Catheter

• US 10,357,194 B2
• Filed: 01/16/2009
• Issued: 07/23/2019
• Est. Priority Date: 01/18/2008
• Status: Active Grant

• Current Assignee: PlaqueTec Ltd.
• Original Assignee: PlaqueTec Ltd.
• Inventors: Blatcher, Stephen, Owen, Richard Harley Greenville, Corrigan, Joseph Peter, Neudeck, Thomas, Scudamore, Andrew Peter, Hourmand, Yannick Pierre Louis
• Primary Examiner(s): Cerioni, Daniel L
• Application Number:
  US12/355,486
• Publication Number:
  US 20090187083A1
• Time in Patent Office: 3,840 Days
• Field of Search: 600581, 600585, 600573, 60410104, 604268, 606159, 607106, 435 74
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150511 Details of construction of shaft
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61B 5/417 the bone marrow
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00

Abstract

A catheter and associated method for taking a plurality of samples from within a length of a blood vessel. The catheter includes an elongate central body arranged to be inserted into and positioned along a central region of a blood vessel. A plurality of collection areas are defined along the elongate central body for collecting samples at the central region of the blood vessel. A plurality of mixers are provided radially outwardly of the elongate central body and arranged to create a flow of blood from a boundary layer at a wall of the blood vessel to the elongate central body. This enables the collection areas to collect samples from the boundary layer.

Claims

1. A vascular catheter for taking a plurality of discrete blood samples in vivo from within a length of a blood vessel, the vascular catheter including:

an elongate central body arranged to be inserted, over a guidewire, into the blood vessel;

a plurality of longitudinally spaced blood collection areas defined along the elongate central body, the plurality of collection areas configured for collecting the discrete blood samples from the lumen of the blood vessel, each of the blood collection areas having at least one blood collection port; and

at least one static mixer comprising a respective plurality of mixing elements extending radially outwardly of the elongate central body and arranged at successive positions along and at corresponding successive angles around the elongate central body, the at least one static mixer being in non-contiguous contact with the blood vessel wall so as to maintain at least one open region between the plurality of mixing elements of the at least one static mixer and the blood vessel wall for blood flow, the at least one static mixer arranged to create a flow of blood from a boundary layer at a wall of the blood vessel, around the entire periphery of the blood vessel, to the elongate central body so as to enable the plurality of longitudinally spaced blood collection areas to collect the discrete blood samples from the boundary layer.

2. The vascular catheter according to claim 1 wherein the at least one static mixer is deployable from an inactive state for insertion into a blood vessel to an active state so as to interfere with a boundary layer of the blood vessel, wherein in the inactive state the at least one static mixer is closer to the elongate central body than when in the active state.

3. The vascular catheter according to claim 1 wherein each of the plurality of mixing elements is pivotally attached to the elongate central body so as to pivot in the elongate direction of the elongate central body and towards and away from the elongate central body.

4. The vascular catheter according to claim 1 wherein each of the plurality of mixing elements has the form of a paddle extending in radial and tangential directions with respect to the elongate central body.

5. The vascular catheter according to claim 1 wherein each of the plurality of mixing elements has a planar extent following a respective plane through a respective diameter of the elongate central body.

6. The vascular catheter according to claim 1 wherein the relative angle around the elongate central body between mixing elements at adjacent positions along the elongate central body is 90°

.

7. The vascular catheter according to claim 1 wherein the plurality of mixing elements are arranged in pairs, each pair of mixing elements being positioned at a respective position along the elongate central body and individual mixing elements of a pair of mixing elements being on opposite respective sides of the elongate central body.

8. The vascular catheter according to claim 7 wherein the at least one static mixer includes at least two pairs of mixing elements.

9. The vascular catheter according to claim 1 wherein the plurality of mixing elements are spaced and shaped such that when mixing elements at adjacent positions along the elongate central body are deflected so as to be parallel with an outer surface of the elongate central body, the mixing elements at adjacent positions do not overlap.

10. The vascular catheter according to claim 1 wherein each of the blood collection areas includes at least one blood collection port located at a respective position along the elongate central body for collecting a respective discrete blood sample at that position.

11. The vascular catheter according to claim 10 wherein the elongate central body includes at least one lumen extending internally along the elongate central body connecting with the at least one blood collection port in each of the blood collection areas.

12. The vascular catheter according to claim 11 wherein the elongate central body includes a plurality of lumens extending internally along the elongate central body, each of the plurality of lumens connecting with a respective blood collection port.

13. The vascular catheter according to claim 10 wherein at each of the plurality of blood collection areas, the elongate central body includes an outer wall having an outwardly facing surface and an inwardly facing surface and an inner body in which the at least one blood collection port is defined, the inwardly facing surface of the outer wall and the inner body defining a circumferential gap therebetween and a circumferential array of through holes being defined through the outer wall between the inwardly facing surface and the outwardly facing surface such that the circumferential gap forms a manifold feeding the at least one blood collection port from a plurality of radial directions.

