] U.S. Patent Publication No. 2020 / 0107836 [Patent Document 3] International Publication No. 2020 / 074738 [Patent Document 4] International Publication No. 2022 / 079235 [Patent Document 5] International Publication No. 2022 / 129257 [Patent Document 6] International Publication No. 202201 / 87168 [Patent Document 7] US Patent No. 6,652,548 [Patent Document 8] U.S. Patent Publication No. 2004 / 219028 [Patent Document 9] U.S. Patent No. 6,454,775 [Patent Document 10] U.S. Patent No. 4,909,789 [Patent Document 11] US Patent US5573530 [Patent Document 12] International Publication No. 20222013 / 109756 Summary of the Invention

[0005] In a first aspect, the present invention provides a method for producing a medicament for the treatment of a pulmonary arthritis, comprising: an access sheath having a lumen; an implant module comprising an implant mountable within the lumen of the access sheath, axially adjustable relative to the lumen of the access sheath, and radially adjustable from a contracted delivery configuration to a radially expanded deployed configuration, the implant module removably coupled to an implant delivery shaft having a lumen; a graft fixation module including a fixator radially adjustable from a contracted delivery configuration to a radially expanded graft fixation configuration; a handle operably coupled to the implant delivery shaft and the access sheath, the handle including a body and an axial actuator configured to adjust the axial position of the implant delivery shaft relative to the access sheath to deploy and / or re-retrieve the implant; A medical transplant system is provided.

[0006] The axial actuator suitably comprises an external actuator sleeve rotatably mounted to the handle body for rotation about the longitudinal axis of the handle, allowing the surgeon to have very precise control over the deployment and resheathing of the implant, as the diameter of the sleeve allows fine adjustment of the axial position of the deployed implant.

[0007] In an embodiment, the graft fixation module includes a fastener delivery shaft mountable within and axially adjustable relative to the lumen of the graft delivery shaft and removably coupled to a fastener, hi another embodiment, the fastener is coupled to the graft for delivery therewith.

[0008] In an embodiment, the handle body includes a central bore and a central axis, and the axial actuator for the implant delivery shaft includes: an actuator arm disposed in the central bore and configured for axial and non-rotational movement relative to the central bore; a translation mechanism configured to translate rotational motion of the axial actuator sleeve into axial motion of the actuator arm; Equipped with The implant delivery shaft is attached to the actuator arm for axial movement therewith.

[0009] In an embodiment, the conversion mechanism comprises: an axial slot formed in a sidewall of the body; a spiral groove formed on an inner wall of the axial actuator; a radial pin coupled to the actuator arm that extends radially outward through the axial slot and engages the helical groove; and Rotational movement of the axial actuator relative to the body thereby causes axial movement of the actuator arm and the implant delivery shaft relative to the access sheath.

[0010] In an embodiment, the actuator arm a distal portion configured to move axially along the central bore of the body, the distal portion including a central bore for receiving the implant delivery shaft; a proximal portion removably coupled to the distal portion; and The implant delivery shaft is attached to the proximal portion, whereby the proximal portion can be decoupled from the distal portion and rotated about a central axis to rotate the implant delivery shaft without rotating the distal portion of the actuator arm.

[0011] In embodiments, the proximal portion of the actuator arm is located proximal to the body.

[0012] In embodiments, the proximal portion includes a cylindrical hub having an internally threaded surface, and the proximal end of the distal portion includes an externally threaded fitting configured to engage the internally threaded surface of the cylindrical hub.

[0013] In embodiments, the axial actuator sleeve is rotatably coupled to a distal end of the handle body.

[0014] In embodiments, the distal portion of the body has a waist and the axial actuator sleeve is rotatably mounted in the waist.

[0015] In embodiments, the fastener delivery shaft extends through the handle and has a proximal end including a fastener shaft hub extending proximally from the proximal end of the handle.

[0016] In embodiments, the handle includes a hemostasis valve for the fastener delivery shaft.

[0017] In embodiments, the handle includes a hemostatic valve for the access sheath.

[0018] In embodiments, the handle includes a hemostatic valve for the implant delivery shaft.

[0019] In embodiments, the actuation length of the implant delivery shaft and the actuation length of the access sheath are configured such that upon assembly of the implant module within the lumen of the access sheath and prior to deployment of the axial actuator of the handle, the implant is positioned within 100 mm, 75 mm, 50 mm, 30 mm, 20 mm, 10 mm, 8 mm, or 5 mm proximal to the distal end of the access sheath. Thus, during assembly, when the implant delivery shaft is advanced sufficiently distally along the access sheath, the implant is positioned within the access sheath adjacent the distal end of the sheath. Further distal advancement of the implant relative to the access sheath requires actuation of the axial actuator of the handle.

[0020] In embodiments, the distal end of the access sheath includes a fluorescent or radiopaque marker.

[0021] In embodiments, the implant comprises a mesh cage with a proximal hub configured to removably attach to the distal end of the implant delivery sheath.

[0022] In embodiments, the proximal hub of the implant includes a fluorescent or radiopaque marker.

[0023] In embodiments, the fastener comprises a proximal fastener hub and a plurality of fastening arms extending distally from the distal fastener hub.

[0024] In embodiments, the fixation arms are configured to self-deploy into contact with a wall outside the body cavity when the fixation arms are advanced distally beyond the proximal hub of the implant.

[0025] In embodiments, the proximal anchor hub is configured to abut the proximal hub of the implant when the fixation arms are fully deployed to limit further distal movement of the implant fixation system.

[0026] In embodiments, the proximal anchor hub of the anchor is configured to nest within the proximal hub of the implant when the fixation arms are fully deployed, limiting further distal movement of the implant fixation system.

[0027] In embodiments, the implant is radially self-adjustable from a contracted delivery configuration to a radially expanded medical implant configuration upon advancement of the implant distal to the distal end of the access sheath.

[0028] In an embodiment, the mesh cage comprises nitinol.

[0029] In an embodiment, the implant comprises one or more electrodes.

[0030] In embodiments, the proximal end of the axial actuator includes a plurality of scale markings disposed along at least a portion of the circumference of the axial actuator including a central marking, and the body includes a body marking on an outer surface of the body, the markings configured such that the central marking and the body marking are aligned when the implant is positioned just proximal to the distal end of the outer sheath.

[0031] In an embodiment, the access sheath includes a dilator.

[0032] In embodiments, the implant is configured to occlude the body cavity upon deployment therein.

[0033] In embodiments, the implant is configured to occlude the blood vessel when deployed within the blood vessel.

[0034] In an embodiment, the implant is configured to occlude the left atrial appendage of the heart.

[0035] In embodiments, the implant includes one or more sensors configured to sense, for example, a body cavity tissue parameter or a blood parameter. The sensors may be located, for example, on the radially expandable portion of the implant or on or within the implant hub. Typically, the sensors are fixed to the implant.

[0036] In embodiments, the fixation system includes one or more sensors configured to sense, for example, a body cavity tissue parameter or a blood parameter. The sensor may be continuous with the medical implant fixation device, or may be attached to the medical implant fixation device (e.g., attached to a fixation arm or protrusion), or may be attached to the fixation device delivery shaft.

[0037] In embodiments, the implant or fixation system may include a wireless communication module. The wireless communication module may be operably coupled to the sensor and configured to relay sensed data to a receiver located on or outside the subject's body. The wireless communication module may be configured for inductive (contactless) charging.

[0038] In an embodiment, the sensor is a light addressable potentiometric (LAP) sensor. In an embodiment, the sensor has a self-cleaning element.

[0039] In an embodiment, the sensor is a micro-electromechanical system (MEMS) sensor.

[0040] In embodiments, the fixation system includes a tissue activation module, e.g., one or more electrodes. This medical module may be continuous with the medical implant fixation device, or may be attached to the medical implant fixation device (e.g., attached to a fixation arm or protrusion), or may be attached to the fixation device delivery shaft. The electrodes may be tissue ablation electrodes, such as non-thermal tissue ablation electrodes.

[0041] In embodiments, the access sheath is steerable. The access sheath may be configured for bidirectional manipulation. The access sheath may include a fixed first curve and a steerable second curve. The access sheath may include one or more symmetrical curves. The access sheath may include one or more asymmetrical curves.

[0042] In embodiments, the fixture (eg, the proximal fixture hub of the fixture or one or more fixation arms of the fixture) comprises a sensor.

[0043] In embodiments, the implant system is configured such that, during use, the sensor senses a left atrial parameter when the implant is deployed in the left atrial appendage and the proximal anchor hub of the anchor abuts the proximal hub of the deployed implant. Thus, the sensor may include a sensing probe or surface disposed on or extending proximally away from the proximal face of the proximal anchor hub. The sensor may be configured to detect a blood parameter, e.g., pressure, such as left atrial pressure.

