Delivery of particles using hygroscopic excipients

Patent metadata

Field	Value
Publication number	US-2016368181-A1
Application number	US-201415022589-A
Country	US
Kind code	A1
Filing date	Sep 19, 2014
Priority date	Sep 20, 2013
Publication date	Dec 22, 2016
Grant date	—

Abstract

An assembly and methods for providing a contoured biological tissue are described. The assembly comprises a first plate and a second plate. The first plate is configured to receive a biological tissue. The second plate is configured to apply a compressive force on the biological tissue that is disposed on the first plate. One or both of the first and second plates comprise a defined shape and a contoured area within the defined shape. The contoured area comprises at least first and second elevations and a continuous transition between the first and second transitions. One or more energy sources is associated with one or both of the first and second plates. The one or more energy sources delivers energy while the second plate applies the compressive force on the biological tissue disposed on the first plate.

First claim

What is claimed is:

1 . An assembly for providing a contoured biological tissue, the assembly comprising:
a first plate configured to receive a biological tissue; a second plate having a surface and being configured to apply a compressive force on the biological tissue disposed on the first plate; wherein one or both of the first and second plates comprise a defined shape and a contoured area within the defined shape, the contoured area comprising at least first and second elevations and a continuous transition between the first and second elevations; and one or more energy sources associated with one or both of the first and second plates, the one or more energy sources delivering energy while the second plate applies the compressive force on the biological tissue.

2 . The assembly of claim 1 , wherein the one or both of the first and second plates are porous.

3 . The assembly of claim 1 , wherein the defined shape is one or a plurality of heart valve leaflets and wherein the heart valve leaflets each have a substantially straight free edge and an arcuate cusp edge.

4 . The assembly of claim 3 , wherein the first elevation is defined along the arcuate cusp edge and the second elevation is located between the arcuate cusp edge.

5 . The assembly of claim 4 , wherein the first elevation is higher relative to the second elevation.

6 . The assembly of claim 4 , wherein the second elevation is higher relative to the first elevation.

7 . The assembly of claim 1 , further comprising a spacer disposed between the first and second plates, the spacer controlling a thickness of the compressed biological tissue.

8 . The assembly of claim 1 , further comprising a blade corresponding substantially to the defined shape on the first plate.

9 . The assembly of claim 1 , wherein the energy delivered by the one or more energy sources is one or a combination selected from the group consisting of: thermal, ultrasound, electromagnetic, vibrational, hydraulic, piezoelectric, pneumatic, and acoustic or sound.

10 . The assembly of claim 9 , wherein the energy is thermal energy and wherein the one or more energy sources is one or a combination selected from the group consisting of: thermal coils disposed within the first plate, thermal coils disposed within the second plate, and a liquid bath.

11 . The assembly of claim 9 , wherein the energy is ultrasound energy and wherein the one or more energy sources is an ultrasound transducer associated with one or both of the first and second plates or with a liquid bath.

12 . The assembly of claim 9 , wherein the energy is electromagnetic energy and wherein the energy source is a RF or microwave antenna embedded in a non-conducting plate or a printed circuit antenna insulated from the tissue.

13 . The assembly of claim 9 , wherein the energy is vibrational energy and wherein the one or more energy sources is a clamp coupled to one or both of the first and second plates, a platform in contact with one or both of the first and second plates, or an actuator coupled to one or both of the first and second plates.

14 . The assembly of claim 1 , wherein the first plate comprises the defined shape and contoured area and the second plate comprises a substantially flat surface.

15 . The assembly of claim 1 , wherein the first and second plates each comprise the defined shape and the contoured area within the defined shape.

16 . A method for preparing a contoured biological tissue comprising:
compressing a layer of biological tissue to reduce a thickness of at least a portion of the tissue; and delivering energy from an energy source to one or both of the first and second plates during the compressing; wherein the tissue following the compressing has at least two areas of different thicknesses and a continuous transition within the defined shape.

17 . The method of claim 16 , further comprising treating the tissue with a first fixative to at least partially fix the tissue before, during and/or after the compressing.

18 . The method of claim 17 , further comprising treating the tissue with a second fixative before, during or before and during the compressing.

19 . The method of claim 18 , wherein the second fixative is one or a combination selected from the group consisting of: polyvinyl alcohols, polyetheramines, polyethyleneimine, di- or poly-amines, polyurethanes, polyepoxies, polysiloxanes, polyacrylates, polyesters, poly block isobutylene-co-maleic acid, collagen, elastin, fibrin, hyaluronic acid, dextrin, genapin, di- or poly-alkynes, di- or poly-azides, and tannins

20 . The method of claim 16 , further comprising soaking the tissue with a fixative, wherein the fixative is a 0.1% polyetheramine solution having an average molecular weight of about 600 and a pH of about 6 to 9.

Assignees

• Univ Virginia Commonwealth
• Argeaux Inc

Inventors

• Longest Philip Worth
• Hindle Michael
• Phillips Elaine M

Classifications

• A61K9/12 Primary

  Aerosols; Foams {(A61K9/0043, A61K9/0056, A61K9/006, A61K9/0073 take precedence; spray-films A61K9/7015)} · CPC title

• B29L2031/753

  Medical equipment; Accessories therefor (bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008) · CPC title

• A61L2430/40

  Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking · CPC title

• A61F2/2415

  Manufacturing methods · CPC title

• A61L27/50

  Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials} · CPC title