# US 11,432,733 B2 · Tissue detection devices, systems and methods

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- Number: US 11,432,733 B2
- Document ID: US11432733B2
- Status: Granted
- Kind: B2
- Application number: 16/801,060
- Filed: 2020-02-25
- Published: 2020-09-17
- Granted: 2022-09-06
- Earliest claimed: 2019-03-13
- Assignees: Blossom Innovations, LLC
- Applicants: Blossom Innovations
- Inventors: Joe Ting; Vincent Zuo; Ben Apollonio; Tania To; James Wright
- Web page: https://patentgrep.com/patent/US11432733B2

## CPC

- A61B 5/0538: invasively, e.g. using a catheter
- A61B 5/0015: {characterised by features of the telemetry system}
- A61B 5/0536: Impedance imaging, e.g. by tomography
- A61B 5/0537: Measuring body composition by impedance, e.g. tissue hydration or fat content
- A61B 5/063: {using impedance measurements}
- A61B 5/7405: {using sound}
- A61B 5/742: {using visual displays (displays for heart-related electrical signals, e.g. ECG, A61B5/339)}
- A61B 5/746: {Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms}
- A61B 10/0283: {with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe (A61B10/025, A61B10/0266 take precedence)}
- A61B 18/14: Probes or electrodes therefor
- A61B 18/1477: {Needle-like probes}
- A61B 2010/045: {Needles (pointed biopsy devices with vacuum aspiration A61B10/0283)}
- A61B 2018/00077: {high, i.e. electrically conducting}
- A61B 2018/00083: {low, i.e. electrically insulating}
- A61B 2018/00577: {Ablation}
- A61B 2018/00755: {Resistance or impedance}
- A61B 2018/00875: {Resistance or impedance}
- A61B 2018/00898: {Alarms or notifications created in response to an abnormal condition}
- A61B 2018/1427: {with a beveled end}
- A61B 2560/0214: of power generation or supply
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

An exemplary tissue detection and location identification apparatus can include, for example, a first electrically conductive layer at least partially (e.g., circumferentially) surrounding a lumen, an insulating layer at least partially (e.g., circumferentially) surrounding the first electrically conductive layer, and a second electrically conductive layer circumferentially surrounding the insulating layer, where the insulating layer can electrically isolate the first electrically conductive layer from the second electrically conductive layer. A further insulating layer can be included which can at least partially surrounding the second electrically conductive layer. The first electrically conductive layer, the insulating layer, and the second electrically conductive layer can form a structure which has a first side and a second side disposed opposite to the first side with respect to the lumen, where the first side can be longer than the second side thereby forming a sharp pointed end via the first side at a distal-most portion. The exemplary configuration can be used for (a) determination/detection of a tissue type using impendence of the electrically conductive layers, and/or (ii) determination of a location of at least one portion of the insertion device/apparatus.

## Claims

### Claim 1

An insertion apparatus, comprising:
a first electrically conductive layer circumferentially surrounding a lumen;
an insulating layer (i) at least partially surrounding the first electrically conductive layer, and (ii) at least one of spray coated, electrochemically deposited, vapor deposited or sputtered on the first electrically conductive layer;
a second electrically conductive layer at least partially surrounding the insulating layer, and
an electrical connector,
wherein the insulating layer electrically isolates the first electrically conductive layer from the second electrically conductive layer,
wherein the first electrically conductive layer has a portion with an outer surface that (i) faces away from the lumen, and (ii) is externally uncovered by the insulating layer and the second electrically conductive layer,
wherein the outer surface of the portion of the first electrically conductive layer is integrally provided with the electrical connector which extends radially outward and provides an electrical connection to the insertion apparatus,
wherein the electrical connector (i) has a terminal end, and (ii) is unconnected to the rest of the insertion apparatus, and
wherein the second electrically conductive layer covers the insulating layer at a most distal pointed terminal end of the insertion apparatus.

### Claim 2 (depends on 1)

The insertion apparatus of claim 1, wherein the first electrically conductive layer, the insulating layer, and the second electrically conductive layer form a structure which has a first side and a second side disposed opposite to the first side with respect to the lumen, and wherein the first side is longer than the second side thereby forming the most distal pointed terminal end which is a sharp pointed end via the first side at a distal-most portion of the insertion apparatus.

### Claim 3 (depends on 1)

The insertion apparatus of claim 1, wherein the first electrically conductive layer, the insulating layer, and the second electrically conductive layer form a beveled structure that has a distal-most grinded end forming the most distal pointed terminal end which is a grinded sharp pointed end at a distal-most portion of the insertion apparatus, and wherein the outer surface of the portion of the first electrically conductive layer is provided on a proximal-most portion of the insertion apparatus.

### Claim 4 (depends on 1)

The insertion apparatus of claim 1, wherein the first electrically conductive layer, the insulating layer, and the second electrically conductive layer form a shaft of the insertion apparatus.

### Claim 5 (depends on 4)

The insertion apparatus of claim 4, further comprising a hub, wherein the shaft extends distally from the hub, and wherein a section of the outer surface of the portion of the first electrically conductive layer is provided adjacent to the hub.