[0044] Also, a medical transplant system, comprising: an access sheath having a lumen; an implant system including an implant disposed within the lumen of the access sheath, axially adjustable relative to the lumen of the access sheath, and radially adjustable from a contracted delivery configuration to a radially expanded deployed configuration, the implant system being removably coupled to an implant delivery shaft having a lumen; a graft fixation system mounted within a lumen of the graft delivery shaft and axially adjustable relative to the lumen, the graft fixation system including a fixator removably coupled to the fixator delivery shaft with the fixator being radially adjustable from a contracted delivery configuration to a radially expanded graft fixation configuration; a handle operably coupled to the implant delivery shaft and the access sheath, the handle including an axial actuator for adjusting the axial position of the implant delivery shaft relative to the access sheath to deploy and / or retrieve the implant; Equipped with A medical implant system is described, wherein the implant delivery shaft includes an electrical supply lead configured to deliver electrical energy from an external energy source to the implant.

[0045] In embodiments, the implant comprises a mesh cage including or formed from a conductive material that is electrically coupled to an electrical supply lead on the implant delivery shaft.

[0046] In embodiments, the implant comprises a mesh cage containing tissue-contacting electrodes electrically coupled to electrical supply leads on the implant delivery shaft.

[0047] In another aspect, the present invention provides a method of implanting a medical implant, comprising: percutaneously advancing an access sheath including a lumen until a distal end of the access sheath is positioned at the target location; coupling an implant delivery shaft of an implant system to a handle, the implant delivery shaft including a medical implant removably attached to the implant delivery shaft; advancing the implant system through the lumen of the access sheath until a medical implant is positioned proximal to the distal end of the access sheath; actuating an axial retractor of the handle to advance the implant system relative to the access sheath and deploy the medical implant protruding from the distal end of the access sheath, wherein the medical implant self-expands to a deployed configuration at the target location; actuating a rotary actuator of the handle to rotate the implant delivery shaft and detach the medical implant from the implant delivery shaft; and c) percutaneously withdrawing the implant delivery shaft and the access sheath, leaving the medical implant at the target location.

[0048] The method generally includes fixating the implant, which may be part of (or adjacent to) (and delivered with) the implant, or may be delivered separately from (or distinct from) the implant.

[0049] Thus, in one embodiment, the method comprises: percutaneously advancing an access sheath including a lumen until a distal end of the access sheath is positioned at the target location; coupling an implant delivery shaft of an implant system to a handle, the implant delivery shaft including a medical implant removably attached to the implant delivery shaft; advancing a fixation system including a medical implant fixator removably attached to a fixator delivery shaft through the implant delivery shaft until the fixator is positioned proximal to a distal end of the implant delivery shaft; advancing the implant system through the lumen of the access sheath until a medical implant is positioned just proximal to the distal end of the access sheath; actuating an axial retractor of the handle to advance the implant system relative to the access sheath and deploy the medical implant protruding from the distal end of the access sheath, wherein the medical implant self-expands to a deployed configuration at the target location; advancing the fastener delivery shaft along the implant delivery shaft to deploy the fastener at the target location, whereby the deployed fastener secures the medical implant at the target location; rotating the proximal end of the fastener delivery shaft to decouple the fastener from the fastener delivery shaft; actuating a rotary actuator of the handle to rotate the implant delivery shaft and detach the medical implant from the implant delivery shaft; percutaneously withdrawing the implant delivery shaft, optionally the fixator delivery shaft, and the access sheath, leaving the medical implant fixed in place; Includes:

[0050] In another embodiment, the method comprises: percutaneously advancing an access sheath including a lumen until a distal end of the access sheath is positioned at the target location; coupling an implant delivery shaft of an implant system to the handle, the implant delivery shaft including a medical implant removably attached to the implant delivery shaft, the medical implant including a deployable fixator; advancing the implant system through the lumen of the access sheath until a medical implant is positioned just proximal to the distal end of the access sheath; actuating an axial retractor on the handle to advance the implant system relative to the access sheath and deploy the medical implant protruding from the distal end of the access sheath, whereby the medical implant and fasteners self-expand into a deployed configuration at the target location; actuating a rotary actuator of the handle to rotate the implant delivery shaft and detach the medical implant from the implant delivery shaft; percutaneously withdrawing the implant delivery shaft and the access sheath, leaving the medical implant fixed at the target location by a fixator; Includes:

[0051] In embodiments, the axial retractor of the handle includes an external actuator sleeve rotatably mounted to the body of the handle about a longitudinal axis of the handle, and actuating the axial retractor includes rotating the external actuator handle relative to the body of the handle. In embodiments, the medical implant includes a mesh cage with a proximal hub having a proximal hub lumen, and the fixator includes a proximal fixator hub and a plurality of fixation arms extending distally from the proximal fixator hub.

[0052] In embodiments, the fixation system is pre-assembled such that the proximal fixator hub is positioned proximal to the proximal hub of the mesh cage and the fixation arms are positioned within the implant delivery shaft.

[0053] In embodiments, the step of advancing the fixation system includes advancing the fixator until the proximal fixator hub abuts the proximal hub lumen.

[0054] In embodiments, the fastener delivery shaft extends through a central lumen of the handle and includes a proximal fastener delivery shaft portion disposed proximally of the handle for manual adjustment of the fastening system.

[0055] In an embodiment, the handle body includes a central bore and a central axis, and the axial actuator for the implant delivery shaft includes: an actuator arm disposed in the central bore and configured for axial and non-rotational movement relative to the central bore; a translation mechanism configured to translate rotational motion of the axial actuator sleeve into axial motion of the actuator arm; Equipped with The implant delivery shaft is attached to an actuator arm for axial movement therewith.

[0056] In an embodiment, the actuator arm comprises a shaft portion removably coupled to the rotary actuator, the implant delivery shaft is attached to the rotary actuator, and the step of actuating the rotary actuator includes decoupling the rotary actuator from the shaft portion of the actuator arm and rotating the rotary actuator to rotate the implant delivery shaft relative to the body of the handle and decoupling the implant delivery shaft from the secured implant.

[0057] In embodiments, the method includes advancing a dilator through a lumen of an access sheath, wherein advancing the access sheath includes advancing the access sheath and the dilator.

[0058] In embodiments, the method includes retracting the dilator from the access sheath before advancing the implant system through the lumen of the access sheath.

[0059] In an embodiment, the access sheath includes a first hemostatic valve disposed at its proximal end, and the step of advancing the graft system through the lumen of the access sheath includes opening the hemostatic valve and inserting the graft system into the access sheath through the first hemostatic valve.

[0060] In an embodiment, the step of advancing the graft system through the lumen of the access sheath includes coupling a loading tool including a second hemostatic valve to the distal end of the graft delivery shaft, coupling the second hemostatic valve to the first hemostatic valve, opening the second hemostatic valve, and advancing the graft system through the first and second hemostatic valves and along the access sheath.

[0061] In an embodiment, the method includes attaching a loader to a distal end of the handle.

[0062] In embodiments, the implant includes a treatment or sensing module, and the method includes treating or sensing before or after the implant is secured and before disconnecting the implant delivery shaft from the implant.

[0063] In embodiments, the implant includes a treatment module, e.g., a tissue energizing module including one or more electrodes, and the treatment step includes activating the tissue energizing module to, e.g., treat tissue at the target location. In one embodiment, the method includes activating one or more electrodes of the tissue energizing module to ablate tissue at the target location.

[0064] In embodiments, the or each electrode of the implant is electrically coupled to an electrical controller via conductive wires, and the method includes activating the electrical controller to energize the or each electrode.

[0065] In an embodiment, the method comprises: actuating the axial actuator of the handle to at least partially re-sheathe the medical implant prior to deployment of the fastener; adjusting the axial position of the medical implant relative to an access sheath; actuating the axial actuator of the handle to redeploy the medical implant; Includes:

[0066] In an embodiment, the method comprises: After the fasteners are deployed, retracting the fastener delivery shaft until the fixation arms are disengaged from the tissue at the target location and optionally resheathed on the implant delivery shaft; adjusting the rotational and / or axial position of the fixture; advancing the fastener delivery shaft until the fixation arms engage tissue at the target location; Includes:

[0067] In embodiments, the steps of placing the access sheath, deploying the implant, or deploying the fixator are performed under imaging, for example, x-ray or fluoroscopic imaging.

[0068] In an embodiment, the method is a method of occluding a body cavity, and the medical implant is configured to occlude the body cavity when deployed in the body cavity.

[0069] In an embodiment, the body cavity is a blood vessel.

[0070] In an embodiment, the body cavity is the left atrial appendage.

[0071] In another aspect, the present invention provides a system for removing tissue from a body cavity, the system comprising: a tissue removal module including a radially expandable body configured to radially expand from a radially contracted delivery configuration to a radially expanded tissue removal configuration, and at least one tissue removal electrode disposed on an outer, body cavity-facing surface of the radially expandable body; an elongate catheter having a conductive element electrically coupled to the electrode; a generator configured to be electrically coupled to the proximal end of the catheter for delivering ablation pulse field energy comprising at least one pulse train of energy to the electrode via the conductive element of the catheter; Equipped with.

[0072] In an embodiment, at least one pulse train of energy comprises or consists essentially of asymmetric pulses.

[0073] In an embodiment, at least one pulse train of energy comprises or consists essentially of a biphasic pulse.

[0074] In an embodiment, at least one pulse train of energy comprises or consists essentially of symmetric pulses.

