The present invention relates generally to medical deployment tools and methods, and more particularly to intravascular deployment tools and methods.
Modern cardiovascular therapies include the use of positioning catheters to navigate the intended therapy to a targeted anatomical location. The trajectory of these catheters requires steerability features that are usually integrated within the shaft body of the catheter, in order to achieve different degrees and planes of steering.
Currently available steerable percutaneous catheters and delivery systems require considerable diameters to allow steerability.
Some embodiments of the present invention provide a probe and a method of using the probe to intravascularly bend an elongate medical instrument, such as an intracardiac medical instrument, a brain medical instrument, a diagnostic medical instrument, and/or a therapeutic medical instrument. The method comprises advancing the elongate medical instrument through vasculature, advancing the probe through the vasculature, and positioning a distal longitudinal probe-portion of the probe at least partially alongside a distal longitudinal medical-instrument-portion of the elongate medical instrument. Thereafter, the distal longitudinal probe-portion is mechanically coupled to the distal longitudinal medical-instrument-portion, and the probe is used to bend the elongate medical instrument. The probe is configured to bend the elongate medical instrument within the body when the distal longitudinal probe-portion is mechanically coupled to the distal longitudinal medical-instrument-portion.
The probe and this method provide steerability to any the elongate medical instrument that lacks a steerability-providing mechanism, or provide additional steerability to any the elongate medical instrument that has a steerability-providing mechanism, such as to in order to provide additional directionality and/or a smaller bend radius to the existing steerability-providing mechanism. An alternative approach of integrating steerability functionality, or additional steerability functionality, directly into the elongate medical instrument during manufacture thereof would require adding additional channels to the elongate medical instrument to accommodate steering wire(s), which might increase the diameter of the elongate medical instrument. The reduced diameter of the elongate medical instrument provided by the probe may enhance minimally invasive procedures, such as by reducing the risk of complications. In addition, the probe is only utilized in cases in which steerability is required, which may provide procedural cost savings. Moreover, in some challenging anatomies, elongate medical instruments that usually do not integrate or require steering features may benefit from the external steerability aid provided by the probe.
In addition, since the probe is coupled to the elongate medical instrument in situ within the vasculature, the additional steerability is provided to the elongate medical instrument without the need for a larger diameter delivery catheter for the elongate medical instrument than would otherwise be needed.
The probe and this method also allow the healthcare worker to configure the resulting steering properties (e.g., bending point) of the elongate medical instrument, such as by selecting the one or more locations along the elongate medical instrument at which the distal longitudinal probe-portion is coupled to the distal longitudinal medical-instrument-portion. For example, steering properties of the elongate medical instrument may be configured based on the relative flexibility of different longitudinal segments of the elongate medical instrument. Optionally, the healthcare worker may configure the steering properties based on medical imaging (e.g., a CT scan) and/or a planned vascular path of the particular procedure and the particular patient's anatomy.
For some applications, the elongate medical instrument is advanced through the vasculature along a first route through the vasculature, and the probe is advanced through the vasculature along a second route through the vasculature, the second route different from the first route.
For some applications, the distal longitudinal probe-portion comprises one or more loops, which are configured to be looped around the distal longitudinal medical-instrument-portion when the distal longitudinal probe-portion is positioned at least partially alongside the distal longitudinal medical-instrument-portion within the body, thereby mechanically coupling the distal longitudinal probe-portion to the distal longitudinal medical-instrument-portion within the body. The distal longitudinal probe-portion is mechanically coupled to the distal longitudinal medical-instrument-portion by looping the one or more loops around the distal longitudinal medical-instrument-portion.
Some embodiments of the present invention provide an attachable bending system and a method of using the attachable bending system to intravascularly bend the elongate medical instrument, in accordance with some applications of the present invention.
The attachable bending system comprises:
The distal-most connector, the one or more proximal-more connectors, and the wire are arranged such that proximal pulling of the wire bends the elongate medical instrument within the body of the subject when the distal-most connector and the one or more proximal-more connectors are coupled to the elongate medical instrument and the elongate medical instrument is within vasculature of the body.
