Body lumen fluid delivery device

• US 9,327,096 B2
• Filed: 09/14/2011
• Issued: 05/03/2016
• Est. Priority Date: 06/02/2011
• Status: Active Grant

• Current Assignee: Atrium Medical Corporation (Getinge AB)
• Original Assignee: Atrium Medical Corporation (Getinge AB)
• Inventors: Herweck, Steve A., Furman, Ronit R.
• Primary Examiner(s): GILBERT, ANDREW M
• Application Number:
  US13/232,340
• Publication Number:
  US 20120310085A1
• Time in Patent Office: 1,693 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 5/0095 by applying light and detecting acoustic waves, i.e. photoacoustic measurements
• CPC Class Codes: A61B 5/055 involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 6/481 involving the use of contrast agents
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 2025/0046 Coatings for improving slidability
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/0073 Tip designed for influencing the flow or the flow velocity of the fluid, e.g. inserts for twisted or vortex flow
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2202/0007 introduced into the body
• CPC Class Codes: A61M 2202/206 Viruses
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 5/007 : for contrast media

Abstract

A method and apparatus for fluid delivery enables navigation through tortuous, spatially restricted body anatomy to access narrow diameter body lumens for the continuous delivery of fluids, including therapeutic fluids, to the lumen in an atraumatic manner that avoids damage to the body lumen. The fluid delivery device can have a flexible conduit having a proximal end, a distal end, and a lumen extending along an interior of the flexible conduit providing a fluid flow path between the proximal and distal ends, where the lumen transitions into a micro-lumen exiting through a port through which a high concentration of fluid injected into the lumen exits laterally out along an image viewable zone at the distal end of the flexible conduit. The flexible conduit has a maximum outer diameter sized sufficient to navigate narrow diameter body lumens.

Claims

1. A fluid delivery device, comprising:

a flexible conduit having a proximal end and a distal end;

an image viewable zone disposed along an exterior of the flexible conduit at a predetermined location suitable for delivery of a fluid from the device and proximally located with respect to the distal end, the image viewable zone defined by one or more markers viewable in vivo by an imaging device; and

a lumen extending along an interior of the flexible conduit providing a fluid flow path between the proximal end and the distal end for a fluid injected into the flexible conduit, the lumen transitioning from a portion having a first cross-sectional flow area into a micro-lumen having a second cross-sectional flow area less than the first cross-sectional flow area, the micro-lumen exiting from the flexible conduit at a port at the image viewable zone, the port configured in such a way as to direct fluid out through the port along a longitudinal length of the flexible conduit and the image viewable zone in a direction primarily parallel with respect to a longitudinal axis of the flexible conduit, the port having a first cross-sectional flow area that is less than a second cross-sectional flow area.

2. The fluid delivery device of claim 1, wherein the device is constructed of one or more biocompatible materials.

3. The fluid delivery device of claim 2, wherein the one or more biocompatible materials comprise a thermoplastic polymer.

4. The fluid delivery device of claim 3, wherein the thermoplastic polymer is selected from the group consisting of PEBA, nylon HDPE, PTFE, FEP, ETFE, ePTFE and combinations thereof.

5. The fluid delivery device of claim 1, further comprising a reinforcement incorporated into the flexible conduit imparting flexibility and kink resistance to the flexible conduit.

6. The fluid delivery device of claim 5, wherein the reinforcement comprises a braided wire structure, slotted metal tube, or a helical coil structure.

7. The fluid delivery device of claim 5, wherein the reinforcement is constructed of a material selected from the group consisting of stainless steel, cobalt, chromium, platinum, nitinol, and combinations thereof.

8. The fluid delivery device of claim 1, wherein the flexible conduit has an outer diameter that varies along the image viewable zone imparting improved flexibility and torque response to the flexible conduit during navigation in vivo.

9. The fluid delivery device of claim 1, wherein the flexible conduit is comprised of multiple sections, each section constructed of materials of varying durometer, imparting improved flexibility and torque response during navigation in vivo.

10. The fluid delivery device of claim 1, wherein the flexible conduit comprises varying durometer ranges along its length ranging from about 50 to about 100 shore A and from about 40 to about 80 shore D.

11. The fluid delivery device of claim 1, wherein the one or more markers comprise heavy radiopaque metal component materials.

12. The fluid delivery device of claim 11, wherein the heavy radiopaque metal component materials are selected from the group consisting of PrIr, Au, tungsten, and combinations thereof.

13. The fluid delivery device of claim 11, wherein the one or more markers comprise radiopaque fillers incorporated into one or more locations along the flexible conduit.

