WO2023036681A1

WO2023036681A1 - Balloon catheter for enteral feeding

Info

Publication number: WO2023036681A1
Application number: PCT/EP2022/074326
Authority: WO
Inventors: Steffen BAUMGART
Original assignee: Fresenius Kabi Deutschland Gmbh
Priority date: 2021-09-07
Filing date: 2022-09-01
Publication date: 2023-03-16

Abstract

A balloon catheter (1) for enteral feeding comprises a tube (10) for extending through a stoma (S) of a patient (P); an outer member (11) fixed on the tube (10) to rest against the patient's (P) skin (A); and an inflatable balloon (12) to rest against an internal patient's (P) lumen wall (G) in an inflated condition, wherein a pressure sensor (130) arranged to obtain sensor values of a pressure in a fluid system (F) comprising an inner volume (120) of the balloon (12), and an antenna (131) for wirelessly communicating sensor data based on the sensor values are provided.

Description

FK21043-03- PAT- WO

Balloon Catheter for Enteral Feeding

Description

The invention relates to a balloon catheter for enteral feeding according to the preamble of claim 1.

Such a balloon catheter comprises a tube for extending through a stoma of a patient, an outer member fixed on the tube to rest against the patient’s skin and an inflatable balloon to rest against an internal patient’s lumen wall in an inflated condition.

Enteral feeding, in particular by percutaneous endoscopic gastrostomy (PEG), is an endoscopic medical procedure in which a tube is inserted into a patient's lumen, particularly the stomach, through the abdominal wall. PEG may be used for feeding when oral intake is not adequate. Thus, although nutrition is not provided via the mouth, the natural digestion process is maintained.

A balloon catheter as mentioned above is described US 2011/152762 A1 and in US 8,142,394 B1.

By using the inflatable balloon, the catheter can be applied from outside the body via a pushing method. However, balloon catheters may often have a limited time of use, such as 3 to 6 months. Typically, balloon catheters need to be checked for leak-tightness regularly. For this purpose, it is known from practice to withdraw the fluid inside the balloon via a filling port and measure the amount of withdrawn fluid. If the amount of fluid is within a predefined range, the balloon is refilled and further used. This procedure is often time consuming and may be too difficult to do for the patient. In addition, repeated deflation and inflation or overfilling may stress the balloon system. The balloon catheters described US 2011/152762 A1 and in US 8,142,394 B1 include visual indicators of an inflation state of the balloon, however, such indicators may be difficult to read and interpret by the user.

It is an object of the instant invention to improve the usability of a balloon catheter for enteral feeding.

This object is achieved by means of a balloon catheter having the features of claim 1.

Accordingly, the balloon catheter further comprises a pressure sensor arranged to obtain sensor values of a pressure in a fluid system comprising an inner volume of the balloon, and an antenna for wirelessly communicating sensor data based on the sensor values.

This is based on the finding that a leak in the fluid system may be detected based on the pressure of the fluid system, particularly of a fluid inside the balloon, and that the usability can be substantially improved by arranging a pressure sensor for measuring the pressure of the fluid system on the balloon catheter which wirelessly transmits pressure data. This allows an electronic analysis of the pressure data on external computing devices and, in turn, an increased usability and reliability of balloon-integrity checks. The sensor data may be derived from the sensor values or may correspond to or be equal to the sensor values.

For example, the pressure sensor and/or the antenna may be arranged in or on the outer member. Therein, pressure sensors of relatively large size can be used. An arrangement of the antenna in the outer member facilitates a wireless communication with an external device, because the wireless (e.g., electromagnetic) signals do not have to pass through body tissue. For example, the pressure sensor is arranged on or in a fluid passage connecting a filling port of the balloon catheter with the balloon.

Alternatively, the pressure sensor may be arranged on the balloon or inside the balloon. Optionally, the pressure sensor comprises a strain gauge. For example, the strain gauge may be attached to the balloon on an outside or an inside thereof. Optionally, the antenna is arranged in or on the outer member, alternatively, at the pressure sensor. It is worth noting that the balloon catheter may comprise more than one pressure sensor, e.g., arranged at different locations, e.g., one sensor at the balloon and one sensor at the outer member.

