Patent Description:
The present disclosure describes systems, devices, and methods related to implant deployment in fluidic systems and filtering mechanisms.

A variety of maladies may affect an individual's body. Such maladies may be of the individual's heart, and may include maladies of the individual's heart valves, including the aortic, mitral, tricuspid, and pulmonary valves. Stenosis, for example, is a common and serious valve disease that may affect the operation of the heart valves and an individual's overall well-being.

Implants may be provided that may replace or repair portions of a subject's heart. Prosthetic implants, such as prosthetic heart valves, may be provided to replace portion of a subject's heart. Prosthetic aortic, mitral, tricuspid, and even pulmonary valves may be provided.

Implants may be deployed to the desired portion of the subject percutaneously, in a minimally invasive manner. Such deployment may occur transcatheter, in which a catheter may be deployed through the vasculature of an individual.

During deployment of such implants, care must be taken not to produce further maladies of the individual. For example, particles may be produced within the subject during deployment of such implants, which may cause maladies such as a stroke.

<CIT> describes a percutaneous transluminal angioplasty device including an embolic filter mounted to the catheter shaft at a location distal to the angioplasty balloon. Thus the filter is downstream from the blockage and is properly positioned to capture embolic particles that may be set loose into the blood stream as the angioplasty procedure is performed. The embolic filter is normally collapsed against the catheter shaft to facilitate introduction and withdrawal of the device to and from the operative site. Once the angioplasty balloon is properly positioned. however, means operatively associated with the embolic filter are actuated to erect the filter to position a filter mesh across the lumen of the vessel.

<CIT> describes an endoluminal catheterization device for providing protection against distal embolization of atherosclerotic debris and thrombi emboli resulting from an endoluminal catheterization procedure. The device is adapted to the new TAVI/PAVI methods to prevent the severe risk of brain embolization and stroke. The embolization protection device may also be an integral part of any other intra-luminal treatment or diagnostic device that may induce embolization, such as a balloon, stent. TAVI or atherectomy.

<CIT> describes an embolic protection system which may include a guidewire having a length, at least a portion of the guidewire having a non-circular cross-sectional shape, and an embolic protection device including a mounting sleeve configured to attach the embolic protection device to the portion of the guidewire having the non-circular cross-sectional shape. The mounting sleeve may include a non-circular interior cross-sectional shape and a non-circular exterior cross-sectional shape.

The present systems, devices and methods relate to filtering particles within a subject in various procedures, including (but not limited to) medical and training procedures. Such filtering may occur as part of a deployment system for an implant within a subject. Subjects include (but are not limited to) medical patients, veterinary patients, animal models, cadavers, and simulators of the cardiac and vasculature system (e.g., anthropomorphic phantoms and explant tissue). In the methods of the presently claimed invention, the subject comprises a cadaver or simulator of the cardiac and vasculature system.

One aspect of the presently claimed invention provides a deployment system for deploying a filter in a subject. The deployment system includes a deployment apparatus including an elongate shaft having a deployment device.

The deployment system includes a filter body having a proximal portion and a distal portion, and configured to have a deployed state in which the filter body extends radially outward from the elongate shaft and increases in size from the proximal portion to the distal portion, the filter body configured to trap particles in the filter body.

The deployment system includes a filter support being positioned distal of the proximal portion of the filter body and configured to couple to the elongate shaft and slide relative to the filter body.

The deployment system includes one or more support tethers extending from the filter support to the distal portion of the filter body.

The deployment system includes a control device passing distally through the proximal portion of the filter body and coupling to the filter support, the control device configured to be slid proximally relative to the filter body to slide the filter support proximally to move the one or more support tethers and transition the filter body to the deployed state.

A second aspect of the presently claimed invention provides a method for deploying a filter in a subject. The method includes inserting a filter within a subject, the filter positioned upon an elongate shaft of a deployment apparatus having a deployment device.

The filter includes a filter body having a proximal portion and a distal portion, and configured to have a deployed state in which the filter body extends radially outward from the elongate shaft and increases in size from the proximal portion to the distal portion, the filter body configured to trap particles in the filter body, a filter support being positioned distal of the proximal portion of the filter body and on the elongate shaft and configured to slide relative to the filter body, and one or more support tethers extending from the filter support to the distal portion of the filter body.

The method includes sliding a control device, that passes distally through the proximal portion of the filter body and couples to the filter support, proximally to slide the filter support proximally to move the one or more support tethers and transition the filter body to the deployed state.

In embodiments of the disclosure herein, a deployment system for an implant may be provided. The deployment system may include a deployment apparatus including an elongate shaft having a deployment device. A filter may be configured to extend radially outward from the elongate shaft and configured to trap particles in the filter. An elongate sheath may be coupled to the filter and having a length and a cut extending along the length of the elongate sheath and an interior cavity configured to receive the elongate shaft of the deployment apparatus, the elongate sheath configured to couple to the elongate shaft of the deployment apparatus by the elongate shaft being passed through the cut of the elongate sheath to be positioned within the interior cavity of the elongate sheath.

In embodiments of the disclosure herein, a method may be provided. The method may include inserting an elongate shaft of a deployment apparatus into an interior cavity of an elongate sheath through a cut extending along a length of the elongate sheath, a distal portion of the elongate sheath being coupled to a filter. The method may include sliding the elongate sheath distally along the elongate shaft. The method may include deploying the filter within vasculature of a subject, the filter extending radially outward from the elongate shaft of the deployment apparatus and configured to trap particles in the filter.

In embodiments of the disclosure herein, a catheter system may be provided. The catheter system may include an expandable catheter sheath configured to be inserted into a vasculature and having an interior lumen configured for an apparatus to be passed through, the interior lumen having an interior diameter that is configured to increase upon the apparatus passing through the interior lumen. The catheter system may include a filter positioned at a distal portion of the expandable catheter sheath and configured to expand from an undeployed state radially outward to a deployed state in response to the apparatus passing through the interior lumen and applying a radial outward force to the interior lumen.

In embodiments of the disclosure herein, a method may be provided. The method may include passing an apparatus through an interior lumen of an expandable catheter sheath positioned within a subject. The method may include applying a radial outward force to the interior lumen with the apparatus to expand a filter positioned at a distal portion of the expandable catheter sheath from an undeployed state radially outward to a deployed state.

In embodiments of the disclosure herein, a catheter system may be provided. The catheter system may include an introducer sheath configured to be inserted into a vasculature and having a length and an interior lumen configured for an apparatus to be passed through. The catheter system may include a filter positioned at a central portion or a proximal portion of the introducer sheath and configured to extend radially outward from the introducer sheath to trap particles in the filter.

