Safety neural injection system and related methods

• US 10,265,504 B2
• Filed: 03/14/2014
• Issued: 04/23/2019
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Custom Medical Applications
• Original Assignee: Custom Medical Applications, Inc.
• Inventors: Racz, N. Sandor
• Primary Examiner(s): Osinski, Bradley J
• Assistant Examiner(s): Ponton, James D
• Application Number:
  US14/210,887
• Publication Number:
  US 20150320972A1
• Time in Patent Office: 1,866 Days
• CPC Class Codes: A61B 10/0233 Pointed or sharp biopsy instruments
• CPC Class Codes: A61B 17/3401 Puncturing needles for the peridural or subarachnoid space or the plexus, e.g. for anaesthesia local anaesthesia A61M19/00
• 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 18/1477 Needle-like probes
• CPC Class Codes: A61B 2017/00455 Orientation indicators, e.g. recess on the handle
• CPC Class Codes: A61B 2017/3456 blunt
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/1425 Needle
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 6/481 involving the use of contrast agents
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes

Abstract

Disclosed herein are safety neural injection systems and related methods of use comprising a cannula, with or without a side port, and a stylet, defined by a first inside diameter, a first outside diameter, a first length, and an open distal end in fluid communication with the inside and outside of the hollow cannula wherein the medicament is administered with the stylet inserted at least partially within the cannula. In various embodiments, the safety neural injection system comprises a metal ball tip.

Claims

1. A safety neural injection system comprising:

an at least partially hollow cannula being defined by a first inside diameter, a first outside diameter, a first length, and a distal end having an opening, wherein the at least partially hollow cannula comprises a metal ball tip at least partially covering and obstructing the opening at the distal end, wherein a maximum outer diameter of the metal ball tip abuts an inward facing wall and inner diameter of the cannula, the metal ball tip having an outward facing surface abutting the inward facing wall of the cannula at a location proximal to the distal end of the cannula;

a wire extending along a length of the at least partially hollow cannula and directly coupled to the metal ball tip, wherein the wire is adapted to be connected to an external instrument configured to provide a signal directly to the metal ball tip via the wire;

a side port located coaxially along the at least partially hollow cannula in fluid communication between the inside and the outside of the at least partially hollow cannula; and

a flexible stylet with a shaped tip, wherein the flexible stylet is capable of being releasably locked in a first position within the at least partially hollow cannula and extends through the at least partially hollow cannula;

wherein the at least partially hollow cannula proximate to the distal end includes a rigid bend so as to facilitate placement of the distal end at a target site, wherein the stylet and the at least partially hollow cannula are sized and configured to, when the stylet is positioned in the at least partially hollow cannula, enable fluid to pass between the stylet and the at least partially hollow cannula and to travel to the side port.

2. The system of claim 1, further comprising an agent selected from the group consisting of a therapeutic agent, a diagnostic agent and a prophylactic agent.

3. The system of claim 2, wherein said therapeutic agent is anesthesia.

4. The system of claim 1, further comprising a connector.

5. The system of claim 4, wherein the metal ball tip is a probe.

6. The system of claim 5, wherein the wire is adapted to be connected about the connector with the instrument.

7. The system of claim 1, further comprising insulation.

8. The system of claim 1, wherein the stylet further comprises a side port.

9. The system of claim 1, further comprising a biopsy needle.

10. A method of injecting a medicament at a neuronal tissue comprising the steps of:

locating a target site for administration;

adjusting the safety neural injection system of claim 1 to position the system relative to the site;

inserting at the target site at least a portion of the safety neural injection system; and

administering an agent about the target site.

11. The method of claim 10, wherein administering the agent about the target site comprises selecting the agent from the group consisting of a therapeutic agent, a diagnostic agent and a prophylactic agent.

12. The method of claim 11, wherein administering the agent about the target site comprises providing anesthesia.

13. The method of claim 10, further comprising creating a neural map of at least a portion of the tissue.

14. The method of claim 10, further comprising selecting the target site from the group consisting of the digestive system, the circulatory system, nervous system, muscular system, skeletal system, respiratory system, urinary system, reproductive system, excretory system, endocrine system, and the immune system of the human body.

15. A kit comprising the safety neural injection system of claim 1 and an agent to be administered.

16. The kit of claim 15, wherein said agent is selected from a group consisting of a therapeutic agent, a diagnostic agent or a prophylactic agent.

17. A safety neural injection system comprising:

an at least partially hollow cannula being defined by an inside diameter, an outside diameter, a length, and a distal end having an opening;

a ball defining a terminal tip of the at least partially hollow cannula, the ball having an outer diameter at least partially covering the opening at the distal end, the ball having an outward facing surface abutting an inward facing wall of the cannula at a location proximal to the distal end of the cannula;

a side port located coaxially along the at least partially hollow cannula in fluid communication between the inside and the outside of the at least partially hollow cannula; and

a flexible stylet with a shaped tip, wherein the flexible stylet is capable of being releasably locked in a position within the at least partially hollow cannula, wherein the at least partially hollow cannula proximate to the distal end includes a rigid bend so as to facilitate placement of the distal end at a target site, wherein the stylet and the at least partially hollow cannula are sized and configured to, when the stylet is positioned in the at least partially hollow cannula, enable fluid to pass between the stylet and the at least partially hollow cannula and to travel to the side port.

18. The system of claim 17, further comprising a wire extending along a length of the at least partially hollow cannula and coupled to the ball, wherein the wire is adapted to be connected to an external instrument configured to provide a signal to the ball via the wire.

19. A safety neural injection system comprising:

an at least partially hollow cannula being defined by an inside diameter, an outside diameter, a length, and a distal end having an opening, wherein the at least partially hollow cannula proximate to the distal end includes a rigid bend so as to facilitate placement of the distal end at a target site;

a ball defining a terminal tip of the at least partially hollow cannula, the ball having an outward facing surface abutting an inward facing wall of the cannula at a location proximal to the distal end of the cannula;

a side port located coaxially along the at least partially hollow cannula, wherein only the side port is configured to provide fluid communication between the inside and the outside of the at least partially hollow cannula proximate the distal end of the at least partially hollow cannula; and

a flexible stylet capable of being releasably locked within the at least partially hollow cannula, wherein the stylet and the at least partially hollow cannula are sized and configured to enable fluid to pass between the stylet and the at least partially hollow cannula when the stylet is positioned in the at least partially hollow cannula.