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US 12,752,080 B2Granted
Surgical therapy systems and related methods
AssigneeClearPoint Neuro, Inc.
InventorPeter G. Piferi
Life of this patent
Estimating the term…
Abstract
Systems for treatment include a sheath assembly with a guide sheath and a shoulder, a stylet releasably couplable to the guide sheath and extending a distance out of a distal end thereof for rigidity to facilitate proper positioning, a bolt configured to hold a seal member, a bolt nut coupleable to the bolt member to clamp the sheath assembly and the seal member in the bolt. A therapy device such as a flexible catheter is releasably interchangeably held in the guide sheath in lieu of the stylet. A portion of the flexible catheter can remain in the guide sheath in a brain of a patient with the guide sheath held by the bolt and bolt nut with another external portion residing outside these devices to allow the portion of the flexible catheter to move with the brain of the patient during treatment.
Claims22
A medical system, comprising:
- a sheath assembly comprising a guide sheath with a proximal end and an opposing distal end and with a lumen extending therethrough, wherein the proximal end comprises a shoulder that extends radially outward from the lumen;
- a bolt configured to threadably engage a skull of a patient, wherein the bolt comprises an open channel that extends axially therethrough, and wherein the guide sheath is configured to reside in the open channel of the bolt with the distal end residing distally of the bolt;
- a seal member inside the bolt adjacent the shoulder of the guide sheath;
- and
- a bolt nut configured to couple to the bolt,
- wherein the guide sheath comprises a wall thickness in a range of 0.002 inches to about 0.025 inches, wherein the medical system further comprises a therapy device that extends through the guide sheath so that a distal end portion of the therapy device is distal to the guide sheath, wherein the therapy device and the guide sheath are sufficiently flexible when coupled together to be able to shift in concert in response to brain shift when implanted.
3 more elements
A medical system, comprising:
- a sheath assembly comprising a guide sheath with a proximal end and an opposing distal end and with a lumen extending therethrough, wherein the proximal end comprises a shoulder that extends radially outward from the lumen;
- a bolt configured to threadably engage a skull of a patient, wherein the bolt comprises an open channel that extends axially therethrough, and wherein the guide sheath is configured to reside in the open channel of the bolt with the distal end residing distally of the bolt;
- a seal member inside the bolt adjacent the shoulder of the guide sheath;
- and
- a bolt nut configured to couple to the bolt,
- wherein the proximal end of the sheath assembly terminates inside the bolt.
3 more elements
A medical system, comprising:
- a sheath assembly comprising a guide sheath with a proximal end and an opposing distal end and with a lumen extending therethrough, wherein the proximal end comprises a shoulder that extends radially outward from the lumen;
- a bolt configured to threadably engage a skull of a patient, wherein the bolt comprises an open channel that extends axially therethrough, and wherein the guide sheath is configured to reside in the open channel of the bolt with the distal end residing distally of the bolt;
- a seal member inside the bolt;
- and
- a bolt nut configured to couple to the bolt,
- wherein the sheath assembly is provided as a set of sheath assemblies, each sheath assembly having a guide sheath with a different length to thereby allow a user to select an appropriate sheath assembly with a guide sheath having a desired length to extend to a target site in the patient for a medical procedure.
3 more elements
A medical system, comprising:
- a sheath assembly comprising a guide sheath with a proximal end and an opposing distal end and with a lumen extending therethrough, wherein the proximal end comprises a shoulder that extends radially outward from the lumen;
- a bolt configured to threadably engage a skull of a patient, wherein the bolt comprises an open channel that extends axially therethrough, and wherein the guide sheath is configured to reside in the open channel of the bolt with the distal end residing distally of the bolt;
- a seal member inside the bolt adjacent the shoulder of the guide sheath;
- a bolt nut configured to couple to the bolt;
- a cap that is configured to attach to the bolt nut;
- and
- a stylet that has increased rigidity relative to the guide sheath, wherein the stylet is releasably and slidably coupled to the sheath assembly.
4 more elements
A medical system, comprising:
- a sheath assembly comprising a guide sheath with a proximal end and an opposing distal end and with a lumen extending therethrough, wherein the proximal end comprises a shoulder that extends radially outward from the lumen;
- a bolt configured to threadably engage a skull of a patient, wherein the bolt comprises an open channel that extends axially therethrough, and wherein the guide sheath is configured to reside in the open channel of the bolt with the distal end residing distally of the bolt;
- a seal member inside the bolt;
- a bolt nut configured to couple to the bolt;
- a stylet that has increased rigidity relative to the guide sheath, and wherein the stylet is releasably and slidably coupled to the sheath assembly;
- and
- an insertion tool assembly with an open through channel, configured to attach the sheath assembly to the bolt prior to coupling the bolt nut to the bolt, wherein the stylet releasably extends concurrently through the open through channel of the insertion tool assembly and the lumen of the sheath assembly to provide rigidity during intrabody placement, and wherein, when assembled together, a distal end of the insertion tool assembly abuts the sheath assembly whereby upon insertion into the bolt, the insertion tool assembly places the sheath assembly in the bolt.
