Instrumentation for injection of therapeutic fluid into joints

• US 8,083,722 B2
• Filed: 10/26/2009
• Issued: 12/27/2011
• Est. Priority Date: 04/29/2005
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: McKay, William F.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): HAYMAN, IMANI N
• Application Number:
  US12/605,780
• Publication Number:
  US 20100056989A1
• Time in Patent Office: 792 Days
• Field of Search: 604/173, 604/191, 604/239, 604/48
• US Class Current: 604/173
• 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 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61M 2025/0085 Multiple injection needles protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 5/32 Needles; Details of needles pertaining to their connection with syringe or hub infusion needles A61M5/158; Accessories for bringing the needle into, or holding the needle on, the body A61M5/42, A61M5/46 take precedence; guide needles for catheters A61M25/065; Devices for protection of needles apparatus specially adapted for cleaning or sterilising needles A61M5/001
• CPC Class Codes: A61M 5/3298 Needles arranged in parallel

Abstract

Described are novel medical delivery devices that can be used to effectively distribute a medical agent to multiple sites within a tissue volume without requiring the device to be repositioned, including for example to distribute the medical agent within the nucleus pulposus tissue of a spinal disc. Also described are medical delivery devices configured to simultaneously remove fluid from the tissue volume into which a medical agent is being delivered, thus avoiding or otherwise decreasing any pressure build-up and facilitating an effective, uniform delivery of the therapeutic agent.

Claims

1. A needle for injecting therapeutic fluid into a target space, the needle comprising:

one or more elongated tissue-penetrating members for penetrating into a target space;

at least one extraction orifice located on said one or more tissue-penetrating members;

an extraction fluid path in fluid communication with said at least one extraction orifice;

at least one injection orifice located on said one or more tissue-penetrating members and positioned remotely from said at least one extraction orifice;

an injection fluid path in fluid communication with said at least one injection orifice;

wherein the number of extraction and injection orifices, their size, and their position relative to each other are selected to create a pressure gradient within the target space when a therapeutic fluid is injected through the at least one injection orifice;

a manifold having a manifold cavity wherein said one or more elongated tissue-penetrating members are attached to said manifold, said manifold cavity further comprising an internal wall configured to form a chamber within that is not in fluid communication with said manifold cavity, and

a connector having a connector opening in fluid communication with said chamber and configured to allow delivery of a medical agent into said chamber without coming in fluid communication with said manifold cavity.

2. The needle of claim 1 comprising a plurality of extraction orifices and a plurality of injection orifices along one or more elongated tissue-penetrating members.

3. The needle of claim 2, wherein the size of the extraction orifices and the injection orifices is progressively varied from the distal end toward the proximal end of one or more tissue-penetrating members and the progression in size of the extraction orifices is opposite to the progression in size of injection orifices.

4. The needle of claim 3, wherein the sizes of the extraction orifices progressively increase from the distal end toward the proximal end of said one or more tissue-penetrating members, whereas the diameter of the injection orifices progressively decrease from the distal end toward the proximal end of said one or more tissue-penetrating members.

5. The needle of claim 1, wherein the target space is an intervetebral disc and the extraction orifice and the injection orifice are about 0.05 mm to about 1 mm in diameter.

6. The needle of claim 1, wherein the distance between the extraction orifice and the injection orifice is about 1 mm to about 20 mm apart.

7. The needle of claim 1, wherein the injection orifice are about 0.05 mm to about 3 mm in diameter.

8. The needle of claim 1, wherein the target space is a knee joint and the distance between the extraction orifice and the injection orifice is about 5 mm to about 20 mm.

9. The needle of claim 1 wherein the one or more extraction ports and the one or more injection ports are located relative to each other depending on the target space fluid contents being extracted and treated.

10. The needle of claim 1 wherein the one or more extraction ports enables removal of target space content at the same or faster rate than the therapeutic fluid is injected into the joint through the one or more injection ports.

11. The needle of claim 1 wherein the extraction lumen and the injection lumen are in a concentric relation to each other.

12. The needle of claim 11, wherein the outside lumen serves as an extraction lumen with at least one orifice in the sidewall and the inside lumen serves as an injection lumen with at least one orifice at the distal end.

13. The needle of claim 12, wherein the extraction lumen comprises a plurality of extraction orifices in the sidewall with progressively varied size from the distal end toward the proximal end of one or more tissue-penetrating members.

14. The needle of claim 1 wherein the extraction lumen and the injection lumen are adjacent to each other.

15. An infusion device for delivering a therapeutic fluid to a joint space comprising:

an extraction chamber having an extraction plunger slidably disposed therein;

an injection chamber fluidly isolated from the extraction chamber and having an injection plunger slidably disposed therein; and

the needle of claim 1,

wherein the extraction lumen of the needle is fluidly connected to the extraction chamber and the injection lumen of the needle is fluidly connected to the injection chamber.

16. The infusion device claim 15 wherein the plungers can be activated independently of each other.

17. The infusion device claim 15 wherein the plungers can be activated simultaneously of each other.

18. A method of delivering therapeutic fluid to a target space comprising the steps of:

a inserting the needle of claim 1 into the target space;

b. extracting at least a portion of the target space content from the target space; and

c injecting the therapeutic fluid into the target space.

19. The method of claim 18, wherein the target space content is exchanged with the therapeutic fluid in equal amounts.