1. Field of Endeavor
The present invention relates to devices, systems, and processes useful as closure devices for arterial punctures.
2. Brief Description of the Related Art
Numerous vascular closure devices have been developed over the years. The most utilized one to date is the Abbott Vascular Perclose device. This device utilizes sutures through the wall of the arteriotomy to dose the vessel after removal of the sheath.
Numerous other devices are on the market and have been tried clinically. These range from clips applied to the exterior of the vessel to perform like a suture through plugs inserted into the vessel, as well as some adhesives applied to the vessel.
Other prior devices include the Abbott Vascular Starclose, St June Angio-Seal, Access Closure Mynx, Medtronic EVS Vascular Staple, Medafor Mpatch, Sutura Super Stitch, Vascular Solutions Duett, and Cordis ExoSeal.
According to a first aspect of the subject matter described in this application, a bioresorbable vascular closure device comprises a sleeve formed of a bioresorbable material, a catch arm formed of a bioresorbable material, and a locking sleeve formed of a bioresorbable material, wherein the sleeve bioresorbable material, the catch arm bioresorbable material, and the locking sleeve bioresorbable material are mutually selected to degrade in vivo at at least two different rates.
According to a second aspect of the subject matter described in this application, a method of maintaining access to the interior of a blood vessel of a patient comprises positioning a hollow sleeve over an opening formed in the blood vessel, positioning a pair of arms around the sleeve and around the blood vessel, each of the arms including a hook on a lower end thereof, and positioning a locking sleeve over the hollow sleeve and the pair of arms, the locking sleeve forcing the pair of arms radially inwardly and the hooks to ensnare the blood vessel.
Still other aspects, features, and attendant advantages of the present invention will become apparent to those skilled in the art from a reading of the following detailed description of embodiments constructed in accordance therewith, taken in conjunction with the accompanying drawings.
The invention of the present application will now be described in more detail with reference to exemplary embodiments of the apparatus and method, given only by way of example, and with reference to the accompanying drawings, in which:
Referring to the drawing figures, like reference numerals designate identical or corresponding elements throughout the several figures.
Devices and processes embodying principles of the present invention capitalize on the benefits of resorbable materials, such as those described in U.S. application Ser. No. 61/737,272, by Fred Burbank and Michael Jones, filed on even date herewith, Attorney Ref. No. 099-001P, entitled Short Term Biomaterials, the entirety of which is incorporated by reference herein. These novel compositions and designs perform the closure of the vessel arteriotomy with an external (to the vessel) system much like the placing of a valve or patch onto a tire.
A series of parts of a vascular closure assembly 10, tailored to match the outer diameter (OD) of the blood vessel B, is assembled over a vascular sheath 12 and introducer 14, as illustrated in sequence in
A sleeve 16 is the first item to be placed against the artery. It includes a saddle cut, described in greater detail elsewhere herein, that allows the sleeve to sit down on the artery and eventually seal around the periphery of the arteriotomy.
Next, a catch arm 18 is slid down the introducer and onto the sleeve. This piece nests onto the sleeve and prongs on the ends of arms of the catch arm grasp and retain the artery. Optionally, a locking sleeve 20 can be slid down over the catch arm to lock this piece in place onto the artery.
Once all of these items are placed on top of the artery, a biological sealant can be applied to the base of sleeve to seal the sleeve to the artery. This material can be a bioadhesive such as TISSEAL, BIOGLUE, or a cyanoacrylate. Alternately, a filler such as chitosan, which is a liquid and gels upon a change in pH, or other biologically acceptable hydrogel, could be used to establish a leak-free connection between the sleeve and the artery.
When the interventional procedure is completed, the catheter and access sheath can be removed and a resorbable plug, such as one made from compressed starch, may be inserted into the sleeve to prevent the backflow of blood, e.g., to act like a cork in a wine bottle. Alternately, the catheter could be removed from the sheath, then the sheath backed out into the sleeve and an expandable plug inserted through the sheath into the sleeve, or flowable material that gels in the sleeve and left in place before removing the sheath from the patient.
Alternate embodiments are envisioned that would use a structure allowing for an increase in surface area in the area of bonding of the sleeve to the artery. These embodiments may not require the catch arms to be utilized and instead will utilize a tissue adhesive and larger surface contact area to provide the seal and bond.
Particularly advantageously, these constructions are formed of a material or materials that is resorbed by the body in a short time span, ranging from 24 to 96 hours, leaving an organized clot as the closure of the vessel.
According to a first exemplary embodiment, the sleeve is formed from a compressed composition of starch with 20% (by weight percent) methyl cellulose mixed as a binder. This material, when compressed at about 40,000 to 50,000 psi, become a useable solid material that has very good compressive strength, but little tensile strength. The catch arms can be made of a moldable composition such as 65/35 copolymer of poly-lactic and poly-glycolic acid. This copolymer may be constructed with a short-term filler, such as starch or other polysaccharide, to accelerate its decomposition in vivo. The locking sleeve is formed from a similar material as the catch arms as it will experience some tensile load as it slides down and locks onto the catch arms. As will be immediately appreciated, alternate materials are possible, while the material construction described above is a preferred embodiment.
