US20100179589A1 - Rapidly eroding anchor - Google Patents

Abstract

An anchor for using a closure device includes a body being configured to move from a pre-deployed state to a deployed state. In the pre-deployed state, the body has a first width aspect relative to a direction of deployment and a second width aspect in the deployed state relative to the direction of deployment, the second width aspect being greater than the first width aspect and wherein the body is formed from a rapidly eroding material configured to erode through dissolution within a body lumen.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This patent application claims the benefit of and priority to U.S. Provisional Patent Application Ser. No. 61/143,751, entitled “Vessel Closure Devices and Methods,” filed Jan. 9, 2009, the disclosure of which is incorporated herein by reference in its entirety.
BACKGROUND
• 1. Technical Field
• The present disclosure relates generally to medical devices and their methods of use. In particular, the present disclosure relates to vessel closure systems and devices and corresponding methods of use.
• 2. The Technology
• Catheterization and interventional procedures, such as angioplasty or stenting, generally are performed by inserting a hollow needle through a patient's skin and tissue into the vascular system. A guidewire may be advanced through the needle and into the patient's blood vessel accessed by the needle. The needle is then removed, enabling an introducer sheath to be advanced over the guidewire into the vessel, e g in conjunction with or subsequent to a dilator.
• A catheter or other device may then be advanced through a lumen of the introducer sheath and over the guidewire into a position for performing a medical procedure. Thus, the introducer sheath may facilitate introducing various devices into the vessel, while minimizing trauma to the vessel wall and/or minimizing blood loss during a procedure.
• Upon completing the procedure, the devices and introducer sheath would be removed, leaving a puncture site in the vessel wall. Traditionally, external pressure would be applied to the puncture site until clotting and wound sealing occur. However, the patient must remain bedridden for a substantial period after clotting to ensure closure of the wound. This procedure may be time consuming and expensive, requiring as much as an hour of a physician's or nurse's time. It is also uncomfortable for the patient and requires that the patient remain immobilized in the operating room, catheter lab, or holding area. In addition, a risk of hematoma exists from bleeding before hemostasis occurs.
BRIEF SUMMARY
• An anchor for using a closure device may include a body being configured to move from a pre-deployed state to a deployed state. In the pre-deployed state, the body has a first width aspect relative to a direction of deployment and a second width aspect in the deployed state relative to the direction of deployment, the second width aspect being greater than the first width aspect and wherein the body is formed from a rapidly eroding material configured to erode through dissolution within a body lumen.
• A method of closing a puncture in a wall of a body lumen may include advancing an anchor in a deployment direction through the anchor, the anchor having a first width aspect relative to the deployment direction, deploying the anchor distally of the wall of the body lumen to cause the anchor to move to have a second width aspect relative to the deployment direction, the second width aspect being larger than the first width aspect, drawing the anchor distally into engagement with a distal side of the wall of the body lumen, and deploying a closure element into the wall of the body lumen, wherein the anchor is formed from a rapidly eroding material that dissolves in the body lumen in less than twelve hours.
• A closure device system may include a delivery sheath, a rapidly eroding anchor at least partially disposed within the delivery sheath in an initial configuration, the closure member comprising one or more sugars, a suture element coupled to the closure member and disposed at least partially through the delivery sheath, and a pusher disposed at least partially within the delivery sheath and configured to deploy the anchor member from a distal end of the delivery sheath.
• It is to be understood that both the foregoing general description and the following detailed description are exemplary and are intended to provide further explanation of the invention claimed.
BRIEF DESCRIPTION OF THE DRAWINGS
• To further clarify the above and other advantages and features of the present disclosure, a more particular description of the disclosure will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is appreciated that these drawings depict only illustrated embodiments of the disclosure and are therefore not to be considered limiting of its scope. The disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
• FIGS. 1A-1C illustrate a closure device in which a rapidly eroding anchor can be implemented according to one example;
