HK40060041B - Adjustable vascular closure device - Google Patents

Description

Adjustable vascular closure device

Technical Field

This application generally relates to closure systems, devices, and related methods for use in surgical procedures.

Cross-reference of related applications

This application claims priority and interest in U.S. Provisional Application No. 62/786,789, filed December 31, 2018, the entire contents of which are hereby incorporated by reference.

Background Technology

During surgical or endoscopic procedures involving body cavities (such as blood vessels), a pore is formed in the tissue of the cavity (e.g., from an arteriotomy). Postoperatively, the pore must be sealed to allow the cavity to heal. A relatively novel sealing device features a flexible disc delivered into the body cavity to seal the pore. The disc maintains tissue juxtaposition until the cavity heals, thereby allowing the wound to heal from within the cavity. The disc can be operated in conjunction with a rigid core that prevents the disc from dislodging from the sealed position.

In certain patient populations, there are lesions and/or accumulations (e.g., plaques or calcified lesions on the tissue walls) in areas surrounding the body cavity. Due to the irregular surface morphology of such areas, the effectiveness of seals made by certain closure devices is reduced because channels are formed between the disc and the tissue surface.

When pores are formed in tissues that enclose body cavities, it is beneficial to improve the seal created by the sealing device.

Summary of the Invention

Generally, this disclosure relates to an implant closure device having a flexible sealable component and a flexible support component, which operate together during closure of an opening in a body cavity to improve the seal formed between the sealable component and the tissue surface of the body cavity. The support component pushes a peripheral portion of the sealable component toward the internal tissue of the body cavity and provides greater rigidity to the peripheral region of the flexible sealable component. The structure, in conjunction with a locator and hydraulic pressure present in the body cavity (e.g., hemodynamic pressure of blood in a blood vessel), improves the packing formed by the device above the opening. The structure has sufficient flexibility to bend to accommodate passage through the opening during deployment of the closure device in the body cavity.

The disclosed technology prevents the closure device from unintentionally dislodging from the sealed location and reduces the risk of the implanted device being unintentionally pulled out of the cavity, for example, during device deployment or after implantation. Surgeons can apply greater force to the tissue, providing better tactile feedback for implant positioning. As shown herein, the provided technology achieves unprecedented acute sealing time when closing blood vessels and unprecedented fluid loss from these vessels. In some embodiments, the increased rigidity is directional to allow greater force to be directed to specific areas of the tissue surrounding the formed pore.

A notable feature of the provided technology is that, due to the adjustability of the locator device, it enables novel interventional, surgical, and endoscopic procedures by reliably and consistently sealing pores in body cavities without regard to tissue surface morphology or wall thickness.

On one hand, the present invention relates to an apparatus for sealing pores in tissue within a body cavity. The apparatus includes a sealable member positioned against an inner surface of the tissue adjacent to the pores when the apparatus is in a sealed position; a support member having a base and a post, wherein the base of the support member has a support surface to support the sealable member against the inner surface of the tissue when the apparatus is in the sealed position, and the post extends through the sealing member and the pores and has an engagement mechanism; and a positioner pivotally coupled to the support member via the engagement mechanism. The positioner, when the apparatus is in the sealed position, is positioned against an outer surface of the tissue adjacent to the pores, such that at least a portion of the tissue is disposed between the positioner and the sealable member. The positioner includes an adjustment mechanism for adapting to varying tissue morphologies, such as surface irregularities and body cavities with walls of varying thicknesses.

On the other hand, the present invention relates to a sealing system for sealing pores in tissues within a body cavity. The system includes a delivery device and a sealing device. The sealing device includes a sealable member positioned against an inner surface of the tissue adjacent to the pores when the device is in a sealed position; a support member having a base and a post, wherein the base of the support member has a support surface to support the sealable member against the inner surface of the tissue when the device is in the sealed position, and the post extends through the sealing member and the pores and has an engagement mechanism; and a locator pivotally coupled to the support member via the engagement mechanism. The locator is positioned against an outer surface of the tissue adjacent to the pores when the device is in the sealed position, such that at least a portion of the tissue is disposed between the locator and the sealable member. The locator includes an adjustment mechanism for adapting to varying tissue morphology as disclosed herein. The delivery device includes an attachment mechanism for releasably attaching the sealing device to the delivery device for delivering the sealing device into the pores in the tissue. The delivery device is also configured to deploy the sealing device within the cavity, which includes expanding and positioning the sealing element within the cavity and actuating the positioner.