In embodiments herein of the disclosure, a method may be provided. The method may include inserting an introducer sheath into a vasculature, the introducer sheath including a filter positioned at a central portion or a proximal portion of the introducer sheath and configured to extend radially outward from the introducer sheath to trap particles in the filter.

These and other features, aspects, and advantages are described below with reference to the drawings, which are intended to illustrate, but not to limit, the disclosure. In the drawings, like reference characters denote corresponding features consistently throughout similar embodiments.

The following description and examples illustrate some example embodiments of the disclosure in detail. Those of skill in the art will recognize that there are numerous variations and modifications of the disclosure that are encompassed by its scope. Accordingly, the description of a certain example embodiment should not be deemed to limit the scope of the present disclosure.

<FIG> illustrates an embodiment of a deployment apparatus <NUM> that may be utilized to deploy an implant to a portion of a subject according to embodiments disclosed herein. The implant <NUM> as marked in <FIG> may be an aortic implant comprising a prosthetic aortic valve. In embodiments, the implant may have other forms than shown in <FIG>, for example the implant may be a mitral, tricuspid, or pulmonary prosthetic valve, among other forms of prosthetics. The implant may comprise a stent, clip, or other form of implant that may be inserted in a portion of the subject, including, in some instances, the heart of a patient.

The implant <NUM> may be an expandable implant as shown in <FIG>, which may be configured to be expanded to be placed in position within the native valve location. The implant <NUM> may include a frame <NUM> including a plurality of supports <NUM> configured to be compressed for positioning within the deployment apparatus <NUM> and configured to be expanded at the desired time. The frame <NUM> may support prosthetic valve leaflets <NUM> that operate in lieu of the native valve leaflets. The frame <NUM> may include couplers <NUM> for coupling to the deployment apparatus <NUM>, to retain the implant <NUM> to the deployment apparatus <NUM> until deployment is desired. The couplers <NUM> may comprise apertures as shown in <FIG>, or may have other forms as desired. Although implant <NUM> is shown in <FIG>, the use of the deployment apparatus <NUM> is not limited to the embodiment of implant <NUM> shown in <FIG>, and may extend to other forms of implants as desired.

Referring back to <FIG>, the deployment apparatus <NUM> may include an elongate shaft <NUM> including a proximal end <NUM> and a distal end <NUM>. A housing in the form of a handle <NUM> may be positioned at the proximal end <NUM> of the elongate shaft <NUM>. The handle <NUM> may be configured for an individual to grip to utilize when operating the deployment apparatus <NUM>. The elongate shaft <NUM> may extend outward from the handle <NUM> and may be configured to be inserted into a subject to be directed to a desired treatment site of the subject. The elongate shaft <NUM> may be configured to be inserted into the vasculature of the subject, or otherwise may be inserted into the vasculature of the subject. Such insertion may be percutaneous and minimally invasive, such as transfemoral entry. Other forms of entry, such as transapical may be utilized as well. The handle <NUM> remains exterior to the subject during insertion.

The elongate shaft <NUM> of the deployment apparatus <NUM> may include a deployment device that it utilizes in the deployment procedure. The deployment device may comprise any device utilized in the deployment procedure. The deployment device, for example, may comprise an implant retention device <NUM>, which for example may comprise a sheath to forming a capsule over an implant retention area. The implant may be retained in the implant retention device <NUM> until the desired time for deployment of the implant. The elongate shaft <NUM> may be inserted into the subject and navigated to the desired deployment location to position the implant retention device <NUM> as desired. The deployment apparatus <NUM> may then be operated to deploy the implant from the implant retention device <NUM> by the implant retention device <NUM> retracting the sheath to expose the implant, allowing the implant to be deployed. In embodiments, the deployment device may comprise a dilation device. For example, the deployment device may comprise an expandable balloon that is utilized to dilate a native valve prior to implantation of the implant, or during or following implantation. In embodiments, the deployment device may comprise a combination of a dilation device and an implant retention device, or other devices. For example, a single deployment apparatus may be configured to perform the deployment operation of dilation, as well as the deployment operation of implant deployment. Other methods may be performed by the deployment apparatus as well.

The elongate shaft <NUM> may further include a nose cone <NUM> at the distal end <NUM> of the elongate shaft <NUM>. The nose cone <NUM> may form the tip of the elongate shaft <NUM> and may be pliable to avoid injury to portions of the subject contacted by the tip of the elongate shaft <NUM>.

Although features of the disclosure are disclosed in regard to the deployment apparatus <NUM> shown in <FIG>, various other forms of deployment apparatuses may be utilized with the embodiments disclosed herein.

A possible issue surrounding insertion and navigation of a deployment apparatus <NUM> to an implant location, as well as actual deployment of an implant to an implant location, is the possibility of particles entering into the bloodstream of the subject or otherwise being produced. Such particles may comprise emboli or other forms of particles that may have severe deleterious effects for a subject. For example, such particles may produce strokes among other maladies of the subject. Accordingly, it may be advantageous to provide a filter for trapping such particles.

<FIG> illustrates a side schematic view of a filter <NUM> that may be utilized to trap particles in the filter <NUM>. Such particles may include emboli or other forms of particles. The filter <NUM> may be configured to allow blood to pass therethrough and trap emboli or other forms of particles. The filter <NUM> may include a filter body <NUM>, a filter base <NUM>, a filter support <NUM>, and one or more support tethers <NUM>. The filter <NUM>, together with a deployment apparatus <NUM> as shown in <FIG> for example, may form a deployment system for an implant, such as the implant <NUM> discussed in regard to <FIG>. The filter <NUM> may be configured to extend radially outward from the elongate shaft <NUM> of the deployment apparatus <NUM> in a deployed state.

The filter body <NUM> may comprise a flattened body (which may include a sheet or panel of material) that includes a plurality of openings (as shown in <FIG>) and/or may be formed into a shape (such as conical or another shape). The openings may be formed in variety of manners. For example, the filter body <NUM> in one embodiment may be made of a woven material or may otherwise be arranged in a grid that leaves openings between the body of the material. The filter body <NUM> may comprise a mesh material, forming a grid that leaves openings between the body of the material. In embodiments, the filter body <NUM> may be made of a unitary sheet of material that has micropores produced on the material. In embodiments, the filter body <NUM> may comprise a diffusive material that allows liquid diffusion through the material yet captures particles. Other forms of filter bodies <NUM> may be utilized as desired.