The method of using the attachable bending system comprises:
The attachable bending system and this method provide steerability to any the elongate medical instrument that lacks a steerability-providing mechanism, or provides additional steerability to any the elongate medical instrument that has a steerability-providing mechanism, such as to in order to provide additional directionality and/or a smaller bend radius to the existing steerability-providing mechanism. An alternative approach of integrating steerability functionality, or additional steerability functionality, directly into the elongate medical instrument during manufacture thereof would require adding additional channels to the elongate medical instrument to accommodate steering wire(s), which might increase the diameter of the elongate medical instrument.
In addition, since the distal-most connector and the one or more proximal-more connectors are coupled to the elongate medical instrument before the elongate medical instrument is introduced into the vasculature, practicing the method does not require additional vascular access than would otherwise be needed.
The attachable bending system and this method also allow the healthcare worker to configure the resulting steering properties (e.g., bending point) of the elongate medical instrument, such as by selecting the distal location and the one or more proximal-more locations along the elongate medical instrument at which the distal-most connector and the one or more proximal-more connectors, respectively, are coupled to the elongate medical instrument. For example, steering properties of the elongate medical instrument may be configured based on the relative flexibility of different longitudinal segments of the elongate medical instrument. Optionally, the healthcare worker may configure the steering properties based on medical imaging (e.g., a CT scan) and/or a planned vascular path of the particular procedure and the particular patient's anatomy.
For some applications, the one or more proximal-more connectors are shaped so as define one or more respective channels therethrough, and the wire passes through the one or more channels.
There is therefore provided, in accordance with an application of the present invention, a probe for use with an elongate medical instrument, the probe configured to be advanced through vasculature of a body of a subject, the probe including:
For some applications, the one or more loops are configured to be looped around the distal longitudinal medical-instrument-portion by passing the one or more loops over the distal end of the distal longitudinal medical-instrument-portion, and thereafter proximally withdrawing the distal longitudinal probe-portion or distally advancing the distal longitudinal medical-instrument-portion, such that the one or more loops are positioned around the distal longitudinal medical-instrument-portion.
For some applications, the distal longitudinal probe-portion includes two or more loops, which are configured to be looped around the distal longitudinal medical-instrument-portion.
For some applications, the one or more loops are configured to be tightened around the distal longitudinal medical-instrument-portion after being looped around the distal longitudinal medical-instrument-portion, so as to mechanically couple the distal longitudinal probe-portion to the distal longitudinal medical-instrument-portion.
For some applications, the probe further includes one or more control wires that pass along the probe, and the one or more loops extend from one or more distal portions of the one or more control wires, and are arranged such that proximal pulling of the one or more control wires tightens the one or more loops around the distal longitudinal medical-instrument-portion.
For some applications, the one or more loops are configured to assume a non-radially-extended configuration and a radially-extended configuration.
For some applications, the one or more loops are retracted into the probe when in the non-radially-extended configuration.
For some applications, the one or more loops are retracted against the probe when in the non-radially-extended configuration.
For some applications, the probe further includes one or more control wires that pass along the probe and are configured to control a transition between the non-radially-extended configuration and the radially-extended configuration.
For some applications, the one or more loops are pivotable with respect to an external surface of the probe, so as to transition between the non-radially-extended configuration and the radially-extended configuration.
For some applications, the probe is axially non-compressible.
For some applications, the probe further includes a steerability-providing mechanism, which is configured to steer the probe so as to bend the elongate medical instrument within the body when the distal longitudinal probe-portion is mechanically coupled to the distal longitudinal medical-instrument-portion.
For some applications, the steerability-providing mechanism includes one or more wires that pass through one or more channels defined by a wall of the probe, and the steerability-providing mechanism is configured such that proximal pulling of at least one of the one or more wires bends the probe.
For some applications, the one or more wires are attached to the one or more loops.
For some applications, the one or more wires are integral with the one or more loops.
For some applications, a kit including the probe is provided, the kit further including the elongate medical instrument.
For some applications, the elongate medical instrument includes an intracardiac medical instrument, which is configured to be advanced through the vasculature into a heart chamber of the subject.
For some applications, the elongate medical instrument includes a brain medical instrument, which is configured to be advanced through the vasculature into a brain of the subject.
For some applications, the elongate medical instrument does not include a steerability-providing mechanism.
