Prosthetic heart valve delivery systems and methods with integrated embolic filter

Abstract

Catheters and related methods for implanting a prosthetic heart valve employ an integrated deployable embolic filter. A catheter for implanting a prosthetic heart valve includes a deployment handle, a filter sheath, an outer sheath, an embolic filter, and a heart valve carriage assembly. The filter sheath extends through the outer sheath. The embolic filter is attached to the filter sheath. The heart valve carriage assembly is configured to carry the prosthetic heart valve in an unexpanded configuration. The deployment handle is operable to expand the prosthetic heart valve.

Description

PROSTHETIC HEART VALVE DELIVERY SYSTEMS AND METHODS WITH INTEGRATED EMBOLIC FILTERCROSS-REFERENCES TO RELATED APPLICATION|0001 | This application claims the benefit of priority to U.S. Provisional Application No. 63 / 661,997 filed June 20, 2024, the contents of which are incorporated herein by reference in their entirety.BACKGROUND

[0002] Transcatheter aortic valve replacement (TAVR) is a proven strategy for the treatment of severe aortic stenosis that has been validated for use in patients who are not eligible for surgical aortic valve replacement (SAVR) due to patient frailty or associated high operative risk. TAVR with the use of a self-expanding or balloon-expanded bioprosthetic valve has been FDA-approved for commercial use in the US in selected patients. TAVR is rapidly becoming the method of choice to treat aortic stenosis in patients deemed to be at increased risk of death if offered a traditional surgical aortic valve replacement. Patients presently selected for TAVR, however, are most often elderly with frailty and a number of comorbidities. The femoral artery is generally the first choice for access to the aortic valve. In patients with significant arterial occlusive disease, however, marked tortuosity of the ileo femoral system and / or significant at risk atheromatous plaque within the native aorta and / or aneurysmal disease may present significant risk for femoral access such that alternate access TAVR is preferable. An alternative route has been proposed several years ago in the form of a trans-apical (TA) approach through the apex of the left ventricle exposed through a left lateral thoracotomy. The TA approach, however, requires opening the left chest in patients having potential pulmonary dysfunction and the rate of bleeding complications may be higher than that observed after traditional trans-femoral (TF) approach. In the search for yet another alternative to compromised peripheral arterial vascular access, a direct trans-aortic (TAo) route has been described in a limited number of cases since 2010. In a recent report, the cases performed through a TAo route represented only 4% of the TAVR cases performed by 2013.

[0003] Although results have been encouraging with TAVR, the risk of stroke has been demonstrated to be significantly higher with TAVR relative to SAVR. Clinically observedstroke (CVA) underestimates the prevalence of embolic events inherent with TAVR. During TAVR, stent and implanted valve expansion (with or without the use of a balloon) results in native valve compression and radial leaflet displacement that leads to the liberation of tissue and particulate matter that travels distally in the arterial tree. Some of the debris lodges in terminal branches of cerebral vessels and will be evidenced with new onset stroke. Other debris released at the time of TAVR lodge in vessels of the peripheral circulation, renal circulation, coronary circulation, and mesenteric circulation. These patients may manifest clinical scenario of renal failure, mesenteric ischemia, peripheral ischemia, and / or myocardial infarction. Other patients may not have acute clinical deterioration but may suffer late effects due to impaired functional reserve related to sub-clinical embolic events. The occurrence of embolic events during TAVR is a significant impediment to offering the technique to larger lower risk groups of patients.

[0004] A number of different approaches have been developed for embolic protection. Existing embolic protection devices are primarily configured for deflecting embolic material from the brachiocephalic vessels or capturing embolic material within the brachiocephalic vessels. There are a number of difficulties with these existing embolic protection devices. First, deployment of the devices requires additional time and can conflict with the performance of the valve implantation procedure. Second, deployment of the devices may lead to additional vessel trauma and liberation of embolic material. Third, the deployment of the devices may be difficult, and stability of deployment may make protection less than dependable. Fourth, the devices may not protect the brain from all sources of blood flow and particularly posterior cerebral blood flow is not filtered. Fifth, systemic embolization may still occur that may lead to intestinal, renal, and / or peripheral manifestations of ischemic gut, renal insufficiency and / or peripheral ischemia. Sixth, coronary embolization and myocardial infarction may occur due to proximal embolization.BRIEF SUMMARY

[0005] The following presents a simplified summary of catheters and methods of the present disclosure in order to provide a basic understanding of the catheters and methods of the present disclosure. This summary is not an extensive overview of the catheters and methods of the present disclosure. It is not intended to identify key / critical elements of the catheters and methods of the present disclosure or to delineate the scope of the catheters and methods of the present disclosure. Its sole purpose is to present some catheters and methodsof the present disclosure in a simplified form as a prelude to the more detailed description that is presented later.

[0006] The transcatheter heart valve replacement (THVR) catheters and methods described herein employ an integrated deployable embolic filter. The THVR catheters and methods described herein are configured for use in heart valve replacement procedures. The THVR catheters and methods described herein are expected to produce substantial benefits in the way of substantially increased safety and efficacy of THVR. As a result, THVR may be performed on a substantially increased number of patients with improved outcomes and reduced recovery times. Specifically, there will be less embolic material conveyed within the circulation system, thereby lowering the incidence of clinical stroke, subclinical stroke, silent cerebral embolization, renal embolization, mesenteric embolization, and peripheral embolization and each of the associated clinical syndromes.

[0007] Thus, in one aspect, a catheter for implanting a prosthetic heart valve includes a deployment handle, a filter sheath, an outer sheath, an embolic filter, and a heart valve carriage assembly. The filter sheath is attached to the deployment handle and defines a filter sheath lumen. The outer sheath defines an outer sheath lumen through which the filter sheath extends. The outer sheath is slidable along the filter sheath. The embolic filter is attached to the filter sheath. The embolic filter is reconfigurable between a collapsed insertion configuration, a deployed configuration, and a collapsed captured configuration. In the deployed configuration, the embolic filter is configured to filter embolic material from blood flowing through the embolic filter. The heart valve carriage assembly is configured to carry the prosthetic heart valve in an unexpanded configuration. The deployment handle is operable to expand the prosthetic heart valve from the unexpanded configuration to an expanded configuration.

[0008] In the catheter, a combination of the heart valve carriage assembly and the prosthetic heart valve in the unexpanded configuration mounted to the heart valve carriage assembly can have a maximum outer diameter that is greater than a minimum diameter of the filter sheath lumen. The minimum diameter of the filter sheath lumen can be smaller since it does not need to accommodate passage of the heart valve carriage assembly and the prosthetic heart valve therethrough.

[0009] In the catheter, the heart valve carriage assembly can include a heart valve carriage shaft, and a heart valve carriage attached to and extending distally from the heart valvecarriage shaft. The heart valve carriage shaft can be coupled with the deployment handle and extends through the filter sheath lumen. The deployment handle can be operable to reposition the heart valve carriage relative to the filter sheath. The ability to reposition the heart valve carriage relative to the filter sheath accommodates repositioning of the prosthetic heart valve relative to the patient after deployment of the embolic filter and prior to expansion of the prosthetic heart valve.