The filter body <NUM> may comprise a flexible movable body that may be formed into shapes and may be configured to transition from an undeployed state or configuration to a deployed state or configuration. <FIG>, for example, illustrates the filter body <NUM> in an undeployed, compressed, or flattened state in which the outer radius of the filter body <NUM> is less than in the deployed, uncompressed, or expanded state. An example of the filter body <NUM> in a deployed, uncompressed, and expanded configuration is shown in <FIG> in which the filter body <NUM> has a larger outer radius than in the unexpanded configuration. The filter <NUM> may extend radially outward from the elongate shaft <NUM> to a greater radial extent than in the undeployed state. Further, as shown in <FIG>, the filter body <NUM> may form an opening <NUM> of an interior cavity <NUM> for retaining the particles and that is configured to trap the particles. The filter body <NUM> may extend around the interior cavity <NUM>. In embodiments, the opening <NUM> is positioned at the distal portion of the filter body <NUM>.

Referring back to <FIG>, the filter body <NUM> may extend around the elongate shaft <NUM> and particularly around the outer surface of the elongate shaft <NUM>. The filter body <NUM> may extend around the entire outer circumference of the elongate shaft <NUM>.

The filter body <NUM> may be configured to slide along the outer surface relative to the elongate shaft <NUM> in either the undeployed or deployed configuration. The filter body <NUM> may be configured to slide in proximal and distal directions.

The filter base <NUM> may be positioned at a proximal portion of the filter body <NUM>. A proximal portion of the filter body <NUM> may be configured to couple to the filter base <NUM>. The filter base <NUM> may couple the filter body <NUM> to the elongate shaft <NUM> and may comprise a ring or other body. The filter base <NUM> may extend around the entire outer circumference of the elongate shaft <NUM> similar to the filter body <NUM>. The filter base <NUM> may include couplers <NUM> configured to couple to a control device such as a sheath for controlling the position of the filter body <NUM>. The couplers <NUM> may comprise ball and socket couplers as shown in <FIG>, or may comprise any other form of coupler. The filter base <NUM> may be configured to slide along the outer surface of the elongate shaft <NUM>.

The filter support <NUM> may include a body that couples to and supports a distal portion of the filter body <NUM>. The filter support <NUM> may comprise a ring or other body and may be configured to extend around the elongate shaft <NUM>. The filter support <NUM> may be configured to be positioned distal of a proximal portion of the filter body <NUM> and configured to couple to the elongate shaft <NUM>. The filter support <NUM> may be configured to couple to tethers <NUM> that couple the filter support <NUM> to the distal portion of the filter body. The filter support <NUM> may be configured to slide along the outer surface of the elongate shaft <NUM> and slide relative to the filter body <NUM>.

The support tethers <NUM> may be configured to couple to a distal portion of the filter body <NUM>, such as the portion proximate to the opening <NUM>. The support tethers <NUM> may extend from the filter support <NUM> to the distal portion of the filter body <NUM>. The support tethers <NUM> may comprise cords or wires or other forms of tethers as desired. The tethers <NUM> may be configured to extend radially outward from the outer surface of the elongate shaft <NUM> when the filter body <NUM> transitions to the deployed state.

A retainer may be utilized to retain the filter <NUM> in an undeployed state or configuration until the time to deploy the filter <NUM>. As shown in <FIG>, the retainer may comprise a sheath <NUM> configured to extend over the filter <NUM>, particularly the filter body <NUM>. However, in other embodiments, the retainer may have a different form, including a clip, a latch, one or more wires, or another form of retainer. The sheath <NUM> may extend over the filter <NUM>, and in some embodiments over the entirety of the filter <NUM>, and may have a diameter sized to press against the filter <NUM> to maintain the filter <NUM> in the undeployed configuration. The sheath <NUM> may be configured to slide along the outer surface of the elongate shaft <NUM>, in a proximal direction, to allow the filter <NUM> to transition to the deployed state. The sheath <NUM> is shown in cross section in <FIG>. The sheath <NUM> may include couplers <NUM> that may be configured similarly as the couplers <NUM> of the filter base <NUM>.

A portion or all of the filter <NUM> may be self-expanding. The filter <NUM> may be made of a shape memory material to automatically transition to a deployed configuration upon being released by the retainer shown in the form of the sheath <NUM>. Such a shape memory material may comprise nitinol or another form of shape memory material. For example, all or a portion of the filter body <NUM> may be made of a shape memory material to cause the filter body <NUM> to transition to the deployed configuration upon the sheath <NUM> uncovering or otherwise exposing the filter body <NUM>. In embodiments, the tethers <NUM> may be made of a shape memory material to extend the filter body <NUM> outward into a deployed configuration.

The filter <NUM> may be coupled to a control device for controlling operation of the filter <NUM>. The control device may control the expansion of the filter <NUM> and may control the position of the filter <NUM> upon the elongate shaft <NUM>. As shown in <FIG>, the control device may comprise two sheaths <NUM>, <NUM>. The sheath <NUM> may extend over the sheath <NUM>. The inner sheath <NUM> may couple to the filter <NUM> (particularly the coupler <NUM> of the filter base <NUM>) and the outer sheath <NUM> may couple to the retainer in the form of the sheath <NUM>. The sheaths <NUM>, <NUM> may both be configured to have a distal end coupled to the respective filter <NUM> and sheath <NUM>, and may include a body that slides along the elongate shaft <NUM> to vary a position of the filter <NUM> and the sheath <NUM> upon the elongate shaft <NUM>. Thus, as the sheaths <NUM>, <NUM> are slid distally along the elongate shaft <NUM> the filter <NUM> and sheath <NUM> are slid distally, and as the sheaths <NUM>, <NUM> are slid proximally along the elongate shaft <NUM> the filter <NUM> and sheath <NUM> are slid proximally.

The control device in the form of the sheaths <NUM>, <NUM> may be utilized with the elongate shaft <NUM> without significant modification of the elongate shaft <NUM> or the handle <NUM>. For example, referring to <FIG>, which illustrates a cross sectional view along line <NUM>-<NUM> in <FIG>, each sheath <NUM>, <NUM> may include a respective longitudinal cut or gap <NUM>, <NUM> extending longitudinally along the sheath <NUM>, <NUM> such that each sheath <NUM>, <NUM> may be passed over the elongate shaft <NUM> through the gap openings. Thus, referring back to <FIG>, each sheath <NUM>, <NUM> may slid onto the elongate shaft <NUM> through the gaps <NUM>, <NUM> shown in <FIG>. The sheaths <NUM>, <NUM> accordingly may be made flexible to allow for the elongate shaft to pass through the gaps <NUM>, <NUM>.

