Methods and articles for delivering viable cells into solid tissue
Inventors
Assignees
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Publication Number
US-10869840-B2
Publication Date
2020-12-22
Expiration Date
Abstract
Embodiments provide swallowable devices, preparations and methods for delivering viable cells (VC) into the GI tract including GI wall tissue or other tissue site. Particular embodiments provide a swallowable device such as a capsule for delivering VC into an intestinal wall or other site. The VC can be contained within a tissue-penetrating shell disposed in the capsule that protects the VC as they pass through the GI tract until they are inserted into GI tract tissue or other location. The shell desirably has shape, size and material consistency to be contained in a swallowable capsule, delivered from the capsule into solid tissue by the application of force on the shell and biodegrade within the solid tissue to release the VC into the tissue. Within the shell or other structure the VC can be maintained in a viability-sustaining gel that preserves the viability of the VC for selected time periods.
Core Innovation
The invention relates to an article for delivering viable cells into solid GI tissue of a patient. The article includes a shell configured for penetration into the GI solid tissue, with a tissue penetrating end, a force application end, and a shell wall defining an interior of the shell. A mass of viable cells is disposed within the interior of the shell, and the cells are present in a viability-sustaining gel.
The shell is shaped and made of material to protect the viability of the cells from the external environment, be contained in a swallowable capsule, and be delivered from the capsule into solid GI tissue by application of force on the force application end. After delivery, the shell biodegrades within the solid tissue to release the viable cells into the solid GI tissue. The shell wall further includes fenestrations dimensioned to allow passage of fluids and small molecules while containing the cells and gel.
In further refinements, the viability-sustaining gel includes a viscoelastic property that allows the gel to act as a shock absorbing medium to absorb a portion of the force imparted from the force application end during insertion, thereby minimizing damage to the viable cells. The gel viscoelastic property may be selected to provide a defined storage modulus range. Additional refinements include saturating the viability-sustaining gel at least partially with nitrogen or other inert gas to preserve cell viability.
Claims Coverage
The partial content includes three independent claims. Across these independent claims, the core inventive features cover a swallowable, force-deliverable, tissue-penetrating and biodegradable shell containing viable cells in a viability-sustaining gel, with fenestrations for fluid and small molecule passage, and additional requirements directed to shock absorption and/or inert-gas gel preservation.
Force-deliverable tissue-penetrating shell with viability-sustaining gel and fenestrations
An article for delivering viable cells into solid GI tissue, comprising a shell configured for penetration into GI solid tissue with a tissue penetrating end, a force application end, and a shell wall defining an interior; a mass of viable cells within the interior; wherein the cells are present in a viability-sustaining gel; wherein the shell has a shape and material to protect viability from the external environment, be contained in a swallowable capsule, be delivered from the capsule into solid GI tissue by force on the force application end, and biodegrade within solid tissue to release the viable cells; and wherein the shell wall has fenestrations dimensioned to allow passage of fluids and small molecules but to contain the cells and gel.
Shock-absorbing gel viscoelastic property to minimize cell damage
An article for delivering viable cells into solid GI tissue, comprising a shell configured for penetration into the GI solid tissue with a tissue penetrating end, a force application end, and a shell wall defining an interior; a mass of viable cells within the interior; wherein the cells are present in a viability-sustaining gel; wherein a viscoelastic property of the gel is selected such that gel acts as a shock absorbing medium to absorb a portion of the force imparted from the force application end when the article is inserted into solid tissue so as to minimize damage to the viable cells.
Inert-gas saturated viability-sustaining gel for preserving cell viability
An article for delivering viable cells into solid GI tissue, comprising a shell configured for penetration into the GI solid tissue with a tissue penetrating end, a force application end, and a shell wall defining an interior; a mass of viable cells within the interior; wherein the cells are present in a viability-sustaining gel at least partially saturated with nitrogen or other inert gas to preserve the viability of the cells; wherein the shell has a shape and material to protect the viability of the cells from the external environment, be contained in a swallowable capsule, be delivered from the capsule into solid GI tissue by force on the force application end, and biodegrade within the solid tissue to release the viable cells into the solid GI tissue.
Across the independent claims, the invention centers on a swallowable, force-deliverable, tissue-penetrating, biodegradable shell containing viable cells in a viability-sustaining gel, with fenestrations that permit fluid and small molecule passage. The independent claim set further specifies gel behavior for shock absorption to minimize cell damage and/or inert-gas saturation to preserve cell viability.
Stated Advantages
Protects viability of the cells from the external environment.
Allows containment in a swallowable capsule and delivery into solid GI tissue by application of force.
Biodegrades within the solid tissue to release the viable cells into the solid GI tissue.
Minimizes damage to the viable cells by using the gel as a shock absorbing medium to absorb a portion of insertion force.
Preserves the viability of the cells by saturating the viability-sustaining gel at least partially with nitrogen or other inert gas.
Documented Applications
Delivering viable cells into solid GI tissue of a patient, including delivery into intestinal wall/solid GI tissue using a swallowable capsule and a tissue-penetrating, biodegradable shell.
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