[0010] The catheter can be configured for deployment of a self-expanding prosthetic heart valve. The catheter can include a nose cone shaft and a nose cone attached to a distal end of the nose cone shaft. The nose cone shaft can be coupled with the deployment handle and extend through a lumen defined by the heart valve carriage shaft. The deployment handle can be operable to reposition the nose cone relative to the heart valve carriage between a delivery configuration and a release configuration. In the delivery configuration, the nose cone can retain the prosthetic heart valve in the unexpanded configuration. In the release configuration, the nose cone can accommodate expansion of the prosthetic heart valve from the unexpanded configuration to the expanded configuration.

[0011] The catheter can be configured for deployment of a balloon expandable prosthetic heart valve. The heart valve assembly can include a deployment balloon that is expandable to expand the prosthetic heart valve.

[0012] In the catheter, the heart valve carriage assembly can have a filter holding configuration and a filter release configuration. The catheter can further include filter release pull wires. A distal end portion of the embolic filter can be restrained via engagement with the filter release pull wires and the heart valve carriage assembly. The filter release pull wires can be configured to be translated proximally relative to the heart valve carriage assembly to reconfigure the heart valve carriage assembly from the filter holding configuration to the filter release configuration to release the distal end portion of the embolic filter from engagement with the filter release pull wires and the heart valve carriage assembly to reconfigure the embolic filter to the deployed configuration. The heart valve carriage assembly can include filter release pull wire recesses. Each of the filter release pull wires can include a filter release pull wire distal end portion that is disposed within a corresponding one of the filter release pull wire recesses when the heart valve carriage assembly is in the filter holding configuration. Each filter release pull wire distal end portion can be configured to be pulled out of the corresponding one of the filter release pull wire recesses to reconfigure theheart valve carriage assembly from the filter holding configuration to the filter release configuration. The filter release pull wires can be coupled with the outer sheath. The outer sheath can be configured to be translated proximally relative to the filter sheath to pull the filter release pull wires proximally relative to the heart valve carriage assembly to reconfigure the heart valve carriage assembly from the filter holding configuration to the filter release configuration. The deployment handle can be drivingly coupled with the filter release pull wires. The deployment handle can be operable to pull the filter release pull wires proximally relative to the heart valve carriage assembly to reconfigure the heart valve carriage assembly from the filter holding configuration to the filter release configuration.

[0013] The proximal end of the embolic filter can be attached to the distal end of the filter sheath or to the filter sheath at a location proximal to the distal end of the filter sheath. For example, the embolic filter can include a proximal end and an open distal end. The proximal end of the embolic filter can be attached to the filter sheath. A distal end of the filter sheath can be disposed distal to the open distal end of the embolic filter in the deployed configuration. The filter sheath can include apertures configured to removal of embolic material captured by the embolic filter through the filter sheath lumen. The embolic filter can include a proximal end and an open distal end. The proximal end of the embolic filter can be attached to and extend distally from a distal end of the filter sheath.

[0014] The filter sheath can be steerable (i.e., controllably deflectable). For example, the catheter can include one or more filter sheath deflection wires attached to the filter sheath. The deployment handle can be drivingly coupled with the one or more filter sheath deflection wires and operable to selectively actuate the one or more filter sheath deflection wires to induce controlled bending of the filter sheath to facilitate advancement of the catheter through a patient’s vasculature and / or withdrawal of the catheter from the patient’s vasculature.

[0015] In the catheter, the outer sheath can be used to constrain the embolic filter in a collapsed configuration. For example, the embolic filter can be disposed within the outer sheath lumen in the collapsed captured configuration. The embolic filter can be disposed within the outer sheath lumen in the collapsed insertion configuration.

[0016] In another aspect, a method of implanting a prosthetic heart valve employs an integrated catheter. The method includes: (a) supporting the prosthetic heart valve in an unexpanded configuration on an integrated catheter comprising a deployment handle, a filtersheath, an outer sheath, an embolic filter, and a heart valve carriage assembly to which the prosthetic heart valve is mounted in the unexpanded configuration; (b) advancing a distal end portion of the integrated catheter through a patient’s vasculature to position the embolic filter and the heart valve carriage assembly for deployment of the embolic filter and the prosthetic heart valve; (c) expanding the embolic filter from a collapsed insertion configuration to a deployed configuration for filtering of embolic material from blood flowing through the embolic filter downstream of the heart valve carriage assembly; (d) expanding the prosthetic heart valve from the unexpanded configuration to an expanded configuration to implant of the prosthetic heart valve; (e) collapsing the embolic filter from the deployed configuration to a collapsed captured configuration; and (f) withdrawing the integrated catheter from the patient’s vasculature.

[0017] In the method, supporting the prosthetic heart valve in the unexpanded configuration can include retaining the prosthetic heart valve in the unexpanded configuration via a nose cone in a delivery configuration. In the method, expanding the prosthetic heart valve from the unexpanded configuration to the expanded configuration can include reconfiguring the nose cone from the delivery configuration to a release configuration that accommodates the expanding of the prosthetic heart valve.

[0018] In the method, the heart valve carriage assembly can include an expandable balloon. In the method, supporting the prosthetic heart valve in the unexpanded configuration can include supporting an inner surface of the prosthetic heart valve on the expandable balloon and expanding the prosthetic heart valve comprises inflating the expandable balloon.

[0019] In the method, the heart valve carriage assembly can have a filter holding configuration and a filter release configuration. In the method, the integrated catheter can further include filter release pull wires. A distal end portion of the embolic filter can be restrained in the collapsed insertion configuration via engagement with the filter release pull wires and the heart valve carriage assembly in the filter holding configuration. Expanding the embolic filter can include translating the filter release pull wires proximally relative to the heart valve carriage assembly to reconfigure the heart valve carriage assembly from the filter holding configuration to the filter release configuration to release the distal end portion of the embolic filter from engagement with the filter release pull wires and the heart valve carriage assembly. The heart valve carriage assembly can include filter release pull wire recesses.Each of the filter release pull wires can include a filter release pull wire distal end portion thatis disposed within a corresponding one of the filter release pull wire recesses when the heart valve carriage assembly is in the filter holding configuration. Expanding the embolic filter can include pulling each filter release pull wire distal end portion out of the corresponding one of the filter release pull wire recesses to reconfigure the heart valve carriage assembly from the filter holding configuration to the filter release configuration. In the method, the filter release pull wires can be coupled with the outer sheath and expanding the embolic filter includes translating the outer sheath proximally relative to the filter sheath to pull the filter release pull wires proximally relative to the heart valve carriage assembly to reconfigure the heart valve carriage assembly from the filter holding configuration to the filter release configuration. In the method, the deployment handle can be drivingly coupled with the filter release pull wires and expanding the embolic filter includes operating the deployment handle to pull the filter release pull wires proximally relative to the heart valve carriage assembly to reconfigure the heart valve carriage assembly from the filter holding configuration to the filter release configuration.