The pressure sensor may be in fluid communication with the fluid system. Thus, the pressure sensor may directly measure the pressure of the fluid, instead of an indirect measurement via, e.g., an expansion of a container of the fluid.

The balloon catheter may comprise a further sensor for measuring a further property of a fluid in the fluid system. The further sensor is arranged to obtain sensor values of the further property of the fluid. For example, the further sensor is one of a pH meter and a temperature sensor. This allows to determine whether a wrong fluid has been filled into the balloon, e.g., a fluid that would damage the balloon. In addition, if a fluid is filled into the balloon with a low temperature, it may expand when heated to body temperature. Monitoring the temperature can thus prevent filling too much cold fluid into the balloon.

The fluid system is in fluid communication with the filling port of the outer member. Via the filling port the fluid may be withdrawn from the balloon and filled into the balloon.

The pressure sensor and the antenna may be integrated into a combined sensor unit. This allows very small form factors.

As another option, the pressure sensor and/or the sensor unit can be configured for receiving power wirelessly, particularly via the antenna. For example, the antenna may be an RFID antenna. This allows a design without any physical connectors. The sensor unit may be arranged inside the balloon catheter, e.g., embedded into material of the balloon catheter. This allows to protect the sensor unit from external influences.

Further, the sensor unit may comprise a memory to store the sensor data. This allows, e.g., to buffer sensor data when no wireless connection is active. When a wireless connection is established, the buffered sensor data may be communicated. For example, a sensor value history may be analyzed, e.g., on an irregular basis.

According to an aspect, a catheter system is provided, comprising the balloon catheter according to any example or embodiment described herein. The catheter system may comprise at least one processor being configured to read and/or to communicate and/or to analyze sensor data. The at least one processor may comprise a processor arranged at the balloon catheter (e.g., in the sensor unit) or, e.g., at an external device. The at least one processor may be configured to calculate a status of the balloon of the balloon catheter based on the sensor data (indicative for one or more pressure values) and to provide a message comprising an indication of the calculated status. The status may be selected from a list comprising: “fully functional”, “approaching need for refill”, “refill needed”, “approaching need for replacement”, “replacement needed”, “overfilling”, “wrong fluid” and/or the like.

In particular, the at least one processor may be configured to receive sensor data based on (e.g., indicative for) sensor values of the pressure sensor measured at different points in time, and to determine a change and/or trend of the pressure of the fluid system of the balloon catheter based on the sensor data. This allows to estimate, in particular, to extrapolate, a pressure of the fluid at a future point in time, e.g., to predict a status of the balloon catheter in the future.

Optionally, the at least one processor may be configured to predict a point in time for refilling the balloon (or exchanging the balloon catheter) based on the change of the pressure. The at least one processor may be further configured to provide a message comprising an indication of the predicted point in time, e.g., a calendar day and/or time of a day. Thus, as an example, the user may be informed that, approximately in two (on in another determined number of) days a refill (or exchange) will be necessary.

The system may further comprise computing device (in particular external to the balloon catheter), e.g., a mobile computing device having a wireless communication interface for establishing a communication link with the balloon catheter antenna and being configured to receive sensor data based on the sensor values of the pressure sensor of the balloon catheter. As an example, the mobile computing device may be a smartphone, tablet, smart watch or the like. The user may conveniently use an application to read and analyze the sensor data.

The idea underlying the invention shall subsequently be described in more detail with reference to the embodiments shown in the figures. Herein:

Fig. 1 shows a schematic view of a patient, a balloon catheter for enteral feeding being placed on the patient; Figs. 2A and 2B show schematic views of the catheter of Fig. 1 while filling a balloon of the balloon catheter;

Fig. 3 shows a schematic view of the balloon catheter of Fig. 1 ;

Fig. 4 shows a schematic view of a sensor unit of the balloon catheter of

Fig. 1 ; and

Fig. 5 shows a schematic view of a catheter system comprising the balloon catheter and a computing device.

