Calculus removal

Surgery – Instruments – Means for concretion removal

Reexamination Certificate

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Details

C606S110000

Reexamination Certificate

active

06319262

ABSTRACT:

FIELD OF THE INVENTION
This invention relates to removing calculi and other objects.
BACKGROUND OF THE INVENTION
In a stone retrieval procedure, a calculus (stone) is removed from, e.g., the bile duct using a catheter device that is passed through an endoscope. The catheter device includes a collapsible basket that is extended from a sheath to capture the stone for removal.
In a lithotripsy procedure, the stone is crushed either to facilitate natural passage or to facilitate removal with a basket. This procedure can be performed with a catheter device that can apply large collapsing force to the basket, which crushes the captured stone. Many other medical procedures also involve grasping, sampling, removal, and/or crushing objects in the body.
SUMMARY OF THE INVENTION
In an aspect, the invention features an instrument for treating an internal organ which is obstructed by a calculus. The instrument includes an elongate catheter sheath extending along an axis from a proximal end to a distal end that is sized for insertion into the organ. A basket-form calculus grasper is formed of flexible wires and adapted to be extended from and withdrawn within the distal end of the catheter sheath such that, when extended from the distal end of the sheath, the wires are spaced to permit passage of the calculus and when withdrawn at least partially into the sheath, the wires collapse in a manner to capture the calculus. A tension element is coupled to the grasper. A handle at the proximal end of the catheter sheath receives the tension element and houses an operating assembly. The operating assembly permits application of axial force to the tension element for extending or withdrawing the grasper from the distal end of the sheath and permits rotating the grasper about the axis. The operating assembly includes a manual actuator and a mechanical actuator. The manual actuator is coupled to the tension element and arranged for applying axial force to the tension element for extending the grasper from the distal end of the sheath and for imparting rotational motion to the tension element for rotating the grasper about the instrument axis to a desired orientation. The mechanical actuator is arranged to apply axial force to the tension element for withdrawing the grasper with mechanical advantage.
In another aspect, the invention features an operating handle for a medical instrument. The operating handle includes a control element extending along an axis and an operating assembly which is coupled to the control element. The operating assembly includes a manual actuator directly connected to the control element for moving the control element axially and for rotating the control element about the axis to a desired orientation. The operating assembly also includes a mechanical actuator coupled to the control element through a selective engagement member, such that the mechanical actuator is actuatable to move the control element axially with mechanical advantage and without rotation from the desired orientation.
In another aspect, the invention features an instrument for grasping or crushing a calculus. The instrument includes an elongate catheter sheath that extends along an axis from a proximal end to a distal end and is sized for insertion into the organ. A basket-form calculus grasper is formed of flexible wires arranged to be extended from and withdrawn within the distal end of the catheter sheath such that, when extended from the distal end of the sheath, the wires are spaced to permit passage of the calculus and when withdrawn at least partially into the catheter sheath, the wires collapse in a manner to capture the calculus. A tension element is coupled to the grasper. A handle is provided at the proximal end of the catheter sheath that receives the tension element and houses an operating assembly to apply axial force to the tension element for extending or withdrawing the grasper from the distal end of the sheath and for rotating the grasper about the axis. The operating assembly includes a manual control knob directly connected to the tension element and arranged for applying axial force to the tension element for extending the grasper from the distal end of the sheath and for imparting rotational motion to the tension element for rotating the grasper about the instrument axis to a desired orientation. A mechanical actuator is arranged to apply axial force to the tension element for withdrawing the grasper with mechanical advantage. The mechanical actuator includes an engaging piece cooperatively constructed with the tension element to bear on the tension element to apply axial force when the tension element is in various rotational states.
Embodiments may include one or more of the following features. The tension element has a substantially smooth cylindrical surface and the engaging piece is a jam element arranged to bear on the surface. The instrument includes a ratchet mechanism for selectively preventing extension of the basket. The ratchet mechanism includes a ratchet jam element arranged to bear on the surface. The mechanical actuator includes a failure element that fails mechanically in response to excessive tension applied to the tension element while permitting actuation of the grasper using the manual control knob. The failure element is a hinge. The hinge is a weakened portion on the mechanical actuator jam element.
Embodiments may include one or more of the following features. The tension element has an outer engaging surface along a segment corresponding to a desired range of rotation and the mechanical actuator includes a complementary engaging element for applying axial withdrawing force. The outer engaging surface and the engaging element are cooperatively constructed to permit the engaging element to apply the axial force to the tension element with the tension element rotationally oriented within the range. The outer engaging surface is a substantially smooth cylindrical surface. The engaging element is a jam element. The jam element is biased in a non-engaging configuration to permit manual operation of the basket using the manual actuator without interference from the mechanical actuator and the jam element can be operated against the bias to engage the tension element for applying axial force to the tension element with mechanical advantage. The jam element is operated through a trigger.
Embodiments may also include one or more of the following features. The instrument includes a ratchet mechanism for preventing extension of the basket. The ratchet mechanism includes an engaging piece cooperatively constructed with the tension element to permit the engaging piece to engage the tension element with the tension element rotationally oriented within the range. The ratchet engaging piece is a ratchet jam element. The ratchet jam element can be operated to a non-engaging configuration to permit operation using the manual control without interference from the ratchet mechanism.
Embodiments may also include one or more of the following features. The manual actuator is actuatable to apply axial force to the tension element for extending and withdrawing the grasper. The catheter sheath is sized to pass through an endoscope. The device includes a fluid port in communication with the catheter sheath. The control element is extended and withdrawn relative to a sheath.
In another aspect, the invention features a method of grasping an object in a body. The method includes providing a medical instrument having an instrument axis and including a grasper actuatable between an open and closed condition. The medical instrument includes an operating mechanism for actuating the grasper alternatively with mechanical advantage or without mechanical advantage and for rotating the grasper about the axis. The grasper is positioned in proximity to the object. The grasper is actuated to open the grasper. The grasper is rotated to a desired orientation and manipulated about the object. The grasper is actuated with mechanical advantage to close the grasper.
Embodiments may also include one or more of

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