Devices and methods for endovascular access and therapy

• US 9,439,653 B2
• Filed: 12/07/2012
• Issued: 09/13/2016
• Est. Priority Date: 12/07/2011
• Status: Active Grant

• Current Assignee: Traumatek Solutions, B.V.
• Original Assignee: Traumatek Solutions, B.V.
• Inventors: Avneri, Itzhak, Avneri, Ben-Ami, Avneri, Shahar, Avneri, Lior
• Primary Examiner(s): ORKIN, ALEXANDER J
• Application Number:
  US13/708,878
• Publication Number:
  US 20130178711A1
• Time in Patent Office: 1,376 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/12031 complete occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61B 17/12168 having a mesh structure A61B17/1214 takes precedence
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2072 Reference field transducer attached to an instrument or patient
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/3954 magnetic, e.g. NMR or MRI
• CPC Class Codes: A61B 46/10 specially adapted for instruments, e.g. microscopes
• CPC Class Codes: A61M 2025/0024 Expandable catheters or sheaths
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/0105 Steering means as part of the catheter or advancing means; Markers for positioning systems for detection of markers A61B
• CPC Class Codes: A61M 25/0127 Magnetic means; Magnetic markers
• CPC Class Codes: A61M 25/065 Guide needles
• CPC Class Codes: A61M 25/09041 Mechanisms for insertion of guide wires

Abstract

The present invention provides for devices and methods for providing endovascular therapy, including facilitating establishment of vascular access, placement of endovascular sheaths, catheter tip localization, and administration of vascular occlusion. The inventions includes a vessel cannulation device, an expandable sheath, an occlusion catheter, and a localizer each of which may be provided separately or used as part of a system.

Claims

1. A vessel cannulation device comprising:

a cannulation device body having

a distal end and proximal end,

a pressure chamber,

a guidewire lumen configured to receive a guidewire,

a pressure sensor operatively coupled to the pressure chamber;

a guidewire advancing member configured for advancing a guidewire through the guidewire lumen, wherein the guidewire advancing member is operably coupled to the pressure sensor; and

a needle on the distal end of the device body, wherein the needle is coupled to the pressure chamber,

wherein the device is configured to automatically advance a guidewire in response to a fluid acting on the pressure sensor, whereby the pressure sensor causes the guidewire advancing member to advance the guidewire.

2. The vessel cannulation device of claim 1, wherein the pressure sensor is a pressure operable diaphragm.

3. The vessel cannulation device of claim 2, wherein the pressure operable diaphragm is located on the exterior of the cannulation body and connected to the pressure chamber.

4. The vessel cannulation device of claim 1, wherein the needle is fluidly coupled to the pressure chamber.

5. The cannulation device of claim 1, further comprising a backplate covering the device body at the proximal end of the device body having an opening configured for passing the guidewire.

6. The cannulation device of claim 1, wherein the guidewire advancing member comprises:

a large compressible member in contact with a backplate configured for passing a guidewire through the cannulation device;

a gripper in connection with the large compressible member having an opening configured for passing a guidewire through the cannulation device, wherein the gripper is configured to engage and grip the guidewire;

a small compressible member in connection with the gripper configured for passing a guidewire through the cannulation device; and

a slidable member having a proximal end, a distal end and an opening configured for passing a guidewire through the cannulation device, wherein the proximal end of the slidable member is configured to be in connection with and surround the small compressible member, wherein the slidable member is positioned to be in connection with at least one side opening of the cannulation device and wherein the slidable member is configured to accommodate a lever; and

the cannulation device further comprising;

an operable lever configured to pass through the at least one side opening and to be in connection with the slidable member, wherein the lever is in connection with the pressure sensor, such that pressure applied to the pressure sensor operates the operable lever.

7. The vessel cannulation device of claim 1, wherein the pressure chamber is partially prefilled with biologically acceptable fluid.

8. The vessel cannulation device of claim 7, wherein the prefilled fluid shortens response time.

9. A kit comprising:

the vessel cannulation device of claim 1;

an expandable sheath;

an occlusion catheter; and

a tip localization device.

10. A system for performing endovascular aortic occlusion comprising:

the vessel cannulation device of claim 1;

an expandable sheath;

an occlusion catheter; and

a tip localization device.

11. A system for treating hemorrhagic shock comprising

the vessel cannulation device of claim 1;

an expandable sheath;

an occlusion catheter; and

a tip localization device.

12. A cannulation device comprising:

a housing having a distal end with a distal tip and a proximal end;

a lumen passing through at least the distal tip;

a sensor coupled to the lumen, the sensor being configured to sense a physiologic parameter, wherein the physiological parameter is a blood pressure; and

a blunting device advancing member configured to advance a blunting device, wherein the blunting device is operably coupled to the sensor and the blunting device comprises at least one guidewire,

wherein the blunting device advancing member is configured to automatically advance the blunting device in response to the sensor detecting the physiologic parameter within a pre-determined range.

13. The cannulation device of claim 12, wherein the sensor is a pressure sensor, a photoelectric sensor, a resistance sensor, or an ultrasonic sensor.

14. The cannulation device of claim 12, wherein the blunting device advancing member is configured to advance the blunting device when the sensor detects a blood pressure between 5-250 mm Hg.

15. The cannulation device of claim 12, wherein the sensor is configured to detect an arterial pressure or a venous pressure.

16. The cannulation device of claim 15, wherein the blunting device advancing member is configured to advance the blunting device when the sensor detects the venous pressure.

17. The cannulation device of claim 16, wherein the venous pressure is between 5-20 mm Hg.

18. The cannulation device of claim 15, wherein the blunting device advancing member is configured to advance the blunting device when the sensor detects the arterial pressure.

19. The cannulation device of claim 18, wherein the arterial pressure is between 20-250 mmHg.

20. The cannulation device of claim 12, wherein the sensor is a membrane or a pressure-operable diaphragm.

21. The cannulation device of claim 12, wherein the device further comprises one or more ultrasound transducers.

22. The cannulation device of claim 12, wherein the device further comprises an imaging system to obtain images of the vessel.

23. The cannulation device of claim 12, wherein the blunting device further comprises a sheath.

24. The cannulation device of claim 12, wherein upon the sensor detecting that the physiologic parameter within a pre-determined range, the device is configured to automatically pass the blunting device into the vessel.

25. The cannulation device of claim 12, wherein upon the sensor detecting that the physiologic parameter within a pre-determined range, the device is configured to immediately automatically pass the blunting device comprising a guidewire through the distal tip of the needle into the vessel, the guidewire extending a distance beyond the distal tip of the needle preventing the needle from puncturing a wall of the vessel.

26. A method of cannulating at least one of an artery and a vein using the device of claim 12.