APPARATUS AND METHODS FOR REMOVING OBSTRUCTIVE MATERIAL FROM BODY LUMENS

• US 20100036312A1
• Filed: 06/08/2009
• Published: 02/11/2010
• Est. Priority Date: 06/08/2008
• Status: Active Grant

• Current Assignee: Teleflex Life Sciences LLC (Teleflex Incorporated)
• Original Assignee: Hotspur Technologies, Inc. (Teleflex Incorporated)
• Inventors: Domingo, Juan, Watanabe, Gwendolyn, Dreher, James H., Krolik, Jeffrey A., Mirzae, Daryush
• Granted Patent: US 8,939,991 B2
• Time in Patent Office: Days
• US Class Current: 604/22
• 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 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/22079 with suction of debris
• CPC Class Codes: A61B 2017/2217 single wire changing shape to a gripping configuration
• CPC Class Codes: A61B 2017/320064 with tissue or sample retaining means
• CPC Class Codes: A61B 2017/320775 Morcellators, impeller or propeller like means
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 2025/09175 having specific characteristics at the distal tip
• CPC Class Codes: A61M 2025/09183 having tools at the distal tip
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/09 Guide wires
• 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

Abstract

An apparatus is provided for removing material within a body lumen that includes a catheter including a proximal end, a distal end for introduction into a body lumen, and an aspiration lumen extending therebetween; a guide member extending from the distal end and terminating in a distal tip, the guide member comprising a track adjacent a track lumen extending from the distal tip into the aspiration lumen; and an obstruction clearing device deployable from the guide member and retractable along the track. In addition or alternatively, the apparatus includes a cutting head reciprocable within the aspiration lumen adjacent the distal end for macerating material being aspirated into the aspiration lumen.

Claims

1. An apparatus for removing material within a body lumen, comprising:

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

a guide member extending from the distal end and terminating in a distal tip, the guide member comprising a track adjacent a track lumen extending from the distal tip into the aspiration lumen; and

an obstruction clearing device comprising a core wire slidable within the track lumen and one or more lumen clearing elements deployable from the distal tip of the guide member when the core wire is advanced relative to the guide member, the lumen clearing elements comprising an expandable structure that is expanded from a contracted condition within the guide member to an expanded condition when deployed from the guide member for engaging material within a body lumen, the expandable structure directable proximally along the track in the expanded condition when the core wire is subsequently retracted relative to the guide member for drawing the one or more lumen clearing elements and any captured material into the aspiration lumen of the tubular member.

2. The apparatus of claim 1, wherein the guide member comprises an orifice in a side wall thereof communicating with the track lumen, the orifice located within the aspiration lumen such that, when the core wire is retracted relative to the guide member, the expandable structure is compressed inwardly towards the contracted condition and the one or more lumen clearing elements are drawn through the orifice into the track lumen.

3. The apparatus of claim 2, wherein the one or more lumen clearing elements are oriented substantially axially within the track lumen when the one or more lumen clearing elements are drawn through the orifice into the track lumen such that, when the core wire is advanced relative to the guide member, the one or more lumen clearing elements are directed through the track lumen in the contracted condition until the one or more lumen clearing elements are redeployed from the distal tip of the guide member.

4. The apparatus of claim 1, wherein the one or more lumen clearing elements comprise a flexible arm coupled to the expandable structure.

5. The apparatus of claim 1, wherein the expandable structure comprises a hoop.

6. The apparatus of claim 1, wherein the expandable structure comprises a plurality of loops.

7. The apparatus of claim 1, wherein the expandable structure comprises one or more cutting edges.

8. The apparatus of claim 1, wherein the track comprises a longitudinal slit in the guide member.

9. The apparatus of claim 1, wherein the one or more lumen clearing elements comprise a plurality of expandable structures spaced apart axially along the core wire such that the expandable structures are deployed successively from the distal tip of the guide member.

10. The apparatus of claim 1, further comprising a handle on the tubular member proximal end and an actuator on the handle coupled to the core wire for directing the core wire axially relative to the guide member for deploying and retracting the one or lumen clearing elements.

11. A method for removing material within a body lumen of a patient, comprising:

introducing a distal end of a tubular member into a body lumen, the tubular member having a guide member extending distally from the distal end;

positioning the tubular member such that the distal end is disposed adjacent material to be removed and a distal tip of the guide member is disposed beyond the material;

deploying one or more lumen clearing elements from the distal tip of the guide member, each lumen clearing element comprising an expandable structure that expands from a contracted condition within the guide member to an expanded condition when deployed from the distal tip; and

retracting the deployed one or more lumen clearing elements along a track of the guide member to engage the material disposed adjacent the distal end of the tubular member and draw the material into a lumen of the tubular member.