For some applications, the elongate medical instrument is shaped so as to define at least one longitudinal channel therethrough.
For some applications, the elongate medical instrument is not shaped so as to define any longitudinal channels therethrough.
For some applications, the elongate medical instrument includes a diagnostic medical instrument.
For some applications, the diagnostic medical instrument is selected from the group consisting of: an intracardiac echocardiography (ICE) probe, a biopsy probe, and an ultrasound probe.
For some applications, the elongate medical instrument includes a therapeutic medical instrument.
For some applications, the therapeutic medical instrument includes an ablation probe.
There is further provided, in accordance with an application of the present invention, an attachable bending system for use with an elongate medical instrument, the attachable bending system including:
For some applications, the one or more proximal-more connectors are shaped so as define one or more respective channels therethrough, and the wire passes through the one or more channels.
For some applications, the distal-most connector includes a loop, and the distal-most connector is configured to mechanically coupled to the elongate medical instrument by looping the loop around the elongate medical instrument.
For some applications, a kit including the attachable bending system is provided, the kit further including the elongate medical instrument.
For some applications, the elongate medical instrument includes an intracardiac medical instrument, which is configured to be advanced through the vasculature into a heart chamber of the subject.
For some applications, the elongate medical instrument includes a brain medical instrument, which is configured to be advanced through the vasculature into a brain of the subject.
For some applications, the elongate medical instrument does not include a steerability-providing mechanism.
For some applications, the elongate medical instrument is shaped so as to define at least one longitudinal channel therethrough.
For some applications, the elongate medical instrument is not shaped so as to define any longitudinal channels therethrough.
For some applications, the elongate medical instrument includes a diagnostic medical instrument.
For some applications, the diagnostic medical instrument is selected from the group consisting of: an intracardiac echocardiography (ICE) probe, a biopsy probe, and an ultrasound probe.
For some applications, the elongate medical instrument includes a therapeutic medical instrument.
For some applications, the therapeutic medical instrument includes an ablation probe.
There is still further provided, in accordance with an application of the present invention, a method including:
For some applications, the distal longitudinal probe-portion includes one or more loops, and mechanically coupling includes looping the one or more loops around the distal longitudinal medical-instrument-portion.
For some applications, looping the one or more loops around the distal longitudinal medical-instrument-portion includes:
For some applications, the distal longitudinal probe-portion includes two or more loops, and mechanically coupling includes looping the two or more loops around the distal longitudinal medical-instrument-portion.
For some applications, mechanically coupling the distal longitudinal probe-portion to the distal longitudinal medical-instrument-portion includes tightening the one or more loops around the one or more loops around the distal longitudinal medical-instrument-portion after looping the one or more loops around the distal longitudinal medical-instrument-portion.
For some applications:
For some applications, the one or more loops are retracted into the probe when in the non-radially-extended configuration.
For some applications, the one or more loops are retracted against the probe when in the non-radially-extended configuration.
For some applications, transitioning the one or more loops to the radially-extended configuration includes using one or more control wires that pass along the probe to transition the one or more loops to the radially-extended configuration.
For some applications, transitioning the one or more loops to the radially-extended configuration includes pivoting the one or more loops with respect to an external surface of the probe.
For some applications, the probe is axially non-compressible.
For some applications:
For some applications, the probe includes a steerability-providing mechanism, and using the probe to bend the elongate medical instrument includes activating the steerability-providing mechanism to steer the probe.
For some applications, the steerability-providing mechanism includes one or more wires that pass through one or more channels defined by a wall of the probe, and activating the steerability-providing mechanism includes pulling at least one of the one or more wires proximally to bend the probe.
For some applications:
For some applications, the elongate medical instrument is an intracardiac medical instrument, and advancing the elongate medical instrument includes advancing the intracardiac medical instrument through the vasculature into a heart chamber of the subject.
For some applications, the elongate medical instrument is a brain medical instrument, and advancing the elongate medical instrument includes advancing the brain medical instrument through the vasculature into a brain of the subject.
For some applications, the elongate medical instrument does not include a steerability-providing mechanism.
For some applications, the elongate medical instrument is shaped so as to define at least one longitudinal channel therethrough.
For some applications, the elongate medical instrument is not shaped so as to define any longitudinal channels therethrough.
