Device and method for monitoring access to a patient, in particular access to vessels during extracorporeal blood treatment

• US 8,177,736 B2
• Filed: 12/08/2006
• Issued: 05/15/2012
• Est. Priority Date: 03/11/2006
• Status: Active Grant

• Current Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius Medical Care AG)
• Original Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius Medical Care AG)
• Inventors: Kopperschmidt, Pascal
• Primary Examiner(s): Zalukaeva, Tatyana
• Assistant Examiner(s): Xie, Xin
• Application Number:
  US12/282,568
• Publication Number:
  US 20090306574A1
• Time in Patent Office: 1,985 Days
• Field of Search: 604/4.1, 604/6.1, 241/29.R, 241/30, 243/35, 243/36, 243/39, 245/45, 245/46, 245/70, 249/10
• US Class Current: 604/6.16
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae
• CPC Class Codes: A61M 1/3656 Monitoring patency or flow at connection sites; Detecting disconnections
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 5/1418 Clips, separators or the like for supporting tubes or leads
• CPC Class Codes: Y10T 24/3439 Plural clasps
• CPC Class Codes: Y10T 24/44 Clasp, clip, support-clamp, or required component thereof
• CPC Class Codes: Y10T 24/44538 Integral locking-means
• CPC Class Codes: Y10T 403/22 with fluid pressure responsive component

Abstract

The invention relates to a device and to a method for monitoring access to vessels during extracorporeal blood treatment. The invention forms a loop in the arterial and/or venous line and provides device for fixing a section of the line in a loop. When the line is stressed under tension, the loop contracts and the line finally kinks. The modification of the diameter of the line and the formation of a kink in the line leads to a rise of pressure in the line, which is monitored by a pressure monitoring device. If the pressure exceeds a predetermined threshold value, the aspirating cannula is in danger of slipping out of the vessel access or has partially or completely slipped out, thus allowing the threshold value to be determined for alarms.

Claims

1. A device for monitoring vascular access in extracorporeal blood treatment comprising:

a hose line having a lumen therethrough, a first segment, and a second segment,

a first fixing element tightly receiving the first segment of the hose line, and

a second fixing element loosely receiving the second segment of the hose line,

wherein said first segment of the hose line enters a first side of the first fixing element, and said second segment of the hose line enters a first side of the second fixing element such that a loop is formed in the hose line between the first fixing element and the second fixing element,

wherein the first segment is received in the first fixing element from a first direction and the second segment is received in the second fixing element from the same first direction.

2. The device of claim 1, wherein the first fixing element has a C-shape comprising a curved central portion and two end pieces defining a gap therebetween for receiving the hose line.

3. The device of claim 2, wherein the second fixing element has a C-shape comprising a curved central portion and two end pieces defining a gap therebetween for receiving the hose line.

4. The device of claim 3, wherein the two end pieces of at least one of the first fixing element or second fixing element extend at an angle outwardly from the C-shape.

5. The device of claim 2, wherein the second fixing element has an upper semi-circular portion and a lower semi-circular portion.

6. The device of claim 5, wherein the upper semi-circular portion has a first locking portion and the lower semicircular portion has a second locking portion,

the first locking portion and the second locking portion capable of unlocking in an open position to receive the hose line, and

the first locking portion and the second locking portion capable of locking together in a closed position to hold the hose line.

7. The device of claim 1, wherein the first fixing element and the second fixing element are connected.

8. The device of claim 1, wherein the first fixing element has a first opening for receiving the first segment of hose line, and the second fixing element has a second opening for receiving the second segment of hose line, and the first opening is smaller than the second opening.

9. The device of claim 8, wherein a diameter of the first opening is smaller than a diameter of the second opening.

10. The device of claim 1, wherein the loop can tighten when a tractive force is applied to the second segment of the hose.

11. The device of claim 10, wherein when the loop tightens, the pressure in the hose line can increase above a pre-set limit.

12. The device of claim 1, wherein the loop in the hose line further comprises a predetermined kinking point.

13. The device of claim 12, wherein the predetermined kinking point has a first wall thickness and the rest of the first segment and the second segment has a second wall thickness, and the first wall thickness is less than the second wall thickness.

14. The device of claim 12, wherein the predetermined kinking point has a non-round cross-section and the rest of the first segment and the second segment has a round cross-section.

15. The device of claim 1, wherein the first segment forming the loop overlaps the second segment forming the loop as the second segment exits from the second fixing element on a second side.

17. The device of claim 1, wherein the loop extends from a second side of the first fixing element to the first side of the second fixing element.

16. A blood treatment apparatus comprising:

an extracorporeal blood circuit having an arterial hose line with an arterial puncture cannula, and a venous hose line with a venous puncture cannula; and

a device for monitoring the pressure in the arterial hose line, the venous hose line, or both, said device comprising;

a first fixing element tightly receiving a first segment of the arterial hose line or the venous hose line, and a second fixing element loosely receiving a second segment of the arterial hose line or the venous hose line, wherein said first segment of the arterial hose line or the venous hose line enters a first side of the first fixing element from a first direction, and said second segment of the arterial hose line or the venous hose line enters a first side of the second fixing element from the same first direction such that a loop is formed in the hose line between the first fixing element and the second fixing element,

wherein the device is configured to determine if the venous puncture cannula or the arterial puncture cannula has slipped out when there is a change in the pressure outside a preset limiting range on account of a tractive loading of the arterial hose line or the venous hose line.

18. A method for monitoring an access to a patient for supplying or carrying away a fluid to or from the patient via a hose line, said method comprising:

using a device for monitoring vascular access in extracorporeal blood treatment comprising;

a hose line having a lumen therethrough, a first segment, and a second segment;

a first fixing element; and

a second fixing element;

tightly receiving the first segment of the hose line in the first fixing element;

loosely receiving the second segment of the hose line in the second fixing element;

forming a loop in the hose line between the first fixing element and the second fixing element, wherein said first segment of the hose line enters a first side of the first fixing element from a first direction, and said second segment of the hose line enters a first side of the second fixing element from the same first direction;

monitoring a pressure in the hose line; and

determining that there is an incorrect patient access when the monitored pressure is outside of a preset limiting range.

19. The method of claim 18 , wherein the hose line includes a predetermined kinking point, further comprising:

applying a tractive load to the hose line; and

kinking the hose line at the predetermined kinking point.