AU2004218771B2 - Intra-abdominal pressure monitoring uninary catheter - Google Patents

Description

WO 2004/080519 PCT/AU2004/000282 1 INTRA-ABDOMINAL PRESSURE MONITORING URINARY CATHETER The following statement Is a full description of the Invention and includes the best method of performing it. This invention relates medical diagnostic equipment and methods and is particularly concerned measuring intra-abdominal pressure using direct or remote sensing of pressure within the organ in particular intra-abdomial pressure and related pressure within adjacent organs The following statement Is a full description of the invention and includes the best method of performing it. Until the advent of recent publication in relating to renal failure and complication of pressure after surgery few considered intra-abdominal pressure measurement to be important, It is now recognized as an important part of post-operative care. Currently intra-abdominal pressure is measured using a urinary catheter requiring insertion of an extra T-piece or a needle directly into the urinary catheter to allow the pressure to be measured using a transducer or a manometer. A wide variety of Innovative techniques have been used to measure IAP in nearly every part of the abdominal cavity, including the rectum, stomach, urinary bladder, uterus, liver, inferior vena cava, and free within the intra-peritoneal cavity SUBSTITUTE SHEET (RULE 26) RO/AU WO 2004/080519 PCT/AU2004/000282 2 Rectal pressure measurement was experimentally popular in the early part of this century, using a Miller Abbott tube .It would appear generally it is a simple but slightly unreliable technique. McCarthy In 1982 in a study of 12 patients undergoing urodynamic evaluation and laparoscopic tubal ligation found that there was a good correlation between Intra abdominal and rectal pressures. He expressed concern that reliability of this technique required the catheter to remain 10cm above the anal verge otherwise the values were greater than the abdominal values. Presumably this was due to the spontaneous activity of the rectal sphincters . Shafik used rectal pressure In many of his experiments in humans on rectal detrusor muscle activity . He used a urinary catheter with an outer diameter of 1.2mm and found that there was good visual correlation between Intraveslcal and rectal pressures. Intra-gastric measurement was used in the early part of this century with a Hamilton rsnorneter, which afforded the simplest and most reliable technique at the time. Simple techniques using nasogastric tubes to measure IAP have been used by Cullen, Fletsam and Collee. Concern has been expressed about simple perfusion techniques using a nasogastric tube, and Lacey in an animal study found that the use of gastric pressure measurement through an irrigational portal of the nasogastric tube is not reproducible. Collee, from London, used an unperfused nasogastric tube to obtain 141 paired measurements in 28 general surgery patients in IOU. He found using appropriate statistical modelling, that gastric pressure may be 2.5cm of water above or below intra-vesical pressure. SUBSTITUTE SHEET (RULE 26) RO/AU WO 2004/080519 PCT/AU2004/000282 3 This is discussed In more detail in Chapter 5. The Intra gastric route has two specific advantages. It can be used when there has been trauma to the bladder or where the patient does not have a urinary catheter in place. Gastric pressures are also very useful when there is a tense pelvic haematoma following pelvic trauma, as vesical pressures In this situation may not reflect general lAPs, Direct cannulation of the perltoneal cavity had been used experimentally, but it is not as accurate as the intravesical technique and is invasive . Motew used a Verres needle to measure IAP in an experiment on 12 women undergoing tubal ligation. The use of a Verres needle to measure IAP may not be accurate during flow states, It Is also dependent on the degree of muscle relaxation required for the laparoscopy. Obeid and colleagues, from Detroit, reported in 1995 a comparison of IAP measurement using four techniques in 26 patients. These Included an Intra-gastric route via a simple NG, a laparoscopic insufflator, rectal pressure via a modified oesophageal stethoscope and a standard Intra-vesical method with a urinary catheter. Obeid found that with a standard GmmHg rise in IAP, as measured by the insufflator, this was best correlated with the intravesical measurements, with a rise of 5.7mmHg (*9.8), The gastric and rectal pressures were less reliable with the following changes recorded, -0.7* 9.8mmHg and 3.3* 8,8mmHg respectively. He found the rectal and gastric pressures were more position dependent and less reliable than the intravesical approach. The specific limitation of the laparoscopic technique in Obeid's study is the lack of validation of the Stryker endoscopy high flow insufflator, which was used as the gold standard to compare with the other methods. In clinical practice pressures measured with such laparoscopic insufflators may fluctuate widely during surgery. This can be related to SUBSTITUTE SHEET (RULE 26) RO/AU WO 2004/080519 PCT/AU2004/000282 4 the depth of anaesthesia and port mechanics Including blockage with blood or other products. Because of the fluid dynamics In the abdominal cavity, IAP can also be measured through a central venous line if its tip Is in the inferior vena cava. This has been utilised by a number of researchers . Lacey in a study of rabbits, comparing different sites of IAP measurement found an excellent correlation between IVC pressures and vesical IAP readings .. It should be remembered that these experiments were performed In rabbits, under general anaesthesIa. In addition Lacey found that there was poor correlation between superior vena cava, rectus abdominus and rectal pressure The gold standard for IAP measurement has been the intravesical technique Unfortunately Kron did not test the reliability of his technique and validation of the intravesical technique wn as undertaken and published by Ilberti and colleagues at Mount Sinai medical centre In 19G9. in a study of post-operative patients with closed Intra-abdominal drains they compared urinary catheter measurements with those recorded from the abdominal drains. They used the pubis as the zero point which may give rise to slightly reduced as it lies above the mid point of the abdominal cavity, SUBSTITUTE SHEET (RULE 26) RO/AU 5 berti's investigations revealed a good correlation between Intra-abdominal and intra vesical pressure, In addition he found that there was little effect of positive end expiratory pressure (PEEP) on IAP, I have modified the technique slightly and the technique used In this project is according to the protocol below; Other techniques, including installation of saline into the bladder and holding the catheter In the air have also been described. They are cumbersome, do not provide on-line monitoring or are time consuming. Previously the direct on-line monitoring of urinary catheters has not been reported as a measure of Intra-abdominal pressure. Urinary catheters usually contain two lumens, one for the balloon and one for the urine flow, For patients with haematurla, triple lumen catheters have been used for years. They allow irrigaion through the third lumen. They havae not been used or repoied to measure intra-ahdominal pressure. The present problems with intra-abdorninal pressure measurement are overcome by the present invention, which provides direct access to the triple lumen urinary catheters third lumen, allowing direct transducing of intra-abdominal pressure directly, without interruption of urine flow, In one embodiment of the Invention, the urinary catheter contains a Luer lock, allowing direct connection to a transducing manometer 'or remote sensor (fIgure 1). When used in this specification and claims, the terms "comprises" and "comprising" and variations thereof mean that the specified features, steps or integers are included. The terms are not to be interpreted to exclude the presence of other features, steps or Components.

