Patent Description:
Recent pre-clinical research has focused on delivering therapeutic materials on scaffolds of bio-compatible materials to the heart to improve retention. These composite "patches" can improve retention of transplanted cells the therapeutic materials in the heart by providing a more hospitable environment as well as reducing washout via capillary and lymphatic channels. These composite patches can also direct cell activity and send molecular signals to the cells. Biomaterials can also act as scaffolds to localize therapeutic materials to a target area and/or in a sustained release manner. However, delivery of biomaterials to the heart by traditional methods typically requires open heart surgery. Additionally, traditional delivery techniques may not be safe because they could result in an embolism that could cause heart attacks and strokes, and intramyocardial delivery techniques could cause cardiac arrhythmias.

Thus, there is a need for an effective, less invasive and safe delivery of therapeutic materials to a region, such as the heart.

The invention, as drafted in claim <NUM>, defines a device for delivering one or more therapeutic materials to a treatment site, comprising:.

Different embodiments are defined in the dependent claims.

The device of the present invention is suitable for delivering therapeutic material (s) without requiring invasive heart surgery. This device allows delivery of bio-material embedded stem cells, cytokines, drugs, biologics, as well as other advanced therapeutics to the heart, for example, via the pericardium. This can allow the therapeutic materials to be delivered in a specific anatomic position (anterior wall, posterior wall, lateral wall) and also allow for adjustment of the size of the patch formed by the bio-material embedded therapeutic material. The delivery device can be temporarily left in place for minutes to days to allow gelation and/or engraftment of the delivered therapeutic materials.

The disclosure relates to a device for delivering one or more therapeutic materials. The device includes a body and one or more members that are movable with respect to the body. The one or more members are configured to connect and/or overlap with respect to the one or more members and/or the body to define a barrier region at the treatment site. The one or more delivery lumens are configured to deliver one or more therapeutic materials to the barrier region.

The device includes a body and at least one member that is movable with respect to the body. The at least one member is configured to define a barrier region at the treatment site. The one or more members may include at least one set of one or more ports disposed on a surface of at least one member and configured to deliver suction. The one or more members may include at least one set of delivery ports disposed on a surface of the at least one member so that the ports surround the barrier region and configured to deliver at least one therapeutic material.

Also described herein (not part of the invention) are methods for delivering one or more therapeutic materials within a pericardium space. In some embodiments, the method may include advancing one or more members into the pericardium space through a body of a device. The method may include forming a barrier region within the pericardium space by connecting or overlapping the one or more members with respect to the one or more members and/or the body. The method may also include delivering one or more therapeutic materials to the barrier region.

Additional advantages of the disclosure will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the disclosure. The advantages of the disclosure will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims.

The detailed technical disclosure set out below may in some respects go beyond the disclosure of the invention per se, and may also provide technical background for related technical developments. It will be appreciated that the additional technical background provided is not intended to define the invention as such (which is defined exclusively by the appended claims), but rather to place it in a broader technical context. Accordingly, it will be appreciated that the terms *examples" "aspects", "subject-matter" reflect specific details of the disclosure, but insofar as they refer to a part of the additional technical background, are not intended to define as part of the invention subject-matter that does not fall within the scope of the appended claims.

The disclosure can be better understood with the reference to the following drawings and description. The components in the figures are not necessarily to scale, emphasis being placed upon illustrating the principles of the disclosure.

In the following description, numerous specific details are set forth such as examples of specific components, devices, methods, etc., in order to provide a thorough understanding of embodiments of the disclosure. It will be apparent, however, to one skilled in the art that these specific details need not be employed to practice embodiments of the disclosure. In other instances, well-known materials or methods have not been described in detail in order to avoid unnecessarily obscuring embodiments of the disclosure. While the disclosure is susceptible to various modifications and alternative forms, specific examples thereof are shown by the drawings and will herein be described in detail. It should be understood, however, that there is no intent to limit the disclosure to the particular forms disclosed, but on the contrary, the disclosure is to cover all modifications.

The terms "distal" and "proximal" used herein with respect to the delivery device and features are with respect to the position of the delivery device when in use. "Distal" indicates an end of the delivery device or a feature of the device closest to, or a direction towards the treatment site, and "proximal" indicates an end of the device or a feature of the device farthest from, or a direction away from the treatment site. "Treatment site" refers to any site or region of a subject, human or animal, intended to be treated, such as a tissue of an organ or muscle. Although the treatment site is discussed with respect to the pericardium space, it will be understood that the treatment site may be other regions, for example, other regions in and/or near the heart, regions in and/or near other organs (e.g., lungs, liver, brain, etc.), vasculature, joint spaces, among others, or a combination thereof. It is also understood that the delivery devices, systems, and methods according to embodiments could be used for delivery of diagnostic or therapeutic materials.

The delivery devices are configured to deliver one or more therapeutic materials in a region defined by the device (referred to as "defined barrier region"). This can enable accurate placement of the one or more therapeutic materials at a treatment site. Also, the device may remain at the treatment site for a period of time until the one or therapeutic materials gelate and/or engraft in the defined barrier region; and thereby can improve retention of the one or more therapeutic materials.

The "therapeutic material" may include any one or more substance, compound, composition, formulation, and/or agent capable of exerting an effect, such as a therapeutic, prophylactic or diagnostic effect, on a patient; and/or medium configured to deliver such material. Examples of therapeutic materials include but are not limited to stem cells, cytokines, biologics, drugs, micro RNAs, among others, or a combination thereof. The medium may be a bio-absorbable medium configured to deliver a therapeutic agent or material. By way of example, the medium may be any material that can cause the agent to gelate and/or engraft. In some embodiments, the devices may include more than one lumen to deliver the same therapeutic material(s), separately deliver different therapeutic materials and/or converge at some point to deliver a combination of one or more therapeutic materials. The multiple lumens may be of different and/or same size, shape and/or location, or a combination thereof, within the device.

In the present invention, the delivery device is a catheter-like device. The delivery devices include a (sheath) body and one or more members configured to move with respect to the body. The one or more members are configured to define a barrier region at a treatment site in which one or more therapeutic materials can be delivered. In some embodiments, the body and/or the one or more members may include one or more lumens.

In some examples, the body, the one or more members, and/or the one or more lumens may have any dimensions (e.g., length and/or diameter) and/or shape. The body, the one or more members, and/or the or more lumens may be adjusted and sized for the anatomy, the direction of the desired point of insertion, the material(s) to be delivered, among others, or a combination thereof. For example, the body may be sized for insertion into a vascular lumen (e.g., <NUM>-<NUM> in diameter). The body, the one or more members and/or the one or more of lumens may also be adjusted according to the requirements of the therapeutic materials to be delivered to the patient.

In some examples, the body may have a first end (also referred to as proximal end), an opposing second end (also referred to as distal end), and a length therebetween. In some embodiments, the body may have a symmetric, elongated shape. In some examples, the body may have an asymmetric, elongated shape, for example, to prevent rotation/rolling of the device while at the treatment site (e.g., in the heart while in the pericardium). In some examples, the body may have a tapered tip disposed at the distal end.

In some examples, the body and/or one or more members may include one or more surface members configured to enhance flexibility and/or favor curling in a direction. For example, in some examples, the body and/or one or more members may include a plurality of serrations and/or slots disposed at least partially along the length. The serrations and/or slots may have any pattern, shape, size, or depth.

In some examples, the body may include one or more stabilizing members disposed adjacent to the distal end at least partially along the length. The one or more stabilizing members may be configured to communicate with the surrounding tissue at a treatment site so as to stabilize the body when the one or more members is moved with respect to the body. In some examples, the one or more stabilizing members may include ports configured to deliver suction provided by a vacuum source, suction cups, needles, spikes, spurs, other protruding members, among others, or a combination thereof. The one or more stabilizing members may have any number, size, shape, pattern, among others, or a combination thereof.