Fig. 1 shows a general scenario of a patient P being subjected to a gastro-intestinal feeding. A PEG balloon catheter 1 is placed on the patient P, entering into the patient P through a stoma S. A container 2 encloses food and/or medicine for administration to the patient P and is in fluid connection with the balloon catheter 1 via a tube.

Figs. 2A, 2B and 3 show the balloon catheter 1 in more detail. The balloon catheter 1 comprises a tube 10 having an opening 102 at an end thereof to be arranged in the stomach M of the patient P. At the other end of the tube 10 a feeding port 112 is provided via which food and/or medicine may be administered though the tube 10. A tab 113 allows to close the feeding port 112.

The feeding port 112 is arranged at an outer member 11 fixed on the tube 10. The outer member 11 , or button, allows to secure the balloon catheter 1 on the skin A of the patient P against displacement and provides access via the feeding port 112.

The balloon catheter 1 further comprises an inflatable balloon 12. The balloon catheter may be applied on the patient P with the balloon 12 being in a deflated state. By this, the deflated balloon 12 and the tube 10 may easily be inserted into the stoma S.

In order to secure the balloon catheter 1 on the inner gastric wall G of the patient P against displacement, and against removal though the stoma S, the balloon may be inflated by means of a fluid, such as air or water. In an inflated condition, the balloon 12 rests against an internal patient’s P lumen wall, here, the gastric wall G.

For filling fluid into the balloon, the outer member 11 comprises a filling port 111. The filling port 111 is in fluid connection with the balloon 12. For this purpose, the tube 10 comprises an inner tube 100 and an outer tube 101. The inner tube 100 is arranged inside the outer tube 101. An inner volume of the inner tube 100 is accessible via the feeding port and ends at the end opening 102. Between an outer surface of the inner tube 100 and an inner surface of the outer tube 101 there is a channel being part of a fluid system F of the balloon catheter 1. This channel connects an inner volume 120 of the balloon 12 with a channel in the outer member 11 leading to the filling port 111.

The balloon 12 is arranged at the (inner) end of the tube 10 facing away from the outer member 11.

Figs. 2A and 2B illustrate the process of inflating the balloon 12. A syringe 3 filled with a predetermined amount of fluid is connected with the filling port 111. The fluid from the syringe 3 is pressed into the filling port 111. The fluid passes though the channel between the outer and inner tubes 100, 101 into the balloon. As soon as fluid enters the balloon 12, it starts to inflate, see Fig. 2A.

When the entire predetermined amount of fluid has been inserted via the filling port 111 , the balloon 12 is fully inflated. The material of the balloon 12 is under elastic tension. The fluid in the balloon 12 has a higher pressure than the pressure in the stomach M outside the balloon 12. Thus, the fluid system F comprising the inner volume 120 of the balloon has overpressure.

Therefore, in case that the fluid system F, particularly the balloon 12, develops a leak, fluid will exit the fluid system F. As a result, the pressure will drop. To ensure the retaining function of the balloon 12, additional fluid will have to be filled into the fluid system F. If the leak is too large, the balloon catheter 1 is exchanged.

To determine the pressure in the fluid system F, the balloon catheter 1 comprises one or more sensor units 13 to measure a pressure of the fluid system F, see Fig. 3. Here, one sensor unit 13 is arranged in the outer member 11. More precisely, this sensor unit 13 is arranged in fluid connection with the fluid system F. Another sensor unit 13 is arranged inside the balloon 12. It is worth noting that the balloon catheter may comprise both sensor units 13, or just one of the two.

Fig. 4 shows an example of one of the sensor units 13 in more detail. The sensor unit 13 comprises a pressure sensor 130, an antenna 131 , a processor 132 and an optional memory 133. The sensor unit 13 may be a system on a chip (SoC). The pressure sensor 130 may be a (e.g., piezoresistive) strain gauge sensor, a capacitive sensor, an electromagnetic sensor, a piezoelectric sensor, an optical sensor or of another sensor type.

