MRI-guided devices and MRI-guided interventional systems that can track and generate dynamic visualizations of the devices in near real time
First Claim
1. An MRI-compatible medical device, comprising:
- an elongated sheath having a distal end, an opposite proximal end, and a central lumen extending between the proximal and distal ends, wherein the sheath includes at least one tracking member adjacent the sheath distal end;
a dilator movably disposed within the sheath lumen and having a distal end, an opposite proximal end, and a lumen extending between the dilator proximal and distal ends, wherein the dilator includes at least one tracking member adjacent the dilator distal end, wherein the at least one tracking member includes a cable configured to electrically connect the at least one tracking member to an MRI scanner, and wherein the dilator distal end is configured to extend outwardly from the sheath distal end; and
a needle movably disposed within the dilator lumen and having a distal end, an opposite proximal end, and a central lumen extending between the needle proximal and distal ends, wherein the needle comprises a main body portion of an MRI-compatible material and a tip portion, wherein the tip portion is located at the needle distal end wherein the needle is movable between retracted and extended positions, wherein the needle distal end is within the dilator lumen when in the retracted position and wherein the needle distal end extends outwardly from the dilator distal end when in the extended position, wherein the needle tip portion includes a tracking member that is closely spaced-apart from the at least one tracking member on the dilator distal end when the needle is in the extended position.
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Accused Products
Abstract
An MRI-guided medical device includes an elongated sheath, an elongated dilator, and an elongated needle. The sheath has a distal end, an opposite proximal end, and a central lumen extending between the proximal and distal ends. The sheath comprises MRI-compatible material and includes a tracking member located adjacent to the sheath distal end that is visible in an MRI image. The dilator comprises MRI-compatible material and is movably disposed within the sheath lumen. A distal end of the dilator is configured to extend outwardly from the sheath distal end and dilator includes at least one tracking member that is visible in an MRI image. The needle is movably disposed within the dilator lumen and is movable between stored and operative positions relative to the dilator. An RF shield may be coaxially disposed within the elongated sheath so as to surround a portion of the sheath central lumen.
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Citations
29 Claims
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1. An MRI-compatible medical device, comprising:
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an elongated sheath having a distal end, an opposite proximal end, and a central lumen extending between the proximal and distal ends, wherein the sheath includes at least one tracking member adjacent the sheath distal end; a dilator movably disposed within the sheath lumen and having a distal end, an opposite proximal end, and a lumen extending between the dilator proximal and distal ends, wherein the dilator includes at least one tracking member adjacent the dilator distal end, wherein the at least one tracking member includes a cable configured to electrically connect the at least one tracking member to an MRI scanner, and wherein the dilator distal end is configured to extend outwardly from the sheath distal end; and a needle movably disposed within the dilator lumen and having a distal end, an opposite proximal end, and a central lumen extending between the needle proximal and distal ends, wherein the needle comprises a main body portion of an MRI-compatible material and a tip portion, wherein the tip portion is located at the needle distal end wherein the needle is movable between retracted and extended positions, wherein the needle distal end is within the dilator lumen when in the retracted position and wherein the needle distal end extends outwardly from the dilator distal end when in the extended position, wherein the needle tip portion includes a tracking member that is closely spaced-apart from the at least one tracking member on the dilator distal end when the needle is in the extended position. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
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14. An MRI-compatible medical device, comprising:
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an elongated sheath having a distal end, an opposite proximal end, and a central lumen extending between the proximal and distal ends, wherein the sheath includes at least one tracking member adjacent the sheath distal end; a dilator movably disposed within the sheath lumen and having a distal end, an opposite proximal end, and a lumen extending between the dilator proximal and distal ends, wherein the dilator includes at least one tracking member adjacent the dilator distal end, wherein the at least one tracking member includes a cable configured to electrically connect the at least one tracking member to an MRI scanner, and wherein the dilator distal end is configured to extend outwardly from the sheath distal end; and a needle movably disposed within the dilator lumen and having a distal end, an opposite proximal end, and a central lumen extending between the needle proximal and distal ends, wherein the needle comprises a main body portion and a tip portion, wherein the needle tip portion comprises a bendable body of a conductive, non-magnetic material and has an electrical length that is about 1/4 lambda or a higher odd harmonic thereof (3/4 lambda, 5/4 lambda and the like) of an operational frequency of an MRI Scanner when in position in a magnetic field associated with the MRI Scanner.