In some examples, the delivery device may include any number of members. In some examples, the delivery device may include one member, two members, three members, four members, etc. The one or more members are configured to connect to and/or overlap (e.g., curl) with respect to itself, another member and/or the second (distal) end of the body so as to define the region by a treatment site. The connected or overlapped state of the member(s) may be referred to as the "closed" state. By way of example, in the connected or overlapped state of the members, the member can surround an area at a treatment site (e.g., the pericardium space). In this way, the member(s) can act like a boundary of (e.g., a fence around) an area at a treatment site, for example, in the pericardium space and thereby form a restricted area at the treatment site (e.g., the barrier region defined by the member(s) in which the therapeutic material can be delivered. During delivery and/or in the expanded form, the region may have any shape. In some examples, the region may circular shape, ovoid shape, D shape, etc., among others.

In some examples, the size and/or shape of the region may be adjustable, for example, by further advancing or deploying the one or more members with respect to the distal end (send end) of the body. In this way, the size and/or the shape of the region may depend on an amount of advancement or deployment of the one or more members with respect to the end of the body. In some examples, the size and/or shape of the region may be predefined. For example, the inflection and/or radius of curvature may be predefined. In some examples, one or more members may each have one point of inflection, two points of inflection, among others, or a combination thereof.

In some examples, the one or more members may include one or more external markings disposed on the outside surface. In some examples, the markings may indicate depth and/or length.

In some examples, the one or more members may be made of biocompatible materials. The materials may be stiff, flexible and/or semi-flexible. The materials may include but are not limited to plastic, shape memory alloy (e.g., nickel Titanium, Nitinol® or high tempered spring steel) rubber, composites, metals, fibers, other synthetic materials, other biological materials, among others, or a combination thereof. The materials may include, for example, single compound polymer or composite reinforced structure such as a braided or coiled layer of metal (such as steel), fiber (such as Kevlar or nylon), embedded within a polymer (such as Polyether block amide, Nylon, or Polyolefin), elastomer (such as Polyurethane), or fluoropolymer (such as Polytetrafluoroethylene).

In some examples, the one or more members may be configured to constrain the one or more therapeutic materials to the defined barrier region in multiple directions, for example, laterally and/or vertically with respect to a treatment site. In some examples, the one or more members may be configured to act a "roof" and "walls" of the defined barrier region.

In some examples, the one or more members and/or the body may include one or more sets of one or more ports configured to deliver suction provided by a vacuum source. For example, the one or more ports may be configured to cause the surrounding tissue to removably adhere to the one or more surfaces of the one or more members and/or the body. For example, for the pericardium space, the one or more ports may cause the pericardial and/or epicardial tissues to adhere to the one or more surfaces of the one or more members and/or the body when suction is applied. For example, the body may include one or more set of ports disposed on one side of the one or more members and/or the body to communicate with the pericardial tissue and/or one more sets of ports disposed on another side of the one or more members and/or the body to communicate with the epicardial tissue. When suction is applied, the pericardial and/or epicardial tissue adhered to the one or more members may act as a "roof" and the one or more members may act as the walls of the defined barrier region. In some embodiments, the ports may be configured to cause the overlapped portions of the one or more members to adhere to each other. In this example, the one or more members may act as the walls of the defined barrier region.

In some examples, the delivery devices may additionally and/or alternatively include one or more constraining members that are disposed on the surface of the one or more members and extend from a surface of the one or more members to within the defined barrier region. In some embodiments, the one or extending members may be disposed on at least one surface of the one or more members. In some examples, the one or more constraining members may be configured to at least to partially cover the bottom and/or top surfaces of the one or more members. The one or more constraining members may act as a "roof" and the one or more members may act as the walls of the defined barrier region.

In some examples, each of the one or more constraining members may be of the same material, same dimensions, different material, different dimensions, or a combination thereof. In some embodiments, the one or more constraining members may be substantially the same material as the one or more members. In some embodiments, each of the one or more members may include the same and/or different constraining member. By way of example, a member may include a constraining member disposed on one surface (e.g., bottom surface and/or top surface) and a constraining member disposed on the opposite surface (e.g., top surface and/or bottom surface), and one of these constraining members extends further into the defined barrier region than the other constraining member.

In some examples, the delivery devices may include one or more steering members configured to be disposed within the one or more members. The steering members may be a wire-like member configured to mechanically and/or electrically control the movement of the one or more members, for example, by axial or torsional driven mechanisms with respect to the body. In some examples, the one or more steering members may be formed of a shape memory alloy (e.g., Nitinol) and therefore may be configured to control the shape of one or more members according to the shape defined by the shape memory alloy. By way of example, the one or more steering members can cause the one or more members to curve or inflect according to the shape defined by the shape memory alloy and thereby cause the one or more steering members to overlap and/or connect to define the barrier region.

In some examples, the one or more steering members may be configured to cause the one or more members to overlap with each other so as to define the barrier region at a treatment site. For example, the one or more steering members may cause a member to curl in a single plane so that the portion of a member overlaps with respect to itself (e.g., another portion of the member) so to form the defined region when the member is caused to be deployed through the body. In this way, by overlapping in a single plane, the member may substantially seal the barrier region to substantially minimize and/or prevent leakage of a therapeutic material at the treatment site.

In some examples, the delivery devices may additionally and/or alternatively include one or connecting members disposed on the body, the one or more members, and/or the one or more steering members. The one or more connecting members may be configured to connect to itself, another member and/or the second end of the body so as to define the barrier region at a treatment site.

In some examples, the one or connecting members may be different and/or complimentary connecting members. The connecting member(s) may include but are not limited to mechanical connecting members (e.g., hook and eye, tongue and groove, barb and cavity, interlocking C clefts, suture with retractable knot, other latching members, etc.), magnetic or electromagnetic connecting members (e.g., ball in socket), material connecting members (e.g., "tacky seal" using low durometer polymers or elastomers (such as Shore 50A-90A or 20D-50D)), members configured to deliver pressure (e.g., bio-absorbable tips, suction, etc.), among others, or a combination thereof.

In some examples, the one or more connecting members may be configured to connect to substantially seal the barrier region. The substantial seal between connecting member(s) may be a connection in which leakage of a therapeutic material can be substantially minimized and/or prevented.

In some examples, the delivery device may include one or more connection points disposed on the body and/or the one or more members at which the connecting members may connect. The one or more connection points may be include but are not limited to within the body, at apex of the defined region, and other locations along the defined region. By way of example, for devices having at least two members and/or two connecting members may expand symmetrically so that they connect at the apex and/or expand asymmetrically (e.g., one member and/or connecting member may be longer than the other member and/or connecting member) so that they connect at other locations.

In some examples, the delivery devices may be configured to release the closed state of the one or more members. In some examples, the closed state (e.g., connected or overlapped) state may be configured to be released, for example, by a retraction of hook, cutting suture, rotation c cleft, retraction of a steering member and/or other mechanical part(s), disruption of magnetic field by electric current, and/or disruption of suction. In some examples, the connecting members can be configured to be disrupted and re-instated once, twice, or more times.

In some examples, the one or more members may be configured to be deployed through the body in a generally elongated or opened state, in a connected or a closed state (e.g., the connecting members (e.g., connected or overlapped) or a combination thereof. In some examples, if the one or more members are deployed in an elongated or opened state, the one or more members may be configured to be caused to be in the closed state (e.g., in an overlapped or connected state) after advancing the one or more members with respect to the body to a certain point, for example, via the one or more steering members. By way of example, the point at which the one or more members are configured to be in a closed state may be preset by the shape memory allow included in the one or more members and/or steering members.