• FIGS. 1D-1F illustrate a method of closing a puncture in a wall of a body lumen in which a rapidly eroding anchor can be implemented;
• FIGS. 2A-2E illustrate a closure device and a method for closing a puncture in a wall of a body lumen in which a rapidly eroding anchor can be implemented according to one example; and
• FIG. 3 illustrates a closure device and a method for closing a puncture in a wall of a body lumen in which a rapidly eroding anchor can be implemented according to one example.
DETAILED DESCRIPTION
• The present disclosure relates to devices, systems, and methods for closing an opening in a body lumen. For example, the present disclosure includes an anchor, such as an intra-arterial “foot,” comprising a rapidly eroding material. The anchor may be passed through an opening defined in a wall of a body lumen and deployed. The anchor can then be drawn proximally to draw the anchor into contact with a distal side of the body lumen wall. A closure element can then be deployed to close the puncture.
• In at least one example, once deployed within a body lumen, the anchor may dissolve in less than a day or even less than an hour as desired. The rapid erosion of the anchor can allow the anchor to be left in place after the closure element has been deployed by obviating the need for removal of the anchor. By leaving the anchor in place until it dissolves, damage that may occur by drawing the anchor through the closed puncture and/or the deployed closure element can be reduced or eliminated.
• In addition, the erosion time of the anchor may fall within the time frame of the action of an anti-thrombotic medication being used in conjunction with the treatment of a patient. Accordingly, the closure element of the present disclosure may reduce the risk of formation of intra-arterial clots associated with the closure of the body lumen opening.
• Reference is now made toFIG. 1A, which illustrates aclosure device100 according to one example. As shown inFIG. 1A, theclosure device100 may include adelivery sheath110 and apusher120 that are configured to cooperate to deploy ananchor130, such as an intra-arterial foot, and aclosure element140, such as a plug, and asuture element150. In at least one example, thedelivery sheath110 is configured to house theanchor130 and theclosure element140 while thepusher120 is configured to deploy theanchor130 and/or theclosure element140 from thedelivery sheath110. Theexemplary delivery sheath110,pusher120,anchor130, andclosure element140 ofFIG. 1A will be discussed in more detail with reference toFIG. 1B.
• FIG. 1B illustrates an exploded view of theclosure device100. As shown inFIG. 1B, thedelivery sheath110 includes anouter housing112 and agrip portion114 while thepusher120 includes ahandle portion122 and ashaft portion124. Aninterior lumen116 is defined in theouter housing112 that is configured to receive thepusher120 in such a manner as to allow thepusher120 to be extended from and retracted within adistal end112A of theouter housing112. For example, theinterior lumen116 can include afirst portion116A configured to receive theshaft portion124 of thepusher120 while asecond portion116B of theinterior lumen116 can be configured to receive adistal end124A of theshaft portion124.
• More specifically, thesecond portion116B of theinterior lumen116 may have a larger width aspect than the width aspect of thefirst portion116A. The width aspects of thefirst portion116A and thesecond portion116B can be the diameters thereof or other cross sectional profiles that are generally transverse to a center axis C of thedelivery sheath110. For ease of reference, the center axis C of thedelivery sheath110 will be referenced in describing the position and movement of the other components described herein. In the illustrated example, theinterior lumen116 may transition from the smaller diameter of thefirst portion116A to a second larger diameter of thesecond portion116B at ashoulder118.
• Such a configuration can allow thepusher120 to translate axially relative to thedelivery sheath110 within a desired range of motion. In particular, thehandle portion122 can translate within thesecond portion116B of theinterior lumen116 to advance theshaft portion124 within theouter housing112 to thereby move thedistal end124A of theshaft portion124 relative to thedistal end112A of theouter housing112. Interaction between thehandle portion122 and theshoulder118 can help ensure thedistal end124A does not extend beyond a desired position within theouter housing112.
• In the illustrated example, thefirst portion116A may also be configured to receive theanchor130 and theclosure element140 proximally of thedistal end124A of theshaft portion124. Accordingly, as thedistal end124A of theshaft portion124 is advanced toward thedistal end112A of theouter housing112, thedistal end124A of theshaft portion124 can engage theanchor130 and/or theclosure element140 to move theanchor130 and/or theclosure element140 distally from theouter housing112.