[0020] In the method, the embolic filter can include a proximal end and an open distal end. The proximal end of the embolic filter can be attached to the filter sheath. A distal end of the filter sheath can be disposed distal to the open distal end of the embolic filter in the deployed configuration. The method can further include removing embolic material captured by the embolic filter via apertures in the filter sheath.

[0021] In the method, advancing the distal end portion of the integrated catheter through the patient’s vasculature can include controllably deflecting the filter sheath. In the method, the filter sheath can be controllably deflected via actuation of one or more filter sheath deflection pull wires attached to the filter sheath.

[0022] For a fuller understanding of the nature and advantages of catheters and methods of the present disclosure, reference should be made to the ensuing detailed description and accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0023] FIG. 1 shows a THVR catheter with an integrated deployable embolic filter positioned for deployment of a prosthetic heart valve in heart, in accordance with catheters and methods of the present disclosure.

[0024] FIG. 2 shows an example of the THVR catheter of FIG. 1 (in an insertion configuration) for implanting a self-expanding prosthetic heart valve.

[0025] FIG. 3 shows the example of the THVR catheter of FIG. 2 in a deflected configuration.

[0026] FIG. 4 shows the example of the THVR catheter of FIG. 2 with the embolic filter deployed.

[0027] FIG. 5 shows the distal end portion of the example of the THVR catheter of FIG. 2 with the embolic filter deployed.

[0028] FIG. 6 shows an axial cross-sectional view through the example of the THVR catheter of FIG. 2.

[0029] FIG. 7 shows a longitudinal cross-sectional view through the distal end portion of the example of the THVR catheter of FIG. 2 with the prosthetic heart valve in an unexpanded (pre-deployment) configuration.

[0030] FIG. 8 shows a longitudinal cross-sectional view through the distal end portion of the example of the THVR catheter of FIG. 2 with the prosthetic heart valve in an expanded (deployed) configuration.

[0031] FIG. 9 shows a longitudinal cross-sectional view through the distal end portion of a variation of the example of the THVR catheter of FIG. 2 with the prosthetic heart valve in an unexpanded (pre-deployment) configuration.

[0032] FIG. 10 shows an example of the THVR catheter of FIG. 1 (in an insertion configuration) for implanting a balloon-expandable prosthetic heart valve.

[0033] FIG. 11 shows the example of the THVR catheter of FIG. 10 with the embolic filter deployed.

[0034] FIG. 12 shows an axial cross-sectional view through the example of the THVR catheter of FIG. 10.

[0035] FIG. 13 shows an alternate configuration of the embolic filter that can be employed in the THVR catheters of FIG. 2 and FIG. 10.

[0036] FIG. 14 shows a close-up view of the embolic filter (in the collapsed insertion configuration) of the alternate configuration of FIG. 13.

[0037] FIG. 15 shows a close-up view of the embolic filter (in the deployed configuration) of the alternate configuration of FIG. 13.

[0038] FIG. 16 shows a close-up view of the embolic filter (in the deployed configuration) of a variation of the alternate configuration of FIG. 13.

[0039] FIG. 17 is a simplified block diagram of acts of a method of implanting a prosthetic heart valve, in accordance with catheters and methods of the present disclosure.DETAILED DESCRIPTION

[0040] In the following description, various catheters and methods of the present disclosure will be described. For purposes of explanation, specific configurations and details are set forth in order to provide a thorough understanding of the catheters and methods of the present disclosure. However, it will also be apparent to one skilled in the art that the catheters and methods of the present disclosure may be practiced without the specific details. Furthermore, well-known features may be omitted or simplified in order not to obscure the catheters and methods of the present disclosure being described.

[0041] Referring now to the drawings, in which like reference numerals represent like parts throughout the several views, FIG. 1 shows a THVR catheter 10 with a deployed integrated embolic filter 12 positioned within a patient’s aorta 14 for deployment of a prosthetic heart valve 16 in the patient’s heart 18 upstream of the embolic filter 12, in accordance with catheters and methods of the present disclosure. The inclusion of the integrated embolic filter 12 enables a THVR procedure to be accomplished with embolic material capture by the THVR catheter 10, which may reduce or eliminate the need for the deployment of a separate embolic filter downstream of the implantation site of the prosthetic heart valve, thereby saving time and expense.

[0042] FIG. 2 shows an example 10- A of the THVR catheter 10 in an insertion configuration for use during insertion and advancement of the distal end portion of the THVR catheter 10-A through a patient’s vasculature. The THVR catheter 10-A includes a deployment handle 20, a steerable filter sheath 22, an outer sheath 24, an outer sheath hub 26, an embolic filter 28, and a heart valve carriage assembly 30. The filter sheath 22 is attached to the deployment handle and defines a filter sheath lumen. The outer sheath 24 defines an outer sheath lumen through which the filter sheath 22 extends. The outer sheath 24 is slidable along the filter sheath 22. The outer sheath hub 26 is attached to the outer sheath 24. The outer sheath hub 26 provides a manipulatable feature for repositioning of the outer sheath 24along the filter sheath 22. The outer sheath hub 26 can be configured to sealingly engages the outer surface of the filter sheath 22 to block leakage of bodily fluid from the proximal end of the outer sheath 24. The outer sheath hub 26 can include a fluid outlet tube 32 for aspiration of bodily fluid from within the outer sheath 24. The embolic filter 28 is attached to the filter sheath 22. The embolic filter 28 is reconfigurable between a collapsed insertion configuration (shown in FIG. 2), a deployed configuration (shown in FIG. 4), and a collapsed captured configuration (as shown in FIG. 2). In the deployed configuration, the embolic filter 28 is configured to filter embolic material from blood flowing through the embolic filter 28.

[0043] The heart valve carriage assembly 30 includes a heart valve carriage shaft 34 and a heart valve carriage 36. The heart valve carriage 36 is attached to and extends distally from the heart valve carriage shaft 34. The heart valve carriage 36 is configured to carry a prosthetic heart valve 38 in an unexpanded configuration (shown in FIG. 7). The heart valve carriage shaft 34 is coupled with the deployment handle 20 and extends through the lumen of the filter sheath 22. The deployment handle 20 is operable to reposition the heart valve carriage 36 relative to the filter sheath 22 and release the prosthetic heart valve 38 to accommodate expansion of the prosthetic heart valve 38 from the unexpanded configuration to an expanded (implanted) configuration.

[0044] The filter sheath 22 can include a steerable (deflectable) distal end portion 40. FIG. 3 shows the THVR catheter 10-A in a deflected configuration. The deflectable distal end portion 40 can be implemented using any suitable approach including any suitable existing approach. For example, The THVR catheter 10-A can include one or more filter sheath deflection wires attached to a distal end segment of the deflectable distal end portion 40. The deployment handle 20 can be drivingly coupled with the one or more filter sheath deflection wires. The deployment handle 20 can be configured to be operable to selectively actuate the one or more filter sheath deflection wires to induce controlled bending of the deflectable distal end portion 40 to facilitate advancement of the THVR catheter 10-A through a patient’s vasculature and / or withdrawal of the THVR catheter 10-A from the patient’s vasculature.

