Monofilament implants and systems for delivery thereof

• US 10,028,819 B2
• Filed: 07/17/2015
• Issued: 07/24/2018
• Est. Priority Date: 05/31/2012
• Status: Active Grant

• Current Assignee: Javelin Medical Ltd.
• Original Assignee: Javelin Medical Ltd.
• Inventors: Shinar, Guy, Yodfat, Ofer
• Primary Examiner(s): SHI, KATHERINE MENGLIN
• Application Number:
  US14/802,978
• Publication Number:
  US 20150320541A1
• Time in Patent Office: 1,103 Days
• Field of Search: 606108, 606191, 606194, 606198, 606200
• CPC Class Codes: A61B 17/12031 complete occlusion
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/12063 electrolytically detachable
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2/0108 Both ends closed, i.e. legs gathered at both ends
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0071 spherical
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

Systems, devices and methods are presented for embolic protection. In some embodiments, a device for implantation in a patient'"'"'s vessel containing a fluid flow is provided which comprises proximal and distal ends, an undeployed, substantially linear state, and a deployed, spring-like (helical) state comprising windings. When the device is deployed, the line segment connecting the proximal and distal ends is approximately perpendicular to the majority of the windings and to the fluid flow. In some embodiments, a delivery device for the monofilament device is provided. The delivery device comprises a needle having a lumen, a sharp distal end, and a pusher slidable within the needle. A method for deploying the monofilament device using the delivery device is provided.

Claims

1. A monofilament filtering device (MFD) implantation system for implanting a MFD within a human blood vessel comprising:

an MFD;

a housing;

a power supply;

a control unit;

at least one of a geared driving mechanism and a motorized driving mechanism;

and

a needle comprising a hollow lumen, a proximal end, and a distal end, wherein the needle is configured to receive the MFD in an undeployed state,

wherein

the MFD is configured for both an undeployed and a deployed state after implantation within a blood vessel including a helical portion,

the MFD is exteriorized from the needle by the operation of the driving mechanism, and

after implantation, at least the helical portion is within the blood vessel.

2. The system of claim 1, wherein the driving mechanism is configured to rotate, bend, or twist the MFD.

3. The system of claim 1, wherein the driving mechanism is configured to advance or retract the MFD.

4. The system of claim 1, wherein the driving mechanism is configured to advance or retract the needle.

5. The system of claim 1, further comprising one or more sensors.

6. The system of claim 5, wherein the at least one sensor is mounted on the needle.

7. The system of claim 5, wherein the at least one sensor comprises a pressure sensor.

8. The system of claim 1, wherein the housing, the power supply, the control unit, and the driving mechanism reside in a patient-external unit.

9. The system of claim 8, wherein the patient-external unit is disposable.

10. The system of claim 8, wherein the patient-external unit is reusable.

11. The system of claim 8, wherein the needle and the MFD comprise a patient-internal unit.

12. The system of claim 11, wherein the patient-external unit and the patient-internal unit are reversibly connected.

13. The system of claim 1, wherein the power supply is electrical and/or mechanical.

14. The system of claim 1, wherein the power supply is a direct current source or an alternating current source.

15. The system of claim 1, wherein the control unit comprises one or more of:

an interface, an input/output device, an analog or digital electronic controller, and a computer processor.

16. The system of claim 1, further comprising at least one of a pusher and a rotor.

17. The system of claim 16, wherein the driving mechanism is configured to move at least one of the pusher, the needle and the MFD so as deploy the MFD into the vessel.

18. The system of claim 16, wherein the pusher configured to push or otherwise move at least the MFD relative to the needle.