### Claim 6 (depends on 5)

The insertion apparatus of claim 5, further comprising:
a barrel connected to the hub; and
a plunger configured to be inserted into the barrel.

### Claim 7 (depends on 1)

The insertion apparatus of claim 1, wherein the first electrically conductive layer is configured to obtain a first electrical signal, and the second electrically conductive layer is configured to obtain a second electrical signal, and further comprising at least one communication device configured transmit information related to the first and second electrical signals.

### Claim 8 (depends on 7)

The insertion apparatus of claim 7, wherein the at least one communication device is embedded in one of (i) a hub proximal to a shaft formed by the first electrically conductive layer, the insulating layer, and the second electrically conductive layer, or (ii) a barrel connected to the hub.

### Claim 9 (depends on 1)

The insertion apparatus of claim 1, wherein the first electrically conductive layer is configured to obtain a first electrical signal, and the second electrically conductive layer is configured to obtain a second electrical signal, further comprising a computer hardware arrangement configured to:
receive information related to the first and second electrical signals;
determine an impedance based on the information; and
determine a tissue type based on the impedance.

### Claim 10 (depends on 9)

The insertion apparatus of claim 9, further comprising at least one audible arrangement configured to emit a sound based on the determined tissue type.

### Claim 11 (depends on 9)

The insertion apparatus of claim 9, wherein the processing arrangement is embedded in one of (i) a hub proximal to a shaft formed by the first electrically conductive layer, the insulating layer, and the second electrically conductive layer, or (ii) a barrel connected to the hub.

### Claim 12 (depends on 9)

The insertion apparatus of claim 9, wherein, upon the determination of the tissue type of a specific tissue that is of interest, at least one current is provided to at least one of the first electrically conductive layer or the second electrically conductive layer so as to generate an energy field detectable by signals detectors which transmit location information of at least one portion of the insertion apparatus to the computer hardware arrangement.

### Claim 13 (depends on 12)

The insertion apparatus of claim 12, wherein the signal detectors include at least two antennas.

### Claim 14 (depends on 12)

The insertion apparatus of claim 12, wherein the computer hardware arrangement is further configured to determine a three-dimensional location of the at least one portion of the insertion apparatus at or in a body based on the location information.

### Claim 15 (depends on 12)

The insertion apparatus of claim 12, wherein the computer hardware arrangement is further configured to generate an image on a display of the at least one portion of the insertion apparatus at or in a body in a three-dimensional space based on the location information.

### Claim 16 (depends on 1)

The insertion apparatus of claim 1, wherein the lumen is configured to at least one of (i) have a pharmacological agent injected therethrough, or (ii) have a biopsy obtained therethrough.

### Claim 17 (depends on 1)

The insertion apparatus according to claim 1, wherein the electrical connector is integrally provided with the outer surface of the portion of the first electrically-conductive layer at a proximal section of the insertion apparatus, and wherein the second electrically conductive layer extends to a distal-most edge of a distal section of the insertion apparatus.

### Claim 18 (depends on 1)

The insertion apparatus according to claim 1, wherein the electrical connector is configured to be connected to at least one of (i) one or more wires, (ii) a flex circuit or (iii) a cable so as to connect to an external device.

### Claim 19 (depends on 1)

The insertion apparatus according to claim 1, wherein the first electrically conductive layer is configured to transmit an electrical signal, and wherein the second electrically conductive layer is configured to receive the electrical signal, wherein a computer arrangement is connected to the insertion arrangement, and is configured to determine information regarding at least one tissue or an orifice of at least one tissue of a subject by using an impedance that is based on the electrical signal.

### Claim 20

An insertion apparatus, comprising:
a hub;
an electrical connector; and
a shaft extending from the hub and surrounding a lumen, wherein the shaft includes an outer surface having at least one first electrode formed thereon or therein, wherein the at least one first electrode extends for more than half of an external circumference of the shaft,
wherein the shaft includes:
at least one second electrode formed or provided on or in an inner surface thereof, and
an insulator (i) separating and insulating the first and second electrodes from one another, and (ii) at least one of spray coated, electrochemically deposited, vapor deposited or sputtered on the second electrode,
wherein the at least one second electrode has an outer portion with an outer surface that (i) faces away from the lumen, and (ii) is not covered externally by the insulator,
wherein the outer surface of the outer portion of the at least one second electrode is integrally provided with the electrical connector which extends radially outward and provides an electrical connection to the insertion apparatus,
wherein the electrical connector (i) has a terminal end, and (ii) is unconnected to the rest of the insertion apparatus, and
wherein the first electrode covers the insulator at a most distal pointed terminal end of the insertion apparatus.

### Claim 21 (depends on 20)

The insertion apparatus of claim 20, further comprising:
a barrel connected to the hub; and
a plunger configured to be inserted into the barrel.

### Claim 22 (depends on 20)

The insertion apparatus according to claim 20, wherein the electrical connector is configured to be connected to at least one of (i) one or more wires, (ii) a flex circuit or (iii) a cable so as to connect to an external device.

