Medical device and method

• US 9,498,604 B2
• Filed: 03/07/2014
• Issued: 11/22/2016
• Est. Priority Date: 11/12/1997
• Status: Active Grant

• Current Assignee: Vascular Development Corporation LLC
• Original Assignee: Genesis Technologies LLC
• Inventors: Dubrul, William R., Seybold, Brent D., Mathis, Mark L., Leopold, Philip M., Fulton, Richard E. III
• Primary Examiner(s): Houston, Elizabeth
• Assistant Examiner(s): BACHMAN, LINDSEY MICHELE
• Application Number:
  US14/201,371
• Publication Number:
  US 20140188127A1
• Time in Patent Office: 991 Days
• Field of Search: 606/200, 606/108, 606113-114, 606127-128, 606/198
• US Class Current: 1/1
• CPC Class Codes: A61B 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• CPC Class Codes: A61B 10/0266 means for severing sample
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/22004 using mechanical vibrations, e.g. ultrasonic shock waves A61B17/225 takes precedence
• 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 17/3421 Cannulas
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 2017/00287 Bags for minimally invasive surgery
• CPC Class Codes: A61B 2017/00955 thermoplastic
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22079 : with suction of debris
• 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 2018/1407 : Loop
• CPC Class Codes: A61B 2090/3904 : specially adapted for marking specified tissue
• CPC Class Codes: A61B 2090/3908 : Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 2090/3962 : palpable
• CPC Class Codes: A61B 6/502 : for diagnosis of breast, i.e. mammography
• CPC Class Codes: A61B 90/39 : Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61B 90/40 : Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment
• CPC Class Codes: A61M 25/0045 : multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/0052 : Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
• CPC Class Codes: A61M 25/0074 : Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0119 : Eversible catheters
• CPC Class Codes: A61M 25/04 : in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/104 : used for angioplasty

Abstract

A vessel-occluding medical device for the use in diagnosis and/or treatment of cardiovascular disease in the human body includes an outer tube, an inner tube slidably housed within the outer tube, and a tubular sleeve comprising a generally U-shaped, direction reversing region, which moves along the length of the tubular sleeve, to assume radially contracted and radially expanded state as the inner and outer tubes move between the first and second positions. When the tubular sleeve is in the radially expanded state, the inner portion of the tubular sleeve has a funnel-shaped surface and a longitudinally-extending opening to permit material to pass therethrough for receipt of material into the inner tube.

Claims

1. A method for occluding a blood vessel, the method comprising:

advancing an occluding catheter through the blood vessel in a direction of blood flow to position a distal end of the catheter near a target site in the blood vessel to be occluded; and

translating an outer tube of the catheter relative to an inner tube of the catheter to cause a flexible mesh braid sleeve to expand out from the distal end of the catheter to contact an inner wall of the blood vessel and occlude blood flow in the blood vessel,

wherein the flexible mesh braid sleeve is partially coated so that upon expansion, the flexible mesh braid sleeve assumes a pre-programmed expanded configuration having a funnel-shaped inner surface in fluid communication with a lumen of the inner tube of the catheter and an outer surface comprising a distal cylindrical portion in contact with the inner wall of the blood vessel and a proximal conical portion,

wherein the flexible mesh braid sleeve comprises a U-shaped, direction reversing region between the inner and outer surfaces and connecting the inner and outer surfaces to one another,

wherein a distal tip of the inner tube of the catheter is connected to a first end of the flexible mesh braid sleeve and a distal tip of the outer tube of the catheter is connected to a second end of the flexible mesh braid sleeve, and

wherein translating the outer tube relative to the inner tube comprises changing the relative positions of the distal tips of the inner and outer tubes of the catheter, thereby changing relative positions of the inner and outer surfaces of the expanded flexible mesh braid sleeve and a location of the U-shaped region.

2. A method as in claim 1, wherein translating the outer tube causes the sleeve to expand such that an outer surface of the expanded sleeve forms a seal with the inner wall of the blood vessel.

3. A method as in claim 1, further comprising adjusting a position of the outer tube relative to a position of the inner tube to provide the expanded flexible mesh braid sleeve with a desired diameter to fit the inner wall of the blood vessel.

4. A method as in claim 1, further comprising moving at least one of the inner tube relative to the outer tube or the outer tube relative to the inner tube to adjust a size of the expanded flexible mesh braid sleeve.

5. A method as in claim 1, further comprising retracting an expandable element disposed on a guide wire disposed within the inner lumen of the inner tube or applying suction force through the lumen of the inner tube.

6. A method as in claim 1, wherein translating the outer tube of the catheter relative to the inner tube of the catheter comprises pulling the inner tube relative to the outer tube.

7. A method as in claim 1, wherein the flexible mesh braid sleeve comprises a tubular, mesh braided sleeve.

8. A method as in claim 7, wherein the tubular, mesh braided sleeve is formed on a conically-shaped mandril and comprises multiple Nitinol strands.

9. A method as in claim 8, wherein each of the Nitinol strands have a diameter of 0.0015-0.0025 inches.

10. A method as in claim 1, wherein the flexible mesh braid sleeve comprises a shape memory material such that the flexible mesh braid sleeve is programmed to form into the pre-programmed expanded configuration.

11. A method as in claim 10, wherein the flexible mesh braid sleeve has gradients of stiffness present along its length to incite buckling and formation of the pre-programmed expanded configuration when the outer tube and inner tube of the catheter are translated relative to one another.

12. A method as in claim 10, wherein the proximal conical portion of the outer surface of the expanded flexible mesh braid sleeve inwardly tapers from the distal cylindrical portion of the outer surface.

13. A method as in claim 1, wherein the flexible tubular mesh braid sleeve is coated with a polymer.

14. A method as in claim 13, wherein the polymer comprises one or more of silicone, polyisoprene, polyurethane, or polyethylene.

15. A method as in claim 13, wherein the polymer-coated portion of the flexible sleeve is fluid-impermeable, and wherein the uncoated portion is fluid-permeable.

16. A method as in claim 13, wherein the polymer-coated portion of the flexible sleeve comprises a flexible, elastic film on an outer surface of the flexible sleeve.

17. A method for at least partially occluding a blood vessel and removing a target object therefrom, the method comprising:

positioning a distal end of an occluding catheter near the target object;

translating inner and outer tubes of the catheter relative to one another thereby causing a flexible, tubular mesh braid sleeve at the distal end of the inner and outer tubes to radially expand to contact an inner wall of the blood vessel and occlude blood flow in the blood vessel, wherein the mesh braid sleeve is at least partially coated so that upon expansion, the mesh braid sleeve assumes a pre-programmed expanded configuration having an inner surface in fluid communication with a lumen of the inner tube of the catheter and an outer surface comprising a distal cylindrical portion sealing against an inner wall of the blood vessel and a proximal conical portion inwardly tapering from the distal cylindrical portion, and wherein a distal tip of the inner tube of the catheter is connected to a first end of the tubular sleeve and a distal tip of the outer tube of the catheter is connected to a second end of the tubular sleeve; and

directing the target object into a lumen of the inner tube through the expanded tubular sleeve by one or more of pulling a guide wire disposed within a lumen of the inner tube to retract an expandable element disposed on the guide wire or applying suction force through the lumen of the inner tube,

wherein the tubular sleeve comprises a shape memory material biased to radially expand and assume the expanded configuration, and

wherein the tubular sleeve comprises a coated portion and an uncoated portion, the coated portion allowing the tubular sleeve to buckle in a desired location to achieve the pre-programmed expanded configuration.