Self-activating endoluminal device

• US 8,382,786 B2
• Filed: 08/13/2010
• Issued: 02/26/2013
• Est. Priority Date: 10/27/2004
• Status: Active Grant

• Current Assignee: Petrus A. Besselink
• Original Assignee: Petrus A. Besselink
• Inventors: Besselink, Petrus A., Hanssen, Hans, Markus, Wouter
• Primary Examiner(s): SEVERSON, RYAN J
• Application Number:
  US12/856,206
• Publication Number:
  US 20110196410A1
• Time in Patent Office: 928 Days
• Field of Search: 600/184, 600433-435, 604104-109, 604/164.01, 604/528, 606/159, 606/191, 606/200
• US Class Current: 606/191
• 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 2017/00309 Cut-outs or slits
• CPC Class Codes: A61B 2017/0046 with a releasable handle; with handle and operating part separable for prosthetic joint-implanting tools A61F2/4603
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2017/22047 Means for immobilising the guide wire in the patient
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2230/0097 Harpoon-shaped
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/09141 made of shape memory alloys which take a particular shape at a certain temperature
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/09025 with sliding mandrils
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

An improved endoluminal device. The device includes at least a control element (such as a guide wire, tube or related structure) connected to a surrounding sheath and an elastic bias section to control changes to a bias force formed between the control element and the sheath. By applying an external force at a proximal end of the device, the shape can change between varying degrees of deformed shapes and an undeformed shape. In this way, both ease of insertion into the body lumen and anchoring to the lumen is promoted. A distal end of the assembly can be made to change shape for improved steerability, anchoring or both. In a particular form, the anchoring section can work as a floating parachute-like device to pull the assembly by means of the flow in the body lumen, while in a more particular form, the floating parachute-like device may be modified to act as a filter for trapping emboli.

Claims

1. A medical device for use in a body lumen, said device comprising:

a tubular sheath comprising;

a proximal end;

a distal end opposite said proximal end;

at least one reconfigurable section disposed intermediate said proximal and distal ends; and

an elastic bias section disposed proximal relative to said reconfigurable section to vary the axial length thereof; and

an elongate control element defining a proximal end and a distal end, said control element sized to allow longitudinal placement thereof within said sheath, said sheath and control element fixedly attached to one another such that a tensile force imposed by said sheath on said control element through said fixed attachment is sufficient to bias at least a portion of said reconfigurable section in a bent shape that can be overcome by imparting an external force on said sheath through said elastic bias section.

2. The device of claim 1, wherein said biased portion of said reconfigurable section comprises a steerable section disposed adjacent said distal end of said sheath.

3. The device of claim 2, wherein said steerable section defines at least one slot formed in said sheath.

4. The device of claim 3, wherein another portion of said reconfigurable section comprises an anchoring section.

5. The device of claim 4, wherein a substantial entirety of said reconfigurable section and said elastic bias section define a substantially similar outer radial profile when said anchoring section is in said substantially undeformed shape.

6. The device of claim 4, wherein said tensile force imposed by said sheath on said control element through said fixed attachment is sufficient to bias said anchoring section in a deformed shape that can be overcome by imparting an external force on said sheath through said elastic bias section.

7. The device of claim 6, wherein said deformed shape comprises an at least partially expanded radial state.

8. The device of claim 6, wherein said deformed shape comprises a substantially helical shape.

9. The device of claim 1, wherein said reconfigurable section comprises a steerable section and an anchoring section proximal relative to said steerable section.

10. The device of claim 9, whereupon a change in said tensile force produced by said imparting an external force on said sheath through said elastic bias section is sufficient to cause said anchoring section to assume a substantially undeformed shape prior to causing said steerable section to assume a substantially undeformed shape.

11. The device of claim 1, wherein said device is selected from the group consisting of a catheter, steerable tip, stent, filter, angioplasty balloon, drain, dilator, basket, anchor, floating anchor, occlusion device, guide wire, stylet, electrode, lead, drain, catheter sheath for use with catheter introducers or a drug infusion catheter, and combinations thereof.