In some examples, the one or more lumens may be disposed at least partially along the length of the body and/or along the length of the one or more members. In some examples, the one or more lumens may extend from the first end to the second (distal) end of the body and/or the one or more members. In other examples, the one or more lumens may extend from a position along the length of the body and/or one or more members to about the second (distal) end. In some examples, the one or more lumens may be of the same and/or different dimensions, shape, length, or a combination thereof.

In some examples, the one or more lumens may include one or more delivery lumens configured to deliver one or more therapeutic materials. The devices may include any number of delivery lumens. In some examples, the devices may include one delivery lumen. In other embodiments, the devices may include more than one delivery lumen (e.g., two lumens, three lumens, four lumens, etc.). In some examples, the device may include at least two delivery lumens configured to deliver one or more therapeutic materials. In some examples, the more than one delivery lumen may be of the same and/or different dimensions, shape, length, or a combination thereof.

In some examples, the one or more delivery lumens may be disposed within the one or more members. In this example, the one or more members include at least two sets of a plurality of delivery ports configured to deliver one or more therapeutic materials to the defined region. In some examples, the delivery ports may be of any number, shape, pattern, spacing, or a combination thereof. In some examples, the ports include but are not limited to symmetric openings, angled openings, among others, or a combination thereof. In some examples, the delivery ports may be disposed along a portion of the length of the one or more members. By way of example, the delivery ports may be disposed on one or more surfaces of the one or more members, one or more regions of the one or more members, or a combination thereof. For example, the ports may be disposed in a pattern along a region or opposing regions of the one or more members that can facilitate gelation and/or mixing of the delivered therapeutic material(s). For example, the delivery ports may be disposed on a surface or side of the one or more members so as to surround or border the defined region so that the ports deliver the material to the defined area. By way of another example, one or more members may include at least two sets of one or more delivery ports, each set being configured to communicate with a delivery lumen.

For more than one delivery lumen, each lumen may be configured to deliver a different therapeutic material. In some examples, the delivery lumens may extend along separately within the body and/or the one or more members so that each lumen separately delivers a therapeutic material (e.g., via a set of delivery ports).

In some examples, the delivery lumen(s) may be disposed parallel, angled, or a combination thereof, with respect to the length of the body and/or the one or more members. In some examples, the one or more delivery lumens may have a diameter that is substantially the same along its length, may have a diameter that is asymmetric along the length, or a combination thereof. In some embodiments, one or more of the delivery lumens may have spirals within its orifice configured to direct and/or influence flow of the therapeutic material (e.g., gel), as well as to influence the outflow of the therapeutic material in a specific direction. In some embodiments, the one or more lumens may have an outflow shape similar to a "duckbill" valve configuration to prevent backflow back into the catheter after gel delivery.

In some examples, the one or more delivery lumens may be disposed in the body. In some embodiments, the first end of the one or more delivery lumens may be disposed at the first end of the body. In other examples, a first end of the one or delivery lumens may be disposed at a position along the body. In this example, the area for which the therapeutic material (e.g., the lumen dead space) may need to flow is minimized and thereby reducing therapeutic material waste.

In some examples, the one or more delivery lumens and/or one or more members may be coated with materials configured to increase the viability of cells or cytokines or to prevent therapeutic material from adhering to the walls of the lumens and/or members.

In some examples, the body and/or the one or more members may include one or more lumens configured for a vacuum source. In some examples, the body and/or the one or more members may also include one or more lumens configured for other components. In some examples, one or more lumens may be configured for a specific component, multiple components, or a combination thereof. In some examples, one or more components may be additionally and/or alternatively disposed on the (surface) of thebody and/or the one or more members.

In some examples, the components may include but are not limited to one or more electrical components (e.g., ultra violet (UV) light generation to facilitate gelation, sensors, fiberoptics, etc.), imaging devices (e.g., camera, intravascular ultrasound, intracardiac echocardiography, etc.), steering components (e.g., guide wire), sampling/biopsy components (e.g., to sample pericardial fluid), among others, or a combination thereof. In some embodiments, the sensors may include any sensors. For example, for the pericardium space, the sensors may include any sensors configured to detect, monitor, and/or alter the electrical activity of the heart. By way of example, the sensors may include voltage sensors configured to detect electrical activity and thereby detect scar tissue, pressure sensors configured to intrapericardial pressure, motion or flow sensors to detect coronary arter or vein blood flow.

It will be understood that the delivery devices according to the embodiments may be implanted into a patient with use of a delivery system. The delivery devices may be a part of the delivery system. <FIG> shows a delivery system <NUM> according to examples. As shown in <FIG>, the system <NUM> may include a delivery device <NUM>, a guide wire <NUM>, and a needle <NUM>. The delivery system <NUM> may also include a handle assembly (not shown). The delivery system <NUM> is not limited to those shown in the figures and the delivery devices according to examples, may be used with other delivery systems. It will also be understood that a clinician may use a delivery system to control the operation of the disclosed delivery devices. It will be further understood that although the operations of the disclosed delivery devices are discussed with respect to the actions of a clinician, delivery systems may be configured to perform these actions.

For example, for delivery of one or more therapeutic materials to the pericardium space, a clinician may direct the needle <NUM> to the pericardium space. To gain access to the pericardium space, a clinician may use any known invasive and less invasive approaches to the heart. The approaches may include but are not limited to subxyhpoid, trans-apical, parasternal/intercostal, surgical (e.g., sternotomy, thoracotomy, mini-sternotomy, Davinci robotic system, etc.), image-guided (e.g., ultrasound guidance, fluoroscopy, CT, MRI, ICE, etc.), etc. After the needle is positioned within the pericardium space, a clinician may then use the guide wire <NUM> to the pericardium space and remove the needle <NUM>. The clinician may then move the device <NUM> into the pericardium space using the guide wire <NUM>.

In some examples, the delivery system <NUM> may also include a sheath to guide and/or direct the guide wire <NUM>. In some examples, the sheath may have an angled or curved shape configured to direct the guide wire <NUM> and/or one or more members before and/or during the procedure. If the device include sheath, the clinician may move the sheath with the device <NUM> using the guide wire <NUM> or may move the sheath in place, remove the guide wire <NUM>, and advance or deploy the device <NUM> into the pericardium.

<FIG> show examples of the delivery devices configured to define a barrier region for delivery of one or more therapeutic materials. It will be understood that the delivery devices are not limited to the configuration and/or combination of the body, one or more members, port(s), steering member(s), lumen(s), and/or one or more connecting members shown in and described with respect to the figures. The delivery devices may include any combination of examples.

It will also be understood that the devices may include additional lumens, for example, for sensing pressure within the delivery space or sampling biological fluids.

<FIG> and <FIG> show a delivery device having one member configured to define a barrier region in which one or more therapeutic materials can be delivered according to examples.

<FIG> show a delivery device <NUM> with a member configured to define a barrier region by a magnetic connection. As shown in <FIG>, the delivery device <NUM> may include a member <NUM> configured to define a barrier region <NUM> in which one or more therapeutic materials may be delivered. The device <NUM> may include a body <NUM>. In some examples, the body <NUM> may include a first (distal) end <NUM> and a second (proximal) end <NUM> and a length therebetween.

In some examples, the member <NUM> may be retractable and/or advanceable or deployable with respect to the body <NUM> and configured to define a barrier region <NUM> when advanced. In some examples, the region <NUM> may be circular. The region may also have a different shape. In some examples, the member <NUM> may include a lumen <NUM> and have at least one open end. In some examples, the device <NUM> may include a steering member <NUM> disposed within the lumen <NUM> configured to control the movement of the member <NUM> in the formation of the region <NUM>. In some examples, the steering member <NUM> may be configured to move with and/or with respect to the member <NUM> within the lumen <NUM>.