[0075] In embodiments, at least one pulse train of energy comprises or consists essentially of monophasic pulses.

[0076] In an embodiment, at least one pulse train of energy comprises or consists essentially of an asymmetric biphasic pulse.

[0077] The present invention also provides a method of removing tissue from a body cavity employing the system of the present invention, comprising the steps of: transluminally advancing the catheter and radially expandable body to a body cavity; deploying the radially expandable body within the body cavity such that energy delivery surfaces of at least some of the electrodes contact tissue of the body cavity; Delivering at least one pulse train of energy to said electrode via a conductive element of the catheter by an ablation pulse field energy generator.

[0078] In embodiments, at least one pulse train of energy comprises or consists essentially of asymmetric biphasic pulses, asymmetric monophasic pulses, symmetric biphasic pulses, or symmetric monophasic pulses.

[0079] In an embodiment, the generator delivers or is configured to deliver at least one pulse train of energy (typically at a predetermined frequency) comprising pulses having a positive voltage between 500V and 2500V.

[0080] In an embodiment, the generator delivers or is configured to deliver at least one pulse train of energy (typically at a predetermined frequency) comprising pulses having a negative voltage between 500V and 2500V.

[0081] In an embodiment, the generator delivers or is configured to deliver at least one pulse train of energy (typically at a predetermined frequency) comprising pulses having a positive pulse width of between 2 μs and 20 μs.

[0082] In an embodiment, the generator delivers or is configured to deliver at least one pulse train of energy (typically at a predetermined frequency) including pulses having a negative pulse width of between 2 μs and 20 μs.

[0083] In an embodiment, the generator delivers or is configured to deliver at least one pulse train of energy (typically at a predetermined frequency) comprising pulses having switching times between 2 μs and 200 μs.

[0084] In an embodiment, the generator delivers or is configured to deliver at least one pulse train of energy (typically at a predetermined frequency) including pulses having a negative pulse delay of between 2 μs and 20 μs.

[0085] In an embodiment, the generator delivers or is configured to deliver at least one pulse train of energy (typically at a predetermined frequency) comprising pulses comprising between 5 and 100 pulses per burst.

[0086] In an embodiment, the generator delivers or is configured to deliver at least one pulse train of energy (typically at a predetermined frequency) comprising pulses having a burst delay of 1 ms to 1000 ms.

[0087] In an embodiment, the generator is adapted to deliver or deliver a train of 1 to 100 pulses of energy.

[0088] In another aspect, the present invention provides a method for producing a pharmaceutical composition comprising: an access sheath having a lumen; an implant module comprising an implant mountable within the lumen of the access sheath, axially adjustable relative to the lumen of the access sheath, and radially adjustable from a contracted delivery configuration to a radially expanded deployed configuration, the implant module removably coupled to an implant delivery shaft having a lumen; a graft fixation module comprising a fastener and a fastener delivery shaft removably coupled to the fastener, the fastener being radially adjustable from a contracted delivery configuration to a radially expanded graft fixation configuration; Equipped with the graft fixation module is mountable within the lumen of the graft delivery shaft and axially adjustable relative to the lumen of the graft delivery shaft; A medical implant system is provided.

[0089] In embodiments, the fastener comprises a proximal fastener hub and a plurality of fastening arms extending distally from the distal fastener hub.

[0090] In embodiments, the fixation arms are configured to self-deploy into contact with a wall outside the body cavity when the fixation arms are advanced distally beyond the proximal hub of the implant.

[0091] In embodiments, the proximal surface of the implant includes an implantation conduit, and the proximal fixator hub is configured to nest within the implantation conduit when the fixation arms are fully deployed to limit further distal movement of the implant fixation system.

[0092] In embodiments, the proximal surface of the implant has an annular recessed portion surrounding the implanted conduit, and the distal end of the conduit is positioned distal (e.g., 1-2 mm) from the annular recessed portion of the proximal surface of the implant. In this manner, when the fixation arms are advanced through the implanted conduit and deployed radially outward, the distal end of the conduit prevents the arms from contacting the annular recessed portion of the implant as they pivot radially outward to the deployed position.

[0093] In an embodiment, the system comprises a handle operably coupled to the implant delivery shaft and the access sheath and including a body and an axial actuator configured to adjust the axial position of the implant delivery shaft relative to the access sheath to deploy and / or re-acquire the implant.

[0094] In another aspect, the present invention provides a method of implanting a medical implant, comprising: percutaneously advancing an access sheath including a lumen until a distal end of the access sheath is positioned at the target location; coupling an implant delivery shaft of an implant system to a handle, the implant delivery shaft including a medical implant removably attached to the implant delivery shaft; advancing the implant system through the lumen of the access sheath until a medical implant is positioned just proximal to the distal end of the access sheath; advancing the implant system relative to the access sheath (optionally by actuating the handle) to deploy the medical implant protruding from the distal end of the access sheath, whereby the medical implant self-expands to a deployed configuration at the target location; advancing a fastener module along the implant delivery shaft, the fastener module including a fastener removably coupled to a distal end of the fastener delivery shaft, to deploy the fastener at the target location, whereby the deployed fastener secures the medical implant at the target location; detaching the fastener from the fastener delivery shaft and detaching the medical implant from the implant delivery shaft; percutaneously withdrawing the implant delivery shaft, the fastener delivery shaft (and optionally the access sheath), leaving the medical implant in place; The present invention provides a method comprising:

[0095] In embodiments, the implant delivery shaft includes a lumen configured to receive the anchor module. In embodiments, the method includes advancing the anchor and the anchor delivery shaft through the lumen of the implant delivery shaft.

[0096] In embodiments, the handle includes a first actuator that rotates the implant delivery shaft and a second actuator that rotates the fastener delivery shaft.

[0097] Other aspects and preferred embodiments of the present invention are separately set forth and described in the following claims. [Brief explanation of the drawings]