For some applications, the elongate medical instrument is a diagnostic medical instrument.
For some applications, the diagnostic medical instrument is selected from the group consisting of: an intracardiac echocardiography (ICE) probe, a biopsy probe, and an ultrasound probe.
For some applications, the elongate medical instrument is a therapeutic medical instrument.
For some applications, the therapeutic medical instrument is an ablation probe.
There is additionally provided, in accordance with an application of the present invention, a method including:
For some applications, the one or more proximal-more connectors are shaped so as define one or more respective channels therethrough, and the wire passes through the one or more channels.
For some applications, mechanically coupling the distal-most connector and the one or more proximal-more connectors to the elongate medical instrument includes gluing the distal-most connector and the one or more proximal-more connectors to the elongate medical instrument.
For some applications, the distal-most connector includes a loop, and mechanically coupling the distal-most connector to the elongate medical instrument includes looping the loop around the elongate medical instrument.
For some applications, the elongate medical instrument is an intracardiac medical instrument, and advancing the elongate medical instrument includes advancing the intracardiac medical instrument through the vasculature into a heart chamber of the subject.
For some applications, the elongate medical instrument is a brain medical instrument, and advancing the elongate medical instrument includes advancing the brain medical instrument through the vasculature into a brain of the subject.
For some applications, the elongate medical instrument does not include a steerability-providing mechanism.
For some applications, the elongate medical instrument is shaped so as to define at least one longitudinal channel therethrough.
For some applications, the elongate medical instrument is not shaped so as to define any longitudinal channels therethrough.
For some applications, the elongate medical instrument is a diagnostic medical instrument.
For some applications, the diagnostic medical instrument is selected from the group consisting of: an intracardiac echocardiography (ICE) probe, a biopsy probe, and an ultrasound probe.
For some applications, the elongate medical instrument is a therapeutic medical instrument.
For some applications, the therapeutic medical instrument is an ablation probe.
The present invention will be more fully understood from the following detailed description of embodiments thereof, taken together with the drawings, in which:
Reference is made to
The method comprises:
Probe 24 is configured to bend elongate medical instrument 20 within the body when distal longitudinal probe-portion 26 is mechanically coupled to distal longitudinal medical-instrument-portion 28.
Probe 24 and this method provide steerability to any elongate medical instrument that lacks a steerability-providing mechanism, or provide additional steerability to any elongate medical instrument 20 that has a steerability-providing mechanism, such as to in order to provide additional directionality and/or a smaller bend radius to the existing steerability-providing mechanism. An alternative approach of integrating steerability functionality, or additional steerability functionality, directly into the elongate medical instrument during manufacture thereof would require adding additional channels to the elongate medical instrument to accommodate steering wire(s), which might increase the diameter of the elongate medical instrument.
In addition, since probe 24 is coupled to elongate medical instrument 20 in situ within vasculature 22, the additional steerability is provided to elongate medical instrument 20 without the need for a larger diameter delivery catheter for elongate medical instrument 20 than would otherwise be needed.
Probe 24 and this method also allow the healthcare worker to configure the resulting steering properties (e.g., bending point) of elongate medical instrument 20, such as by selecting the one or more locations along elongate medical instrument 20 at which distal longitudinal probe-portion 26 is coupled to distal longitudinal medical-instrument-portion 28. For example, steering properties of elongate medical instrument 20 may be configured based on the relative flexibility of different longitudinal segments of elongate medical instrument 20. Optionally, the healthcare worker may configure the steering properties based on medical imaging (e.g., a CT scan) and/or a planned vascular path of the particular procedure and the particular patient's anatomy.
For some applications, elongate medical instrument 20 is advanced through vasculature 22 along a first route 23A through vasculature 22, and probe 24 is advanced through vasculature 22 along a second route 23B through vasculature 22, second route 23B different from first route 23A.
