Patent Application
20160120526
The field of the present invention pertains to medical devices, and more particularly, medical devices and methods designed for percutaneous vascular access closure.
Wounds such as arteriotomies can arise in the blood vessel from various medical procedures, especially for blood vessels acting as sites for catheter insertion during diagnostic and/or interventional catheterization.
Although such wounds may be fixed by application of pressure by hand, a number of vascular closure devices have been developed to address the need to close such wounds in a safe and more efficient manner.
Various closure devices tend to rely on either purely mechanical or purely biological means to close the wound.
US Patent Publication No. 2008/0249545 to Shikhman et al., for example, describes a mechanical based device. The Shikhman publication describes a percutaneous surgical device, which comprises a combination wound suturing and crimping and cutting device. In one exemplary embodiment a crimping and cutting device portion nests within a suturing device portion. The combined device may locate a vessel wound and pass suture through the vessel walls surrounding the wound. Then, the crimping and cutting portion may detach, the suturing portion may be removed, and the crimping and cutting portion may be located to the wound site to apply a fastener (e.g., a ferrule). See also Patent Publication Nos. 2010/0069930; 2004/0097968; 2003/0216755; 2003/0078601 also to Shikhman et al.
U.S. Pat. No. 7,060,078 to Hathaway et al. describes another mechanical based device. The '078 patent describes a device having two components: a needle advancing apparatus slidable longitudinally along a catheter to advance needles into a tissue membrane, such as a blood vessel wall, around an opening in the membrane; and, a suture retrieval assembly insertable through the catheter beyond a distal side of the tissue membrane. The needle advancing apparatus advances suture through the tissue wall. The suture retrieval assembly grabs the suture on the distal side of the tissue membrane for extraction thereof through the opening in the tissue membrane. A method for suturing a membrane beneath the patient's skin is also disclosed.
Such mechanical approaches tend to require precise positioning within the tissue tract, typically provide point (instead of a continuum of tissue purchase) support, and lead to permanent foreign-body implants that interfere with subsequent catheterization at the same vascular site. Additionally, a purely mechanical support of the wound could lead to implanting substantially non-absorbable foreign material that provides only point-support to the wound lips.
Various biological approaches to vascular closure are described in U.S. Pat. Nos. 5,108,421; 5,601,602 each to Fowler. In the '421 patent, a device and method of closing an incision or puncture in a patient is disclosed. The method includes inserting a vessel plug into the incision or puncture until the distal end of the vessel plug is adjacent to the outer lumen of the blood vessel. The vessel plug is positioned so that it does not obstruct the flow of fluid through the blood vessel or target organ. The precise positioning of the vessel plug in the incision or puncture is accomplished through the use of a balloon catheter or a cylindrical insertion assembly having a proximal plunger member associated therewith. See also U.S. Pat. No. 7,331,979 to Khosravi. Purely biological implants tend to provide relatively weak-mechanical support (especially in large wounds). Additionally, purely biological wound coverage, while being bioabsorbable, does not necessarily guarantee instant securing of the wound lips.
U.S. Pat. Nos. 5,021,059; 5,222,974; and US Patent Publication No. 2001/0003158 each to Kensey et al. describe another biological closure approach. The '059 patent, for example, describes deploying a collagen plug to seal the closure. In order to block the collagen from entering the vessel, a footplate is installed on the interior of the blood vessel. The footplate is held in place with a suture. The approaches described in the '059 patent, however, do not physically approximate the lips of the arteriotomy. The '059 patent describes a system which undesirably relies on only the collagen to close the wound.
It is thus desirable for a vascular closure device that is conveniently installed, that is efficient for the physician to deploy, and that addresses the above mentioned shortcomings.
The description, objects and advantages of the present invention will become apparent from the detailed description to follow, together with the accompanying drawings.
A vascular closure device includes both a mechanical component and a biological component for sealing an arteriotomy. The mechanical component reduces the size or closes the arteriotomy. The biological component covers and fills any spaces or cracks (fissures) present after the arteriotomy has been mechanically reduced in size.