5a The above references to and descriptions of prior proposals or products are not intended to be, and are not to be construed as, statements or admissions of common general knowledge in the art in Australia. SUMMARY OF THE iNVENTION Embodiments of the present invention provides direct access to the triple lumen urinary catheters third lumen, allowing direct transducing of intra-abdominal pressure directly, without interruption of urine flow. According to an embodiment of the invention, there is provided an apparatus for determining the intra-abdominal pressure of a medical patient, the apparatus comprising: an elongate urinary catheter adapted to permit measurement of pressure inside a medical patient's bladder while permitting uninterrupted draining of urine from the medical patient's bladder, the urinary catheter comprising: a first lumen adapted for fluid communication with a retention balloon carried at a distal end of the catheter; a second lumen adapted for draining urine and a pressure transmitting medium from the medical patient's bladder; and a third lumen adapted for open fluid communication through proximal and distal ends of the urinary catheter to permit injection of the pressure transmitting medium through the third lumen into the medical patient's bladder and to permit transmission of change of the pressure through the third lumen via the pressure transmitting medium, without interrupting urine flow from the urinary catheter through the second lumen; a pressure sensor for measuring the pressure of the pressure transmitting medium; and a removable coupling structure comprising an adapter that can be affixed to a proximal end of the third lunen and operable to place the pressure sensor into fluid communication with the pressure transmitting medium.

5b According to a first aspect of the invention, there is provided a method for direct, on-line monitoring of the intra-abdominal pressure of a medical patient, the method comprising: a) installing into the medical patient an apparatus comprising: an elongate urinary catheter comprising: a first lumen adapted for fluid communication with a retention balloon carried at a distal end of the elongate urinary catheter, a second lumen adapted for uninterrupted draining of urine from the medical patient's bladder, and a third lumen adapted for open fluid communication through proximal and distal ends of the elongate urinary catheter to permit instilling of a pressure transmitting medium into the medical patient's bladder allowing drainage of the pressure transmitting medium through the second lumen and to permit the transmission of change of the pressure through the third lumen via the pressure transmitting medium, without interrupting urine flow from the elongate urinary catheter; a pressure sensor for measuring the pressure of the pressure transmitting medium; and a removable coupling structure comprising an adapter that can be affixed to a proximal end of the third Iumen and operable to place the pressure sensor into fluid communication with the pressure transmitting medium; b) irrigating the third lumen thereof with a pressure transmitting medium; and c) monitoring the pressure of the pressure transmitting medium without interruption of urine discharge from the patient so as to determine the intra-abdominal pressure of the medical patient with the apparatus.

