AU2022211788A1

AU2022211788A1 - Electrode Deployment System

Info

Publication number: AU2022211788A1
Application number: AU2022211788A
Authority: AU
Inventors: Zoran Milijasevic
Original assignee: Eim Holdings Pty Ltd
Current assignee: Eim Holdings Pty Ltd
Priority date: 2021-08-02
Filing date: 2022-08-01
Publication date: 2023-02-16

Abstract

A device for delivering one or more electrodes within the shaft and having the ability to deploy the electrodes through windows in the shaft by pushing the electrodes from the opposite end of the shaft. Controlling the direction and stability of the electrodes, that it delivered every time at the right angle and distance or depth, depending on the target position. 9 310 300 R1 R2 320 -R3 R4 R5 L1 Fig 13 Fig 14

Description

310 300

R1

R2

320

-R3

R4

R5

L1

Fig 13 Fig 14

AUSTRALIA Patents Act 1990

COMPLETE SPECIFICATION STANDARD PATENT

Electrode Deployment System

The following statement is a full description of this invention, including the best method of performing it known to me:

Electrode Deployment System

In the medical industry catheters with electrodes are used for a variety of applications including sensing, stimulating, ablation etc.

Typically, electrodes are arranged in rings on an insulating tube and are inserted into the required area via an introducer or catheter. The electrodes are sometimes stiffened or steered with the use of a stylet or they may have a steering mechanism built in. The electrode connection to the ring is usually a multistrand wire, which can be made from a variety of conducting materials. In most cases the electrodes are not able to penetrate tissue and are placed through blood vessels or other .0 conduits.

An electrode of the present invention can be delivered to the tissue of a patient so that it is precise. The electrode can be delivered into tissue every time at the right angle and distance or depth, depending on the target position.

In a situation where there is a known and identified cancer for example and it can be imaged by MRI .5 or other means, the electrodes can be tailored to penetrate at the right angle and distance.

Present invention is all about controlling the direction and stability of the electrodes. The site can be targeted with accuracy.

Another advantage of the deployment method is that if the electrodes need to pass through another catheter such as a Foley to ablate a cancer, it is able to penetrate the Foley in a consistent manner .0 and deliver the electrical charge or sense in the particular area for diagnosis or similar.

Present invention has two main components, the electrode and the shaft. Both are important to give accuracy and work together to allow for precise direction and distance. Another component is the handle or delivery mechanism. This is just a means of ejecting the electrodes and is not dealt with in detail here. These mechanisms are well known and can be utilised if required.

.5 The shaft can be made from a plastic such as PVC, PE, ABS or any other preferably non-conductive material, although metal coils could also be used to make the shaft for flexibility and guidance.

The shaft can be a simple tube with a single lumen or it can be a multi-lumen tube. The lumen can be a variety of shapes, but essentially it needs to be a slot. A circular lumen may be used, but it will not prevent the electrode from rotating or twisting.

The shaft may also have a flat ribbon or other cross-sectional shapes and it may be steerable.

The shaft has windows (exits) for the electrodes and these can be as lumen that go straight through or there may be windows or slots in the side of the shaft to allow the electrodes to exit. To do this, the shape of the electrode has to be such that it allows the exit through the window.

The invention may be better understood with reference to the illustrations of the embodiments of the invention in which:

Figure 1 is a side elevation of a flat type shaft of this invention showing the rounded tip and windows on the sides for electrodes to exit.

Figures 2 and 3 are isometric views of the shaft of Figure 1.

Figure 4 is an isometric view of a circular shaft of this invention with windows at the end of the shaft.

Figure 5 is a side view of the shaft shown in Figure 4.

Figure 6 is an isometric view of the shaft as shown in Figure 4.

Figure 7 is a cross-section of the shaft of this invention with three slot type lumens. The dimensions X and Y may vary to suit the size and shape of the electrode shaft.

Figure 8 is a cross-section of the shaft of this invention with four variable shaped lumens.

Figure 9 is a cross-section of the shaft of this invention with same lumens as Figure 7.

Figure 10 is a cross-section of the shaft of this invention with two slots type lumens.

Figure 11 is a cross-section of the shaft of this invention with two slots intersecting.

Figure 12 is a cross-section of the shaft of this invention with a single slot which can accommodate a circular or a ribbon type electrode.

Figure 13 is a side view of an electrode of this invention.

.0 Figure 14 is a side view of an electrode of this invention.

Figure 15 is a top view of a device of this invention utilising the circular shaft with windows at one end.

Figure 16 is an isometric view of the device shown in Figure 15.

Figure 17 is another isometric view of the device shown in Figure 15.

.5 Figure 18 is a side view of the device shown in Figure 15.

Figure 19 is a top view of a device of this invention utilising a flat and shaft with windows on the side of the shaft.

Figure 20 is a side view of the device shown in Figure 19.

Figure 21 is another side view of the device shown in Figure 19.

The disclosed device comprises 2 major types of components, the shaft 100 or 200 and the electrodes 300.

ABSTRACT

The electrode shaft 300 as used in this invention is described in Figures 13 and 14. Figure 14 shows one important part of the invention, the electrode construction. The electrode is made up of two main components, the exposed electrode 310 and the insulation 320. To anyone skilled in the art, it will be obvious that the electrode shaft 300 can have more than one electrode 310 as rings or as the end as shown. It can also be hollow and have another electrode or electrodes come out through that lumen. The shaft may be made from a plastic or elastic material. Preferably the shaft is made from a super-elastic material such as nitinol. However, to anyone skilled in the art, it is obvious that the electrode may be conductive or non-conductive. When conductive, the shaft itself may be a return electrode or a sensing electrode. When non-conductive, the electrode shaft may be plated or have wires running through it and have conducting rings or pads.

