Therapeutic delivery device

• US 9,113,950 B2
• Filed: 11/04/2010
• Issued: 08/25/2015
• 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.
• Primary Examiner(s): BOUCHELLE, LAURA A
• Application Number:
  US12/939,856
• Publication Number:
  US 20110276001A1
• Time in Patent Office: 1,755 Days
• Field of Search: 604/164.01, 604/164.11, 604/170.03
• US Class Current: 1/1
• 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 minimally invasive device for delivering a therapeutic 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 tip to the target site, wherein the hollow shaft of the needle is sufficiently rigid to maintain a pre-insertion shape during insertion of the needle tip to the target 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 preconfigured single constant-radius arch to full extension; 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 though the preconfigured single constant-radius arch 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 therapeutic 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 therapeutic into the catheter.

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

4. The device of claim 2 wherein the handle port is a luer lock and the therapeutic is delivered to the handle by locking a syringe having the therapeutic to the luer lock on the handle.

5. The device of claim 2 wherein the therapeutic is stem cells.

6. The device of claim 5 wherein the stem cells are mesenchymal stem cells (MSCs).

7. The device of claim 1 wherein the cannula is made from a shape memory material.

8. The device of claim 7, wherein the shape memory material is a shape memory metal or a shape memory polymer.

9. The device of claim 7, wherein the shape memory material is Nitinol.

10. The device of claim 1 wherein the cannula and the catheter are made from a shape memory material.

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

12. The device of claim 1 wherein the cannula forms a single constant-radius arch between 1°

and 180°

when fully advanced from the tip of the hollow needle, measured between the shaft of the hollow needle and the distal end of the cannula.

13. The device of claim 1, wherein the configuration of the single constant-radius arch is based on the target location.

14. The device of claim 1, wherein the cannula has a length of 0.1 to 4.0 inches.

15. The device of claim 1 wherein, upon insertion of the needle and the extension of the cannula and catheter to the target location, the distal end of the catheter is positioned at a distance from the first end of the elongated hollow needle that is less than the distance between the first end of the elongated hollow needle and the opening at the tip of the needle.

16. The device of claim 1 wherein the cannula forms a single constant-radius arch of greater than 90°

when fully advanced from the tip of the hollow needle, measured between the shaft of the hollow needle and the distal end of the cannula.

17. A minimally invasive device for delivering a therapeutic 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 tip to the target site, wherein the hollow shaft of the needle is sufficiently rigid to maintain a pre-insertion shape during insertion of the needle tip to the target site; 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 preconfigured single constant-radius arch to full extension;

wherein the device, once positioned at the target location, is capable of delivering a therapeutic through the cannula to the target location.

18. The device of claim 17 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 handle assembly for accepting, attaching and advancing the cannula within the needle;

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

19. The device of claim 18 wherein the handle port is a luer lock and the therapeutic are delivered to the handle by locking a syringe having the therapeutic to the luer lock on the handle.

20. The device of claim 17 wherein the therapeutic is stem cells.

21. The device of claim 20 wherein the stem cells are mesenchymal stem cells (MSCs).

22. The device of claim 17 wherein the cannula is made from a shape memory material.

23. The device of claim 22, wherein the shape memory material is a shape memory metal or a shape memory polymer.

24. The device of claim 22, wherein the shape memory material is Nitinol.

25. The device of claim 17 wherein the target site is an invertebral disc, a joint, a labrum or a ligament.

26. The device of claim 17 wherein the cannula forms a single constant-radius arch of between 1°

and 180°

when fully advanced out the tip of the hollow needle, measured between the shaft of the hollow needle and the distal end of the cannula.

27. The device of claim 17, wherein the configuration of the single constant-radius arch is based on the target location.

28. The device of claim 17, wherein the cannula has a length of 0.1 to 4.0 inches.

29. The device of claim 17 wherein, upon insertion of the needle and the extension of the cannula to the target location, the distal end of the cannula is positioned at a distance from the first end of the elongated hollow needle that is lesser than the distance between the first end of the elongated hollow needle and the opening at the tip of the needle.

30. The device of claim 17 wherein the cannula forms a single constant-radius arch of greater than 90°

when fully advanced from the tip of the hollow needle, measured between the shaft of the hollow needle and the distal end of the cannula.

31. A minimally invasive device for delivering a therapeutic to a target location in relation to a target site, 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 in communication along the length of the elongated needle and the second end further defining a tip configured to allow insertion of the needle assembly to the target site, wherein the elongated needle is sufficiently rigid to maintain a pre-insertion shape during insertion of the needle tip to the target site, and wherein the needle assembly further comprises a cannula that sits internally within the elongated needle, the cannula configured to advance along the length of the needle and through the opening at the tip of the needle in a preconfigured single constant-radius arch to full extension;

an adapter that operably attaches to the needle assembly, the adapter configured with a port for connection to the therapeutic, the adapter configured to reduce shearing force on the therapeutic once the therapeutic enters the adapter;

wherein the device, once positioned at the target site, is capable of delivering the therapeutic through the cannula of the needle assembly to the target location within the target site.

32. The device of claim 31 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.

33. The device of claim 31 wherein, upon insertion of the needle and the extension of the cannula to the target location, the distal end of the cannula is positioned at a distance from the first end of the elongated hollow needle that is lesser than the distance between the first end of the elongated hollow needle and the opening at the tip of the needle.

34. The device of claim 31 wherein the cannula forms a single constant-radius arch of greater than 90°

when fully advanced from the tip of the hollow needle, measured between the shaft of the hollow needle and the distal end of the cannula.