[0045] FIG. 4 shows the THVR catheter 10-A with the embolic filter 28 deployed. The THVR catheter 10-A can be configured to deploy the embolic filter 28 using any suitable approach, such as any of the approaches described herein. For example, the embolic filter 28can be held in the collapsed insertion configuration within the lumen of the outer sheath 26 and is deployed via proximal retraction of the outer sheath 26 relative to the filter sheath 22.

[0046] The integrated nature of the THVR catheter 10- A enables a reduction in the diametrical size of the THVR catheter 10-A relative to a separate embolic filter catheter sized to accommodate the passage of the heart valve carriage assembly 30 therethrough. FIG. 5 shows the distal end portion of the THVR catheter 10-A with the embolic filter 28 deployed. In the insertion configuration shown, the heart valve carriage assembly 30 has a maximum diametrical dimension 42 and the filter sheath 22 has an inner lumen diameter 44. The inner lumen diameter 44 of the filter sheath 22 can be less than the maximum diametrical dimension 42 of the heart valve carriage assembly 30 since the lumen of the filter sheath 22 is not sized to accommodate passage of the heart valve carriage assembly 30 therethrough. In contrast, the lumen of a separate embolic filter catheter sized to accommodate passage of the heart valve carriage assembly 30 would have a larger diameter than the maximum diametrical dimension 42 of the heart valve carriage assembly 30.

[0047] FIG. 6 shows an axial cross-sectional view through the elongated members of the THVR catheter 10-A. FIG. 7 shows a longitudinal cross-sectional view through the distal end portion of the THVR catheter 10-A with the prosthetic heart valve 38 in an unexpanded (predeployment) configuration. FIG. 8 shows a longitudinal cross-sectional view through the distal end portion of the THVR catheter 10-A with the prosthetic heart valve 38 in an expanded (deployed) configuration. The elongated members include the filter sheath 22, the outer sheath 24, the heart valve carriage shaft 34, and a nose cone shaft 46. As described herein, the outer sheath 24 surrounds and is slidably along the filter sheath 22 for deployment and / or capture of the embolic filter 28. The heart valve carriage shaft 34 is attached to the heart valve carriage 36, extends through the lumen of the filter sheath 22, and is coupled with the deployment handle 20. The deployment handle 20 is configured to be operable to translate the heart valve carriage shaft 34 relative to the filter sheath 22 for selective repositioning of the heart valve carriage 36 relative to the end of the filter sheath 22. A nose cone 48 is attached to a distal end of the nose cone shaft 46. The nose cone shaft 46 is coupled with the deployment handle 20 and extends through a lumen defined by the heart valve carriage shaft 34. The deployment handle 20 is operable to reposition the nose cone 48 relative to the heart valve carriage 36 between a delivery configuration and a release configuration. In the delivery configuration, the nose cone 48 is configured to retain the prosthetic heart valve 38 in the unexpanded configuration. In the release configuration, thenose cone 48 is configured to accommodate expansion of the prosthetic heart valve 38 from the unexpanded configuration to the expanded configuration. In the THVR catheter 10- A, the outer sheath 24 can have an outer diameter of 0.24 inches, the filter sheath 22 can have an outer diameter of 0.18 inches, the heart valve carriage shaft 34 can have an outer diameter of 0.13 inches, and the nose cone shaft 46 can have an outer diameter of 0.06 inches. The THVR catheter 10-A can include a stabilization layer. The stabilization layer can form an outer layer of the filter sheath 22 and can be configured to insulate the filter sheath 22 from the vasculature and the outer sheath 24 so that the valve can be positioned more accurately. The stabilization layer can be made from TPE or similar polymer with a metal braid for reinforcement. The thickness of the stabilization layer can be approximately 0.020 inches.

[0048] FIG. 9 shows a longitudinal cross-sectional view through the distal end portion of a variation of the THVR catheter 10 with the prosthetic heart valve 38 in the unexpanded (predeployment) configuration. The variation consists of a shorter filter shaft 22 and the proximal end of the embolic filter 28 is attached to the distal end of the filter shaft 22.

[0049] FIG. 10 shows another example 10-B of the THVR catheter 10. FIG. 11 shows the THVR catheter 10-B with the embolic filter 28 deployed. FIG. 12 shows an axial cross- sectional view through the THVR catheter 10-B. The THVR catheter 10-B is configured for implanting a balloon-expandable prosthetic heart valve 38BE. Many components and aspects of the THVR catheter 10-B are the same as components and aspects of the THVR catheter 10-A so the description of such components and aspects described herein with respect to the THVR catheter 10-A is applicable to the THVR catheter 10-B. The THVR catheter 10-B includes a ballon shaft assembly 30B that includes an expandable balloon 36B and a balloon shaft 34B. The expandable balloon 36B is configured to carry a balloon expandable prosthetic heart valve 38BE in an unexpanded (crimped) configuration. The balloon shaft 34B is coupled with the deployment handle 20 and extends through the lumen of the filter sheath 22. The deployment handle 20 is operable to reposition the expandable balloon 36B relative to the filter sheath 22 and supply pressurized air to the expandable balloon 36B for expansion of the balloon-expandable prosthetic heart valve 38BE from the unexpanded configuration to an expanded (implanted) configuration. In the THVR catheter 10-B, the outer sheath 24 can have an outer diameter of 0.270 inches, the filter sheath 22 can have an outer diameter of 0.195 inches, and the balloon shaft 34B can have an outer diameter of 0.110 inches.

[0050] FIG. 13 shows a THVR catheter 10-C that employs an alternate example 28-ER of the embolic filter 28. FIG. 14 shows a close-up view of the embolic filter 28-ER in the collapsed insertion configuration. The THVR catheter 10-C is configured similar to the THVR catheters 10-A, 10-B except for how the distal end of the embolic filter 28-ER is restrained in the collapsed insertion configuration. Accordingly, many components and aspects of the THVR catheter 10-C are the same as components and aspects of the THVR catheters 10-A, 10-B so the description of such components and aspects described herein with respect to the THVR catheters 10-A, 10-B is applicable to the THVR catheter 10-C. The THVR catheter 10-C includes filter release pull wires 50. A distal end portion of the embolic filter 28-ER is restrained via engagement with the filter release pull wires 50 and the heart valve carriage assembly 30 or the expandable balloon 36B. The filter release pull wires 50 are configured to be translated proximally relative to the heart valve carriage 36 or the expandable balloon 36B to reconfigure the heart valve carriage 36 from the filter holding configuration to the filter release configuration to release the distal end portion of the embolic filter 28-ER from engagement with the filter release pull wires 50 and the heart valve carriage 30 or the expandable balloon 36B to reconfigure the embolic filter 28-ER to the deployed configuration. The heart valve carriage 30 or the expandable balloon 36B can include filter release pull wire recesses. Each of the filter release pull wires 50 can include a filter release pull wire distal end portion that is disposed within a corresponding one of the filter release pull wire recesses when the heart valve carriage 36 or the expandable balloon 36B is in the filter holding configuration. Each filter release pull wire distal end portion can be configured to be pulled out of the corresponding one of the filter release pull wire recesses to reconfigure the heart valve carriage 36 or the expandable balloon 36B from the filter holding configuration to the filter release configuration.

