Splitable tissue-cutting devices, assemblies, and methods
Tissue-cutting devices and methods thereof, where a tissue-cutting device is coupleable with a catheter. The tissue-cutting device includes a blade that cuts the skin during insertion of the device in a needle track to enlarge to needle tract. The tissue-cutting device is configured for lateral separation from the catheter and/or a guidewire. The tissue-cutting device includes a channel for receiving the catheter and/or a guidewire. The channel can be configured to (i) retain the catheter/guidewire within the channel in the absence of a deliberate action by the clinician and (ii) facilitate lateral removal of the catheter/guidewire from the channel in response to the deliberate action. A catheter assembly includes a catheter coupled with the tissue-cutting device. The tissue-cutting device may include a sheath extending along a distal portion of the tissue-cutting device.
1 . A tissue-cutting device, comprising:
a body including a channel extending longitudinally between a distal end of the body and a proximal end of the body, wherein:
the body includes a first body side coupled to a second body side via a longitudinally oriented hinge,
the channel is disposed between the first body side and the second body side and is configured to receive a vascular catheter therein, the channel including a first diameter at the proximal end of the body and a second diameter at the distal end of the body, wherein the first diameter is greater than the second diameter,
rotation of the second body side with respect to the first body side transitions the channel between a closed state and an open state,
the vascular catheter is laterally constrained within the channel in the closed state, and
the vascular catheter is laterally removable from the channel in the open state; and
a tissue-cutting blade attached to the body, wherein the tissue-cutting blade:
extends distally away from the distal end of the body, and
extends laterally away from a longitudinal axis of the channel such that a cutting edge of the tissue-cutting blade is disposed opposite the longitudinal axis.
2 . The device of claim 1 , wherein the tissue-cutting device is configured for insertion along a needle tract extending between a skin surface and a blood vessel wall of a patient.
3 . The device of claim 2 , wherein the tissue-cutting blade is configured to enlarge the needle tract during insertion of the tissue-cutting device.
4 . The device of claim 3 , wherein the distal end of the body provides an insertion stop for the tissue-cutting device during insertion of the tissue-cutting device.
5 . The device of claim 4 , wherein the cutting edge of the tissue-cutting blade is disposed at an angle with respect to the longitudinal axis of the channel so that a distal portion of the cutting edge is closer to the longitudinal axis than a proximal portion of the cutting edge.
6 . The device of claim 5 , wherein the insertion stop defines a depth of cut for the tissue-cutting blade in accordance with the angle of the cutting edge.
7 . The device of claim 1 , wherein the body includes one or more protrusions extending laterally away from the body, the one or more protrusions defining a handle for the tissue-cutting device.
8 . The device of claim 1 , wherein the tissue-cutting blade is formed of a stainless steel.
9 . The device of claim 1 , wherein;
the body is formed of a thermo-plastic material via an injection molding process, and
the tissue-cutting blade is insert-molded into the body.
10 . The device of claim 1 , wherein:
the body further includes a sheath extending distally away from the distal end,
the sheath extends along the tissue-cutting blade,
the channel extends along the sheath, and
a sharp distal tip of the tissue-cutting blade is insert-molded into a wall of the sheath.
11 . The device of claim 10 , wherein the sheath includes a taper such that insertion of the sheath within a needle track dilates the needle track.
12 . The device of claim 1 , wherein the tissue-cutting device is configured to:
allow lateral decoupling of the tissue-cutting device from the vascular catheter in response to a deliberate action by a clinician, and
inhibit lateral decoupling of the tissue-cutting device from the vascular catheter in an absence of the deliberate action by the clinician.
13 . The device of claim 1 , wherein the longitudinally oriented hinge is a living hinge formed via an injection molding process.
14 . The device of claim 1 , wherein:
the body includes:
a first protrusion extending away from the first body side; and
a second protrusion extending away from the second body side, and
applying a squeezing force to the first protrusion and the second protrusion transitions the channel from the closed state to the open state.
15 . The device of claim 14 , wherein:
the body includes one or more frangible connecting members extending between the first body side and the second body side at a location opposite the longitudinally oriented hinge, such that the one or more frangible connecting members constrain the channel in the closed state, and
applying the squeezing force breaks the one or more frangible connecting members.
16 . The device of claim 1 , further comprising:
a blade cover selectively transitionable between a safety state and a use state, wherein the blade cover:
extends over the cutting edge in the safety state, and
is disposed away from the cutting edge in the use state.
17 . The device of claim 16 , wherein:
the blade cover is rotatably coupled with the body, and
transitioning the blade cover away from the safety state toward the use state includes rotating the blade cover.
18 . The device of claim 17 , wherein rotation of the blade cover away from the safety state is inhibited by a detent.
19 . A catheter assembly, comprising:
a catheter configured for advancement along a vasculature of a patient, and
the tissue-cutting device of claim 1 coupled with the catheter.
20 . The assembly of claim 19 , wherein the tissue-cutting device is attached to the catheter via an adhesive.
21 . The assembly of claim 19 , wherein the tissue-cutting device is attached to the catheter adjacent a diameter transition portion of the catheter.
22 . The assembly of claim 19 , wherein the tissue-cutting device is attached to the catheter adjacent a distal end of the catheter.
23 . The assembly of claim 19 , wherein, during use, manipulation of the catheter is facilitated by grasping the tissue-cutting device.