VASCULATURE CLOSURE METHODS
Vasculature closure devices, and systems and methods for their use, are provided. In one embodiment, the method includes deploying a vasculature closure device including a support frame and a sealing membrane into a vessel through a puncture site, wherein the support frame is in a collapsed configuration during deployment, and expanding the support frame into an expanded configuration within the vessel such that the sealing membrane is pushed against the puncture site.
This application is a divisional of U.S. application Ser. No. 12/852,893, filed on Aug. 9, 2010, which claims the benefit of U.S. Provisional Application No. 61/251,054, filed on Oct. 13, 2009, and U.S. Provisional Application No. 61/285,503, filed on Dec. 10, 2009. The priority and benefit of these applications are hereby claimed, and the disclosures of these applications are incorporated herein by reference in their entirety.
BACKGROUND OF THE INVENTIONThis disclosure relates generally to the field of implantable medical devices and associated methods, and more particularly to vascular devices and methods for closing openings in vessel walls.
During certain endovascular surgery procedures, intravascular catheters are inserted through an incision in the patient's skin and underlying tissue to access an artery or vein. After the surgical procedure is completed and the catheter is removed from the vessel, the puncture providing the access through the patient's vessel wall must be closed. This is quite difficult, not only because of the high blood pressure within an artery, but also because of the many layers of tissue that must be penetrated to reach the vessel to achieve closure.
Physicians currently use a number of methods to close a vessel puncture, which include applying localized compression, sutures, collagen plugs, adhesives, gels, and/or foams. To provide localized compression, the physician applies pressure against the vessel to facilitate natural clotting of the vessel puncture. However, this method can take up to a half hour or more and requires the patient to remain immobilized while providing the compression and to remain in the hospital for a period thereafter for observation. The amount of time necessary to apply compression can, in some circumstances, be even greater, depending upon the levels of anti-clotting agents (e.g., heparin, glycoprotein IIb/IIA antagonists, etc.) administered during the endovascular procedure. In addition, applying localized compression can increase the potential for blood clots at the puncture site to become dislodged. Closing procedures in which sutures, collagen plugs, adhesives, gels, and/or foams are applied suffer from variability and unpredictability associated with implantation procedures, many of which are complicated and require highly technical implantation techniques. Some of these closure methods occasionally cause undesirable deformation of the vessels. Moreover, for newer endovascular procedures, such as abdominal or thoracic aortic aneurysm repair, percutaneous valve replacement and repair, or cardiac ablation, which use large diameter delivery systems typically in the range of 8-25 Fr, these conventional closure methods are suboptimal.
Thus, there is a desire for improved vasculature closure devices and methods for deploying and performing treatment using the same. It would, therefore, be advantageous to provide a vasculature closure device that would more quickly and effectively close vessel wall punctures.
BRIEF SUMMARYVasculature closure devices and systems and methods for their use are provided. According to one aspect, a vasculature closure device is provided. In one embodiment, the vasculature closure device includes an expandable support frame deployable within a vessel and a sealing membrane at least partially supported by the expandable support frame. Upon expanding the support frame, the vasculature closure device is configured to intraluminally secure the sealing membrane against a puncture site existing in a vessel wall.
According to another aspect, a method is provided for closing a vessel puncture. In one embodiment, the method includes deploying, via a sheath, a vasculature closure device including a support frame and a sealing membrane into a vessel through the puncture site, wherein the support frame is in a compressed configuration during deployment; and then positioning and expanding the support frame within the vessel to cause the sealing membrane to at least partially seal the puncture site.
According to yet another aspect, a system is provided for closing a vessel puncture. In one embodiment, the system includes a vasculature closure device that includes an expandable support frame and a sealing membrane at least partially supported by the expandable support frame. The vasculature closure device is configured to expand from a collapsed configuration to intraluminally secure the sealing membrane against a puncture site existing in a vessel. The system can further include a sheath operable to receive the vasculature closure device in the collapsed configuration and to facilitate deploying the vasculature closure device through the puncture site and into the vessel and a push rod operable to advance the vasculature closure device through the sheath.
Improved vasculature closure devices and systems to facilitate hemostasis and closure of vessel punctures are provided, along with methods for delivering the vascular closure device (VCD) into a patient in need thereof. A VCD, according to various embodiments, includes at least one sealing membrane and at least one support frame attached, integrated, or otherwise supporting the sealing membrane. The support frame is utilized to expand the sealing membrane from a collapsed configuration to an expanded configuration when deployed within a vessel. The support frame can be configured such that it expands enough to force the sealing membrane against a vessel puncture. The pressure exerted by the support frame can vary, but is effective to at least partially maintain the VCD at the desired position within the vessel—which at least partially presses the sealing membrane against the vessel puncture. Upon positioning and exerting pressure by the sealing membrane against the vessel puncture, blood leakage is prevented and/or reduced, and hemostasis and healing are promoted. In some instances, the sealing membrane of the VCD may significantly reduce blood leakage from the vessel puncture, while complete hemostasis is achieved by a thrombus formed on or around the sealing membrane against the puncture. Thrombus forming capabilities may be enhanced by providing thrombus promoting materials on the sealing membrane and/or the anchoring tab or pull wire. The VCD may be left in the secured position within the vessel for essentially any period of time, which may be indefinitely in certain embodiments.
According to various embodiments, portions of the VCD are biodegradable, bioabsorbable, and/or bioerodable (collectively referred to herein as “biodegradable” unless expressly stated otherwise), such that after a period of time portions degrade, absorb, or erode. For example, at least the sealing membrane, and in some embodiments the support frame or portions thereof and/or an anchoring tab or pull wire, absorb after time, minimizing the components remaining within the vessel over time, which simplifies subsequent access at or near the vessel puncture site and reduces potential long-term complications. The shape, configuration, and composition of the various components of the VCD, and the systems and methods for delivering the same, can be embodied in a number of manners, representative examples of which are described below.
The VCD described herein may be used to close punctures or penetrations in vessels in human or other animals (e.g., mammalian). Such an animal may be referred to herein as a patient. As used herein, the term “vessel” refers to arteries, veins, other vascular lumens for carrying blood or lymph, or other body lumens, such as, but not limited to, body lumens of the gastrointestinal system (e.g., the esophagus, the stomach, the small intestine, or the large intestine), the airway system (e.g., the trachea, the bronchus, or the bronchioles), the urinary system (e.g., the bladder, the ureters, or the urethra), or the cerebrospinal system (e.g., subarachnoid space or the ventricular system around and/or inside the brain and/or the spinal cord). The VCD can be dimensioned for effective use with a variety of vessel anatomies and sizes in adult and pediatric patients, as well as with punctures at a variety of vessel sites within the patient. It is envisioned that the VCD can be adapted for use in closing punctures in other body lumens in conjunction with various surgical procedures. For example, in one other embodiment, the VCD can be adapted for use to close lumen punctures during natural orifice transluminal endoscopic surgery or to close a lumbar puncture.
Vasculature Closure Devices
Referring to the figures,
The sealing membrane 105, and thus generally the VCD 100 of this embodiment, may be formed in any shape that may be rolled and unrolled along a longitudinal axis generally aligned with and extending along the length of the vessel 10 when implanted. For example, a simple form is similar in configuration to a sheet that can roll or unroll, or a tube that is slit entirely along its longitudinal axis (referred to as a “gull wing” shape in U.S. Provisional Application No. 61/251,054). As described below, however, any other shape that can be collapsed and then expanded within a vessel to promote securement of the VCD 100 can be provided.
According to the embodiment shown in
An anchoring tab 120 is also secured to the VCD 100, according to one embodiment. The anchoring tab 120 may be attached to and/or extend from the sealing membrane 105, the cross-member support 115, and/or the support frame 110. During placement of the VCD 100, the anchoring tab 120 may be pulled in the proximal direction (away from and out of the puncture site 15), thereby pulling the VCD 100 against the inner vessel wall so that it can be oriented at or near the target area at the puncture site 15. The orientation of the anchoring tab 120 and/or the cross-member support 115 relative to the sealing membrane 105 surface further facilitates centering the VCD 100 within the vessel 10 during implantation, as the VCD 100 will migrate within the vessel 10 (typically downstream) until the anchoring tab 120 abuts an edge of the vessel puncture 15. Thus, the position of the cross-member support 115 may be adjusted along the width of the sealing membrane 105 and/or the position of the anchoring tab 120 may be adjusted along the length of the cross-member support 115 to accommodate for anticipated VCD 100 migration within the vessel 10.