The pressure sensor 130 is operationally (e.g., electrically) coupled to the processor 132. Thus, the processor 132 may read senor values from the pressure senor 130. The processor 132 may store, e.g., buffer, sensor data based on the sensor values in the memory 133. The memory 133 may be a non-volatile memory. The processor 132 is communicatively coupled with the memory 133. The processor 132 is part of a chip that may comprise further components, e.g., of a communication interface etc. The processor 132 may analyze the sensor data, e.g., stored in the memory 133. The processor 132 may be configured to determine a trend of the pressure measured by the pressure sensor 130 based on the sensor values. For example, the processor 132 may be configured to calculate the first derivative of the pressure versus time. Based thereon, the processor 132 may determine the integrity of the balloon 12.

Further, the processor 132 is operatively coupled to the antenna 131. In this example, the antenna 131 is an RFID tag antenna.

The antenna 131 collects energy and provides it to the processor 132. The antenna 131 can be made from a variety of materials. It can be printed, etched, stamped with conductive ink, or vapor deposited. The tag antenna not only transmits an electromagnetic wave carrying data indicative for the sensor values stored in the tag, but also receives electromagnetic waves from an external device to supply energy for the operation of the sensor unit 13. The antenna 131 may have a single turn or multiple turns as shown in Fig. 4.

In particular, the sensor unit(s) 13 may be near-field communication (NFC) capable. Alternatively or in addition to RFID or NFC, the sensor unit(s) 13 may be Bluetooth, Bluetooth LE and/or Wi-Fi capable. In general, the sensor unit(s) 13 may be configured for contactless data communication, particularly by means of electromagnetic signals, e.g., using a radio frequency. The antenna 131 is a part of a communication interface.

The sensor unit 13 comprises an optional further sensor 134 operationally (e.g., electrically) coupled to the processor 132 for measuring a further property of the fluid in the fluid system F. The further sensor 134 is adapted to obtain sensor values of the further property of the fluid, e.g., one of pH values and temperature values. Optionally, a further sensor 134 as pH meter and a further sensor 134 as temperature sensor are provided.

Fig. 5 shows a use case where the balloon catheter 1 is applied on the patient’s P abdominal wall. The outer member 11 rests against the skin A of the patient P. The balloon 12 rests against the gastric wall G of the patient’s P stomach M. The tube 10 connecting the outer member 11 and the balloon 12 extends through a stoma S in the abdominal wall.

A mobile computing device 4 and the balloon catheter 1 together constitute a catheter system with a monitored balloon catheter 1.

In the present example, the mobile computing device 4 is a smartphone. The mobile computing device 4 comprises a communication interface with an antenna 40, a memory 41 , a processor 42 and a display.

The communication interface of the mobile computing device 4 is adapted for wireless communication with the communication interface of the sensor unit(s) 13. The antenna 40 is adapted to establish a wireless communication link with the antenna 131 of the balloon catheter 1 .

The memory 41 is non-volatile. The memory 41 is adapted to store data indicative for sensor values received from the sensor unit(s) 13. In addition, the memory 41 stores instructions to be executed by the processor 42.

The processor 42 executes the instructions stored in the memory 41 to receive and analyze the data indicative for sensor values of the pressure sensor 130 of the balloon catheter 1 . Specifically, the processor 42 calculates a status of the balloon 12 of the balloon catheter 1 based on the received data and, optionally, provides a message comprising an indication of the calculated status. The indication of the status may be selected from a list comprising indications for: “fully functional”, “approaching need for refill”, “refill needed”, “approaching need for replacement” and/or “replacement needed”. In a basic alternative, the indication of the status and/or integrity may be selected from a list comprising indications for “good”, “refill” and “bad”, or even just “good” or “bad”.

Further, the processor 42 executes instructions to receive data indicative for sensor values of the pressure sensor(s) 130 and/or of the further sensor(s) 134 of the balloon catheter 1 measured at different points in time, and to determine a change of the pressure of the fluid system F of the balloon catheter 1 based on these sensor values.

The processor 42 may be configured to determine a trend of the pressure measured by the sensor unit(s) 13 based on the sensor values. For example, the processor 42 may be configured to calculate the first derivative of the pressure versus time.