In another aspect, the present invention relates to a method for securing an apparatus for sealing pores in tissue of a body cavity. The method includes the steps of: positioning at least a portion of the apparatus within the body cavity via a delivery device; deploying a sealable member against an inner surface of the tissue adjacent to the pores in the tissue; deploying a support member having a base and a post, wherein the base of the support member has a support surface to support the sealable member against the inner surface of the tissue when the apparatus is in the sealed position, and the post extends through the sealing member and the pores and includes an engagement mechanism; and actuating a locator pivotally coupled to the support member from a first position to a second position via the engagement mechanism to engage the wall of the body cavity and secure the apparatus in place. In some embodiments, various steps (e.g., deployment of the sealable and support members) may be performed simultaneously, while in other cases (e.g., deployment of the apparatus in a blood vessel without flowing fluid), the deployment step is a separate and distinct step. In various embodiments, the method includes the step of positioning a column relative to a support member, such that an adjustment mechanism on the locator engages at least a portion of the column to accommodate a cavity wall having an irregular morphology as disclosed herein. In various embodiments, the adjustment mechanism engages a portion of the column to form an interference fit therebetween.

In various embodiments of the foregoing aspects, the aperture is a surgical perforation within a body cavity, such as the gastrointestinal tract, heart, abdominal cavity, esophagus, vagina, rectum, trachea, bronchi, or blood vessels, such as (e.g.) the femoral vein, vena cava, jugular vein, femoral artery, subclavian artery, ascending aorta, accessory artery, and brachial artery. The device can be positioned and deployed within the cavity via a deployment tool or device (e.g., a device comprising several tubular bodies slidably mounted on a cannula or similar device). In some cases, the device is configured to be deployed above a guidewire.

In an additional embodiment of the foregoing aspects, the engagement mechanism includes a portion of a post extending laterally from the top of the support surface and defining an aperture therein, and a support shaft configured to be disposed within the post aperture to secure the locator to the support member, wherein the support shaft engages with the surface of the locator to provide a sealing force to the tissue. Additional engagement mechanisms are contemplated and considered within the scope of the invention, provided they allow the locator to pivot or rotate relative to the support mechanism. Generally, the locator will also slide relative to the post as it is pivoted into a sealing position.

In various embodiments, the locator has an elongated, generally planar body, a non-planar distal portion (e.g., angled or arcuate), and a guiding mechanism for engaging with a delivery device to deploy the locator. The adjusting mechanism is disposed along the elongated body of the locator. In some embodiments, the elongated body defines a generally centrally located elongated opening configured to engage with the engaging mechanism, and in some cases, the elongated body may form part of the adjusting mechanism.

Generally, the adjustment mechanism is formed as a portion of the elongated body and includes at least one of the following: a section of the elongated body of varying thickness to form a ramp for slidably engaging the engagement mechanism; or a section of the elongated body comprising a non-planar portion configured to fold upon engagement with the engagement mechanism. The non-planar portion may include a combination of arcuate portions, angular portions, or both with varying radii. Alternatively, the elongated body includes a cut-off portion on its top surface for locking the locator in place upon engagement with the engagement mechanism. In various embodiments, the guide mechanism includes two tracks positioned on the outside of the elongated body and extending upward from the top surface of the elongated body. The tracks define a space between them for slidably engaging the delivery device. In some embodiments, the guide mechanism may include a sleeve or similar structure. The locator may be deployed via a push tube located on the delivery device and pushed toward the guide mechanism.

In various embodiments, the non-planar distal end of the elongated body may include any combination of angular and arcuate portions. For example, in one embodiment, the non-planar distal end portion includes at least one angular portion. In another embodiment, the non-planar distal end portion includes a first angular portion extending upward from the elongated body and a second angular portion extending from the first angular portion, as described in more detail below. Generally, the non-planar distal end prevents the locator from engaging with the aperture, while the second angular portion assists in pivotally deploying the locator against the tissue. In other embodiments, the non-planar distal end includes at least one curved or arcuate portion.