In some examples, the steering member <NUM> may include a connecting member <NUM> disposed at the end, as shown in enlarged view in <FIG>. In some examples, the body <NUM> may include a complimentary connecting member <NUM>. In some examples, the connecting members <NUM> and <NUM> may be magnets of opposite polarity so that they form a magnetic connection. In this way, when the connecting members <NUM> and <NUM> are engaged, the member may be in a closed state.

In some examples, the connecting member <NUM> may be disposed at the second end <NUM> of the body <NUM>. In other embodiments, the connection point may be disposed in other places. For example, the connecting member <NUM> may be disposed within the body <NUM> so that the connection body is within a lumen of the body <NUM>.

In some examples, the member <NUM> is configured to define the region so as to surround a delivery lumen. In this way, the member <NUM> can form a barrier region in which one or more therapeutic materials may be delivered.

In some examples, as shown in the cross-section in <FIG>, the body <NUM> may include a plurality of lumens. In some embodiments, the body <NUM> may include a lumen <NUM> disposed in substantially the center of the body <NUM> configured for a guide wire <NUM>. In some embodiments, the body may include a lumen <NUM> configured for the member <NUM>. The body <NUM> may also include one or more lumens for delivering one or more therapeutic materials. In some embodiments, the body may include lumens <NUM> and <NUM> for delivering the same therapeutic material and/or different therapeutic materials.

<FIG> show a member <NUM> configured to define a barrier region by connecting to a point along the length of the member <NUM>. In some examples, like the member <NUM>, the member <NUM> may be deployable and retractable with respect to body, and configured to define a barrier region <NUM> when advanced.

In some examples, the member <NUM> may include a connecting member <NUM> disposed at the end. The connecting member <NUM> may have magnetic polarity. In some examples, at least at one area along the length of the member <NUM> may have opposite magnetic polarity so that the connecting member <NUM> and the member <NUM> form a magnetic connection to define the region <NUM>. In this way, when the connecting member <NUM> and the member <NUM> are engaged, the member may be in a closed state. In some examples, the member <NUM> may include a plurality of ports <NUM> to deliver one or more therapeutic materials within the defined barrier region (e.g., formed by the closed state).

In operation, the member <NUM> may be configured to be advanced or deployed through a body (not shown) in an elongated state (e.g., open state) and caused to curve (to form the closed state) as shown <FIG> by using mechanical force (e.g., a mechanical pulley system) and/or electrical force. By way of example, the member <NUM> may made of a shape memory alloy configured to form the shape to define the region <NUM>. In other examples, the member <NUM> may include a steering member (not shown) configured to cause the curve shown in <FIG>. After the connecting member <NUM> magnetically connects to the member <NUM> to define the region <NUM>, one or more therapeutic materials <NUM> may be delivered into the region <NUM>. The member <NUM> may be remain within the target site until one or more therapeutic materials <NUM>, for example, engraft and/or gelate, as shown in <FIG>. After which, the connection may be released, and the member <NUM> may be unfurled from and around the materials <NUM> and retracted back into the body (e.g., in the elongated or open state).

In some examples, one or more members may further include one or more electrical sensors configured to detect areas of variable electrical activity, such as scar. The one or more sensors may be disposed along a portion of the length of the one or more members. In this way, the sensors may be configured to detect target sites. In some examples, the one or more electrical sensors may be disposed at various positions along the length of the member.

<FIG> shows a member <NUM> having a plurality of electrical sensors <NUM> disposed along the length. The member <NUM> may be similar to the member <NUM> shown in <FIG>. The member <NUM> may include a plurality of ports <NUM> for delivery of one or more therapeutic materials <NUM> into a barrier region <NUM> defined by a connecting member <NUM> configured magnetically connected a position on the member <NUM>. It will be understood that members according to any of the examples, discussed herein may also include electrical sensors.

In some examples, one or more members may further include a port disposed along the length of the member for delivery of one or more therapeutic materials. <FIG> shows an example of a member <NUM> according to examples. The member <NUM> is shown similar to member <NUM>. The member <NUM> may include one or more ports <NUM> disposed at a plurality of positions along its length, a port <NUM> extending at least partially along the length of the member <NUM>, and a connecting member <NUM> configured to magnetically connect to a position disposed on the member <NUM>. However, it will be understood that members according to other examples discussed herein may also include electrical sensors.

<FIG> show a delivery device <NUM> with a member configured to define a barrier region by a pressure seal. Like the delivery device <NUM>, the delivery device <NUM> may include a member <NUM> configured to define a barrier region <NUM> in which one or more therapeutic materials may be delivered.

In some examples, the device <NUM> may include a body <NUM>. In some embodiments, the member <NUM> may be deployable and retractable with respect to the body <NUM> and configured to define a barrier region <NUM> (e.g., in a closed state) when the member <NUM> is advanced. In some embodiments, the member <NUM> may include a connecting member <NUM> disposed at a closed end of the member <NUM> and one or more lumens <NUM> that extends along at least partially the length of the member. In this example, the member <NUM> includes two lumens <NUM>.

In some examples, the device <NUM> may include one or more steering members <NUM> configured to control the movement of the member <NUM> in the formation of the region. In some examples, the device <NUM> may include two steering members <NUM>. In some examples, each steering member <NUM> may be configured to move with the member <NUM> within respective lumen <NUM>.

In some examples, the member <NUM> may include a plurality of ports <NUM> for delivery of one or more therapeutic materials. In some examples, the ports <NUM> may be any number, shape, pattern, size, or spacing. In some examples, the ports <NUM> may be disposed at an angle.

In some examples, the member <NUM> may be configured to define the region by the connecting member <NUM> asserting pressure against a point along the member <NUM>. In other examples, the member <NUM> may be configured to assert pressure against the body <NUM>. Using the steering members <NUM> to apply pressure (e.g., mechanical force), the tip <NUM> can compress against the member <NUM> and thereby the connection can form a seal.

In some examples, as shown in the cross-section in <FIG>, the body <NUM> may include a plurality of lumens. In some examples, the body <NUM> may include a lumen <NUM> disposed in substantially the center of the body <NUM> configured for a guide wire <NUM>. In some examples, the body <NUM> may include a lumen <NUM> configured for the movement of the member <NUM>. The body <NUM> may also include a lumen <NUM> for delivering one or more therapeutic materials. In some examples, the lumen <NUM> may be divided into at least two lumens for delivering the same therapeutic material and/or different therapeutic materials.

<FIG> show a delivery device <NUM> with a member configured to define a barrier region by a suction seal. Like the delivery device <NUM>, the delivery device <NUM> may include a member <NUM> configured to advance and/or retract with respect to a body (not shown) and configured to define a barrier region <NUM> in which one or more therapeutic materials may be delivered when the member <NUM> is advanced, and the body (not shown). It will be understood that the body may correspond, for example, the body described with respect to <FIG> and <FIG>.

In some examples, the member <NUM> may be retractable with respect to a body (not shown) and configured to define the barrier region <NUM> (e.g., in a closed state). In some examples, the member <NUM> may be configured to curl upon itself so that a portion of the member <NUM> overlaps with another portion of the member <NUM>, for example, as shown in <FIG>. In some examples, the member <NUM> may include one or more ports <NUM> disposed at an end of the member <NUM> and/or along one or more surfaces of the member <NUM>. In some examples, the one or more ports <NUM> may be configured to delivery suction so as to cause the member <NUM> to seal the defined region by sealing upon itself.