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15. An MRI-compatible medical device, comprising:
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an elongated sheath having a distal end, an opposite proximal end, and a central lumen extending between the proximal and distal ends, wherein the sheath includes at least one tracking member adjacent the sheath distal end; a dilator movably disposed within the sheath lumen and having a distal end, an opposite proximal end, and a lumen extending between the dilator proximal and distal ends, wherein the dilator includes at least one tracking member adjacent the dilator distal end, wherein the at least one tracking member includes a cable configured to electrically connect the at least one tracking member to an MRI scanner, and wherein the dilator distal end is configured to extend outwardly from the sheath distal end; and at least one RF shield coaxially disposed within the elongated sheath and surrounding a portion of the sheath central lumen, the at least one RF shield comprising; elongated inner and outer conductors, each having respective opposite first and second end portions; and an elongated dielectric layer of MRI compatible material sandwiched between the inner and outer conductors and surrounding the inner conductor, wherein only the respective first end portions of the inner and outer conductors are electrically connected, and wherein the second end portions are electrically isolated. - View Dependent Claims (16, 17, 18, 19)
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20. An MRI guided interventional system, comprising:
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a flexible medical device configured to be introduced into a patient via a tortuous and/or natural lumen path, comprising; an elongated sheath having a distal end, an opposite proximal end, and a central lumen extending between the proximal and distal ends, wherein the sheath includes at least one tracking member adjacent the sheath distal end; a dilator movably disposed within the sheath lumen and having a distal end, an opposite proximal end, and a lumen extending between the dilator proximal and distal ends, wherein the dilator includes at least one tracking coil adjacent the dilator distal end, wherein the at least one tracking coil is connected to a channel of an MRI scanner, and wherein the dilator distal end is configured to extend outwardly from the sheath distal end; and a needle movably disposed within the dilator lumen and having a distal end, an opposite proximal end, and a central lumen extending between the needle proximal and distal ends, wherein the needle comprises a main body portion of an MRI-compatible material and a tip portion, wherein the tip portion is located at the needle distal end, wherein the needle is movable between retracted and extended positions, wherein the needle distal end is within the dilator lumen when in the retracted position and wherein the needle distal end extends outwardly from the dilator distal end when in the extended position; and a circuit adapted to communicate with and/or reside in the MRI Scanner, the circuit configured to;
(a) obtain MR image data and generate a series of near real time (RT) MRI images of target anatomy of a patient during a surgical procedure using relevant anatomical scan planes associated with a 3-D MRI image space having a coordinate system;
(b) identify coordinates associated with a location of at least a distal portion of the dilator using a tracking signal from at least one tracking coil in the 3-D MM image space; and
(c) render near RT interactive visualizations of the flexible medical device in the 3-D image space with near RT image data of target patient anatomical structure, wherein the circuit illustrates the flexible medical device with a physical representation in the visualizations. - View Dependent Claims (21, 22, 23, 24, 25, 26, 27)
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28. An MRI-guided septal puncture kit, comprising:
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an elongated sheath having a distal end, an opposite proximal end, and a central lumen extending between the proximal and distal ends, wherein the sheath includes at least one tracking member adjacent the sheath distal end; a dilator movably disposed within the sheath lumen and having a distal end, an opposite proximal end, and a lumen extending between the dilator proximal and distal ends, wherein the dilator includes at least one tracking member adjacent the dilator distal end, wherein the at least one tracking member is configured to be connected to a channel of an MRI scanner, and wherein the dilator distal end is configured to extend outwardly from the sheath distal end; a needle movably disposed within the dilator lumen and having a distal end, an opposite proximal end, and a lumen extending between the needle proximal and distal ends, wherein the needle comprises a main body portion of MRI-compatible material and a tip portion, wherein the needle is movable between retracted and extended positions, wherein the needle distal end is within the dilator lumen when in the retracted position and wherein the needle distal end extends outwardly from the dilator distal end when in the extended position; and a guidewire having a distal end, and an opposite proximal end, wherein the guidewire includes at least one tracking member adjacent the guidewire distal end, and wherein the guidewire is configured to be movably disposed within the dilator lumen when the needle is absent therefrom.
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29. An MRI-guided septal puncture kit, comprising:
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an elongated sheath having a distal end, an opposite proximal end, and a central lumen extending between the proximal and distal ends, wherein the sheath includes at least one tracking member adjacent the sheath distal end; a dilator movably disposed within the sheath lumen and having a distal end, an opposite proximal end, and a lumen extending between the dilator proximal and distal ends, wherein the dilator includes at least one tracking member adjacent the dilator distal end, wherein the at least one tracking member is configured to be connected to a channel of an MRI scanner, and wherein the dilator distal end is configured to extend outwardly from the sheath distal end; a needle movably disposed within the dilator lumen and having a distal end, an opposite proximal end, and a lumen extending between the needle proximal and distal ends, wherein the needle comprises a main body portion of MRI-compatible material and a tip portion, wherein the needle is movable between retracted and extended positions, wherein the needle distal end is within the dilator lumen when in the retracted position and wherein the needle distal end extends outwardly from the dilator distal end when in the extended position; a guidewire having a distal end, and an opposite proximal end, wherein the guidewire includes at least one tracking member adjacent the guidewire distal end, and wherein the guidewire is configured to be movably disposed within the dilator lumen when the needle is absent therefrom; and at least one RF shield coaxially disposed within the elongated sheath and surrounding a portion of the sheath central lumen, the at least one RF shield comprising; elongated inner and outer conductors, each having respective opposite first and second end portions; and an elongated dielectric layer of MRI compatible material sandwiched between the inner and outer conductors and surrounding the inner conductor, wherein only the respective first end portions of the inner and outer conductors are electrically connected, and wherein the second end portions are electrically isolated.
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Specification