# US 2025/0366758 A1 · Guide apparatus, method for manufacturing same and method for using same

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- Number: US 2025/0366758 A1
- Document ID: US20250366758A1
- Status: Published application
- Kind: A1
- Application number: 18/876,298
- Filed: 2022-06-29
- Published: 2025-12-04
- Earliest claimed: 2022-06-20
- Assignees: Shanghai Stairmed Technology Co., Ltd.
- Applicants: Shanghai Stairmed Technology Co., Ltd.
- Inventors: Zhengtuo ZHAO; Xue LI; Yu BAO
- Web page: https://patentgrep.com/patent/US20250366758A1

## CPC

- A61B 5/293: Invasive
- A61B 5/6851: {Guide wires}
- A61B 17/34: Trocars; Puncturing needles
- A61L 31/022: {Metals or alloys}
- A61N 1/05: for implantation or insertion into the body, e.g. heart electrode (A61N1/06 takes precedence)
- A61N 1/36: for stimulation
- C25F 3/02: Etching
- A61B 2560/063: Devices specially adapted for delivering implantable medical measuring apparatus
- A61B 2562/028: Microscale sensors, e.g. electromechanical sensors [MEMS]
- A61B 2562/125: characterised by the manufacture of electrodes
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- C25F: PROCESSES FOR THE ELECTROLYTIC REMOVAL OF MATERIALS FROM OBJECTS; APPARATUS THEREFOR

## Abstract

A guide apparatus (1) for implanting a wire electrode (2) with a through hole provided thereon. The guide apparatus (1) includes, in a length direction thereof: a first portion (111) at an end, a maximum outer diameter size of the first portion (111) being smaller than a size of the through hole; and a second portion (112) connected to the first portion (111), a minimum outer diameter size of the second portion (112) being larger than the size of the through hole, wherein the second portion (112) and the first portion (111) are connected via a step structure.

## Claims

### Claim 1

A guide apparatus for implanting a wire electrode with a through hole provided thereon, the guide apparatus comprising, in a length direction thereof:
a first portion at an end, a maximum outer diameter size of the first portion being smaller than a size of the through hole; and
a second portion connected to the first portion, a minimum outer diameter size of the second portion being larger than the size of the through hole,
wherein the second portion and the first portion are connected via a step structure.

### Claim 2 (depends on 1)

The guide apparatus of claim 1, wherein the step structure is constructed to be platform-like and/or slope-like.

### Claim 3 (depends on 1)

The guide apparatus of claim 1, wherein the outer diameter size of the first portion is between 5 μm and 15 μm.

### Claim 4 (depends on 1)

The guide apparatus of claim 1, wherein the outer diameter size of the first portion is between 7 μm and 8 μm.

### Claim 5 (depends on 1)

The guide apparatus of claim 1, wherein the outer diameter size of the second portion is between 40 μm and 70 μm.

### Claim 6 (depends on 1)

The guide apparatus of claim 1, wherein the outer diameter size of the second portion is between 40 μm and 50 μm.

### Claim 7 (depends on 1, 2, 3, 4, 5, 6)

The guide apparatus of any one of claims 1 to 6, wherein a length of the first portion is between 0.05 mm and 0.3 mm, and a total length of the first portion and the second portion is not less than 3 mm.

### Claim 8 (depends on 1, 2, 3, 4, 5, 6)

The guide apparatus of any one of claims 1 to 6, wherein the first portion and the second portion are formed integrally.

### Claim 9 (depends on 1, 2, 3, 4, 5, 6)

The guide apparatus of any one of claims 1 to 6, wherein the first portion and the second portion are formed integrally of substantially columnar tungsten or stainless steel by an etching process.

### Claim 10 (depends on 1, 2, 3, 4, 5, 6)

The guide apparatus of any one of claims 1 to 6, further comprising a substantially columnar fixation section for fixing the guide apparatus to a movement apparatus for implantation, the fixation section being connected with the second portion and an outer diameter size of the fixation section being larger than the outer diameter size of the second portion.

### Claim 11 (depends on 10)

The guide apparatus of claim 10, wherein the outer diameter size of the fixation section is between 100 μm and 200 μm.

### Claim 12 (depends on 10)

The guide apparatus of claim 10, wherein a total length of the guide apparatus is between 1.5 cm and 2.0 cm.

### Claim 13 (depends on 10)

The guide apparatus of claim 10, wherein the guide apparatus is formed integrally.

### Claim 14 (depends on 10)

The guide apparatus of claim 10, wherein the guide apparatus is formed integrally of substantially columnar tungsten or stainless steel by an etching process.

### Claim 15

A guide apparatus for a wire electrode, the guide apparatus being constructed to be able to pass through an engagement part of the wire electrode so as to be engaged with the engagement part in order to guide the wire electrode, the guide apparatus having an implantation section constructed to at least partially enter a target object, wherein the implantation section has a first portion at a front end, a second portion adjoining a rear of the first portion, and a transition portion for connecting the first portion and the second portion, wherein the first portion is constructed to be able to pass through the engagement part, and the second portion is constructed to be unable to pass through the engagement part, so that the engagement part of the wire electrode can be stopped at the transition portion.

