Patent Application
20230053713
The invention relates generally to medical devices for catheterization.
Heart disease is the leading killer in the United States. Percutaneous coronary intervention (PCI) is a non-surgical procedure used to treat stenosis of the coronary arteries in both urgent and chronic cardiovascular conditions. In patients with acute coronary syndromes, timely application of PCI is essential: it is estimate that 1% of brain function is lost for each minute that PCI is delayed.
Two routes are used to access to the coronary arteries by PCI, but each is problematic. Currently, the predominant route of access is via the femoral artery in the upper leg. One problem with transfemoral artery (TFA) access is the high rate of bleeding and access site complications associated with the procedure. In addition, TFA requires patients to lie flat during the procedure and tends to be uncomfortable. As a result, there is growing trend in favor of accessing the coronary arteries via the radial artery near the wrist. Transradial artery (TRA) access, however, is technically challenging due to the small size of arteries in the arm and the tendency of the arteries to spasm during catheterization. Moreover, patients must maintain their wrists in a hyperextended position throughout the procedure, which can be difficult. Consequently, there are significant barriers that curb the effectiveness of existing methods of PCI as well as serious side effects associated with such methods.
The invention provides devices and methods that allow safe, effective TRA catheterization to allow TRA-based coronary intervention. Among the devices are arm-securing devices that retain a patient's arm in a stable position with a hyperextended wrist and stabilization devices that couple the arm-securing devices to catheterization devices, included ultrasonic, image-guided catheters. The stabilization devices permit the catheterization device to be immobilized in relation to the patient's arm during the procedure to facilitate catheterization and minimize complications during the procedure. At the same time, the stabilization devices allows adjustment of the positioning of the catheterization device in relation to the arm-securing device so that the system can be adjusted to account for patient variables such as arm size, flexibility, and proximity of the radial artery to the skin. The invention further provides methods of using the aforementioned devices to perform transradial catheterization.
In an aspect, the invention provides devices that include an anchor configured to receive a catheterization device and a stabilizer coupled to the anchor and rotatable relative to the anchor.
The anchor may include an adjustable port for receiving the catheterization device. The catheterization device may have a longitudinal axis when it is coupled to the device, and the adjustable port may be adjustable along an axis perpendicular to the longitudinal axis of the catheterization device.
The stabilizer may be couplable to an arm-securing device configured to secure the arm of a human.
The device may include a catheterization device coupled to the anchor. The catheterization device may be reversibly coupled to the anchor.
The catheterization device may include an imaging device. The imaging device may be a forward-viewing ultrasound device. The ultrasound device may operate at a frequency of from about 1 MHz to about 200 MHz or from about 14 MHz to about 20 MHz. The ultrasound device may include a transducer that includes from about 20 to about 128 elements. The imaging device may have a flat face, a perpendicular face, or an angled face.
The catheterization device may be an image-guided catheter. Examples of image-guided catheters that may be used with any of the devices provided herein are described in U.S. Pat. Nos. 8,147,413; 8,147,414; 8,403,858; 8,403,859; 9,149,257; and 9,855,021, and in U.S. Patent Publication Nos. 2018/0116630; 2019/0142371; and 2019/0142373, the contents of each of which are incorporated herein by reference.
The catheter of the catheterization device may have a variable diameter. The diameter may be from about 2 mm to about 15 mm.
In another aspect, the invention provided devices for securing the arm of a human. The devices include a first portion for contacting a posterior surface of a forearm of an arm, a second portion for contacting a posterior surface of a hand of the arm, and a joint that connects the first portion to the second portion and permits the first portion to rotate relative to the second portion such that when the arm is secured to the device, a wrist of the arm is hyperextended.
The joint may include a locking mechanism that maintains the wrist in a hyperextended position when the arm is secured to the device. The joint may define an angle between a longitudinal axis of the first portion and a longitudinal axis of the second portion and permit rotation such that the angle may be from about 130° to about 180°. The joint may permit rotation in discrete increments. The increments may be from about 2° to about 5°.
The device may include one or more fasteners that secure the arm or portion of the arm to the device. The fastener may secure the forearm to the first portion of the device. The fastener may secure the hand to the second portion of the device. The fastener may be a strap, belt, or band. The fastener may include a hook-and-loop fastener system.
Each of the first and second portions of the device may be flat, curved, or concave. The surface of the first portion in contact with the posterior of the forearm may be flat, curved, or concave. The surface of the second portion in contact with the posterior of the hand may be flat, curved, or concave.
The device may include padding. The padding may be positioned on a surface of the first portion in contact with the posterior of the forearm. The padding may be positioned on a surface of the second portion in contact with the posterior of the hand.