In some examples, the member <NUM> may include one or more ports <NUM> configured to deliver suction so that the surrounding tissue temporarily adheres to the member <NUM>. In some examples, the member <NUM> may include two sets of the one or more ports <NUM> disposed on opposing surfaces of member <NUM>. In some examples, the member <NUM> may include less or more sets of one or more ports <NUM>. By way of example, the member <NUM> may include on one set of ports <NUM> disposed on one surface of the member <NUM>. When the suction is applied, the one or more ports <NUM> may cause the surrounding tissue to act as a roof for the defined region.

In some examples, the member <NUM> may include a plurality of ports <NUM> configured to deliver one or more therapeutic materials. In some examples, the ports <NUM> may be any number, shape, pattern, size, or spacing. In some examples, the member <NUM> may include two sets of the ports <NUM> disposed at different positions on a surface of the member <NUM>. In some examples, each set of the ports <NUM> may be configured to deliver a different therapeutic material. In some examples, the member <NUM> may include more or less sets of ports. In some embodiments, each set of the ports <NUM> may be configured to deliver the same therapeutic material. In some examples, the ports <NUM> may be disposed at an angle.

In some examples, the sets of the ports <NUM> may be disposed on a region or surface of the member <NUM> between the sets of the ports <NUM> configured to delivery suction. The ports <NUM> may be disposed on the surface of the member <NUM> so that in use the ports <NUM> can be disposed in the internal surface of the defined region (e.g., when the member <NUM> is in a closed state) so that the ports <NUM> can deliver the therapeutic materials within the defined region. In some examples, the sets of ports <NUM> can be disposed on opposing surfaces that are perpendicular to the surface of the ports <NUM> so to surround region and/or face the surrounding tissue. In some examples, the ports <NUM> may be disposed on the region or surface opposite of the ports <NUM> so that in use, the ports <NUM> can face a surface of the member <NUM>.

In some examples, the member <NUM> may include a plurality of electrical sensors <NUM> disposed along the length of the member. Each sensor <NUM> may be disposed at least partially about the circumference of the member <NUM>.

In some examples, as shown in the cross-section in <FIG>, the member <NUM> may include a plurality of lumens disposed along its length. In some examples, the member <NUM> may include a lumen <NUM> configured for a steering member (not shown) that can control the movement of the member <NUM> in the formation of the region (e.g. so as to be in a closed state) with respect to a body. The other lumens may be arranged so as to surround the lumen <NUM>.

In some examples, the member <NUM> may also include lumens <NUM> and <NUM> configured to deliver one or more therapeutic materials. For example, each lumen may deliver a different part of a two-part material. In some examples, the lumens <NUM> and <NUM> may be combined for delivering the same therapeutic material and/or different therapeutic materials. The lumens <NUM> and <NUM> may communicate with a set of the one or more ports <NUM> to deliver the material within the defined region.

The member <NUM> may include one or more lumens <NUM> and <NUM> configured to deliver suction to the surrounding tissue through the ports <NUM> and/or <NUM>. In some examples, the suction may be provided for each lumen by the same vacuum source or independently provided. By way of example, the lumen <NUM> may be for the set of ports <NUM> configured to face the epicardial tissue and the lumen <NUM> may be for the set of ports <NUM> configured to face the pericardial tissue when the member <NUM> is in use. The member <NUM> and/or the body may include one or more lumens <NUM> in which sensing wires may be disposed. The one or more lumens <NUM> may be arranged so that the sensing wires communicate with the sensors <NUM> disposed along the length of the member. The sensors <NUM> may include any sensor, such as sensors configured to detect electrical activity in the heart.

<FIG> show a delivery device including a member <NUM> configured to curl within itself so that a portion of the member overlaps with another portion of the member and a body according to r examples.

<FIG> show a body including one or more stabilizing members configured to stabilize the body with respect to the treatment site when the member <NUM> is retracted from the overlapped or closed state. In this way, by stabilizing the body with respect to the treatment site, the member <NUM> may be retracted without disrupting the delivered therapeutic material and prevent movement of the body that could be caused by the force of the retraction.

<FIG> show a delivery device that includes body according to different examples It will be understood that the delivery device is not limited to the configuration shown in the figures. By way of example, it will be understood that it may include a different member(s) and/or the member <NUM> may be disposed within a different body.

As shown in <FIG> and <FIG>, the delivery device <NUM> may include the member <NUM> and a body <NUM>. In some examples, the delivery device <NUM> may be advanced or deployed from the body <NUM> so that a section of the member <NUM> curls until a portion of the member <NUM> disposed at an end <NUM> overlaps with another portion. For example, in use, the member <NUM> can be advanced or deployed from so that a portion <NUM> of the member <NUM> (disposed adjacent to the end of the member <NUM>) is disposed adjacent to portion <NUM> (disposed adjacent to the end of the member <NUM>).

In some examples, the member <NUM> may include one or more sets of one or more ports <NUM> configured to deliver suction so that the surrounding tissue at the treatment site temporarily adheres to the member <NUM>. In some examples, the member <NUM> may include two sets of the one or more ports <NUM> disposed on opposing surfaces of member <NUM>. In some examples, the member <NUM> may include less or more sets of one or more ports <NUM>. By way of example, the member <NUM> may include one set of ports <NUM> disposed on one surface of the member <NUM>. When the suction is applied, the one or more ports <NUM> may cause the surrounding tissue to act as a roof for the defined region.

In some examples, the member <NUM> may include one or more sets of plurality of ports <NUM> configured to deliver of one or more therapeutic materials. In some examples, the ports <NUM> may be any number, shape, pattern, size, or spacing. In some examples, the member <NUM> may include two sets of the ports <NUM> and <NUM> disposed at different positions on a surface of the member <NUM>. In some embodiments, each set of the ports <NUM> may be configured to deliver a different therapeutic material. In some examples, the member <NUM> may include more or less sets of ports. In some embodiments, each set of the ports <NUM> may be configured to deliver the same therapeutic material. In some embodiments, the ports <NUM> may be disposed at an angle.

In some examples, the sets of the ports <NUM> may be disposed on a region or surface of the member <NUM> between the sets of the ports <NUM> configured to delivery suction. The ports <NUM> may be disposed on the surface of the member <NUM> so that in use the ports <NUM> can be disposed in the internal surface of the defined region (e.g., when the member <NUM> is in a closed state) so that the ports <NUM> can deliver the therapeutic materials within the defined region. In some examples, the sets of ports <NUM> can be disposed on opposing surfaces that are perpendicular to the surface of the ports <NUM> so to surround region and/or face the surrounding tissue. In some examples, the ports <NUM> may be disposed on the region or surface on the member opposite of the ports <NUM> so that in use, the ports <NUM> can face a surface of the member <NUM> when overlapped.

In <FIG> and <FIG>, the member <NUM> has a closed end. The end may be blunt, rounded, as well as other shapes. In some embodiments, the member <NUM> may have a port disposed at the end, for example, to deliver one or more therapeutic materials.

In some examples, as shown in the cross-section in <FIG>, the member <NUM> may include a plurality of lumens disposed at least partially along its length. In some examples, the member <NUM> may include a lumen <NUM> configured for a steering member (not shown) that can control the movement of the member <NUM> in the formation of the region (e.g. so as to be in a closed state) with respect to a body. For example, the steering member may be configured to cause the member <NUM> to overlap as shown in <FIG> and <FIG>. The other lumens may be arranged so as to surround the lumen <NUM>.

In some examples, the member <NUM> may also include lumens <NUM> and <NUM> configured to deliver one or more therapeutic materials. For example, each lumen may deliver a different part of a two-part material. In some examples, the lumens <NUM> and <NUM> may be combined for delivering the same therapeutic material and/or different therapeutic materials. The lumens <NUM> and <NUM> may communicate with ports sets1437 and <NUM>, respectively, to deliver the material within the defined region.

