Autonomously controllable pull wire injection catheter, robotic system comprising said catheter and method for operating the same

• US 10,166,368 B2
• Filed: 09/21/2017
• Issued: 01/01/2019
• Est. Priority Date: 09/21/2016
• Status: Active Grant

• Current Assignee: Peter Law
• Original Assignee: Peter Law
• Inventors: Law, Peter
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US15/711,308
• Publication Number:
  US 20180078739A1
• Time in Patent Office: 467 Days
• Field of Search: None
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2061 using shape-sensors, e.g. fiber shape sensors with Bragg gratings
• CPC Class Codes: A61B 2034/301 for introducing or steering flexible instruments inserted into the body, e.g. catheters or endoscopes
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61B 2090/374 NMR or MRI
• CPC Class Codes: A61B 2090/376 using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 34/30 Surgical robots
• CPC Class Codes: A61B 34/32 operating autonomously
• CPC Class Codes: A61B 34/71 Manipulators operated by drive cable mechanisms
• CPC Class Codes: A61B 5/055 involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61B 6/485 involving fluorescence X-ray imaging
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61M 2025/0047 the inner layer having a higher lubricity
• CPC Class Codes: A61M 2025/0089 Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 2025/015 Details of the distal fixation of the movable mechanical means
• CPC Class Codes: A61M 2025/0166 : Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided
• CPC Class Codes: A61M 2025/0681 : Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2205/3306 : Optical measuring means
• CPC Class Codes: A61M 2205/3317 : Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/332 : Force measuring means
• CPC Class Codes: A61M 2205/50 : with microprocessors or computers
• CPC Class Codes: A61M 2205/70 : with testing or calibration facilities
• CPC Class Codes: A61M 25/0026 : Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/0041 : pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/005 : with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0084 : being one or more injection needles
• CPC Class Codes: A61M 25/0133 : Tip steering devices
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0662 : Guide tubes

Abstract

An autonomously controllable pull wire injection 5 catheter 1 and a method for operating the same are provided. The catheter 1 includes an outer catheter guide 2, 33 having an outer catheter guide casing 39 and an inner operating catheter 3, 31 having an inner operating catheter casing 16, wherein the inner operating catheter 3, 31 includes a catheter handle 30, a catheter tip 10, at least one needle 5 that is connected to at least one source of medicinal solution via at least one needle 10 channel 4, 26, at least one contact force sensor 9a-f, 25, at least one electrode 7, 24, at least four actuator driven pull wires 12-15, 20-23 for moving the tip 10 of the inner operating catheter 3, 31.

Claims

1. Autonomously controllable pull wire injection catheter (1) comprising an outer catheter guide (2, 33) having an outer catheter guide casing (39) and an inner operating catheter (3, 31) having an inner operating catheter casing (16), wherein the inner operating catheter (3, 31) comprises a catheter handle (30), a catheter tip (10), at least one needle (5) that is connected to at least one source of medicinal solution via at least one needle channel (4, 26), at least one contact force sensor (9a-f, 25), at least one electrode (7, 24), at least four actuator driven pull wires (12-15, 20-23) for moving the tip (10) of the inner operating catheter (3, 31), wherein the inner diameter of the outer catheter guide casing (39) is larger than the outer diameter of the inner operating catheter casing (16), characterized in that the inner operating catheter (3, 31) is adapted to be controlled by a microcontroller, wherein the at least one electrode (7, 24) and the at least one contact force sensor (9a-f, 25) are adapted for data exchange with the microcontroller, and wherein the at least four actuator driven pull wires (12-15, 20-23) are attached inside the inner operating catheter (3, 31) perpendicular to each other at a pre-defined distance from the tip (10) in the distal region (6).

2. Catheter (1) according to claim 1, characterized in that the autonomously controllable pull wire cell injection catheter (1) further comprises an electromagnetic position sensor.

3. Catheter (1) according to claim 1, characterized in that the at least one electrode (7, 24) is adapted to operate in Laplacian mode.

4. Catheter (1) according to claim 1, characterized in that the inner operating catheter (3, 31) comprises eight actuator driven pull wires.

5. Catheter (1) according to claim 1, characterized in that the casing (16) of the inner operating catheter (3, 31) has a wall that consists of at least three layers with an outer layer (17) of thermoplastic polyurethane, a braided or coiled stainless steel middle layer (18), and an inner layer (19) of perfluoroethylene (PTFE).

6. Catheter (1) according to claim 1, characterized in that the at least one contact force sensor (9a-f, 25) is a fiber optic sensor (9a-f).

7. Catheter (1) according to claim 1, characterized in that the at least one medicinal solution is a cell solution.

8. A robotic system comprising an autonomously controllable pull wire injection catheter (1) according to claim 1, a robotic arm (28), a microcontroller, a holder and contraption for at least one source of medicinal solution (37), characterized in that the robotic arm (28) is maneuverable at least in forward and backward direction, wherein the inner operating catheter (3, 31) of the autonomously controllable pull wire injection catheter (1) is fixed onto the robotic arm (28) as such that the catheter handle (30), the at least one needle (5), the at least one contact force sensor (9a-f, 25), the at least one electrode (7, 24), and each of the at least four actuator driven pull wires (12-15, 20-23) are separately connected to the robotic arm (28), and wherein the robotic arm (28) is adapted to be controlled by the microcontroller.

9. System according to claim 8, characterized in that the robotic system further comprises an imaging unit selected from the group consisting of an ultrasound unit, a magnetic resonance unit or a fluoroscopy unit.

10. System according to claim 9, characterized in that the imaging unit is a 3D or 4D ultrasound unit.

11. System according to claim 9, characterized in that the robotic arm (28) is made up of at least 70% of polylactid acid.

12. Process for operating a robotic system comprising an autonomously controllable pull wire injection catheter (1) according to claim 1, a robotic arm (28), a microcontroller, a holder and contraption for at least one source of medicinal solution (37), wherein the robotic arm (28) is maneuverable at least in forward and backward direction, wherein the inner operating catheter (3, 31) of the autonomously controllable pull wire injection catheter (1) is fixed onto the robotic arm (28) as such that the catheter handle (30), the at least one needle (5), the at least one contact force sensor (9a-f, 25), the at least one electrode (7, 24), and each of the at least four actuator driven pull wires (12-15, 20-23) are separately connected to the robotic arm (28), and wherein the robotic arm (28) is adapted to be controlled by the microcontroller, characterized in that the process comprises the following steps:

(a) Position the autonomously controllable pull wire injection catheter (1) in an operating environment so as to situate the tip of the inner operating catheter (3, 31) on a desired surface;

(b) Calibrate the at least one electrode (7, 24) and the tip (10) of the inner operating catheter (3, 31) with respect to its movement and orientation;

(c) Manipulate the tip (10) of the inner operating catheter (3, 31) so as to sample the surface area for one or more injection sites according to a measured electrical potential difference and actuate the at least one needle (5) and the at least one syringe to inject the at least one medicinal solution at the determined injection site;

(d) Repeat step (c) until the desired surface area is sampled and return the tip (10) of the inner operating catheter (3) to its position in step (a).

13. Process according to claim 12, characterized in that a total volume of from 5-15 mL of solution is injected in step (c).

14. Process according to claim 12, characterized in that the total number of injections performed in step (c) is of from 10 to 25.

15. Process according to claim 12, characterized in that steps (b) to (d) are performed by the microcontroller.