Returning to the support member, in various embodiments, the post of the base of the support member includes a shoulder portion to secure the sealable member to the support member via curling. In some embodiments, the sealing member is secured to the support member at least until the device has been substantially reabsorbed. In some embodiments, the sealing member is sufficiently secured to align and position the sealing member at least within the cavity. Furthermore, the sealable member and the support member together form a single integrated structure. The sealable member and the support member are separate and dissimilar components that are not fixedly coupled together.

For example, the sealing component and the supporting component may be formed as a single piece or by permanently coupling the two components together.

In some embodiments, the post of the support member includes a generally cylindrical base portion disposed transversely to the support surface, and a neck portion extending at an angle from the top portion of the base portion and defining an aperture along an axis corresponding to the longitudinal axis of the delivery device. The delivery device may be releasably attached to the closure device, for example, via a suture or braid traveling through the delivery device and the aperture in the neck portion. In some embodiments, the neck portion forms an angle of about 10 to 70 degrees relative to the post and may have a flat side surface for engaging with the delivery device in a fixed position. Additionally, the post may also include a shoulder configured for aligning the sealable member or securing at least one of the sealable members thereto.

In various embodiments, the base of the support member comprises a generally circular support consisting of one or more rings and an elongated central spine including proximal and distal ends. The spine extends through the center point of the circular support, and each of the proximal and distal ends extends beyond the outer diameter of the support. In some embodiments, the one or more rings are concentrically oriented. The central spine may be generally rigid, with at least one end configured to engage with the pores in the tissue. In various embodiments, the support member and/or the sealable member may be made of one or more of the following materials: polydioxanone, poly-L-lactide, poly-D-lactide, poly-DL-lactide, polyglycolic acid, ε-caprolactone, polyethylene glycol, or copolymers thereof. In some embodiments, the monomers forming the polymeric material are bioabsorbable.

The advantages and features of these and other objects, as well as the disclosed systems and methods, will become apparent from the following description and accompanying drawings. Furthermore, it should be understood that the features of the various embodiments described are not mutually exclusive and can exist in various combinations and arrangements.

Attached Figure Description

In the drawings, similar reference characters typically refer to the same portion throughout different views. Furthermore, the drawings are not necessarily scaled; rather, they generally focus on illustrating the principles of the disclosed systems and methods and are not intended to be limiting. For clarity, not every component can be labeled in every drawing. In the following description, various embodiments are described with reference to the following drawings, wherein:

Figure 1A is a perspective view of a fully assembled apparatus for sealing pores in tissues according to one or more embodiments of the present invention;

Figure 1B is an exploded view of the apparatus of Figure 1A depicting its various components according to one or more embodiments of the present invention.

Figures 2A to 2C are perspective views of the apparatus of Figure 1A at various stages of assembly according to one or more embodiments of the present invention;

Figure 3 is a perspective view of a support member used with the device of Figure 1A according to one or more embodiments of the present invention;

Figure 4 is a side view of the support member of Figure 3 according to one or more embodiments of the present invention;

Figure 5 is a perspective view of a fully assembled apparatus for sealing pores in tissue containing a part of a body cavity according to one or more embodiments of the present invention;

Figure 6 is a perspective view of the device of Figure 5 depicted in a stage of deployment according to one or more embodiments of the present invention;

Figure 7 is a side view of the device of Figure 6 according to one or more embodiments of the present invention;

Figure 8 is a side view of the device of Figure 6 depicted in a later stage of deployment according to one or more embodiments of the present invention;

Figure 9 is a cross-sectional view of a positioner for use with a device according to one or more embodiments of the present invention;

Figure 10 is a perspective view of an alternative positioner for use with a device according to one or more embodiments of the present invention;

Figure 11 is a perspective view of another alternative positioner for use with a device according to one or more embodiments of the present invention;

Figure 12 is a side view of another alternative positioner for use with a device according to one or more embodiments of the present invention;

Figure 13 is a perspective view of another alternative positioner for use with a device according to one or more embodiments of the present invention;

Figure 14 is a side view of an alternative locator of Figure 13 engaged with a support member according to one or more embodiments of the present invention;

Figure 15 is a side view of an alternative embodiment of the positioner of Figure 13 that engages with a support member according to one or more embodiments of the present invention.