According to one embodiment, the anchoring tab 120 may be affixed (e.g., sutured, glued, hooked, held by an elastic retaining means, etc.) to the patient's epidermis, dermis, sub-dermal layer, adipose layer, or muscle tissue at or near the vessel access site (e.g., at or near the initial incision created for access to the vessel). According to various embodiments, the VCD 100 may additionally, or instead, include a pull string, which similarly facilitates positioning the VCD 100 at or near the target area by pulling distally. The pull string can be attached to the VCD 100, such as to the sealing membrane 105, the cross-member support 115, and/or the support frame 110, or it may be attached to and extend from the anchoring tab 120.
According to one embodiment, the anchoring tab 120 is flexible and may vary in size. In one embodiment, the anchoring tab 120 has a relatively thin cross section, such as being thread-like, or a thick cross section, such as a diameter similar to or slightly smaller than the puncture site 15 (e.g., from approximately 1 mm to approximately 9.0 mm in diameter). The anchoring tab 120 beneficially may further assist in promoting hemostasis by at least partially filling the puncture site 15 and the access channel through the patient's tissue. In one embodiment, the anchoring tab 120 and a pull string are integrated and together are sufficiently long enough to exit the proximal end of a delivery sheath or other delivery system (e.g., approximately 10 cm to approximately 100 cm). Excess length may be removed after securing the anchoring tab 120 to the patient's epidermis, dermis, sub-dermal layer, adipose layer, or muscle tissue at or near the puncture site. In other embodiments, the anchoring tab 120 and pull string are different members separately attached or otherwise included with the VCD 100; have different diameters, widths, and lengths; and/or are constructed from different materials. For example, the anchoring tab 120 may be fabricated shorter (e.g., approximately 10 mm to approximately 100 mm) than a pull string and/or may be thicker than a pull string. In one embodiment, an anchoring tab 120 may also include a connecting means at its proximal end, such as an eye, a hook, a toggle, and the like, to which a separate pull string can be permanently or removably attached.
It is appreciated that
With reference to the embodiment of
Thus, by having a natural stable state with a larger radius of curvature than the interior vessel wall, the peripheral support frame 110 will expand during implantation to exert a force against the vessel inner wall. This force, coupled with the pressure created by the blood pressure exerted against the membrane 105 and peripheral support frame 110, retains the VCD 100 in place at or near the puncture site. However, the amount of force exerted against the vessel wall is to be limited to avoid injury to the vessel wall. For example, when in an expanded configuration, the VCD 100 (and any other VCD embodiments described herein) may exert a pressure on the vessel inner wall ranging between approximately 0.3 mm Hg to approximately 400 mm Hg, in various embodiments, and in one embodiment, a pressure between approximately 2 mm Hg and approximately 50 mm Hg can be exerted on the vessel inner wall. To achieve a pre-shaped peripheral support frame 110 having the desired shape and curvature described herein, a shape memory metal or alloy, such as nickel-titanium alloy (e.g., Nitinol), a shape memory polymer, or any combination thereof, and/or temperature treatments thereof, may be used to fabricate all or a portion of the peripheral support frame 110.
The cross-sectional thickness of the members comprising the peripheral support frame 110 may contribute to the amount of force exerted by the VCD 100 when in the natural stable (expanded) configuration. For example, according to various embodiments, the thickness may range between approximately 0.01 mm and approximately 2.0 mm, and in some embodiments between approximately 0.04 mm and approximately 0.2 mm, while in other embodiments the thickness may range between 0.2 mm and approximately 0.7 mm. For example, in one embodiment, the members of the peripheral support frame 110 are formed to have a greater width (the dimension lying along the surface of the sealing membrane 105) than the thickness (the dimension perpendicular to the top and the bottom of the sealing membrane 105 surface), such as a width ranging between approximately 0.05 mm and approximately 1.5 mm, or between approximately 0.2 mm and approximately 0.7 mm in one embodiment, and a thickness ranging between approximately 0.01 mm and approximately 0.3 mm, or between approximately 0.04 mm and approximately 0.1 mm in another embodiment. It is appreciated that these dimensions are illustrative and are not intended to be limiting. The width and thickness of the peripheral support frame 110 members may vary as desired and may depend upon the intended implantation.
A VCD 100 having a peripheral support frame 110 also minimizes interference during subsequent vessel access if the VCD 100 (or at least the peripheral support frame 110) remains within the vessel. The peripheral support frame 110 is distanced from the current puncture site because it is oriented only around the periphery of the sealing membrane 105. In addition, by having a support frame only around the periphery of the sealing membrane 105 (and optionally a cross-member support 115), the space occupied by the peripheral support frame 110 can be minimized. In many circumstances, there are a limited number of vessels that provide suitable access for vasculature intervention procedures. Access is especially limited for patients having vessels suffering from stenosis or calcification. Accordingly, in some instances, it may be desirable to reduce the amount of additional vessel obstruction by minimizing the components of the VCD 100 that may remain within the vessel or otherwise inhibit subsequent access, which may include the peripheral support frame 110.
According to some embodiments, the sealing membrane 105 is biodegradable. Thus, after time, at least the sealing membrane 105 will degrade and will not itself obstruct vessel access. According another embodiment, the sealing membrane 105, whether biodegradable or not, is sufficiently thin or composed of material weak enough to not substantially interfere with vessel re-accessing. For example, in some embodiments, the sealing membrane 105 can be partially, or completely, fabricated from a biodegradable material, such as, but not limited to, modified cellulose, collagen, fibrin, fibrinogen, elastin, tissue, biological membrane (e.g., pericardium, etc.), or other connective proteins or natural materials; polymers or copolymers, such as, but not limited to, aliphatic polyester (e.g., poly-L-lactide (PLLA), poly-D-lactide (PDLA)), polyglycolide (PGA), poly(glycolic-co-lactic acid) (PLGA), polydioxanone (PDS), polycaprolactone (PCL), poly(glycolide-co-trimethylene carbonate) (PGA-TMC), polygluconate, polylactic acid-polyethylene oxide copolymers, poly(hydroxybutyrate), polyanhydride, polyphosphoester, poly(amino acids), poly(alpha-hydroxy acid), or any other similar copolymers; magnesium or magnesium alloys; or aluminum or aluminum alloys; as well as any composites and combinations thereof, and combinations of other biodegradable materials, which, after a period of time resorb into the body. In other embodiments, the sealing membrane is partially, or completely, fabricated from any other biocompatible material, which may not be completely bioabsorbable, such as, but not limited to, expanded polytetrafluoroethylene (ePTFE), polyethylene, polypropylene, polyester, polyurethane, silicone, Dacron, urethane, polyaryletheretherketone (PEEK), stainless steel, titanium, nickel-titanium, cobalt, nickel-chromium, gold, platinum, and/or any composite, alloy, or combination of these or other suitable materials. It is appreciated that in some embodiments, the sealing membrane may be fabricated from a combination of one or more biodegradable materials and non-absorbable materials.
Moreover, according to some embodiments, the sealing membrane 105 may be formed as a continuous material, while, in other embodiments, the sealing membrane 105 may be formed in a woven or mesh configuration. A woven or mesh configuration facilitates forming a barrier to blood leakage by sealing as thrombus or other body material or cells attached to the woven or mesh sealing membrane 105. Similarly, the sealing membrane 105 may include holes, perforation, or partial perforation, at least at or near the area designed to be positioned at or near the puncture site. In some embodiments, holes may be provided only at a portion of the sealing membrane 105; though, in other embodiments, as much as 60% or more of the sealing membrane 105 may include holes or perforation. The holes or perforations may be formed in any suitable size, such as having a diameter ranging from approximately 0.05 mm to approximately 2 mm in one embodiment; though, holes or perforations may have other dimensions in other embodiments. Holes or perforations serve to promote cell growth over the sealing membrane 105 and the sealing membrane's 105 integration to the vessel. Moreover, a perforated sealing membrane 105 also reduces the total amount of foreign matter (e.g., the sealing membrane 105) implanted within the patient, and thus promotes membrane degradation. According to some embodiments, sealing membrane 105 materials are chosen to exhibit one or more of the following traits: to avoid inflammation or toxic response when implanted, to have acceptable shelf life, to control degradation rate if biodegradable, to metabolize if biodegradable, and/or to be easily sterilized.
