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EP-3930569-B1 - ESOPHAGEAL PRESSURE MEASUREMENT CATHETER

EP3930569B1EP 3930569 B1EP3930569 B1EP 3930569B1EP-3930569-B1

Inventors

  • FLINK, Rutger Christiaan
  • HOGENBIRK, Laurens Bastiaan Josef
  • SCHAART, Teunis Hendrik

Dates

Publication Date
20260506
Application Date
20200225

Claims (14)

  1. A catheter (1) comprising a tube (2) having a proximal end and a distal end, wherein the distal end of the tube (2) is arranged to be inserted into the esophagus of a patient, wherein the tube (2) is provided with at least one pressure sensor (7) for measuring a pressure in the esophagus region of a patient, wherein the tube (2) is provided with at least one inflatable balloon (8) adjacent to the at least one pressure sensor (7), wherein the catheter (1) is an esophageal pressure measurement catheter (1), wherein the tube (2) comprises a feeding lumen (3) for transporting liquid food, medication and/or gastric acid to and/or from the stomach of a patient, wherein the balloon (8), when inflated, has a diameter of between 7 mm and 18 mm , and wherein a distance between an edge of the balloon (8) and the centre of the pressure sensor (7) is less than 20 mm, such that the balloon (8), when inflated, acts as a spacer to keep the wall of the esophagus away from the pressure sensor (7)..
  2. The esophageal pressure measurement catheter (1) in accordance with claim 1, wherein the tube (2) comprises a pressure sensor lumen (4) for accommodating a connection for the at least one pressure sensor (7).
  3. The esophageal pressure measurement catheter (1) in accordance with claim 1 or 2, wherein the tube (2) comprises a balloon inflation lumen (5) for transporting a fluid, such as air, to the at least one inflatable balloon (8).
  4. The esophageal pressure measurement catheter (1) in accordance with any of the previous claims, wherein the balloon (8), when inflated, has a diameter of between 10 mm and 15 mm.
  5. The esophageal pressure measurement catheter (1) in accordance with any of the previous claims, wherein the distance between an edge of the balloon (8) and the centre of the pressure sensor (7) is less than 10 mm, preferably less than 7 mm, more preferably less than 5mm, most preferably less than 3 mm.
  6. The esophageal pressure measurement catheter (1) in accordance with any of the previous claims, wherein the balloon (8) has a spherical shape, or the balloon (8) has a cylindrical shape with a substantially rectangular longitudinal cross section.
  7. The esophageal pressure measurement catheter (1) in accordance with any of the previous claims, wherein the length of the tube (2) is at least 80 cm, preferably at least 95 cm.
  8. The esophageal pressure measurement catheter (1) in accordance with any of the previous claims, wherein the diameter of the tube (2) is between 2 mm and 6 mm.
  9. The esophageal pressure measurement catheter (1) in accordance with any of the previous claims, wherein said at least one pressure sensor (7) is a solid state pressure sensor.
  10. The esophageal pressure measurement catheter (1) in accordance with any of the previous claims, wherein the balloon (8) is made of urethane, PET and/or nylon.
  11. The esophageal pressure measurement catheter (1) in accordance with any of the previous claims, wherein the wall thickness of the balloon (8) is between 0.01 mm and 0.06 mm.
  12. The esophageal pressure measurement catheter (1) in accordance with any of the previous claims, wherein the balloon (8) has a leg (82) on either side for fixating the balloon (8) on the tube (2), wherein the length of said leg (82) is less than 7 mm, preferably less than 5 mm, more preferably less than 3 mm in axial direction.
  13. The esophageal pressure measurement catheter (1) in accordance with any of the previous claims, wherein the tube (2) is provided with two of said inflatable balloons (8) adjacent to and at each side of the at least one pressure sensor (7), wherein a distance between an edge of each of the balloons (8) and the centre of the pressure sensor (7) is less than 20 mm, preferably less than 10 mm, more preferably less than 7 mm, even more preferably less than 5mm, most preferably less than 3 mm.
  14. The esophageal pressure measurement catheter (1) in accordance with any of the previous claims, wherein said tube (2) is provided with a plurality of said pressure sensors (7) distributed along a length of the tube (2), each pressure sensor (7) being provided with at least one inflatable balloon (8) adjacent to the at least one pressure sensor (7), wherein a distance between an edge of the balloon (8) and the centre of the pressure sensor (7) is less than 20 mm, preferably less than 10 mm, more preferably less than 7 mm, even more preferably less than 5mm, most preferably less than 3 mm.