Figure 16 is a perspective view of another alternative positioner for use with a device according to one or more embodiments of the present invention;

Figure 17 is a side view of an alternative locator of Figure 16 engaged with a support member according to one or more embodiments of the present invention;

Figures 18A and 18B are perspective views of apparatus and delivery tools at various stages of deployment according to one or more embodiments of the present invention;

Figures 19A and 19B are perspective and side views of the apparatus of Figures 18A and 18B after deployment, according to one or more embodiments of the present invention.

Figures 20A and 20B are perspective and side views of the apparatus of Figures 19A and 19B in a later stage of deployment according to one or more embodiments of the present invention.

Figures 21A to 21C are plan views of a sealing member according to one or more embodiments of the present invention; and

Figures 22 to 24 are perspective views of apparatus and delivery tools at various stages of deployment according to one or more embodiments of the present invention.

Detailed Implementation

As described herein, illustrative embodiments provide surgical closure systems, devices, and methods for (i) aligning tissue surrounding a perforation in a body cavity to close the opening in the body cavity, (ii) forming a tampon at the opening during tissue alignment, and (iii) maintaining the tissue alignment around the perforation until the perforation is sealed. In some embodiments, the devices, systems, and methods are used to close surgical perforations in body cavities, such as the gastrointestinal tract, heart, abdominal cavity, esophagus, vagina, rectum, trachea, bronchi, and blood vessels, including, for example (but not limited to), the femoral vein, jugular vein, vena cava, femoral artery, subclavian artery, ascending aorta, accessory artery, and brachial artery.

Figures 1A and 1B depict a vascular closure implant (device 10) for sealing punctures in hollow blood vessels. Device 10 comprises four components: a flexible sealable member 12 (e.g., a patch), a support member 14 (e.g., a rigid stent), an external support member (positioner 16), and a locking member 18 for the external support member (e.g., a support shaft). Device 10 is shown in an assembled state in Figure 1A, while Figure 1B depicts device 10 in an exploded view to illustrate each component.

Figures 2A to 2C depict one manner of assembling the basic sealing device 10; however, other assembly methods and different sequences of steps are contemplated and considered within the scope of the invention as needed to suit specific applications (e.g., cavity type, cavity size, and cavity location). For example, in one embodiment, the device 10 is assembled by first loading the sealable component 12 onto the support component 14 (Figure 2A). The locator 16 is then placed on the sealable component 12 (Figure 2B). A support shaft 18 is positioned through a hole in a post 24 of the support component 14 above the locator 16 (Figure 2C), wherein each end of the support shaft extends beyond the post 24 to secure the locator 16 to the support component 14.

A sealable member 12 (in some embodiments this component is a flexible wing) can be positioned against the inner surface of a vessel wall (e.g., 146 in Figure 6) adjacent to an pore (e.g., 144 in Figure 6) to form a plug at the pore. The sealable member 12 is typically larger than the diameter of the pore. The sealable member 12 shown has a generally circular shape; however, other geometries (e.g., elliptical or polygonal) are contemplated as needed to suit a particular application. Although flat or slightly curved in a relaxed state, in a deployed state, the sealable member 12 flexibly bends to conform to the inner surface of the cavity it engages with. Generally, the sealable member 12 includes an opening located at or near the center of the member 12, sized to allow the member 12 to extend beyond the post 24. In some embodiments, the sealable member 12 can rotate freely relative to the base 19 of the support member 14 about an axis concentric with the post 24. Additional details of the sealing component are disclosed in U.S. Patent No. 9,572,558, U.S. Patent Publications Nos. 2016/0174953 and 2017/0181736, and PCT Publication No. WO2011/080588, the entire disclosure of which is hereby incorporated herein by reference. Examples of the sealable components described in the incorporated reference are shown in Figures 21A through 21C.

Figures 3 and 4 depict the support member 14 in more detail. As shown in Figure 3, the support member 14 includes a base portion 19 and a column portion 24 extending upward from and generally perpendicular to the base 24. In the illustrated embodiment, the column includes a generally cylindrical base portion 25 and a neck portion 26 extending at an angle from the top portion of the base portion 25. The neck 26 defines an aperture along an axis corresponding to the longitudinal axis of the delivery shaft to which the support member is releasably attached. In some embodiments, the neck 26 is positioned at an angle of approximately 10 to 70 degrees relative to the column. The neck 26 may also include a section having a flat side surface 27 for engagement (e.g., bonding) with a delivery device in a fixed position.

