Bronchial catheter and method of use

• US 8,425,455 B2
• Filed: 03/29/2011
• Issued: 04/23/2013
• Est. Priority Date: 03/30/2010
• Status: Active Grant

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: AngioDynamics, Inc.
• Inventors: Nentwick, Brian F
• Primary Examiner(s): Cattungal, Sanjay
• Application Number:
  US13/074,536
• Publication Number:
  US 20110245665A1
• Time in Patent Office: 756 Days
• Field of Search: 600407-430, 600473-480, 600/309, 600/310, 606/194, 604/96.01, 604/93.01, 604/122, 604/129, 604/500, 604/509, 604/99.03
• US Class Current: 604/96.01
• CPC Class Codes: A61B 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 6/00 Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment instruments measuring radiation intensity for application in the field of nuclear medicine, e.g. in vivo counting, G01T1/161; apparatus for taking X-ray photographs G03B42/02
• CPC Class Codes: A61B 8/00 Diagnosis using ultrasonic, sonic or infrasonic waves imaging of objects using sonar G01S15/00
• CPC Class Codes: A61M 1/285 Catheters therefor
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/0046 Coatings for improving slidability
• CPC Class Codes: A61M 2025/0078 for fluid inflow from the body into the catheter lumen
• CPC Class Codes: A61M 2025/0081 Soft tip
• CPC Class Codes: A61M 2025/0188 having slitted or breakaway lumens
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/1047 having centering means, e.g. balloons having an appropriate shape
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1061 having separate inflations tubes, e.g. coaxial tubes or tubes otherwise arranged apart from the catheter tube
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 2025/1084 having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
• CPC Class Codes: A61M 2210/1039 Lungs
• CPC Class Codes: A61M 25/0023 : by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/0029 : characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• 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 25/01 : Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0108 : using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/04 : in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/0662 : Guide tubes
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 : characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

A catheter assembly and method of using the catheter assembly is provided herein. The catheter assembly has a catheter shaft having an elongated body extending about a longitudinal axis, a proximal portion and a distal portion, an outer surface, and at least one lumen extending therethrough the elongated body at least one means for sealing at least a portion of the lumen of the bronchial vessel. At least a portion of the catheter assembly is configured for insertion into at least a portion of a bronchial vessel of a target lung region. The means for sealing is moveable between a collapsed state and an expanded state. At least a portion of the vessel can be sealed by inflating the means for sealing. The catheter assembly can then be used to infuse a dialysate solution into the target lung region.

Claims

1. A dialysis catheter assembly comprising:

a catheter shaft having an elongated body extending along a longitudinal axis, a proximal portion and a distal portion, an outer catheter surface, and a first and second lumen extending therethrough, wherein the first lumen terminates in a first opening and the second lumen terminates in a second opening, wherein the first and second openings are disposed at the distal end of the catheter, and wherein the first opening is configured proximal of the second opening; and

a means for sealing at least a portion of the lumen of the bronchial vessel, wherein the means for sealing comprises a flexible member coaxially disposed about a portion of the outer catheter surface proximal of the first and second openings, the flexible member having an inner flexible member surface and an outer flexible member surface, wherein the means for sealing is moveable between a collapsed insertion state and an expanded sealing state, and wherein the inner flexible member surface is in fluid communication with an inflation lumen.

2. The catheter assembly of claim 1, wherein the means for sealing comprises is a balloon.

3. The catheter assembly of claim 1, herein the means for sealing has a pre-formed expanded configuration.

4. The catheter assembly of claim 1, wherein when the means for sealing is in the expanded sealing state, at least a portion of the outer flexible member surface of the means for sealing engages the inner wall of the bronchial vessel lumen, thereby substantially sealing a portion of the bronchial vessel lumen.

5. The catheter assembly of claim 1, wherein in the expanded sealing state, the means for sealing has a maximum outer diameter, and wherein the maximum outer diameter is substantially equal to or greater than the inner diameter of the bronchial vessel lumen.

6. The catheter assembly of claim 1, wherein the means for sealing is capable of being inflated or deflated in response to infusion or withdrawal of at least one of:

fluid, air, or gas through the inflation lumen.

7. The catheter assembly of claim 1, wherein the means for sealing further comprises at least one radially extending ridge, wherein the at least one ridge forms an integral part of the means for sealing, and wherein when the balloon is in the expanded state, the at least one ridge forms a substantially complete seal with the inner wall of the bronchial vessel.

8. The catheter assembly of claim 1, wherein the outer flexible member surface of the means for sealing is configured to conform to a space between at least two successive cartilaginous rings of at least one of:

a trachea and a bronchial vessel, thereby forming a substantially complete seal.

9. The catheter assembly of claim 1, wherein the means for sealing further comprises a tubular mesh, and wherein at least a portion of the tubular mesh is operatively connected to at least a portion of the outer flexible member surface of the means for sealing.

10. The catheter of claim 1, wherein the means for sealing further comprises a self-expandable cage, wherein the cage comprises a plurality of radially extending ribs, and wherein at least a portion of the self-expandable cage is operatively connected to at least a portion of the inner flexible member surface of the means for sealing.

11. The catheter of claim 1, wherein the catheter comprises at least one valve, and wherein the valve is coupled to at least a portion of the at least one lumen of the catheter, and wherein the at least one valve is configured to open upon a pressure differential and permit fluid flow in one direction.