• Theanchor130 can be configured to move from a pre-deployed state having a pre-deployed width aspect to a deployed state having a deployed width aspect. The deployed width aspect may be greater than the pre-deployed width aspect. Theanchor130 can have any configuration that allows for this. In the illustrated example,anchor130 is configured to rotate or be rotated between the pre-deployed state and the deployed state. In other examples, theanchor130 may be configured to unfold from a configuration have a pre-deployed width aspect to a deployed state having a greater width aspect. For example, one or more arms may be configured to unfold and fold about a plurality of pivot or hinge points.
• As shown inFIG. 1B, theanchor130 includesleg members132,134 that define amajor axis136 of theanchor130. Theanchor130 can further include aneyelet138 coupled to one or both of theleg members132,134. Theeyelet138 can be located at a position that causes theanchor130 to rotate when a force acting initially parallel to themajor axis136 is exerted on theeyelet138. Such a configuration can allow theanchor130 to move from a state in which themajor axis136 is aligned with the central axis C to a state in which themajor axis136 is oriented more obliquely to the central axis C, such as generally perpendicular to the central axis C.
• This rotation can be accomplished by applying a distally acting force on theanchor130 to move theanchor130 out of theouter housing112 and then a proximally directed force to theanchor130 by way of theeyelet138. In at least one example, the distally acting force applied to theanchor130 can be provided from thepusher120 by way of theclosure element140 while the proximally directed force can be applied by way of thesuture element150. Theanchor130 can thus be used to position theclosure device100 for deployment of theclosure element140.
• In one embodiment, theclosure element140 may be configured to close an opening in a lumen as well as at least partially obstruct a tissue tract leading from an external surface of the tissue to the lumen. The shape of theclosure element140 may be configured to be housed within thefirst portion116A of theinterior lumen116. For example, theclosure element140 may conform to the shape of theinterior lumen116. In one embodiment, theclosure element140 may be cylindrical in shape prior to being deployed from thedelivery sheath110. Once deployed from thedelivery sheath110, theclosure element140 may be deformable to conform to any desired shape to close an opening in a body lumen and/or the tissue tract leading to the lumen opening.
• As shown, theexample pusher120 can be coupled to theclosure element140 and/oranchor130 by way of thesuture element150. In particular, thesuture element150 can loop through theanchor130 such that thesuture element150 has two free ends that pass through or near theclosure element140, and extend proximally into or beyond thehandle portion122 of thepusher120. In at least one example, the free ends of thesuture element150 pass through separate portions or channels of theclosure element140. In one embodiment, thepusher120 can have asuture lumen126 defined therein that extends through theshaft portion124 and extends proximally to or even through thehandle portion122. Thesuture element150 can be extended from theclosure element140 and into thepusher120 by way of thesuture lumen126.
• In one embodiment, thedelivery sheath110 may include aguidewire lumen160 with aproximal guidewire port162 therein near theproximal end112B of theouter housing112 and adistal guidewire port164 near thedistal end112A of theouter housing112. Theguidewire lumen160 may be at least partially integrated or entirely distinct from theinterior lumen116 of thedelivery sheath110. Accordingly, a guidewire can enter theproximal guidewire port162, pass through theguidewire lumen160, and exit thedistal guidewire port164. As a result, theexample closure device100 can advance over a guidewire and into position with a lumen opening as part of a method to close the lumen opening. One such method will now be discussed in more detail with reference toFIGS. 1C-1F.
• Reference is now made toFIG. 1C, which illustrates a step in the process of deploying theanchor130. As shown inFIG. 1C, thedelivery sheath110 can be positioned to move thedistal end112A of theouter housing112 through atract170 defined intissue172 and into proximity with alumen174 and apuncture176 defined in alumen wall178 in particular.
• Thereafter, as shown inFIG. 1D, thepusher120 can be manipulated as described above to cause theanchor130 to be pushed out of thedistal end112A of theouter housing112. For example, thepusher120 may push theclosure element140 which may, in turn, push theanchor130 distally relative to theouter housing112, thereby deploying theanchor130 from thedistal end112A of theouter housing112. In one embodiment, once deployed, theanchor130 may rotate or be rotated from a first orientation, in which themajor axis136 of theanchor130 is at a small angle or generally parallel with theouter housing112 and generally perpendicular to thelumen wall178 as shown inFIG. 1C, to a second orientation in which themajor axis136 of theanchor130 is generally parallel with thelumen170 and at a greater angle or generally perpendicular to thedelivery sheath110 as shown inFIG. 1D.