### Claim 16 (depends on 15)

The guide apparatus of claim 15, wherein, when the engagement part of the wire electrode is stopped at the transition portion, a first section of the wire electrode that is adjacent to the engagement part is attached to the transition portion.

### Claim 17 (depends on 15)

The guide apparatus of claim 15, wherein the transition portion is constructed to have a plane substantially perpendicular to a longitudinal direction of the guide apparatus, the plane being sized to be unable to pass through the engagement part, so that the engagement part of the wire electrode can be stopped at the plane of the transition portion.

### Claim 18 (depends on 15)

The guide apparatus of claim 15, wherein the transition portion is constructed to have an increasing outer diameter in a direction from the first portion to the second portion, so that an outer peripheral edge at a specific position of the transition portion applies pressure to the engagement part of the wire electrode in a longitudinal direction of the guide apparatus, thus the engagement part of the wire electrode can be stopped at the specific position of the transition portion.

### Claim 19 (depends on 15)

The guide apparatus of claim 15, wherein the guide apparatus further has a fixation section for fixing the guide apparatus to a driving apparatus for moving the guide apparatus, the fixation section being located at a rear end of the guide apparatus.

### Claim 20 (depends on 19)

The guide apparatus of claim 19, wherein the fixation section and the implantation section are constructed integrally.

### Claim 21 (depends on 19)

The guide apparatus of claim 19, wherein the fixation section is constructed to be hollow, and the second portion of the implantation section can be received and fixed in the hollow structure of the fixation section.

### Claim 22 (depends on 21)

The guide apparatus of claim 21, wherein a stiffness of a material of the fixation section is higher than a stiffness of a material of the implantation section.

### Claim 23 (depends on 15)

The guide apparatus of claim 15, wherein the engagement part is constructed with a through hole, and a size of the first portion is smaller than a size of the through hole, and a size of the second portion is larger than the size of the through hole.

### Claim 24 (depends on 15)

The guide apparatus of claim 15, wherein at least the implantation section is made of a metal, alloy, carbon fiber or diamond with a Young's modulus greater than 20 GPa.

### Claim 25 (depends on 15)

The guide apparatus of claim 15, wherein at least the implantation section is made of tungsten or stainless steel by etching.

### Claim 26 (depends on 15)

The guide apparatus of claim 15, wherein the first portion is constructed to be columnar with a diameter between 5 μm and 15 μm, and/or, the second portion is constructed to be a columnar with a diameter between 40 μm and 70 μm.

### Claim 27 (depends on 19)

The guide apparatus of claim 19, wherein the fixation section is constructed to be a columnar with a diameter between 100 μm and 200 μm.

### Claim 28

A method for manufacturing a guide apparatus, comprising:
immersing a first section of an etchable blank into an etchant, and performing a first electrochemical etching on the first section, so as to obtain a semi-finished product with one step structure; and
immersing a first sub-section at an end of the first section into the etchant, and performing a second electrochemical etching on the first sub-section, so as to obtain the guide apparatus with two step structures,
wherein an implantation section of the guide apparatus is obtained on the first section, the implantation section having a first portion corresponding to the first sub-section and a second portion corresponding to the rest of the first section except for the first sub-section, the first portion being thinner than the second portion.

### Claim 29 (depends on 28)

The method of claim 28, wherein the etchant is an alkaline solution.

### Claim 30 (depends on 28)

The method of claim 28, wherein the etchant is a potassium hydroxide solution.

### Claim 31 (depends on 28)

The method of claim 28, wherein the immersing a first section of an etchable blank into an etchant comprises:
laterally immersing the first section of the blank into the etchant, so that an electrochemical etching state of the first section can be observed from above with an observation apparatus for observing the electrochemical etching state of the first section.

### Claim 32 (depends on 31)

The method of claim 31, wherein the observation apparatus observes the electrochemical etching state of the first section vertically from above.

### Claim 33 (depends on 31)

The method of claim 31, wherein the observation apparatus is constructed as an optical microscope.

### Claim 34 (depends on 28)

The method of claim 28, further comprising: covering at least a second sub-section of the first section that adjoins the first sub-section with an isolation material before performing the second electrochemical etching on the first sub-section of the first section, so that the second sub-section is not in contact with the etchant during the second electrochemical etching.

### Claim 35 (depends on 34)

The method of claim 34, wherein the isolation material is a silicone adhesive.

### Claim 36 (depends on 34)

The method of claim 34, wherein the covering a second sub-section with an isolation material comprises: making an end of the isolation material that is close to the first sub-section form a substantially flat surface which has an angle with respect to a longitudinal direction of the second sub-section that is not less than a threshold angle.