Description

The invention relates to a catheter comprising a tube having a proximal end and a distal end, wherein the tube is provided with at least one pressure sensor for measuring a pressure, and wherein the tube is provided with at least one inflatable balloon adjacent to the at least one pressure sensor. Such a catheter is disclosed in US 2017/136220 A1, which relates generally to catheter devices for the site-specific delivery of agents to biological spaces such as blood vessels for treatment of said blood vessels and/or other organ systems. In other embodiments other target spaces that may be accessed by the distal end of the catheter include the gastroesophageal tract. The catheter is designed with at least two occlusion balloons, one proximal and one distal, which are large enough so as to produce a closed off agent delivery segment. The catheter optionally comprises a pressure sensing means, whereby the pressure of the fluid environment in the closed off agent delivery segment can be measured. The current invention relates to different type of catheters, namely an esophageal pressure measurement catheter which is specifically designed for measuring pressures in a patient's esophagus. US 2013/281885 A1 discloses a method for monitoring physiologic conditions of a patient by inserting an esophageal or other suitable tube into the patient. The tube comprising a lumen having a proximal end, a distal end, and central portion, and a pressure sensor disposed about at least a portion of an outer surface of the lumen of the tube. The pressure sensor is capable of detecting a change in pressure when a force is exerted against the outer surface of the lumen. The medical device may be an endotracheal tube, an esophageal feeding tube, a catheter, or a dermal pad. A problem when measuring pressures in a patient's esophagus is that any interaction between the esophagus wall and the pressure sensor, such as the wall touching the pressure sensor, may influence the measurement in a negative manner. The invention aims at a more reliable esophageal pressure measurement catheter. To that end, the tube comprises a feeding lumen for transporting liquid food, medication and/or gastric acid to and/or from the stomach of a patient, the balloon is inflatable to a diameter of between 7 mm and 18 mm, and a distance between an edge of the balloon and the centre of the pressure sensor is less than 20 mm. The balloon, when inflated, acts as a spacer to keep the wall of the esophagus away from the pressure sensor, such that the measurement is more accurate. Said at least one pressure sensor preferably is a solid state pressure sensor. The tube preferably comprises a pressure sensor lumen for accommodating a connection for the at least one pressure sensor. The tube preferably comprises a balloon inflation lumen for transporting a fluid, such as air, to the at least one inflatable balloon. The balloon, when inflated under normal, nominally designed operating conditions, preferably has a diameter of between 7 mm and 18 mm, more preferably between 10 mm and 15 mm. The distance between an edge of the balloon and the centre of the pressure sensor is preferably less than 10 mm, more preferably 7 mm, even more preferably less than 5mm, most preferably less than 3 mm. Preferably the balloon has a spherical shape, or the balloon has a cylindrical shape with a substantially rectangular longitudinal cross section. Preferably the balloon is located at the side of the pressure sensor that is nearer to the proximal end than to the distal end of the tube. The balloon is preferably made of urethane, PET and/or nylon. The wall thickness of the balloon is preferably between 0.01 mm and 0.06 mm. The balloon may have a leg on either side for fixating the balloon on the tube, and said leg is less preferably than 7 mm, more preferably less than 5 mm, most preferably less than 3 mm. The length of the tube is preferably at least 80 cm, preferably at least 95 cm. The diameter of the tube is preferably between 2 mm and 6 mm. The tube is preferably provided with two of said inflatable balloons adjacent and at each side of the at least one pressure sensor, wherein a distance between an edge of each of the balloons and the centre of the pressure sensor is less than 20 mm, preferably less than 10 mm, more preferably less than 7 mm, even more preferably less than 5 mm, most preferably less than 3 mm. Said tube is preferably provided with a plurality of said pressure sensors distributed along a length of the tube, each sensor being provided with at least one inflatable balloon adjacent the at least one pressure sensor, wherein a distance between an edge of the balloon and the centre of the pressure sensor is less than 20 mm, preferably less than 10 mm, more preferably less than 7 mm, even more preferably less than 5mm, most preferably less than 3 mm. At least one of said pressure sensors is preferably provided near the distal end of the tube, for instance in the last 25%, 1