Apparatus and methods for treating obstructions within body lumens

• US 10,624,656 B2
• Filed: 09/07/2017
• Issued: 04/21/2020
• Est. Priority Date: 07/03/2008
• Status: Active Grant

• Current Assignee: Teleflex Life Sciences LLC (Teleflex Incorporated)
• Original Assignee: Arrow International Incorporated (Teleflex Incorporated)
• Inventors: Krolik, Jeffrey A., Domingo, Juan, Watanabe, Gwendolyn, Betelia, Ray, Fernandez, Lucas
• Primary Examiner(s): Holwerda, Kathleen S
• Application Number:
  US15/698,622
• Publication Number:
  US 20170367720A1
• Time in Patent Office: 957 Days
• 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. An apparatus for treating a body lumen, the apparatus comprising:

an outer member including a proximal end, a distal end sized for introduction into a body lumen, and a first lumen extending between the proximal and distal ends;

an expandable balloon comprising a proximal end secured to the outer member distal end, and a distal end comprising an outlet, the balloon comprising an interior communicating with the first lumen and the balloon outlet;

an inner member slidably disposed within the first lumen, the inner member comprising a proximal end adjacent the outer member proximal end, and a distal end within the balloon interior adjacent the balloon outlet;

a sealing member on the inner member distal end;

a handle on the outer member proximal end;

an actuator on the handle coupled to the inner member for directing the inner member between a proximal position wherein the sealing member is spaced from the outlet such that fluid introduced through the first lumen passes through the outlet into a region around the apparatus, and a distal position wherein the sealing member is received at least partially within the balloon distal end to substantially seal the outlet; and

a tensioning element coupled between a stop in the balloon distal end and the sealing member for biasing the sealing member towards the proximal position.

2. The apparatus of claim 1, wherein the tensioning element is biased to automatically direct the inner member from the distal position to the proximal position when the actuator is released.

3. The apparatus of claim 1, wherein the actuator is configured to overcome the bias of the tensioning element to direct the inner member from the proximal position to the distal position.

4. The apparatus of claim 1, wherein the sealing member comprises a stop that engages the stop in the balloon distal end to limit distal advancement of the inner member in the distal position.

5. The apparatus of claim 1, wherein the sealing member comprises a valve body sized to be received through the balloon distal end, and one or more valve seals on the valve body that slidably engage an inner surface of the balloon distal end for substantially sealing the outlet.

6. The apparatus of claim 1, wherein the inner member has a cross-section smaller than the first lumen such that an annular lumen is defined between the inner member and the outer member for delivering fluid from the outer member proximal end into the balloon interior.

7. The apparatus of claim 1, further comprising another tensioning element coupled between the proximal and distal ends of the balloon for biasing the balloon distal end distally.

8. The apparatus of claim 1, further comprising a distal tip on the distal end of the inner member, the distal tip comprising a flexible curved shape.