Method of pulsatile neurovascular aspiration with telescoping catheter

• US 10,661,053 B2
• Filed: 02/27/2017
• Issued: 05/26/2020
• Est. Priority Date: 02/24/2016
• Status: Active Grant

• Current Assignee: Imperative Care, Inc., Incept LLC
• Original Assignee: Incept LLC
• Inventors: Yang, Yi, Khosravi, Farhad, Rimsa, Joseph
• Primary Examiner(s): Schwiker, Katherine H
• Application Number:
  US15/443,841
• Publication Number:
  US 20170238950A1
• Time in Patent Office: 1,184 Days
• 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 17/12168 having a mesh structure A61B17/1214 takes precedence
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 17/2202 the ultrasound transducer being inside patient's body at the distal end of the catheter
• CPC Class Codes: A61B 17/22031 Gripping instruments, e.g. forceps, for removing or smashing calculi A61B17/221 takes precedence
• CPC Class Codes: A61B 17/3203 Fluid jet cutting instruments
• CPC Class Codes: A61B 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• 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 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00734 battery operated
• CPC Class Codes: A61B 2017/00862 elastic or resilient for sutures A61B2017/0618
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00898 expandable upon contact with fluid
• CPC Class Codes: A61B 2017/00955 thermoplastic
• CPC Class Codes: A61B 2017/22025 applying a shock wave A61B2017/22091 takes precedence
• CPC Class Codes: A61B 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/22038 : with a guide wire
• CPC Class Codes: A61B 2017/22062 : to be filled with liquid
• 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 2017/22084 : stone- or thrombus-dissolving
• CPC Class Codes: A61B 2017/320733 : with a flexible cutting or scraping element, e.g. with a whip-like distal filament member
• 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: A61B 6/481 : involving the use of contrast agents
• CPC Class Codes: A61B 6/501 : for diagnosis of the head, e.g. neuroimaging or craniography
• CPC Class Codes: A61F 2/95 : Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2007/126 : for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/12 : Devices for heating or cooling internal body cavities
• CPC Class Codes: A61L 2400/10 : Materials for lubricating medical devices
• CPC Class Codes: A61L 2400/16 : Materials with shape-memory or superelastic properties
• CPC Class Codes: A61L 29/02 : Inorganic materials
• CPC Class Codes: A61L 29/041 : obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/06 : obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/14 : Materials characterised by their function or physical properties , e.g. lubricating compositions
• CPC Class Codes: A61M 1/32 : Oxygenators without membranes
• CPC Class Codes: A61M 1/743 : by changing the cross-section of the line, e.g. flow regulating valves A61M1/7413 takes precedence
• CPC Class Codes: A61M 1/80 : Suction pumps A61M1/64, A61M1/71, A61M60/00 take precedence
• CPC Class Codes: A61M 1/84 : Drainage tubes; Aspiration tips for negative pressure wound therapy A61M1/90; for surgical cutting instruments A61B17/32
• CPC Class Codes: A61M 2025/0002 : with a pressure sensor at the distal end
• CPC Class Codes: A61M 2025/0004 : having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0046 : Coatings for improving slidability
• CPC Class Codes: A61M 2025/0058 : having an electroactive polymer material, e.g. for steering purposes, for control of flexibility, for locking, for opening or closing
• CPC Class Codes: A61M 2025/0059 : having means for preventing the catheter, sheath or lumens from collapsing due to outer forces, e.g. compressing forces, or caused by twisting or kinking
• CPC Class Codes: A61M 2025/0079 : Separate user-activated means, e.g. guidewires, guide tubes, balloon catheters or sheaths, for sealing off an orifice, e.g. a lumen or side holes, of a catheter
• CPC Class Codes: A61M 2025/0096 : being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 2025/0175 : having telescopic features, interengaging nestable members movable in relations to one another
• CPC Class Codes: A61M 2039/062 : used with a catheter
• CPC Class Codes: A61M 2205/0216 : Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
• CPC Class Codes: A61M 2205/0266 : Shape memory materials
• CPC Class Codes: A61M 2205/3344 : Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2210/12 : Blood circulatory system
• CPC Class Codes: A61M 25/0009 : Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0012 : with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
• CPC Class Codes: A61M 25/0023 : by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/0045 : multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/005 : with embedded materials for reinforcement, e.g. wires, coils, braids
• 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 25/0053 : having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
• CPC Class Codes: A61M 25/007 : Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0074 : Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/008 : Strength or flexibility characteristics of the catheter tip
• CPC Class Codes: A61M 25/0082 : Catheter tip comprising a tool
• CPC Class Codes: A61M 25/0097 : characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/01 : Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0102 : Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/0108 : using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0662 : Guide tubes
• 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
• CPC Class Codes: A61M 25/1027 : Making of balloon catheters
• CPC Class Codes: A61M 31/005 : for contrast media
• CPC Class Codes: A61M 39/06 : Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
• CPC Class Codes: A61M 5/007 : for contrast media
• CPC Class Codes: B29C 41/02 : for making articles of definite length, i.e. discrete articles
• CPC Class Codes: B29C 41/14 : Dipping a core B29C41/10 takes precedence
• CPC Class Codes: B29C 41/22 : Making multilayered or multicoloured articles
• CPC Class Codes: B29C 41/42 : Removing articles from moulds, cores or other substrates B29C33/444 and B29C37/0017 take precedence
• CPC Class Codes: B29C 63/18 : using tubular layers or sheathings B29C63/26 and B29C63/38 take precedence; placing tubular labels around rigid containers B65C3/065
• CPC Class Codes: B29C 63/20 : using pressure difference, e.g. vacuum
• CPC Class Codes: B29C 63/22 : using layers or sheathings having a shape adapted to the shape of the article B29C63/26 and B29C63/38 take precedence
• CPC Class Codes: B29C 66/52 : Joining tubular articles, bars or profiled elements
• CPC Class Codes: B29C 66/522 : Joining tubular articles B29C66/53241 takes precedence
• CPC Class Codes: B29C 66/5221 : for forming coaxial connections, i.e. the tubular articles to be joined forming a zero angle relative to each other
• CPC Class Codes: B29K 2027/18 : PTFE, i.e. polytetrafluorethene , e.g. ePTFE, i.e. expanded polytetrafluorethene
• CPC Class Codes: B29K 2075/00 : Use of PU, i.e. polyureas or polyurethanes or derivatives thereof, as moulding material
• CPC Class Codes: B29L 2031/7542 : Catheters