In some embodiments, the peripheral support frame 110 can also be fabricated at least partially from biodegradable materials, such as, but not limited to, those described above. According to one embodiment, the peripheral support frame 110 may be fabricated from materials such as, but not limited to, aliphatic polyester (e.g., poly-L-lactide (PLLA), poly-D-lactide (PDLA), polyglycolide (PGA), poly(glycolic-co-lactic acid) (PLGA)), polydioxanone (PDS), polycaprolactone (PCL), poly(glycolide-co-trimethylene carbonate) (PGA-TMC), polygluconate, polylactic acid-polyethylene oxide copolymers, poly(hydroxybutyrate), polyanhydride, polyphosphoester, poly(amino acids), poly(alpha-hydroxy acid), or any other similar copolymers; magnesium or magnesium alloys; or aluminum or aluminum alloys; as well as any composites or combinations thereof, or combinations of other biodegradable materials, which, after a period of time resorb into the body. However, in other embodiments, the peripheral support frame 110 is at least partially fabricated from non-absorbable materials, including, but not limited to, nickel-titanium alloy (Nitinol), stainless steel, titanium, cobalt-based alloy, chromium alloys, gold, platinum, tantalum, a biocompatible polymer, such as a shape memory polymer, or any combination thereof. Thus, for embodiments in which the peripheral support frame 110 is fabricated from non-absorbable materials, it may be desirable to minimize the size and space occupied by the frame, such as is accomplished by its orientation around the periphery of the sealing membrane 105. Moreover, as described above, many of the aforementioned materials or combinations thereof exhibit elastic, super-elastic, and/or shape memory characteristics that can beneficially be formed into a desired shape to permit self-expansion of the VCD 100 to a stable natural state from a flexed or otherwise altered state during implantation and to improve securement of the VCD 100 within a vessel.
The cross-member support 115 extending between opposite sides of the peripheral support frame 110 serves at least two functions. First, the cross-member support 115 supports the sealing membrane 105 at or near its center to avoid sagging where it will be in contact with a vessel puncture site, thus improving the seal created therebetween. Second, the cross-member support 115 may include an attachment means 205 for attaching an anchoring tab and/or pull string to the VCD 100, such as is described with reference to
In one embodiment, the cross-member support 115 is fabricated from a material having additional strength and/or rigidity relative to the rest of the peripheral support frame 110, such as is described with reference to straight edge portion of
According to one embodiment, the cross-member support 115 is fabricated from a biodegradable polymer, a biodegradable metal or metal alloy, any other biodegradable material, or any combination thereof. A biodegradable cross-member support 115 will improve subsequent access to the vessel at or near the implantation site at any time after its degradation. Because the cross-member support 115, in this embodiment, will span across or be located proximate the puncture site, being formed from a biodegradable material will avoid impeding access to the puncture site. In one example embodiment, the cross-member support 115 may be configured as a wire, extending between, but separate from, the peripheral support frame 110 at or near the same position as shown in
According to one embodiment, a VCD 100 having some or all components fabricated from biodegradable materials, is manufactured in a manner to result in a predictable degradation rate. For example, in one embodiment, biodegradable components are fabricated from a material having at least 1 day degradation time, and can be up to at least 720 days. For example, in one embodiment, the degradation time may be between approximately 20 days and approximately 120 days. These degradation rates are illustrative purposes only and are not intended to be limiting. In other embodiments, the degradation time may be greater than or less than these ranges as desired, which may depend upon the implantation site and/or procedure being performed. Moreover, in some embodiments, different components of a VCD 100 can degrade at different rates, such as a VCD 100 having a sealing membrane 105 that degrades at a quicker rate than the peripheral support frame 110 and/or the cross-member support 115.
In addition, the material from which the VCD 100 components are fabricated should be stable over a Wide range of temperatures to avoid degradation or defects during manufacturing, sterilization, and storing. Example temperature ranges over which VCD 100 components should be stable may range from approximately −20° C. to approximately 65° C., or, in some embodiments, from approximately −10° C. to approximately 45° C. It is appreciated that, according to some embodiments, VCD 100 components may be stable at temperatures above and below this range. Example materials which exhibit desirable qualities for manufacturing biodegradable VCD 100 components include, but are not limited to, the Resomer® products manufactured by Boheringer Ingelheim GmbH, of Ingelheim am Rhein, Germany, which are based on lactic acid and glycolic acids.
In other embodiments, the VCD 100, including the sealing membrane 105 and the peripheral support frame 110, may be configured in a different shape, such as, but not limited to, oval, asymmetrical, elliptical, rectangular, rhombus, triangular, pentagonal, hexagonal, or any other polygonal shape. In embodiments having a sealing membrane 105 configured in a different shape than that illustrated in
In the embodiment shown in
To provide the desired hemostasis, the dimensions of the sealing membrane 105 are at least as large as or larger than the puncture site according to one embodiment, such as is illustrated by
The sealing membrane 105 may be formed in any number of configurations, including, but not limited to, a woven membrane, a non-woven membrane, a mesh, a film, a gel, a single membrane, a multilayer membrane, or any combination thereof. The sealing membrane 105 may be constructed according to any number of techniques, including, but not limited to, extrusion, solution deposition, coating, molding, electrospinning, weaving, or any other suitable method for manufacturing polymeric sheets, textiles, or membranes.
According to one embodiment, the sealing membrane 105 is produced either by weaving, air spinning, or electrospinning, which uses an electrical charge to draw fibers from a liquid form. Weaving, air spinning, and electrospinning allow controlling the density, the surface area topography, and the flexibility of the sealing membrane 105. As a result, increased control is provided over the sealing membrane's 105 degradation rate, whereby a larger effective surface area results in faster degradation. Controlling membrane flexibility allows controlling the ability of the sealing membrane 105 to roll or fold into the collapsed configuration during delivery, while also avoiding significant wrinkles or creases, which may otherwise occur with extruded membranes. Moreover, a sealing membrane 105 with reduced density, such as may be accomplished by weaving or electrospinning, increases the compressibility of the sealing membrane 105, which improves the ability of the sealing membrane 105 to adjust to vascular inner wall topography (e.g., surface roughness that may occur from calcification, etc.) and improves its sealing capabilities.
The sealing membrane 105 may be a single material or it may be a composite material. The single or composite material may be porous, non-porous, or a combination thereof.
According to various embodiments, the sealing membrane 105 may have substantially uniform properties throughout, or the sealing membrane 105 may exhibit varied properties, such as including multiple layers of different materials and/or including layers having different densities or porosities. For example, according to one embodiment in which the sealing membrane 105 is formed from multiple layers, the sealing membrane 105 is constructed from at least a first porous material forming a first layer and a second layer formed from a less porous and, thus, smoother material. The first layer may be the same material as the second layer but fabricated in a different manner to generate different porosities, or the first and second layers may be formed from different materials. In one example, a VCD 100 with a sealing membrane 105 having a more porous surface facing inward toward the vessel lumen relative to the surface facing outward toward the vessel's inner wall allows faster degradation of the sealing membrane 105 on its inner surface facing the vessel interior. In another embodiment, however, a less porous layer may face outward toward the vessel wall, providing the smoother surface in contact with blood flowing through the vessel. Weaving and electro spinning, for example, may be used to create various combinations of densities, porosities, and surface area properties, which may differ from the representative examples described herein.