In some embodiments, the post further includes a shoulder 28, which can be used to align or secure at least one of the sealable components via, for example, curling. In some embodiments, at least a portion of the shoulder is threaded to minimize stress and deformation on the sealable component. As shown in the figures, the post includes two apertures; one for receiving the support shaft 18, and the other in the neck 26 for receiving sutures or braids (e.g., 134 in FIG. 5), through which the sutures or braids are looped to allow the device 10 to be connected to a delivery device (e.g., 136 in FIG. 6).

The base 19 of the support member 14 includes a generally circular support structure consisting of one or more rings 22 and an elongated central spine 20 having a proximal end 21A and a distal end 21B. The circular support shown in Figure 3 includes two generally concentrically arranged rings 22 to aid in positioning the sealable member 12 and maintaining contact between the sealable member 12 and the surface of the vascular lumen. However, other numbers of rings may be included to suit specific applications (e.g., large pores), and the rings may have other shapes and orientations (e.g., eccentric) to suit specific applications.

The spine 20 extends through the center point of the circular support, and each of the proximal and distal ends 21 extends beyond the outer diameter 23 of the support. Generally, the spine 20 has a generally rigid body, or at least a portion of the spine 20 is rigid (e.g., a central region overlapping with the sealable member 12). At least one end 21 of the spine 20 is configured to “hook” or otherwise engage the vessel wall 46 during the retraction of the device into the orifice 44 in the vessel. For example, one end 21 of the spine may include a generally planar extension that engages with the distal edge of the orifice, thereby providing a tactile sensation to the user. In some embodiments, the end 21 of the spine may be reinforced (e.g., slightly thickened) to provide additional rigidity. In other embodiments, the end 21 of the spine may include a textured surface, a widened end, or other structures suitable for a particular application.

Generally, when the closure device 10 is in the sealed position, the support member 14 supports the sealable member 12 during delivery and deployment in the body cavity by holding and/or retaining the sealable member 12 against the inner surface of the tissue. The sealable member 12 and the support member 14 are depicted in a relaxed state throughout the figures; however, members 12, 14 may be compressed, rolled, folded, or otherwise reduced in size to allow the device to be delivered into the cavity via a tubular means. Additional embodiments of the support member 14 (and exemplary dimensions for various components) and methods for delivering and deploying the device are described in the above-incorporated references.

Figures 5 to 8 depict the device 100 according to one or more embodiments of the invention in various deployment states. In Figure 5, the device 100 is shown fully assembled and mounted on the front of the delivery device 136, wherein the tubular body of the delivery device 136 is located within the guide mechanism 154 of the locator 116, and the device 100 is secured to the delivery device 136 via stitches or braided threads 136.

Figures 6 and 7 depict a device 100 positioned within a blood vessel, adjacent to an orifice 144 to be sealed. As can be seen, the leading edge (e.g., the non-planar distal end 152 of the locator) is positioned directly above and outside the orifice 144. As discussed below, this configuration allows the sealable component 112 and the support component 114 to be inserted into the blood vessel without the locator 116 engaging the vessel wall 146 prior to deployment. A push tube 142 for actuating the locator 116 from a first position to a second position is also shown on a delivery device 136. At this stage, the assembly device 110 has been pulled back to allow the sealable component 112 to contact the vessel wall.

Figure 8 depicts the device 100 after the locator 116 has been actuated to a second position outside the blood vessel. As can be seen, the push tube 142 is advanced forward to engage the locator 116, pivoting it about the support axis 118 to a flat or generally planar orientation, wherein the vessel wall 146 is secured between the locator 116 and the sealable member 112. The locator 116 and consequently the entire device 100 can be secured in place using any of the adjustment mechanisms described below with respect to Figures 9 through 17.

