Local Drug Delivery Devices and Methods for Treating Cancer

Patent metadata

Field	Value
Publication number	US-2022054719-A1
Application number	US-202117520891-A
Country	US
Kind code	A1
Filing date	Nov 8, 2021
Priority date	Apr 10, 2013
Publication date	Feb 24, 2022
Grant date	—

Abstract

Drug-eluting devices and methods for the treatment of tumors of the pancreas, biliary system, gallbladder, liver, small bowel, or colon, are provided. Methods include deploying a drug-eluting device having a film which includes a mixture of a degradable polymer and a chemotherapeutic drug, wherein the film has a thickness from about 2 μm to about 1000 μm, into a tissue site and releasing a therapeutically effective amount of the chemotherapeutic drug from the film to treat the tumor, wherein the release of the therapeutically effective amount of the drug from the film is controlled by in vivo degradation of the polymer at the tissue site.

First claim

1 . A drug-eluting device for the treatment of a tumor of the pancreas, biliary system, gallbladder, liver, small bowel, or colon, comprising:
a film having a thickness from about 2 μm to about 1000 μm and comprising a mixture of a degradable polymer and a chemotherapeutic drug, wherein the device is configured for deployment into a tissue site of a patient, the film being configured to provide controlled release, by in vivo degradation of the polymer at the tissue site, of a therapeutically effective amount of the chemotherapeutic drug to the tissue site to treat the tumor.

2 . The device of claim 1 , wherein the release of the therapeutically effective amount of the chemotherapeutic drug follows a delay period of from about 1 day to about 14 days after deploying of the device into the tissue site.

3 . The device of claim 2 , wherein the release of the therapeutically effective amount of the chemotherapeutic drug, after the delay period, has an initial release rate that is substantially linear for at least 3 days.

4 . The device of claim 1 , wherein the degradable polymer is a hydrolytically degradable polymer.

5 . The device of claim 1 , wherein the degradable polymer comprises poly(lactic-co-glycolic acid).

6 . The device of claim 1 , wherein the chemotherapeutic drug is selected from the group consisting of paclitaxel, gemcitabine, nab-paclitaxel, 5-fluorouracil, oxaliplatin, irinotecan, and combinations thereof.

7 . The device of claim 1 , wherein the chemotherapeutic drug is paclitaxel and the degradable polymer is poly(lactic-co-glycolic acid).

8 . The device of claim 7 , wherein the therapeutically effective amount is at least 1 mg/day of the paclitaxel.

9 . The device of claim 7 , wherein the therapeutically effective amount of paclitaxel is released over a treatment period from about 10 days to about 90 days.

10 . The device of claim 7 , wherein the therapeutically effective amount comprises a mean average amount of from 5 mg/day to 125 mg /day of the paclitaxel.

11 . The device of claim 1 , wherein the film has a thickness from about 5 μm to about 500 μm.

12 . The device of claim 1 , wherein the mixture comprises from about 1 wt % to about 10 wt % of paclitaxel or another chemotherapeutic agent.

13 . The device of claim 1 , wherein the device further comprises a biocompatible substratum to which the film is adhered.

14 . The device of claim 13 , wherein the substratum comprises a stent, and wherein the device is configured for insertion into a biliary or pancreatic duct of the patient.

15 . The device of claim 13 , wherein the substratum comprises a flexible patch, a rigid patch, or a mesh, and wherein the device is configured to be implanted directly onto the tumor.

16 . The device of claim 13 , wherein the substratum comprises a metal, a polymer, or a ceramic material.

17 . The device of claim 13 , wherein the substratum comprises stainless steel alloy, cobalt chromium alloy, nitinol, platinum alloy, titanium alloy, silicone, expanded polytetrafluoroethylene (ePTFE), or polyethylene.

Assignees

• Massachusetts Inst Technology
• Massachusetts Gen Hospital

Inventors

• Indolfi Laura
• Edelman Elazer R
• Langer Robert S
• Clark Jeffrey W
• Ting David T
• Ferrone Cristina Rosa Annamaria
• Ligorio Matteo

Classifications

• A61K47/34

  Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers (A61K47/10 takes precedence) · CPC title

• A61L31/16

  Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)} · CPC title

• A61F2002/041

  Bile ducts · CPC title

• A61L2300/416

  Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus · CPC title

• A61P1/00

  Drugs for disorders of the alimentary tract or the digestive system · CPC title