Implantable therapy systems and methods

• US 6,179,826 B1
• Filed: 10/29/1996
• Issued: 01/30/2001
• Est. Priority Date: 11/17/1987
• Status: Expired due to Fees

• Current Assignee: Neurotech S.A. (LivaNova Plc)
• Original Assignee: Brown University
• Inventors: Aebischer, Patrick, Sanberg, Paul R., Vasconcellos, Alfred V., Goddard, Moses, Moldauer, John G., Rathbun, Anne M., Mulhauser, Paul J., Warner, Nicholas F.
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US08/741,228
• Time in Patent Office: 1,554 Days
• Field of Search: 604/891.1, 604/522, 604/93.01, 424/422, 424/424-425, 424/570
• US Class Current: 604/522
• 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: A61K 2035/126 Immunoprotecting barriers, e.g. jackets, diffusion chambers
• CPC Class Codes: A61K 35/12 Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells vaccines or medicinal preparations containing antigens or antibodies A61K39/00
• CPC Class Codes: A61K 35/55 Glands not provided for in groups A61K35/22 - A61K35/545, e.g. thyroids, parathyroids or pineal glands
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/0085 Brain, e.g. brain implants; Spinal cord
• CPC Class Codes: A61K 9/0092 Hollow drug-filled fibres, tubes of the core-shell type, coated fibres, coated rods, microtubules or nanotubes
• CPC Class Codes: A61M 2210/0687 Skull, cranium
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61M 37/0069 Devices for implanting pellets, e.g. markers or solid medicaments for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: B01J 13/02 Making microcapsules or microballoons for medical preparations A61K9/50
• CPC Class Codes: C12N 11/04 entrapped within the carrier, e.g. gel or hollow fibres
• CPC Class Codes: C12N 2533/30 Synthetic polymers
• CPC Class Codes: C12N 5/0012 Cell encapsulation
• CPC Class Codes: C12N 5/0614 Adrenal gland
• CPC Class Codes: C12N 5/0619 Neurons
• CPC Class Codes: C12N 5/0676 Pancreatic cells

Abstract

Implantable therapy systems are disclosed for the local and controlled delivery of a biologically active factor to the brain, spinal cord and other target regions of a subject suffering from a dibilatating condition. The method of the invention involves surgically exposing an insertion site, generally located above a predetermined treatment site (12), in a patient. A cannula (20), having an obturator (30) or dilator (104) positioned therein, is inserted at the insertion site, defining a pathway to the treatment site. In some instances, the cannula can be inserted along the path of a guidewire (102) previously positioned at the treatment site. The cannula (20) is preferably a low friction polymeric material such as polytetrafluoroethylene. The cannula (20) generally has an open proximal end for receiving the obturator (30) or dilator (104), and an open distal end, preferably a tapered end, for delivery of neurologically active factors to the treatment site (12). The obturator (30) is then removed from the cannula (20), and a biocompatible tethered vehicle (40) containing a biologically active material is inserted into the cannula along the passageway. A pusher can be inserted within the cannula, behind the vehicle (40), to position the proximal end of the vehicle at the proximal tip of the cannula (20b). Once the vehicle (40) is positioned near the proximal end of the cannula (20), the cannula is removed from the passageway, followed by the pusher, leaving the vehicle (40) positioned at the treatment site (12).

Claims

1. A method for delivering a biologically active factor to a patient, comprising

introducing through the bore of a single cannula into the subarachnoid space of a spinal column at least one vehicle comprising a biocompatible semipermeable outer membrane and which encapsulates cells that produce the biologically active factor, wherein the cannula is adapted for penetration through tissue, the cannula having a bore with a substantially smooth surface running axially therethrough through which a vehicle may slidably move, an open, proximal end into which the vehicle may be slidably inserted and a distal end having an opening through which the vehicle may slidably move wherein the external diameter and bore diameter are tapered toward the distal tip

whereby the biologically active factor is released from the cells through the semipermeable membrane of the vehicle into the central nervous system of the patient.

2. The method of claim 1 wherein the biologically active factor is an antinociceptive agent.

3. The method of claim 1 wherein the cells are adrenal chromaffin cells.

4. The method of claim 1 wherein the vehicle additionally comprises a tether.

5. The method of claim 1 wherein the semipermeable membrane of the vehicle has a molecular weight occlusion of 50 kD to 300 kD.

6. The method of claim 1 wherein the semipermeable membrane comprises a polymeric material.

7. The method of claim 1 wherein the semipermeable membrane additionally comprises a surfactant, an anti-inflammatory agent, an angiogenic factor or an anti-oxidant.

8. The method of claim 1 wherein the biologically active factor is selected from the group consisting of neurotransmitters, neuropeptides, biological response modifiers, enzymes, antibodies, neuroactive factors, growth factors and trophic factors.

9. The method of claim 1 wherein the vehicle contains multiple cell types, tissue or multiple tissue types.