Implantable systems and stents containing cells for therapeutic uses

• US 9,788,978 B2
• Filed: 10/21/2005
• Issued: 10/17/2017
• Est. Priority Date: 12/20/2004
• Status: Active Grant

• Current Assignee: Nicholas A. Rojo
• Original Assignee: Nicholas A. Rojo
• Inventors: Rojo, Nicholas A.
• Primary Examiner(s): PREBILIC, PAUL B
• Application Number:
  US11/256,362
• Publication Number:
  US 20060136049A1
• Time in Patent Office: 4,379 Days
• Field of Search: 623 141- 143, 62328801, 62328804, 60428801, 60428804, 6048911, 6048921, 604 9601, 60410301, 60410305
• CPC Class Codes: A61F 2/022 Artificial gland structures using bioreactors hemodialysis A61M1/16; hemofiltration A61M1/34; other extracorporeal blood treatment A61M1/36
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61M 2005/1652 Filter with duct, e.g. filtering element incorporated in a flow line, tube, duct

Abstract

An implantable system includes cells that produce and release a therapeutic agent, or agents, to a host in need. The system can include cells capable of eluting therapeutic agents in response to changing physiological conditions within a host. The system may comprise naked cells, encapsulated cells, or a mixture of non-encapsulating and encapsulated cells. The system may also comprise cells, and/or cell groups, of different origins. The implantable device may be placed intra-vascular, within bone marrow, within soft tissue, in the peritoneal cavity, or intra-hepatic, etc. The system can be comprised of a stent, or like devices. Such stents and like devices may optionally include port(s), catheter(s), and containment envelope systems for holding the above cells.

Claims

1. A medical device comprising:

an elongated catheter comprising an intravascularly implantable tip end and a port end; and

a porous sac radially disposed about and enclosing said tip end thereby forming a containment envelope between said sac and said tip end;

said tip end having openings or side holes in communication with said containment envelope within said sac;

said sac capable of eluting one or more therapeutic agents that elute through said sac in response to a stimulus when biologically active cells for containing one or more therapeutic agents are optionally disposed in said containment envelope.

2. A medical device of claim 1, wherein said catheter is composed of two lumens, one of said lumens for providing nutrient to said containment envelope and the other lumen for removing waste from said containment envelope.

3. A medical device of claim 1, wherein the port end of said catheter is connected to a port providing a transcutaneous passageway, said port having a base for attachment to the host, said port having an inlet covered with a diaphragm, said inlet connected to an outlet, said catheter connected to said outlet.

4. A medical device of claim 1, wherein the device is designed for intravascular deployment via venous or arterial approach.

5. A medical device of claim 1, wherein the device is designed for intravascular placement that is performed via a femoral, jugular, cephalic, basilic, or subclavian venous approach.

6. A medical device of claim 1, wherein the device is connected to a port for adding cell components to said device.

7. A medical device of claim 1, wherein the device is designed for intravascular placement and is connected to an implantable port that provides transdermal access to said intravascularly placed device.

8. A medical device of claim 1, wherein the device further comprises a stent.

9. A medical device of claim 1, wherein the cells comprise islets cells, endocrine cells, immune system cells, bone marrow cells, thyroid cells, mast cells, dermal cells, nervous system cells, or skin cells.

10. A medical device of claim 1, wherein the therapeutic agent is for:

treating local, regional, or systematic disease;

promoting new cell production;

adding to a depleted marrow cell line;

activating cell function;

buffering or blocking a specific cell dysfunction;

altering, treating or influencing oncogenesis;

contributing to enhancement of a local cell population;

gene therapy;

or tumor specific vaccinations.

11. A medical device of claim 1, wherein the therapeutic agent is insulin.

12. A medical device of claim 1, wherein the sac comprises an alginate or a porous polymer.

13. A medical device of claim 1, wherein the stimulus is a change in blood glucose concentration, a change in blood level of a hormone, a metabolic signaling agent or a chemical signaling molecule.

14. A medical device of claim 8, wherein the stent has a diameter of approximately 2-5 mm when collapsed.

15. A medical device comprising:

an implantable portion comprising;

an elongated catheter comprising an intravascular tip end and a port end; and

a porous sac radially disposed and encompassing the intravascular tip end thereby forming a containment envelope between the sac and the tip end, the tip end having openings or side holes in communication with the containment envelope within the sac, the sac capable of eluting one or more therapeutic agents through the sac in response to a stimulus when biologically active cells for containing one or more therapeutic agents are optionally disposed in the containment envelope, and the sac allowing transfer of nutrients from medium surrounding the sac to the cells; and

a port connecting to the port end of the elongated catheter.