The elongate sheath <NUM> may be coupled to the filter <NUM> and may have a length with the longitudinal cut or gap <NUM> extending along the length of the elongate sheath <NUM>. An interior cavity <NUM> may be configured to receive the elongate shaft <NUM> of the deployment apparatus. The elongate sheath <NUM> may be configured to couple to the elongate shaft <NUM> of the deployment apparatus by the elongate shaft <NUM> being passed through the longitudinal cut or gap <NUM> of the elongate sheath <NUM> to be positioned within the interior cavity <NUM> of the elongate sheath <NUM>. The elongate sheath <NUM> is configured to be slid onto the elongate shaft <NUM> with the elongate shaft <NUM> passing through the cut <NUM> of the elongate sheath <NUM>. The elongate sheath <NUM> surrounds the elongate shaft <NUM> as shown in <FIG>. The elongate sheath <NUM> joins with the elongate shaft <NUM> in a similar manner through the cut <NUM>, and extends over the elongate sheath <NUM>. Distal portions of the sheaths <NUM>, <NUM> may be engaged with the elongate shaft <NUM> and proximal portions of the sheath <NUM>, <NUM> may be disengaged, with the proportion of the engaged and disengaged portions varying due to the movement of the sheaths <NUM>, <NUM> either on or off the elongate shaft <NUM>.

In this manner, the distal movement of the filter <NUM> and the sheath <NUM> may be controlled by the length of the sheath <NUM>, <NUM> that is slid onto the elongate shaft <NUM> distally, and the proximal movement of the filter <NUM> and the sheath <NUM>, <NUM> may be controlled by the length of the sheath <NUM>, <NUM> that is slid off of the elongate shaft <NUM> proximally in a reverse operation. The elongate shaft <NUM> may be inserted into the interior cavity <NUM> through the cuts <NUM>, <NUM> extending along the lengths of the elongate sheaths <NUM>, <NUM>. A distal portion of the elongate sheath <NUM> may be coupled to the filter <NUM>. The elongate sheaths <NUM>, <NUM> may be slid distally along the elongate shaft <NUM> according to embodiments herein, and the filter <NUM> may be deployed within the vasculature of the subject.

Further, rotational control of the rotational orientation of the filter <NUM> and sheath <NUM> may be provided by rotating the proximal portion of the sheath <NUM>, <NUM> that the individual is gripping.

Other control devices may be utilized, including wire guided control or motorized control, among other forms of control devices. The housing comprising the handle <NUM> may be modified in certain embodiments to allow a sheath to pass through the handle <NUM>.

In operation, the filter <NUM>, covered with the sheath <NUM> may be advanced distally along the elongate shaft <NUM> to a desired position. The sheaths <NUM>, <NUM> shown in <FIG> may be slid onto the elongate shaft <NUM> to increase the length of the sheaths <NUM>, <NUM> upon the elongate shaft <NUM> and move the filter <NUM> and sheath <NUM> proximally. In certain embodiments, the filter <NUM> may be slid into the subject along with the elongate shaft <NUM>, and thus may remain in position with the elongate shaft <NUM> during insertion of the elongate shaft <NUM>. The filter <NUM> may subsequently have its position adjusted to a desired location.

The filter <NUM> may be deployed by the sheath <NUM> being withdrawn proximally to uncover the filter <NUM>. Such a configuration is shown in <FIG>. The filter <NUM> transitions to the expanded or deployed state or configuration, with an increased outer radius than shown in <FIG>. The tethers <NUM> may restrain the distal portion of the filter <NUM> from further expansion. The filter <NUM> may form a configuration as shown in perspective view in <FIG>. The filter body <NUM> may form a conical shape enclosing an interior cavity <NUM>. The conical shape may increase in size from a proximal portion of the filter body <NUM> to a distal portion of the filter body <NUM>. The filter body <NUM> may transition to the deployed state in which the filter body <NUM> extends radially outward from the elongate shaft <NUM> and increases in size from the proximal portion to the distal portion. The filter body <NUM> is configured to trap particles in the filter body <NUM>.

The proximal end of the filter body <NUM> couples to the filter base to prevent particles from passing through the filter body <NUM> at the apex of the conical shape. In other embodiments, other shapes of filter bodies <NUM> may be utilized, including spheroid or dome shaped, cylindrical, rectangular, or triangular, among others. A conical shape may preferably have a large symmetrical opening <NUM> at a distal portion of the filter body <NUM> that may contour to the shape of the vasculature of the subject. The distal portion may be made flexible and may comprise a contact surface for contacting an interior of the vasculature. The taper of the conical shape may drive the trapped particles to a central position at the proximal end of the filter body <NUM>.

The filter <NUM> may be deployed to allow fluid, including colloid fluid (such as blood), to pass through, yet to trap particles. As such, the openings of the filter <NUM> may be sized as desired to prevent particles of a certain size from passing through and may yet allow colloidal members of fluid to pass.

With the desired particles trapped by the filter <NUM>, the sheath <NUM> may be advanced distally by the sheath <NUM> being advanced distally. Such a movement may slide the sheath <NUM> back over the filter <NUM> to produce a configuration as shown in <FIG>. The filter body <NUM> may close upon any particles trapped therein, to retain the particles under the sheath <NUM> and within the filter body <NUM>. The entire elongate shaft <NUM> may then be retracted along with the filter <NUM> and sheath <NUM>, or the filter <NUM> and sheath <NUM> may be retracted separately.

<FIG> and <FIG> illustrate a possible position of the filter <NUM> in use. The filter <NUM> inserted within the subject, with the filter <NUM> positioned upon an elongate shaft <NUM> of a deployment apparatus. The filter <NUM> is deployed within vasculature of the subject, with the filter <NUM> extending radially outward from the elongate shaft <NUM> and configured to trap particles in the filter <NUM>. The elongate shaft <NUM> may be advanced distally to the desired implantation location for the implant as shown in <FIG> as the aortic valve <NUM>. The filter <NUM> may be slid upon the elongate shaft <NUM> if desired. The filter <NUM> may be positioned proximal of the deployment device of the deployment apparatus. Prior to, during, or possibly even after the deployment of the implant occurs, the filter <NUM> may be placed in position.

As shown in <FIG>, the filter <NUM> is positioned proximal of the distal end of the elongate shaft <NUM> and proximal of the deployment device <NUM> and is configured to trap particles passing proximally from the distal end of the elongate shaft <NUM> and from the deployment device <NUM>.