12. The device of claim 11, wherein said floating anchor is configured as an anchoring section such that radial expansion thereof is not constrained by said body lumen upon insertion of said floating anchor therein.

13. The device of claim 1, wherein said elongate control element is made of at least one of a polymer wire, a polymer strip, a polymer tube, a metal wire, a metal strip, a metal tube, a shape memory tube, a superelastic tube and combinations thereof.

14. The device of claim 13, further comprising an endoluminal device configured to slidably fit through said elongated control element when said elongated control element defines a tubular structure.

15. A medical device for use in a body lumen, said device comprising:

a tubular sheath comprising;

a proximal end;

a distal end opposite said proximal end;

at least one reconfigurable section disposed intermediate said proximal and distal ends; and

an elastic bias section disposed proximal relative to said reconfigurable section; and

an elongate control element defining a proximal end and a distal end, said control element sized to allow longitudinal placement thereof within said sheath, said sheath and control element fixedly attached to one another such that a tensile force is imposed by said sheath on said control element through said fixed attachment, said tensile force sufficient to bias said reconfigurable section in an deformed first shape that can be overcome by imparting an external force on said sheath through said elastic bias section such that said medical device assumes a second shape different from said first shape, said reconfigurable section and said elastic bias section sized such that they define a substantially similar outer radial profile while in a substantially undeformed form of said second shape.

16. The device of claim 15, wherein said elastic bias section is integrally formed within said tubular sheath.

17. The device of claim 15, wherein said reconfigurable section comprises a steerable section and an anchoring section.

18. The device of claim 17, wherein said steerable section in said deformed first shape defines a bent shape and said anchoring section in said deformed first shape defines an expanded shape.

19. The device of claim 18, wherein said second shape comprises at least one of:

said steerable section defining either a bent shape that is less bent than in said deformed first shape or substantially unbent; and

said anchoring section defining either an expanded shape that is less expanded than in said expanded first shape or substantially unexpanded.

20. The device of claim 15, wherein said device is selected from the group consisting of a catheter, steerable tip, stent, filter, angioplasty balloon, drain, dilator, basket, anchor, floating anchor, occlusion device, guide wire, stylet, electrode, lead, drain, catheter sheath for use with catheter introducers or a drug infusion catheter, and combinations thereof.

21. The device of claim 15, wherein said elongate control element defines a tubular structure.

22. The device of claim 21, further comprising an endoluminal device configured to fit within a lumen defined by said tubular structure of said elongate control element.

23. An assembly for medical use, said assembly comprising:

a tubular sheath defining a proximal end, a distal end and a reconfigurable section disposed intermediate said proximal and distal ends, said reconfigurable section comprising a steerable section and an anchoring section;

a wire defining a proximal end and a distal end, said wire and said sheath fixedly attached to one another at substantially opposing ends thereof such that a tensile force imposed by said sheath on said wire through said fixed attachment is sufficient to bias at least one of said steerable and anchoring sections in a deformed first shape; and

an elastic bias section cooperative with said sheath and configured such that upon application of a variation in said tensile force through movement of said elastic bias section relative to said sheath, at least one of said steerable and anchoring sections assumes a second shape that is at least less deformed than said first shape.

24. The assembly of claim 23, further comprising a tool coupled to said elastic bias section to control said variation in said force between said sheath and said wire.

25. The assembly of claim 23, wherein said first shape comprises a bent shape for said steerable section.

26. The assembly of claim 23, wherein said assembly is selected from the group consisting of a catheter, steerable tip, stent, filter, angioplasty balloon, drain, dilator, basket, anchor, floating anchor, occlusion device, guide wire, stylet, electrode, lead, drain, catheter sheath for use with catheter introducers or a drug infusion catheter, and combinations thereof.

27. The assembly of claim 26, wherein said floating anchor is configured as an anchoring section such that radial expansion thereof that corresponds to said deformed first shape is not constrained by a body lumen upon insertion of said floating anchor therein.