The sealing membrane 105 may be integrated with or otherwise coupled to the peripheral support frame 110 at one or more points along the peripheral support frame 110 and/or the cross-member support 115 using any number of suitable techniques, including, but not limited to, adhesive, solvent adhesion, heat welding, laser welding, ultrasonic welding, mechanical attachment, layered integration, or any combination thereof. The technique chosen to couple the sealing membrane 105 to the peripheral support frame 110 may depend in part on the manufacturing technique utilized to fabricate the sealing membrane 105 and/or the peripheral support frame 110.
According to one embodiment, the peripheral support frame 110 may be sandwiched between two membrane layers forming the sealing membrane 105 and securing the peripheral support frame 110 in position therebetween. For example, in one technique, a first membrane layer is formed over a mandrel, which provides the same, or slightly larger, radius of curvature (and, thus, relatively flatter) as the vessel into which the VCD 100 is intended to be implanted. After forming the first membrane layer of the mandrel, the peripheral support frame 110 is placed over the first membrane layer. In one embodiment, at this step the peripheral support frame 110 is treated into its natural stable state around the mandrel, such as if the peripheral support frame 110 is fabricated from a shape memory metal, metal alloy, or polymer. Though, in other embodiments utilizing shape memory metals, metal alloys, or polymers, the peripheral support frame 110 can be treated to its natural stable state at another stage of manufacturing (e.g., before or after), or the peripheral support frame 110 may not be fabricated from shape memory metals, metal alloys, or polymers at all.
According to one embodiment, the support frame 110 is manufactured from a shape memory alloy, such as nickel-titanium alloy, either by cutting the frame from a sheet of desired dimensions, by cutting from a tube of desired dimensions, or formed from a wire (flat or round cross-section) by crimping, brazing, welding, and the like. Nickel-titanium alloy may be cut by a laser, chemical etching, electro-erosion, or any combination thereof. After cutting and/or otherwise forming the support frame 110 into its desired dimension, the support frame 110 is pre-shaped to its desired natural stable shape (e.g., its super-elastic state, etc.), such as by thermal treatment, as is known in the art for shape memory materials. Pre-shaping may be performed on the mandrel, or separately. According to some embodiments, the support frame 110 surface is further treated, such as, but not limited to, removing oxides, smoothing, electropolishing, passivating to improve corrosion resistance, and/or increasing surface roughness to improve adhesion to a sealing membrane 105. The aforementioned example of forming a support frame 110 is illustrative and is not intended to be limiting.
After applying the peripheral support frame 110 to the mandrel over the first membrane layer, a second membrane layer may be formed over the peripheral support frame 110 and the sealing membrane 105. Accordingly, by fusing or otherwise affixing the two membrane layers with the peripheral support frame 110 sandwiched therebetween, the sealing membrane 105 and the peripheral support frame 110 become an integrated component. Similar techniques may be used in embodiments including a cross-member support 115 or any other support frame structure. Other suitable techniques for coupling a sealing membrane to a support frame can be performed, such as techniques similar to those used for the design and manufacturing of covered stents or stent grafts.
In one embodiment, the sealing membrane 105 and/or the peripheral support frame 110 may be coated, impregnated, covered, and/or include means for releasing chemical components into the surrounding environment, such as within the vessel at or near the puncture site after implantation. Examples of such chemical components include, but are not limited to, hemostatic agents, drugs, biological agents, viruses, cells, or any other material that may influence or control biological processes. For example, one or more chemical components can be utilized to promote the healing of the blood vessel and/or the puncture site; to control, reduce, or mitigate cell proliferation, such as is similar to that utilized by a drug eluting stent; to control, reduce, or mitigate blood coagulation (e.g., by releasing heparin, etc.); to enhance blood coagulation (e.g., by releasing thrombin, etc.); and/or to reduce the risk of infection by releasing antibiotics or other medicinal substances. Chemical components may be applied to the peripheral support frame 110, to the sealing membrane 105, and/or to the anchor tab 120 or pull string by at least partially coating its surface. In other embodiments, the chemical components may be coupled, either mechanically or chemically, to at least one of the materials forming the peripheral support frame 110 and/or the sealing membrane 105, or may be mixed into the sealing membrane 105 during its manufacturing. According to one embodiment, one or more chemical components are released upon the absorption, degradation, or erosion of one or more components of the VCD 100.
According to various embodiments, the total length of the VCD 100, from one edge of the sealing membrane 105 to an opposite edge along the longitudinal axis, may range between approximately 4 mm to approximately 50 mm, and in one embodiment, between approximately 5 mm and approximately 25 mm. According to various embodiments, the diameter of the VCD 100 in a collapsed state, such as is illustrated by and described with reference to
The aforementioned materials, manufacturing techniques, and characteristics of the VCD 100 and individual components may likewise apply to any other VCD embodiment described herein.
Also shown with the VCD 100 is a containment mechanism 305 embodied as one or more strings, wires, ribbons, bands, or cords encircling the VCD 100 to releasably retain the VCD 100 in a collapsed configuration. Upon releasing the containment mechanism 305 after suitable positioning within a vessel, the VCD 100 expands to its expanded configuration. As shown in the embodiment of
With reference to
In operation, the containment means releases the VCD 100 from its collapsed position by pulling the loop retainer pin 340 in the proximal direction. Any suitable actuating mechanism may be included with the chosen delivery device to allow pulling the loop retainer pin 340. By pulling the loop retainer pin 340 in the proximal direction, the looped end 339 of the loop 335 is released and the VCD 100 is freed and allowed to expand to its stable expanded configuration. Because the loop 335 remains secured to the loop retainer support 330 at its secured end 337, the loop 335 can be removed from the vessel by removing the loop retainer support 330 and/or the delivery device utilized.
According to one embodiment, the loop retainer support 330 is formed from a flexible film having a thickness between approximately 0.05 mm and approximately 5 mm, or between approximately 0.1 mm and approximately 0.5 mm in other embodiments, for example. The width of the loop retainer support 330 may be between approximately 1 mm and approximately 5 mm in one embodiment, or between approximately 2 mm and approximately 4 mm in other embodiments, for example. The loop retainer support 330 may be made from any flexible materials, such as, but not limited to, a polymer (e.g., polytetrafluoroethylene or other fluoropolymer, polyethylene, polyurethane, polyamide, polyimide, PEEK, or any other suitable polymer), or a metal (e.g., Nitinol, stainless steel, cobalt alloys, or any other suitable metal), or any combination thereof. However, other suitable loop retainer support 330 configurations and dimensions can be provided, such as a more rigid member and/or one formed from different suitable materials, such as any other biocompatible material described herein.
According to various embodiments, the loop retainer pin 340 may have a cross-sectional diameter ranging between approximately 0.02 mm and approximately 3 mm, or between approximately 0.05 mm and approximately 0.5 mm in other embodiments. As described, in one embodiment, the loop retainer pin 340 extends through the delivery device and is connected to an actuation mechanism for actuation by an operator, such as, but not limited to, a slider, a push button, a wheel, opposing handles, or any other suitable means for pulling the loop retainer pin 340 in the proximal direction. In other embodiments, the loop retainer pin 340 may have a shorter length, such as between approximately 2 mm and approximately 50 mm, or between approximately 4 mm and approximately 15 mm in other embodiments, and is connected to an actuating mechanism by an intermediary member, such as a string or wire. According to various embodiments, the loop retainer pin 340 is formed from a polymer (e.g., polytetrafluoroethylene or other fluoropolymer, polyethylene, polyurethane, polyamide, polyimide, PEEK, or any other suitable polymer), or a metal (e.g., Nitinol, stainless steel, cobalt alloys, or any other suitable metal), or any combination thereof. Although not shown, the VCD 100 may further include an anchoring tab 120 and/or pull string, such as is illustrated in
One purpose served by the arcuate edge 414 and opposing straight edge 412 is to prevent flaring of the edges of the sealing membrane 405, such as may occur during delivery when in a collapsed configuration or after implantation. The arcuate edge 414 reduces the surface area of the sealing membrane 405 on at least one side, minimizing the additional drag created by fluid flowing thereover during implantation. In addition, the peripheral support frame 410 along the straight edge 412 may be stiffer and thus more rigid than the support frame along the arcuate edge 414. In the embodiment shown in
In addition, providing a stiffer peripheral support frame 410 along the straight edge 412 also serves to reduce flaring when in a collapsed configuration, as shown above in
In other embodiments, instead of a release pin, one or more wires, cords, or string members are provided, such as the containment mechanism 305 described with reference to
In addition, the VCD 442 in this embodiment includes two cross-member supports 455, 457, similar to the cross-member support 115 shown in
Moreover, according to this embodiment, a first cross-member support 455 is oriented at or near the latitudinal center of the sealing membrane 445, while a second cross-member support 457 is oriented off-center from the latitudinal center. Having the second cross-member support 457 oriented off-center provides additional support and rigidity to the sealing membrane 445 and further prevents the support frame 450 and/or sealing membrane 445 edges from flaring or otherwise undesirably deforming when in a rolled or collapsed configuration. Any of the VCD embodiments described herein may optionally include more than one cross-member support, any of which may be centered or off-center. Similarly, the attachment means 205 may be oriented off-center along the longitudinal axis to allow for more effective centering of the VCD 100 along the longitudinal axis.