The filter <NUM> is shown to be deployed within the aortic arch proximal of the aortic valve <NUM>. The filter <NUM> may be deployed via operation of a control device (e.g., the sheaths <NUM>, <NUM>) that may release the retainer and cause the filter <NUM> to transition from an undeployed state to a deployed state. The filter <NUM> is positioned within a blood vessel of the subject and is positioned proximal of a heart valve (the aortic valve) that the deployment apparatus is deploying a device to. The filter <NUM> is positioned distal of the arteries extending from the aortic arch, to trap any particles that otherwise may pass through such arteries. The filter <NUM> is positioned proximal of a deployment device of the deployment apparatus. The opening of the filter <NUM> faces distally and the interior cavity of the filter <NUM> is configured to retain particles travelling proximally from the deployment device of the deployment apparatus.

The deployment device <NUM> as shown in <FIG> may comprise an inflatable balloon, which may dilate the aortic valve <NUM> prior to deployment of the implant. The filter <NUM> may be slid along the elongate shaft <NUM> to be placed in position. Here, the filter <NUM> may beneficially trap any calcification or other particles that are released in the proximal direction during an aortic valve deployment procedure. The filter <NUM> may be utilized to trap particles as a result of an implant deployment procedure, which as shown in <FIG> may include inflating a balloon to dilate the aortic valve <NUM>. Such other procedures may include actual implantation of the implant, and any subsequent dilation of the implant or the aortic valve, among other procedures. The filter <NUM> may then be transitioned to the undeployed state and retracted along with the elongate shaft <NUM> and withdrawn from the subject. The filter <NUM>, when closed, may trap the particles therein for removal from the subject.

<FIG> illustrates an implant <NUM> that may be deployed by the deployment apparatus and may remain in position within the native valve. The deployment apparatus and filter <NUM> may be retracted proximally and withdrawn from the subject.

<FIG> illustrates an embodiment of a filter <NUM> that may include a plurality of micropores to allow colloidal fluid to pass through, yet allow the filter body to trap particles. The filter <NUM> may not utilize a filter base or filter support or tethers. The filter <NUM>, for example, may be coupled directly to a position on the elongate shaft <NUM>. A control device in the form of a sheath <NUM> may be utilized to expand and collapse the filter <NUM> in a manner disclosed herein.

<FIG> illustrates an embodiment of the presently claimed invention in which a control device may be in the form of a control tether <NUM> such as a push or pull tether. In embodiments, other forms of control devices may be utilized.

The control device passes through a proximal portion <NUM> of the filter body <NUM> and couples to the filter support <NUM>. The control device is configured to be slid relative to the filter body <NUM> to slide the filter support <NUM> to move the support tethers <NUM> and transition the filter body <NUM> to the deployed state. The control device is configured to be slid proximally relative to the filter body <NUM> to slide the filter support <NUM> to move one or more support tethers <NUM> and transition the filter body <NUM> to the deployed state.

The control device may be slid to move the tethers <NUM> and accordingly expand or collapse the filter <NUM> as desired. The control device may have a proximal end configured to be controlled by an individual, similar to the proximal end <NUM> shown in <FIG> for example. The control device may be slid to transition the filter body <NUM> to the deployed state. The filter <NUM> may remain in position on the elongate shaft <NUM> or may have a variable position controlled by another control device if desired (e.g., the filter <NUM> may be slidable along the elongate shaft <NUM>). The control device may be configured to be slid distally relative to the filter body <NUM> to slide the filter support <NUM> to move one or more support tethers <NUM> and transition the filter body <NUM> to an undeployed state. Further, by varying the position of the control device, by sliding the control device, a size of the distal portion of the filter body <NUM> may be controlled.

Various other modifications are within the scope of this disclosure.

<FIG> illustrates an embodiment of a catheter sheath that may be utilized in a catheter system. As shown, the catheter sheath comprises an introducer sheath <NUM>, yet other forms of catheter sheaths may be utilized herein. The catheter sheath that may utilize a filter. The introducer sheath <NUM> may include an elongate shaft <NUM> having a proximal end <NUM> and a distal end <NUM> and an interior lumen <NUM> (marked in <FIG>) configured for another apparatus to pass through. For example, an apparatus such as a deployment apparatus <NUM> as shown in <FIG> may be utilized in embodiments.

A handle <NUM> may be positioned at the proximal end <NUM> of the elongate shaft <NUM> and may be configured to be gripped by a user. The introducer sheath <NUM> may be utilized to be introduced into a subject and may serve as a channel for other apparatuses to pass through to perform procedures within a subject.

In embodiments, the introducer sheath <NUM> may be flexible and configured to flex along with a curved or tortuous path of the vasculature. In embodiments, the introducer sheath <NUM> may be sufficiently long to pass, for example, from an entry point in the subject's leg, over the aortic arch and may have the distal end <NUM> positioned proximate the native aortic valve. Other lengths and configurations of introducer sheaths <NUM> may be utilized in embodiments.

<FIG> illustrates a cross sectional view of the distal end <NUM> of the introducer sheath <NUM>. A filter <NUM> may be positioned within the interior lumen <NUM> of the introducer sheath <NUM> and may be retained within the interior lumen <NUM> in an undeployed or unexpanded state. As such, the filter <NUM> may be retained within the lumen <NUM> by the interior surface <NUM> of the wall <NUM> of the elongate shaft <NUM>.

The filter <NUM> may be configured to be biased to expand radially outward from the interior lumen <NUM>. The filter <NUM>, for example, may have a shape memory that causes the filter <NUM> to expand radially outward upon being passed out of the lumen <NUM> of the elongate shaft <NUM>. The filter <NUM> may otherwise be configured to expand, for example, via a spring bias force or other device to cause the filter <NUM> to expand radially outward.

The filter <NUM>, in embodiments, may comprise a mesh material or other material configured to trap particles, yet allow fluid, including colloidal fluid such as blood, to pass through. Other configurations of filters, such as configurations utilizing micropores or other configurations as disclosed herein, may be utilized.

The filter <NUM> may have a proximal portion <NUM> that is coupled to a control device <NUM>. The control device <NUM>, for example, may comprise a shaft that extends along the lumen <NUM> of the elongate shaft <NUM>. The shaft may comprise a sheath having its own interior lumen <NUM> that may allow apparatuses to pass therethrough. The shaft may have a proximal end <NUM> (as shown in <FIG>) that a user may control to control movement of the filter <NUM>. In embodiments, other configurations of control devices such as tethers or other forms of devices for controlling movement of the filter <NUM> may be utilized.