In one embodiment the device includes a suture or clip to approximate the edges of the arteriotomy, and a smooth rounded plug is advanced along the suture towards the closed arteriotomy. In another embodiment a sealant plug is advanced along a guidewire extending from the closed arteriotomy. In another embodiment a sealant plug is advanced alongside a guidewire extending from the closed arteriotomy. In situ, the plug transforms to a flowable or gel state and fills and covers any cracks and spaces along the closed arteriotomy.
In embodiments, the plug transforms from a solid structure to a more flowable gel state, and reconfigures to the shape of the puncture. In embodiments, the sealant is a PEG which cross links in situ. The sealant covers and fills the micropores arising from the mechanically closed lips of the arteriotomy. In a sense, the sealant is cast or molded in situ to match the puncture, fissures, and micropores created between the suture strands in the closed arteriotomy. Examples of sealants which may swell, reconfigure, and/or cross link in situ include biodegradable gels as described, for example, in US Patent Publication No. 2012/0209323.
In embodiments, the suture defines a central axis, and the sealant is advanced along an axis offset from the central axis. The sealant is directed towards the microspaces in the closed arteriotomy rather than merely on top of the suture bundle or knot. In other embodiments, the guidewire defines a central axis and extends directly from the micro spaces formed by the closed arteriotomy, and the sealant is advanced along the central axis towards the micro spaces so as to avoid merely being placed on top of the suture knots or bundles. The invention is intended to include a sealant being advanced on-axis or off-axis (namely, offset from the central guide axis).
In another embodiment, a surgical method for closing an open arteriotomy in a blood vessel comprises mechanically approximating a first lip of the arteriotomy to a second lip of the arteriotomy thereby forming a closed arteriotomy. The method further comprises covering the closed arteriotomy with a sealant.
In another embodiment a hybrid vascular access closure method and system provides both adequate mechanical support to the wound lips, and comprehensive sealing/coverage of the wound.
In another embodiment a method and system for vascular access closure minimizes the size of foreign-materials left in the tissue tract, without jeopardizing secure wound closure.
In another embodiment a system for large-bore vascular access closure is provided. In embodiments, a dilator is effective to enlarge the opening to a diameter ranging from 2 mm to 10 mm, and preferably, to at least 6 mm. In other embodiments, a smaller diameter dilator may be used to enlarge the opening.
In another embodiment a device and method include a biological space filler combined with minimum mechanical support to provide vascular closure.
In another embodiment a mechanical structure is deployed pre-procedure, thus providing assurance for the interventionalist during subsequent steps.
In another embodiment the mechanical component can provide a path (or reference point) for subsequent insertion of biological composition.
In another embodiment the mechanical component or biological component or both components include a radiopaque material.
In embodiments, a method and system comprise an additional feature for securing (e.g., cinching, tightening) the mechanical component, whereby the feature also serves as the biological component.
In embodiments, a sealant plug comprises a cable or zip tie opening. Free suture limbs extending from the lips of the arteriotomy are drawn through the tie opening, thereby approximating the tissue lips. After cinching, and the plug has been advanced through the tissue tract and urged against the exterior wall of the closed arteriotomy, the plug transforms from a first relatively firm state to a second gel-like (or flowable) state. The sealant flows across, covers, and fluidly seals the arteriotomy. The sealant also serves to mechanically secure (e.g., bond, weld, fix) the suture limbs. The tissue lips are held in a closed position.
Before the present invention is described in detail, it is to be understood that this invention is not limited to particular variations set forth herein as various changes or modifications may be made to the invention described and equivalents may be substituted without departing from the spirit and scope of the invention. As will be apparent to those of skill in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present invention. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process act(s) or step(s) to the objective(s), spirit or scope of the present invention. All such modifications are intended to be within the scope of the claims made herein.
Methods recited herein may be carried out in any order of the recited events which is logically possible, as well as the recited order of events. Furthermore, where a range of values is provided, it is understood that every intervening value, between the upper and lower limit of that range and any other stated or intervening value in that stated range is encompassed within the invention. Also, it is contemplated that any optional feature of the inventive variations described may be set forth and claimed independently, or in combination with any one or more of the features described herein.