[0098] [Figure 1] FIG. 1 is a side view of a medical implant system according to the present invention prior to advancement of an access sheath through an access sheath hemostatic valve. [Figure 2] FIG. 2 is a cross-sectional view taken along line AA in FIG. [Figure 3]FIG. 3 is a detailed view of a portion of the medical implant system of FIG. 2 showing the distal end of the access sheath with an undeployed implant housed within the access sheath and an undeployed fastener housed within the implant delivery shaft. [Figure 4] FIG. 4 is a side view of the medical implant system of FIGS. 1-3 shown after the access sheath has been advanced through the access sheath hemostatic valve, after deployment of the graft, and before deployment of the fixation device. [Figure 5] FIG. 5 is a cross-sectional view taken along line GG in FIG. [Figure 6] FIG. 6 is a detailed view of a portion of the medical implant system of FIG. 5 showing the distal end of the access sheath with the implant deployed distally of the access sheath and an undeployed fastener housed within the implant delivery shaft. [Figure 7] FIG. 7 is a side view of the medical implantation system of FIGS. 1-3 after deployment of the implant and during deployment of the fixation devices, where the fixation arms have not yet self-deployed into an extended tissue fixation position. [Figure 8] FIG. 8 is a cross-sectional view taken along line LL in FIG. [Figure 9] FIG. 9 is a detailed view of a portion of the medical implant system of FIG. 8 showing the distal end of the access sheath deployed distally of the access sheath, with the anchors partially advanced to a deployed position and the proximal anchor hub nested within the proximal hub of the implant. [Figure 10] FIG. 10 is a side view of the medical implant system of FIGS. 1-3 shown after fully deploying the fixation arms into an outwardly spread tissue fixation position. [Figure 11] FIG. 11 is a cross-sectional view taken along line NN in FIG. [Figure 12] FIG. 12 is a detailed view of a portion of the medical implant system of FIG. 11 showing the fixation arms extended outward to the implant fixation position and the fixator delivery shaft removed from the proximal fixator hub. [Figure 13]FIG. 13 is a side view of the medical implantation system of FIGS. 1-3 while the implant delivery shaft is being disconnected from the implant, with one of the surgeon's hands holding the proximal portion of the actuator arm after being released from the distal portion of the actuator arm. [Figure 14] FIG. 14 is a cross-sectional view taken along line WW in FIG. [Figure 15] FIG. 15 is a detailed view of a portion of the medical implant system of FIG. 11 showing the fixator delivery shaft retracted within the lumen of the implant delivery sheath, the implant delivery shaft disconnected from the distal portion of the actuator arm, and then rotationally separated from the implant by rotating the proximal portion of the actuator arm (rotational actuator). [Figure 16A] 16A is a schematic diagram illustrating the use of the system of the present invention. FIG. 16A shows the distal end of the access sheath positioned at the opening of the left atrial appendage (LAA), with the graft (in its contained delivery configuration) and graft delivery shaft positioned within the access sheath, the undeployed graft positioned just proximal to the distal end of the access sheath, and the fixator and fixator delivery shaft positioned within the graft delivery sheath, with the distal tips of the fixation arms positioned distal to the proximal hub of the graft. [Figure 16B] FIG. 16B is a schematic diagram illustrating the use of the system of the present invention. FIG. 16B shows deployment of the implant by advancing the implant delivery shaft proximally approximately 50 mm until the implant is exposed distally of the access sheath and it radially deploys and circumferentially engages the opening of the LAA. [Figure 16C] FIG. 16C is a schematic diagram illustrating the use of the system of the present invention, showing deployment of the anchor by advancing the anchor delivery shaft distally approximately 20 mm until the proximal anchor hub abuts and nests within the proximal hub of the implant and the anchoring arms are positioned within the implant and expand outward to engage tissue through openings in the implant wall, securing the implant in place. [Figure 16D] 16A-16D are schematic diagrams illustrating the use of the system of the present invention, with FIG. 16D showing the fastener delivery shaft detached from the fastener proximal hub and retracted within the implant delivery shaft. [Figure 16E] FIG. 16E is a schematic diagram illustrating the use of the system of the present invention, showing the implant delivery shaft being detached from the implant's proximal hub, retracted into the implant delivery shaft, and retracted into the access sheath; once this is complete, the access sheath containing the implant delivery shaft and fixator delivery shaft is percutaneously retracted, securing the implant to the LAA. [Figure 17] FIG. 17 shows a fastener system that includes a fastener delivery shaft attached to the proximal hub of the fastener. [Figure 18] FIG. 18 shows a fastener that includes eight fastening arms (shown in an extended tissue-engaging position) attached to a proximal hub. [Figure 19] FIG. 19 shows a medical implant with a proximal hub and the distal end of the implant delivery sheath prior to attachment to the proximal hub. [Figure 20] FIG. 20 shows the proximal end of the handle showing the separation of the rotational actuator from the proximal end of the actuator arm shaft; upon release, the rotational actuator can be rotated to rotate the graft delivery shaft and decouple the graft delivery shaft from the graft; prior to release, the graft delivery shaft is attached to the actuator arm and therefore cannot rotate. [Figure 21] FIG. 21 is an image of the recessed hub taken from inside the mesh cage implant showing the distal tips of the fixation arms protruding through the proximal hub of the mesh cage prior to deployment of the fixation devices, which is the position of the fixation arms in the pre-loaded configuration prior to deployment of the fixation devices. [Figure 22] FIG. 22 shows the assembly of the access sheath and dilator and the first hemostatic valve. [Figure 23] FIG. 23 shows the proximal end of the hemostatic valve clip arm, showing the proximal end of the dilator. [Figure 24] FIG. 24 shows an access sheath and dilator being advanced percutaneously over a guidewire into the femoral vein, with the proximal end of the dilator not fully abutting the hemostatic valve. [Figure 25]FIG. 25 shows the access sheath and dilator passing over the guidewire along the femoral artery and into the left atrium. [Figure 26] FIG. 26 shows the pre-assembly of the handle, implant system (implant and implant delivery shaft), and second hemostatic valve. [Figure 27] FIG. 27 shows the fixator system (fixator + fixator delivery shaft) attached to the handle after the fixator has been advanced through the third hemostatic valve and graft delivery sheath to a position just proximal to the proximal hub of the graft. [Figure 28] Figure 28 shows the second hemostatic valve attached to the first hemostatic valve while the access sheath is positioned within the vasculature, at which stage the dilator has been retracted and removed from the access sheath. [Figure 29] FIG. 29 shows the second hemostatic valve rotated counterclockwise to allow the graft system and fixator system to be advanced through the second hemostatic valve and along the sheath. [Figure 30] FIG. 30 shows the second hemostatic valve coupled to the handle after the graft system and anchor system have been advanced through the access sheath into position where the graft will be placed just proximal to the distal end of the access sheath. [Figure 31] FIG. 31 shows the graft placed just proximal to the distal end of the access sheath. [Figure 32] FIG. 32 shows the handle and implant system (and fixator system) advanced through the access sheath. [Figure 33] FIG. 33 illustrates the use of a rotating sleeve to deploy the graft from the distal end of the access sheath. [Figure 34A] FIG. 34A is a side view of an implant of the present invention. [Figure 34B] FIG. 34B is a perspective exploded view of the implant showing the components of the implant, including the cover, the circumferential array of electrodes, and the mesh cage. [Figure 34C] FIG. 34C is a side view of the implant of FIG. 34A, with the front of the cover cut away for clarity. [Figure 35A] FIG. 35A is a side cross-sectional view of a system of the present invention including an implant and a fastener in a deployed configuration, with the proximal fastener hub nested within the implantation conduit (hub) of the implant. [Figure 35B] FIG. 35B is a detailed view of the implantation conduit of the implant with the fixator module removed, showing the distal end of the implantation conduit extending distally of the annular recess in the proximal face of the implant. [Figure 35C] FIG. 35C is a detailed view of the implantation conduit of the graft with the proximal fixator hub nested within the implantation conduit and the fixation arms deployed. DETAILED DESCRIPTION OF THE INVENTION

[0099] All publications, patents, patent applications, and other references mentioned herein are incorporated by reference in their entirety for all purposes to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference and the contents of which were set forth in full.

[0100] Definitions and General Settings As used herein, and unless specifically indicated otherwise, the following terms are intended to have the following meanings in addition to the broader (or narrower) meaning that those terms may have in the art.

[0101] Unless the context requires otherwise, the use of the singular herein shall be read to include the plural, and vice versa. The term "a" or "an" when used in connection with an entity shall be construed to refer to one or more of that entity. That is, the terms "a" (or "an"), "one or more," and "at least one" are used interchangeably herein.

[0102] As used herein, the term "comprise," or variations such as "comprises" or "comprising," should be read to indicate the inclusion of a recited integer (e.g., feature, element, characteristic, property, method / process step, or limitation) or group of integers (e.g., feature, element, characteristic, property, method / process step, or limitation), but not the exclusion of other integers or groups of integers. Thus, as used herein, the term "comprises" is inclusive or open-ended and does not exclude additional, unrecited integers or method / process steps.

[0103] As used herein, the term "disease" is used to define an abnormal condition associated with a specific symptom in which physiological function is impaired. The term is used broadly to encompass any disorder, ill-health, abnormality, condition, illness, state, or syndrome in which physiological function is impaired, regardless of the nature of the etiology (or whether an etiological basis for the disease has actually been established). Thus, conditions resulting from infection, trauma, injury, surgery, radiation ablation, age, poisoning, or nutritional deficiency are included.

[0104] As used herein, the term "treatment" or "treating" refers to an intervention (e.g., administration of an agent to a subject) that cures, ameliorates, or reduces the symptoms of a disease or eliminates (or reduces the effects of) its cause(s) (e.g., increased levels of tight junction proteins). In this context, the term is used interchangeably with the term "therapy."

[0105] Additionally, the terms "treatment" or "treating" refer to an intervention (e.g., administration of an agent to a subject) that prevents or delays the onset or progression of a disease, or reduces (or eliminates) its incidence within a treated population. In this instance, the term treatment is used synonymously with the term "prevention."

[0106] In the context of the treatment defined above, the term subject (which shall be read to include "individual," "animal," "patient," or "mammal," where the context permits) defines a subject, particularly a mammalian subject, for whom treatment is required. Mammalian subjects include, but are not limited to, humans, farm animals, domestic animals, zoo animals, sport animals, pet animals such as dogs, cats, guinea pigs, rabbits, rats, mice, horses, camels, bison, cattle, and cows; primates such as apes, monkeys, orangutans, and chimpanzees; canines such as dogs and wolves; felines such as cats, lions, and tigers; equines such as horses, donkeys, and striped lions; food animals such as cows, pigs, and sheep; ungulates such as deer and giraffes; and rodents such as mice, rats, hamsters, and guinea pigs. In a preferred embodiment, the subject is a human. As used herein, the term "equine" refers to mammals of the family Equidae, including horses, donkeys, asses, guinea pigs, and zebras.

