Post-biopsy cavity treatment implants and methods
View Patent ↗A post-biopsy cavity treatment implant includes a radiopaque element, a core portion and a shell portion. The core portion is coupled to the radiopaque element, and includes a first porous matrix defining a first controlled pore architecture. The shell portion is coupled to the core portion and includes a second porous matrix defining a second controlled pore architecture that is different from the first controlled pore architecture.
1. A post-biopsy cavity treatment implant, comprising:
at least one radiopaque element;
a core portion coupled to the at least one radiopaque element, the core portion including a first porous matrix defining a first controlled pore architecture, the core portion including at least one of a polylactide (PLA), a polyglycolide (PGA), a poly(lactide-co-glycolide) (PLGA) and a polyglyconate, and
a collagenous shell portion coupled to the core portion, the collagenous shell portion including a second porous matrix defining a second controlled pore architecture that is different from the first controlled pore architecture.
2. The post-biopsy cavity treatment implant of claim 1 , wherein the core portion surrounds the radiopaque element.
3. The post-biopsy cavity treatment implant of claim 1 , wherein the shell portion surrounds the core portion.
4. The post-biopsy cavity treatment implant of claim 1 , wherein the core portion surrounds the radiopaque element and the shell portion surrounds the core portion.
5. The post-biopsy cavity treatment implant of claim 1 , wherein the core portion is configured to biodegrade at a first controlled rate and the collagenous shell portion is configured to biodegrade at a second controlled rate that is higher than the first controlled rate when the implant is placed in the biological fluid environment.
6. The post-biopsy cavity treatment implant of claim 1 , wherein the at least one radiopaque element includes a portion having a paramagnetic property.
7. The post-biopsy cavity treatment implant of claim 1 , wherein at least one of the core and collagenous shell portions includes a dye disposed therein.
8. The post-biopsy cavity treatment implant of claim 1 , wherein at least one of the core and collagenous shell portions includes a pigment disposed therein.
9. The post-biopsy cavity treatment implant of claim 1 , wherein at least one of the core and collagenous shell portions includes a contrast medium disposed therein.
10. The post-biopsy cavity treatment implant of claim 1 , wherein at least one of the core and collagenous shell portions includes a therapeutic agent disposed therein.
11. The post-biopsy cavity treatment implant of claim 1 , wherein the core portion further includes at least one of a polyanhydride, PEG, cellulose, a gelatin, a lipid, a polysaccharide, a starch and a polyorthoester.
12. The post-biopsy cavity treatment implant of claim 1 , wherein the core and collagenous shell portions are configured so as to form a laminar structure.
13. The post-biopsy cavity treatment implant of claim 1 , wherein at least one of the core and shell portions is echogenic.
14. The post-biopsy cavity treatment implant of claim 1 , wherein at least the collagenous shell portion includes a plurality of fibers.
15. The post-biopsy cavity treatment implant of claim 1 , wherein at least one of the core and collagenous shell portions includes an internal reservoir configured to contain at least one of a dye, a pigment and a therapeutic agent.
16. The post-biopsy cavity treatment implant of claim 15 , wherein the internal reservoir is configured to deliver the at least one of dye, pigment and therapeutic agent through elution when the implant is placed in a biological fluid environment.
17. The post-biopsy cavity treatment implant of claim 15 , wherein the internal reservoir is configured to deliver the at least one of dye, pigment and therapeutic agent at a first rate when the reservoir is breached and at a second rate that is lower than the first rate when the reservoir is not breached.
18. The post-biopsy cavity treatment implant of claim 17 , wherein the collagenous shell portion is configured to swell to a greater degree than the core portion when the implant is placed in a biological fluid environment.
19. The post-biopsy cavity treatment implant of claim 1 , wherein a crosslinking density of the collagenous shell portion is controlled through adding a selected amount of a bifunctional reagent to the collagen.
20. The post-biopsy cavity treatment implant of claim 19 , wherein the bifunctional reagent includes at least one of an aldehyde and a cyanamide.
21. The post-biopsy cavity treatment implant of claim 20 , wherein the aldehyde includes a glutaraldehyde.
22. The post-biopsy cavity treatment implant of claim 1 , wherein a crosslinking density of the collagenous shell portion is controlled by an application of energy to the collagen.
23. The post-biopsy cavity treatment implant of claim 22 , wherein the application of energy includes at least one of dehydrothermal processing, exposure to UV light and radiation.
24. The post-biopsy cavity treatment implant of claim 23 , wherein a crosslinking density of the shell portion is controlled by a combination of dehydrothermal processing and exposure to cyanamide.
25. The post-biopsy cavity treatment implant of claim 1 , wherein the implant, in a state prior to being placed in a biological fluid environment, is generally wedge-shaped.
26. The post-biopsy cavity treatment implant of claim 1 , wherein the implant, in a state prior to being placed in a biological fluid environment, has a shape of a disk that has been folded multiple times.
27. The post-biopsy cavity treatment implant of claim 1 , wherein the implant, in a state prior to being placed in a biological fluid environment, has a rectangular shape.
28. The post-biopsy cavity treatment implant of claim 1 , wherein the shell portion defines a center portion and a peripheral portion and wherein the peripheral portion defines a plurality of independently movable free ends.
29. A method of treating a cavity created by a percutaneous excisional procedure carried out through an incision, comprising the steps of:
providing a post-procedure cavity implant, the post-procedure cavity implant including a radiopaque element; a core portion coupled to the radiopaque element, the core portion including a first porous matrix defining a first controlled pore architecture, and a shell portion coupled to the core portion, the shell portion including a second porous matrix defining a second controlled pore architecture that is different from the first controlled pore architecture;
implanting the post-procedure cavity implant into the cavity, and closing the incision.
30. A method of treating a cavity created by an excisional procedure, comprising the steps of:
selecting a first biodegradation rate range;
selecting a second biodegradation rate range that is different from the first biodegradation rate range;
providing a post-procedure cavity implant, the post-procedure cavity implant including a radiopaque element; a core portion coupled to the radiopaque element, the core portion being configured to biodegrade at a first effective rate within the first biodegradation rate range, and a shell portion coupled to the core portion, the shell portion being configured to biodegrade at a second effective rate within the second biodegradation rate range, and
implanting the post-procedure cavity implant within the cavity.