• In particular, as shown inFIG. 1D, once theanchor130 is pushed from thedistal end112A of theouter housing112, theanchor130 may rotate or be rotated to the second orientation, such as by tension applied to by thesuture element150 to theanchor130 by way of theeyelet138. Theanchor130 can then be drawn in the proximal direction to secure theanchor130 against adistal surface178A of thelumen wall178. Theanchor130 may comprise any of a number of different materials. In one example, theanchor130 may comprise a bioabsorbable material. In a further embodiment, theanchor130 may comprise a rapidly eroding material as disclosed in more detail herein.
• As also shown inFIG. 1D, theanchor130 can be used to stabilize tissue around thepuncture176 in order to facilitate closure of thepuncture176. In particular, once theanchor130 is deployed, theanchor130 may then be secured against adistal side178A of thelumen wall178 by pulling thesuture element150, which is coupled to theanchor130, proximally. In one example, a suture lock (not shown) can be utilized to help maintain the tension in thesuture element150. Once theanchor130 is secured against thedistal side178A of thelumen wall178, theouter housing112 may be advanced distally. In particular, theouter housing112 can be advanced to exert a force against aproximal side178B of thelumen wall178. The combination of the forces exerted by theanchor130 and theouter housing112 on thelumen wall178 may result in a compressive force on the tissue near thepuncture176. As a result, thepuncture176 may be compressed and/or located by thedelivery sheath110 and theouter housing112 in particular. This may allow an adjustable sandwiching and location of the lumen opening by the combination of tension in thesuture element150 and compression created by thedelivery sheath110.
• With theanchor130 deployed, thepusher120 may then deploy theclosure element140 within thepuncture176 and/or thetract170 near aproximal side178B of thelumen wall178. In particular, as shown inFIG. 1E thepusher120 can be advanced distally, thedelivery sheath110 can be drawn proximally, and/or some combination of such movements can be used to move theclosure element140 distally out of theouter housing112 and into contact with theproximal side178B of thelumen wall178 adjacent thepuncture176.
• In such a step, thelumen wall178 is positioned between theanchor130 and theclosure element140. Thus, theclosure element140 can be positioned to reduce or stop the flow of fluid out of thetract170 by covering thepuncture176 and/or obstructing thetract170.
• In one embodiment, thepusher120 remains in continuous contact with theclosure element140 throughout the deployment process. Such a configuration can allow theanchor130 and/orclosure element140 to be deployed by advancing thepusher120 in a single direction. By facilitating deployment of theanchor130 andclosure element140 using one-way movement of thepusher120, and by utilizing asingle pusher120, theclosure device100 may result in a quicker and easier deployment of theanchor130 and/orclosure element140.
• The engagement of theanchor130 and theclosure element140 to thelumen wall178 may be secured in any desired manner. In at least one example, the free ends of thesuture element150 may pass from theanchor130 through theclosure element140. In such an example, a suture lock and/or a knot pusher can be used to advance a knot into proximity with theclosure element140 and tighten the knot to thereby maintain tension between theanchor130 and theclosure element140. A suture cutter can then sever thesuture element150. A suture lock, a knot pusher, and/or a suture cutter can be advanced through asuture lumen126 defined in thepusher120 either before or after thedelivery sheath110 and thepusher120 are withdrawn from thetract170. As a result, thesuture element anchor130,closure element140, andsuture element150 can remain in thetissue tract170 as shown inFIG. 1F.
• As previously introduced, theanchor130 can be formed of a rapidly eroding material that allows theanchor130 to be left in place within thelumen174. The composition of theanchor130 allows theanchor130 to remain in position for a long enough period to enable the closure procedure and a short enough period to allow sufficient erosion of theanchor130 while the patient is still under physician control or in the hospital. This time period can therefore be in a range of roughly between 30 minutes and 12 hours. Theanchor130 may be formed of a material that is strong enough to allow for secure anchoring of a closure element, such as the plug and/or other closure elements described below.