<FIG> illustrates the filter <NUM> expanded out of the distal end <NUM> of the introducer sheath <NUM>. The control device <NUM> may be advanced distally by the user distally advancing the proximal end <NUM> (shown in <FIG>) of the control device <NUM>. The filter <NUM> may advance distally and may expand radially outward as shown in <FIG>. The shape may be a conical shape as shown in <FIG>, or another shape as desired. The filter <NUM> may include an interior cavity <NUM> configured to trap particles therein. The filter <NUM>, in the expanded state shown in <FIG>, may be positioned to allow an apparatus to pass through the interior lumen <NUM> of the control device <NUM> and the interior lumen <NUM> of the introducer sheath <NUM>.

<FIG>, for example, illustrate an exemplary use of the introducer sheath <NUM>. The introducer sheath <NUM> may have a length sufficient to extend over the aortic arch and towards the aortic valve <NUM> as shown in <FIG>. The introducer sheath <NUM> may have sufficient flexibility to extend over the aortic arch.

The filter <NUM> may then be extended out of the distal end <NUM> of the introducer sheath <NUM>. The filter <NUM> may be advanced distally as shown in <FIG> to be deployed at the desired position. The filter <NUM>, as shown in <FIG>, may be deployed at a position that is proximate the aortic valve <NUM> and between the aortic valve <NUM> and channels that particle may flow into, such as the ostia <NUM> positioned along the aortic arch. As such, the filter <NUM> may reduce the possibility of particles from entering such ostia <NUM> and producing an adverse effect for the subject.

<FIG>, for example, illustrates an elongate shaft <NUM> of a deployment apparatus passing through the introducer sheath <NUM>, for deployment to the aortic valve <NUM>. Various procedures may be provided at the aortic valve <NUM>. Such procedures may release particles, which may flow in a downstream direction and may be captured by the filter <NUM>.

Following a procedure being performed to the aortic valve <NUM>, the deployment apparatus may be retracted from the introducer sheath <NUM> and the filter <NUM> and introducer sheath <NUM> may be retracted as well. The particles trapped within the filter <NUM> may be removed with the filter <NUM> and introducer sheath <NUM>. In embodiments, the control device <NUM> shown in <FIG> may be retracted to cause the filter <NUM> to retract into the interior lumen <NUM> of the introducer sheath <NUM>.

Various modifications to the filters and methods of utilization may be provided.

<FIG>, for example, illustrates an embodiment of a filter <NUM> configured to automatically deploy upon an apparatus being passed through the interior lumen <NUM> of a catheter sheath. In embodiments, the catheter sheath may comprise an expandable catheter sheath that is configured to be inserted into a vasculature and have an interior lumen <NUM> configured for an apparatus to be passed through, the interior lumen <NUM> having an interior diameter <NUM> that is configured to increase upon the apparatus passing through the interior lumen <NUM>. The catheter sheath may comprise an expandable introducer sheath <NUM> that is configured to expand radially outward.

The interior lumen <NUM> of the expandable introducer sheath <NUM> may have a diameter <NUM>. The diameter <NUM> may be configured to increase upon an apparatus passing through the interior lumen <NUM>. The wall <NUM> of the expandable introducer sheath <NUM>, for example, may be configured to expand. The expansion may occur due to the wall <NUM> deforming upon the apparatus passing through the interior lumen <NUM>. The wall <NUM>, for example, may be constructed of an expandable or tearable material that deforms upon an apparatus passing through the interior lumen <NUM>. The deformation may comprise a plastic deformation in embodiments that may reduce the possibility of the wall <NUM> returning to the narrow diameter <NUM> shown in <FIG>. In embodiments, the wall <NUM> may include one or more folded portions that may allow the wall <NUM> to expand upon an apparatus passing through the interior lumen.

The filter <NUM> may be positioned at a distal portion of the expandable catheter sheath and may be configured to expanded from an undeployed state radially outward to a deployed state in response to the apparatus passing through the interior lumen <NUM> and applying a radially outward force to the interior lumen <NUM>.

The filter <NUM> may be coupled to the introducer sheath <NUM> and may be coupled to the wall <NUM>. The filter <NUM>, in embodiments, may be embedded within the wall <NUM>, and may be embedded in an unexpanded state as shown in <FIG>. The wall <NUM>, for example, may comprise a multi-layered structure, and one of the layers may include the filter <NUM> in an unexpanded state.

Layers may include a liner layer <NUM> that may be positioned radially inward of the filter <NUM> and between the filter <NUM> and the interior lumen <NUM>. The liner layer <NUM> may be configured to contact the apparatus as the apparatus passes through the interior lumen <NUM> and applies the radial outward force to the interior lumen. The filter <NUM> may be positioned in a mid-layer <NUM> that may extend over the liner layer <NUM>. In embodiments, an outer layer or retention layer <NUM> may be positioned radially outward of the filter <NUM> and configured to retain the filter <NUM> in the undeployed state. The retention layer <NUM> may extend over the filter <NUM> to retain the filter <NUM> in the undeployed or unexpanded state. In embodiments, the retention layer <NUM> may include pores <NUM> or other forms of openings that may be configured to allow fluid to flow therethrough when the filter <NUM> is deployed.

The filter <NUM> in the unexpanded state may have a cylindrical shape, or may have another shape as desired.

An apparatus, such as an elongate shaft <NUM> of a deployment apparatus <NUM>, may be passed through the interior lumen <NUM> and may have a diameter <NUM> that is larger than the diameter <NUM> of the interior lumen <NUM> shown in <FIG>. As shown in <FIG>, the relatively large diameter <NUM> of the apparatus, as the apparatus is passed through the interior lumen <NUM>, may expand the wall <NUM> of the introducer sheath <NUM> radially outward. A radially outward force may be applied by the apparatus to the interior surface <NUM> of the wall <NUM>. The radially outward force may deform the wall <NUM>, as discussed herein.

