Apparatus and methods for treating obstructions within body lumens

• US 8,945,160 B2
• Filed: 07/23/2010
• Issued: 02/03/2015
• Est. Priority Date: 07/03/2008
• 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, Betelia, Ray, Dreher, James H., Mirzaee, Daryush, Fernandez, Lucas
• Primary Examiner(s): HOLWERDA, KATHLEEN SONNETT
• Application Number:
  US12/843,004
• Publication Number:
  US 20110125132A1
• Time in Patent Office: 1,656 Days
• Field of Search: 606/127, 606/159, 606/194, 606/200, 604 9601-10314, 604/509
• US Class Current: 606/159
• 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 17/320725 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 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2017/2215 having an open distal end
• 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 2025/1068 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 25/104 : used for angioplasty
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

An apparatus is provided that is operable in different modes to perform various functions for treating a body lumen. The apparatus includes a shaft including proximal and distal ends, a lumen extending therebetween, and a balloon on the distal end. 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 valve may be biased to be closed, e.g., by a spring element disposed within the balloon. Optionally, the apparatus also includes an actuator for expanding a helical member within the balloon interior, e.g., either before or after expanding the balloon, such that the helical member and balloon may adopt an expanded helical shape for removing material within a body lumen.

Claims

1. A method for treating a body lumen of a patient using a balloon apparatus comprising an outer member including a first lumen extending between proximal and distal ends thereof, an inner member having a proximal end and a distal end slidable within the first lumen, an inner member distal tip, wherein the inner member distal tip is softened, and a balloon comprising a proximal end attached to the outer member distal end, a distal end including an outlet and an interior communicating with the first lumen and the outlet, and a helical member coupled between the outer member and the inner member, wherein the inner member comprises a second lumen that is sized to slideably receive a guidewire that may be delivered into the body lumen, the method comprising, in combination:

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

directing an actuator on a proximal end of the balloon apparatus to move the inner member to a distal position consequently directing the sealing member distally to open the outlet;

delivering a first fluid through the first lumen such that the first fluid passes through the balloon interior and exits the open outlet into the body lumen;

directing the inner member towards the proximal position to substantially seal the outlet with the sealing member, a spring element biasing the inner member to enhance the sealing member sealing the outlet; and

delivering a second fluid through the first lumen with the outlet substantially sealed, thereby expanding the balloon from the contracted condition to an enlarged condition.

2. The method of claim 1, 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 to the location of material and distal to the location of material in the expanded helical shape to remove material from the wall of the body lumen.

3. The method of claim 2, wherein directing the balloon to the expanded helical shape comprises:

expanding the balloon at least partially towards the enlarged condition;

expanding the helical member within the balloon interior with the balloon at least partially expanded towards the enlarged condition; and

collapsing the balloon around the expanded helical member such that the balloon conforms substantially to the shape of the helical member.

4. The method of claim 2, wherein directing the balloon to the expanded helical shape comprises expanding the helical member within the balloon interior with the balloon collapsed such that the balloon conforms substantially to the shape of the helical member.

5. The method of claim 2, wherein directing the balloon to the expanded helical shape comprises directing the inner member proximally relative to the outer member, thereby compressing the balloon axially and expanding the helical member within the balloon interior, the balloon conforming substantially to the shape of the helical member as the helical member is expanded.

6. The method of claim 1, wherein the body lumen comprises at least one of an arterio-venous graft and an arterio-venous fistula.

7. The method of claim 1, wherein the helical member is disposed around the inner member within the balloon interior in a reduced profile when the distal end of the outer member is introduced into the body lumen, wherein a distal end of the helical member is coupled to the spring element, the spring element providing compliance to the helical member in the reduced profile when the inner member is directed to the distal position.

8. The method of claim 1, wherein the balloon is expanded to the enlarged condition to dilate a lesion within the body lumen.

9. The method of claim 1, wherein the first fluid or the second fluid comprises contrast, the method further comprising:

imaging the body lumen using external imaging that is enhanced by the contrast; and

manipulating the distal end of the outer member within the body lumen based at least in part on the external imaging.

10. The method of claim 1, wherein the first fluid or the second fluid comprises one or more diagnostic or therapeutic agents.

11. A method for treating a body lumen of a patient using an apparatus comprising an outer tubular member comprising a first lumen extending between proximal and distal ends thereof, and a balloon comprising a proximal end attached to the outer tubular member distal end, a distal end including an outlet and an interior communicating with the first lumen and the outlet, and a helical member coupled between the outer tubular member and an elongate member, the method comprising, in combination:

introducing a distal end of the elongate member into a patient'"'"'s body until the distal end is disposed within a body lumen, the elongate member comprising a sealing member on the distal end;

advancing the distal end of the outer member over the elongate member with the balloon in a contracted condition until the balloon outlet is disposed adjacent the sealing member;

coupling an actuator on the outer member proximal end to the elongate member;

directing the actuator to a first position wherein the sealing member substantially seals the outlet;

delivering fluid into the first lumen with the outlet substantially sealed, thereby expanding the balloon to an enlarged condition;

directing the actuator to a second position wherein the sealing member is spaced from the outlet;

delivering fluid into the first lumen with the sealing member spaced from the outlet, thereby delivering the fluid from the outlet into the body lumen; and

directing the balloon to an expanded helical shape within the body lumen wherein the expanded helical shape includes a first helix and a second helix, the first helix and the second helix having different diameters;

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; and

collapsing the balloon around the helical member.

12. The method of claim 11, further comprising:

decoupling the actuator from the elongate member; and

removing the outer member from around the elongate member.

13. The method of claim 11, further comprising:

directing the balloon to an expanded helical shape within the body lumen whereby the expanded helical shape includes more than two helices having different diameters.