Bulkhead for implantable infusion device

• US 6,572,583 B1
• Filed: 04/28/2000
• Issued: 06/03/2003
• Est. Priority Date: 04/28/2000
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Hegland, Michael, Olsen, James, Christenson, Steve
• Primary Examiner(s): Look, Edward K.
• Assistant Examiner(s): White, Dwayne J.
• Application Number:
  US09/561,557
• Time in Patent Office: 1,131 Days
• Field of Search: 604/131, 604/890.1, 604/93.01
• US Class Current: 604/93.01
• 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: A61M 5/14276 specially adapted for implantation

Abstract

The present invention relates to an implantable medical device that is used to deliver drugs or other therapeutic agents into a patient. More specifically, the present invention is for a drug infusion device which features a bulkhead having integrated subsystems. The bulkhead is the main structural component of the implantable medical device. The integrated bulkhead of the present invention has all or portions of subassemblies, such as a pump, motor and gear train, electronics, drug fill port, catheter access port, fluid pathways, filter and overpressure mechanism, built into the bulkhead. Integrating the subsystems of the bulkhead simplifies the assembly process and reduces the overall cost of manufacture by reducing the number of components to assemble and reducing the number of manufacturing steps. Additionally, integrating the subassemblies into the bulkhead allows for increased accuracy in controlling the connections between the subsystems, which allows for improved delivery of drugs to the patient. The invention also provides a new configuration of the motor and gear train and pump sub-assemblies within the bulkhead, which provides for an implantable drug infusion pump having a low profile.

Claims

1. An implantable medical device for the infusion of a drug through a catheter into an anatomy, said medical device comprising:

a drug reservoir;

a bulkhead, said bulkhead including;

(a) an integral fill port cavity,

(b) an integral over pressure mechanism cavity, said over pressure mechanism cavity communicating with said fill port cavity,

(c) an integral filter cavity, said filter cavity communicating with said drug reservoir,

(d) an integral pump chamber, said pump chamber communicating with said drug reservoir,

(e) an integral catheter port, said catheter port communicating with said pump chamber, whereby said fill port, said over pressure mechanism cavity, said filter cavity, said drug reservoir, said pump chamber, and said catheter port defining a first fluid pathway allowing a drug to enter said medical device, pass through said medical device, and exit said device through the catheter port into a catheter; and

(f) an integral catheter access port, said catheter access port defining a second fluid pathway allowing a drug to enter said catheter, bypassing said first fluid pathway.

2. An implantable medical device for the infusion of drugs having an integrated bulkhead comprising:

a bulkhead including a first chamber, a second chamber, and a catheter access port, said first and second chambers being essentially co-planar, said first chamber configured and sized to house a peristaltic pump assembly;

said second chamber configured and sized to house a motor assembly.

3. An implantable drug infusion medical device, said device comprising:

a bulkhead including a pump assembly chamber, a motor assembly chamber, and an integral catheter side access port, said pump assembly chamber adjacent said motor assembly chamber, said bulkhead formed from a single piece of bio-compatible material.

4. An implantable medical device for the infusion of drugs contained in a fluid comprising:

an upper shield;

a bulkhead, said bulkhead having an upper surface, a lower surface, and an outer periphery;

said lower surface of said bulkhead defining a datum plane, said bulkhead having a plateaued region descending from said datum plane, said region having a height, said region including a first lower chamber and a second lower chamber, said first lower chamber sized and configured to house an over pressure mechanism, said second lower chamber sized and configured to house a filter;

a lower shield, said lower shield having an upper surface, a lower surface, and a side rising vertically from said upper surface, said side having a height greater than the height of said region, said lower shield sized and configured to enclose said region thereby defining a space between said upper surface of said lower shield and said lower surface of said bulkhead

said upper surface of said bulkhead including a centrally located fill port cavity, said fill port cavity housing configured and sized to house a fill port assembly, said fill port cavity having a wall;

said wall having an orifice thereby creating a fluid pathway between said fill port cavity and said first lower chamber;

said upper surface of said bulkhead including a pump inlet cavity and a pump race inlet ramp, said pump inlet cavity having an orifice thereby creating a fluid pathway between said pump inlet cavity and said second lower chamber, said pump inlet cavity communicating with said pump race inlet ramp;

said upper surface of said bulkhead including a first upper chamber, said first upper chamber sized and configured to house a peristaltic pump assembly, said first chamber defining a circular pump race, said first chamber communicating with said pump race inlet ramp;

said upper surface of said bulkhead including a pump race outlet ramp and pump outlet cavity, said pump outlet cavity having an orifice, said pump race outlet ramp communicating with said first upper chamber, said pump race outlet ramp communicating with said pump outlet cavity;

said periphery of said bulkhead having a catheter port, said catheter port conmunuicating with said pump outlet cavity;

said upper surface of said bulkhead including an upper catheter access port cavity, said

said lower surface of said bulkhead including a lower catheter access port cavity, said lower catheter access ports positioned outside said region, said upper and lower catheter access cavities connected by an axial bore thereby creating a fluid pathway between said upper and lower catheter access cavities;

said upper surface of said bulkhead including a second upper chamber, and a third upper chamber, said second upper chamber configured and sized to house a motor assembly, said third upper chamber configured and sized to house electronics for operating said medical device, said first, second, and third upper chambers being essentially co-planar, said first, second, and third chambers separated by walls.

5. A method of manufacturing a medical device for the infusion of drugs into an anatomy, said method comprising:

providing a singular block of material; and

forming said material into a bulkhead, said bulkhead having a plurality of integral cavities, said cavities including an electronics cavity, a motor cavity, a pump cavity, said electronics, motor, and pump cavities being essentially co-planar.