US-12616500-B2 - Cannula insertion system and methods of using the same

US12616500B2US 12616500 B2US12616500 B2US 12616500B2US-12616500-B2

Abstract

A cannula insertion system for cannulating a blood vessel includes a cannula system having a cannula that defines a cannula lumen and has a distal and proximal end. The system includes a cannula insertion device for coupling with the system that includes a dilator having a dilator body and a dilator lumen; a needle having a needle body and a needle lumen, the needle being translatable within the dilator lumen along a first direction; a movable dilator actuator configured to cause the dilator to move along the first direction; a movable needle actuator configured to cause movement of the needle along the first direction; and a housing defining housing recess. The housing recess is configured to receive the cannula system, the dilator, and the needle. The needle and the dilator are configured to be moved within the cannula lumen along the first direction.

Inventors

Alan W. Flake
Marcus Graeme Davey
Joseph W. Jackson
Dylan J. PAPROSKI
Ryan Christopher Meers
Joseph Gordon
Dustin GAIDOS
Spencer Brown
Philip Bussone, JR.

Assignees

THE CHILDREN'S HOSPITAL OF PHILADELPHIA

Dates

Publication Date: 20260505
Application Date: 20210428

Claims (20)

1 . A cannula insertion system for cannulating a blood vessel in a tissue, the cannula insertion system comprising: a cannula system including a cannula that defines a cannula lumen therethrough, the cannula having a distal end and a proximal end opposite the distal end; a collet jaw configured to releasably secure the cannula to the blood vessel, the collet jaw being affixed to the cannula, the collet jaw having a base, a deformable arm, and a head; and a cannula insertion device configured to couple with the cannula system, the cannula insertion device including: a dilator having a dilator body that defines a dilator lumen therethrough; a needle having a needle body that defines a needle lumen therethrough, the needle being translatable within the dilator lumen along a first direction; a dilator actuator configured to be moved such that movement of the dilator actuator causes movement of the dilator along the first direction; a needle actuator configured to be moved such that movement of the needle actuator causes movement of the needle along the first direction; and a housing defining a housing recess therein, the housing recess being configured to receive the cannula system, the dilator, and the needle, wherein the needle and the dilator of the cannula insertion device are configured to be moved within the cannula lumen along the first direction, wherein when the collet jaw is in an open position, the head is spaced away from the blood vessel and the cannula, and when the collet jaw is in a closed position, the head is in contact with the tissue such that the blood vessel is held in place between the collet jaw and the cannula.
2 . The cannula insertion system of claim 1 , wherein the needle actuator is configured to translate the needle from a first position, in which a distal end of the needle is positioned distally of a distal end of the dilator, to a second position, in which the distal end of the needle is positioned proximally of the distal end of the dilator.
3 . The cannula insertion system of claim 1 , wherein the cannula system includes a Y-connector adjacent to the proximal end of the cannula, the Y-connector having a first proximal portion, which defines a first proximal channel, and a second proximal portion, which defines a second proximal channel, wherein the first and second proximal channels are configured to be in fluid communication with the cannula lumen.
4 . The cannula insertion system of claim 3 , wherein the first proximal portion defines a slit seal that separates the first proximal channel from the second proximal channel, the slit seal having an open configuration, in which the dilator and the needle are inserted therethrough, and a closed configuration, in which the needle and the dilator are not extending therethrough, wherein when the slit seal is in the closed configuration, liquid from the cannula lumen is precluded from moving into the first proximal channel.
5 . The cannula insertion system of claim 3 , further comprising a plug configured to be removably inserted into the first proximal channel.
6 . The cannula insertion system of claim 1 , wherein the cannula system further includes a locking element thereon, and the housing includes a locking element thereon, wherein the locking element of the cannula system is configured to releasably engage with the locking element of the housing such that the cannula system is affixed to the housing.
7 . The cannula insertion system of claim 1 , wherein the collet jaw further comprises a tine on the head that extends towards the blood vessel, wherein the tine is configured to dig into the tissue when the collet jaw is in the closed position.
8 . The cannula insertion system of claim 1 , wherein the housing includes a translucent portion configured to allow visibility through the housing into the housing recess.
9 . The cannula insertion system of claim 1 , wherein the cannula system is configured to be operatively connected to an extracorporeal membrane oxygenation (ECMO) system.
10 . The cannula insertion system of claim 1 , wherein the tissue includes an umbilical cord of a neonate.
11 . A method of cannulating a blood vessel in a tissue, the method comprising the steps of: creating an opening in a wall of the blood vessel by piercing the wall with a distal end of a needle by moving the needle towards the vessel and through the wall of the vessel; inserting a dilator into the opening and expanding the opening; retracting the needle such that the needle is moved out of the blood vessel; retracting the dilator such that the dilator is moved out of the blood vessel; inserting a cannula into the opening in the wall of the blood vessel; and moving a collet jaw from an unlocked position to a locked position to secure the cannula in the blood vessel, the collet jaw in the unlocked position configured to not contact the tissue, and the collet jaw in the locked position configured to clamp the tissue such that the blood vessel is held between the collet jaw and the cannula to preclude at least a portion of the blood vessel from translating relative to the cannula, wherein the cannula defines a cannula lumen therethrough extending between a distal end and a proximal end, and wherein the dilator and the needle are movable within the cannula lumen.