[0107] "Implant" or "medical implant" refers to a device configured to be implanted in a subject's body, particularly a body cavity, particularly a device configured to be implanted in the heart, for example, partially or completely within the left atrial appendage. The implant may be for occluding a body cavity, for treatment or sensing, or both. If the implant is an occlusion device, it is configured to be activated / positioned to at least partially or completely fluidly occlude a body cavity. The implant is typically removably connected to an implant delivery shaft / catheter that delivers the implant to a target site, typically remains attached during the occlusion, sensing, and / or energy delivery procedure, and in one embodiment, is generally detached after the energy delivery procedure, leaving the occlusion device implanted in the body cavity. The implant generally includes a central proximal connection hub (also referred to herein as a "proximal fixation hub" and an "implantation conduit") for attachment to a delivery catheter and a radially expandable body. The occlusion can be a complete blockage (closure) or a partial blockage (narrowing or near-complete occlusion of the body cavity). The implant typically comprises a body expandable from a contracted delivery configuration to an expanded deployment configuration. The body can take many forms, e.g., a wire frame structure formed from a braided or mesh material (e.g., a mesh basket). Examples of expandable wire frame structures suitable for transluminal delivery are known in the literature and are described, for example, in U.S. Patent Nos. 6,213,259; 6,213,259; 6,213,259; 6,213,259; 6,213,259; 6,213,259; and 6,213,259. Other body forms suitable for use with the present invention include dish- or saucer-shaped scaffolds or stents. In one embodiment, the body is formed from a metal, e.g., a shape-memory metal such as nitinol. The body can have any shape suitable for the purposes of the present invention, e.g., a cylindrical, disc-shaped, or spherical shape. In a preferred embodiment, the device comprises a cylindrical body, e.g., a cylindrical basket body. In one embodiment, the body comprises a tissue-energizing module. In one embodiment, the ablation device includes an electrode array, typically a circumferential electrode array, hi one embodiment, the electrode array is configured to deliver pulsed field ablation to tissue.In one embodiment, the distal surface of the radially expandable body includes a covering configured to promote epithelial cell growth. In an embodiment, the electrodes are coupled to a mesh cage. In an embodiment, the electrodes are coupled to a covering. In an embodiment, the electrodes are coupled to the mesh cage, with at least a portion of each electrode being covered by the covering. In one embodiment, the body includes a graduated radial force stiffness profile from the distal to the proximal device. In one embodiment, the body includes a metal mesh cage scaffold. In one embodiment, the connection (e.g., a joint hub) between the body and the catheter member is located distally on the side of the body facing the left atrium. In one embodiment, the body in the deployed configuration has a radial diameter at the deployment point that is at least 10% larger than the radial diameter of the left atrial appendage. In one embodiment, the distal-most portion is configured to atraumatically protect cardiac tissue. In one embodiment, the body includes a braided mesh scaffold that promotes collagen infiltration to thermal energy delivery to promote increased antimigration resistance.

[0108] "Body cavity" means a cavity within the body, and may be an elongated cavity such as a vessel within the body (i.e., artery, vein, lymphatic vessel, urethra, ureter, sinus, Eustachian tube, nasal cavity, bronchi) or an annular space within the heart, such as the left atrial appendage, left ventricular outflow tract, aortic valve, mitral valve, mitral valve duct, or heart valve or valve orifice.

[0109] "Transluminal delivery" refers to delivery of an implant to a target site (e.g., the heart) via a body cavity, such as delivery via an artery or vein. In one embodiment, a device of the present invention is advanced through an artery or vein to deliver the occlusion device to the left atrium of the heart and at least partially within the LAA. In one embodiment, the device is delivered such that the distal portion is positioned within the LAA and the proximal portion is positioned in the left atrium just outside the LAA. In one embodiment, the device is delivered such that the distal portion is positioned within the LAA and the proximal portion is positioned in the left atrium abutting the ostium of the LAA. In one embodiment, the device is delivered such that both the distal and proximal portions are positioned within the LAA.

[0110] By "anchor" is meant a device that can be adjusted between a delivery configuration for percutaneous delivery to a target location and a deployed configuration in which the device secures the implant to the target location, e.g., the wall of a body cavity. In one embodiment, the anchor comprises anchoring arms and, preferably, an array of anchoring arms that can be deployed to secure the implant within a body cavity. The anchoring arms may be made of a shape-memory material such as Nitinol. The anchoring arms are generally adjustable (e.g., pivotally adjustable about their proximal ends) from a pre-deployed axial position (the anchoring arms are generally bunched along or proximal to the longitudinal axis of the device) to an outwardly spread configuration. When fully deployed, the distal ends of at least some of the anchoring arms generally extend through openings in the radially expandable body and engage tissue. The anchoring arms are generally biased to the outwardly spread configuration and deployed by releasing a restraining member, such as a deployment catheter. This is also referred to herein as self-deployment. In some of the embodiments described herein, the anchoring arms are attached to the proximal hub of the implant. The fixation module may include a fixation hub. The fixation module's proximal connection hub and hub may be configured to abut to prevent further axial movement of the fixation device distally relative to the implant. The fixation module may include at least two, three, four, five, or six fixation arms. In embodiments, one or more of the fixation arms include a tissue treatment element, such as a tissue ablation electrode. The fixation arms, particularly the tips of the fixation arms, may include a radiopaque material. This aids in determining placement and contact. The fixation device may include a sensor, for example, a sensor of a blood parameter (e.g., pressure), for example, a left atrial pressure sensor.

[0111] "Cover": Typically, the graft has a proximal cover that is impermeable to blood and may include a reclosable opening, e.g., a lid of overlapping material. The reclosable opening may be configured to allow proximal movement of the graft delivery shaft or fastener delivery shaft therethrough while preventing blood flow through the opening. The graft may include a connection hub distal to the cover and configured to mate with the distal end of the graft delivery shaft. The cover may be configured to function as a scaffold for bio-endothelialization, and may be configured to become impermeable to blood as a result of bio-epithelialization. The cover may be formed from a woven mesh material.

[0112] "Covering / covering configured to function as a scaffold for biological endothelialization" means that the material used promotes epithelialization of the distal or proximal body. In one embodiment, the covering is a membrane containing an agent that promotes epithelial cell growth. Examples include growth factors such as fibroblast growth factor, transforming growth factor, epidermal growth factor, and platelet-derived growth factor, cells such as endothelial cells or endothelial progenitor cells, and biological materials such as tissue or tissue components. Examples of tissue components include endothelial tissue, extracellular matrix, submucosal, dura, pericardium, endocardium, serosa, peritoneum, and basement membrane tissue. In one embodiment, the covering is porous. In one embodiment, the covering is a biocompatible scaffold formed from a biomaterial. In one embodiment, the covering is a porous scaffold formed from a biomaterial such as collagen. In one embodiment, the covering is a lyophilized scaffold.

[0113] The implant or fixation device used in the system of the present invention may include a tissue energization module. As used herein, "tissue energization module" refers to an array of tissue treatment elements configured to treat tissue, for example, by applying heat, cooling, sound, light, microwave energy, or RF energy. The elements can be electrodes. The electrodes disposed on the implant can be configured for electrical coupling with an electrical controller. The electrodes are generally individually coupled to the controller to enable electrode-specific energization of the electrodes. The array of electrodes is generally disposed on the implant in a circumferential arrangement and configured to contact the wall of the body cavity in a circumferential pattern when the device is deployed. The electrodes are configured to deliver energy, typically PFA, circumferentially around the wall of the body cavity. The electrodes can also function as sensors to detect electrical parameters, such as electrical impedance or electrical activity (voltage), of tissue in the wall of the body cavity. The electrodes can be configured to measure electrical parameters radially across the wall of the body cavity or circumferentially along a peripheral portion of the wall of the body cavity. Generally, when measuring electrical parameters such as electrical impedance radially across a wall of a body cavity, electrodes in an electrode array and an earth or ground pad placed on the patient's body, often the leg, are used. When measuring electrical parameters such as electrical impedance circumferentially along a portion of the body cavity, two electrodes are used, with one electrode functioning as the current-carrying electrode and the other electrode functioning as the sensing electrode. Electrical parameters such as electrical impedance can be measured at one frequency or over a range of frequencies. The implant may include a battery, and the tissue current-carrying module may be electrically coupled to the battery to power the electrodes. The implant may include a wireless communication module (Bluetooth or RF-based) for transmitting / receiving data to / from a remote source, such as an electrical controller, computer, or mobile communication device. The implant may include a power source configured for wireless inductive charging.

[0114] The system of the present invention can be used to prevent, treat, or diagnose cardiac conditions such as atrial fibrillation. The present invention can also relate to a method for preventing, treating, or diagnosing atrial fibrillation. "Atrial fibrillation" or "AF" is a common cardiac rhythm disorder that affects an estimated 6 million patients in the United States alone. AF is the second leading cause of stroke in the United States and may account for approximately one-third of strokes in elderly patients. In over 90% of cases in which a blood clot (thrombus) is present in an AF patient, the clot occurs in the left atrial appendage (LAA) of the heart. The irregular heartbeat of AF causes blood to pool in the left atrial appendage, and clotting can occur when blood pools, resulting in the formation of a clot or thrombus in the LAA. These clots can migrate from the left atrial appendage and enter the cranial circulation, causing a stroke; the coronary circulation, causing a myocardial infarction; the peripheral circulation, causing limb ischemia; and other vascular beds. The term includes all forms of atrial fibrillation, including paroxysmal (intermittent) AF and persistent, long-standing persistent AF (PLPAF).

[0115] The systems of the present invention can be used to prevent, treat, or diagnose cardiac conditions, such as ischemic events. The present invention also relates to methods for preventing, treating, or diagnosing ischemic events. An "ischemic event" refers to a restriction in blood supply to an organ or tissue of the body, resulting in an inadequate supply of oxygen or glucose to the affected organ or tissue. The term includes stroke, an obstruction in blood supply to a portion of the brain caused by a blood clot blocking the blood supply to the brain and resulting damage to the affected area of ​​the brain, and transient ischemic events (TIAs), also known as "minor strokes," which are similar to strokes but are transient in nature and generally do not cause lasting damage to the brain. When the restriction in blood supply occurs in a coronary artery, the ischemic event is known as a myocardial infarction (MI) or heart attack.

[0116] The implant and / or the fixation device may be self-deployable. The radially expandable body may be self-deployable. At least one of the fixation arms may be self-deployable. The implant may include a shape memory material. At least one of the fixation arms may be self-deployable.