As the apparatus approaches the filter <NUM> of the introducer sheath <NUM>, which may be positioned at the distal end <NUM> of the introducer sheath <NUM>, the force of the apparatus against the wall <NUM> may deform the retention layer <NUM> and may reduce the force applied by the retention layer <NUM> against the filter <NUM>. The retention layer <NUM>, for example, may be configured to deform in the response to the apparatus passing through the interior lumen <NUM> and applying the radial outward force to the interior lumen <NUM>. The retention layer <NUM> may be deformed to change its structural configuration such that the retention force applied by the retention layer <NUM> to the filter <NUM> may be reduced. Such reduction may be due to a deformation of the retention layer <NUM>, which may be a plastic deformation of the retention layer <NUM>, a tearing of the retention layer <NUM>, or an unfolding of at least one fold of the retainer layer <NUM> in an embodiment in which the retention layer <NUM> includes at least one fold (such as an embodiment as shown in <FIG>). In an embodiment in which the retention layer is torn, a tear or split line, such as perforations, may be provided on the retention layer <NUM>. The retention layer <NUM> may reduce its retention force against the filter <NUM>, and allow the filter <NUM> to expand radially outward to the configuration shown in <FIG>, for example.

As such, as an apparatus is passed through the interior lumen of the expandable catheter sheath positioned within the subject, a radially outward force may be applied to the interior lumen <NUM> to expand the filter <NUM> positioned at the distal end of the expandable catheter sheath from the undeployed state radially outward to the deployed state.

The filter <NUM> may be biased radially outward, and with the reduce retention force applied by the retention layer <NUM> may be configured to form a shape extending radially outward from the introducer sheath <NUM>, as shown in <FIG>. The filter <NUM>, as such, may be in position to trap particles therein, in a similar manner as discussed in regard to <FIG> for example. The filter <NUM> may include a filter body that includes a plurality of openings, as disclosed herein. The filter <NUM> may have a conical shape as disclosed herein when the filter is in the deployed state, with the conical shape increasing in size from a proximal portion of the filter body to a distal portion of the filter body. The retention layer <NUM> may include pores <NUM>, in embodiments, which may allow the filter <NUM> to continue to allow fluid, including colloidal fluid such as blood to pass through, yet while retaining particles therein. The filter <NUM> may filter blood within the subject.

The filter <NUM> may automatically deploy to the deployed or expanded state shown in <FIG> upon an apparatus passing through the interior lumen <NUM>. As such, the activation of the filter <NUM> may be a passive activation according to embodiments herein.

Upon completion of a medical procedure utilizing the apparatus, the apparatus and introducer sheath <NUM> may be withdrawn, with the filtered particles retained within the filter <NUM>.

Various configurations of the filters and sheaths disclosed herein may be provided.

<FIG>, for example, illustrates an embodiment of an introducer sheath in which the retainer layer <NUM> includes fold portions 132a, b configured to unfold as an apparatus is passed through the interior lumen <NUM>. The unfolding of the fold portions 132a, 132b, may allow the filter <NUM> to expand to the expanded configuration, as shown in <FIG> for example. The introducer sheath may include at least one fold portion in embodiments herein.

<FIG> illustrates an embodiment of a catheter sheath in the form of an introducer sheath <NUM> configured to be inserted into a vasculature and having a length and an interior lumen configured for an apparatus to be passed through. The introducer sheath <NUM> may have a distal portion <NUM>, a central portion <NUM>, and a proximal portion <NUM>, with a filter <NUM> positioned at the central portion <NUM> of the introducer sheath <NUM>. The introducer sheath <NUM> may otherwise be configured similarly as the other introducer sheaths disclosed herein. For example, the introducer sheath <NUM> may be configured to expand in embodiments. The introducer sheath <NUM> may include a handle <NUM> coupled to the proximal portion <NUM> of the introducer sheath <NUM>.

<FIG> illustrates a close-up cross-sectional view of the filter <NUM> positioned on the introducer sheath <NUM>. The introducer sheath <NUM> may include an interior lumen <NUM> and a wall <NUM> extending around the interior lumen <NUM>. The filter <NUM> may be configured to extend radially outward from the wall <NUM>, and may surround the introducer sheath <NUM>. The filter <NUM> may have a proximal portion <NUM> that is coupled to the wall <NUM> and may have a distal portion <NUM> that extends in a distal direction relative to the introducer sheath <NUM>. The filter <NUM> may increase in size from the proximal portion of the filter <NUM> to the distal portion of the filter <NUM> in a direction towards a distal portion of the introducer sheath <NUM>. The distal portion <NUM> may form an opening that leads to an interior cavity <NUM> for retaining particles therein, similar to the configuration of other filters disclosed herein. In embodiments, the filter <NUM> may have a conical shape, or another shape as desired when in a deployed state. The filter <NUM> may include a filter body having a plurality of openings, as disclosed herein. In embodiments, biasing members such as supports <NUM> may be configured to apply a radially outward force against the filter <NUM> to bias the filter <NUM> radially outward to the deployed state. The supports <NUM>, for example, in embodiments, may comprise one or more springs such as leaf springs or other forms of springs. In embodiments, a shape memory for the filter <NUM> may be provided, utilizing shape memory materials. Any embodiment of filter disclosed herein may utilize a shape memory and shape memory materials as desired.

The filter <NUM> accordingly may be configured to transition from an undeployed state or state in which the filter <NUM> is compressed to the introducer sheath <NUM>, and a deployed state as shown in <FIG>, in which the filter <NUM> extends radially outward from the introducer sheath <NUM> to trap particles in the filter <NUM>. The supports <NUM> may transition the filter <NUM> towards the deployed state.

The filter <NUM> is preferably positioned at the central portion <NUM> or the proximal portion <NUM> of the introducer sheath <NUM>. The filter <NUM> preferably is positioned at such a location to enhance the likelihood of the filter <NUM> trapping particles passing along the introducer sheath <NUM> as the introducer sheath is inserted into the vasculature, with the introducer sheath possibly contacting the interior surface of the vasculature and releasing particles from the interior surface. Such contact may be more likely at a central <NUM> or proximal portion <NUM> of the introducer sheath <NUM>, as typically the diameter of the vasculature is lesser at the entry point of the introducer sheath <NUM> into the vasculature. As such, particles created upon the entry of the introducer sheath <NUM> into the vasculature may be greater at a central <NUM> or proximal portion <NUM> of the introducer sheath <NUM> and thus the filter <NUM> may beneficially be provided at such a location. In embodiments, the filter <NUM> may be positioned proximate the handle <NUM>.

Further, as the introducer sheath <NUM> is withdrawn, particles may also be created by the contact of the introducer sheath <NUM> with the interior surface of the vasculature, and a filter <NUM> positioned at a central <NUM> or proximal portion <NUM> may enhance the ability of the filter <NUM> to trap such particles.