The device may include a securing mechanism for securing a stabilization device to the arm-securing device. The securing mechanism may be a mount or band. The stabilization device may include an anchor configured to receive a catheterization device and a stabilizer coupled to the anchor and rotatable relative to the anchor. The stabilization device may include any of the elements described above in relation to devices containing an anchor and a stabilizer. The stabilization device may be coupled to a catheterization device. The catheterization device may include any of the elements described above.
In another aspect, the invention provides device for transradial catheterization. The devices include an arm-securing device configured to secure an arm of a human, a stabilization device coupled to the arm-securing device, and a catheterization device coupled to the stabilization device.
The longitudinal axis of the arm-securing device and the longitudinal axis of the catheterization device may lie in a plane. The arm-securing device and the catheterization device may be rotatable about an axis perpendicular to the plane.
The stabilization device may be releasably coupled to the arm-securing device. The arm-securing device may include one or more one securing mechanism that releasably receives the stabilization device. The securing mechanism may be a mount or band. The stabilization device may include an anchor configured to receive a catheterization device and a stabilizer coupled to the anchor and rotatable relative to the anchor.
The stabilization device may be releasably coupled to the catheterization device. The stabilization device may be adjustably coupled to the catheterization device such that the imaging device is movable along an axis perpendicular to the longitudinal axis of the arm-securing device. The stabilization device may be coupled to the catheterization device via a port on the stabilization device.
The arm-securing device may include any of the elements described above in relation to devices for securing the arm of a human. The arm-securing device may include a first portion for contacting a posterior surface of a forearm of the arm, a second portion for contacting a posterior surface of a hand of the arm, and a joint that connects the first portion to the second portion and permits the first portion to rotate relative to the second portion such that when the arm is secured to the device, a wrist of the arm is hyperextended. The arm-securing device may include a locking mechanism that maintains the wrist in a hyperextended position when the arm is secured to the device.
The catheterization device may include any of the elements described above. The catheterization device may include an imaging device.
In another aspect, the invention provides methods of transradial catheterization. The methods include securing the arm of a human to an arm-securing device coupled to a catheterization device and inserting a needle from the catheterization device into a radial artery in the arm.
The inserting step may include making a single puncture in the radial artery.
The arm may be secured in a position in which a wrist of the arm is hyperextended. The arm may be secured by contacting the posterior surface of the forearm to a first portion of the arm-securing device and contacting the posterior surface of the hand of the arm to a second portion of the arm-securing device.
The arm-securing device may be coupled to the catheterization device via a stabilization device. The stabilization device may include any of the elements described above in relation to devices containing an anchor and a stabilizer. The stabilization device may include an anchor secured to the catheterization device and a stabilizer coupled to the anchor and secured to the arm-securing device. The stabilization device may include any of the elements described above in relation to devices containing an anchor and a stabilizer.
The catheterization device may include any of the elements described above.
The method may include guiding a catheter from the catheterization device toward a heart of the human. The guiding step may include transmitting sound waves at a frequency of from about 1 MHz to about 200 MHz.
In another aspect, the invention provides kits for performing transradial catheterization. The kits may include one or more of the devices described above. The kit may include instructions for assembling the devices. The kit may include instructions for performing methods, such as any of the methods described above.
The joint permits rotation of the first and second portions relative to each other. In particular, when an arm is secured in the arm-securing device, the joint permit rotations of the hand backward from the forearm so that the wrist is hyperextended. The joint defines an angle between the longitudinal axis of the first portion and the longitudinal axis of the second portion. The joint may allow rotation so that the angle from about 130° to about 180°, with 180° being a straight line between the forearm and hand and 130° being the greatest degree of hyperextension of the wrist. The joint may include a locking mechanism that locks the joint a particular angle. The joint may be adjustable in discrete increments. For example and without limitation, the increments may be from about 2° to about 5°.
Each of the first and second portions of the arm-securing device may independently include padding on the surface contacting the posterior portion of the forearm or hand. The padding may include foam, fabric, or other cushioning material.
Any fastener suitable for securing the arm or portions of the arm to the arm-securing device may be used. For example and without limitation, the fasteners may be straps, belts, or bands. The fasteners may include a hook-and-loop fastener system, such as the one sold by the trade name Velcro by Velcro. Multiple types of fasteners may be used on in the arm-securing device. Each of the first and second portions may contain different types of fasteners or the same type of fasteners. The first and second portions may contain the same types of fasteners, or the two portions may contain different types of fasteners from each other.
The arm-securing device may include one or more securing mechanisms. The securing mechanisms may be attached to the first portion, the second portion or both. Any type of securing mechanisms may be used. For example and without limitation, the securing mechanisms may be mounts or bands.