[0117] Example The present invention will now be described with reference to specific examples. These examples are merely exemplary and are for illustrative purposes only. They are not intended to limit in any way the scope of the claimed exclusive rights or the invention described. These examples constitute the best mode presently contemplated for carrying out the invention.

[0118] 1-15, a medical implantation system in accordance with the present invention is illustrated, generally designated by the reference numeral 1, for delivering and securing a medical implant within a body cavity during assembly and use of the system. System 1 includes an access sheath 2 having a lumen 3 extending along the entire length of the sheath, an implant system including an implant delivery shaft 4 having a lumen 5 extending along the entire length of the shaft, an implant 6 removably attached to the distal end of shaft 4, a fastener delivery shaft 7, and a fastener system removably attached to the distal end of fastener delivery shaft 7. The system also includes a handle 9, and a first hemostatic valve 10 for the implant delivery shaft and a distal coupling conduit 11.

[0119] Figures 1-3 show the graft system pre-loaded with the fastener system prior to advancement through the access sheath 2. Figures 4-6 show the graft delivery system fully advanced through the access sheath 2 and a second hemostatic valve 12 for the access sheath disposed distally of the first hemostatic valve 10. The first hemostatic valve 10 is coupled to the distal end 14 of the handle 9, and the second hemostatic valve 12 is coupled to the distal connection conduit 11 of the first hemostatic valve 10. Referring to Figure 6, the graft 6 is shown advanced distally of the distal end 13 of the access sheath 2 and radially self-deployed in a radially expanded configuration. At this point, the majority of the fastener 8 is disposed within the graft delivery shaft 4. The fastener delivery shaft 7 extends from the fastener 8 through the graft delivery shaft 4 and handle 9, resulting in a proximal portion 15 having a fastener shaft hub 16. A third hemostatic valve 17 for the fixator delivery shaft 7 is attached to the distal end of the handle 9 .

[0120] More specifically, the handle comprises a body 20 having a longitudinal axis 21 and a central bore 22 formed along the axis 21, and an axial actuator having a sleeve 23 rotatably mounted in a recessed distal portion 24 of the body 20 for rotation about the longitudinal axis 21 of the handle 9. The axial actuator also comprises an actuator arm 26 having a shaft 27 with a central shaft bore 25 mounted within the central bore 22, and a translation mechanism configured to translate rotational movement of the sleeve 23 into axial movement of the actuator arm 26. The actuator arm 26 has a proximal portion 28 including a rotational actuator 29 removably coupled (e.g., threadedly engaged) to a proximal end 30 of the shaft 27, and the distal end of the graft delivery sheath is attached to the rotational actuator 29 via a third hemostatic valve 17.

[0121] Although not shown, shaft 27 has a square cross-section, and bore 22 in the body has a secondary cross-section that prevents rotational movement of the shaft within the bore while allowing axial movement of the shaft along the bore. The rotation-to-axial translation mechanism includes a slot (not shown) in concave distal portion 24 of the body, a helical groove 32 on the inner wall of sleeve 23, and a driven pin (not shown) attached to shaft 27 that extends through the slot and engages with helical groove 32. Thus, when sleeve 23 rotates about handle axis 21, this rotational motion is translated into axial movement of shaft 27 (and actuator arm 26), resulting in axial movement of implant delivery shaft 4 relative to access sheath 2. By providing an axial actuator for implant deployment in the handle in the form of a rotatable sleeve forming part of the handle's exterior surface, the surgeon can controllably deploy and retract the implant with great precision, as shown in FIGS. 1-4. In Figure 1, the system is shown prior to deployment of the implant 6, with the actuator arm 26 positioned proximally relative to the handle body, and in Figure 4, after the implant has been deployed, the actuator arm is shown advanced distally through the handle body. The axial position of the handle's proximal portion 28 (comparing the positions in Figures 1 and 4) provides the surgeon with a visual cue as to the extent of implant deployment during the procedure.

[0122] 17 and 18, a fixation system includes an elongated fixation shaft 7 having a proximal end 15 with a proximal fixation shaft hub 16, and a fixation device 8 including a proximal fixation hub 35 and eight fixation arms 36 extending distally from hub 35. The distal end of fixation device shaft 7 is externally threaded, and proximal fixation shaft hub 16 includes corresponding internal threads to allow the shaft and fixation device to be separated in vivo by rotation of the fixation device delivery shaft relative to the deployed fixation device. In the figures, the arms are shown in their deployed, outwardly splayed configuration. The fixation device is formed with the arms biased to the deployed configuration such that they self-deploy when advanced beyond the constraints of the implant delivery shaft.

[0123] 19, the implant 6 in this embodiment comprises a nitinol mesh cage 40 having a concave hub 42, sidewalls 43, and a concave proximal end 41 with an open proximal end. Although not shown, the proximal end of the mesh cage is covered with a blood-impermeable cover to make the case blood-tight, which is necessary if the implant is an occlusive implant. The interior surface of the concave hub 42 is threaded, and the distal end of the implant delivery shaft is externally threaded to allow the implant and implant delivery shaft to be separated in vivo.

[0124] Figures 7-9 show the inventive system 1 for the fastener system during deployment. The fastener delivery shaft 7 is advanced through the implant delivery shaft 4 from the position shown in Figure 6 to the fully advanced position shown in Figure 9. This is accomplished by pushing the proximal fastener shaft hub 16 distally from the position shown in Figure 4 to the position shown in Figure 7. At this position, the proximal fastener hub 35 nests and abuts the implant's recessed hub 41, thereby limiting further distal movement of the fastener relative to the implant. Proximal movement of the fastener is limited by the fastener arms engaging the tissue of the body cavity and the fastener barb configuration at the tip of the proximally moved fastener arms. The fastener arms 36 are shown in their constrained delivery configuration; however, as soon as the arms advance through the implant's proximal hub, they self-deploy and engage the tissue of the body cavity through gaps in the mesh cage 40 (as shown in Figures 10-12).

[0125] 9, the system is shown after fastener delivery shaft 7 has been removed from proximal fastener hub 35. This is accomplished by loosening third hemostatic valve 17, grasping proximal fastener shaft hub 16, rotating hub 16 counterclockwise to disengage the fastener delivery shaft from the deployed fastener, and then pulling proximal fastener hub 35 proximally to retract the fastener delivery shaft 7 into graft delivery shaft 4.

[0126] 10-12 and 20, the system is shown in a state during which the graft 6 and graft delivery shaft 4 are being separated. This is accomplished by disengaging the rotary actuator 29 from the proximal end 30 of the shaft 27 (thereby disengaging the rotary actuator 29 from the axial actuator arm) and rotating the rotary actuator 29 counterclockwise. When the graft delivery shaft 4 is attached to the rotary actuator 29 via the third hemostatic valve 17, this results in rotation of the graft delivery shaft and separation of the graft delivery shaft from the secured graft. Once separated, the graft delivery shaft 4 is retracted within the access sheath.

[0127] 16A-16E are schematic diagrams illustrating the implantation of an occlusion graft 6 and fixation device 8 into the left atrial appendage (LAA) 50 of a human heart using the system of the present invention, and in particular, show how the graft and fixation device are sequentially deployed before retracting the fixation device and graft delivery shafts, which keep the graft fixed in the LAA.

[0128] 16A shows the access sheath 2 positioned at the opening 51 of the left atrial appendage (LAA), with the graft 6 (in its contained delivery configuration) and graft delivery shaft 4 positioned within the access sheath 2, the undeployed graft positioned just proximal to the distal end 13 of the access sheath 2, and the fixator 8 and fixator delivery shaft 7 positioned within the graft delivery sheath 4 with the distal tips of the fixation arms positioned just distal to the proximal hub of the graft. The distal end 13 of the sheath 2 includes a radiopaque marker band 52 that is visible on imaging and can be used to properly position the sheath 2.

[0129] FIG. 16B illustrates the deployment of the implant 6 by advancing the implant delivery shaft 4 proximally approximately 20 mm until the implant is exposed distally of the access sheath and radially deployed to circumferentially engage the ostium of the LAA. As previously described, this is accomplished by the surgeon carefully rotating the actuator sleeve 23. The recessed hub 42 also includes a radiopaque marker band (not shown) that is visible on imaging and can be used to properly position the implant 6 relative to the sheath 2 and ensure that the implant is fully deployed. At this stage, the fixator 8 is retracted within the implant delivery shaft 4 with the distal tips of the fixation arms 36 protruding through the proximal hub of the implant (as shown in FIG. 21).

[0130] 16C illustrates deployment of the fixator 8 by advancing the fixator delivery shaft 7 distally (as previously described) approximately 10 mm until the fixator proximal hub 35 abuts and nests within the proximal hub 42 of the implant 6, and the fixation arms 36 are positioned within the implant 6 and spread outward to engage the LAA wall 53 through openings in the implant wall to secure the implant in place. At this stage, the implant is secured to the LAA wall 53, the implant is attached to the implant delivery catheter, and the fixator is attached to the fixator delivery catheter. Complete fixation can be confirmed by pulling proximally on the proximal fixator shaft hub 16 to ensure the fixator does not move.