• Further, theanchor130 may be formed of a material that is biocompatible in an intravascular environment and non-thrombogenic. An anchor with these characteristics may be obtained by using a mechanism of dissolution rather than chemical degradation. Rapidly dissolving compounds that are suitable include, but are not limited to, sugars and sugar-derivatives like sugar-alcohols. Representative examples are sugars like glucose, fructose, lactose, maltose, and sugar alcohols like mannitol, sorbitol and isomalt. Strength can be added to the formulation by including a polymeric component, such as poly-vinylpyrrolidone, poly-ethyleneglycol, or a polysaccharide like starch, hydroxyethylstarch, dextran or dextran sulfate. Sugar alcohols such as mannitol, sorbitol, and isomalt have relatively low melting points, and form good solvents for the polysaccharides. This can facilitate manufacturing, since a simple melt process can be used. Various mixtures of these components are possible, resulting in potentially different anchor properties. Hydroxyethyl starch has a relatively low glass transition temperature, and so has a mannitol-sorbitol mixture. A solution of hydroxyethyl starch in mannitol-sorbitol, when solidified, may have a glass transition below body temperature, which will create a tough, but not brittle anchor. On the other end of the spectrum, a mixture of dextran with isomalt has a much higher glass transition, resulting in a very hard and strong anchor, but with higher brittleness. Since all these components are miscible, a wide range of properties can be achieved by mixing them in corresponding proportions to achieve the desired properties.
• In one embodiment, the rapidly eroding material can be configured to be at least partially porous and/or micro-porous. Accordingly, one or more beneficial agents can be incorporated into at least one of the pores of the rapidly eroding material. For example, the beneficial agents may include anti-clotting agents, such as heparin, anti-inflammatory agents, and/or other beneficial agents. One method for producing a porous rapidly eroding material may include freeze drying the rapidly eroding material. In particular, in one example embodiment, acetic acid may be used as a solvent for freeze drying the rapidly eroding material. Polymers, such as PLGA, which are soluble in acetic acid, may be used as part of the freeze-drying process.
• In a further embodiment, a micro-porous silicon may be used. In particular, the micro-porous silicon may be prepared with various degradation rates, including rapidly degrading forms. The micro-porous silicon may be sufficiently strong to be used in an anchor, such as a bioerodible foot, and/or may also have sufficient porosity to allow incorporation of beneficial agents. For example, in one embodiment, it may be desirable to incorporate a hydrophobic heparin derivative, such as benzalkonium heparin, into the porosity of the anchor because of its low solubility. Theclosure element140 may comprise any number of different materials suitable for use as a plug.
• FIG. 2A illustrates aclosure device200 in which ananchor130′ similar to theanchor130 described above may be implemented. In the illustrated example, theclosure device200 can include adelivery sheath110′ having anouter housing112′ and agrip portion114′. Aninterior lumen116′ is defined in theouter housing112′ configured to house theanchor130′. Theclosure device200 further includesdeployment assembly210 that includes agarage sheath220 configured to house anactuator member230, which in turn can be configured to house acarrier tube240, which in turn is configured to house apusher120′.
• Thepusher120′ can be configured to translate axially within thecarrier tube240 to deploy theanchor130′ from theclosure device200. Aclosure element250 is configured to be positioned on thecarrier tube240. As will be discussed in more detail below, distal movement of theactuator member230 relative to thecarrier tube240 may deploy theclosure element250.
• In the illustrated example, thegarage sheath220 includes ahousing portion222 coupled to aplunger portion224. Thefirst plunger portion224 can be positioned proximally of thegrip portion114′ of thedelivery sheath110. Theactuator member230 can include ahousing portion232 and asecond plunger portion234. Thecarrier tube240 can also include ahousing portion242 and athird plunger portion244. Thepusher120′ includes ahandle portion122′ and ashaft portion124′.
• As shown inFIG. 2B, thepusher120′ can be used to deploy theanchor130′ from thedelivery sheath110′ using asuture element150′ in a similar manner as described above. Once theanchor130′ is deployed, thefirst plunger portion224 can be advanced proximally relative to thedelivery sheath110′ along with thesecond plunger portion234 and thethird plunger portion244 to position thedeployment assembly210 in proximity with thelumen wall178.
• Thereafter, as shown inFIG. 2C, thefirst plunger portion224 may be drawn proximally toward thesecond plunger portion234 and thethird plunger portion244, thesecond plunger portion234 and thethird plunger portion244 may be advanced distally, and/or some combination of those movements may be performed to expose theactuator member230 and thecarrier tube240 from thegarage sheath220 while maintaining thecarrier tube240 in engagement with thelumen wall178. In such an example, thedelivery sheath110′ can remain in place to maintain thelumen wall178 between thedelivery sheath110′ and theanchor130′.