Abstract

A method of aspirating a vascular occlusion from a remote site is provided. The method includes the steps of advancing a first elongate tubular body through a vascular access site and into a body vessel, advancing a second tubular body distally to extend beyond the first elongate tubular body to reach the remote site, and aspirating thrombus from the site into the lumen by applying pulsatile vacuum to the first elongate tubular body. The second tubular body has a lumen and a length that is shorter than the first elongate tubular body. The pulsatile application of vacuum may cause the distal tip of the second tubular body to open and close like a jaw, which facilitates reshaping the thrombus or biting or nibbling the thrombus material into strands or pieces to facilitate proximal withdrawal under negative pressure through the lumen of the second tubular body.

Claims

1. A method of aspirating a vascular occlusion from a remote site, comprising the steps of:

advancing a first elongate tubular body through a vascular access site and into a body vessel, the first elongate tubular body having a distal end;

thereafter advancing a second tubular body distally such that the second tubular body extends beyond the first elongate tubular body distal end to reach the remote site, the second tubular body having a lumen and a length, the length of the second tubular body being shorter than a length of the first elongate tubular body, wherein advancing the second tubular body distally comprises;

distally advancing a control wire, the control wire comprising a central lumen and a distal end, the distal end of the control wire being attached to and extending proximally from a proximal end of the second tubular body;

aspirating a thrombus from the remote site into the lumen of the second tubular body by applying pulsatile vacuum to the first elongate tubular body; and

advancing an agitator distally through the central lumen of the control wire such that a distal end of the agitator extends beyond the distal end of the control wire and is positioned within the lumen of the second tubular body, wherein the agitator extends beyond the distal end of the control wire and is positioned within the lumen of the second tubular body while applying the pulsatile vacuum such that the agitator is configured to agitate the thrombus and to facilitate the aspirating the thrombus through the lumen of the second tubular body during the application of pulsatile vacuum.