All existing subject matter mentioned herein (e.g., publications, patents, patent applications and hardware) is incorporated by reference herein in its entirety except insofar as the subject matter may conflict with that of the present invention (in which case what is present herein shall prevail).
Reference to a singular item, includes the possibility that there are plural of the same items present. More specifically, as used herein and in the appended claims, the singular forms “a,” “an,” “said” and “the” include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation. Last, it is to be appreciated that unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.
After the vessel is accessed, needle 4 is removed leaving guidewire 6 in place.
Next, and with reference to
Alternatively, a sheath may be provided through which a suturing device is delivered to the vessel. See for example U.S. Pat. No. 8,197,510 to Nobles.
The suturing device 8 shown in
The desired medical procedure is performed through the vascular sheath. The vascular sheath and guidewire are removed, leaving the previously placed sutures.
In embodiments, the sealant can be introduced over the suture, or alongside the suture. The invention is intended to include all variations except as where specifically recited in the appended claims.
Consequently, the plug is deployed or ejected and subject to reacting with the physiological materials of the tract. Preferably, plug absorbs or otherwise reacts with the environment to change shape and properties which better serve to close the arteriotomy. In embodiments, the sealant transforms from a first relatively firm state to a second more gelatinous state. Examples of plug materials are described herein.
In embodiments the sealant additionally welds the suture limbs 9a, 9b together. In embodiments the suture and or plug are biodegradable and are fully absorbed over a time period. Preferably the materials are selected such that the time period is less than 90 days.
In embodiments, in situ, the sealant expands and migrates or flows into small spaces, cracks and micro-openings left remaining after the wound lips have been mechanically approximated.
In embodiments, the biological components can be polymers, proteins, other molecules, or a conjugation/combination of types of these components, individually or collectively designed to provide continuous wound coverage. Non limiting examples of biological sealants include biodegradable gels such as PEG, and collagens. The sealant may have a first plug shape, and transform to a flowable expandable gel, for example. Non limiting examples of biological sealants are described in U.S. Pat. Nos. 6,152,943; 6,165,201; 8,348,971; and 7,790,192 and US Patent Publication 2012/0209323 to Uchida et al.
Suture channel 310 can have one or more clamping members 314. The clamps 314 are disposed at an angle to facilitate movement of the suture limbs (not shown) upwards (U). And to prohibit movement of the suture downwards (D).
With reference to
Optionally, suture legs may include enlarged sections, filled sections, bulbs, and other zip lock engagement features to allow engagement between the suture channel 310 and the suture legs 344.
The apertures 322a, b are preferably spaced such that drawing the sutures through the apertures causes the lips to firmly shut. In one embodiment the clip has two circular shaped apertures and a space (G) separating the apertures ranging from 0.5 to 5 mm and preferably 0.5 to 1 mm.
The clip may have a thin, button or circular shape. Its thickness (t) may range from 1 to 5 mm, for example.
In embodiments, the sealant capsule 340 is a reservoir or volume (e.g., a cylinder, or bullet shape) of sealant. A cylindrical shaped PEG is an exemplary sealant capsule.
The sealant capsule is advanced proximal to, distal to, or straddling the clip portion. The sealant capsule may be a component of the clip or reside within a cavity in the clip.
After cinching the sutures 344, and the biological assembly has been advanced through the tissue tract and urged against the exterior wall of the closed arteriotomy, the sealant capsule transforms from a first relatively firm state 340 to a second gel-like (or flowable) state 340′. The sealant flows across, covers, and fluidly seals the arteriotomy. The sealant also serves to mechanically secure (e.g., bond, weld, etc.) the suture limbs within the clip. Consequently, the tissue lips are held in a closed position.
The biological member shown in
The devices and components described herein may be deployed in various order. For example,
First, a mechanical component reduces the size of the wound as shown in
In embodiments, in situ, the sealant plug flows and expands into micro-openings to fluidly seal the wound in combination with the suture or other mechanical structures.