As described herein, it is advantageous for the sealing membrane to conform to the inner vessel shape and to cover the vessel puncture site to facilitate hemostasis. According to various methods, conforming the sealing membrane to the vessel shape may be aided by the natural elasticity and/or deformability of the sealing membrane material, by any excess sealing membrane material relative to the peripheral support frame that allows variability in the membrane surface shape, and/or by multiple attachment points intermittently attaching the sealing membrane to the support frame to allow movement of the membrane relative thereto, such as provided according to this embodiment.
As shown by
In one embodiment, the sealing membrane 498 is coupled to the support frame 496, such that the membrane 498 is positioned over the vessel facing surface of the support frame 496, positioning the sealing membrane 498 between the inner vessel wall and the support frame 496 upon implantation. In one embodiment, the tabs 495 are folded around the top of the support frame 496 and affixed to the sealing membrane 498 bottom surface (e.g., the surface facing away from the vessel wall upon implantation). Fixation of the tabs 495 to the sealing membrane 498 surface may be accomplished using, but not limited to, glue, solvent, heat, ultrasonic welding, or any other means to affix polymer surfaces. In various embodiments, the sealing membrane 498 can be coupled to the support frame 496 by tabs 495 at any number of locations, such as any number greater than two locations. For example, in various embodiments, two to twelve tabs 495 are used, or two to six tabs 495 are used.
According to one embodiment, all or some of the tabs 495 and the coupling means allow a small amount of relative movement between the sealing membrane 498 and the support frame 496. Movement may serve to reduce the strain on the sealing membrane 498, while also allowing the membrane 498 to conform to the vessel wall shape at or near a vessel puncture site to promote hemostasis. Moreover, in circumstances when vessel re-access is desired at the same puncture site, sliding attachment tabs 495 will allow continued support of the sealing membrane 498 by the support frame 496 while the membrane 498 is punctured, minimizing the portion of the sealing membrane 498 entering the vessel and possibly blocking the blood flow during the subsequent procedure. According to various embodiments, the range of relative movement between the sealing membrane 498 and the support frame 496 may vary between approximately 0.1 mm to approximately 5 mm, for example.
According to one embodiment, the sealing membrane 498 is also coupled to the support frame 496 near the longitudinal axis (e.g., in proximity to the support member 493 connecting means 497, described below). In one embodiment, the sealing membrane 498 is attached to the support frame 496 only at or near the longitudinal axis, which allows the sealing membrane 498 to otherwise move independently of the support frame 496, subject to the radial force applied by the support frame 496 against the vessel wall. In embodiments in which the sealing membrane 498 is only connected to the support frame 496 at or near the longitudinal axis, the sealing membrane 498 may be shaped and sized to have the same or larger dimension than the support frame 496. For example, the sealing member may be up to approximately 6 mm greater, or even larger, in some embodiments. In another embodiment, the sealing membrane 498 is attached to the support frame 496 at or near the longitudinal axis and at one or more other locations along the support frame 496.
According to one embodiment, as illustrated, the peripheral support frame 496 does not include an integrated cross-member support, such as a cross-member support 115 described herein with respect to other embodiments. However, in one embodiment, such as is illustrated by
Also, as shown in
It is appreciated that the features of a sealing membrane coupled to a support frame described with reference to the embodiment of
The sealing membrane 483 of this embodiment is formed in a quadrilateral geometry (e.g., square, rectangle, diamond, etc.) with two opposing corners being oriented at respective ends of the support frame 489 and the other two opposing corners being oriented at respective ends of the cross-member support 487. The quadrilateral geometry reduces flaring or deformation of the sealing membrane 483 along its edges. The sealing membrane 483 may be constructed of any biodegradable or non-absorbable materials, or a combination thereof, such as those described with reference to
According to one embodiment, the cross-member support 487 differs from other cross-member supports described herein by including a guide channel 484 passing therethrough. The guide channel 484 is sized and configured to allow one or more guide wires to pass therethrough, which are used to facilitate delivery and placement of the VCD 481 using conventional guide wire techniques and/or to preserve access for the guide wire after VCD deployment. As illustrated in
A guidewire may be utilized to facilitate advancing and positioning the VCD within a vessel or other lumen. According to some embodiments, a guidewire may be removed after delivering and prior to releasing the containment means. In other embodiments, a guidewire may be removed after the VCD is in position and its performance is observed. A guidewire, thus, eases subsequent access within the vessel, such as may be performed in the case of a VCD malfunction, failure, or other reason calling for the removal of a delivered VCD. Upon removal of an initial VCD, a replacement VCD may be delivered over the guidewire. Moreover, a guidewire further facilitates introducing additional means to prevent and/or reduce bleeding from an un-sealed puncture, such as may be useful during replacement or repositioning of a VCD prior to scaling the puncture.
It is appreciated that any of the VCD embodiments described or illustrated herein may be delivered utilizing one or more guidewires in a same or similar manner as described with reference to
According to various embodiments, the cross-member support 487 has a length between approximately 3 mm to approximately 50 mm, and between approximately 4 mm to approximately 20 mm in one embodiment. The thickness or width of the cross-member support 487 may range between approximately 0.5 mm and approximately 3 mm, and between approximately 1 mm to approximately 2 mm in one embodiment. In other embodiments, instead of a square or rectangular cross section as illustrated in
The VCD 481 of this embodiment therefore provides an advantageous configuration by including a limited number of non-biodegradable or non-absorbable components having a minimized size relative to other embodiments described herein, such as only the cross-member support 487 and/or the single member forming the support frame 489. The reduced number and size of support components also allows the VCD 495 to be rolled or otherwise compressed into a collapsed configuration that may ultimately be smaller than other embodiments described herein, and thus capable for delivery through smaller punctures and/or utilizing smaller delivery systems.
It is appreciated that any of the features described with reference to the additional example VCD embodiments of
The sealing membrane 505 may be constructed at least partially from biodegradable materials, or may be constructed from non-absorbable materials, such as any of those materials described by example with reference to
In one embodiment, the sealing membrane 505 is connected to the support frame 510 at one or multiple attachment points 512, either on the underneath side of the sealing membrane 505 facing inward toward the vessel 10 interior or on the upper side of the sealing membrane 505 facing toward the vessel wall 12. In the embodiment shown in
According to this embodiment, the VCD 502 also optionally includes an anchoring tab 120 for passing through the puncture site 15 and securing to the patient's tissue to facilitate securing the VCD 502 in place, such as is described with reference to
According to one embodiment, the protrusion 555 is formed from multiple wire elements, such as braided or twisted wires, which provide structural support and at least partial rigidity to the protrusion 555. The wire elements may be formed from any biocompatible material, such as those described with reference to
In another embodiment, however, the protrusion 555 is at least partially covered by a sealing membrane 545. The sealing membrane 545 may cover some or all of the support frame 510 in addition to the protrusion 555, or only cover the protrusion 555. In another embodiment, instead of, or in addition to, the protrusion 555 being formed from an underlying structure, the protrusion 555 may be formed from excess membrane material, which may be the same or different material forming the sealing membrane 545.
