Apparatus and methods for treating obstructions within body lumens

• US 8,926,649 B2
• Filed: 04/11/2012
• Issued: 01/06/2015
• 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:
  US13/444,739
• Publication Number:
  US 20120197193A1
• Time in Patent Office: 1,000 Days
• Field of Search: 606/108, 606/127, 606/159, 606/190, 606/192, 606/194, 606/200, 623/1.11, 623/1.12, 604/30, 604/33, 604 9901- 9904, 604/167.03
• US Class Current: 606/194
• 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, 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 end and an outlet in the distal end;

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 portion extending distally beyond the outer member distal end;

a sealing member fixedly connected to the inner member distal end portion comprising one or more passages within the sealing member between an outer surface of the sealing member and an outer surface of the inner member; and

an expandable balloon comprising a distal end secured to the inner member distal end portion distally beyond the sealing member, and a proximal end secured to the sealing member such that an interior of the balloon is in fluid communication with the one or more passages;

the inner member being movable between a first position wherein the sealing member is spaced from the outlet of the outer member such that fluid introduced through the first lumen passes through the outlet into a region around the apparatus, and a second position wherein the sealing member substantially seals the outlet such that fluid introduced through the first lumen passes through the one or more passages and enters the balloon interior to expand the balloon.

2. The apparatus of claim 1, further comprising a spring element coupled between the inner member and the outer member for biasing the inner member towards the second position.

3. The apparatus of claim 1, further comprising a handle on the outer member proximal end, and an actuator on the handle for directing the inner member from the second position to the first position to open the outlet of the outer member.

4. The apparatus of claim 1, wherein the inner member comprises a second lumen extending between the inner member proximal and distal ends for receiving an elongate member therethrough.

5. The apparatus of claim 1, wherein the sealing member comprises a tapered proximal end for enhancing seating the sealing member in the outlet of the outer member in the second position.

6. The apparatus of claim 1, further comprising a helical member comprising a first end coupled to the outer member distal end and a second end coupled to the inner member distal end portion, the helical member extending helically around the inner member within the balloon interior, the inner member movable distally to a third position to cause the helical member to expand radially outwardly, the balloon overlying the helical member to define an expanded helical shape.

7. The apparatus of claim 1, further comprising:

a handle on the outer member proximal end; and

an actuator on the handle coupled to the inner member for directing the inner member between the first and second positions.

8. An apparatus for treating a body lumen, 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 end and an outlet in the distal end;

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 portion extending distally beyond the outer member distal end;

a sealing member fixedly connected to the inner member distal end portion comprising one or more passages within the sealing member between an outer surface of the sealing member and an outer surface of the inner member; and

an expandable balloon comprising a distal end secured to the inner member distal end portion distally beyond the sealing member, and a proximal end secured to the sealing member such that an interior of the balloon is in fluid communication with the one or more passages;

a handle on the outer member proximal end; and

an actuator on the handle coupled to the inner member for directing the inner member between a distal position wherein the sealing member is spaced from the outlet such that the first lumen communicates with a region around the apparatus, and a proximal position wherein the sealing member substantially seals the outlet such that fluid introduced through the first lumen passes through the one or more passages and enters the balloon interior to expand the balloon.

9. The apparatus of claim 8, further comprising a tensioning element coupled between the inner member and the outer member for biasing the inner member towards the proximal position.

10. The apparatus of claim 8, wherein the inner member comprises a second lumen extending between the inner member proximal and distal ends for receiving an elongate member therethrough.

11. The apparatus of claim 8, wherein the sealing member comprises a tapered proximal end for enhancing seating the sealing member in the outlet of the outer member in the second position.

12. The apparatus of claim 8, wherein the sealing member comprises a valve body sized to be received through the outlet into the first lumen in the proximal position, and one or more valve seals on the valve body that slidably engage an inner surface of the first lumen for substantially sealing the outlet.

13. The apparatus of claim 8, further comprising a helical member comprising a first end coupled to the outer member distal end and a second end coupled to the inner member distal end portion, the helical member extending helically around the inner member within the balloon interior, the inner member movable distally to a third position to cause the helical member to expand radially outwardly, the balloon overlying the helical member to define an expanded helical shape.

14. An apparatus for treating a body lumen, 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 end and an outlet in the distal end;

an inner member slidably disposed within the first lumen, the inner member comprising a proximal end, and a distal portion extending distally beyond the outer member distal end;

a treatment element on the distal portion;

a sealing member fixedly connected to the distal portion proximal to the treatment element, the sealing member having one or more passages within the sealing member between an outer surface of the sealing member and an outer surface of the inner member;

wherein the treatment element is secured to the sealing member such that the sealing member is in fluid communication with the treating element;

a handle on the outer member proximal end; and

an actuator on the handle coupled to the inner member for directing the inner member between a distal 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 proximal position wherein the sealing member substantially seals the outlet.

15. The apparatus of claim 14, wherein the treatment element comprises a balloon having an interior communicating with the one or more passages extending through the sealing member such that, with the inner member in the proximal position, fluid introduced through the first lumen passes through the one or more passages and enters the balloon interior to expand the balloon.

16. The apparatus of claim 15, wherein the treatment element further comprises a prosthesis on the balloon that is expandable when the balloon is expanded.

17. The apparatus of claim 15, wherein the treatment element further comprises one or more elements on the balloon for delivering energy to tissue adjacent a body lumen.

18. The apparatus of claim 17, further comprising a generator coupled to the handle for delivering electrical energy to the one or more elements on the balloon.

19. The apparatus of claim 15, wherein the treatment element further comprises a cooling apparatus within the balloon for cooling tissue adjacent the body lumen.

20. The apparatus of claim 14, wherein the treatment element comprises a prosthesis carried on the distal portion in a contracted condition and biased to expand to an enlarged condition, the treatment element further comprising a constraint that overlies the prosthesis to maintain the prosthesis in the contracted condition, the constraint being removable to expose the prosthesis, whereupon the prosthesis resiliently expands towards the enlarged condition.

21. The apparatus of claim 20, wherein the constraint comprises a sleeve overlying the prosthesis, the handle comprising a second actuator coupled to the sleeve for directing the sleeve axially to expose the prosthesis.

22. The apparatus of claim 14, further comprising a distal tip on the distal portion of the inner member distally beyond the treatment element, the distal tip comprising a guidewire lumen communicating between a distal port and a side port proximal to the distal port and distal to the treatment element.

23. The apparatus of claim 14, further comprising a distal tip on the distal portion of the inner member distally beyond the treatment element, the distal tip comprising a flexible curved shape, and wherein the inner member is rotatable relative to the outer member for changing an orientation of the distal tip.

24. The apparatus of claim 14, further comprising a distal tip on the distal portion of the inner member distally beyond the treatment element, the distal tip being biased to a flexible curved shape, the inner member comprising a guidewire lumen extending between the proximal end and the distal portion and through the distal tip, the distal tip sufficiently flexible such that the distal tip is at least partially straightened when a guidewire is introduced through the guidewire lumen, the distal tip biased to the curved shape.