Remotely activated piezoelectric pump for delivery of biological agents to the intervertebral disc and spine

• US 8,827,986 B2
• Filed: 10/19/2009
• Issued: 09/09/2014
• Est. Priority Date: 10/19/2009
• Status: Active Grant

• Current Assignee: Cognos Therapeutics, Inc.
• Original Assignee: Pharmaco Kinesis Corporation
• Inventors: Shachar, Yehoshua, Chen, Thomas C., Farkas, Leslie, Jordan, Brett, Zimmerman, Kyle, Chan, Herwin, Wu, Winston
• Primary Examiner(s): SCHMIDT, EMILY LOUISE
• Application Number:
  US12/581,785
• Publication Number:
  US 20110092948A1
• Time in Patent Office: 1,786 Days
• Field of Search: 604/151, 604/288.04, 604/500, 604/891.1
• US Class Current: 604/891.1
• CPC Class Codes: A61F 2/4465 having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/30593 hollow
• CPC Class Codes: A61F 2002/3067 for data transfer
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30785 parallel
• CPC Class Codes: A61F 2002/30787 inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/30841 Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/3092 having an open-celled or open-pored structure
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61M 2205/0294 Piezoelectric materials
• CPC Class Codes: A61M 2205/8243 by induction
• CPC Class Codes: A61M 2210/1003 Spinal column
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons

Abstract

A remotely activated piezoelectric pump for delivery of biological agents to the intervertebral disc and spine in order to achieve spinal fusion. A spinal pump is implanted on the vertebrae of a patient and a spinal cage is inserted in between two adjacent vertebrae after removal of the vertebrae disc. A piezoelectric motor drives the pump and pushes osteogenetic agent through the spinal cage and into a sponge disposed within the cage. The pump is charged by an external removable induction belt worn by the patient. Delivery duration and delivery frequency may be changed before implantation of the spine pump according to the specific needs of the patient. The current device employs a mathematical model that enables the regulation as well as attenuation of the bone fusion process by extending and generalizing the model to enhance and optimize the delivery of osteogenetic agent in a regulated manner.

Claims

1. A method for osteogenetic treatment in a patient comprising:

surgically implanting a selectively controllable and inductively rechargeable spine pump with a wireless transceiver and with a fluid reservoir for holding an osteogenetic agent into a patient, the spine pump including a first accelerometer fixed thereto;

fixing the spine pump to a selected vertebra of the patient, where the selected vertebra is to be fused to an adjacent vertebra;

surgically implanting a spinal cage having a fluid distribution subsystem defined therein into a vertebra disc space between the selected vertebra and an adjacent vertebra, which is to be fused to the selected vertebra;

fluidicly communicating the spine pump to the fluid distribution subsystem of the spinal cage;

surgically implanting a fitting fixed to the adjacent vertebra;

coupling a second accelerometer to the fitting fixed to the adjacent vertebra;

electrically communicating the first and second accelerometers to the wireless transceiver in the spine pump;

selectively dispensing selected amounts of osteogenetic agent from the fluid reservoir to the fluid distribution subsystem in the spinal cage over an extended time period of treatment during which the selected and adjacent vertebrae are fusing together, the amount of osteogenetic agent delivered to the fluid distribution subsystem in the spinal cage being alterable during the extended time period of treatment according to a set of received dosing instructions wirelessly transmitted to the receiver of the spine pump over a communications link exterior to the patient;

calibrating the first and second accelerometers by means of the wireless transceiver when the patient and consequently the selected and adjacent vertebrae are stationary in space to remove the effect of gravity upon the calibration of the first and second accelerometers;

monitoring the first and second accelerometers by means of the wireless transceiver while the patient is ambulatory;

determining the vector difference in the outputs of the first and second accelerometers to assess the efficacy of osteogenetic treatment of the vertebra disc space between the selected and adjacent vertebrae; and

selectively modifying amounts of the osteogenetic agent to be dispensed from the fluid reservoir to the fluid distribution subsystem in the spinal cage over an extended time period of treatment in response to the assessed efficacy of osteogenetic treatment of the vertebra disc space between the selected and adjacent vertebrae as determined by the vector difference in the outputs of the first and second accelerometers.

2. The method of claim 1 further comprising inductively recharging the spine pump by:

placing an external inductive charger substantially over the area where the spine pump has been implanted;

generating an induced voltage in the inductive charger;

driving the induced voltage through a plurality of induction coils in the induction charger;

receiving the induced voltage through a plurality of induction coils in the spine pump; and

driving a piezoelectric motor within the spine pump with the received induced voltage.

3. The method of claim 1 where selectively dispensing the osteogenetic agent from the reservoir of the spine pump to the spinal cage comprises:

driving a piezoelectric motor with an induced voltage;

pushing down a plunger within a reservoir in the spinal pump; and

dispensing the osteogenetic agent out of a outlet port defined within the reservoir.

4. The method of claim 1 where selectively dispensing comprises:

introducing the osteogenetic agent into a main internal channel circumferentially defined within an inner radius of the spinal cage;

diverting the osteogenetic agent into a network of sub-channels coupled to the main internal channel and disposed about the spinal cage; and

distributing the osteogenetic agent evenly about an absorbable sponge disposed within the spinal cage by means of the network of sub-channels.

5. The method of claim 4 further comprising delivering the osteogenetic agent systematically and evenly throughout the spinal cage according to a diffusion model stored within a pump control system in the spinal pump.

6. The method of claim 1 further comprising refilling the reservoir within the spine pump with the osteogenetic agent by means of a syringe.