4 more elements
A medical system, comprising:
- a sheath assembly comprising a guide sheath with a proximal end and an opposing distal end and with a lumen extending therethrough, wherein the proximal end comprises a shoulder that extends radially outward from the lumen;
- a bolt configured to threadably engage a skull of a patient, wherein the bolt comprises an open channel that extends axially therethrough, and wherein the guide sheath is configured to reside in the open channel of the bolt with the distal end residing distally of the bolt;
- a seal member inside the bolt;
- a bolt nut configured to couple to the bolt;
- and
- a flexible catheter configured with a portion that slidably extends through the sheath assembly, wherein the flexible catheter has axially opposed proximal and distal ends and a length sufficient to position the distal end internal to the patient outside the distal end of the guide sheath, wherein the flexible catheter has sufficient flexibility to be able to bend at an angle of 45-90 degrees without breaking and wherein the flexible catheter comprises a luer connector on the proximal end.
3 more elements
A medical system, comprising:
- a sheath assembly comprising a guide sheath with a proximal end and an opposing distal end and with a lumen extending therethrough, wherein the proximal end comprises a shoulder that extends radially outward from the lumen;
- a bolt configured to threadably engage a skull of a patient, wherein the bolt comprises an open channel that extends axially therethrough, and wherein the guide sheath is configured to reside in the open channel of the bolt with the distal end residing distally of the bolt;
- a seal member inside the bolt adjacent the shoulder of the guide sheath;
- and
- a bolt nut configured to couple to the bolt,
- wherein the open channel of the bolt defines a seat for the shoulder of the sheath assembly, and wherein the bolt nut comprises a distal end that resides in the open channel of the bolt and cooperates with the bolt to clamp against the seal member to inhibit fluid leakage from the patient distal to the seal member.
3 more elements
An image-guided surgical system comprising:
- a surgical navigation trajectory guide comprising a tower that is moveable to define a trajectory path angle;
- a sheath assembly comprising a guide sheath with a proximal end and an opposing distal end and with an open through lumen extending therethrough, wherein the proximal end comprises a radially outwardly extending shoulder;
- a bolt configured to threadably engage a skull of a patient, wherein the bolt comprises an open channel that extends axially therethrough, wherein the guide sheath is configured to reside in the open channel of the bolt with the distal end residing distally of the bolt and with the proximal end terminating inside the bolt;
- a bolt nut configured to couple to the bolt;
- a stylet releasably insertable through the sheath assembly;
- and
- an insertion tool assembly with an open through channel, configured to attach the sheath assembly to the bolt prior to coupling the bolt nut to the bolt, wherein the stylet releasably and concurrently extends through the open through channel of the insertion tool assembly and the lumen of the sheath assembly, wherein, when assembled together, a distal end of the insertion tool assembly abuts the sheath assembly whereby upon insertion into the bolt, the insertion tool assembly places the sheath assembly in the bolt with the shoulder thereof or a seal member in the bolt against a seat inside the bolt, and wherein the insertion tool assembly has a length sufficient to extend at least partially through the tower with a proximal end residing outside and more proximal to the tower.
4 more elements
A method of providing a therapy, comprising:
- providing a set of surgical components comprising a sheath assembly with a guide sheath, a stylet configured to releasably couple to the sheath assembly, an insertion tool assembly, a bolt configured to attach to a skull, and a bolt nut;
- positioning a trajectory guide with a tower on or about a head of patient, the trajectory guide defining a trajectory axis into the patient to a target site;
- attaching the bolt to a skull of the patient at a brain entry point of the trajectory axis;
- inserting the sheath assembly, insertion tool assembly and stylet, coupled together as an assembly, through an open channel of the tower and into the bolt;
- removing the insertion tool assembly from the tower with or separately from removing the stylet from the sheath assembly;
- then
- coupling a bolt nut to the bolt with a distal end portion of the bolt nut facing and adjacent a shoulder of the sheath assembly in the bolt and/or a seal member in the bolt.
4 more elements
Dependencies are inferred from the claim text.