According to one embodiment, a sealing membrane 565 covers at least part of the support frames 570, 575 and/or at least part of the joint 580. The sealing membrane 565, the two radial support frames 570, 575, and/or the joint 580 may be fabricated from any biodegradable or non-absorbable material, or any combinations thereof, such as those described with reference to
According to various embodiments, the overall dimensions of an articulated VCD 562 may be the same or similar to that described with reference to
In one embodiment of the VCD 582, the spacing between the braided or interwoven wire elements of the support frame 585 is sufficiently small enough that hemostasis can be achieved without a sealing membrane. In other words, the wire elements perform the sealing function. According to some embodiments, the spacing between the braided or interwoven wire elements of the support frame 585 may differ and/or the wire elements may have different density or shape in different areas of the frame. For example, in one embodiment, the support frame 585 elements are denser at or near the area of the VCD 582 which is intended to be positioned proximate to the vessel's 10 puncture site 15, so as to achieve homeostasis without a sealing membrane.
According to various embodiments, the braided or interwoven wire elements described with reference to
A VCD 592 embodiment that includes an expandable balloon 597 to expand the support frame 595 permits the use of a non self-expanding material for forming the support frame 595. For example, the support frame 595 of this embodiment may be formed from, but is not limited to, bioabsorbable polymers or copolymers, including, but not limited to, polylactide (e.g., PLLA, PDLA), PGA, PLGA, PDS, PCL, PGA-TMC, polygluconate, PLA, polylactic acid-polyethylene oxide copolymers, poly(hydroxybutyrate), polyanhydride, polyphosphoester, poly(amino acids), poly(alpha-hydroxy acid), or any other similar copolymers; magnesium or magnesium alloys; or aluminum or aluminum alloys; as well as any composites and combinations thereof. Other combinations that may include biodegradable materials may also be utilized to form part or all of the support frame 595.
The foregoing VCD embodiments described with reference to
Methods of Delivery and Corresponding Delivery System
In various embodiments, the VCD and delivery systems are used by a physician, surgeon, interventional cardiologist, emergency medical technician, other medical specialist, or the like. In describing the methods of use of the VCD and deployment systems, such persons may be referred to herein as an “operator”.
Following block 605 is block 610, in which an endovascular procedure is performed via the access to the vessel 10 provided by the sheath 700. In one embodiment, the procedure is performed prior to delivery of the VCD 100. Representative examples of suitable endovascular procedures in this step include percutaneous valve replacement or repair, cardiac ablation, endovascular graft implantation, coronary or peripheral stent implantation, diagnostic catheterization, or carotid stent implantation. Essentially any procedure requiring access to a body lumen through a puncture site may be performed.
After the endovascular procedure is performed, the same sheath may be utilized to deliver the VCD or a different sheath may be utilized.
If a different sheath is utilized, blocks 615 and 620 are performed. At block 615, the first sheath is removed, leaving a guidewire within the puncture. At block 620, the VCD delivery sheath is inserted into the puncture site in the same or similar manner as described with reference to block 605 or otherwise according to suitable techniques. To position the sheath 700 (e.g., a different sheath than that positioned at block 605) within the vessel at block 620, the sheath 700 is retrieved in the proximal direction until its distal end is proximate the puncture site 15. In one embodiment, the sheath 700 is pulled proximally into the desired position with the visual aid of marks or gradations on the sheath 700 and/or by utilizing one or more sides hole 715 formed through the wall of the sheath 700. If included, blood will stop flowing through the side hole 715 when the side hole 715 is removed from the blood stream of the vessel 10, which indicates that the sheath 700 is in the desired position relative to the vessel 10, as shown by
According to some embodiments, a guidewire may optionally be utilized to facilitate delivering and positioning the VCD 100 within the vessel 10. A guidewire may be delivered through the sheath 700 after the sheath is properly positioned, as described with reference to block 620. A guidewire can further be utilized to ease subsequent access within the vessel 10, such as may be performed in the case of a VCD 100 malfunction, failure, or other reason calling for the removal of a delivered VCD 100. Upon removal of the initial VCD, a replacement VCD 100 may be delivered over the guidewire. Moreover, a guidewire further facilitates introducing additional means to prevent and/or reduce bleeding from an un-sealed puncture 15, such as may be useful during replacement or repositioning of a VCD 100 prior to sealing the puncture 15. If used, a guidewire may be removed after the VCD 100 is positioned (e.g., after block 640 below).
In yet other embodiments, a guidewire may be inserted after a collapsed VCD 100 is advanced into the vessel (e.g., after block 635 below). The guidewire may be delivered through the same delivery sheath 700 (e.g., parallel to the VCD 100), or, in some embodiments, the delivery system may include an additional passage or lumen through which the guidewire may be passed, positioning the guidewire parallel to the collapsed VCD 100.
Operations continue to block 625, in which a loading tube 705 housing a compressed VCD 100 is inserted into the sheath 700, as illustrated in
Following block 625 is block 630, in which the VCD 100 is pushed through the loading tube 705 and the sheath 700 until it exits into the lumen of the vessel 10. In one embodiment, a push rod 710 (also interchangeably referred to herein as a “pusher” or “pusher device”) is utilized to push the VCD 100 into the sheath 700 until it exits the sheath 700 into the vessel 10, such as is shown by
Block 635 follows block 630, in which the sheath 700, the push rod 710, and the VCD 100 are retrieved in the proximal direction until its distal end is proximate the puncture site 15, such as is shown by
Following block 635 is block 640, in which, according to one embodiment, a containment mechanism releasably retaining the VCD 100 in a collapsed configuration is released to permit the support frame to fully expand and position the sealing membrane against the vessel puncture site 15, such as is shown by
Block 645 follows block 640, in which the anchoring tab 120 is secured to the patient's tissue to further secure the VCD 100 within the vessel and to prevent intraluminal migration of the VCD. In certain embodiments, the anchoring tab 120 is secured to the patient's tissue at or near the vessel access site using suture, biocompatible adhesive, bandage, tape, or an integral hook. In another embodiment, the anchoring tab 120 is secured by suturing or taping closed the vessel access site, trapping the anchoring tab 120 therein.
In another embodiment, as illustrated in
The anchoring tab 120 is threaded through or otherwise adjustably coupled to the rebounding member 1150. When positioning the VCD 100 within the vessel 10, the rebounding member 1150 is positioned against the patient's skin surface 1152. The anchoring tab 120, which extends through from the VCD 100 through the patient's skin tissue 1154, is then secured in a relatively taut position against the rebounding member 1150. In one embodiment, the anchoring tab 120 is secured in tension by a locking means 1156, which selectively locks the rebounding member 1150 against the anchoring tab 120 (or pull string extending therefrom). The locking means 1156 may be configured as, but is not limited to, a slip-knot, a clamp, a tab and teeth assembly, and or any other means operable to selectively secure the rebounding member 1150 at one or more positions along the anchoring tab 120.
The method 600 may end after block 645, having delivered and secured a VCD 100 within a vessel 10 at or near a puncture site 15 to facilitate hemostasis at the puncture site. As discussed, after implantation of the VCD 100, some or all of the VCD 100 may degrade and/or absorb over time, reducing the contents remaining within the vessel. This characteristic of the VCD may be beneficial, for example, to simplify subsequent access at or near the same vessel site, for example if the patient needs another endovascular procedure.
In some instances, it may be desirable to remove a VCD from a vessel during or after implantation, such as in the case of device failure, surgical complications, or for any other reason. In one embodiment, a VCD having a peripheral support frame, such as those described with reference to
The VCD may be retrieved using other methods and devices. For example, a snaring loop may be used to capture and grasp the VCD, and optionally collapse the VCD prior to retrieval. In another example, an elongated member, such as a wire or rod, having a hook at its distal end may be inserted into to the vessel, for example, through a sheath via the same puncture site through which the VCD was delivered. The elongated member and its hook enable capturing at least a portion of the VCD (e.g., a portion of the support frame, a cross-member support, the anchoring tab, etc.) to pull the VCD proximally, causing it to bend and allowing retrieval through a sheath.