[0051] Any suitable approach can be used to actuate the filter release pull wires 50 to release the end of the embolic filter 28-ER. For example, the filter release pull wires can be coupled with the outer sheath and the outer sheath can be configured to be translated proximally relative to the filter sheath to pull the filter release pull wires proximally relative to the heart valve carriage to reconfigure the heart valve carriage assembly from the filter holding configuration to the filter release configuration. The deployment handle can be drivingly coupled with the filter release pull wires and the deployment handle is operable to pull the filter release pull wires proximally relative to the heart valve carriage to reconfigurethe heart valve carriage assembly from the filter holding configuration to the filter release configuration.

[0052] FIG. 15 and FIG. 16 shows a close-up partial cross-sectional views of alternative configurations of the filter sheath 22 THVR catheter 10-C. In the configuration shown in FIG. 15C, the filter sheath 22 extends distal of the distal end of the embolic filter 28-ER in the deployed configuration. In the configuration shown in FIG. 16, the filter sheath 22 is shorter and the proximal end of the embolic filter 28-ER is attached to the distal end of the filter sheath 22. The configuration shown in FIG. 15, the deflectable section 40 of the filter sheath 22 can extend closer to the heart valve carriage 30 or the expandable balloon 36B thereby providing increase control of positioning of the prosthetic heart valve prior to deployment. In the configuration shown in FIG. 16, embolic material collected by the embolic filter 28-ER may be effectively directed into the lumen of the filter sheath 22 for removal from the patient.

[0053] FIG. 17 is a simplified block diagram of acts of a method 100 of implanting a prosthetic heart valve, in accordance with catheters and methods of the present disclosure. The method 100 can be practiced with any suitable THVR catheter that includes a deployable embolic filter, such as the THVR catheters described herein.

[0054] In act 102, the prosthetic heart valve, in an unexpanded configuration, is supported on a THVR catheter that includes an integrated filter. The THVR catheter can include a deployment handle, a filter sheath, an outer sheath, an embolic filter, and a heart valve carriage assembly to which the prosthetic heart valve is mounted in the unexpanded configuration. Supporting the prosthetic heart valve in the unexpanded configuration can include retaining the prosthetic heart valve in the unexpanded configuration via a nose cone in a delivery configuration. The heart valve carriage assembly can include an expandable balloon, and an inner surface of the prosthetic heart valve can be supported on the expandable balloon.

[0055] In act 104, the distal end portion of the THVR catheter is advanced through a patient’s vasculature to position the embolic filter and the heart valve carriage assembly for deployment. The filter sheath can be configured to be controllably deflectable via operation of the deployment handle to aid in the advancement of the distal end portion of the THVR catheter.

[0056] In act 106, the embolic filter is deployed downstream of the implantation site for the prosthetic heart valve. The embolic filter can be deployed by expanding the embolic filter from a collapsed insertion configuration to a deployed configuration for filtering of embolic material from blood flowing through the embolic filter downstream of the heart valve carriage assembly. The THVR catheter can include a heart valve carriage assembly that has a filter holding configuration and a filter release configuration; the integrated catheter includes filter release pull wires. A distal end portion of the embolic filter can be restrained in the collapsed insertion configuration via engagement with the filter release pull wires and the heart valve carriage assembly in the filter holding configuration. The embolic filter can be released for expansion by translating the filter release pull wires proximally relative to the heart valve carriage assembly to reconfigure the heart valve carriage assembly from the filter holding configuration to the filter release configuration to release the distal end portion of the embolic filter from engagement with the filter release pull wires and the heart valve carriage assembly. The heart valve carriage assembly can include filter release pull wire recesses. Each of the filter release pull wires can include a filter release pull wire distal end portion that can be disposed within a corresponding one of the filter release pull wire recesses when the heart valve carriage assembly is in the filter holding configuration. Expanding the embolic filter can include pulling each filter release pull wire distal end portion out of the corresponding one of the filter release pull wire recesses to reconfigure the heart valve carriage assembly from the filter holding configuration to the filter release configuration. The filter release pull wires can be coupled with the outer sheath and expanding the embolic filter can include translating the outer sheath proximally relative to the filter sheath to pull the filter release pull wires proximally relative to the heart valve carriage assembly to reconfigure the heart valve carriage assembly from the filter holding configuration to the filter release configuration. The deployment handle can be drivingly coupled with the filter release pull wires. Expanding the embolic filter can include operating the deployment handle to pull the filter release pull wires proximally relative to the heart valve carriage assembly to reconfigure the heart valve carriage assembly from the filter holding configuration to the filter release configuration.

[0057] In act 108, the prosthetic heart valve is expanded from the unexpanded configuration to an expanded configuration to implant of the prosthetic heart valve. The prosthetic heart valve can be self-expanding and expanded via reconfiguring the THVR catheter, via operation of the deployment handle, to remove a constraint holding theprosthetic heart valve in the unexpanded configuration. For example, the prosthetic heart valve can be expanded from the unexpanded configuration to the expanded configuration by reconfiguring a nose cone from the delivery configuration to a release configuration that accommodates the expanding of the prosthetic heart valve. The prosthetic heart valve can be balloon expandable. The THVR catheter can include an inflatable balloon. The prosthetic heart valve can be crimped onto an inflatable balloon that is inflated to expand the prosthetic heart valve from the unexpanded configuration to the expanded configuration.

[0058] In act 110, the embolic filter is captured to facilitate withdrawal of the THVR catheter from the patient’s vasculature. The outer sheath can be advance distally relative to the filter sheath to capture the embolic filter within the outer sheath.

[0059] In act 112, the THVR catheter is withdrawn from the patient’s vasculature. The filter sheath can be steerable via operation of the deployment handle and can be controllably deflected during the withdrawal to facilitate the withdrawal of the THVR catheter from the patient’s vasculature.

[0060] The method 100 may further include removing embolic material captured by the embolic filter via the lumen of the filter sheath. The embolic material can be removed via apertures in the filter sheath.

[0061] The catheters and methods described herein are expected to produce substantial benefits in the way of substantially increased safety and efficacy of THVR. As a result, THVR may be performed on a substantially increased number of patients with improved outcomes and reduced recovery times. Specifically, there will be less embolic material conveyed within the circulation system, thereby lowering the incidence of clinical stroke, subclinical stroke, silent cerebral embolization, renal embolization, mesenteric embolization, and peripheral embolization and each of the associated clinical syndromes.

[0062] The THVR catheters and related methods described herein can be adapted for use in procedures involving covered or uncovered stenting of arteries for capture and extraction of embolic material that may be liberated during their implantation for the treatment of aneurysms, dissections, stenosis or thrombus. The THVR catheters and related methods described herein can be adapted for prevention of injury resulting from embolic events occurring during balloon aortic valvuloplasty. The THVR catheters and related methods described herein can be adapted for prevention of tissue injury resulting from the performance of mitral balloon valvuloplasty or replacement.