For some applications, probe 24 comprises a steerability-providing mechanism, which is configured to steer probe 24 so as to bend elongate medical instrument 20 within the body when distal longitudinal probe-portion 26 is mechanically coupled to distal longitudinal medical-instrument-portion 28. Probe 24 is used to bend elongate medical instrument 20 by activating the steerability-providing mechanism to steer distal longitudinal medical-instrument-portion 28 of probe 24. For example, the steerability-providing mechanism may comprise:
For some applications, such as shown in
For some of these applications, looping the one or more loops 30 around distal longitudinal medical-instrument-portion 28 comprises passing the one or more loops 30 over the distal end of distal longitudinal medical-instrument-portion 28; and thereafter, proximally withdrawing distal longitudinal probe-portion 26 or distally advancing distal longitudinal medical-instrument-portion 28, such that the one or more loops 30 are positioned around distal longitudinal medical-instrument-portion 28.
For some of these applications, distal longitudinal probe-portion 26 is mechanically coupled to distal longitudinal medical-instrument-portion 28 by tightening the one or more loops 30 around distal longitudinal medical-instrument-portion 28 after looping the one or more loops 30 around distal longitudinal medical-instrument-portion 28. For example, probe 24 may comprise one or more control wires 32 that are configured to tighten the one or more loops 30, such as described hereinbelow with reference to
Reference is now made to
Reference is now made to
Reference is further made to
Reference is still further made to
Reference is also made to
The configurations shown in
In the configurations shown in
Optionally, the one or more loops 30 are enlarged as they are transitioned to the radially-extended configuration by being extended away from probe 24.
Optionally, the same mechanism is used in opposite manners to enlarge the one or more loops 30 during deployment of the one or more loops 30 away from probe 24, and to subsequently tighten the one or more loops 30 around distal longitudinal medical-instrument-portion 28 after looping the one or more loops 30 around distal longitudinal medical-instrument-portion 28.
Optionally, probe 24 comprises one or more control wires 32 that pass along (e.g., inside) probe 24 for controlling the extension and/or tightening of the one or more loops 30. The one or more loops 30 extend from one or more distal portions of the one or more control wires 32. The one or more control wires 32 are arranged such that:
Optionally, the one or more control wires 32 are integrally formed with the one or more loops 30, i.e., the one or more loops 30 are defined by one or more distal portions of the one or more control wires 32. Alternatively, the one or more control wires 32 and the one or more loops 30 are formed separately and coupled together during manufacture.
Optionally, all or a portion of the one or more loops pass through one or more openings 34 in a wall of probe 24, e.g., a single opening 34 per loop 30, as shown in
Reference is now made to
For some of these applications, distal longitudinal probe-portion 26 comprises the one or more loops 30, the one or more wires 32 are attached to or define the one or more loops 30, respectively, and the one or more loops 30 are configured to be looped around distal longitudinal medical-instrument-portion 28 so as to mechanically couple distal longitudinal probe-portion 26 to distal longitudinal medical-instrument-portion 28, such as shown in
Reference is now made to
In this configuration, probe 24 comprises one or more loops 30 (for example, exactly one loop 30, as shown) that are pivotable with respect to an external surface of probe 24, for example about one or more respective shafts 54. Typically, the one or more loops 30 are pivotable between:
For some applications, probe 24 comprises one or more control wires 56, which are configured to transition the one or more loops 30 between the non-radially-extended configuration (collapsed configuration) and the radially-extended configuration and vice versa, such as by pivoting the one or more loops 30 about the one or more respective shafts 54, optionally using respective levers. More particularly, the one or more control wires 56 are arranged such that:
For some applications, instead of, or in addition to, the one or more loops 30, probe 24 comprises one or more C-shaped clips 50, which are configured to snap onto distal longitudinal medical-instrument-portion 28 of elongate medical instrument 20. The one or more C-shaped clips 50 may be configured to assume non-radially-expanded (collapsed) and radially-expanded configurations as described hereinabove for the one or more loops 30.
For some applications, separate control wires 56 are provided for each of the one or more loops 30 and/or the one or more C-shaped clips 50 (configuration not shown). Alternatively, a same control wire 56 is provided for more than one loop 30 and/or more than one C-shaped clip 50, such as shown.
