CONTROL DEVICES FOR DEPLOYING A PROSTHESIS
The present disclosure relates to devices and methods for implanting a prosthesis into a heart of a mammal, such as a person. The disclosure includes a prosthesis that acts as a pressure vent between the left and right atria of the heart. The disclosure also includes a mounting tool for mounting the prosthesis onto a loading tool, the loading tool useful for loading the prosthesis onto a device for delivering the prosthesis into the patient's heart. Control devices and methods for using these devices are also disclosed. The intracardiac pressure vents disclosed allow sufficient flow from the left atrium to the right atrium to relieve elevated left atrial pressure and resulting patient symptoms. The devices also limit the amount of flow from the right atrium to the left atrium to minimize the potential for thrombi or other embolic material from entering arterial circulation.
1 . A control device for delivering an implantable prosthesis via a catheter, the control device comprising:
a control body comprising at least one finger ring and a series of orifices, the series of orifices arranged in a line, the control body connected to an outer sheath containing an implantable atrial septum prosthesis; and
a control handle comprising a thumb ring and a tab arranged and designed to fit into each of the series of orifices, the control handle connected to a control wire attached to the implantable atrial septum prosthesis,
wherein the control device is configured for implantation of the prosthesis by a sequential and discrete series of movements using the tab and the series of orifices.
2 . The control device of claim 1 , wherein distances between the orifices comprise 16 mm, 5 mm and 11 mm.
3 . The control device of claim 1 , further comprising a first connector for connecting the control body to the outer sheath and a second connector for connecting the control wire to the control handle.
4 . A control device for delivering an implantable prosthesis via a catheter, the control device comprising:
a housing;
a slider within the housing for connection to an outer sheath of the catheter;
a hand actuator connected to the slider and mounted on the housing; and
first and second tracks molded into the housing, the first and second tracks separated by a central portion and adapted for travel within the tracks by a pin connected to the slider,
wherein the control device is adapted to withdraw the outer sheath a first predetermined distance by moving the pin within the first track and a second predetermined distance by moving the pin within the second track, thus deploying the implantable prosthesis.
5 . The control device of claim 4 , further comprising an adapter for connecting the hand actuator to the slider.
6 . The control device of claim 4 , further comprising a rear retainer within the housing.
7 . The control device of claim 6 , further comprising a traversing mechanism connected to the rear retainer.
8 . A control device for delivering an implantable prosthesis via a catheter, the control device comprising:
a housing;
a slider within the housing for connection to an outer sheath of the catheter;
a hand actuator connected to the slider and mounted on the housing; and
first and second tracks molded into the housing, the first and second tracks each having a predetermined length and adapted for travel within the tracks by a member connected to the slider,
wherein the control device is adapted to withdraw the outer sheath a first predetermined distance by moving the member within the first track and a second predetermined distance by moving the member within the second track, thus deploying the implantable prosthesis.
9 . The control device of claim 8 , wherein the first and second predetermined distances are equal.
10 . The control device of claim 8 , wherein the first and second tracks are generally parallel and are separated by a short perpendicular region.
11 . The control device of claim 8 , wherein the first and second tracks are separated by a central transition region that is transverse to the first and second tracks.
12 . A control device for delivering an implantable prosthesis via a catheter, the control device comprising
a housing;
a trigger mounted on the housing;
a first plate mounted on the housing for engaging an inner wire of the catheter;
a second plate mounted on the housing for engaging a sheath of the catheter, wherein the sheath covers the inner wire and an implantable prosthesis for an atrial septum of a patient loaded onto the catheter;
a horizontal activating bar mounted within the housing and operatively connected to the second plate and the trigger;
a vertical cantilever bar mounted around the activating bar;
a vertical braking bar mounted around the activating bar;
a return spring mounted between the vertical cantilever bar and the vertical braking bar; and
a trigger spring mounted between the trigger and the housing,
wherein a first actuation of the trigger retracts the second plate and the sheath a first instance of a fixed distance, uncovering a first portion of the implantable prosthesis, and wherein a second actuation of the trigger retracts the second plate and the sheath a second instance of the same fixed distance, uncovering a second portion of the implantable prosthesis for the atrial septum of the patient.
13 . The control device of claim 12 , wherein the first and second portions comprise left and right flanges of an atrial septum.
14 . The control device of claim 12 , wherein the fixed distance is set by dimensions of the activating bar and apertures within the cantilever and braking bars for accommodating the activating bar.
15 . A control device for delivering an implantable prosthesis via a catheter-based delivery system, comprising:
a housing;
a first plate mounted on said housing for engaging an inner wire of said catheter;
a second plate mounted on said housing for engaging a sheath of said catheter, wherein said sheath covers said inner wire and an implantable prosthesis for an atrial septum of a patient loaded onto said catheter; and
a trigger mechanism operatively coupled to said second plate and causing said sheath to move a preselected distance,
wherein a first instance of said preselected distance is a distance sufficient to uncover a first portion of the loaded implantable device; and
wherein a second instance of said preselected distance is a distance sufficient to uncover a second portion of the loaded implanted device, implanting said device into a patient.