• As shown inFIG. 2D, thesecond plunger portion234 can then be advanced distally relative to thethird plunger portion244 to expand and deploy theclosure element250. In particular, as shown inFIG. 2D, thecarrier tube240 includes rampedportions246. As thesecond plunger portion234 advances distally relative to thethird plunger portion244, theactuator member230 pushes theclosure element250 over the rampedportions246 of the carrier tube, thereby expanding theclosure element250. Thereafter, theclosure device200 can be removed and thesuture element250 cut as described above.
• Continued advancement of theactuator member230 distally relative to thecarrier tube240 moves tissue-engagingportions252 of theclosure element250 into engagement with thelumen wall178. Further distal movement of theactuator member230 pushes theclosure element250 distally of thecarrier tube240. In at least one example, theclosure element250 can be formed of a resilient material having a trained or default state having a narrow diameter. Theclosure element250 can be partially expanded onto thecarrier tube240 prior deployment. As theclosure element250 moves distally from thecarrier tube240, theclosure element250 can move toward the trained or default state, thereby closing thepuncture176.
• As shown inFIG. 2E, once theclosure element250 is deployed, aplug material260 may be injected near the lumen wall and within thetract170. Asuture element150′ may be secured, such as by knotting, and then severed, thereby leaving theanchor130′,closure element250, and plug260 in place while the remaining components of theclosure device200 are retracted. Thereafter, the rapidly eroding material of theanchor130′ may then dissolve into the fluid flow within the lumen. In another example, the anchor maybe dissolved soon after the procedure allowing thesuture element250 to be removed and obviating the use of theplug material260. In still further examples, theanchor130′ may be let go down stream by slipping off the suture from the anchor, thus leaving behind only theclosure element250.
• FIG. 3 illustrates aclosure device200′ configured for use as an over-the wire deployment that is similar to theclosure device200 shown inFIGS. 2A-2E. Theclosure device250′ may be advanced over aguidewire300. In the example shown inFIG. 3, thedelivery sheath110′ andgarage sheath220 ofFIGS. 2A-2E have been omitted. In such an example, theanchor130′ can be housed within thecarrier tube240 and pushed distally using apusher120′ translating therein. Thereafter, theclosure device200′ can deploy theanchor130′ and theclosure element250 in a similar manner as described above with reference toFIGS. 2A-2E by advancing anactuator member230 relative to acarrier tube240.
• Embodiments of the closure element, the delivery sheath, and the like may include a material made from any of a variety of known suitable biocompatible materials, such as a biocompatible shape memory material (SMM). For example, the SMM may be shaped in a manner that allows for a delivery orientation while within the tube set, but may automatically retain the memory shape of the component once deployed into the tissue to close the opening. SMMs have a shape memory effect in which they may be made to remember a particular shape. Once a shape has been remembered, the SMM may be bent out of shape or deformed and then returned to its original shape by unloading from strain or heating. Typically, SMMs may be shape memory alloys (SMA) comprised of metal alloys, or shape memory plastics (SMP) comprised of polymers. The materials may also be referred to as being superelastic.
• Usually, an SMA may have an initial shape that may then be configured into a memory shape by heating the SMA and conforming the SMA into the desired memory shape. After the SMA is cooled, the desired memory shape may be retained. This allows for the SMA to be bent, straightened, twisted, compacted, and placed into various contortions by the application of requisite forces; however, after the forces are released, the SMA may be capable of returning to the memory shape. The main types of SMAs are as follows: copper-zinc-aluminum; copper-aluminum-nickel; nickel-titanium (NiTi) alloys known as nitinol; nickel-titanium platinum; nickel-titanium palladium; and cobalt-chromium-nickel alloys or cobalt-chromium-nickel-molybdenum alloys known as elgiloy alloys. The temperatures at which the SMA changes its crystallographic structure are characteristic of the alloy, and may be tuned by varying the elemental ratios or by the conditions of manufacture. This may be used to tune the component so that it reverts to the memory shape to close the arteriotomy when deployed at body temperature and when being released from the tube set.
• For example, the primary material of a closure element and the like may be of a NiTi alloy that forms superelastic nitinol. In the present case, nitinol materials may be trained to remember a certain shape, retained within the tube set, and then deployed from the tube set so that the tines penetrate the tissue as it returns to its trained shape and closes the opening. Also, additional materials may be added to the nitinol depending on the desired characteristic. The alloy may be utilized having linear elastic properties or non-linear elastic properties.