In some applications of the present invention, for example those described hereinabove with reference to
Reference is now made to
For some applications, steerability-providing mechanism 46 comprises a plurality of nested pre-shaped flexible catheters 48. At least a distal portion of each of catheters 48 is configured to assume a pre-defined shape when not constrained, including not constrained by one or more more-radially-outward catheters 48, a delivery sheath (not shown), anatomy of the subject, or otherwise. Catheters 48 are configured such that the overall shape of a given longitudinal segment is defined by the shape of the outermost catheter 48 along the segment. For example, the nested catheters 48 may have differing respective stiffnesses, with the more outer catheters having greater stiffnesses. For example, the relative stiffnesses may be due to the relative thicknesses or material properties of the catheters. The shapes of the longitudinal segments, and thus the overall shape of the probe 24, is set by controlling (a) the distance by which each catheter 48 is exposed from the radially closest more-radially-outward catheter 48 and (b) the rotation of the catheters 48 with respect to one another about the longitudinal axis. Steerability-providing mechanism 46 thus allows various shapes, orientations, and degrees of freedom.
Any of catheters 48 may comprise the one or more loops 30 described herein. For example, in
Reference is made to
Reference is still made to
For some applications, probe 24 has an outer diameter of 2-8 mm.
Reference is still made to
Reference is now made to
As shown in
As shown in
The method of using attachable bending system 90 comprises:
Attachable bending system 90 and this method provide steerability to any elongate medical instrument 20 that lacks a steerability-providing mechanism, or provides additional steerability to any elongate medical instrument 20 that has a steerability-providing mechanism, such as to in order to provide additional directionality and/or a smaller bend radius to the existing steerability-providing mechanism. An alternative approach of integrating steerability functionality, or additional steerability functionality, directly into the elongate medical instrument during manufacture thereof would require adding additional channels to the elongate medical instrument to accommodate steering wire(s), which might increase the diameter of the elongate medical instrument.
In addition, since distal-most connector 100 and the one or more proximal-more connectors 102 are coupled to elongate medical instrument 20 before elongate medical instrument 20 is introduced into vasculature 22, practicing the method does not require additional vascular access than would otherwise be needed.
Attachable bending system 90 and this method also allow the healthcare worker to configure the resulting steering properties (e.g., bending point) of elongate medical instrument 20, such as by selecting distal location 140 and the one or more proximal-more locations 142 along elongate medical instrument 20 at which distal-most connector 100 and the one or more proximal-more connectors 102, respectively, are coupled to elongate medical instrument 20. For example, steering properties of elongate medical instrument 20 may be configured based on the relative flexibility of different longitudinal segments of elongate medical instrument 20. Optionally, the healthcare worker may configure the steering properties based on medical imaging (e.g., a CT scan) and/or a planned vascular path of the particular procedure and the particular patient's anatomy.
For some applications, the one or more proximal-more connectors 102 are shaped so as define one or more respective channels therethrough, and wire 150 passes through the one or more channels.
For some applications, distal-most connector 100 and the one or more proximal-more connectors 102 are mechanically coupled to elongate medical instrument 20 by gluing distal-most connector 100 and the one or more proximal-more connectors 102 to elongate medical instrument 20.
For some applications, such as shown in
Reference is made to
For some applications, such as shown in
For some applications, elongate medical instrument 20 is a brain medical instrument, and advancing elongate medical instrument 20 comprises advancing the brain medical instrument through vasculature 22 into a brain of the subject.
For some applications, elongate medical instrument 20 is shaped so as to define at least one longitudinal channel therethrough. Alternatively, elongate medical instrument 20 is not shaped so as to define any longitudinal channels therethrough.
For some applications, elongate medical instrument 20 is a diagnostic medical instrument. For example, the diagnostic medical instrument may be selected from the group consisting of: an intracardiac echocardiography (ICE) probe, a biopsy probe, and an ultrasound probe.
For some applications, elongate medical instrument 20 is a therapeutic medical instrument. For example, the therapeutic medical instrument may be an ablation probe.
It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.
The present patent application claims priority from U.S. Provisional Application 63/123,533, filed Dec. 10, 2020, and U.S. Provisional Application 63/123,534, filed Dec. 10, 2020, which are assigned to the assignee of the present application and incorporated herein by reference.
Filing Document | Filing Date | Country | Kind |
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PCT/IB2021/061477 | 12/9/2021 | WO |
Number | Date | Country | |
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63123534 | Dec 2020 | US | |
63123533 | Dec 2020 | US |