Figures 9 to 17 depict various embodiments of a locator according to one or more embodiments of the invention for use with devices 10, 100. Generally, the locators 16, 116 are designed to deploy when devices 10, 100 are positioned at the puncture site. The basic locator is shown in Figure 9 and includes a generally planar elongated body 50, a non-planar distal end 52 disposed at the front of the locator 16, and a guide mechanism 54 extending upward from the top surface 60 of the locator to movably (e.g., slidably) engage a delivery tool. Generally, the front of the locator has an angled surface extending from the puncture site when the sealable component contacts the vessel wall. As discussed above, this non-planar portion may, as needed, include any combination of angled and/or arcuate shapes to suit a particular application. The purpose of this non-planar surface is to ensure that the locator 16 passes over the vessel wall during deployment and is not deployed inside the wall. The locator 16 is designed to have some flexibility so that it can bend and flex to allow it to pass over the blood vessel wall during deployment without deforming or damaging the vascular tissue.

At least a portion of the distal end 152 of the locator (e.g., A in FIG. 9) has a narrower cross-section than the main portion of the elongated body 50 (e.g., B in FIG. 9). This narrower region provides a clearance for the locator 16 to be deployed between the support shaft 18 and the support member 14. This clearance will allow the locator to bend and flex as it passes over the vessel wall. FIG. 10 depicts the locator 16 engaged with the support shaft 18 and in its deployed position. Generally, the device achieves closure by positioning the sealable member 12 against the vessel wall between the locator 16 and the support member 14. The locator 16 is secured in place by the support shaft 18, and its positioning relative to the vessel wall and the cross-sectional area at position B is shown in FIG. 9 and 10.

Various modifications to the design of positioner 16 (e.g., adding ramps or spring-like features) allow device 10 to close pores in blood vessel walls of varying thicknesses and morphologies. These modifications increase the range of wall thicknesses that the device can be used to close within blood vessel walls.

Figures 11 and 12 depict a positioner 316, wherein a portion of the top surface 360 has an inclined profile (e.g., adjustment mechanism 358) to increase the interference fit with the support shaft 318. Figure 11 depicts only the positioner 316, while Figure 12 depicts the positioner 316 engaging the support shaft 318.

Figures 13 to 15 depict positioners 416 and 516, wherein a portion of the elongated bodies 450 and 550 is non-planar. As shown in the figures, portions of the elongated bodies engaging with support shafts 418 and 518 have arcuate or angled portions (adjustment mechanisms 462 and 562) that define the space between the bottom surface 461 and 561 of the elongated bodies and the outer surface of the vessel wall. Figure 13 depicts positioner 416 alone, while Figure 14 depicts positioner 416 with a first profile, and Figure 15 depicts positioner 516 with a second, larger profile. These profiles may include any combination of arcuate and/or angled portions as needed to suit a particular application and provide spring force to the device. Specifically, positioners 416 and 516 will act as springs and pull support members 414 and 514 upward into the vessel wall via support shafts 418 and 518, as can be seen in Figures 14 and 15. Figure 15 depicts a positioner 516 with a more exaggerated spring profile (adjustment mechanism 562), which can provide greater force and/or be better suited for blood vessels with very thin walls.

Figures 16 and 17 depict a positioner 616, wherein a portion of an elongated body 650 includes a cutout (positioner lock 664) on its top surface 660. The lock 664 is located on the elongated body 650 at a position generally corresponding to the location where the positioner 616 interfaces with the support shaft 618. Specific dimensions for the cutout will vary to suit a particular application. Figure 16 depicts only the positioner 616, while Figure 17 depicts the positioner 616 engaging with the support shaft 618. The positioner lock 664 can be used with any of the positioner designs disclosed herein. As shown in Figure 17, once deployed, the support shaft 618 is locked within the cutout to prevent movement of the positioner relative to it.

Figures 18 to 20 and 22 to 24 depict various methods of using the device 700, 800 according to one or more embodiments of the invention. Generally, the device 700, 800 is intended to close orifices in hollow blood vessels of various sizes. It is particularly advantageous to use the sealable components disclosed herein in combination with the locators and support components also disclosed herein to close blood vessels (e.g., arteries and veins). The device is designed to provide the ability to be loaded into a loading cannula and delivered into a blood vessel in the same manner as the devices disclosed in the incorporated references.

Figures 18 to 20 generally depict the deployment of the device as follows. After the sealable and supportive components have been positioned within the blood vessel, the device is pulled back into the packing material (e.g., to provide closure to pores in the vessel wall (Figure 18A)). Once effective packing is achieved, the locator 716 is deployed by advancing the push tube 742 (Figure 18B). Once the locator 716 has been deployed, the suture/braided suture 734 is released from the device handle and the handle is removed (Figures 19A and 19B). If hemostasis has been achieved, the suture/braided suture 734 is removed, thereby completing the closure (Figures 20A and 20B). If bleeding continues at the puncture site, a small amount of tension can be applied to the suture until hemostasis is achieved.