In some examples, the member <NUM> may include lumens <NUM> and <NUM>. The lumens <NUM> and <NUM> may be configured to deliver suction to the surrounding tissue at least through the ports <NUM>. In some examples, the suction may be provided for each lumen by the same vacuum source or independently provided. By way of example, the lumen <NUM> may be for the set of ports <NUM> configured to face the epicardial tissue and the lumen <NUM> may be for the set of ports <NUM> configured to face the pericardial tissue when the member <NUM> is in use.

In some examples, the member <NUM> may include one or more lumens <NUM> in which sensing wires or other component wires may be disposed. In some examples, the member <NUM> may include two lumens <NUM> configured for sensing wires. In some embodiments, the member <NUM> may include more or less lumens. The one or more lumens <NUM> may be arranged so that the sensing wires communicate with the sensors <NUM> disposed along the length of the member. The sensors <NUM> may include any sensor, such as sensors configured to detect electrical activity in the heart.

In some examples, the member <NUM> may also include one or more ports disposed along the portions <NUM> and/or <NUM> of the member <NUM>. The one or more ports may communicate with the lumens <NUM> and/or <NUM>. In some examples, the one or more ports may be configured to deliver suction so as to cause the member <NUM> to seal the defined region by sealing upon itself. In some examples, the member <NUM> may additionally or alternatively further include other connecting members disposed on the portions <NUM> and/or <NUM>. In some examples, the connecting members may include but are not limited to complimentary magnets.

In some examples, the body <NUM> may include a tapered tip <NUM> disposed at the distal end <NUM>. The body <NUM> may also include one or more stabilizing members <NUM> disposed at least partially along the length of the body <NUM> near the distal end and along the circumference of the body <NUM>. By way of example, the one or more stabilizing members <NUM> may be one or more ports configured to deliver suction to the adjacent tissue at the treatment site. In some examples, the one or more stabilizing members <NUM> may include a plurality of sets of one or more stabilizing members that are disposed offset with respect to the length of the body <NUM>. In some examples, each set of stabilizing members may include any number of stabilizing members and may be more or less than the four stabilizing members <NUM> shown. In some examples, the plurality of stabilizing members <NUM> may be aligned with respect to the length. In some examples, the one or more stabilizing members <NUM> may another type of stabilizing member (e.g., retractable spike, other protruding element, clamp, hook, etc.).

As shown in <FIG>, the body <NUM> may include at least one lumen <NUM> that is adjacent to the lumen <NUM>. The lumen <NUM> may be configured for the member <NUM>. The member <NUM> may be configured to move (advance and/or retract) with respect to the body through the lumen <NUM>. In some examples, the lumen <NUM> may be configured to surround the lumen <NUM>. In some examples, the lumen <NUM> may be configured to activate the stabilizing members <NUM>. For example, the lumen <NUM> may be configured to deliver suction from a vacuum source through the stabilizing members <NUM> to the surrounding tissue at the treatment site. In some examples, the lumen <NUM> may be compartmentalized and/or integrated for each set of members <NUM>.

In use, the member <NUM> may be advanced through the lumen <NUM> of the body <NUM> using a steering member disposed in the lumen <NUM>. In some examples, the member <NUM> may be advanced past the body into the treatment site so that the portions <NUM> and <NUM> are caused to be adjacent to each other (overlap) to define the region <NUM> as shown in <FIG> and <FIG>. After the barrier region is form, the suction may be applied through ports <NUM> so that the surrounding tissue (e.g., epicardial and pericardial tissue) may also temporarily adhere to the respective surfaces of the member and thereby the tissues can act as a roof for the barrier region <NUM>. In this way, the region <NUM> may be substantially sealed. After the region <NUM> is sealed, one or more therapeutic materials may be delivered into the barrier region <NUM> defined by the member <NUM> using the ports <NUM>. In some examples, a different therapeutic material may be delivered through each set of ports through the respective lumen in the member <NUM>. The members <NUM> may be remain within the target site until the one or more therapeutic materials, for example, engraft and/or gelate. After which, the suction delivered through the ports <NUM> of the member <NUM> may be stopped and the suction may then be delivered through the ports <NUM> through the lumen <NUM> of the body <NUM> to stabilize the body <NUM> with respect to the treatment site. After the body <NUM> is stabilized, the member <NUM> may be unfurled from around the material(s) <NUM> without disturbing the material and retracted back into the body (not shown), for example, using the steering member (not shown) via the lumen <NUM>. By way of example, the steering member and/or the member <NUM> may be made of a shape memory alloy with a predefined shape that may allow formation of the barrier region by the member <NUM> and the retraction of the member <NUM> without disturbing the delivered material.

In some examples, the body may have a different configuration of the stabilizing members. <FIG> and <FIG> show examples of delivery devices with different bodies according to examples. It will be understood that the body may have a different configuration. By way of example, the body may include any number of lumens, any number of sets of stabilizing members, any shape, any size, any pattern, any stabilizing members, among others, or a combination thereof.

<FIG> and <FIG> show a delivery device <NUM> that includes a body <NUM> and the member <NUM> according to examples. In some examples, the body <NUM> may include a tapered tip <NUM> disposed at the distal end <NUM>. The body <NUM> may also include one or more stabilizing members <NUM> disposed at least partially along the length of the body <NUM> near the distal end <NUM>. By way of example, the one or more stabilizing members <NUM> may include one or more ports configured to deliver suction to the adjacent tissue at the treatment site. In some examples, the one or more stabilizing members <NUM> may include a plurality of sets of one or more stabilizing members that are spaced in a row partially along the length of the body <NUM>. In some examples, each set of stabilizing members may include any number of stabilizing members and may be more or less than the stabilizing members <NUM> shown. In some examples, the one or more stabilizing members <NUM> may another type of stabilizing member (e.g., retractable spike, other protruding element, etc.).

As shown in <FIG> and <FIG>, the body <NUM> may include at least one lumen <NUM> that is adjacent to the lumen <NUM>. The lumen <NUM> may be configured for the member <NUM>. The member <NUM> may be configured to move (advance and/or retract) with respect to the body through the lumen <NUM>. In some examples, the body <NUM> may be divided into the lumen <NUM> and the lumen <NUM>. In some embodiments, the lumen <NUM> may be configured to activate the stabilizing members <NUM>. For example, the lumen <NUM> may be configured to deliver suction from a vacuum source through the stabilizing members <NUM> to the surrounding tissue at the treatment site. In some examples, the lumen <NUM> may be compartmentalized and/or integrated for each set of members <NUM>. In use, the device <NUM> may be operated the same as the device <NUM> by using the lumens <NUM> and <NUM>.

<FIG> and <FIG> show a delivery device <NUM> that includes a body <NUM> and the member <NUM> according to examples. In some examples, the body <NUM> may include a tapered tip <NUM> disposed at the distal end <NUM>. The body <NUM> may also include one or more stabilizing members <NUM> disposed at least partially along the length of the body <NUM> near the distal end. By way of example, the one or more stabilizing members <NUM> may be one or more ports configured to deliver suction to the adjacent tissue at the treatment site. In some examples, the one or more stabilizing members <NUM> may include a plurality of sets of eight stabilizing members that are aligned with respect to the length of the body <NUM>. In some examples, the stabilizing members <NUM> may include four sets of stabilized members that are aligned along the length of the body <NUM> and evenly spaced around the circumference. The plurality of sets may include more or less than the number of the stabilizing members shown. In some examples, the stabilizing members may include any number of stabilizing members <NUM> and may be more or less than the stabilizing members <NUM> shown. In some examples, the one or more stabilizing members <NUM> may another type of stabilizing member (e.g., retractable spike, other protruding element, etc.).

