Apparatus and methods for treating obstructions within body lumens

• US 9,101,382 B2
• Filed: 08/23/2011
• Issued: 08/11/2015
• Est. Priority Date: 02/18/2009
• Status: Active Grant

• Current Assignee: Teleflex Life Sciences LLC (Teleflex Incorporated)
• Original Assignee: Hotspur Technologies, Inc. (Teleflex Incorporated)
• Inventors: Krolik, Jeffrey A., Domingo, Juan, Watanabe, Gwendolyn, Betelia, Ray, Fernandez, Lucas
• Primary Examiner(s): HOLWERDA, KATHLEEN SONNETT
• Application Number:
  US13/216,208
• Publication Number:
  US 20120078096A1
• Time in Patent Office: 1,449 Days
• Field of Search: 623 111- 154, 604 9601-10314
• US Class Current: 1/1
• CPC Class Codes: A61B 17/22032 having inflatable gripping elements balloon catheters A61M25/10
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 17/32056 Surgical snare instruments for removing or smashing calculi A61B2017/2212; tonsillotomes A61B17/26
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1068 having means for varying the length or diameter of the deployed balloon, this variations could be caused by excess pressure
• CPC Class Codes: A61M 2025/1077 having a system for expelling the air out of the balloon before inflation and use
• 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 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2025/109 having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• CPC Class Codes: A61M 25/0075 : Valve means
• CPC Class Codes: A61M 25/0097 : characterised by the hub connectors A61M39/10
• 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
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters
• CPC Class Codes: A61M 25/10185 : Valves
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61M 5/007 : for contrast media

Abstract

Apparatus and methods are provided for delivering fluid into a body lumen during a medical procedure. A distal end of an apparatus may be introduced into a body lumen, and a valve on the distal end may be opened to deliver fluid through a first lumen into the body lumen, e.g., contrast and/or other diagnostic or therapeutic agents. The valve may be closed, and a procedure may be performed within the body lumen, e.g., using a treatment element carried on the distal end. For example, the treatment element may include a balloon that may be inflated when fluid is delivered through the first lumen with the valve closed. Optionally, a prosthesis, energy source, drug platform, and the like may be carried by the balloon for treating the body lumen. In various embodiments, the valve may be located proximal or distal to the treatment element.

Claims

1. A method for treating a body lumen of a patient, the method comprising:

receiving an apparatus comprising;

an outer member including a first lumen extending between a proximal end and an outlet in a distal end of the outer member,

an inner member slidable within the first lumen, the inner member including a distal portion extending beyond the outlet of the outer member, the inner member comprising a second lumen,

a treatment element on the distal portion, and

a sealing member at least partially proximal to the treatment element on the distal portion, the sealing member being in direct contact with the treatment element, the sealing member having one or more passages in fluid communication with an interior of the treatment element, and the sealing member being sized to at least partially enter the first lumen of the outer member such that the sealing member may substantially seal the outlet of the outer member;

introducing the distal end of the outer member into the body lumen with the inner member in a proximal position such that the sealing member substantially seals the outlet of the outer member;

actuating a proximal end of the apparatus to slide the inner member to a distal position, such that the sealing member is directed away from the outlet of the outer member;

delivering fluid through the first lumen such that some of the fluid exits through the outlet of the outer member into the body lumen and some of the fluid is delivered through the one or more passages in the sealing member directly into the treatment element; and

performing a procedure within the body lumen using the treatment element,

wherein the sealing member is configured to slide axially to partially obstruct the outlet of the outer member.

2. The method of claim 1, wherein the treatment element comprises a balloon, the method further comprising:

directing the inner member towards the proximal position such that the sealing member substantially seals the outlet and the one or more passages in the sealing member communicate between the first lumen and an interior of the balloon; and

delivering the fluid through the first lumen with the outlet substantially sealed, such that the fluid is delivered through the one or more passages into the interior of the balloon to expand the balloon within the body lumen.

3. The method of claim 2, further comprising:

directing the balloon to an expanded helical shape within the body lumen; and

directing the balloon along a wall of the body lumen in the expanded helical shape to remove material from the wall of the body lumen.

4. The method of claim 2, wherein the treatment element further comprises a prosthesis carried on the distal portion over the balloon, and wherein the prosthesis is expanded within the body lumen when the balloon is expanded.

5. The method of claim 4, wherein the prosthesis comprises at least one of a stent, a stent-graft, and a prosthetic valve.

6. The method of claim 2, wherein the balloon is expanded until the balloon contacts a wall of the body lumen, the method further comprising delivering energy via the balloon to tissue adjacent the wall of the body lumen.

