# US 2022/0183597 A1 · Implantable electrochemical sensors for the ph measurement

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- Number: US 2022/0183597 A1
- Document ID: US20220183597A1
- Status: Published application
- Kind: A1
- Application number: 17/595,388
- Filed: 2020-05-18
- Published: 2022-06-16
- Earliest claimed: 2019-05-20
- Assignees: M.G.A. Medical Srl; Fabiana Arduini
- Applicants: M.G.A. Medical Srl
- Inventors: Fabiana Arduini; Luca Fiore; Vincenzo Mazzaracchio; Alessandro Riparbelli; Danila Moscone
- Web page: https://patentgrep.com/patent/US20220183597A1

## CPC

- A61B 5/14539: {for measuring pH}
- A61B 5/1473: invasive, e.g. introduced into the body by a catheter
- A61B 5/4851: {Prosthesis assessment or monitoring}
- A61B 5/686: {Permanently implanted devices, e.g. pacemakers, other stimulators, biochips (A61B5/6861 takes precedence)}
- A61F 2/30: Joints
- A61B 5/14735: {comprising an immobilised reagent}
- A61F 2002/4674: {for measuring the pH}
- A61F 2310/00017: Iron- or Fe-based alloys, e.g. stainless steel
- A61F 2310/00023: Titanium or titanium-based alloys, e.g. Ti-Ni alloys
- A61F 2310/00077: Copper or Cu-based alloys
- A61F 2310/00113: Silver or Ag-based alloys
- A61F 2310/00149: Platinum or Pt-based alloys
- A61F 2310/00155: Gold or Au-based alloys
- A61F 2310/00389: The prosthesis being coated or covered with a particular material
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

Implantable electrochemical sensors for the pH measurement are herein described, comprising a working electrode and a reference electrode, in which both the working electrode and the reference electrode are integral part of an implantable orthopaedic medical device, as well as a method for their preparation and their use for monitoring the progression of bacterial infections in the implant sites of such orthopaedic medical devices.

## Claims

### Claim 1

An implantable electrochemical sensor for the pH measurement comprising a working electrode and a reference electrode, wherein both the working electrode and the reference electrode are integral part of an implantable orthopaedic medical device.

### Claim 2 (depends on 1)

The implantable electrochemical sensor of claim 1, wherein the implantable orthopaedic medical device is selected between a prosthesis for total or partial replacement of an articulation and means for osteosynthesis.

### Claim 3 (depends on 1)

The implantable electrochemical sensor of claim 1, wherein the working electrode consists in one or more patches to be applied on the implantable orthopaedic medical device.

### Claim 4 (depends on 1)

The implantable electrochemical sensor of claim 1, wherein the reference electrode consists of
one or more patches to be applied on the implantable orthopaedic medical device; or
a metal wire inserted within or on the implantable orthopaedic medical device.

### Claim 5 (depends on 4)

The implantable electrochemical sensor of claim 4, wherein the metal is a conductive metal selected from the group consisting of gold, silver, titanium, iron, steel, platinum and copper.

### Claim 6 (depends on 1)

A method for preparing the implantable electrochemical sensor of claim 1, wherein
the working electrode is prepared by
(A) totally or partially immersing the implantable orthopaedic medical device, or one or more patches to be applied on or in the same, in a solution containing IrCI4-XH2) at a concentration between 0.01% (P/V) and 0.30% (P/V);
or
(B) totally or partially immersing the implantable orthopaedic medical device, or one or more patches to be applied on or in the same, in a solution containing aniline at a concentration between 0.01% (P/V) and 1% (P/V); and
the reference electrode is prepared by
totally or partially applying on the implantable orthopaedic medical device, or on one or more patches to be put on or in the same, an ink comprising a conductive metal selected from the group consisting of platinum, gold, silver and copper.

### Claim 7 (depends on 6)

The method of claim 6, wherein the patch is prepared by using a biocompatible material selected from the group consisting of: polyester, polydioxanone, polyglycolic acid, polyglactin 910, poliglecaprone 25, maxonon, flax, silk, polyamides and polypropylene.

### Claim 8 (depends on 1)

An implantable orthopaedic medical device comprising the electrochemical sensor of claim 1.

### Claim 9 (depends on 8)

The implantable orthopaedic medical device of claim 8, comprising a detection and transmission data system.

### Claim 10 (depends on 9)

The implantable orthopaedic medical device of claim 9, wherein the transmission data system is wireless.

### Claim 11 (depends on 2)

The implantable electrochemical sensor of claim 2, wherein said mean for osteosynthesis are selected from the group consisting of Schanz screws, bars, clamps, nails, washers, guide wire, shafts, bolts, staples and plates.

### Claim 12 (depends on 6)

The method of claim 6, wherein the concentration of said IrCI4 is between 0.10% (P/V) and 0.20% (P/V).

### Claim 13 (depends on 6)

The method of claim 6, wherein the concentration of said IrCI4 is 0.15% (P/V).

### Claim 14 (depends on 6)

The method of claim 6, wherein the concentration of said aniline is between 0.05% (P/V) and 0.20% (P/V).

### Claim 15 (depends on 6)

The method of claim 6, wherein the concentration of said aniline is 0.10% (P/V).