As shown in <FIG> and <FIG>, the body <NUM> may include a plurality of lumens that are adjacent to the lumen <NUM>. The lumen <NUM> may be configured for the member <NUM>. The member <NUM> may be configured to move (advance and/or retract) with respect to the body through the lumen <NUM>. The plurality of lumens may be disposed to surround the lumen <NUM>. In some examples, the plurality of lumens may include four lumens <NUM>-<NUM>. For example, the lumen <NUM> shown in <FIG> may be separated into a plurality of lumens, each lumen communicating with a set of ports. In the example shown in <FIG>, each lumen <NUM>-<NUM> may communicate with each set (e.g., row) of the ports <NUM>. In some examples, the body <NUM> may include more or less number of lumens. In some examples, the lumens <NUM>-<NUM> may be configured to activate the stabilizing members <NUM>. For example, the lumen <NUM>-<NUM> may be configured to deliver suction from a vacuum source through each set of the stabilizing members <NUM> to the surrounding tissue at the treatment site. In use, the device <NUM> may be operated the same as the device <NUM> by using the lumens <NUM>-<NUM> and <NUM>.

<FIG> shows an example of a delivery system <NUM> for a delivery device according to examples. In some examples, the delivery system <NUM> may include the delivery device <NUM>. In some examples, the delivery system <NUM> may include a line <NUM> that is attached to the body <NUM> and is configured to communicate with a vacuum source. The line <NUM>, for example, may communicate with the lumen <NUM> of the body <NUM> to deliver the suction. In some examples, the system <NUM> may include a separate line for the lumens <NUM> and/or <NUM> of the member <NUM> to deliver the suction and/or the line <NUM> may be configured to communicate with the member <NUM>. The system <NUM> may also include a hemostatic seal <NUM> attached to the body <NUM> and configured to deliver the device <NUM> to the treatment site.

It will be understood that the delivery system <NUM> is not limited to the delivery device <NUM>. The delivery system <NUM> may be used with other delivery devices according to examples.

For example, the delivery system <NUM> may include the delivery devices <NUM> and/or <NUM>.

<FIG> show a delivery device having two members configured to magnetically connect to define a barrier region in which one or more therapeutic materials may be delivered according to examples.

<FIG> show a delivery device <NUM> including two members <NUM> and <NUM> configured to define a barrier region <NUM> in which one or more therapeutic materials may be delivered by magnetically connecting to each other. The device <NUM> may include a body <NUM>.

In some examples, the members <NUM> and <NUM> may be controllable collectively and/or individually. The members <NUM> and <NUM> may be configured to be deployable and retractable with respect to the body <NUM> and configured to define the circular region <NUM> when deployed with respect to the body <NUM> into the treatment site. In some examples, each of the members <NUM> and <NUM> may include lumens <NUM> and <NUM>, respectively and have at least one open end. In some examples, the device <NUM> may include one or more steering members <NUM> and <NUM> disposed within the lumens <NUM> and <NUM>, respectively, configured to control the movement of the members <NUM> and <NUM>, respectively, in the formation of the region <NUM>. In some examples, the steering members <NUM> and <NUM> may be configured to move with and/or with respect to the respective members <NUM> and <NUM> within the respective lumens <NUM> and <NUM>.

In some examples, each of the steering members <NUM> and <NUM> may include connecting members <NUM> and <NUM> disposed at the end, as shown in enlarged view in <FIG>. In some embodiments, the connecting members <NUM> and <NUM> may be complimentary. In some examples, the connecting members <NUM> and <NUM> may be magnets of opposite polarity so that they form a magnetic connection.

In some examples, the members <NUM> and <NUM> may be configured to connect to each other at about the apex of the defined region <NUM>. In other examples, the members <NUM> and <NUM> may be configured to connect to each other at other points.

In some examples, the members <NUM> and <NUM> may each include a plurality of ports <NUM> disposed along the length configured to deliver one or more therapeutic materials.

In some examples, as shown in the cross-section in <FIG>, the body <NUM> may include a plurality of lumens. In some examples, the body <NUM> may include a lumen <NUM> disposed in substantially the center of the body <NUM> configured for a guide wire <NUM>. In some examples, the body may include lumens <NUM> and <NUM> configured for the members <NUM> and <NUM>, respectively. In some embodiments, the members <NUM> and <NUM> may also include one or more lumens for delivering one or more therapeutic materials. In some examples, the members <NUM> and <NUM> may include lumens <NUM> and <NUM>, respectively, for delivering the same therapeutic material and/or different therapeutic materials.

<FIG> show operation of members <NUM> and <NUM> similar to the device <NUM> shown in <FIG>. Like the device <NUM>, each of the members <NUM> and <NUM> may include a lumen for steering members <NUM> and <NUM>. In some examples, each of the steering members <NUM> and <NUM> may include a connecting member <NUM> and <NUM>, respectively, disposed at the end. The connecting members <NUM> and <NUM> may have complementary magnetic polarity. In some examples, each of the members <NUM> and <NUM> may include a plurality of ports <NUM> to deliver one or more therapeutic materials and radiopaque tips <NUM> and <NUM>, respectively, disposed at the ends. In some examples, the members <NUM> and <NUM> may be configured to fold or curl while disposed inside the body to assume a smaller shape, then enlarge or unfurl when outside of the device body.

In operation, the steering members <NUM> and <NUM> may be advance or deployed through a body (not shown) and the respective members <NUM> and <NUM> to cause the members <NUM> and <NUM> to curve as shown <FIG>. The steering members <NUM> and <NUM> may be made of a shape memory material so as to cause the members <NUM> and <NUM> to form a pre-defined shape and region <NUM>. After the connecting members <NUM> and <NUM> magnetically connect to define the region <NUM> shown in <FIG>, one or more therapeutic materials <NUM> may be delivered into the region <NUM> as shown in <FIG>. The members <NUM> and <NUM> may be remain within the target site until one or more therapeutic materials <NUM>, for example, engraft and/or gelate, as shown in <FIG>. After which, the members <NUM> and <NUM> may be unfurled from around the material(s) <NUM> and retracted back into the body (not shown).

<FIG> show a delivery device <NUM> including two members <NUM> and <NUM> configured to define a barrier region <NUM> by mechanically connecting to each other. The device <NUM> may include a body <NUM>. In some examples, the body <NUM> may include a tapered tip <NUM>.

In some examples, the members <NUM> and <NUM> may be controllable collectively and/or individually. In some examples, the members <NUM> and <NUM> may be retractable with respect to the body <NUM> and configured to define the circular region <NUM>. In other examples, one of the members <NUM> and <NUM> may be fixedly disposed with respect to the body <NUM>.

In some examples, each of the members <NUM> and <NUM> may include connecting members <NUM> and <NUM> disposed at the end. In some examples, the connecting members <NUM> and <NUM> may be complimentary. In some examples, the connecting members <NUM> and <NUM> may be a hook and eye, respectively. In other examples, other mechanical connecting members may be used. In some embodiments, the body <NUM> may include a delivery lumen <NUM> configured to deliver one or more therapeutic materials <NUM>.

In some examples, the members <NUM> and <NUM> may be configured to connect to each other at a position near and/or within the body <NUM>. In other examples, the members <NUM> and <NUM> may be configured to connect to each other at other points. In some examples, the member <NUM> may be or deployed through the body <NUM> in a connected state with the member <NUM>. In some examples, the advancement of the member <NUM> (without moving the member <NUM>) may cause the member <NUM> to advance through the body in a connected state and to define the region <NUM>.

In operation, after the one or more therapeutic materials <NUM>, for example, engraft and/or gelate, as shown in <FIG>, the member <NUM> may be unfurled from around the material(s) <NUM> and retracted back into the body <NUM>, as shown in <FIG>. As shown in these figures, the member <NUM> may be released from the connecting member <NUM>, unfurled from the material <NUM>, and retracted back into the body <NUM>. In some examples, the member <NUM> may also be further retracted into the body <NUM>. In other examples, the position of the member <NUM> may not change with respect the body <NUM>.