7. The method of claim 2, wherein the balloon is expanded until the balloon contacts a wall of the body lumen, thereby delivering one or more agents carried by the balloon to tissue adjacent the wall of the body lumen.

8. The method of claim 2, wherein the treatment element comprises a carrier on the balloon comprising one or more diagnostic or therapeutic agents, and wherein the carrier is expanded within the body lumen when the balloon is expanded.

9. The method of claim 1, wherein the treatment element comprises a balloon, the method further comprising sliding the inner member towards the proximal position such that the sealing member partially obstructs the outlet of the outer member.

10. The method of claim 9, wherein the apparatus further comprises an actuator on the proximal end of the apparatus, the method further comprising manipulating the actuator to adjust the amount of fluid that exits the outlet of the outer member and is delivered into the interior of the balloon.

11. The method of claim 9, further comprising sliding the inner member towards the proximal position such that the sealing member substantially seals the outlet of the outer member with the balloon partially expanded, thereby reducing normal flow within the balloon.

12. The method of claim 11, further comprising evacuating fluid from the partially expanded balloon through the first lumen to collapse the balloon and allow normal flow to resume within the balloon.

13. The method of claim 11, wherein the fluid comprises a contrast agent, and wherein the balloon is partially expanded for a desired time to reduce washout of the contrast agent by normal flow through the body lumen while the body lumen is imaged.

14. The method of claim 11, wherein the fluid comprises one or more therapeutic agents, and wherein the balloon is partially expanded for a desired time to reduce washout of the one or more therapeutic agents by normal flow through the body lumen to enhance treatment of the body lumen by the one or more therapeutic agents.

15. The method of claim 1, wherein the apparatus further comprises a tensioning element coupled between the inner and outer members, the tensioning element biasing the inner member proximally to enhance the sealing member sealing the outlet of the outer member in the proximal position.

16. The method of claim 1, further comprising aspirating the fluid from the body lumen into the outlet of the outer member and through the first lumen.

17. The method of claim 1, wherein a proximal end of the treatment element overlaps with a distal end of the sealing member.

18. A method for treating a body lumen of a patient, the method comprising:

receiving a balloon apparatus comprising;

an outer member including a first lumen extending between a proximal end and an outlet in a distal end of the outer member,

an inner member slidable within the first lumen, the inner member comprising a second lumen,

a balloon attached to a distal end of the inner member distally beyond the distal end of the outer member, and

a sealing member on the inner member at least partially proximal to the balloon, the sealing member being in direct contact with the balloon, the sealing member having one or more passages in fluid communication with an interior of the balloon, and the sealing member being sized to at least partially enter the first lumen of the outer member such that the sealing member may substantially seal the outlet of the outer member;

introducing the distal end of the outer member into the body lumen with the balloon in a contracted condition and the inner member in a proximal position such that the sealing member substantially seals the outlet of the outer member;

actuating a proximal end of the apparatus to slide the inner member to a distal position, such that the sealing member is directed away from the outlet of the outer member;

delivering fluid through the first lumen such that some of the fluid exits through the outlet of the outer member into the body lumen and some of the fluid is delivered through the one or more passages in the sealing member directly into the interior of the balloon;

sliding the inner member towards the proximal position to substantially seal the outlet of the outer member with the sealing member such that the one or more passages in the sealing member communicate directly between the first lumen and the interior of the balloon; and

delivering the fluid through the first lumen with the outlet substantially sealed, thereby delivering fluid through the one or more passages of the sealing member into the interior of the balloon to expand the balloon from the contracted condition to an enlarged condition,

wherein the sealing member is configured to slide axially to partially obstruct the outlet of the outer member.

19. The method of claim 18, wherein the apparatus further comprises a tensioning element coupled between the inner and outer members, the tensioning element biasing the inner member proximally to enhance the sealing member sealing the outlet of the outer member in the proximal position.

20. The method of claim 18, further comprising:

directing the balloon to an expanded helical shape within the body lumen; and

directing the balloon along a wall of the body lumen in the expanded helical shape to remove material from the wall of the body lumen.

21. The method of claim 18, wherein the balloon further comprises a prosthesis in the contracted condition, and wherein the balloon expands the prosthesis within the body lumen when the balloon is expanded to the enlarged condition.

22. The method of claim 21, wherein the prosthesis comprises at least one of a stent, a stent-graft, and a prosthetic valve.

23. The method of claim 18, further comprising aspirating the fluid from the body lumen into the outlet of the outer member and through the first lumen.

24. The method of claim 18, wherein a proximal end of the balloon overlaps with a distal end of the sealing member.