Devices as described herein can have numerous advantages over prior closure devices. Devices embodying principles of the present invention work well with small arteriotomies that accompany small introducers in the 5 to 7 Fr range and work adequately on larger introducers up to 9Fr. Another benefit is that nothing is left within the artery as a nidus for clot formation or narrowing within the vessel. Additionally, there will be nothing left long term to cause the artery to narrow at the entry site due to exterior inflammation.
I. The sleeve is molded from a bioresorbable polymer such as 63/35 PLGA with resorption time of 6-8 weeks in vivo. The catch arm is molded from a bioresorbable polymer such as 63/35 PLGA with resorption time of 6-8 weeks in vivo. The locking sleeve is molded from a bioresorbable polymer such as 63/35 PLGA with resorption time of 6-8 weeks in vivo. The hemostatic plug is made from a compressed starch with 20% by weight methyl cellulose as a binder. This plug will be resorbed in the body in about 4-7 days.
II. The sleeve is compression molded from a bioresorbable, hemostatic starch with 20% by weight methyl cellulose as a binder. The catch arm is molded from a bioresorbable polymer such as 63/35 PLGA with resorption time of 6-8 weeks in vivo. The locking sleeve is molded from a bioresorbable polymer such as 63/35 PLGA with resorption time of 6-8 weeks in vivo. The hemostatic plug is made from a compressed starch with 20% by weight methyl cellulose as a binder. This plug will be resorbed in the body in about 4-7 days.
III. The sleeve is compression molded from a bioresorbable, hemostatic chitosan with 20% by weight methyl cellulose as a binder. The catch arm is molded from a bioresorbable polymer such as 63/35 PLGA with resorption time of 6-8 weeks in vivo. The locking sleeve is molded from a bioresorbable polymer such as 63/35 PLGA with resorption time of 6-8 weeks in vivo. The hemostatic plug is made from a compressed starch with 20% by weight methyl cellulose as a binder. This plug will be resorbed in the body in about 4-7 days.
IV. The sleeve is formed from a freeze dried bioresorbable, hemostatic chitosan. The catch arm is molded from a bioresorbable polymer such as 63/35 PLGA with resorption time of 6-8 weeks in vivo. The locking sleeve is molded from a bioresorbable polymer such as 63/35 PLGA with resorption time of 6-8 weeks in vivo. The hemostatic plug is made from a compressed starch with 20% by weight methyl cellulose as a binder. This plug will be resorbed in the body in about 4-7 days.
V. The sleeve is molded from a bioresorbable polymer composite containing 20 to 50% by weight starch in a 63/35 PLGA with resorption time of 4-6 weeks in vivo. The catch arm is molded from a bioresorbable polymer composite containing 20 to 50% by weight starch in a 63/35 PLGA. The locking sleeve is molded from a bioresorbable polymer composite containing 20 to 50% by weight starch in a 63/35 PLGA. The hemostatic plug is made from a compressed starch with 20% by weight methyl cellulose as a binder. This plug will be resorbed in the body in about 4-7 days.
VI. The sleeve is molded from a bioresorbable polymer composite containing 20 to 50% by weight chitosan in a 63/35 PLGA with resorption time of 4-6 weeks in vivo. The catch arm is molded from a bioresorbable polymer composite containing 20 to 50% by weight starch in a 63/35 PLGA. The locking sleeve is molded from a bioresorbable polymer composite containing 20 to 50% by weight starch in a 63/35 PLGA. The hemostatic plug is made from a compressed starch with 20% by weight methyl cellulose as a binder. This plug will be resorbed in the body in about 4-7 days.
VII. The sleeve is formed from a freeze dried bioresorbable composite, of 20 to 50% by weight starch in chitosan. The catch arm is molded from a bioresorbable polymer composite of 20 to 50% starch in 63/35 PLGA with resorption time of 4-6 weeks in vivo. The locking sleeve is molded from a bioresorbable polymer composite of 20 to 50% starch in 63/35 PLGA with resorption time of 4-6 weeks in vivo. The hemostatic plug is made from a compressed starch with 20% by weight methyl cellulose as a binder. This plug will be resorbed in the body in about 4-7 days.
Other uses of include vascular graft or fistula creation for use in kidney dialysis patients. In these patients, a graft is created between an artery and vein in the arm to allow for easy access with two cannulae for dialysis. In this use, there would be two of these connectors, one positioned on the artery and another positioned on the vein with a graft synthetic or a harvested vein extending between the two. This would allow for optimization of the graft takeoff and return angle to minimize fluid flow disruption at the graft and re-entry site. Additionally, with no suture in the inner lumen of the vessel, clotting would be less of a problem than with current solutions.
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Number | Date | Country | |
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61737323 | Dec 2012 | US |