Biomedical implant for sustained agent release

• US 20040143221A1
• Filed: 12/27/2003
• Published: 07/22/2004
• Est. Priority Date: 12/27/2002
• Status: Abandoned Application

• Current Assignee: John H. Shadduck
• Original Assignee: John H. Shadduck
• Inventors: Shadduck, John H.
• Application Number:
  US10/748,909
• Publication Number:
  US 20040143221A1
• Time in Patent Office: Days
• US Class Current: 604/175
• CPC Class Codes: A61M 25/0084 being one or more injection needles

Abstract

A biomedical implant for sustained local delivery of at least one pharmacologically active agent to the duodenum and small intestine of the GI tract. In one embodiment, the implant body comprises and elongate flexible, biodegradable polymeric element that is attached to the wall of the duodenum after introduction through a gastroscope. Biodegradation of the polymeric releases the pharmacologically active agent. Another embodiment of the implant carries transducer means for monitoring at least one physiological parameter of the targeted site, such as the acidity-alkalinity level. The drug-eluting implant body can carry and release agents such antibiotics and antibacterial agents, anti-fungal agents, anti-viral agents, anti-allergenics, anesthetics, analgesics, anti-cancer agents, immunological response modifiers and any other drug for treating irritable bowel syndrome (IBS) or other disorders requiring sustained agent release.

Claims

1. A method for drug delivery comprising the steps of providing an implantable agent-release body carrying at least one pharmacologically active agent, and implanting the agent-release body in a targeted site within the gastrointestinal (GI) tract for sustained release of the pharmacologically active agent in the region of the duodenum and small intestine.

2. A method as in claim 1 wherein the implanting step includes utilizing attachment means to attach the agent-release body to a wall of the GI tract.

3. A method as in claim 2 wherein the agent-release body is attached to a wall of the duodenum.

4. A method as in claim 1 wherein the implanting step includes deployment of the agent-release body from a first shape to a second shape.

5. A method as in claim 4 wherein the providing step includes fabricating the agent-release body at least partly of a biodegradable polymer.

6. A method as in claim 4 wherein the providing step includes fabricating the agent-release body at least partly of a shape memory polymer.

7. A method as in claim 1 wherein the agent-release body releases an agent selected from the class consisting of antibiotics, antibacterial agents, anti-fungal agents, anti-viral agents, anti-allergenics, anesthetics, analgesics, cell transport/mobility impending agents, decongestants, anti-diabetic agents, anti-cancer agents, immunosuppresants, immunological response modifiers, hormones, cell cycle inhibitors, gene therapy compounds, miotics, anticlotting agents, peptides and nucleic acids.

8. A biomedical implant comprising an elongated flexible implant body dimensioned for extending within the GI tract implantation from the region of duodenal bulb or duodenum, attachment means at an end portion of the implant body and at least one pharmacologically active composition within the implant body.

10. The biomedical implant of claim 8 wherein the implant body comprises a biodegradable polymer with the pharmacologically active composition carried therein.

13. The biomedical implant of claim 8 wherein the attachment means is selected from the class consisting of a barb-tipped member, a toggle-tipped member, a staple, a spring clip, a polymer clip, a helically-formed fastener, an adhesive fastener, a thermal-energy adhering member and a band-type mechanism for disposition around a tissue protrusion.

15. The biomedical implant of claim 8 wherein the pharmacologically active composition is selected from the class consisting of antibiotics, antibacterial agents, anti-fungal agents, anti-viral agents, anti-allergenics, anesthetics, analgesics, cell transport/mobility impending agents, decongestants, anti-diabetic agents, anti-cancer agents, immunosuppresants, immunological response modifiers, hormones, cell cycle inhibitors, gene therapy compounds, miotics, anticlotting agents, peptides and nucleic acids.

16. The biomedical implant of claim 8 further comprising transducer means in the implant body for acquisition of data concerning a physiological parameter about the duodenum or small intestine and transmission means for transmitting the data to an external monitoring system.

17. The biomedical implant of claim 16 wherein the transducer means and transmission means include a transponder system.

9. The biomedical implant wherein the implant body is at least partly of a biodegradable polymer.

12. The biomedical implant of claim 9 wherein the biodegradable polymer is at least in part a hydrogel.

11. The biomedical implant wherein the implant body is at least partly of a shape memory polymer.

14. The biomedical implant of claim 11 wherein the implant body defines a first temporary shape for introduction and a second memory shape for extending within the GI tract.

18. A drug-eluting implant comprising a first portion of a shape memory polymer (SMP) portion and a second portion of a pharmacologically active composition, the shape memory polymer capable of a temporary shape and a memory shape.

19. The drug-eluting implant as in claim 18 wherein the shape memory polymer has a compact temporary shape and an elongated memory shape.

20. The drug-eluting implant as in claim 18 further comprising a fastener portion for fastening an end of the implant the wall of a body lumen.