After retrieving a VCD, the same sheath may be utilized for the re-delivery of the same or different VCD, or a new sheath may be inserted. The new sheath may be inserted over a guide wire inserted prior to removal of the prior sheath, or may be inserted over the anchoring tab and/or pull string extending through the puncture from a VCD prior to its removal. In one embodiment in which an anchoring tab and/or pull string is utilized to deliver a subsequent sheath, additional support is provided by passing a needle or other low profile sleeve over the anchoring tab and/or pull string, over which the new sheath is delivered. Other means for removing an expanded or collapsed VCD may be utilized. The aforementioned procedures are illustrative and are not intended to be limiting.
After preliminarily positioning in a proximal or distal vessel, the VCD 100 is ready for rapid deployment, such as by methods similar to those described with reference to
According to another similar embodiment, the VCD 100 may preliminarily be delivered within the same vessel (e.g., the vessel 10, as shown in
In the embodiment illustrated in
In one embodiment, a dilator 925 is also included with the delivery system to facilitate insertion of the sheath 905 into the vessel.
In one embodiment, the distal end 926 of the dilator 925 is formed in a substantially conical shape, which reaches its maximum outer diameter at or near location 923 along the dilator 925. The dilator diameter at this location 923 is close to the same, slightly smaller than, or slightly larger than, the internal diameter of the introducer sheath channel 910, providing tight fitment of the dilator 925 within the channel 910 of the sheath 905. A tight fit accomplishes sealing the distal end 909 of the sheath 905 when the dilator 925 is extended therethrough, such as is illustrated in and described with reference to
In one embodiment, the dilator 925 has a stepped-down, reduced outer diameter proximally and beginning at location 924, which is proximal to the location 923 along the dilator 925. For example, in one embodiment, the reduced diameter of the dilator decreases by at least approximately 0.05 mm from the maximum outer diameter at area 923, such as decreasing between approximately 0.05 mm and approximately 2.5 mm, or between approximately 0.1 mm and approximately 1 mm. The position of location 924, where the stepped-down outer diameter of the dilator 925 occurs, is determined such that upon inserting the dilator 925 into the sheath 905 a predetermined amount, the area 924 is oriented between the side hole 920 and the distal end of the sheath 905. Therefore, as described below, blood may flow through the side hole 920 and into the channel 910 proximally toward the outlet port 915, while still achieving a seal at the distal end 909 of the sheath 905. In some embodiments, the distance between the areas 923 and 924 may need to accommodate greater areas on one side of the sheath 905 than another, such as when the sheath's 905 distal end 909 is angled. The distal end 926 of the dilator 925 may be formed in any other suitable shape as desired.
In one embodiment, after insertion of the dilator 925 through the sheath 905, there still exists fluid communication between the side hole 920 and the port 915. Such fluid communication permits detecting when the side hole 920 is inserted into or removed from a vessel, because blood (or other fluid) will flow into the side hole 920, through the channel 910, and exit the port 915 when exposed to blood flow, as described with reference to
In one embodiment, the dilator 925 further includes at least one lumen 930 extending along its length through which a guide wire or other instrument can be passed. For example, the lumen 930 may have an inner diameter that accommodates guide wires or other instruments with an outer diameter or profile ranging between approximately 0.1 mm and approximately 1 mm, such as 0.9 mm in one embodiment. One or more lumens 930 formed through the dilator may be sized to accommodate larger or smaller instruments than provided by example, which may depend upon the procedure being performed and/or the patient's anatomy. The aforementioned dimensions are illustrative and are not intended to be limiting.
Accordingly,
After insertion of the sheath 905 and the dilator 925 into the vessel and achieving the desired positioning based on the blood flow through the side hole 920 and the port 915, the dilator 925 is removed. In other embodiments, one or more markers may be included on the sheath 905 instead of, or in addition to, the side hole 920 and the port 915 for determining the depth of insertion of the delivery system. Upon removal of the dilator 925, the sheath 905 is ready to be loaded with the VCD for delivery.
In one embodiment, one or more additional outer sleeves 927 are included with the delivery system, as illustrated in
Accordingly, the differently sized outer sleeves 927 permit one to use the same sheath 905 with different puncture sizes through a vessel. Each outer sleeve 927 is sized to a different puncture size, effectively interchangeably altering the outer diameter of the delivery system. In one embodiment, a VCD is sized to be compatible with punctures ranging from approximately 12 Fr to approximately 21 Fr. However, a sheath 905 that is 12 Fr compatible may result in undesirable blood leakage if attempted for use after a procedure utilizing a 21 Fr sheath and similarly sized puncture site. Thus, with the inclusion of additional outer sleeves 927, the VCD delivery sheath 905 can be sized to have the smallest desired outer diameter (e.g., 12 Fr, in one embodiment, though even smaller in other embodiments), while the outer sleeves 927 allow adjusting the overall outer diameter of the delivery system for use in procedures creating larger punctures. For example, with reference to the above scenario, an outer sleeve 927 can be added that will increase the overall diameter of a 12 Fr sized sheath 905 to a 21 Fr sized puncture site, preventing undesirable leakage after insertion of the delivery system including an outer sleeve 927.
In certain embodiments, an outer sleeve 927 is formed from a pliable material and/or is relatively soft in comparison to the sheath 905 material. In yet other embodiments, different outer sleeves 927 may be formed from materials that differ in stiffness, which may vary according to sleeve size. For example, in an illustrative embodiment, an adapter operably working with a 21 Fr sleeve 927 may be significantly stiffer than one working with a 14 Fr sleeve 927. Thus, an assembly that includes an outer sleeve 927 to fit the 21 Fr adapter may be stiffer, which may also be required when inserting a larger sheath into a blood vessel. In other embodiments, the stiffness or rigidity of an outer sleeve 927 varies along its length.
In various embodiments, outer sleeves 927 are supplied with a VCD, with a delivery system, with a VCD and delivery system kit, as a separate set of outer sleeves 927, or in individual sterile packages. In one embodiment, each different outer sleeve 927 and/or its packaging contains markings or other identifiers (e.g., colors, shapes, labels, etc.) to permit easy identification between the different sleeve sizes.
According to yet another embodiment, as illustrated in
To minimize or avoid these and other possible complications, one or more holes or other passages are formed through the sheath 905 at or near its distal 909. According to the embodiment shown in
In one embodiment, an internal member, such as a tube, rod, or dilator, is used to selectively seal one or more of the first series of holes 921 and/or the second series of holes 922, allowing for selectively maintaining some holes 921, 922 in an open state, while maintaining other holes 921, 922 in a closed state. Selectively sealing the holes 921, 922 may be desirable when positioning the sheath 905 within the vessel 10 results in some of the holes 921, 922 within the vessel and some outside, allowing those outside the vessel to be sealed to prevent blood loss.
In one embodiment, the method of delivering a VCD may include a stage during which a sheath 905 is positioned within a vessel 10 to test for acceptable blood flow levels and/or whether the vessel 10 inner diameter is an acceptable size prior to delivering a VCD. For example, a test may be performed by introducing a contrast medium through the sheath 905 and visualizing (by any known means for visualizing flow and/or substance within a vessel) the contrast medium's passage to the distal vessel side 17. Moreover, to further reduce vessel restriction and/or blockage, vasodilatation drugs for treating spasm or vasodilatation of the vessel 10, such as, but not limited to, Nitroglycerin, Papaverine, etc., may be delivered at any stage of the delivery procedure.
The VCD 100 may be any VCD described herein. In this embodiment, VCD 100 includes at least an anchoring tab 120 and/or pull string and a containment mechanism having a release wire 945, both of which pass through and are operably integrated with the actuator handle 940. As shown, the VCD 100 is loaded into the loading tube 935, such as in a rolled or otherwise collapsed configuration. The VCD 100 may be pre-loaded, such as during manufacturing and/or packaging prior to delivery, or may be loaded into the loading tube 935 by an operator as part of the delivery procedure. When loaded, the anchoring tab 120 and/or pull string extend proximally from the loading tube 935. The containment mechanism may be any suitable containment mechanism described herein. The release wire 945 may be one or more wires or other members operable for selectively releasing the containment mechanism and allowing expansion of the VCD 100, which may depend upon the design and operation of the containment mechanism.