12. The catheter assembly of claim 1, wherein the catheter further comprises at least one collar, wherein the at least one collar is operatively coupled to the outer surface of the catheter shaft, and wherein the at least one collar is configured to secure at least a portion of the catheter shaft within a portion of the bronchial vessel.

13. A method of using a dialysis catheter, wherein the method comprises:

providing a catheter comprising;

a catheter shaft having an elongated body extending along a longitudinal axis, a proximal portion and a distal portion, an outer catheter surface, and a first and second lumen extending therethrough, wherein the first lumen terminates in a first opening and the second lumen terminates second opening, wherein the first and second openings are disposed at the distal end of the catheter, and wherein the first opening is configured proximal of the second opening; and

a means for sealing at least a portion of the lumen of the bronchial vessel, wherein the means for sealing comprises a flexible member coaxially disposed about a portion of the outer catheter surface proximal of the first and second openings, the flexible member having an inner flexible member surface and an outer flexible member surface, wherein the means for sealing is moveable between a collapsed insertion state and an expanded sealing state, and wherein the inner flexible member surface is in fluid communication with an inflation lumen;

identifying a target lung region, wherein the target lung region comprises at least one bronchial vessel;

inserting at least a portion of the distal portion of the catheter shaft into a portion of the target lung region;

inflating the at least one means for sealing to form a substantially complete seal between a portion of the outer surface of the means for sealing and a portion of the inner wall of the bronchial vessel;

infusing a dialysate solution into a portion of the target lung region.

14. The method of claim 13, wherein the method further comprises deflating the means for sealing before inserting at least a portion of the distal portion of the catheter shaft into at least a portion of the bronchial vessel lumen such that the means for sealing is in a collapsed insertion state.

15. The method of claim 13, wherein the method further comprises determining the diameter of the bronchial lumen before inserting at least a portion of the distal portion of the catheter shaft into at least a portion of the bronchial vessel lumen.

16. The method of claim 13, wherein the method further comprises advancing at least a portion of the distal portion of the catheter assembly into a portion of a patient'"'"'s trachea further into a patient'"'"'s bronchi after inserting the catheter assembly.

17. The method of claim 13, wherein the method further comprises advancing at least a portion of the distal portion of the catheter assembly into a portion of the bronchial vessel through the outer wall of the bronchial vessel after inserting the catheter assembly.

18. The method of claim 13, wherein the method further comprises identifying at least one intercostal space before inserting the distal portion of the catheter assembly, and advancing the catheter assembly into the intercostal space.

19. The method of claim 13, wherein the method further comprises advancing the distal portion of the catheter into a portion of a bronchial vessel after inserting the distal portion of the catheter assembly into a target lung region.

20. The method of claim 13, wherein the method further comprises introducing one of at least air, a fluid, or a gas into the sealing means after the catheter assembly is inserted, such that when the sealing means is radially expanded, a portion of the outer flexible member surface of the means for sealing engages a portion of the inner wall of the bronchial vessel sufficiently to form a substantially complete seal of the bronchial lumen.

21. The method of claim 20, wherein the method further comprises infusing a fluid into the catheter assembly and into the bronchial vessel, wherein the fluid is selected from the group comprising:

a dialysate fluid, a medicament, and a contrast agent.

22. The method of claim 13, wherein the method further comprises withdrawing contaminated fluid from the target lung region for drainage.

23. The method of claim 13, wherein the method further comprises:

withdrawing a bodily fluid to be treated from the bronchial vessel;

treating the bodily fluid; and

infusing the treated fluid into the bronchial vessel through the catheter assembly.

24. The method of claim 20, wherein the method further comprises infusing a dialysate solution through the catheter assembly and into the target lung region, wherein the dialysate solution comprises a therapeutically effective amount of at least one of:

sodium, potassium, chloride, calcium, magnesium, bicarbonate, acetate, water, and dextrose.

25. The method of claim 13, wherein the method further comprises inserting at least a portion of the proximal portion of the catheter assembly into a patient'"'"'s bladder, thereby allowing contaminated fluid to empty through the patient'"'"'s bladder and urethra.

26. The method of claim 13, wherein the method further comprises selectively deflating the means for sealing and removing the catheter the target lung region.

27. A method for dialysis treatment of a patient using an indwelling catheter device, wherein the method comprises;

providing an indwelling catheter assembly comprising;

a catheter shaft having an elongated body extending along a longitudinal axis, a proximal portion and a distal portion, an outer catheter surface, a first and second lumen extending therethrough, wherein the first lumen terminates in a first opening and the second lumen terminates in a second opening, wherein the first and second openings are disposed at the distal end of the catheter, and wherein the first opening is configured proximal of the second opening; and

a means for sealing at least a portion of a bronchial vessel of a patient, wherein the means for sealing comprises a flexible member coaxially disposed about a portion of the outer catheter surface proximal of the first and second openings, the flexible member having an inner flexible member surface and an outer flexible member surface, wherein the means for sealing is moveable between a collapsed insertion state and an expanded sealing state, and wherein the inner flexible member surface is in fluid communication with an inflation lumen;

inserting the distal portion of the catheter into the bronchial vessel; and

sealing at least a portion of the bronchial vessel by expanding the means for sealing.