2. A method of aspirating a vascular occlusion as in claim 1, wherein the aspirating comprises biting the thrombus by changing the size of a distal opening on the second tubular body.

3. A method of aspirating a vascular occlusion as in claim 2, wherein the changing the size of the distal opening is accomplished in response to the application of pulsatile vacuum.

4. A method of aspirating a vascular occlusion as in claim 1, further comprising vibrating the first elongate tubular body during the advancing of the first elongate tubular body.

5. A method of aspirating a vascular occlusion as in claim 1, further comprising vibrating the second tubular body during the advancing of the second tubular body.

6. A method of aspirating a vascular occlusion as in claim 1, further comprising vibrating at least a distal section of the second tubular body during the aspirating of the thrombus.

7. A method of aspirating a vascular occlusion as in claim 1, wherein the second tubular body has a proximal opening, and the proximal opening is positioned within the first elongate tubular body within about 25 cm of the distal end of the first elongate tubular body following the advancing of the second tubular body distally.

8. A method of aspirating a vascular occlusion as in claim 1, wherein the second tubular body is introduced into the first elongate tubular body following the advancing of the first elongate tubular body.

9. A method of aspirating a vascular occlusion as in claim 1, wherein the second tubular body is carried within the first elongate tubular body during the advancing of the first elongate tubular body.

10. A method of aspirating a vascular occlusion as in claim 1, further comprising introducing a lubricant through the agitator to assist the aspirating of the thrombus.

11. A method of aspirating a vascular occlusion as in claim 10, wherein introducing the lubricant comprises introducing polyethylene glycol through the agitator to assist the aspirating of the thrombus.

12. A method of aspirating a vascular occlusion as in claim 1, wherein the applying pulsatile vacuum comprises applying intermittent negative pressure to the first elongate tubular body.

13. A method of aspirating a vascular occlusion as in claim 1, wherein the applying pulsatile vacuum comprises applying alternating negative and positive pressure to the first elongate tubular body.

14. A method of aspirating a vascular occlusion as in claim 1, further comprising rotating the agitator after advancing the agitator distally through the control wire until the distal end of the agitator is positioned beyond the control wire and exposed within the lumen of the second tubular body.

15. A method of aspirating a vascular occlusion as in claim 1, further comprising axially reciprocating the agitator after advancing the agitator distally through the control wire until the distal end of the agitator is positioned beyond the control wire and exposed within the lumen of the second tubular body.

16. A method of aspirating a vascular occlusion as in claim 1, wherein a portion of the agitator configured to agitate the thrombus is asymmetrically distributed across a cross section of the second tubular body when the distal end of the agitator is positioned beyond the control wire and exposed within the lumen of the second tubular body.

17. A method of aspirating a vascular occlusion as in claim 1, wherein the agitator comprises a shaft and the central lumen of the control wire is configured to receive the shaft, the central lumen being sized to substantially constrain at least a portion of the shaft from laterally moving within the second tubular body.

18. A method of aspirating a vascular occlusion as in claim 1, wherein at least a portion of the distal end of the agitator expands radially outward after emerging from the distal opening of the control wire.

19. A method of aspirating a vascular occlusion as in claim 1, further comprising introducing the distal end of the agitator into a proximal opening of the control wire prior to advancing the agitator distally through the control wire.

20. A method of aspirating a vascular occlusion as in claim 1, wherein the distal end of the agitator is a single flexible wire.