### Claim 23 (depends on 20)

The insertion apparatus according to claim 20, wherein the at least one first electrode is configured to transmit an electrical signal, and wherein the at least one second electrode is configured to receive the electrical signal, wherein a computer arrangement is connected to the insertion arrangement, and is configured to determine information regarding at least one tissue or an orifice of at least one tissue of a subject by using an impedance that is based on the electrical signal.

### Claim 24

A method for determining information regarding at least one tissue of a subject or an orifice of the at least one tissue using an insertion arrangement, comprising:
introducing the insertion arrangement into at least one target site of the subject to reach the at least one tissue;
transmitting an electrical signal using a first electrically conductive layer of the insertion arrangement that at least partially surrounds a lumen of the insertion arrangement;
receiving the electrical signal using a second electrically conductive layer of the insertion arrangement that at least partially surrounds an insulating layer which at least partially surrounds the first electrically conductive layer;
providing the electrical signal from an external source via an electrical connector that extends radially outward and is integrally provided with an outer surface of a portion of the first electrically conductive layer that (i) faces away from the lumen, and (ii) is externally uncovered by the insulating layer and the second electrically conductive layer, wherein the electrical connector (i) has a terminal end, and (ii) is unconnected to the rest of the insertion arrangement; and
determining an impedance based on the electrical signal, thereby determining the information regarding the at least one tissue or the orifice of the at least one tissue of the subject.

### Claim 25 (depends on 24)

The method of claim 24, wherein the outer surface of the portion of the first electrically conductive layer is provided on a proximal-most portion of the insertion arrangement.

### Claim 26 (depends on 24)

The method of claim 24, further comprising at least one of (i) administering a pharmacological agent to the subject through the lumen, or (ii) obtaining a biopsy sample from the subject through the lumen.

### Claim 27 (depends on 24)

The method of claim 24, wherein the at least one tissue is muscle or fat.

### Claim 28 (depends on 24)

The method of claim 24, further comprising determining whether a particular type of tissue or the orifice of the at least one tissue has been reached based on the impedance, and based on the determination of whether the type or the orifice of the at least one tissue has been reached, providing at least one current to at least one of the first electrically conductive layer or the second electrically conductive layer so as to generate an energy field detectable by signals detectors which transmit location information of at least one portion of the insertion apparatus to a computer hardware arrangement.

### Claim 29 (depends on 28)

The method of claim 28, further comprising determining a three-dimensional location of the at least one portion of the insertion apparatus at or in a body based on the location information.

### Claim 30 (depends on 28)

The method of claim 28, further comprising generating an image on a display of the at least one portion of the insertion apparatus at or in a body in a three-dimensional space based on the location information.

### Claim 31 (depends on 24)

The method according to claim 24, wherein the electrical connector is configured to be connected to at least one of (i) one or more wires, (ii) a flex circuit or (iii) a cable so as to connect to the external source.

### Claim 32 (depends on 24)

The method according to claim 24, wherein the insulating layer is at least one of spray coated, electrochemically deposited, vapor deposited or sputtered on the first electrically conductive layer, and wherein the second electrically conductive layer covers the insulating layer at a most distal pointed terminal end of the insertion arrangement.

### Claim 33

A hollow tubular structure, comprising:
a first electrically conductive layer circumferentially surrounding a lumen;
an insulating layer (i) at least partially surrounding the first electrically conductive layer, and (ii) at least one of spray coated, electrochemically deposited, vapor deposited or sputtered on the first electrically conductive layer;
a second electrically conductive layer at least partially surrounding the insulating layer, and
an electrical connector,
wherein the first and second electrically conductive layers, the insulating layer and the electrical connector are provided in a fixed manner,
wherein the insulating layer electrically isolates the first electrically conductive layer from the second electrically conductive layer,
wherein the first electrically conductive layer has a portion with an outer surface that (i) faces away from the lumen, and (ii) is externally uncovered by the insulating layer and the second electrically conductive layer,
wherein the outer surface of the portion of the first electrically conductive layer is integrally provided with the electrical connector which extends radially outward and provides an electrical connection to the hollow tubular structure,
wherein the electrical connector (i) has a terminal end, and (ii) is unconnected to the rest of the hollow tubular structure, and
wherein the second electrically conductive layer covers the insulating layer at a most distal pointed terminal end of the tubular structure.

### Claim 34 (depends on 33)

The hollow tubular structure according to claim 33, wherein the electrical connector is configured to be connected to at least one of (i) one or more wires, (ii) a flex circuit or (iii) a cable so as to connect to an external device.

### Claim 35 (depends on 33)

The hollow tubular structure according to claim 33, wherein the first electrically conductive layer is configured to transmit an electrical signal, wherein the second electrically conductive layer is configured to receive the electrical signal, and wherein the hollow tubular structure is connected to a computer arrangement which configured to determine information regarding at least one tissue or an orifice of at least one tissue of a subject by using an impedance that is based on the electrical signal.