Sc According to a second aspect of the invention, there is provided a method for measuring the intra-abdominal pressure of a medical patient, the method comprising the steps of: placing an apparatus comprising: an elongate urinary catheter comprising: a first lumen adapted for fluid communication with a retention balloon carried at a distal end of the elongate urinary catheter; a second lumen adapted for uninterrupted draining of urine from the medical patient's bladder; and a third lumen adapted for open fluid communication through proximal and distal ends of the elongate urinary catheter to pennit instilling of a pressure transmitting medium into the medical patient's bladder allowing drainage of the pressure transmitting medium through the second lumen and to permit the transmission of change of the pressure through the third lumen via the pressure transmitting medium, without interrupting urine flow from the elongate urinary catheter; a pressure sensor for measuring the pressure of the pressure transmitting medium; and removable coupling structure comprising an adapter that can be affixed to a proximal end of the third lumen and operable to place the pressure sensor into fluid communication with the pressure transmitting medium and into fluid communication with a bladder of the medical patient; connecting a pressure sensor to the apparatus's urinary catheter effective to permit the sensor to measure a pressure of fluid in the bladder; and measuring the pressure while permitting urine discharge from the medical patient's bladder. BRIEF DESCRIPTION OF THE DRAWINGS Preferred embodiments of the invention will hereinafter be described, by way of example only, with reference to the accompanying drawings in which: Figure 1 shows components of the intra-abdominal pressure measuring urinary catheter; and 5d Figure 2 shows a cross-sectional view of the intra-abdominal pressure measuring urinary catheter. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS In one embodiment of the invention, the urinary catheter contains a Luer lock, allowing direct connection to a transducing manometer or remote sensor (Figure 1).

WO 2004/080519 PCT/AU2004/000282 6 The line is irrigated with a liquid and connected to a pressure transducer for on-line pressure measurement. A cross section of the tube is shown in figure 2. In yet another aspect or embodiment the device uses, a T-piece attached either to the pressure transducing channel to allow remote pressure reading. Optionally when a temperature sending means Is required this may be added to the catheter. in an embodiment of the- present invention a pressure transmitting channel which is filled with a medium either air or liquid can be attached to a Luer lock with a three way tap allowing Irrigation or perfusion of that channel. The change in pressure at the end of the catheter is thereby transmitted and communicated to the to the pressure transducing medium. In an embodiment of the Invention the pressure transmission can be connected to a manometer or liquid column at he patient bedside. The pressure measuring urinary catheter may be left In the patient for unspecified times and measurement recoded continuously or at intervals. The catheter may be made of a material meeting international standards for medical use, silicone, pvc latex or other material. The urinary catheter Is inserted through the urethra, under standard sterile conditions, with use of the retention balloon insufflated with saline. SUBSTITUTE SHEET (RULE 26) RO/AU

Claims (6)

1. A method for direct, on-line monitoring of the intra-abdominal pressure of a medical patient, the method comprising: a) installing into the medical patient an apparatus comprising: an elongate urinary catheter comprising: a first lumen adapted for fluid communication with a retention balloon carried at a distal end of the elongate urinary catheter, a second lumen adapted for uninterrupted draining of urine from the medical patient's bladder, and a third lumen adapted for open fluid communication through proximal and distal ends of the elongate urinary catheter to permit instilling of a pressure transmitting medium into the medical patient's bladder allowing drainage of the pressure transmitting medium through the second lumen and to pennit the transmission of change of the pressure through the third lumen via the pressure transmitting medium, without interrupting urine flow from the elongate urinary catheter; a pressure sensor for measuring the pressure of the pressure transmitting medium; and a removable coupling structure comprising an adapter that can be affixed to a proximal end of the third lumen and operable to place the pressure sensor into fluid communication with the pressure transmitting medium; b) irrigating the third lumen thereof with a pressure transmitting medium; and c) monitoring the pressure of the pressure transmitting medium without interruption of urine discharge from the patient so as to determine the intra-abdominal pressure of the medical patient with the apparatus.

2. The method according to claim 1, further comprising the steps of: installing coupling structure into a proximal end of the third lumen; and 8 operating the coupling structure to place the third lumen and a pressure sensor into fluid communication.

3. The method according to claim 2, wherein the coupling structure comprises a Luer-lock fitting.

4. The method according to claim 2, wherein the coupling structure comprises a T-piece.

5. The method according to claim 2, wherein the coupling structure comprises a 3-way tap.

6. A method for measuring the intra-abdominal pressure of a medical patient, the method comprising the steps of: placing an apparatus comprising: an elongate urinary catheter comprising: a first lumen adapted for fluid communication with a retention balloon carried at a distal end of the elongate urinary catheter; a second lumen adapted for uninterrupted draining of urine from the medical patient's bladder; and a third lumen adapted for open fluid communication through proximal and distal ends of the elongate urinary catheter to permit instilling of a pressure transmitting medium into the medical patient's bladder allowing drainage of the pressure transmitting medium through the second lumen and to permit the transmission of change of the pressure through the third lumen via the pressure transmitting medium, without interrupting urine flow from the elongate urinary catheter; a pressure sensor for measuring the pressure of the pressure transmitting medium; and