Figure 13 shows the features of the electrode 300. For the electrode to come out through a window 120 in the shaft as shown in Figure 1, the electrode needs to have a curve such as defined by R2. However, if the electrode needs to penetrate a catheter such as a Foley, the curvature of R2 is not sufficient and a smaller radius RI is required at the distal end. With the correct combination of RI and R2, the electrode will always exit the shaft through the window 120. There may be other changes to RI and R2 such as them being variable, but this is considered in this invention. The electrode may be sharp at the tip to penetrate a catheter.

When sitting in a slot and the electrode itself is a circular wire, it is possible over a long length for the electrode 300 to twist and the ejection can be at various angles, particularly if it has to penetrate a Foley or similar. To prevent twisting the electrode has serpentine type (curves) as defined by R3, R4 and R5 which sit in the elongated lumen of the shaft 100 or 200. To anyone skilled in the art, it is obvious that the number of serpentines or just additional curves can vary as can the location. The radii of R1-R5 and may be changed to suit. More curves may be added as needed. When inserted into a slot type lumen, the serpentine(s) straighten out substantially and are locked from rotating by sitting in the slot. In such a case, the slot lumens define the exit angle from the shaft in conjunction with the pre-set shape of the electrode. The serpentines may be changed to variable radii and can .0 have various permutations but still fall within the scope of this invention. The stimulating part of the electrode may be plated and exposed. The insulation may be PTFE, PET, FEP, Perylene and such other coatings that may insulate the conductive shaft.

The electrode may also have other cross-sections such as a square or rectangle to fit the lumen in the shaft 100 or 200. When circular, the shaft diameter affects the stability of the exit angle of the .5 electrode. The closer the fit, the more stable.

The electrode has serpentines at different levels to prevent the electrode from "flipping" 180 degrees from the tip facing the window to facing inwards and therefore not exiting the window or exiting in the wrong direction where the window is at the distal end as in Figures 15-18. The flipping happens when the shaft is rotated, and this is because the lowest energy state for the curved .0 electrode is in the direction of the curvature. If there is a serpentine in that area and another serpentine in another part of the shaft 200 or 300, there is a curvature already there in the correct direction, so the tendency to flip is not as strong.

The device as shown in Figures 15-18 comprises, a shaft 200 with a shaft member 210 and three slotted lumen 230 and three electrodes 300. The shaft may be flexible to be able to be introduced .5 into the human body. The number of electrodes may vary from zero if just a catheter to whatever number is required and fits on a particular sized shaft. Figures 8-12 show some of the possible shaft cross-sections. It is obvious to anyone skilled in the art that different cross-sections may be utilised for this purpose and work well based on this method.

The device in Figures 15-18 is operated by pushing the electrodes 300 from the proximal end 330 and through the windows 220 at the distal end. Similarly, the electrodes may be withdrawn by pulling on the proximal end 330 and holding the shaft 200. The mechanism for pushing and pulling electrodes is not drawn here for clarity, but there are many variations possible. Mechanisms can vary from a caulking gun type to a syringe type of mechanism, but are not important in this invention.

Another embodiment of this invention is shown in Figures 19-21. In this version, the shaft 100 has flattened ends and windows 120. The electrodes 300 can exit those windows because of a correct choice for RI and R2 as shown in Figure 13. Under most circumstances, RI will be smaller than R2.

The electrodes may be deployed one at a time or multiple electrodes as desired. This can be done manually where the electrical connection is made at the proximal end 330 where there is an uninsulated part of the electrode shaft 300. The delivery may be done manually or with a mechanism. The electrical connections are made to the uninsulated parts of the electrodes 300, preferably at the proximal end 330.

Claims

CLAIMS The claims defining the invention are as follows:

1. A device for delivering one or more electrodes within the shaft and having the ability to deploy the electrodes through windows in the shaft by pushing the electrodes from the opposite end of the shaft. The shaft having rectangular type lumens and the electrodes being curved to exit the shaft.

2. The device as claimed in claim 1 where the shaft is made from a plastic such as ABS, polycarbonate, polyurethane etc.

3. The device as claimed in claim 1 where the shaft is made from an elastic such as silicone, .0 natural rubber etc.

4. The device as claimed in claim 1 where the shaft is made from a conductive material such as a coiled wire, stainless steel, nitinol etc.

5. The device as claimed in claim 4 but the conductive material is at least partially insulated.

6. The device as claimed in claim 1 where the electrodes have a variable radius at the distal .5 end.

7. The device as claimed in claim 1 where the electrodes have one or more serpentine segments.

8. The device as claimed in claim 1 where the electrode has a circular cross-section.

9. The device as claimed in claim 1 where the electrode has a rectangular cross-section. .0

10. The device as claimed in claim 1 where the electrode has an irregular cross-section.

11. The device as claimed in claim 1 where the electrode has a curved distal end and is plated with a biocompatible material.

12. The device as claimed in claim 1 where the electrode or electrodes have a mechanism to eject the electrode(s) and control the distance of ejection. .5

13. The device as claimed in claim 1 where the shaft may have rounded rectangular lumens.

14. The device as claimed in claim 1 where the shaft may have oval lumens.

15. The device as claimed in claim 1 where the shaft may have variable shaped lumens.

16. The device as claimed in claim 1 where the shaft may be steerable.

17. The device as claimed in claim 1 where the electrode width is matched to the lumen width and/or length.

18. The device as claimed in claim 12 where the mechanism is a syringe type mechanism.

19. The device as claimed in claim 12 where the mechanism is a lever action type.

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