Flexible debulking catheters with imaging and methods of use and manufacture

• US 9,326,789 B2
• Filed: 06/13/2014
• Issued: 05/03/2016
• Est. Priority Date: 11/11/2010
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Fruland, Benjamin Robert, Garvey, Zachary Thomas, Guggenheimer, Ethan Andrew, McPeak, Thomas John, Pedersen, John Arthur, Petersen, Scott Robert, Crescenzo, Lindsay Ann
• Primary Examiner(s): Landry, II, Gerald
• Application Number:
  US14/303,760
• Publication Number:
  US 20150080700A1
• Time in Patent Office: 690 Days
• Field of Search: 600/459, 604/95.04, 604/264, 604/528
• US Class Current: 1/1
• CPC Class Codes: A61B 10/04 Endoscopic instruments
• CPC Class Codes: A61B 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/320791 with cutter extending outside the cutting window
• CPC Class Codes: A61B 2090/3784 both receiver and transmitter being in the instrument or receiver being also transmitter
• CPC Class Codes: A61B 5/0066 Optical coherence imaging
• CPC Class Codes: A61B 5/0086 using infrared radiation
• CPC Class Codes: A61B 5/055 involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 8/0891 for diagnosis of blood vessels
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/4209 by using holders, e.g. positioning frames
• CPC Class Codes: A61B 8/4281 characterised by sound-transmitting media or devices for coupling the transducer to the tissue
• CPC Class Codes: A61B 8/445 Details of catheter construction
• CPC Class Codes: A61B 8/4461 Features of the scanning mechanism, e.g. for moving the transducer within the housing of the probe
• CPC Class Codes: A61B 8/4472 Wireless probes
• CPC Class Codes: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/0082 : Catheter tip comprising a tool
• CPC Class Codes: A61M 25/01 : Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0136 : Handles therefor
• CPC Class Codes: G01R 33/287 : involving active visualization of interventional instruments, e.g. using active tracking RF coils or coils for intentionally creating magnetic field inhomogeneities
• CPC Class Codes: G10K 11/004 : Mounting transducers, e.g. provided with mechanical moving or orienting device mountings specially adapted to a particular sound-producing device, see the preceding groups G10K1/00 - G10K9/00, e.g. G10K1/26, G10K1/28, G10K9/22; arrangements of sonic watch equipment on submarines B63G8/39; buoys B63B22/00
• CPC Class Codes: Y10T 29/49826 : Assembling or joining

Abstract

Catheters and methods for removing material from (or “debulking”) a body lumen while imaging the region comprised of the material are provided. The catheters can be used in body lumens, including but not limited to intravascular lumens such as coronary or peripheral arteries. The catheters include housings or other structures to mount or protect an imaging transducer. Generally, debulking catheters include a proximal portion, a distal portion having an opening, a cutting element which may be exposed through the opening to contact material in a body lumen and an imaging transducer with associated circuitry and display. The catheter debulks a body lumen when it is moved while the cutting element is in contact with the material in the lumen and the region comprised of the material is imaged before, after, or during catheter movement.

Claims

1. A catheter for deployment in a vessel comprising:

a control handle;

an elongate proximal segment having proximal and distal ends, the proximal end being connected to the control handle;

a distal tip assembly having proximal and distal ends;

a tissue-removing element in the distal tip assembly;

a housing having a proximal end portion comprising a first material, a distal end portion comprising a second material, and a body portion extending between the proximal and distal end portions, the body portion comprising a third material, the first and second materials being different from the third material, the proximal end portion being connected to the distal end of the elongate proximal segment, the distal end portion being connected to the proximal end of the distal tip assembly, the housing having a luminal wall with an inner surface defining a lumen, the luminal wall having at least one slot; and

a transducer mounted at least partially within the lumen of the housing.

2. The catheter of claim 1 wherein an outer surface of the housing has at least one longitudinally extending rib on the outer surface of the luminal wall.

3. The catheter of claim 2 wherein the at least one longitudinally extending rib on the outer surface of the luminal wall is in the range of 5 to 8 ribs.

4. The catheter of claim 1 wherein the at least one slot in the luminal wall is two slots.

5. The catheter of claim 1 wherein the transducer is at a position spaced from the luminal wall to form a gap between the transducer and the luminal wall.

6. The catheter of claim 1 wherein the transducer is configured to have 360°

image capability of the vessel through the luminal wall of the housing and through the at least one slot of the housing, a radial angle of the circumference of the housing imaged by the transducer through the at least one slot in the luminal wall of the housing is in the range of 60°

to 180°

.