12. The method of claim 11, further comprising aspirating the material drawn into the lumen of the tubular member to remove the material from the body lumen.

13. The method of claim 11, wherein, as the deployed one or more lumen clearing elements are retracted along a track, the expandable structure is directed into the tubular member lumen and compressed towards the contracted condition.

14. The method of claim 13, wherein the material engaged by the lumen clearing elements is separated into multiple pieces as the expandable structure is directed into the tubular member lumen and compressed towards the contracted condition.

15. The method of claim 11, wherein retracting the deployed one or more lumen clearing elements along the track of the guide member comprises retracting the one or more lumen clearing elements through an orifice into the guide member to compress and draw the one or more lumen clearing elements into the guide member.

16. The method of claim 15, further comprising redeploying the one or more lumen clearing elements from the distal tip of the guide member after retracting the one or more lumen clearing elements through the orifice into the guide member.

17. The method of claim 11, wherein the expandable structure comprises a hoop that extends substantially across the body lumen in the expanded condition when deployed from the distal tip.

18. The method of claim 17, wherein the expandable structure further comprises a flexible arm coupled to the hoop, the flexible arm sliding along the track when the deployed one or more lumen clearing elements are retracted along the track.

19. The method of claim 11, wherein the one or more lumen clearing elements comprise a plurality of expandable structures spaced apart from one another such that the expandable structures are deployed successively from the distal tip of the guide member.

20. The method of claim 11, wherein the expandable structure is aligned axially within the guide member in the contracted condition, and wherein the expandable structure resiliently extends transversely relative to the guide member when deployed in the expanded condition.

21. An apparatus for removing material within a body lumen, comprising:

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

a cutting head disposed within the aspiration lumen adjacent the distal end, the cutting head being reciprocable axially within the aspiration lumen for macerating material being aspirated into the aspiration lumen.

22. The apparatus of claim 21, further comprising a vacuum source communicating with the aspiration lumen for selectively applying vacuum to the aspiration lumen to aspirate material into the distal end of the tubular member.

23. The apparatus of claim 21, further comprising a control system carried within a handle on the proximal end of the tubular member, the control system controlling reciprocation of the cutting head within the aspiration lumen.

24. The apparatus of claim 23, further comprising a drive shaft extending from the cutting head to the proximal end of the tubular member, the control system comprising a motor coupled to the drive shaft for reciprocating the drive shaft axially, thereby reciprocating the cutting head axially within the aspiration lumen.

25. The apparatus of claim 21, wherein the cutting head comprises a rounded tip that is exposed from the distal end of the tubular member and a plurality of teeth extending along a side edge of the cutting head.

26. The apparatus of claim 21, wherein the distal end of the tubular member terminates in a beveled tip, the tubular member further comprising an expandable member on an outer wall of the tubular member opposite the beveled tip.

27. The apparatus of claim 26, wherein the cutting head is reciprocable relative to the distal end of the tubular member such that the cutting head moves between a proximal position fully within the aspiration lumen and a distal position wherein the cutting head does not extend beyond the beveled tip.

28. The apparatus of claim 21, further comprising a flow restoration device extending distally beyond the distal end of the tubular member, the flow restoration device comprising an expandable member on a distal tip thereof.

29. The apparatus of claim 28, further comprising a clutch device within a handle on the proximal end of the tubular member, the clutch device coupled to the flow restoration device such that, when the cutting head is activated, the clutch device causes the expandable member on the flow restoration device to move proximally towards the distal end of the tubular member.

30. The apparatus of claim 28, wherein the expandable member of the flow restoration device comprises one or more cutting elements for removing adherent material from a wall of a body lumen within which the apparatus is disposed.

31. A method for removing material within a body lumen of a patient, comprising:

introducing a distal end of a tubular member into a body lumen, the tubular member comprising an aspiration lumen and a cutting head disposed within the aspiration lumen near the distal end;

positioning the tubular member such that the distal end is disposed adjacent material to be removed;

applying a vacuum pressure to the aspiration lumen to draw material within the body lumen towards the distal end of the tubular member; and

activating the cutting head to cause the cutting head to reciprocate axially relative to the distal end to macerate material drawn to the distal end of the tubular member to break the material into pieces sufficiently small to be aspirated into the aspiration lumen by the vacuum pressure.