12 . The method of claim 11 , wherein the needle defines a distal end and a proximal end opposite the distal end, wherein the dilator defines a dilator lumen extending through the dilator between a distal end and a proximal end, and wherein the step of retracting the needle includes moving the needle in the dilator lumen from a first position, in which the distal end of the needle is outside of the dilator lumen and is distal to the distal end of the dilator, to a second position, in which the distal end of the needle is in the dilator lumen and is proximal to the distal end of the dilator.
13 . The method of claim 11 , further comprising the step of digging into the tissue with a tine disposed on the collet jaw.
14 . The method of claim 11 , further comprising connecting the cannula to an extracorporeal membrane oxygenation (ECMO) system.
15 . The method of claim 14 , wherein the cannula is connected to a Y-connector that splits into a first proximal portion and a second proximal portion separate from the first proximal portion, and wherein the step of connecting the cannula to the ECMO system includes connecting the second proximal portion of the Y-connector to the ECMO system.
16 . The method of claim 11 , further comprising moving the dilator and the needle out of the cannula lumen after the step of securing the blood vessel to the cannula.
17 . The method of claim 16 , wherein the cannula is connected to a Y-connector that splits into a first proximal portion and a second proximal portion separate from the first proximal portion, and wherein the step of moving the dilator and the needle out of the cannula lumen includes moving the dilator and the needle through the first proximal portion.
18 . The method of claim 17 , further comprising moving the needle and the dilator through a slit seal defined in the first proximal portion of the Y-connector.
19 . The method of claim 17 , further comprising inserting a plug into a first proximal channel of the Y-connector to prevent blood flow out of the first proximal portion.
20 . The method of claim 11 , wherein the tissue includes an umbilical cord of a neonate.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application is a National Phase entry of International Application No. PCT/US2021/029548, filed Apr. 28, 2021, which claims priority to and the benefit of U.S. Provisional Application No. 63/017,204, filed Apr. 29, 2020, the entirety entireties of which is are incorporated herein for any and all purposes. TECHNICAL FIELD The present disclosure is related to embodiments of a cannula insertion system, including a cannula system and a cannula insertion device. BACKGROUND Extreme prematurity is the leading cause of infant morbidity and mortality in the United States, with over one third of all infant deaths and one-half of cerebral palsy diagnoses attributed to prematurity. Respiratory failure represents the most common and challenging problem associated with extreme prematurity, as gas exchange in critically preterm neonates is impaired by structural and functional immaturity of the lungs. Advances in neonatal intensive care have achieved improved survival and pushed the limits of viability of preterm neonates to 22 to 24 weeks gestation, which marks the transition from the canalicular to the saccular phase of lung development. Although survival has become possible, there is still a high rate of chronic lung disease and other complications of organ immaturity, particularly in neonates born prior to 28 weeks gestation. The development of a system that could support normal neonatal growth and organ maturation for even a few weeks could significantly reduce the morbidity and mortality of extreme prematurity, and improve quality of life in survivors. SUMMARY The above deficiencies are addressed by cannula insertion systems and methods of using them described throughout this specification. According to an aspect of this disclosure, a cannula insertion system for cannulating a blood vessel of a tissue includes a cannula system having a cannula that defines a cannula lumen therethrough. The cannula has a distal end and a proximal end opposite the distal end. The cannula insertion system further includes a cannula insertion device configured to couple with the cannula system. The coupling between the cannula insertion device and the cannula system may be releasable. The cannula insertion device includes a dilator having a dilator body that defines a dilator lumen therethrough; a needle having a needle body that defines a needle lumen therethrough, the needle being translatable within the dilator lumen along a first direction; a dilator actuator configured to be moved such that movement of the dilator actuator causes movement of the dilator along the first direction; a needle actuator configured to be moved such that movement of the needle actuator causes movement of the needle along the first direction; and a housing defining a housing recess therein. The housing recess is configured to receive the cannula system, the dilator, and the needle. The needle and the dilator of the cannula insertion device are configured to be moved within the cannula lumen along the first direction. The actuator may be configured to translate the needle from a first position, in which a distal end of the needle is positioned distally of a distal end of the dilator, to a second position, in which the distal end of the needle is positioned proximally of the distal end of the dilator. The cannula system may include a Y-connector adjacent to the proximal end of the cannula, the Y-connector having a first proximal portion, which defines a first proximal channel, and a second proximal portion, which defines a second proximal channel. The first and second proximal channels may be configured to be in fluid communication with the cannula lumen. In some aspects, the first proximal portion may define a slit seal that separates the first proximal channel from the second proximal channel. The slit seal has an open configuration, in which the dilator and the needle are inserted therethrough, and a closed configuration, in which the needle and the dilator are not extending therethrough. When the slit seal is in the closed configuration, liquid from the cannula lumen is precluded from moving into the first proximal channel. In some aspects, the cannula insertion system may include a plug configured to be removably inserted into the first proximal channel. The cannula system may include a locking element thereon, and the housing may include a locking element thereon as well. The locking element of the cannula system can be configured to releasably engage with the locking element of the housing such that the cannula system is affixed to the housing. The system may further include a collet jaw configured to releasably secure the cannula to the blood vessel. The collet jaw may be affixed to the cannula system. The collet jaw may have a base, a deformable arm, and a head. When the collet jaw is in an open position, the head is spaced away from the blood vessel and the cannula, and when the collet jaw is in a closed