• An SMP is a shape-shifting plastic that may be fashioned into a closure element in accordance with the present disclosure. Also, it may be beneficial to include at least one layer of an SMA and at least one layer of an SMP to form a multilayered body; however, any appropriate combination of materials may be used to form a multilayered device. When an SMP encounters a temperature above the lowest melting point of the individual polymers, the blend makes a transition to a rubbery state. The elastic modulus may change more than two orders of magnitude across the transition temperature (Ttr). As such, an SMP may be formed into a desired shape of an endoprosthesis by heating it above the Ttr, fixing the SMP into the new shape, and cooling the material below Ttr. The SMP may then be arranged into a temporary shape by force and then resume the memory shape once the force has been released. Examples of SMPs include, but are not limited to, biodegradable polymers, such as oligo(ε-caprolactone)diol, oligo(ρ-dioxanone)diol, and non-biodegradable polymers such as, polynorborene, polyisoprene, styrene butadiene, polyurethane-based materials, vinyl acetate-polyester-based compounds, and others yet to be determined. As such, any SMP may be used in accordance with the present disclosure.
• The closure element, the delivery sheath, and the like may have at least one layer made of an SMM or suitable superelastic material and other suitable layers may be compressed or restrained in its delivery configuration within the garage tube or inner lumen, and then deployed into the tissue so that it transforms to the trained shape. For example, the closure element may be set in a trained shape that has a relative small diameter. The closure element can then be expanded and moved into engagement with a body lumen wall adjacent a puncture. The closure element can then be allowed to return to the trained state to close the puncture.
• Also, a closure element, the delivery sheath or other aspects or components of the closure system may be comprised of a variety of known suitable deformable materials, including stainless steel, silver, platinum, tantalum, palladium, nickel, titanium, nitinol, having tertiary materials (U.S. 2005/0038500, which is incorporated herein by reference, in its entirety), niobium-tantalum alloy optionally doped with a tertiary material (U.S. 2004/0158309, 2007/0276488, and 2008/0312740, which are each incorporated herein by reference, in their entireties) cobalt-chromium alloys, or other known biocompatible materials. Such biocompatible materials may include a suitable biocompatible polymer in addition to or in place of a suitable metal.
• In one embodiment, the closure element, the delivery sheath, and the like may be made from a superelastic alloy such as nickel-titanium or nitinol, and includes a ternary element selected from the group of chemical elements consisting of iridium, platinum, gold, rhenium, tungsten, palladium, rhodium, tantalum, silver, ruthenium, or hafnium. The added ternary element improves the radiopacity of the nitinol.
• In one embodiment, the closure element, the delivery sheath, and the like may be made at least in part of a high strength, low modulus metal alloy comprising Niobium, Tantalum, and at least one element selected from the group consisting of Zirconium, Tungsten, and Molybdenum.
• In further embodiments, the closure element, the delivery sheath, and the like may be made from or be coated with a biocompatible polymer. Examples of such biocompatible polymeric materials may include hydrophilic polymer, hydrophobic polymer biodegradable polymers, bioabsorbable polymers, and monomers thereof. Examples of such polymers may include nylons, poly(alpha-hydroxy esters), polylactic acids, polylactides, poly-L-lactide, poly-DL-lactide, poly-L-lactide-co-DL-lactide, polyglycolic acids, polyglycolide, polylactic-co-glycolic acids, polyglycolide-co-lactide, polyglycolide-co-DL-lactide, polyglycolide-co-L-lactide, polyanhydrides, polyanhydride-co-imides, polyesters, polyorthoesters, polycaprolactones, polyesters, polyanydrides, polyphosphazenes, polyester amides, polyester urethanes, polycarbonates, polytrimethylene carbonates, polyglycolide-co-trimethylene carbonates, poly(PBA-carbonates), polyfumarates, polypropylene fumarate, poly(p-dioxanone), polyhydroxyalkanoates, polyamino acids, poly-L-tyrosines, poly(beta-hydroxybutyrate), polyhydroxybutyrate-hydroxyvaleric acids, polyethylenes, polypropylenes, polyaliphatics, polyvinylalcohols, polyvinylacetates, hydrophobic/hydrophilic copolymers, alkylvinylalcohol copolymers, ethylenevinylalcohol copolymers (EVAL), propylenevinylalcohol copolymers, polyvinylpyrrolidone (PVP), combinations thereof, polymers having monomers thereof, or the like.
• The present disclosure may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the disclosure is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims (23)