The catheterization device may include an imaging device. The imaging device may be an ultrasound device, such as a forward-viewing ultrasound device.
The ultrasound device may operate at a frequency of from about 20 kHz to about 1000 MHz, from about 100 kHz to about 1000 MHz, from about 250 kHz to about 1000 MHz, from about 500 kHz to about 1000 MHz, from about 1 MHz to about 1000 MHz, from about 5 MHz to about 1000 MHz, from about 10 MHz to about 1000 MHz, from about 14 MHz to about 1000 MHz, from about 20 kHz to about 500 MHz, from about 100 kHz to about 500 MHz, from about 250 kHz to about 500 MHz, from about 500 kHz to about 500 MHz, from about 1 MHz to about 500 MHz, from about 5 MHz to about 500 MHz, from about 10 MHz to about 500 MHz, from about 14 MHz to about 500 MHz, from about 20 kHz to about 200 MHz, from about 100 kHz to about 200 MHz, from about 250 kHz to about 200 MHz, from about 500 kHz to about 200 MHz, from about 1 MHz to about 200 MHz, from about 5 MHz to about 200 MHz, from about 10 MHz to about 200 MHz, from about 14 MHz to about 200 MHz, from about 20 kHz to about 100 MHz, from about 100 kHz to about 100 MHz, from about 250 kHz to about 100 MHz, from about 500 kHz to about 100 MHz, from about 1 MHz to about 100 MHz, from about 5 MHz to about 100 MHz, from about 10 MHz to about 100 MHz, from about 14 MHz to about 100 MHz, from about 20 kHz to about 50 MHz, from about 100 kHz to about 50 MHz, from about 250 kHz to about 50 MHz, from about 500 kHz to about 50 MHz, from about 1 MHz to about 50 MHz, from about 5 MHz to about 50 MHz, from about 10 MHz to about 50 MHz, from about 14 MHz to about 50 MHz, from about 20 kHz to about 20 MHz, from about 100 kHz to about 20 MHz, from about 250 kHz to about 20 MHz, from about 500 kHz to about 20 MHz, from about 1 MHz to about 20 MHz, from about 5 MHz to about 20 MHz, from about 10 MHz to about 20 MHz, or from about 14 MHz to about 20 MHz,
The ultrasound device may include a transducer that includes from about 2 to about 1000 elements. from about 5 to about 1000 elements, from about 10 to about 1000 elements, from about 20 to about 1000 elements, from about 2 to about 500 elements. from about 5 to about 500 elements, from about 10 to about 500 elements, from about 20 to about 500 elements, from about 2 to about 250 elements. from about 5 to about 250 elements, from about 10 to about 250 elements, from about 20 to about 250 elements, from about 2 to about 128 elements. from about 5 to about 128 elements, from about 10 to about 128 elements, or from about 20 to about 128 elements.
The imaging device may have a flat face, a perpendicular face, or an angled face.
The invention also provides kits for performing transradial catheterization. The kits may include one or more of the devices described above. The kit may include instructions for assembling the devices or for performing transradial catheterization.
The inventor also provides methods of transradial catheterization. The methods include securing the arm of a human to an arm-securing device coupled to a catheterization device and inserting a needle from the catheterization device into a radial artery in the arm.
The inserting step may include making a single puncture in the radial artery.
The arm may be secured in a position in which a wrist of the arm is hyperextended. The arm may be secured by contacting the posterior surface of the forearm to a first portion of the arm-securing device and contacting the posterior surface of the hand of the arm to a second portion of the arm-securing device.
The arm-securing device may be coupled to the catheterization device via a stabilization device. The stabilization device may include any of the elements described above in relation to devices containing an anchor and a stabilizer. The stabilization device may include an anchor secured to the catheterization device and a stabilizer coupled to the anchor and secured to the arm-securing device. The stabilization device may include any of the elements described above in relation to devices containing an anchor and a stabilizer.
The catheterization device may include any of the elements described above.
References and citations to other documents, such as patents, patent applications, patent publications, journals, books, papers, web contents, have been made throughout this disclosure. All such documents are hereby incorporated herein by reference in their entirety for all purposes.
Various modifications of the invention and many further embodiments thereof, in addition to those shown and described herein, will become apparent to those skilled in the art from the full contents of this document, including references to the scientific and patent literature cited herein. The subject matter herein contains important information, exemplification, and guidance that can be adapted to the practice of this invention in its various embodiments and equivalents thereof.
This application claims the benefit of, and priority to, U.S. Provisional Patent Application No. 62/960,198, filed Jan. 13, 2020, the contents of which are incorporated by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2021/012132 | 1/5/2021 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 62960198 | Jan 2020 | US |