[0131] 16D shows the fastener delivery shaft 7 disengaged from the proximal fastener hub 35. As previously described, this is done by loosening the third hemostatic valve 17 and rotating the fastener delivery shaft 7 counterclockwise until it is clear of the fastener 8. The fastener 8 is then retracted inside the graft delivery shaft 4 by pulling the fastener delivery shaft 7 proximally with the proximal fastener hub 35.

[0132] 16E shows the implant delivery shaft detached from the proximal hub 42 of the implant 6 and retracted within the access sheath 2. Once this is complete, the access sheath can be retracted percutaneously.

[0133] Figures 22-33 illustrate the assembly and use of the medical implant system (1) of the present invention.

[0134] The first step (FIG. 22) involves providing an access sheath 2 with a first hemostatic valve 10 attached to the proximal end of the access sheath and advancing a dilator 54 through the lumen 3 of the access sheath 2. FIG. 23 shows the proximal end of the hemostatic valve clip arm, showing the proximal end of the dilator.

[0135] In a second step (FIG. 24), the pre-assembled access sheath / dilator is inserted into the femoral vein 57 via a conventional introducer 58 and advanced over a guidewire 59 until the distal end 13 of the access sheath 2 is positioned at the target location (in this case, the left atrium of the heart 60). A first hemostatic valve 10 prevents bleeding through the access sheath 2. FIG. 25 shows the access sheath and dilator being passed over the guidewire along the femoral artery and into the left atrium 60.

[0136] Once the access sheath 2 is positioned in the left atrium 60, the dilator 54 can be removed. At this stage, the handle 9, graft system, and fixator system are assembled. FIG. 26 shows the handle 9, graft system (graft 6 and graft delivery shaft 4), and pre-assembly of the loading tool, including the second hemostatic valve 12 and hemostatic valve clip arm 61. Upon assembly, the third hemostatic valve 17 at the proximal end of the handle 9 opens, and the fixator system (fixator 8 and fixator delivery shaft 7) is advanced through the third hemostatic valve 17 and the graft delivery shaft 4 ( FIG. 27 ) to a position where the fixator 8 is just proximal to the proximal hub 42 of the graft 6.

[0137] Figure 28 shows the second hemostatic valve 12 attached to the first hemostatic valve 10 while the access sheath 2 is positioned within the vasculature. Figure 29 shows the second hemostatic valve 12 rotated counterclockwise to allow the graft system and fixator system to be advanced through the second hemostatic valve and along the sheath 2. Figure 30 shows the second hemostatic valve 12 coupled to the handle 9 after the graft system and fixator system have been advanced through the access sheath 2 to a position where the graft will be positioned just proximal to the distal end of the access sheath.

[0138] Figure 31 shows the graft 6 positioned just proximal to the distal end 13 of the access sheath 2. Figure 32 shows the handle 9 and graft system (and fixation system) being advanced through the access sheath. Figure 33 shows the use of the actuator sleeve 23 to deploy the graft 6 from the distal end 13 of the access sheath 2.

[0139] FIG. 34 illustrates an implant for use in a system according to one embodiment of the present invention, where parts previously described with reference to the previous embodiment are labeled with the same reference numerals. The implant 6 is shown assembled in FIGS. 34A and 34C, and the implant's components are shown in an exploded configuration in FIG. 34B. The cover 65 has an open distal end 67, a closed proximal end 68, and a sidewall 69. The proximal end 68 has a recess 70 and a hub portion 71 that proximally projects from the recess. The proximal end 68 of the cover is dimensioned to closely abut the proximal end 41 of the mesh cage 40. The electrode array 66 includes eight electrodes 72, each connected to a central electrode hub 73 by a conductor 74. To assemble the implant, the electrode array 66 is attached to the exterior surface of the mesh cage 40, and then the cover 65 is attached over the electrode array such that the electrodes 72 are positioned between the mesh cage and the cover, as shown in the cross-sectional view of the implant in FIG. 34C.

[0140] 35A-35C illustrate a further embodiment of the system of the present invention, in which parts described with reference to the previous embodiment are assigned the same reference numerals. In this embodiment, the system, generally designated by reference numeral 80, includes an implant 6 with a proximal hub 42 (implantation conduit) having an internally threaded proximal end 81, a distal end 82, and an internal annular shoulder 83 disposed between the distal and proximal ends. The shoulder provides a platform against which the proximal fixator hub 35 rests when the fixator hub 35 is nested within the implant's proximal hub 42. The implant includes a mesh cage 40 having a proximal face 41 with an annular recess 85 surrounding the proximal hub 42. As shown in FIG. 35B, the distal end 82 of the proximal hub 42 extends distally of the annular recess 85. This ensures that the self-deploying fixation arms 36 are biased away from the struts of the mesh cage 40 as they advance through the hub 32 and pivot radially outward.

[0141] In one aspect of the invention, the fastener system is not preloaded into the handle and implant delivery shaft and can be advanced through the handle and implant delivery shaft after the implant is deployed but before the implant and implant delivery shaft are separated. In these embodiments, the method typically includes advancing the handle to advance the implant delivery system (without the fastener system preloaded) through the access sheath. In these embodiments, the method includes treating tissue (or sensing a tissue parameter) in the body cavity after the implant is deployed but before advancement and deployment of the fastener system. For example, the treatment step can include ablating the body cavity tissue using a tissue-energizing module, such as an electrode. The tissue-energizing module (or sensor) can be attached to the implant or separate from the implant and advanced through the implant delivery sheath and deployed to the target location. The treatment can include several treatment steps in which the implant is fully or partially retracted after a first treatment step, then repositioned (e.g., using the handle) and a second treatment step is performed.

[0142] Reference number Medical Transplant System 1 Access sheath 2 Access sheath lumen 3 Graft delivery shaft 4 Graft Delivery Shaft Lumen 5 graft 6 Fixture delivery shaft 7 Fixtures 8 Handle 9 First (access sheath) hemostatic valve 10 Distal connecting conduit 11 Second (graft delivery shaft) hemostatic valve 12 Distal Access Sheath 13 Distal end of handle 14 Proximal portion (of fixator delivery shaft) 15 Fixture Shaft Hub 16 Third (fixator delivery shaft) hemostatic valve 17 (Handle) Body 20 Vertical axis (of the handle) 21 (Handle) Center hole 22 Actuator sleeve 23 Implanted distal part (of the body) 24 Central hole (of shaft) 25 Actuator Arm 26 Shaft (of actuator arm) 27 Proximal portion (of actuator arm) 28 Rotary Actuator 29 Proximal end (of shaft) 30 Spiral groove 32 Fixator Proximal Hub 35 Fixed arm 36 Mesh cage 40 Proximal end (of mesh cage) 41 Recessed hub (mesh cage) 42 Sidewall (of mesh cage) 43 Ostium of left atrial appendage 51 Marker band 52 Left atrial appendage wall 53 Dilator 54 Clip arm of first hemostatic valve 55 Proximal end of dilator 56 femoral vein 57 introducer 58 Guidewire 59 left atrium 60 Clip arm of second hemostatic valve 61 Graduated sleeve 62 Center mark 63 Scale mark body 64 Cover 65 Electrode array 66 Open distal end 67 Closed proximal end of cover 68 Cover sidewall 69 Recessed proximal portion of cover 70 Hub part of cover 71 electrode 72 Electrode Hub 73 Conductor 74 System 80 Proximal end of internal thread (proximal hub) 81 Distal end of proximal hub 82 Inner annular shoulder (hub) 83 Annular recess (graft) 85

[0143] equivalent The foregoing description details presently preferred embodiments of the present invention. Numerous modifications and variations in practice will occur to those skilled in the art in light of these descriptions. These modifications and variations are intended to be encompassed within the scope of the claims appended hereto.

Claims

1. A medical implant system (1), comprising: an access sheath (2) having a lumen (3); an implant system disposed within the lumen (3) of the access sheath (2) and axially adjustable relative to the lumen (3) of the access sheath (2), the implant system comprising an implant (6) radially adjustable from a contracted delivery configuration to a radially expanded deployed configuration, the implant system being removably coupled to an implant delivery shaft (4) having a lumen (5); a fixation system mounted within the lumen (5) of the implant delivery shaft (4) and axially adjustable relative to the lumen (5), the fixation system comprising a fixation device (8) removably coupled to the fixation device delivery shaft (7), the fixation device being radially adjustable from a contracted delivery configuration to a radially expanded implant fixation configuration; a handle (9) configured to be operatively coupled to the implant delivery shaft (4) and the access sheath (2), the handle comprising an axial actuator for adjusting the axial position of the implant delivery shaft (4) relative to the access sheath (2) to deploy and / or recapture the implant (6), the axial actuator comprising an external actuator sleeve (23) rotatably mounted on a body (20) of the handle (9) for rotation about a longitudinal axis (21) of the handle (9), the external actuator sleeve (23) forming a portion of an outer surface of the handle (9); A medical implantation system comprising:

2. 2. The medical implant system of claim 1, wherein the handle (9) is configured to rotate the implant delivery shaft (4) relative to the body (20) of the handle (9) to remove the implant delivery shaft (4) from the deployed implant (6).