In embodiments, the mechanical and biological components may be deployed in parallel, or simultaneously. In embodiments, the components are deployed completely independent of each other.
In embodiments, the mechanical component can be transiently applied such as to provide initial wound support, and can be removed once the wound healing can be sustained with biological component alone.
In embodiments, the mechanical components or techniques for approximating the wound lips can include temporary or permanent implants, and/or techniques for tissue reorientation. An example of a temporary mechanical component is a biodegradable suture. An example of a permanent mechanical tissue approximation device is a metal clip or staple or non-absorbable suture.
In embodiments, the mechanical component or techniques for approximating the wound lips can include a temporary (PGLA, PLLA, hydrogel, etc) or permanent (Nitinol, stainless steel, platinum, titanium, etc) implant, and or techniques for securing mechanical component (suture, clip). The implant can comprise means for delivering biological component to the desired site.
In embodiments, the biological component can be: a smart moiety that selectively binds to domains in proximity of the wound; a moiety that infiltrates the wound and wound surrounding tissue such as to seal the wound; a composition of infiltrating and selectively binding moieties; and/or incorporate other materials/components that provide enhancement to the biological moiety such as reinforcement, visibility, expansion, etc. Examples of biological components include PEG, collagens, and hydrogels already cross linked to that cross link in situ.
In embodiments, the biological component can be solid or injectable, and it can comprise of a plurality of different biological forms. An example of a biological sealant is described in U.S. Pat. Nos. 6,152,943; 6,165,201, and 7,553,319.
In embodiments the biological component can be applied to wound proximity using an applicator, such as a catheter, or a part of a catheter system.
In embodiments, the biological component can operate in conjunction with a mechanical component, or uses a previously applied mechanical component as a reference during operation.
In embodiments, the biological component can operate as an adjunct, but is not dependent on mechanical component.
In embodiments an apparatus is configured to locate the wound level. For example, the applicator can be equipped with means to engage the wound, thereby providing reference for the wound level during operation, such means include balloons, expandable frames/shapes, structures temporarily/permanently attached to the wound etc. An example of a wound location configuration is described in U.S. Pat. No. 7,331,979.
In embodiments, the applicator can have a blunt tip, such as to stop at the wound level, and resists entering from the tissue tract into the vascular lumen.
In embodiments, the applicator can be equipped with means for preparing the tissue surrounding the wound. For example, the applicator can have an uneven, irregular, jagged, rough portion to dissect tissue away from the wound.
In embodiments, the applicator is adapted to provide a temporary seal of the wound for the duration of application of the moiety. For example, a balloon can be incorporated in the center of the applicator, that can be inflated such as to provide temporary seal of the vascular wound during operation.
In embodiments, the applicator is adapted to provide ports/channels for locally administering fluids/buffers/solutions aimed at catalyzing a chemical reaction within the biological moiety at wound level.
In embodiments, the applicator is adapted to incorporate mechanisms to deploy and/or optimize mechanical component. For example, the applicator could be equipped with means to house an elongate object connected to pre-deployed mechanical components, thereby using the elongate object as a path to reach the mechanical component.
In embodiments, the applicator is equipped with an asymmetric/eccentric balloon that can be inflated intravascularly (beneath the wound); the asymmetric balloon can achieve desirable tissue reorientation transiently for subsequent steps.
Embodiments include any one or combination of the devices, methods, kit of apparatuses, systems, and implants as described herein.
Other modifications and variations can be made to the disclosed embodiments without departing from the subject invention.
This application claims priority to the following provisional patent application Nos. 61/764,749, filed Feb. 14, 2013; 61/801,694, filed Mar. 15, 2013; and 61/930,624, filed Jan. 23, 2014.
| Number | Date | Country | |
|---|---|---|---|
| 61764749 | Feb 2013 | US | |
| 61801694 | Mar 2013 | US | |
| 61930624 | Jan 2014 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 14179767 | Feb 2014 | US |
| Child | 14994496 | US |