As shown in
If a hemostasis valve 903 is provided on the sheath 905, the insertion of the loading tube 935 in the distal direction into the sheath 905 will force open the hemostasis valve, providing selective access into the channel 910 of the sheath 905. With reference to
The actuator handle 940 includes a push rod 947 slideably contained within the body of the actuator handle 940 and operably attached to the actuating mechanism 950. The push rod 947 is used to advance the VCD 100 distally out of the loading tube 935 and into the inner channel 910 of the sheath 905. An operator advances the push rod 947 by grasping and sliding the safety catch 960 distally through the first elongated slot 943.
Next, as illustrated in
Accordingly, release of the containment mechanism causes the VCD 100 to expand and position against the vessel wall at or near the puncture site in part due to the pre-shaped configuration of its support frame expanding to its natural stable state. After expansion, the operator may complete the procedure by securing the anchoring tab 120 and/or pull string to the patient's tissue.
The delivery system described with reference to
According to another embodiment, a protecting member may be integrated with, or otherwise adapted to, a push rod device at or near its distal end in the same or similar manner as described with reference to
The protecting members described herein may be formed from one or a combination of flexible or elastic polymers, such as those described with reference to
In one embodiment, a protecting member is formed from a thin membrane with one or more expanding or elastic members coupled thereto and operable to cause radial expansion when the protecting member is released into a vessel. For example, each elastic member may be configured as an elastic or super-elastic wire, ribbon, or mesh, which may be formed from materials, such as, but not limited to, nickel-titanium alloy, stainless steel, super-elastic polymers, or any other suitable elastic or expandable materials, such as those described with reference to
In use, according to one embodiment, after concluding an endovascular procedure, the two guide wires 1062, 1064 are inserted through a sheath 1050, one extending from the access site in the distal direction of the vessel 10 and the other extending in the proximal direction, as illustrated in
In operation, the first end 1072 is threaded through the channel of the cutting tube 1080 while the second end 1074 is passed outside the cutting tube 1080, between its external surface and the inner surface of the sheath 1085. By pushing the sharp edge of the cutting tube 1080 against the cutting surface 1089 at the end of the sheath 1085, a shearing force severs the second end 1074. Severing the second end 1074 of the wire loop 1070 in any of these embodiments releases the containment mechanism and allows the VCD 100 to expand from its compressed state.
In use, while retracting the sheath 1099 and leaving the push rod 1095 within the puncture, the release rod 1097 is pulled out of the ring, hole, or loop 1092 in the second end of the wire loop 1090, which releases the tension on the wire loop 1090. After the wire loop 1090 is released by extracting the release rod 1097, the push rod 1095 is also retracted from the vessel puncture. Because the wire loop 1090 is secured to the push rod 1095 and no longer held in position by the release rod 1097, the wire loop 1090 is released from the VCD 100, allowing the VCD 100 to expand. In one embodiment, an anchoring tab 120 and/or pull string remains connected to the VCD 100, which can be used to facilitate positioning the VCD 100 within the vessel and to be secured to the patient as described herein.
The VCDs and associated delivery systems described herein advantageously provide means for at least temporarily closing or otherwise sealing punctures in a patient's vasculature or other body lumen. Quicker and more effective sealing advantageously avoids the time and expense of applying manual pressure to the puncture, which would otherwise be required by conventional methods. The various support frames and sealing membranes disclosed effectively retain the closure device within the vessel while requiring little additional surgical manipulation by the operator during delivery. Moreover, the embodiments described herein also avoid unnecessary widening of the vessel puncture due to their ability to collapse the VCD in a significantly reduced profile during delivery. Similarly, the ability to deploy example VCDs via various sheath configurations provides some embodiments that are more beneficial for use with smaller sheath access than are presently available, such as with sheaths used during cardiac catheterization procedures.
It is appreciated that these and many other advantages will be appreciated, and modifications and variations of the devices, systems, and methods described herein, such as dimensional, size, and/or shape variations, will be apparent to those skilled in the art from the foregoing detailed description. Such modifications and variations are intended to come within the scope of the appended claims.
Claims
1. A method for sealing a puncture site existing in a wall of a vessel, the method comprising:
- deploying a vasculature closure device comprising a support frame and a sealing membrane into the vessel through the puncture site, wherein the support frame is in a collapsed configuration during deployment; and
- expanding the support frame into an expanded configuration within the vessel such that the sealing membrane is pushed against the puncture site.
2. The method of claim 1, wherein the support frame extends along a majority of an inner circumference of the vessel when the support frame is in the expanded configuration.
3. The method of claim 1, wherein the support frame holds the device in place within the vessel when the support frame is in the expanded configuration.
4. The method of claim 1, wherein expanding the support frame comprises unrolling the device along a longitudinal axis generally aligned with and extending along a length of the vessel.
5. The method of claim 1, wherein expanding the support frame comprises unrolling the device from the collapsed configuration having a first radius of curvature less than a radius of curvature of the vessel into the expanded configuration having a second radius of curvature greater than the radius of curvature of the vessel.
6. The method of claim 1, wherein opposing sides of the support frame overlap one another when the support frame is in the collapsed configuration.
7. The method of claim 6, wherein the opposing sides of the support frame are spaced apart from one another when the support frame is in the expanded configuration.
8. The method of claim 1, further comprising allowing at least a portion of the sealing membrane to move relative to the support frame such that the sealing membrane conforms to a shape of the wall of the vessel near the puncture site.
9. The method of claim 1, wherein the sealing membrane comprises excess material relative to the support frame such that the sealing membrane conforms to a shape of the wall of the vessel near the puncture site.
10. The method of claim 1, further comprising, prior to expanding the support frame, positioning the device within the vessel proximate the puncture site.
11. The method of claim 10, wherein positioning the device comprises pulling an anchoring tab or a pull string of the device through the puncture site.
12. The method of claim 11, further comprising securing the anchoring tab or the pull string to tissue outside of the vessel.
13. The method of claim 1, wherein deploying the device comprises deploying the device into the vessel via a sheath.
14. The method of claim 1, wherein deploying the device further comprises passing the device through the sheath via a push rod.
15. The method of claim 1, further comprising:
- prior to deploying the device, inserting the device into a loading tube in the collapsed configuration;
- inserting the loading tube into a sheath; and
- removing the loading tube from the sheath, leaving the support frame and the sealing membrane within the sheath for deployment into the vessel.
16. The method of claim 1, wherein expanding the support frame comprises releasing a containment mechanism encircling the device when in the collapsed configuration to allow the support frame to expand within the vessel.
17. The method of claim 16, wherein the support frame is formed of a pre-shaped material adapted for expanding toward a stable state.
18. The method of claim 1, wherein the support frame is formed of a non-biodegradable material, and wherein the sealing membrane is formed of a biodegradable material.
19. The method of claim 1, wherein the vessel is a femoral artery.
20. A method for sealing a puncture site existing in a wall of a vessel, the method comprising:
- deploying a vasculature closure device comprising a non-biodegradable support frame and a biodegradable sealing membrane into the vessel through the puncture site, wherein the support frame is in a collapsed configuration during deployment;
- expanding the support frame into an expanded configuration within the vessel such that the sealing membrane at least partially seals the puncture site.
21. A method for sealing a puncture site existing in a wall of a vessel, the method comprising:
- deploying a vasculature closure device comprising a support frame and a sealing membrane into the vessel through the puncture site, wherein the support frame is in a collapsed configuration during deployment;
- unrolling the support frame into an expanded configuration within the vessel such that the sealing membrane at least partially seals the puncture site.
Type: Application
Filed: Sep 29, 2014
Publication Date: Apr 30, 2015
Inventors: Abraham Penner (Tel Aviv), Lone Wolinsky (Ramat Gan), Alon Ben-Yosef (Ramot Manasha)
Application Number: 14/499,911
International Classification: A61B 17/00 (20060101);
