Devices, systems, and methods for transradial access

• US 10,219,828 B2
• Filed: 10/27/2011
• Issued: 03/05/2019
• Est. Priority Date: 10/27/2010
• Status: Active Grant

• Current Assignee: DTherapeutics LLC
• Original Assignee: DTherapeutics LLC
• Inventors: Kassab, Ghassan S.
• Primary Examiner(s): Eastwood, David C
• Assistant Examiner(s): Nguyen, Tin
• Application Number:
  US13/283,024
• Publication Number:
  US 20120108926A1
• Time in Patent Office: 2,686 Days
• Field of Search: 606185, 606108, 606159, 606167, 606170, 606184, 606213, 606214, 600323, 600309, 600547, 60416408
• 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 17/3496 Protecting sleeves or inner probes; Retractable tips for protecting body piercing guide needles A61M25/0612
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00907 for light
• CPC Class Codes: A61B 2017/3405 using mechanical guide means
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes

Abstract

Devices, systems, and methods for transradial access. In at least one embodiment of a device for providing access to a vessel or other luminal organ of the present disclosure, the device comprises a needle having a needle tip, a sheath positioned around at least part of the needle, the sheath defining an aperture at a distal sheath end, and a protractor in communication with the needle, whereby engagement of the protractor causes the needle tip to protract from the sheath, and whereby release of the protractor causes the needle tip to retract into the sheath.

Claims

1. A device for providing access to a vessel or other luminal organ and to prevent overperforation of the same, the device comprising:

a needle having a needle tip and having a sensor coupled to the needle, the sensor operable to detect blood;

a sheath positioned around at least part of the needle, the sheath defining an aperture at a distal sheath end through which the needle Up can protract, an interior space around the needle positioned therein, and having a tapered distal end configured for percutaneous insertion into a vessel or other luminal organ, wherein at least a portion of a wall of the sheath is comprised of translucent or transparent material;

a protractor in communication with the whereby engagement of the protractor causes the needle tip to protract from the sheath through the aperture, and whereby release of the protractor causes the needle tip to retract through the aperture into the sheath;

an actuator in communication with the needle, the actuator configured to facilitate movement of the needle within the sheath while the sheath remains fixed; and

a processor operably coupled to the actuator, the processor operable to direct operation of the actuator;

wherein the device is configured so that when the needle tip punctures the vessel or other luminal organ underneath skin after puncturing the skin and is advanced along with the sheath so that the distal sheath end is also positioned within the vessel or other luminal organ and so that fluid within the vessel or other luminal organ is in contact with the needle tip, the fluid can enter the interior space of the sheath directly through the aperture and be visually detected within the sheath through the portion of the sheath wall comprising the translucent or transparent material to indicate that the distal sheath end is positioned within the vessel or other luminal organ;

wherein the device is further configured and operable to operate the actuator, from directions from the processor, to retract the needle tip of the needle into the aperture of the sheath in response to blood being detected by the sensor so to prevent overperforation of the vessel or other luminal organ; and

wherein the sheath is detachable from a remainder of the device, and wherein the remainder of the device includes at least the needle, protractor actuator and processor, such that the remainder of the device can be withdrawn from the vessel or other luminal organ without removing the sheath.

2. The device of claim 1, wherein the protractor is selected from the group consisting of a button and a rotatable dial.

3. The device of claim 1, wherein the tapered distal end of the sheath is configured to allow blood or other bodily fluids to pass between an outside wall of the needle and the aperture when the needle is protracted from the sheath.

4. The device of claim 1, further comprising:

a needle mechanism in communication with the needle and the protractor, the needle mechanism operable to facilitate protraction and retraction of the needle tip from the sheath.

5. The device of claim 4, wherein the needle mechanism is selected from the group consisting of a spring, a compliant polymer, a coil, a sponge, and a bladder.

6. The device of claim 1, further comprising:

one or more wire apertures defined therethrough, the one or more wire apertures configured to receive a wire.

7. The device of claim 6, further comprising:

a wire positioned through the one or more wire apertures, the wire configured to permit a second device to be delivered over the wire.

8. The device of claim 7, wherein the wire comprises a guide wire.

9. The device of claim 1, wherein the device comprises part of a system, the system further comprising:

a dilator configured to surround at least part of the sheath, the dilator further configured for partial insertion into the vessel or other luminal organ;

a guide wire configured for partial insertion into one of a sheath lumen and a needle lumen, the guide wire further configured for advancement into the vessel or other luminal organ; and

an access catheter configured for advancement over the guide wire and further advancement into the vessel or other luminal organ.

10. A system for providing access to a vessel or other luminal organ and to prevent overperforation of the same, the system comprising:

a needle having a needle tip and having a sensor coupled to the needle, the sensor operable to sense at least one bodily parameter;

a sheath positioned around at least part of the needle, the sheath defining an aperture at a distal sheath end through which the needle tip can protract, an interior space around the needle positioned therein, and having a tapered distal end configured for percutaneous insertion into a vessel or other luminal organ, wherein at least a portion of a wall of the sheath is comprised of translucent or transparent material; and

an actuator in communication with the needle, the actuator configured to facilitate movement of the needle within the sheath, whereby a first operation of the actuator causes the needle tip to protract from the sheath through the aperture while the sheath remains fixed, and whereby a second operation of the actuator causes the needle tip to retract through the aperture into the sheath in response to sensor sensing a threshold level of the at least one bodily parameter,

wherein the system is configured so that when the needle Up punctures the vessel or other luminal organ underneath skin after puncturing the skin and is advanced along with the sheath so that the distal sheath end is also positioned within the vessel or other luminal organ and so that fluid within the vessel or other luminal organ is in contact with the needle tip, the fluid can enter the interior space of the sheath directly through the aperture and be visually detected within the sheath through the portion of the sheath wail comprising the translucent or transparent material to indicate that the distal sheath end is positioned within the vessel or other luminal organ so to prevent overperforation of the vessel or other luminal organ; and

wherein the sheath is detachable from a remainder of the system, and wherein the remainder of the system includes at least the needle, sensor, and actuator, such that the remainder of the system can be withdrawn from the vessel or other luminal organ without removing the sheath.

11. The system of claim 10, further comprising:

a needle mechanism in communication with the needle and the actuator, the needle mechanism operable to facilitate protraction and retraction of the needle tip from the sheath.

12. The system of claim 10, wherein the sensor that is coupled to the needle is operable to sense blood.

13. The system of claim 12, wherein the at least one bodily parameter comprises an impedance, an oxygen concentration, and a lactate concentration.

14. The system of claim 12, further comprising:

a wire coupled to the sensor and directly or indirectly coupled to the actuator, the wire capable of transmitting a signal from the sensor to the actuator.

15. The system of claim 12, further comprising:

a processor operably coupled to the sensor, the processor operable to control actuation of the actuator.

16. The system of claim 15, wherein when the sensor senses a threshold bodily parameter, the processor operates to control actuation of the actuator to protract or retract the needle.

17. The system of claim 10, wherein the tapered distal end of the sheath is configured to allow blood or other bodily fluids to pass between an outside wall of the needle and the aperture when the needle is protracted from the sheath.