Apparatus and methods for treating obstructions within body lumens

• US 9,731,099 B2
• Filed: 10/24/2012
• Issued: 08/15/2017
• 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., Watanabe, Gwendolyn, Domingo, Juan
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): Snyder, Melissa A
• Application Number:
  US14/353,868
• Publication Number:
  US 20140303554A1
• Time in Patent Office: 1,756 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 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 17/32056 Surgical snare instruments for removing or smashing calculi A61B2017/2212; tonsillotomes A61B17/26
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/22001 Angioplasty, e.g. PCTA
• 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 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61B 2090/0811 for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• 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 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• 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 2025/1052 for temporarily occluding a vessel for isolating a sector
• 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 25/1018 : Balloon inflating or inflation-control devices
• CPC Class Codes: A61M 25/10184 : Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 25/10185 : Valves
• CPC Class Codes: A61M 25/104 : used for angioplasty

Abstract

An apparatus is provided that operable in different modes to perform various functions for treating a body lumen. The apparatus includes a shaft including a proximal end, a distal end, a lumen extending therebetween, and a balloon on the distal end having an interior communicating with the lumen. The apparatus includes a valve on the distal end that selectively opens or closes an outlet communicating with the lumen. With the valve open, fluid introduced into the lumen exits the outlet into a body lumen. With the valve closed, fluid introduced into the lumen expands the balloon. The apparatus also includes an actuator for axially compressing the balloon, and a helical member extends between ends of the balloon interior that expands the balloon from a contracted condition to an expanded helical shape when the actuator is activated.

Claims

1. An apparatus for treating a body lumen, comprising:

an elongate tubular 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 balloon wall, a proximal end secured to the distal end of the elongate tubular member, a distal end comprising an outlet, and an interior defined by the balloon wall communicating with the first lumen and the balloon outlet;

an elongate member slidably disposed within the first lumen, the elongate member comprising a proximal end adjacent the proximal end of the elongate tubular member, and a distal end at least partially extending from the balloon outlet; and

a sealing member on the distal end of the elongate member, the sealing member comprising a first bump and a second bump spaced from and distal to the first bump, the first bump and second bump having a cross-sectional area greater than a cross-sectional area of the balloon outlet,

wherein the elongate member is movable between a first position wherein the balloon outlet is spaced from and between the first bump and the second bump of the sealing member such that fluid introduced through the first lumen passes through the balloon interior and out the balloon outlet, and a second position wherein the second bump is in contact with the balloon outlet to substantially seal the balloon outlet such that fluid introduced through the first lumen enters the balloon interior to expand the balloon.

2. The apparatus of claim 1, wherein the distal end of the elongate member has a cross-sectional area smaller than the balloon outlet such that an annular lumen is defined between the elongate member and the balloon outlet for delivering fluid from the balloon interior through the balloon outlet when the elongate member is in the first position.

3. The apparatus of claim 1, wherein the elongate member has a cross-sectional area smaller than the first lumen such that an annular lumen is defined between the elongate member and the elongate tubular member for delivering fluid from the proximal end of the elongate tubular member into the balloon interior.

4. The apparatus of claim 1, wherein the balloon wall comprises elastic material.

5. The apparatus of claim 1, wherein the balloon wall comprises substantially inelastic material.

6. The apparatus of claim 1, further comprising a handle on the proximal end of the elongate member, and an actuator on the handle for directing the elongate member between the first and second positions.

7. The apparatus of claim 1, wherein the elongate member is biased to one of the first and second positions.

8. The apparatus of claim 1, further comprising a helical member including a first end coupled to the distal end of the elongate tubular member and a second end coupled to the distal end of the elongate member, the helical member extending helically around the elongate member within the balloon interior, the elongate member movable to a third position in which the distal end of the elongate member is directed towards the distal end of the elongate tubular member to cause the helical member to expand radially outwardly to an expanded helical shape, thereby expanding the balloon to the expanded helical shape.

9. The apparatus of claim 8, wherein the second end of the helical member is coupled to a stop secured to the distal end of the elongate member, the stop having a cross-section larger than the balloon outlet such that the stop limits relative movement of the distal end of the balloon relative to the distal end of the elongate member as the elongate member is directed between the second and third positions.

10. The apparatus of claim 8, further comprising a source of vacuum communicating with the first lumen for collapsing the balloon before the elongate member is directed to the third position such that the balloon conforms substantially to the expanded helical shape of the helical member.

11. The apparatus of claim 8, wherein the distal end of the balloon is directed towards the proximal end of the balloon when the elongate member is moved to the third position, thereby axially compressing the balloon.

12. The apparatus of claim 11, further comprising a stop on the distal end of the elongate member proximal to the distal end of the balloon, the elongate member movable from the third position back towards the second position, thereby extending and collapsing the helical member, the stop engaging the distal end of the balloon and directing the distal end of the balloon distally as the elongate member is moved from the third position back towards the second position, thereby axially extending and collapsing the balloon.

13. The apparatus of claim 8, wherein the helical member comprises first and second regions between the first and second ends, the first region expandable to a diameter greater than the second region such that the balloon defines first and second helical regions in the expanded helical shape, the first helical region having a diameter greater than the second helical region.

14. The apparatus of claim 1, wherein the elongate member is movable to a third position wherein the first bump is in contact with the balloon outlet to axially extend and collapse the balloon.

15. The apparatus of claim 1, further comprising a helical member integral with or coupled directly to the balloon wall, the helical member helically extending between the proximal end of the balloon and the distal end of the balloon.

16. The apparatus of claim 15, wherein the helical member comprises wires or fibers.

17. The apparatus of claim 15, wherein the helical member is radiopaque.

18. The apparatus of claim 15, wherein the helical member is integral with the balloon wall.

19. The apparatus of claim 1, wherein the proximal end and the distal end of the balloon comprise stiffening members.