Therapeutic Delivery Device

• US 20110276001A1
• Filed: 11/04/2010
• Published: 11/10/2011
• Est. Priority Date: 11/04/2009
• Status: Active Grant

• Current Assignee: Regenexx LLC
• Original Assignee: Regenerative Sciences, Llc
• Inventors: Schultz, John Richard, Centeno, Christopher J.
• Granted Patent: US 9,113,950 B2
• Time in Patent Office: Days
• US Class Current: 604/164.01
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00331 with preformed bends
• CPC Class Codes: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence

Abstract

Methods and device are provided for delivery of biologics to an intervertebral disc. Device described herein include a needle assembly and handle assembly that optimize biologic delivery parameters to a target location within a disc. The needle assembly includes the capability of advancing into the disc at pre-configured pathways that allow for minimized damaged and maximized positioning of the biologic.

Claims

1. A device for delivering therapeutics to a target location in relation to a target site, the device comprising:

an elongated hollow needle having a first end, a hollow shaft, and a second end, the first and the second ends forming openings and in communication along the hollow shaft of the elongated needle and the second end further defining a tip configured to allow insertion of the needle into a predetermined site;

a cannula that sits internally within the hollow shaft of the needle, the cannula configured to advance along the shaft of the needle and through the opening at the tip of the needle, wherein a distal end of the cannula exits the tip of the needle in a predetermined configuration; and

a catheter that sits internally within the cannula and is independently advanced in relation to the needle and cannula, the catheter capable of advancement through the pre-determined configuration at the distal end of the cannula and into the target location of the target site;

wherein the device, once positioned in the target location, is capable of delivering the biologic through the catheter to the target location in relation to the target site.

2. The device of claim 1 further comprising:

an elongated handle assembly operably attached to the first end of the needle, the handle defining a passageway in communication with the opening in the first end of the needle, the passageway extending the length of the handle; and

separate means within the passageway for accepting, attaching and independently advancing the cannula and catheter;

wherein the handle has a port for receiving and allowing passage of the therapeutics into the catheter.

3. The device of claim 2 wherein the handle assembly is non-removable from the needle.

4. The device of claim 2 wherein the catheter is a spinal catheter.

5. The device of claim 2 wherein the handle port is a luer lock and the therapeutics are delivered to the handle by locking a syringe having the biologics to the luer lock on the handle.

6. The device of claim 2 wherein the therapeutics are stem cells.

7. The device of claim 6 wherein the stem cells are mesenchymal stem cells (MSCs).

8. The device of claim 1 wherein the cannula is made from a memory metal and wherein the distal end of the cannula can form a pre-determined curved configuration once fully advanced out the tip of the needle of between 1 and 120°

and wherein the pre-determined curved configuration is based on the target location.

9. The device of claim 2 wherein the elongated handle assembly is ergonomically designed for manipulation by a user.

14. The device of claim 1 wherein the cannula and catheter are made from Nitinol.

15. The device of claim 1 wherein the target site is an intervertebral disc, a joint, a labrum or a ligament.

10. A device for delivering biologics to a target location in an intervertebral disc, the device comprising:

an elongated hollow needle having a first end, a hollow shaft, and a second end, the first and the second ends forming openings and in communication along the hollow shaft of the elongated needle and the second end further defining a tip configured to allow insertion of the needle into the intervertebral disc; and

a cannula that sits internally within the shaft of the elongated hollow needle, a distal end of the cannula configured to advance along the length of the needle and through the opening at the tip of the needle in a pre-determined configuration;

wherein the device, once positioned in the intervertebral disc, is capable of delivering the biologic through the cannula to the target location in the intervertebral disc.

11. The device of claim 10 further comprising:

an elongated handle assembly operably attached to the first end of the needle, the handle defining a passageway in communication with the opening in the first end of the needle, the passageway extending the length of the handle; and

means within the passageway for accepting, attaching and advancing the cannula within the needle;

wherein the handle has a port for receiving and allowing passage of the biologics into the cannula.

12. A device for delivering biologics to a target location in an intervertebral disc, the device comprising:

a needle assembly having an elongated needle with a first end and a second end, the first and the second ends forming openings and in communication along the length of an elongated needle and the second end further defining a tip configured to allow insertion of the needle assembly into the intervertebral disc, and further comprising a cannula that sits internally within the elongated hollow needle, the cannula configured to advance along the length of the needle and through the opening at the tip of the needle in a pre-determined configuration;

an adapter that operably attaches to the needle assembly, the adapter configured with a port for connection to the biologics, the adapter configured to reducing shearing force on the biologics once the biologics enter the adapter;

wherein the device, once positioned in the intervertebral disc, is capable of delivering the biologic through the cannula of the needle assembly to the target location in the intervertebral disc.

13. The device of claim 12 further comprising a handle assembly, the handle assembly defining a passageway in communication with the adapter and needle assembly, the passageway extending the length of the handle.