Body lumen fluid delivery device

• US 10,357,632 B2
• Filed: 05/02/2016
• Issued: 07/23/2019
• 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): Gray, Phillip A
• Application Number:
  US15/144,419
• Publication Number:
  US 20160354579A1
• Time in Patent Office: 1,177 Days
• Field of Search: 604508
• 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 general flow characteristics A61M2206/10
• 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 for treating a body lumen or cavity, comprising:

a flexible conduit having a first lumen defined within an inner wall and a second lumen defined within an outer wall positioned radially outwardly of the inner wall;

a polymer sleeve sandwiched between an outer surface of the inner wall and an inner surface of the outer wall;

a hole formed through the outer wall of the flexible conduit and positioned adjacent the polymer sleeve;

wherein the polymer sleeve comprises a micro-lumen therethrough that redirects a flow of fluid in the second lumen from a longitudinal direction along the flexible conduit to a radial direction out through the hole.

2. The fluid delivery device of claim 1, wherein the polymer sleeve is sealed at a distal end to promote redirection of the flow of fluid from the longitudinal direction to the radial direction through the micro-lumen.

3. The fluid delivery device of claim 1, wherein the polymer sleeve comprises ePTFE.

4. The fluid delivery device of claim 1, wherein the micro-lumen has a maximum cross-sectional flow area of 0.01 mm.

5. The fluid delivery device of claim 1, further comprising one or more markers viewable in vivo by an imaging device, the one or more markers comprised of heavy radiopaque metal component materials;

a coating applied, painted, printed, etched, grafted, or laminated onto the flexible conduit forming the image viewable zone;

or a combination including at least one of the foregoing.

6. The fluid delivery device of claim 1, wherein fluid flowing through the second lumen exits the hole into a target body location at a rate insufficient to damage tissue.

7. 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.

8. 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.

9. 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.

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

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

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

13. The fluid delivery device of claim 12, wherein the coating is a lubricious coating.

14. The fluid delivery device of claim 12, wherein the coating is a therapeutic coating.

15. The fluid delivery device of claim 14, wherein the therapeutic coating comprises omega-3 fatty acids.

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

17. 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.

18. 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.

19. A fluid delivery device for treating a body lumen or cavity, comprising:

a flexible conduit having a first lumen defined within an inner wall and a second lumen defined within an outer wall positioned radially outwardly of the inner wall;

a polymer sleeve sandwiched between an outer surface of the inner wall and an inner surface of the outer wall;

a hole formed through the outer wall of the flexible conduit and positioned adjacent the polymer sleeve;

wherein the polymer sleeve comprises a micro-lumen therethrough that redirects a flow of fluid in the second lumen from a longitudinal direction along the flexible conduit to a radial direction out through the hole; and

wherein the fluid delivery device has a monolithic construction.