Haemonetics has filed a patent for an apparatus and method for sealing a vascular wall penetration. The apparatus includes a shaft, an optional occlusion element, a hydratable hemostatic implant, and a protective sleeve. The method involves introducing the shaft through the tissue tract, retracting the protective sleeve to expose the hemostatic implant, and withdrawing the shaft while leaving the expanded implant in place. The implant is designed to enhance closure of the vascular wall penetration with minimal scarring. GlobalData’s report on Haemonetics gives a 360-degree view of the company including its patenting strategy. Buy the report here.
According to GlobalData’s company profile on Haemonetics, glucose monitoring wearbles was a key innovation area identified from patents. Haemonetics's grant share as of September 2023 was 53%. Grant share is based on the ratio of number of grants to total number of patents.
Method for sealing a blood vessel penetration with implant
A recently filed patent (Publication Number: US20230309980A1) describes a method for sealing a blood vessel penetration at the end of a tissue tract. The method involves using a specialized apparatus that includes a shaft, a hemostatic implant, a soluble plug, and a protective sleeve.
To perform the method, the shaft is introduced through the tissue tract, positioning the hemostatic implant within the tract. The hemostatic implant and soluble plug are covered by the protective sleeve during this process. The protective sleeve is then retracted, exposing the soluble plug and the hemostatic implant. The soluble plug dissolves and is absorbed into the surrounding tissue, while the hydratable implant expands and occludes the tissue tract. Finally, the shaft is withdrawn, leaving the expanded hemostatic implant in place within the tissue tract.
The patent also mentions additional features of the apparatus and method. For example, the soluble plug is designed to seal against and prevent fluid ingress through the open end of the protective sleeve. The soluble plug is made of a resorbable biopolymer, such as hyaluronic acid. The apparatus may also include an occlusion element, which can be deployed to inhibit blood flow from the blood vessel into the tissue tract. The occlusion element can be shifted between a radially contracted configuration for passage through the tissue tract and a radially expanded configuration for deployment within the blood vessel.
The protective sleeve is latched to the shaft during the introduction process and can be unlatched before retracting it. The hemostatic implant is prevented from being displaced proximally by a back stop on the shaft while the sleeve is retracted and the shaft is withdrawn. The protective sleeve consists of an outer sleeve and an inner release sheath, with the outer sleeve being retracted first to prevent sticking between the sleeve and the hemostatic implant.
The hemostatic implant itself can be a cylindrical body that circumscribes the shaft or a body that opens laterally and releases from the shaft after the protective sleeve is withdrawn. It is made of a hydratable, biodegradable polymer that is not fully hydrated when covered by the protective sleeve but hydrates when exposed by retracting the sleeve. The polymer can be composed of materials like polyethylene glycols, collagens, and gelatins. Additionally, the hemostatic implant may contain an active agent, such as an anti-proliferative agent or an anticoagulant, incorporated in a degradable carrier.
Lastly, at least a portion of the hemostatic implant or tube is radiopaque, allowing for observation of the occlusion element to ensure correct orientation before retracting the protective sleeve.
In summary, the patent describes a method and apparatus for sealing a blood vessel penetration using a specialized implant and protective sleeve. The method involves introducing the implant through a tissue tract, retracting the protective sleeve to expose the implant, and withdrawing the shaft, leaving the expanded implant in place. The apparatus includes various features to ensure proper sealing and deployment of the implant.
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