Based on the change, trend and/or derivative, the processor 42 predicts a point in time in the future when refilling the balloon 12 (and/or exchanging the balloon catheter 1) is advisable based on the change of the pressure. In this regard, the processor 42 may extrapolate the trend of the received sensor data (e.g., into the future) and, e.g., determine the point in time when the extrapolated pressure reaches a threshold value. The mobile computing device 4 may then provide a message comprising an indication of the predicted point in time.

The current status and the predicted time (e.g. day) is then displayed on the monitor of the mobile computing device 4.

List of Reference Numerals

1 Balloon catheter

10 Tube

100 Inner tube

101 Outer tube

102 Opening

103 Annular volume

11 Outer member

110 Body

111 Filling port

112 Feeding port

113 Tab

12 Balloon

120 inner volume

13 Sensor unit

130 Pressure sensor

131 Antenna

132 Processor

133 Memory

134 Further sensor

2 Container

3 Syringe

4 Mobile computing device

40 Antenna

41 Memory

42 Processor

A Skin

C Chamber

F Fluid system

G Gastric wall

M Stomach

P Patient

S Stoma

Claims

Claims:

1 . Balloon catheter (1) for enteral feeding, comprising: a tube (10) for extending through a stoma (S) of a patient (P); an outer member (11) fixed on the tube (10) to rest against the patient’s (P) skin (A); and an inflatable balloon (12) to rest against an internal patient’s (P) lumen wall (G) in an inflated condition, characterized by a pressure sensor (130) arranged to obtain sensor values of a pressure in a fluid system (F) comprising an inner volume (120) of the balloon (12), and an antenna (131) for wirelessly communicating sensor data based on the sensor values.

2. Balloon catheter (1) according to claim 1 , characterized in that the pressure sensor (130) and the antenna (131) are arranged in the outer member (11).

3. Balloon catheter (1) according to claim 1 , characterized in that the pressure sensor (130) is arranged on or inside the balloon (12).

4. Balloon catheter (1) according to any of the preceding claims, characterized in that the pressure sensor (130) is in fluid communication with the fluid system (F).

5. Balloon catheter (1) according to any of the preceding claims, characterized by a further sensor (134) arranged to obtain sensor values of a property of a fluid in the fluid system (F), wherein the further sensor is one of a pH meter and a temperature sensor.

6. Balloon catheter (1) according to any of the preceding claims, characterized in that the fluid system (F) is in fluid communication with a filling port (111) on the outer member (11).

7. Balloon catheter (1) according to any of the preceding claims, characterized in that the pressure sensor (130) and the antenna (131) are integrated in a sensor unit (13).

8. Balloon catheter (1) according to claim 7, characterized in that the sensor unit (13) is configured for receiving power wirelessly by means of the antenna (131).

9. Balloon catheter (1) according to claim 7 or 8, characterized in that the sensor unit (13) further comprises a memory (133) to store the sensor data.

10. Catheter system, comprising the balloon catheter (1) according to any of the preceding claims, characterized in that at least one processor (132, 42) of the catheter system is configured to analyze the sensor data.

11. Catheter system according to claim 10, characterized in that the at least one processor (132, 42) is configured to calculate a status of the balloon (12) of the balloon catheter (1) based on the sensor data and to provide a message comprising an indication of the calculated status.

12. Catheter system according to claim 10 or 11 , characterized in that the at least one processor (132, 42) is configured to receive sensor data based on sensor values of the pressure sensor (130) measured at different points in time and to determine a change of the pressure in the fluid system (F) based on the sensor data.

13. Catheter system according to claim 12, characterized in that the at least one processor (132, 42) is configured to predict a point in time for refilling the balloon (12) based on the change of the pressure and to provide a message comprising an indication of the predicted point in time.

14. Catheter system according to any of claims 10 to 143, characterized by a mobile computing device (4) having a wireless communication interface (40) for establishing a communication link with the antenna (131) of the balloon catheter (1).

15. Catheter system according to claim 14, characterized in that the mobile computing device (4) comprises the at least one processor (42).