[0063] The following relate to numbers aspect of catheters and methods of the present disclosure:1. A catheter for implanting a prosthetic heart valve, the catheter comprising: a deployment handle; a filter sheath attached to the deployment handle and defining a filter sheath lumen; an outer sheath defining an outer sheath lumen through which the filter sheath extends, wherein the outer sheath is slidable along the filter sheath; an embolic filter attached to the filter sheath, wherein the embolic filter is reconfigurable between a collapsed insertion configuration, a deployed configuration, and a collapsed captured configuration, and wherein the embolic filter, in the deployed configuration, is configured to filter embolic material from blood flowing through the embolic filter; and a heart valve carriage assembly configured to carry the prosthetic heart valve in an unexpanded configuration, and wherein the deployment handle is operable to expand the prosthetic heart valve from the unexpanded configuration to an expanded configuration.2. The catheter of aspect 1, wherein a combination of the heart valve carriage assembly and the prosthetic heart valve in the unexpanded configuration mounted to the heart valve carriage assembly has a maximum outer diameter that is greater than a minimum diameter of the filter sheath lumen.3. The catheter of aspect 1, wherein: the heart valve carriage assembly comprises a heart valve carriage shaft and a heart valve carriage attached to and extending distally from the heart valve carriage shaft; the heart valve carriage shaft is coupled with the deployment handle and extends through the filter sheath lumen; and the deployment handle is operable to reposition the heart valve carriage relative to the filter sheath.4. The catheter of aspect 3, further comprising a nose cone shaft and a nose cone attached to a distal end of the nose cone shaft, wherein the nose cone shaft is coupled with the deployment handle and extends through a lumen defined by the heart valve carriage shaft, wherein the deployment handle is operable to reposition the nose cone relative to the heart valve carriage between a delivery configuration and a release configuration, wherein the nose cone, in the delivery configuration, is configured to retain the prosthetic heart valve in the unexpanded configuration, and wherein the nose cone, in the release configuration, is configured to accommodate expansion of the prosthetic heart valve from the unexpanded configuration to the expanded configuration.5. The catheter of any one of aspect 1 through aspect 4, wherein: the prosthetic heart valve is configured to be balloon expanded; and the heart valve carriage assembly comprises a deployment balloon that is expandable to expand the prosthetic heart valve.6. The catheter of any one of aspect 1 through aspect 4, wherein: the heart valve carriage assembly has a filter holding configuration and a filter release configuration; the catheter further comprises filter release pull wires; a distal end portion of the embolic filter is restrained via engagement with the filter release pull wires and the heart valve carriage assembly; and the filter release pull wires are configured to be translated proximally relative to the heart valve carriage assembly to reconfigure the heart valve carriage assembly from the filter holding configuration to the filter release configuration to release the distal end portion of the embolic filter from engagement with the filter release pull wires and the heart valve carriage assembly to reconfigure the embolic filter to the deployed configuration.The catheter of aspect 6, wherein: the heart valve carriage assembly comprises filter release pull wire recesses; each of the filter release pull wires comprises a filter release pull wire distal end portion that is disposed within a corresponding one of the filter release pull wire recesses when the heart valve carriage assembly is in the filter holding configuration; and each filter release pull wire distal end portion is configured to be pulled out of the corresponding one of the filter release pull wire recesses to reconfigure the heart valve carriage assembly from the filter holding configuration to the filter release configuration. The catheter of aspect 7, wherein: the filter release pull wires are coupled with the outer sheath; and the outer sheath is configured to be translated proximally relative to the filter sheath to pull the filter release pull wires proximally relative to the heart valve carriage assembly to reconfigure the heart valve carriage assembly from the filter holding configuration to the filter release configuration. The catheter of aspect 7, wherein: the deployment handle is drivingly coupled with the filter release pull wires; and the deployment handle is operable to pull the filter release pull wires proximally relative to the heart valve carriage assembly to reconfigure the heart valve carriage assembly from the filter holding configuration to the filter release configuration. The catheter of any one of aspect 1 through aspect 4, wherein: the embolic filter comprises a proximal end and an open distal end; the proximal end of the embolic filter is attached to the filter sheath; and a distal end of the filter sheath is disposed distal to the open distal end of the embolic filter in the deployed configuration. The catheter of aspect 10, wherein the filter sheath includes apertures configured to removal of embolic material captured by the embolic filter through the filter sheath lumen.The catheter of aspect 10, further comprising one or more filter sheath deflection wires attached to the filter sheath, wherein the deployment handle is drivingly coupled with the one or more filter sheath deflection wires and operable to selectively actuate the one or more filter sheath deflection wires to induce controlled bending of the filter sheath to facilitate advancement of the catheter through a patient’s vasculature and / or withdrawal of the catheter from the patient’s vasculature. The catheter of any one of aspect 1 through aspect 4, wherein: the embolic filter comprises a proximal end and an open distal end; and the proximal end of the embolic filter is attached to and extends distally from a distal end of the filter sheath. The catheter of any one of aspect 1 through aspect 4, wherein the embolic filter is disposed within the outer sheath lumen in the collapsed captured configuration. The catheter of aspect 14, wherein the embolic filter is disposed within the outer sheath lumen in the collapsed insertion configuration. A method of implanting a prosthetic heart valve, the method comprising: supporting the prosthetic heart valve in an unexpanded configuration on an integrated catheter comprising a deployment handle, a filter sheath, an outer sheath, an embolic filter, and a heart valve carriage assembly to which the prosthetic heart valve is mounted in the unexpanded configuration; advancing a distal end portion of the integrated catheter through a patient’s vasculature to position the embolic filter and the heart valve carriage assembly for deployment of the embolic filter and the prosthetic heart valve; expanding the embolic filter from a collapsed insertion configuration to a deployed configuration for filtering of embolic material from blood flowing through the embolic filter downstream of the heart valve carriage assembly; expanding the prosthetic heart valve from the unexpanded configuration to an expanded configuration to implant of the prosthetic heart valve; collapsing the embolic filter from the deployed configuration to a collapsed captured configuration; and withdrawing the integrated catheter from the patient’s vasculature.17. The method of aspect 16, wherein: supporting the prosthetic heart valve in the unexpanded configuration comprises retaining the prosthetic heart valve in the unexpanded configuration via a nose cone in a delivery configuration; and expanding the prosthetic heart valve from the unexpanded configuration to the expanded configuration comprises reconfiguring the nose cone from the delivery configuration to a release configuration that accommodates the expanding of the prosthetic heart valve.18. The method of aspect 16, wherein: the heart valve carriage assembly comprises an expandable balloon; supporting the prosthetic heart valve in the unexpanded configuration comprises supporting an inner surface of the prosthetic heart valve on the expandable balloon; and expanding the prosthetic heart valve comprises inflating the expandable balloon.19. The method of any one of aspect 16 through aspect 18, wherein: the heart valve carriage assembly has a filter holding configuration and a filter release configuration; the integrated catheter further comprises filter release pull wires; a distal end portion of the embolic filter is restrained in the collapsed insertion configuration via engagement with the filter release pull wires and the heart valve carriage assembly in the filter holding configuration; and expanding the embolic filter comprises translating the filter release pull wires proximally relative to the heart valve carriage assembly to reconfigure the heart valve carriage assembly from the filter holding configuration to the filter release configuration to release the distal end portion of the embolic filter from engagement with the filter release pull wires and the heart valve carriage assembly.20. The method of aspect 19, wherein: the heart valve carriage assembly comprises filter release pull wire recesses; each of the filter release pull wires comprises a filter release pull wire distal end portion that is disposed within a corresponding one of the filter release pull wire recesses when the heart valve carriage assembly is in the filter holding configuration; and expanding the embolic filter comprises pulling each filter release pull wire distal end portion out of the corresponding one of the filter release pull wire recesses to reconfigure the heart valve carriage assembly from the filter holding configuration to the filter release configuration.21. The method of aspect 20, wherein: the filter release pull wires are coupled with the outer sheath; and expanding the embolic filter comprises translating the outer sheath proximally relative to the filter sheath to pull the filter release pull wires proximally relative to the heart valve carriage assembly to reconfigure the heart valve carriage assembly from the filter holding configuration to the filter release configuration.22. The method of aspect 20, wherein: the deployment handle is drivingly coupled with the filter release pull wires; and expanding the embolic filter comprises operating the deployment handle to pull the filter release pull wires proximally relative to the heart valve carriage assembly to reconfigure the heart valve carriage assembly from the filter holding configuration to the filter release configuration.23. The method of any one of aspect 16 through aspect 18, wherein: the embolic filter comprises a proximal end and an open distal end; the proximal end of the embolic filter is attached to the filter sheath; and a distal end of the filter sheath is disposed distal to the open distal end of the embolic filter in the deployed configuration.24. The method of aspect 23, further comprising removing embolic material captured by the embolic filter via apertures in the filter sheath.25. The method of aspect 23, wherein advancing the distal end portion of the integrated catheter through the patient’s vasculature comprises controllably deflecting the filtersheath via actuation of one or more filter sheath deflection pull wires attached to the filter sheath.26. The method of any one of aspect 16 through aspect 18, wherein: the embolic filter comprises a proximal end and an open distal end; and the proximal end of the embolic filter is attached to and extends distally from a distal end of the filter sheath.27. The method of any one of aspect 16 through aspect 18, wherein: the outer sheath defines an outer sheath lumen; the embolic filter is disposed within the outer sheath lumen in the collapsed captured configuration; and collapsing the embolic filter comprises distally advancing the outer sheath relative to the filter sheath to capture the embolic filter within the outer sheath lumen.28. The method of aspect 27, wherein: the embolic filter is disposed within the outer sheath lumen in the collapsed insertion configuration; and expanding the embolic filter comprises proximately retracting the outer sheath relative to the filter sheath to remove the embolic filter from the outer sheath lumen.

