Transradial access devices, systems, and methods

• US 10,265,100 B2
• Filed: 01/20/2016
• Issued: 04/23/2019
• Est. Priority Date: 10/27/2010
• Status: Active Grant

• Current Assignee: DTherapeutics LLC
• Original Assignee: DTherapeutics LLC
• Inventors: Kassab, Ghassan S.
• Primary Examiner(s): Nguyen, Victor
• Application Number:
  US15/001,770
• Publication Number:
  US 20160135842A1
• Time in Patent Office: 1,189 Days
• 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 18/1477 Needle-like probes
• 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 2017/3443 with means for adjusting the length of a cannula
• CPC Class Codes: A61B 2017/347 Locking means, e.g. for locking instrument in cannula
• 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
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

Transradial access devices, systems, and methods. An exemplary device of the present disclosure for providing access to a vessel or other luminal organ and to prevent overperforation of the same comprises a needle having a needle tip and at least one current element positioned thereon or embedded therein at or near the needle tip, a sheath positioned around at least part of the needle, and a protractor in communication with the needle, 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. Activation of the at least one current element can facilitation vasodilation of the vessel or other luminal organ.

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 at least one current element positioned thereon or embedded therein at or near the needle tip;

a sheath positioned around at least part of the needle, the sheath defining an aperture at a distal sheath end, an interior space around the needle positioned therein, and having a blunt non-piercing 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

a protractor in communication with the needle, 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,

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, activation of the at least one current element can facilitation vasodilation of the vessel or other luminal organ and the fluid can enter the interior space of the sheath 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 so to prevent overperforation of the vessel or other luminal organ.

2. The device of claim 1, wherein the at least one current element comprises an excitation electrode configured to generate an electric current.

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

4. 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.

5. 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.

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

7. 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.

8. The device of claim 7, 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.

9. The device of claim 8, wherein the wire further comprises at least one wire current element positioned thereon or embedded therein at or near a wire tip, the at least one wire current element configured to generate an electric current to cause vasodilation of the vessel or other luminal organ.

10. 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.

11. The device of claim 1, wherein the needle further comprises a sensor coupled thereto or embedded therein, the sensor operable to sense at least one bodily parameter.

12. 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 at least one current element positioned thereon or embedded therein at or near the needle tip;

a sheath positioned around at least part of the needle, the sheath defining an aperture at a distal sheath end, an interior space around the needle positioned therein, and having a blunt non-piercing 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 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, and whereby a second operation of the actuator causes the needle tip to retract through the aperture into the sheath,

wherein the system 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, activation of the at least one current element can facilitation vasodilation of the vessel or other luminal organ and the fluid can enter the interior space of the sheath 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 so to prevent overperforation of the vessel or other luminal organ.

13. The system of claim 12, 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.

14. The system of claim 12, further comprising:

a sensor coupled to the needle and operable to sense at least one bodily parameter selected from the group consisting of impedance, an oxygen concentration, and a lactate concentration.

15. The system of claim 14, 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.

16. The system of claim 14, further comprising:

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

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

18. The system of claim 12, 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.

19. A method for accessing a mammalian bodily vessel and to prevent overperforation of the same, the method comprising the steps of:

protracting a needle tip of a needle from a sheath of a device, at least a portion of a wall of the sheath comprising translucent or transparent material and the sheath comprising an interior space around the needle positioned therein;

percutaneously puncturing mammalian skin using the needle tip;

puncturing a mammalian bodily vessel under the mammalian skin using the needle tip so that the needle tip and a blunt non-piercing tapered distal end of the sheath of the device surrounding the needle tip access a lumen of the mammalian bodily vessel and operating at least one current element positioned upon or coupled to at least one of the needle and a wire positioned at least partially within the mammalian bodily vessel to cause vasodilation of the mammalian bodily vessel; and

retracting the needle tip into the sheath of the device upon visual detection of blood from the mammalian bodily vessel within the interior space of the sheath of the device through the portion of the sheath wall comprising the translucent or transparent material so to prevent overperforation of the vessel or other luminal organ.