<FIG>, for example, illustrates the introducer sheath <NUM> being inserted through a skin <NUM> and into the vasculature. <FIG>, for example, illustrates the introducer sheath <NUM> inserted into a vasculature. The introducer sheath <NUM> is passed through the skin <NUM> and positioned within the vasculature, such as a venous structure, which may be an artery or vein. The filter <NUM> extends radially outward and may contact the interior surface <NUM> of the vasculature. The handle <NUM> remains exterior to the skin. Notably, the introducer sheath <NUM> itself during insertion or withdrawal, may contact the interior surface <NUM> of the vasculature. Thus, particles may be released from the interior surface <NUM> and may be trapped by the filter <NUM>.

At a desired time, the introducer sheath <NUM> may be withdrawn from the vasculature. Such a time may be at the completion of a procedure within the subject. <FIG>, for example, illustrates a withdrawal procedure. During withdrawal, the introducer sheath <NUM> may contact the interior surface <NUM> of the vasculature and release further particles <NUM>. Such particles <NUM> may be trapped by the filter <NUM> and may be retained between the filter <NUM> and the exterior surface of the introducer sheath <NUM>. The angle of the filter <NUM> may be such that as the introducer sheath <NUM> is withdrawn from the vasculature as shown in <FIG>, the bias of the support <NUM> may be overcome and the filter <NUM> may collapse to transition to an unexpanded or undeployed state. The particles <NUM> accordingly may be trapped by the filter <NUM> between the filter <NUM> and the introducer sheath <NUM> with the filter <NUM> in the undeployed state and withdrawn from the subject. Such an operation may occur automatically when the filter <NUM> is retracted from the vasculature due to the angled shape of the filter <NUM>.

Various other configurations of filters may be utilized in embodiments. <FIG>, for example, illustrates an embodiment of the filter <NUM> positioned upon a jacket or sheath <NUM> that is slidable relative to the introducer sheath <NUM>. As such, the filter <NUM> may be variably positioned upon the introducer sheath <NUM>. In such an embodiment, as the introducer sheath <NUM> is withdrawn from the vasculature, the filter <NUM> may be held in position at the interior surface <NUM> of the vasculature. As such, the filter <NUM> may be in position to trap all the particles produced by the introducer sheath <NUM> contacting the interior surface <NUM> while being retracted proximally out of the subject. Once the introducer sheath <NUM> is fully retracted, the jacket or sheath <NUM> coupled to the filter <NUM> may be retracted and collapsed by being drawn through the opening in the skin, in a similar manner as shown in <FIG>.

The configuration of the filters and other components of the deployment systems may be varied in other embodiments.

The use of a filter disclosed herein is not limited to use with a deployment system or a deployment apparatus and may extend to use with any medical device to be inserted or withdrawn within a subject. For example, the use may extend to general medical cannula for insertion into a portion of a subject.

A filter may be utilized in a variety of subjects and procedures. Subjects include (but are not limited to) medical patients, veterinary patients, animal models, cadavers, and simulators of the cardiac and vasculature system (e.g., anthropomorphic phantoms and explant tissue). Procedures include (but are not limited to) medical and training procedures.

The deployment apparatus and the systems disclosed herein may be used in transcatheter aortic valve implantation (TAVI). The deployment apparatus and the systems disclosed herein may be utilized for transarterial access, including transfemoral access, to a subject's heart. In embodiments, various forms of implants may be delivered by a deployment apparatus utilized with system herein, such as stents or filters, or diagnostic devices, among others. The deployment apparatus may be utilized for mitral, tricuspid, and pulmonary replacement and repair as well. Other forms of implants may include stents, clips, and sutures that may be used for valve repair, among other forms of implants.

The deployment systems may be utilized in transcatheter percutaneous procedures, including transarterial procedures, which may be transfemoral or transjugular. Transapical procedures, among others, may also be utilized.

Features of embodiments may be modified, substituted, excluded, or combined.

In addition, the methods herein are not limited to the methods specifically described and may include methods of utilizing the systems and apparatuses disclosed herein.

In closing, it is to be understood that although aspects of the present specification are highlighted by referring to specific embodiments, one skilled in the art will readily appreciate that these disclosed embodiments are only illustrative of the principles of the subject matter disclosed herein. Therefore, it should be understood that the disclosed subject matter is in no way limited to a particular methodology, protocol, and/or reagent, etc., described herein. Lastly, the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to limit the scope of systems, apparatuses, and methods as disclosed herein, which is defined solely by the claims. Accordingly, the systems, apparatuses, and methods are not limited to that precisely as shown and described.

Certain embodiments of systems, apparatuses, and methods are described herein, including the best mode known to the inventors for carrying out the same. Of course, variations on these described embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventor expects skilled artisans to employ such variations as appropriate, and the inventors intend for the systems, apparatuses, and methods to be practiced otherwise than specifically described herein. Accordingly, the systems, apparatuses, and methods include all modifications of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described embodiments in all possible variations thereof is encompassed by the systems, apparatuses, and methods unless otherwise indicated herein or otherwise clearly contradicted by context.

Groupings of alternative embodiments, elements, or steps of the systems, apparatuses, and methods are not to be construed as limitation.

Unless otherwise indicated, all numbers expressing a characteristic, item, quantity, parameter, property, term, and so forth used in the present specification and claims are to be understood as being modified in all instances by the term "about. " As used herein, the term "about" means that the characteristic, item, quantity, parameter, property, or term so qualified encompasses an approximation that may vary, yet is capable of performing the desired operation or process discussed herein.

Claim 1:
A deployment system for deploying a filter (<NUM>) in a subject, the deployment system comprising:
a deployment apparatus including an elongate shaft (<NUM>) having a deployment device;
a filter body (<NUM>) having a proximal portion (<NUM>) and a distal portion, and configured to have a deployed state in which the filter body (<NUM>) extends radially outward from the elongate shaft (<NUM>) and increases in size from the proximal portion (<NUM>) to the distal portion, the filter body (<NUM>) configured to trap particles in the filter body (<NUM>);
a filter support (<NUM>) being positioned distal of the proximal portion (<NUM>) of the filter body (<NUM>) and configured to couple to the elongate shaft (<NUM>) and slide relative to the filter body (<NUM>);
one or more support tethers (<NUM>) extending from the filter support (<NUM>) to the distal portion of the filter body (<NUM>); and
a control device (<NUM>) passing distally through the proximal portion (<NUM>) of the filter body and coupling to the filter support (<NUM>), the control device (<NUM>) configured to be slid proximally relative to the filter body (<NUM>) to slide the filter support (<NUM>) proximally to move the one or more support tethers (<NUM>) and transition the filter body (<NUM>) to the deployed state.