[0064] Other variations are within the spirit of the catheters and methods of the present disclosure. Thus, while the catheters and methods of the present disclosure are susceptible to various modifications and alternative constructions, certain illustrated examples thereof are shown in the drawings and have been described above in detail. It should be understood, however, that there is no intention to limit the catheters and methods of the present disclosure to the specific form or forms disclosed, but on the contrary, the catheters and methods of the present disclosure are to cover all modifications, alternative constructions, and equivalents falling within the spirit and scope of the catheters and methods of the present disclosure, as defined in the appended claims.

[0065] The use of the terms “a” and “an” and “the” and similar referents in the context of describing the catheters and methods of the present disclosure (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The terms “comprising,”“having,” “including,” and “containing” are to be construed as open-ended terms (i.e., meaning “including, but not limited to,”) unless otherwise noted. The term “connected” is to be construed as partly or wholly contained within, attached to, or joined together, even if there is something intervening. Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein, is intended merely to better describe the catheters and methods of the present disclosure and does not pose a limitation on the scope of the catheters and methods of the present disclosure unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the catheters and methods of the present disclosure.

[0066] Preferred catheters and methods of the present disclosure are described herein, including the best mode known to the inventors for carrying out the catheters and methods of the present disclosure. Variations of those preferred catheters and methods of the present disclosure may become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventors expect skilled artisans to employ such variations as appropriate, and the inventors intend for the catheters and methods of the present disclosure to be practiced otherwise than as specifically described herein. Accordingly, the catheters and methods of the present disclosure include all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the catheters and methods of the present disclosure unless otherwise indicated herein or otherwise clearly contradicted by context.

[0067] All references, including publications, patent applications, and patents, cited herein are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.

Claims

WHAT IS CLAIMED IS:

1. A catheter for implanting a prosthetic heart valve, the catheter comprising: a deployment handle; a filter sheath attached to the deployment handle and defining a filter sheath lumen; an outer sheath defining an outer sheath lumen through which the filter sheath extends, wherein the outer sheath is slidable along the filter sheath; an embolic filter attached to the filter sheath, wherein the embolic filter is reconfigurable between a collapsed insertion configuration, a deployed configuration, and a collapsed captured configuration, and wherein the embolic filter, in the deployed configuration, is configured to filter embolic material from blood flowing through the embolic filter; and a heart valve carriage assembly configured to carry the prosthetic heart valve in an unexpanded configuration, and wherein the deployment handle is operable to expand the prosthetic heart valve from the unexpanded configuration to an expanded configuration.

2. The catheter of claim 1, wherein a combination of the heart valve carriage assembly and the prosthetic heart valve in the unexpanded configuration mounted to the heart valve carriage assembly has a maximum outer diameter that is greater than a minimum diameter of the filter sheath lumen.

3. The catheter of claim 1, wherein: the heart valve carriage assembly comprises a heart valve carriage shaft and a heart valve carriage attached to and extending distally from the heart valve carriage shaft; the heart valve carriage shaft is coupled with the deployment handle and extends through the filter sheath lumen; and the deployment handle is operable to reposition the heart valve carriage relative to the filter sheath.

4. The catheter of claim 3, further comprising a nose cone shaft and a nose cone attached to a distal end of the nose cone shaft, wherein the nose cone shaft is coupled with the deployment handle and extends through a lumen defined by the heart valve carriage shaft, wherein the deployment handle is operable to reposition the nose cone relative to the heart valve carriage between a delivery configuration and a release configuration,wherein the nose cone, in the delivery configuration, is configured to retain the prosthetic heart valve in the unexpanded configuration, and wherein the nose cone, in the release configuration, is configured to accommodate expansion of the prosthetic heart valve from the unexpanded configuration to the expanded configuration.

5. The catheter of any one of claim 1 through claim 4, wherein: the prosthetic heart valve is configured to be balloon expanded; and the heart valve carriage assembly comprises a deployment balloon that is expandable to expand the prosthetic heart valve.

6. The catheter of any one of claim 1 through claim 4, wherein: the heart valve carriage assembly has a filter holding configuration and a filter release configuration; the catheter further comprises filter release pull wires; a distal end portion of the embolic filter is restrained via engagement with the filter release pull wires and the heart valve carriage assembly; and the filter release pull wires are configured to be translated proximally relative to the heart valve carriage assembly to reconfigure the heart valve carriage assembly from the filter holding configuration to the filter release configuration to release the distal end portion of the embolic filter from engagement with the filter release pull wires and the heart valve carriage assembly to reconfigure the embolic filter to the deployed configuration.