Device 800 is typically designed for delivery via a catheter through a guidewire into the interior of a hollow blood vessel (Figures 22-24). Device 800 (e.g., support member 814 and sealable member 812) is first folded into the delivery system and then delivered into the blood vessel via guidewire 848 through inserter 836. Once inside the blood vessel, the device is allowed to open to its original pre-delivery shape (Figure 22). The next step is to gently bring the device back into the orifice in the blood vessel above guidewire 848 using the delivery system (Figure 23). Once there, the device (e.g., support member 814) hooks onto the distal edge of the orifice and then seals the orifice when fully positioned across it. Guidewire 148 is then removed, and positioner 816 is moved to its final straddle position (Figure 24). Device 800 is released from the delivery system, and the delivery system is removed.

Figures 21A to 21C depict the sealable component as described above. Generally, the sealable component 12 is made of a bilayer bioabsorbable polymer membrane, which consists of an extruded component and an electrospun component, which can be formed as two dissimilar layers bonded together or as a single component. The thickness of the extruded layer can range from about 10 μm to 500 μm. The electrospun layer can consist of fibers with a diameter ranging from about 0.3 μm to 30 μm, wherein the layer thickness ranges from about 10 μm to 2000 μm. The fibers can be randomly or patterned and their diameter and density can vary within the electrospun layer. In one example, the electrospun layer immediately adjacent to the extruded layer consists of high-density narrow fibers, and as the depth of the electrospun layer increases, the fiber diameter increases and the density decreases (more pores), resulting in a softer top surface on the electrospun layer to facilitate conformation to the morphology of the blood vessel lumen when pulled back to the position to close the pore size.

The alternative sealable component 12 is fully electrospun and consists of fibers having a diameter ranging from about 0.1 μm to 30 μm and a layer thickness ranging from about 50 μm to 2500 μm. This alternative component 12 will have an impermeable or semi-impermeable bottom surface and a softer top surface on the electrospun layer to facilitate conformation to the morphology of the vessel lumen when pulled back to the position to close the pore.

Generally, a locator ensures that the gap between the sealable component and the vessel surface is sealed, regardless of the vessel surface morphology (e.g., calcification, plaque, disease, venous valves, varying wall thickness, or the anatomy of the puncture site). The locator allows the device to be customized to close various vessel types because its geometry can be altered to accommodate thick vessel walls (e.g., the aorta) or thin vessel walls (e.g., the femoral vein or large intestine). The geometry and size of the locator/device can be adjusted to close large or small vessel openings. Additionally, the device can accommodate surgical guidewires to facilitate wire-to-vessel delivery, such as guidewires with diameters of 0.038", 0.035", 0.018", or 0.014".

When deployed, the locator provides contact on both the distal and proximal sides of the external vessel wall. When combined with a support shaft, the locator 16 provides a range of operations to accommodate varying wall thicknesses within the vessel with orifices for closure and facilitates the closure of larger orifices (e.g., >24F). For example, when used in veins, recoil at the puncture site is minimized because the locator is designed to straddle both the distal and proximal sides of the orifice. The device also provides faster closure and improved sealing due to the snap-fit effect of the locator on both the distal and proximal sides of the device, thereby providing better safety and a lower risk of dislodgement due to the clamping design of the locator on both the distal and proximal sides of the orifice. Additionally, the device adapts better to rough and uneven luminal surfaces of the vessel wall due to the novel support component design combined with the locator design. This robust deployment (e.g., more difficult to move/dislodge once deployed) minimizes the risk of embolism. The device can be used for transcatheter venous, patent foramen ovale (PFO), or natural orifice endoscopic procedures (NOTES). The device also provides a direct means of controlling the juxtaposition of the device at the pores, thereby better managing any bleeding after deployment.

Although some figures and embodiments relate to the use of systems and devices for closing perforations associated with vascular surgery, those skilled in the art will understand that the components of the provided devices are size-independent (e.g., scalable) and therefore can be used to close any perforations in the cavities of mammals.