3. The body (20) of the handle (9) includes a central bore (22) disposed along the longitudinal axis (21) of the handle (9), and the axial actuator for the implant delivery shaft (4) comprises: an actuator arm (26) disposed in the central bore (22) and configured for axial and non-rotational movement relative to the central bore; a translation mechanism configured to translate rotational movement of the outer actuator sleeve (23) into axial movement of the actuator arm (26); 3. The medical implant system of claim 1, wherein the implant delivery shaft (4) is attached to the actuator arm (26) for axial movement therewith.

4. The conversion mechanism is an axial groove formed in the side wall of the body (20); a spiral groove (32) formed on the inner wall of the axial actuator; a radial pin coupled to the actuator arm (26) that extends radially outward through the axial groove and cooperates with the helical groove (32); Equipped with 4. The medical implant system of claim 3, wherein rotational movement of the axial actuator relative to the body (20) causes axial translational movement of the actuator arm (26) and the implant delivery shaft (4) relative to the access sheath (2).

5. The actuator arm (26) a shaft (27) configured to move axially along the central bore (22) of the body (20), the shaft (27) including a central bore (25) for receiving the implant delivery shaft (4); a proximal portion (28) including a rotary actuator (29) removably attached to said shaft (27); Equipped with 5. The medical implant system of claim 3 or 4, wherein the implant delivery shaft (4) is attached to a rotary actuator (29), whereby the rotary actuator (29) can be detached from the shaft (27) and rotated about the longitudinal axis (21) to rotate the implant delivery shaft (4) without rotating the shaft (27) of the actuator arm (26).

6. The medical implant system of claim 5, wherein the rotary actuator (29) is located proximal to the body (20).

7. 7. The medical implant system of claim 5 or 6, wherein the rotary actuator (29) comprises a cylindrical hub having an internally threaded surface, and the proximal end of the shaft (27) comprises an externally threaded connection configured to engage with the internally threaded surface of the cylindrical hub.

8. 8. The medical implant system of any one of claims 3 to 7, wherein the outer actuator sleeve (23) is rotatably coupled to the distal end (14) of the body (20) of the handle (9).

9. 9. The medical implant system of claim 8, wherein the distal portion of the body (20) has a waisted portion, and the actuator sleeve (23) is rotatably mounted in the waisted portion.

10. 10. The medical implant system of any one of claims 1 to 9, wherein the fastener delivery shaft (7) extends through the handle (9) and has a proximal portion (15) including a fastener shaft hub (16) extending proximally from the proximal end of the handle (9).

11. 11. The medical implant system of claim 1, comprising a first hemostatic valve (10) for the access sheath (2), a second hemostatic valve (12) for the graft delivery shaft (4), and a third hemostatic valve (17) for the fixation device delivery shaft (7).

12. 12. The medical implant system of claim 11, wherein the third hemostatic valve is coupled to a proximal end of the handle, and optionally, the third hemostatic valve is coupled to the rotary actuator (29) of the actuator arm (26).

13. 13. The medical implant system of claim 11 or 12, wherein the access sheath (2) is configured to be indirectly coupled to the distal end (14) of the handle (9) by coupling the access sheath (2) to the first hemostatic valve (10), coupling the first hemostatic valve (10) to the second hemostatic valve (12), and coupling the second hemostatic valve (12) to the distal end (14) of the handle (9).

14. 14. The medical implant system of any one of claims 1 to 13, wherein the working length of the implant delivery shaft (4) and the working length of the access sheath (2) are configured such that when assembling an implant module within the lumen (3) of the access sheath (2), the implant is positioned no more than 50 mm proximal to the distal end of the access sheath before deploying the axial actuator of the handle.

15. The implant (6) includes a mesh cage (40) with a proximal hub (42) configured to be removably attached to the distal end of the implant delivery shaft (4); The fastener (8) comprises a proximal fastener hub (35) and a plurality of fastener arms (36) extending distally from the distal fastener hub prior to deployment; 15. The medical implant system of claim 1, wherein the fixation arms (36) are configured to self-deploy to contact a wall outside the body cavity when the fixation arms advance distally beyond the proximal hub (42) of the implant (6).

16. A medical implant system (1), comprising: an access sheath (2) having a lumen (3); an implant system including an implant (6) disposed within the lumen (3) of the access sheath (2), axially adjustable relative to the lumen (3) of the access sheath (2), and radially adjustable from a contracted delivery configuration to a radially expanded deployed configuration, the implant (6) being removably coupled to an implant delivery shaft (4) having a lumen (5); a fixation system mounted within the lumen (5) of the implant delivery shaft (4) and axially adjustable relative to the lumen (5), the fixation system comprising a fixation device (8) removably coupled to the fixation device delivery shaft (7), the fixation device being radially adjustable from a contracted delivery configuration to a radially expanded implant fixation configuration; a handle (9) configured to be operably coupled to the implant delivery shaft (4) and the access sheath (2), the handle comprising an axial actuator for adjusting the axial position of the implant delivery shaft (4) relative to the access sheath (2) to deploy and / or recapture the implant (6); Equipped with The fastener delivery shaft (7) extends through the handle (9) and has a proximal end (15) including a fastener shaft hub (16) extending proximally from the proximal end of the handle (9).

17. A medical implant system (1), comprising: an access sheath (2) having a lumen (3); an implant system including an implant (6) disposed within the lumen (3) of the access sheath (2), axially adjustable relative to the lumen (3) of the access sheath (2), and radially adjustable from a contracted delivery configuration to a radially expanded deployed configuration, the implant (6) being removably coupled to an implant delivery shaft (4) having a lumen (5); a fixation device system including a fixation device (8) that is radially adjustable from a contracted delivery configuration to a radially expanded implant fixation configuration; a handle (9) configured to be operably coupled to the implant delivery shaft (4) and the access sheath (2), the handle comprising an axial actuator for adjusting the axial position of the implant delivery shaft (4) relative to the access sheath (2) to deploy and / or recapture the implant (6); Equipped with The medical implant system, wherein the fastener is coupled to the implant (6) for delivery therewith.

18. A medical implant system (1), comprising: an access sheath (2) having a lumen (3); an implant system including an implant (6) disposed within the lumen (3) of the access sheath (2), axially adjustable relative to the lumen (3) of the access sheath (2), and radially adjustable from a contracted delivery configuration to a radially expanded deployed configuration, the implant (6) being removably coupled to an implant delivery shaft (4) having a lumen (5); a graft fixation system mounted within the lumen (5) of the graft delivery shaft (4) and axially adjustable relative to the lumen (5), the graft fixation system comprising a fixator (8) removably coupled to the fixator delivery shaft (7), the fixator (8) being radially adjustable from a contracted delivery configuration to a radially expanded graft fixation configuration; a handle (9) configured to be operably coupled to the implant delivery shaft (4) and the access sheath (2), the handle comprising an axial actuator for adjusting the axial position of the implant delivery shaft (4) relative to the access sheath (2) to deploy and / or recapture the implant (6); Equipped with 1. A medical implant system, comprising: the implant including a proximal hub configured to removably attach to a distal end of the implant delivery shaft; the fastener including a proximal fastener hub and a plurality of fastener arms extending distally from the proximal fastener hub; the proximal fastener hub configured to abut the implant proximal hub when the fastener arms are fully deployed to limit any further distal movement of the implant fastener system.

19. 20. The medical implant system of claim 18, wherein the proximal anchor hub of the anchor comprises a sensor.

20. 20. The medical implant system of claim 19, wherein, in use, the sensor is configured to sense a left atrial parameter when the implant is deployed in a left atrial appendage and the proximal anchor hub of the anchor abuts the proximal hub of the deployed implant.

21. A medical implant system (1), comprising: an access sheath (2) having a lumen (3); an implant system including an implant (6) disposed within the lumen (3) of the access sheath (2), axially adjustable relative to the lumen (3) of the access sheath (2), and radially adjustable from a contracted delivery configuration to a radially expanded deployed configuration, the implant (6) being removably coupled to an implant delivery shaft (4) having a lumen (5); a graft fixation system mounted within the lumen (5) of the graft delivery shaft (4) and axially adjustable relative to the lumen (5), the graft fixation system comprising a fixator (8) removably coupled to the fixator delivery shaft (7), the fixator (8) being radially adjustable from a contracted delivery configuration to a radially expanded graft fixation configuration; a handle (9) configured to be operably coupled to the implant delivery shaft (4) and the access sheath (2), the handle comprising an axial actuator for adjusting the axial position of the implant delivery shaft (4) relative to the access sheath (2) to deploy and / or recapture the implant (6); Equipped with The implant delivery shaft comprises a power supply lead configured to deliver electrical energy from an external energy source to the implant.

22. 22. The medical implant system (a) of claim 21, wherein the implant comprises a mesh cage formed from an electrically conductive material electrically coupled to the power supply lead of the implant delivery shaft.

23. 22. The medical implant system (a) of claim 21, wherein the implant comprises a mesh cage with tissue-contacting electrodes electrically coupled to the power supply leads of the implant delivery shaft.

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