7. The catheter of claim 6, wherein: the heart valve carriage assembly comprises filter release pull wire recesses; each of the filter release pull wires comprises a filter release pull wire distal end portion that is disposed within a corresponding one of the filter release pull wire recesses when the heart valve carriage assembly is in the filter holding configuration; and each filter release pull wire distal end portion is configured to be pulled out of the corresponding one of the filter release pull wire recesses to reconfigure the heart valve carriage assembly from the filter holding configuration to the filter release configuration.

8. The catheter of claim 7, wherein: the filter release pull wires are coupled with the outer sheath; and the outer sheath is configured to be translated proximally relative to the filter sheath to pull the filter release pull wires proximally relative to the heart valve carriage assembly to reconfigure the heart valve carriage assembly from the filter holding configuration to the filter release configuration.

9. The catheter of claim 7, wherein: the deployment handle is drivingly coupled with the filter release pull wires; and the deployment handle is operable to pull the filter release pull wires proximally relative to the heart valve carriage assembly to reconfigure the heart valve carriage assembly from the filter holding configuration to the filter release configuration.

10. The catheter of any one of claim 1 through claim 4, wherein: the embolic filter comprises a proximal end and an open distal end; the proximal end of the embolic filter is attached to the filter sheath; and a distal end of the filter sheath is disposed distal to the open distal end of the embolic filter in the deployed configuration.

11. The catheter of claim 10, wherein the filter sheath includes apertures configured to removal of embolic material captured by the embolic filter through the filter sheath lumen.

12. The catheter of claim 10, further comprising one or more filter sheath deflection wires attached to the filter sheath, wherein the deployment handle is drivingly coupled with the one or more filter sheath deflection wires and operable to selectively actuate the one or more filter sheath deflection wires to induce controlled bending of the filter sheath to facilitate advancement of the catheter through a patient’s vasculature and / or withdrawal of the catheter from the patient’s vasculature.

13. The catheter of any one of claim 1 through claim 4, wherein: the embolic filter comprises a proximal end and an open distal end; and the proximal end of the embolic filter is attached to and extends distally from a distal end of the filter sheath.

14. The catheter of any one of claim 1 through claim 4, wherein the embolic filter is disposed within the outer sheath lumen in the collapsed captured configuration.

15. The catheter of claim 14, wherein the embolic filter is disposed within the outer sheath lumen in the collapsed insertion configuration.

16. A method of implanting a prosthetic heart valve, the method comprising: supporting the prosthetic heart valve in an unexpanded configuration on an integrated catheter comprising a deployment handle, a filter sheath, an outer sheath, an embolic filter, and a heart valve carriage assembly to which the prosthetic heart valve is mounted in the unexpanded configuration; advancing a distal end portion of the integrated catheter through a patient’s vasculature to position the embolic filter and the heart valve carriage assembly for deployment of the embolic filter and the prosthetic heart valve; expanding the embolic filter from a collapsed insertion configuration to a deployed configuration for filtering of embolic material from blood flowing through the embolic filter downstream of the heart valve carriage assembly; expanding the prosthetic heart valve from the unexpanded configuration to an expanded configuration to implant of the prosthetic heart valve; collapsing the embolic filter from the deployed configuration to a collapsed captured configuration; and withdrawing the integrated catheter from the patient’s vasculature.

17. The method of claim 16, wherein: supporting the prosthetic heart valve in the unexpanded configuration comprises retaining the prosthetic heart valve in the unexpanded configuration via a nose cone in a delivery configuration; and expanding the prosthetic heart valve from the unexpanded configuration to the expanded configuration comprises reconfiguring the nose cone from the delivery configuration to a release configuration that accommodates the expanding of the prosthetic heart valve.

18. The method of claim 16, wherein: the heart valve carriage assembly comprises an expandable balloon; supporting the prosthetic heart valve in the unexpanded configuration comprises supporting an inner surface of the prosthetic heart valve on the expandable balloon; and expanding the prosthetic heart valve comprises inflating the expandable balloon.

19. The method of any one of claim 16 through claim 18, wherein: the heart valve carriage assembly has a filter holding configuration and a filter release configuration; the integrated catheter further comprises filter release pull wires; a distal end portion of the embolic filter is restrained in the collapsed insertion configuration via engagement with the filter release pull wires and the heart valve carriage assembly in the filter holding configuration; and expanding the embolic filter comprises translating the filter release pull wires proximally relative to the heart valve carriage assembly to reconfigure the heart valve carriage assembly from the filter holding configuration to the filter release configuration to release the distal end portion of the embolic filter from engagement with the filter release pull wires and the heart valve carriage assembly.

20. The method of claim 19, wherein: the heart valve carriage assembly comprises filter release pull wire recesses; each of the filter release pull wires comprises a filter release pull wire distal end portion that is disposed within a corresponding one of the filter release pull wire recesses when the heart valve carriage assembly is in the filter holding configuration; and expanding the embolic filter comprises pulling each filter release pull wire distal end portion out of the corresponding one of the filter release pull wire recesses to reconfigure the heart valve carriage assembly from the filter holding configuration to the filter release configuration.

21. The method of claim 20, wherein: the filter release pull wires are coupled with the outer sheath; and expanding the embolic filter comprises translating the outer sheath proximally relative to the filter sheath to pull the filter release pull wires proximally relative to the heart valve carriage assembly to reconfigure the heart valve carriage assembly from the filter holding configuration to the filter release configuration.

22. The method of claim 20, wherein: the deployment handle is drivingly coupled with the filter release pull wires; and expanding the embolic filter comprises operating the deployment handle to pull the filter release pull wires proximally relative to the heart valve carriage assembly to reconfigure the heart valve carriage assembly from the filter holding configuration to the filter release configuration.

23. The method of any one of claim 16 through claim 18, wherein: the embolic filter comprises a proximal end and an open distal end; the proximal end of the embolic filter is attached to the filter sheath; and a distal end of the filter sheath is disposed distal to the open distal end of the embolic filter in the deployed configuration.

24. The method of claim 23, further comprising removing embolic material captured by the embolic filter via apertures in the filter sheath.

25. The method of claim 23, wherein advancing the distal end portion of the integrated catheter through the patient’s vasculature comprises controllably deflecting the filter sheath via actuation of one or more filter sheath deflection pull wires attached to the filter sheath.

26. The method of any one of claim 16 through claim 18, wherein: the embolic filter comprises a proximal end and an open distal end; and the proximal end of the embolic filter is attached to and extends distally from a distal end of the filter sheath.

27. The method of any one of claim 16 through claim 18, wherein: the outer sheath defines an outer sheath lumen; the embolic filter is disposed within the outer sheath lumen in the collapsed captured configuration; and collapsing the embolic filter comprises distally advancing the outer sheath relative to the filter sheath to capture the embolic filter within the outer sheath lumen.

28. The method of claim 27, wherein: the embolic filter is disposed within the outer sheath lumen in the collapsed insertion configuration; and expanding the embolic filter comprises proximately retracting the outer sheath relative to the filter sheath to remove the embolic filter from the outer sheath lumen.

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