Apparatus and methods for sealing a vascular puncture
Inventors
Mylonakis, Andreas • Au-Yeung, Jacky • Lim, Florencia
Assignees
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Publication Number
US-10456124-B2
Publication Date
2019-10-29
Expiration Date
Abstract
A sealant for sealing a puncture through tissue includes a first section, e.g., formed from freeze-dried hydrogel, and a second section extending from the distal end. The second section may be formed from PEG-precursors including PEG-ester and PEG-amine, e.g., in an equivalent ratio of active group sites of PEG-ester/PEG-amine greater than one-to-one, e.g., such that excess esters may provide faster activation upon contact with physiological fluids and enhance adhesion of the sealant within a puncture. At least some of the precursors remain in an unreactive state until exposed to an aqueous physiological environment, e.g., within a puncture, whereupon the precursors undergo in-situ cross-linking to provide adhesion to tissue adjacent the puncture. For example, the PEG-amine precursors may include the free amine form and the salt form. The free amine form at least partially cross-links with the PEG-ester and the salt form remains in the unreactive state in the sealant before introduction into the puncture.
Core Innovation
The invention provides a sealant for sealing a puncture through tissue that includes a mass of PEG precursors comprising PEG-ester precursors and PEG-amine precursors. The PEG-amine precursors include a free-amine form of PEG-amine precursors and a salt form of PEG-amine precursors, and the free-amine form is at least partially cross-linked with the PEG-ester precursors.
The sealant is provided so that the salt form of PEG-amine precursors remains in an unreactive state until exposed to an aqueous physiological environment. Upon exposure to the aqueous physiological environment, the salt form undergoes in-situ cross-linking with the PEG-ester precursors to provide adhesion to tissue adjacent the puncture.
In a further form, the sealant comprises a first section and a second section. The first section includes a freeze-dried hydrogel that expands when exposed to physiological fluid within the puncture, and the second section includes the mass of PEG precursors fused to the freeze-dried hydrogel.
Claims Coverage
The document includes four independent claims: clm-00001 (sealant composition), clm-00010 (sectioned sealant with freeze-dried hydrogel and fused PEG precursors), clm-00016 (method of sealing a puncture using the specified sealant), and clm-00019 (method of making the sealant by melting and fusing PEG precursors onto a delivery section). Across these, the inventive features focus on combining PEG-ester and PEG-amine precursors with distinct reactivity states and optionally using a freeze-dried hydrogel first section that expands in the puncture.
PEG-precursor sealant with free-amine and salt-form PEG-amine reactivity states
A sealant for sealing a puncture through tissue comprising a mass of PEG precursors comprising PEG-ester precursors and PEG-amine precursors, the PEG-amine precursors including a free-amine form and a salt form, wherein the free-amine form is at least partially cross-linked with the PEG-ester precursors, and the salt form remains in an unreactive state until exposed to an aqueous physiological environment, whereupon the salt form undergoes in-situ cross-linking with the PEG-ester precursors to provide adhesion to tissue adjacent the puncture.
Sectioned sealant with freeze-dried hydrogel expansion fused to PEG precursors
The sealant comprises a first section and a second section, the first section comprising a freeze-dried hydrogel that expands when exposed to physiological fluid within the puncture and the second section comprising the mass of PEG precursors fused to the freeze-dried hydrogel.
Method of sealing a puncture via in-situ cross-linking of unreactive salt-form PEG-amine
A method for sealing a puncture extending through tissue, comprising introducing a sealant into a puncture, the sealant comprising a mass of PEG precursors comprising PEG-ester precursors, a free-amine form of PEG-amine precursors, and a salt form of PEG-amine precursors, wherein the free-amine form is at least partially cross-linked with the PEG-ester precursors, and the salt form remains in an unreactive state until exposed to fluid within the puncture, whereupon the salt form undergoes in-situ cross-linking with the PEG-ester precursors to provide adhesion to tissue adjacent the puncture.
Method of making sealant by melting PEG precursors and fusing to a puncture-deliverable first section
A method for making a sealant, comprising forming an elongate first section having a cross-section sized for delivery into a puncture through tissue; melting a mixture of PEG precursors comprising PEG-ester precursors, a free-amine form of PEG-amine precursors, and a salt form of PEG-amine precursors; and fusing the mixture of PEG precursors onto an end of the first section, wherein the free-amine form at least partially cross-links with the PEG-ester precursors, and the salt form remains in an unreactive state until exposed to an aqueous physiological environment.
Across the independent claims, the core coverage centers on a PEG-precursor sealant where PEG-ester precursors interact with PEG-amine precursors using two reactivity states to provide adhesion to tissue adjacent the puncture, optionally combined with a freeze-dried hydrogel first section that expands when exposed to physiological fluid within the puncture and with manufacturing steps based on melting and fusing the PEG precursor mixture onto a puncture-deliverable section.
Stated Advantages
Provides adhesion to tissue adjacent the puncture through in-situ cross-linking after exposure to an aqueous physiological environment.
The sealant is configured to withstand higher pressures as compared to a comparison sealant lacking the free-amine form of PEG-amine precursors.
Documented Applications
Sealing a puncture through tissue, including a puncture extending through tissue, where the sealant provides adhesion to tissue adjacent the puncture.
Sealing vascular puncture/arteriotomy in a puncture through tissue context using an apparatus configured for delivery of the sealant into a puncture.
Use in a percutaneous procedure context, involving introduction of the sealant into a puncture via a delivery apparatus with a tubular member and distal opening positioning.
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