Furthermore, it is anticipated that the systems, apparatus, methods, and processes of this application encompass variations and adaptations developed using information from the embodiments described below. Adaptations or modifications to the methods and processes described in this specification can be performed by those skilled in the art.

Throughout the description, where a composition, compound, or product is described as having, containing, or comprising specific components, or where a process or method is described as having, containing, or including specific steps, it is anticipated that there will be additional articles, apparatus, and systems of this application that are substantially composed of or comprised of the stated components, and that there will be processes and methods of this application that are substantially composed of or comprised of the stated processing steps.

It should be understood that the order of steps or the order in which actions are performed is irrelevant as long as the described method remains operational. Furthermore, two or more steps or actions can be performed simultaneously.

Claims (14)

1. A sealing system for sealing pores in tissue of a body cavity, the system comprising a sealing device and a delivery device, wherein the delivery device has an attachment mechanism for releasably attaching the sealing device and delivering the sealing device to the pores in the tissue, and the delivery device is configured to deploy the sealing device within the body cavity, and wherein the sealing device comprises: A sealable component that, when the closure device is in the sealed position, is positioned against the inner surface of the tissue adjacent to the pores in the tissue; A support member comprising a base and a post, wherein the base of the support member includes a support surface to support the sealable member against the inner surface of the tissue when the closure device is in the sealed position, and the post extends through the sealable member and the orifice and includes an engagement mechanism; and A positioner, pivotally coupled to the support member via the engagement mechanism, and positioned against the outer surface of the tissue adjacent to the pore when the closure device is in the sealed position, such that at least a portion of the tissue is disposed between the positioner and the sealable member, characterized in that the positioner comprises: Adjustment mechanisms are used to adapt to changing organizational structures. An elongated body, wherein the elongated body is a flat body; The non-planar distal portion includes a first corner portion extending upward from the elongated body and a second corner portion extending from the first corner portion; A guiding mechanism, extending upward from the top surface of the locator, is movably engaged with the delivery device to deploy the locator. The adjustment mechanism is positioned along the elongated body of the positioner. 2. The system according to claim 1, wherein the engagement mechanism comprises: A portion of the column is positioned transversely to the support surface and defines a pore therein; and A support shaft, configured to be disposed within the column aperture to secure the locator to the support member, wherein the support shaft engages with the surface of the locator to provide a sealing force to the tissue. 3. The system of claim 1, wherein the adjustment mechanism comprises at least one of the following: The elongated body includes sections of varying thickness to form ramps for slidably engaging the engagement mechanism; or The elongated body includes sections of non-planar portions configured to fold when engaged with the engagement mechanism. 4. The system of claim 1, wherein the elongated body includes a cutout portion on its top surface for locking the locator in place when engaged with the engagement mechanism. 5. The system of claim 1, wherein the guiding mechanism comprises two tracks disposed on the outside of the elongated body and extending upward from the top surface of the elongated body, wherein the tracks define a space therebetween for slidably engaging the delivery device. 6. The system of claim 1, wherein the locator is deployed via a push tube located on the delivery device and pushed toward the guiding mechanism. 7. The system of claim 1, wherein the elongated body defines a centrally located elongated opening, the elongated opening being configured to engage with the engagement mechanism. 8. The system of claim 1, wherein the column of the base of the support member includes a shoulder portion to secure the sealable member to the support member via curling. 9. The system of claim 8, wherein the sealable component and the support component are formed together as a single integrated structure via a non-fixed fit. 10. The system of claim 1, wherein the closure device is configured to be deployed above the guidewire. 11. The system of claim 1, wherein the column of the support member comprises: The cylindrical base portion is positioned transversely to the supporting surface; and The neck portion extends at an angle from the top portion of the base portion and defines the aperture along an axis corresponding to the longitudinal axis of the delivery shaft to which the support member is releasably attached. 12. The system of claim 11, wherein the post further includes a shoulder configured to align or secure at least one of the sealable components. 13. The system of claim 1, wherein the base of the supporting member comprises: A circular support, comprising one or more rings; and A slender central spine, comprising a proximal end and a distal end, wherein the spine extends through the center point of the circular support, and each of the proximal and distal ends extends beyond the outer diameter of the support. 14. The system of claim 13, wherein the central spine is rigid and at least one end is configured to engage with the pores in the tissue.