Methods and articles for delivering viable cells into solid tissue
Inventors
Assignees
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Publication Number
US-10220003-B2
Publication Date
2019-03-05
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 provides swallowable tissue-penetrating delivery articles and capsules for oral delivery of viable cells into the GI tract and solid tissue. The article has a tissue-penetrating shape that contains a mass of the cells in a viable state and is configured to penetrate and be implanted within solid tissue. At least a portion of the article biodegrades within the solid tissue while the cells remain in a viable state.
The cells are suspended in a viability-sustaining gel and are released into the tissue in a viable state upon implantation and biodegradation. The viability-sustaining gel includes alginate, protein, and carbohydrate gels, and embodiments include partially or fully saturating the gel with oxygen or an inert gas such as nitrogen. The article's biodegradation timing is configurable to maintain viability during tissue residence.
The tissue-penetrating article can include a fenestrated shell or fenestrated walls that allow fluid and/or molecule exchange, including fenestration dimensions and fenestrated structural features with degradation signatures observable by acoustic or ultrasound means. Delivery apparatus embodiments include an oral capsule with pH-sensitive enteric coatings and an expandable or deployable mechanism that aligns and propels the tissue penetrating assembly into the intestinal wall.
Additional embodiments include reversible suspended animation of cells and regimen-based dosing, along with reseeding specific GI regions with enteroendocrine and mucosal cells. Structural enhancements described include moisture barriers, shock absorbers, radio-opaque and echogenic markers, and biodegradable seams or tearable designs, together with controlled release and deflation strategies to support viable cell delivery into solid tissue.
Claims Coverage
Independent claim clm-00001 covers a method for delivering viable cells into solid tissue by administering a tissue-penetrating, biodegradable article that implants within solid tissue and releases cells in a viable state. Only this single independent claim is provided in the partial content, so three inventive features are extracted for clm-00001 only.
Administering a tissue-penetrating article containing viable cells
Administering an article having a tissue penetrating shape and containing a mass of the cells in a viable state.
Penetrating and implanting the article into solid tissue with biodegradation
Penetrating the article into the solid tissue such that the article is implanted within the solid tissue, wherein at least a portion of the article biodegrades within the solid tissue.
Releasing the cells into tissue in a viable state
Releasing the cells therein into the tissue in a viable state.
The provided independent claim is directed to implanting a tissue-penetrating, biodegradable article into solid tissue and releasing the contained cells in a viable state. The related dependent refinements specify viability-sustaining gels, optional oxygen or inert gas saturation, controlled biodegradation timing, and optional fenestrated structures with specified geometry.
Stated Advantages
Releases viable cells into solid tissue in a viable state.
Maintains cell viability during GI transit via a tissue-penetrating shell and viability-sustaining gel.
Allows fluid and/or molecule exchange through fenestrated walls while the article biodegrades.
Supports delivery using pH-sensitive capsule protection and activation for penetrating the intestinal wall.
Documented Applications
Oral delivery of viable cells into the GI tract and/or intestinal wall using a swallowable tissue-penetrating delivery capsule or article that biodegrades within solid tissue and releases cells in a viable state.
Reseeding specific GI regions with enteroendocrine and mucosal cells using the described viable cell delivery approach.
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