DE202019103379U1 - Implantable device with sensor for monitoring tumor markers - Google Patents

Abstract

Sensor arrangement for an implant, wherein the sensor arrangement is adapted to detect tumor markers in the human or animal body.

Description

The present invention relates to an implantable device having a sensor for monitoring tumor markers.

W02016044651A1 describes an implant with a sensor module, wherein the sensor module is adapted to receive data with which the integrity and effectiveness of the implant can be observed and evaluated after implantation. For example, it can be observed on the basis of the sensor data whether the tissue surrounding the implant has changed. Tissue changes that do not affect the tissue surrounding the implant can not be detected.
In addition, known solutions merely provide for the monitoring of tissue changes at irregular intervals (such as 4 times a year), thereby risking a tissue change being detected too late.

Tumor markers are proteins, peptides or other biological substances in the blood that are found in tissues or other bodily fluids. Their increased concentration may indicate a tumor or the recurrence of a tumor. An exemplary list of known tumor markers can be found in Table 1. Table 1 tumor histological type recommended tumor markers lung Unknown CYFRA 21-1, NSE, CEA * Squamous cell Ca CYFRA 21-1, SCC Adeno-Ca CEA, CYFRA 21-1 Small Cell Ca NSE, CEA esophagus Squamous / AdenoCa CYFRA 21-1, SCC, CEA stomach adenocarcinoma CA 72-4 u. CA 19-9 liver Hepatocellular Ca AFP Metastases of primary tumors CEA and CA 19-9 biliary tract adenocarcinoma CA 19-9 and CEA pancreas adenocarcinoma CA 19-9 and CEA Colorectal adenocarcinoma CEA u. CA 19-9 Mamma All types CA 15-3 and CEA Estrogen receptor ¹⁾ Progesterone receptor ¹⁾ DNA ploidy, S phase HER2 / neu uPA, PAI-1 bone metastases Pyridinolines, deoxypyridinoline uterus adenocarcinoma TPS and CYFRA 21-1 Chorion carcinoma HCG cervix Squamous cell Ca SCC, CYFRA 21-1 ovary Serous adeno-Ca CA125 Mucinous Ca CA 72-4 Germ cell tumor AFP, βhCG granulosa Inhibin B (**) tumor histological type recommended tumor markers prostate adenocarcinoma PSA At PSA of 4-20 ng / ml Quotient fPSA / PSA or complexed PSA (cPSA) bone metastases BAP (Ostase) testicle Germ cell tumor AFP, βhCG seminoma PLAP, βhCG kidney M2-PK bladder Transitional epithelium-Ca NMP-22 ***

It is an object of the present invention to provide an implant, whereby the observation of tissue changes is feasible for tissue that is not located in the immediate vicinity of the implant.

Another object is to provide a sensor for an implant to detect tumor markers in the human or animal body.

The objects are achieved by the features of the independent claims. Favorable embodiments and advantages of the invention will become apparent from the other claims and the description.

According to the invention, there is proposed a sensor for monitoring tumor markers for an implantable device, such as a cardiac pacemaker implant for treating bradycardia or tachycardia, a cardiac monitoring implant, a spinal cord stimulator, an implantable drug pump, or the like.

According to one embodiment, the sensor according to the invention comprises an evaluation unit, which is designed to detect at least one tumor marker. For example, the evaluation unit may be designed to detect at least one of the tumor markers listed in Table 1.

Furthermore, according to one embodiment of the invention, the sensor according to the invention has a transmission unit which transmits information to an implantable device, an external device or external data center. In one aspect of the invention, the sensor is integrated into an implantable device.

According to an advantageous realization of the present invention, the sensor is integrated in an electrode line, which is electrically connected to the implantable device.

According to one embodiment variant, the electrode lead can fulfill a plurality of functions, for example it can be used as an electrical stimulation electrode, defibrillation electrode or measuring electrode, and in this case have a sensor according to the invention. According to one embodiment of the present invention, a cardiac implant for measuring cardiac signals and / or stimulation of the heart is described, wherein the implant comprises a sensor according to the invention, which is designed to detect tumor markers. Such a heart implant may be a pure monitoring device, such as a cardiac loop recorder, or a heart implant with pacing therapy function, such as a pacemaker, implantable cardioverter-defibrillator (ICD), or CRT (Cardiac Resynchronization Therapy) device.
The implant records the values recorded via the sensor and transmits them to a service center and / or a doctor / patient.
Pacemakers and ICDs typically have an elongated electrode lead that measures the electrical potential in the heart and delivers pacing therapy. The implementation of the sensor according to the invention in the electrode line is advantageous because it is permanently in the bloodstream of the patient. Tumor markers in the patient's blood can thus be reliably detected. For implants without an elongated electrode lead, such as cardiac loop recorders, the sensor can be installed directly on the housing. Such a sensor measures in the tissue environment of the implantation site, eg under the skin.

The sensor according to the invention may be integrated in the header of an implantable device or in the housing of an implantable device.

The inventive sensor is implementable in any type of medical implant whose implantation site milieu is suitable for the measurement of tumor markers (e.g., brain pacemaker, spinal cord stimulator, bladder pacemaker, implantable bone prosthesis, etc.). If the sensor data can not be transferred to an external data center, doctor or patient via the implant's own data transfer system, it is necessary that the sensor has its own data transfer module.

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• WO 2016044651 A1 [0002]

Claims (7)

Sensor arrangement for an implant, wherein the sensor arrangement is adapted to detect tumor markers in the human or animal body. Sensor arrangement after Claim 1 wherein the sensor arrangement comprises an evaluation unit which is designed to detect at least one tumor marker. Sensor arrangement after Claim 1 or 2 wherein the sensor arrangement comprises a transmission unit that transmits information to an implantable device, an external device or external data center. Electrode line, comprising the sensor arrangement according to one of the preceding claims, wherein the sensor arrangement and the electrode line are electrically conductively connected. Implantable medical device, comprising the sensor arrangement according to one of the preceding claims. Implantable medical device after Claim 5 wherein the implantable medical device is embodied as a cardiac pacing implant, a cardiac monitoring implant, a spinal cord stimulator, a brain pacemaker, or an implantable drug pump. Implantable medical device after Claim 5 or 6 wherein the sensor arrangement is integrated in a device housing or in a header of the implantable medical device.