14. The vascular catheter according to claim 1 including a plurality of static mixers arranged along the length of the central body wherein each of the plurality of collection areas is defined between adjacent ones of said static mixers.

15. The vascular catheter according to claim 14 wherein at least one collection area is defined between adjacent static mixers.

16. The vascular catheter according to claim 14 where a collection area is defined at one end of the catheter so as to be upstream of any mixer when in use.

17. The vascular catheter according to claim 1 further comprising a sleeve within which the elongate central body and the at least one mixer can be stowed, the sleeve being withdrawable so as to expose the at least one mixer and the at least one collection area.

18. The vascular catheter of claim 1, the plurality of mixing elements configured to mix blood as it flows through the at least one static mixer along the elongate central body thereby to create a flow of blood from a boundary layer at a wall of the blood vessel, around the entire periphery of the blood vessel, to the elongate central body so as to enable the blood collection area to collect the plurality of discrete blood samples from the boundary layer,

wherein at least one of the plurality of mixing elements, when in a deployed, active state, extends away from the elongate central body at least partially in a respective direction which is angularly offset with respect to a plane perpendicular to a longitudinal axis of the elongate central body.

19. The vascular catheter of claim 18 wherein the relative angle around the elongate central body between mixing elements at adjacent positions along the elongate central body is 90°

.

20. The vascular catheter of claim 18 wherein the plurality of mixing elements are arranged in pairs, each pair of mixing elements being positioned at a respective position along the elongate central body and individual mixing elements of a pair of mixing elements being on opposite respective sides of the elongate central body.

21. The vascular catheter of claim 20 wherein an open region defined by one of the pairs of mixing elements is obstructed by an adjacent pair of mixing elements.

22. The vascular catheter of claim 18 wherein at least one of the plurality of longitudinally spaced blood collection areas is defined at one end of the vascular catheter so as to be upstream of any mixer when in use.

23. The vascular catheter of claim 1, the at least one static mixer configured to sequentially separate, rotate and recombine a flow of blood as it moves through the mixer along the elongate central body so as to effect mixing of blood across the radius of the blood vessel.

24. The vascular catheter of claim 23 wherein the relative angle around the elongate central body between mixing elements at adjacent positions along the elongate central body is 90°

.

25. The vascular catheter of claim 23 wherein the plurality of mixing elements are arranged in pairs, each pair of mixing elements being positioned at a respective position along the elongate central body and individual mixing elements of a pair of mixing elements being on opposite respective sides of the elongate central body.

26. The vascular catheter of claim 25 wherein an open region defined by one of the pairs of mixing elements is obstructed by an adjacent pair of mixing elements.

27. The vascular catheter of claim 23 wherein at least one of the plurality of longitudinally spaced blood collection areas is defined at one end of the vascular catheter so as to be upstream of any mixer when in use.

28. The vascular catheter of claim 1 wherein the at least one static mixer, when in a deployed, active state, extends away from the elongate central body at least partially in a direction which is angularly offset with respect to a plane perpendicular to a longitudinal axis of the elongate central body.

29. The vascular catheter of claim 1 wherein the plurality of mixing elements are configured to mix blood as it flows through the mixer along the elongate central body thereby to create a flow of blood from a boundary layer at a wall of the blood vessel, around the entire periphery of the blood vessel, to the elongate central body so as to enable the blood collection area to collect blood samples from the boundary layer,

wherein at least one of the plurality of mixing elements, when in a deployed, active state, extends away from the elongate central body at least partially in a respective direction which is angularly offset with respect to a plane perpendicular to a longitudinal axis of the elongate central body.

30. The vascular catheter of claim 1 wherein at least one of the plurality of mixing elements, when in a deployed, active state, extending away from the elongate central body at least partially in a respective direction which is angularly offset with respect to a plane perpendicular to the longitudinal axis of the elongate central body, the at least one static mixer configured to sequentially separate, rotate and recombine a flow of blood as it moves through the at least one static mixer along the elongate central body so as to effect mixing of blood across the radius of the blood vessel.

32. A vascular catheter according to claim 1, wherein the plurality of mixing elements deploy by expanding outwardly from the elongate central body.

31. A vascular catheter for sampling blood in vivo from a blood vessel, comprising:

a flexible catheter body for insertion over a guidewire into the blood vessel;

a plurality of longitudinally spaced blood collection ports for simultaneously capturing discrete blood samples taken along a length of the blood vessel; and

a static mixer located upstream of the plurality of longitudinally spaced blood collection ports and adapted to be deployed radially outwardly along a section of the catheter body for continuously mixing blood substantially across the entire radial extent of the blood vessel to include, in the discrete blood samples, blood present in a boundary layer at the blood vessel wall as blood flows through the static mixer,

in which the deployable static mixer comprises a plurality of groups of mixing elements, each group of mixing elements being arranged at a respective position along the section of the catheter body and angularly offset relative to any preceding group of mixing elements, thereby in use to sequentially separate, rotate and recombine blood as it flows through the static mixer.