7. The catheter of claim 6 wherein the radial angle is in the range of 120°

to 150°

.

8. The catheter of claim 7 wherein the radial angle is 130°

.

9. The catheter of claim 4 wherein the transducer is configured to have 360°

image capability of the vessel through the luminal wall of the housing and through the at least one slot of the housing, radial angle of the circumference of the housing imaged by the transducer through each slot in the luminal wall of the housing is in the range of 60°

to 180°

.

10. The catheter of claim 9 wherein the radial angle is in the range of 65°

to 90°

.

11. The catheter of claim 10 wherein the radial angle is 73°

.

12. The catheter of claim 1 wherein the first and second materials comprise metal and the third material comprises polymer.

13. The catheter of claim 12 wherein the first material comprises stainless steel, the second material comprises tungsten and the third material comprises acrylonitrile butadiene styrene (ABS).

14. The catheter of claim 12 wherein the distal end of the elongate proximal segment connected to the proximal end portion of the housing comprises stainless steel.

15. The catheter of claim 1 further comprising:

a first tubular member having proximal and distal ends and a wall defining a lumen, at least a portion of the first tubular member being positioned within the lumen of the housing and being connected to the proximal end portion of the housing.

16. The catheter of claim 15 wherein a proximal portion of the first tubular member extends proximally from the proximal end of the housing within a lumen in the elongate proximal segment such that the proximal end of the first tubular member is proximal of the distal end of the elongate proximal segment.

17. The catheter of claim 15 further comprising:

a second tubular member having proximal and distal ends and a wall defining a lumen, at least a portion of the second tubular member being positioned within the lumen of the first tubular member, a distance between an outer surface of the wall of the second tubular member and an inner surface of the wall of the first tubular member defining a gap between the first and second tubular members; and

wherein the transducer further comprises wires extending proximally to the control handle, the wires being positioned to extend through the gap between the first and second tubular members.

18. The catheter of claim 15 wherein the distal end of the first tubular member is proximal of the slot in the housing.

19. The catheter of claim 17 wherein the distal end of the second tubular member is positioned between the distal and proximal ends of the first tubular member and the proximal end of the second tubular member is positioned proximal of the proximal end of the first tubular member.

20. The catheter of claim 1 wherein the distal end of the elongate proximal segment is connected to the proximal end portion of the housing by a weld.

21. The catheter of claim 1 wherein the distal end portion of the housing includes opposing pin holes which are positioned to align with opposing pin holes in the distal tip assembly and wherein the catheter further comprises pins positioned in the aligned pin holes.

22. The catheter of claim 17 further comprising a potting material contained within the gap between the first and second tubular members.

23. A catheter for deployment in a vessel comprising:

a control handle;

an elongate proximal segment having proximal and distal ends, the proximal end being connected to the control handle;

a distal tip assembly having proximal and distal ends;

a tissue-removing element in the distal tip assembly;

a housing having a proximal end portion, a distal end portion, and a body portion extending between the proximal and distal end portions, the proximal end portion being connected to the distal end of the elongate proximal segment, the distal end portion being connected to the proximal end of the distal tip assembly, the housing having at least one slot;

a first tubular member having proximal and distal ends and a wall defining a lumen, at least a portion of the first tubular member being positioned within the lumen of the housing and being connected to the proximal end portion of the housing; and

a transducer mounted at least partially within the lumen of the housing, at least a portion of the transducer being positioned within the lumen of the first tubular member, the transducer having image capability of the vessel through the at least one slot of the housing, the transducer including wires extending proximally to the control handle.

24. The catheter of claim 23 wherein a proximal portion of the first tubular member extends proximally from the proximal end of the housing within a lumen in the elongate proximal segment such that the proximal end of the first tubular member is proximal of the distal end of the elongate proximal segment.

25. The catheter of claim 23 further comprising:

a second tubular member having proximal and distal ends and a wall defining a lumen, at least a portion of the second tubular member being positioned within the lumen of the first tubular member, a distance between an outer surface of the wall of the second tubular member and an inner surface of the wall of the first tubular member defining a gap between the first and second tubular members, the wires extending through the gap between the first and second tubular members.

26. The catheter of claim 23 wherein the distal end of the first tubular member is proximal of the slot in the housing.

27. The catheter of claim 25 wherein the distal end of the second tubular member is positioned between the distal and proximal ends of the first tubular member and the proximal end of the second tubular member is positioned proximal of the proximal end of the first tubular member.

28. The catheter of claim 25 further comprising a potting material contained within the gap between the first and second tubular members.