### Claim 37 (depends on 36)

The method of claim 36, further comprising: placing the blank upright and positioning the first sub-section above the second sub-section, and pouring flowable isolation material into a container that is provided around the outside of the second sub-section and has an upward opening, so that an upper surface of the poured isolation material forms the substantially flat surface under an effect of gravity.

### Claim 38 (depends on 28)

The method of claim 28, further comprising:
performing electrochemical etching on multiple blanks simultaneously, and separately controlling the electrochemical etching process of each blank respectively.

### Claim 39 (depends on 38)

The method of claim 38, wherein, before performing the first electrochemical etching, each blank is connected in series with a separate switching element respectively, and corresponding sub-circuits each including a corresponding blank and a corresponding switching element are connected in parallel to a main circuit.

### Claim 40 (depends on 28)

The method of claim 28, wherein an etching speed of the second electrochemical etching is less than an etching speed of the first electrochemical etching.

### Claim 41

A method for manufacturing a guide apparatus, comprising:
immersing a first sub-section at an end of a first section of an etchable blank into an etchant, and performing a first electrochemical etching on the first sub-section, so as to obtain a semi-finished product with one step structure; and
immersing the first section into the etchant, and performing a second electrochemical etching on the first section, so as to obtain the guide apparatus with two step structures,
wherein an implantation section of the guide apparatus is obtained on the first section, the implantation section having a first portion corresponding to the first sub-section and a second portion corresponding to the rest of the first section except for the first sub-section, the first portion being thinner than the second portion.

### Claim 42

A method for guiding a wire electrode, comprising:
placing, at a first position, the wire electrode with a through hole provided at an end portion thereof;
aligning a guide apparatus with the through hole, wherein the guide apparatus comprises, in a length direction thereof, a first portion at a front end and a second portion connected to the first portion, a maximum outer diameter size of the first portion being smaller than a size of the through hole and a minimum outer diameter size of the second portion being larger than the size of the through hole, wherein the second portion and the first portion are connected via a step structure;
moving the guide apparatus forward so that the first portion passes through the through hole and the end portion of the wire electrode is stopped at the step structure due to pressure from the step structure in a longitudinal direction of the guide apparatus; and
moving the guide apparatus to guide at least the end portion of the wire electrode from the first position to a second position.

### Claim 43 (depends on 42)

The method of claim 42, wherein the wire electrode is placed at the first position by adhering the wire electrode to a substrate located at the first position, and the method further comprises:
at least partially peeling off the wire electrode from the substrate by moving the guide apparatus, so as to guide at least the end portion of the wire electrode from the first position to the second position.

### Claim 44

A method for using a guide apparatus, comprising:
bringing the guide apparatus close to an engagement part of a wire electrode, wherein the guide apparatus comprises a thinner first portion at a front end, a thicker second portion adjoining a rear of the first portion, and a transition portion connecting the first portion and the second portion, wherein the first portion is constructed to be able to pass through the engagement part, and the second portion is constructed to be unable to pass through the engagement part;
passing the first portion through the engagement part of the wire electrode, and stopping the engagement part of the wire electrode at the transition portion; and
guiding the wire electrode using the guide apparatus.

### Claim 45 (depends on 44)

The method of claim 44, further comprising:
spraying a liquid on the wire electrode before guiding the wire electrode using the guide apparatus, so that at least a first section of the wire electrode is attached to the transition portion and/or the second portion of the guide apparatus.

### Claim 46 (depends on 44)

The method of claim 44, wherein the engagement part is constructed with a through hole, and an outer diameter of the first portion is smaller than an inner diameter of the through hole, and an outer diameter of the second portion is larger than the inner diameter of the through hole.

### Claim 47

A method for guiding a wire electrode using a guide apparatus, the guide apparatus comprising a thinner first portion at a front end, a thicker second portion adjoining a rear of the first portion, and a transition portion for connecting the first portion and the second portion, wherein the first portion is constructed to be able to pass through an engagement part, the second portion is constructed to be unable to pass through the engagement part, a first end portion of the wire electrode is constructed with the engagement part, and the method comprises:
passing the first portion through the engagement part, and stopping the engagement part of the wire electrode at the transition portion;
further moving the guide apparatus to apply pull force to the first end portion of the wire electrode, so as to at least partially separate the wire electrode from a fixation apparatus for the wire electrode;
guiding the wire electrode to a target position using the guide apparatus.

### Claim 48 (depends on 47)

The method of claim 47, wherein the further moving the guide apparatus to apply pull force to the first end portion of the wire electrode comprises:
moving the guide apparatus towards the target position at an angle with respect to a fixation plane for the wire electrode on the fixation apparatus to apply pull force to the first end portion of the wire electrode.

### Claim 49 (depends on 47)

The method of claim 47, wherein the engagement part is constructed as a through hole, and an outer diameter of the first portion is smaller than an inner diameter of the through hole, and an outer diameter of the second portion is larger than the inner diameter of the through hole.