1. An anchor for using a closure device, the anchor comprising:

a body being configured to move from a pre-deployed state to a deployed state, wherein in the pre-deployed state the body has a first width aspect relative to a direction of deployment and a second width aspect in the deployed state relative to the direction of deployment, the second width aspect being greater than the first width aspect and wherein the body is formed from a rapidly eroding material configured to erode through dissolution within a body lumen.

2. The anchor ofclaim 1, wherein the body is configured to erode in less than twelve hours.

3. The anchor ofclaim 1, wherein the body is configured to erode in less than one hour.

4. The anchor ofclaim 1, wherein the body includes a major axis and wherein the body is configured to rotate in response to a force applied parallel to the major axis.

5. The anchor ofclaim 1, wherein the rapidly eroding material includes at least one of a sugar and a sugar-derivative.

6. The anchor ofclaim 5, wherein the sugar derivative includes sugar alcohols including mannitol, sorbitol, and isomalt.

7. The anchor ofclaim 5, wherein the sugar includes at least one of a group including glucose, fructose, lactose and maltose.

8. The anchor ofclaim 1, wherein the body further includes at least one polymeric component.

9. The anchor ofclaim 8, wherein the polymeric component includes at least one of poly-vinylpyrrolidone, poly-ethyleneglycol, hydroxyethyl starch, dextran or dextran sulfate.

10. The anchor ofclaim 1, wherein the rapidly eroding material is water soluble.

11. The anchor ofclaim 1, wherein the rapidly eroding material forms a crystalline matrix.

12. The anchor ofclaim 1, wherein the rapidly eroding material forms a glass structure.

13. The anchor ofclaim 1, wherein the rapidly eroding material includes a plurality of pores.

14. The anchor ofclaim 13, wherein at least one of the pores includes at least one beneficial agent.

15. The anchor ofclaim 13, wherein the anchor member includes at least one of poly-vinyl pyrrolidone, hyaluronic acid, dextran, hydrogel, heparin, and benzalkonium heparin.

16. The closure device ofclaim 1, wherein the anchor member is formed using a freeze-drying process.

17. A method of closing a puncture in a wall of a body lumen, comprising:

advancing an anchor in a deployment direction through the anchor, the anchor having a first width aspect relative to the deployment direction;

deploying the anchor distally of the wall of the body lumen to cause the anchor to move to have a second width aspect relative to the deployment direction, the second width aspect being larger than the first width aspect;

drawing the anchor distally into engagement with a distal side of the wall of the body lumen; and

deploying a closure element into the wall of the body lumen, wherein the anchor is formed from a rapidly eroding material that dissolves in the body lumen in less than twelve hours.

18. The method ofclaim 17, wherein rapidly eroding material dissolves in the body lumen in less than one hour.

19. The method ofclaim 17, wherein deploying a closure element includes deploying an expandable plug.

20. The method ofclaim 17, wherein deploying a closure element includes deploying tines into the wall of the body lumen.

21. A closure device system comprising:

a delivery sheath;

a rapidly eroding anchor at least partially disposed within the delivery sheath in an initial configuration, the closure member comprising one or more sugars;

a suture element coupled to the closure member and disposed at least partially through the delivery sheath; and

a pusher disposed at least partially within the delivery sheath and configured to deploy the anchor member from a distal end of the delivery sheath.

22. The closure device system ofclaim 21, further comprising an expandable plug configured to be positioned between the anchor and the pusher.

23. The closure device system ofclaim 21, further comprising an expandable closure element configured to be moved between an expanded state and a restricted state to close a puncture in a wall of a body lumen.

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