14. The fluid delivery device of claim 13, wherein the radiopaque fillers are selected from the group consisting of barium sulfate, tungsten, and bismuth subcarbonate.

15. The fluid delivery device of claim 1, wherein the one or more markers are comprised of a coating applied, painted, printed, etched, grafted, or laminated onto the flexible conduit forming the image viewable zone.

16. The fluid delivery device of claim 1, wherein fluid flowing through the fluid flow path exits the port into a target body location at a rate insufficient to damage tissue.

17. The fluid delivery device of claim 1, wherein if a fluid having a viscosity of 1 cps at 25°

C. is supplied to the flexible conduit at a pressure of between about 1 atmosphere and about 4 atmospheres, a flowrate through the flexible conduit does not exceed 17 cc/min.

18. The fluid delivery device of claim 1, wherein if a fluid having a viscosity of 5 cps at 25°

C. is supplied to the flexible conduit at a pressure of between about 1 atmosphere and about 4 atmospheres, a flowrate through the flexible conduit does not exceed 4 cc/min.

19. The fluid delivery device of claim 1, wherein if a fluid having a viscosity of 11 cps at 25°

C. is supplied to the flexible conduit at a pressure of between about 1 atmosphere and about 4 atmospheres, a flowrate through the flexible conduit does not exceed 2 cc/min.

20. The fluid delivery device of claim 1, further comprising a rapid exchange port proximal to the port at the image viewable zone, wherein the relative distances between the rapid exchange port, the port at the image viewable zone, and the one or more markers, provide an image guidance means through which navigation of the flexible conduit through tortuous, spatially restricted body channels can be optimized.

21. The fluid delivery device of claim 1, wherein the flexible conduit has a hydrophilic exterior surface.

22. The fluid delivery device of claim 1, wherein the flexible conduit has a hydrophobic exterior surface.

23. The fluid delivery device of claim 1, further comprising a coating disposed on an exterior surface of the flexible conduit.

24. The fluid delivery device of claim 23, wherein the coating is a lubricious coating.

25. The fluid delivery device of claim 23, wherein the coating is a therapeutic coating.

26. The fluid delivery device of claim 25, wherein the therapeutic coating comprises omega-3 fatty acids.

27. The fluid delivery device of claim 1, wherein the fluid comprises a medication, a therapeutic agent, a diagnostic agent, or any combination thereof.

28. The fluid delivery device of claim 1, wherein the fluid comprises an emulsion, a nanoemulsion, or a cellular suspension comprised of cellular, genetic or viral material.

29. The fluid delivery device of claim 1, wherein the fluid comprises at least one of antioxidants, anti-hypertensive agents, anti-inflammatory agents, anti-infective agents, antibiotic agents, growth factor antagonists, anti-platelet agents, anti-coagulant agents, thrombolytic agents, drugs to alter lipid metabolism, ACE inhibitors, anti-proliferatives, anti-neoplastics, tissue growth stimulants, gasses, agents for promotion of hollow organ occlusion or thrombosis, agents for functional protein or factor delivery, agents for second messenger targeting, angiogenic agents, anti-angiogenic agents, agents for gene delivery, agents for local tissue perfusion, nitric oxide donating derivatives, thrombus-inducing agents, vasodilators, neuroprotective agents, neuronal healing agents, saline, and contrast media.

30. The fluid delivery device of claim 1, wherein the fluid comprises abciximab.

31. The fluid delivery device of claim 1, wherein the fluid comprises eptifibatide.

32. The fluid delivery device of claim 1, wherein the fluid comprises TPA.

33. The fluid delivery device of claim 1, wherein the fluid comprises at least one of a contrast agent or a dye.

34. The fluid delivery device of claim 1, wherein the fluid delivery device is a medical treatment device for treating a body lumen or cavity.

35. The fluid delivery device of claim 1, wherein the fluid delivery device is a medical diagnostic device for diagnosing a disease in a body lumen or cavity.

36. The fluid delivery device of claim 1, wherein the imaging device utilizes image viewing technology in the form of one or more of radiography, magnetic resonance imaging, nuclear imaging, photo acoustic imaging, thermal imaging, or ultrasound.

37. The fluid delivery device of claim 1, wherein the image viewable zone permits a user of the fluid delivery device to observe a region in which the fluid is being delivered in real-time such that the user can determine a concentration of fluid to deliver to a target treatment site within a target body location.

38. The fluid delivery device of claim 1, wherein the port is formed shaped as an elongated half-funnel with side wall baffles facing in the direction primarily parallel with respect to the longitudinal axis of the flexible conduit.

39. The fluid delivery device of claim 1, wherein the direction is oriented distally.