<FIG> show a delivery device <NUM> including two member <NUM> and <NUM> each having two connection members configured to magnetically connect to each other to define a barrier region in which one or more therapeutic materials may be delivered.

In some examples, the device <NUM> may include a body <NUM>. Each of the members <NUM> and <NUM> may each include two lumens each for steering members <NUM> and <NUM>, and steering members <NUM> and <NUM>, respectively. In some embodiments, the steering members <NUM> and <NUM>, and the steering members <NUM> and <NUM> may be configured to control the movement of the members <NUM> and <NUM>, respectively, in the formation of a barrier region. In some examples, the steering members <NUM> and <NUM>, and steering members <NUM> and <NUM> may be configured to move with and/or with respect to the respective members <NUM> and <NUM> within the respective lumens. By having additional steering members, the steering capabilities of the members may be enhanced. For example, the additional steering members may result more controlled unfurling of the members after the therapeutic material(s) are delivered and engrafted and/or gelated, and thereby may minimize interference with the engrafted and/or gelated therapeutic material(s).

In some examples, the members <NUM> and <NUM> may be controllable collectively and/or individually. The members <NUM> and <NUM> may be retractable with respect to the body <NUM> and configured to define a barrier region.

In some examples, each of the steering members <NUM> and <NUM>, and the steering members <NUM> and <NUM> may include a connecting members disposed at an end. In some examples, the connecting members may be complimentary. In some examples, the connecting members of the steering members <NUM> and <NUM> and the connecting members of the steering members <NUM> and <NUM> may be magnets of opposite polarity so that they form a magnetic connection.

In some examples, the members <NUM> and <NUM> may be configured to connect to each other at about the apex of the defined region. In other examples, the members <NUM> and <NUM> may be configured to connect to each other at other points.

In some examples, as shown in the cross-section in <FIG>, the body <NUM> may include a plurality of lumens. In some examples, the body <NUM> may include a lumen <NUM> disposed in substantially the center of the body <NUM> configured for a guide wire. In some examples, the body <NUM> may include lumens <NUM> and <NUM> configured for the members <NUM> and <NUM>, respectively. In some examples, the body <NUM> may include two delivery lumens <NUM> and <NUM> configured for delivering the same therapeutic material and/or different therapeutic materials. In some examples, the body <NUM> may also include one or more lumens <NUM> for sensors. For example, the one or more lumens <NUM> may be for sensors for detecting electrical activity in the heart.

<FIG> show a delivery device <NUM> having a body <NUM> that is configured to be self-folding. For example, the end <NUM> may be configured to deform to form a barrier region with a specific radius of curvature. As shown in <FIG>, the body <NUM> may include a plurality of slots or serrations <NUM> disposed in the inner surface. The slots and/or serrations <NUM> may be laser cut, or formed by other methods. These serrations <NUM> can be configured to facilitate bending to an engineered radius to facilitate formation of the region by the members.

The serrations <NUM> may have any size, pattern, or shape. In some examples, the body <NUM> may include different size serrations on each side to allow selection of larger or smaller fence sizes. The serrations <NUM> can also facilitate uncurling in a way that will not disturb the delivered therapeutic material(s). The serrations may be of the same size and/or of different sizes along the length of the body.

Like <FIG>, the device <NUM> may include two steerable, bidirectional members <NUM> and <NUM> configured to magnetically connect to each other to define a barrier region in which one or more therapeutic materials may be delivered.

As shown in <FIG>, the body <NUM> may include a plurality of lumens. In some examples, the body <NUM> may include a lumen <NUM> disposed in substantially the center of the body <NUM> configured for a guide wire. In some examples, the body <NUM> may include lumens <NUM> and <NUM> configured for the members <NUM> and <NUM>, respectively. In some examples, the body <NUM> may include two delivery lumens <NUM> and <NUM> configured for delivering the same therapeutic material and/or different therapeutic materials. The delivery lumens <NUM> and <NUM> may be disposed between the guide wire lumen <NUM> and the lumens <NUM> and <NUM> for the members <NUM> and <NUM> so that the therapeutic material(s) can be delivered within the defined region. In some examples, the body <NUM> may also include one or more lumens <NUM> for sensors. For example, the one or more lumens <NUM> may be for sensors for detecting electrical activity in the heart.

<FIG> show a delivery device <NUM> including members <NUM> and <NUM> that are configured to expand radially with respect to the body <NUM> to define a barrier region <NUM>. It will be understood that the delivery device <NUM> are not limited two members as shown in the figures and the delivery device <NUM> may also include additional members.

In some examples, the members <NUM> and <NUM> may be controllable collectively. In some embodiments, the members <NUM> and <NUM> may be configured to expand radially with respect to a guide wire <NUM> disposed in a lumen substantially in the center of the body <NUM> and configured to define the circular region <NUM>. The members <NUM> and <NUM> may be configured to be disposed in an elongate form (i.e., in line with the diameter of the body) when in unexpanded state, as shown in <FIG>.

In some examples, each of the members <NUM> and <NUM> may include lumens <NUM> and <NUM>, respectively. In some embodiments, the device <NUM> may include one or more steering members <NUM> and <NUM> disposed within the lumens <NUM> and <NUM>, respectively, configured to control the radial expansion of the members <NUM> and <NUM>, respectively, in the formation of the region <NUM>.

In some examples, each of the members <NUM> and <NUM> may include a plurality of ports <NUM> configured to deliver one or more therapeutic materials and disposed on the internal surface (facing the region <NUM>). In some examples, each of the members <NUM> and <NUM> may include delivery lumens <NUM> and <NUM>, respectively, configured to deliver the same therapeutic material(s) or different therapeutic materials.

As shown in <FIG>, the body <NUM> may include a plurality of lumens. In some examples, the body <NUM> may include a lumen <NUM> disposed in substantially the center of the body <NUM> configured for a guide wire <NUM>. In some examples, the body <NUM> may include lumens <NUM> and <NUM> configured for the members <NUM> and <NUM>, respectively.

In some examples, the delivery devices may be sterilized. In some examples, one, some, or all parts of the delivery devices may be reused. In further examples, one, some, or all parts of the delivery devices may be disposable. In further examples, the delivery devices may be a single, use device.

Claim 1:
A device for delivering one or more therapeutic materials to a treatment site, comprising:
a body (<NUM>; <NUM>; <NUM>);
a member (<NUM>; <NUM>) that is movable with respect to the body (<NUM>; <NUM>; <NUM>) and that is configured to curl within itself so that a portion of the member (<NUM>; <NUM>) overlaps with another portion of the member (<NUM>; <NUM>) to define a barrier region (<NUM>; <NUM>) at the treatment site; and
one or more delivery lumens (<NUM>, <NUM>; <NUM>, <NUM>) configured to deliver one or more therapeutic materials to the barrier region (<NUM>; <NUM>);
characterized in that the member (<NUM>; <NUM>) includes at least two sets of a plurality of delivery ports (<NUM>; <NUM>, <NUM>) disposed at different positions on a surface of the member (<NUM>; <NUM>) so that the at least two sets of delivery ports (<NUM>; <NUM>, <NUM>) can be disposed in the internal surface of the defined barrier region (<NUM>; <NUM>); and
in that each set of delivery ports (<NUM>; <NUM>, <NUM>) communicates with a delivery lumen of the one or more delivery lumens (<NUM>, <NUM>; <NUM>, <NUM>) and is configured to deliver a therapeutic material to the defined barrier region (<NUM>; <NUM>).