Patent Grant
11666280
The present invention relates to the field of medical devices, and specifically to catheters for performing various diagnostic and therapeutic medical procedures where the depth of an ablation needs to be controlled. More specifically, the present invention relates to ablation catheters for treating cardiac arrhythmias by ablating near pulmonary venous tissue. Other exemplary uses for the present ablation catheters include the treatment of hypertension and ablation of renal tissue.
An ablation catheter according to the present invention includes an ablation head/spring assembly connected to the distal end of the main catheter body. A proximally-facing mirror having varied light reflectivity across its surface is supported at the proximal end of the ablation head. A system of optical fibers extending to a distal end of the main catheter body is spaced proximally from the mirror. When light from the optical fibers shines on the mirror, its varied light reflectivity is used to indicate to the surgeon the amount of force that the ablation head is exerting on the myocardial tissue during the ablation procedure. Optionally, the varied light reflectivity of the mirror is used to indicate the exact orientation of the catheter body and its ablation head inside the vasculature.
The human heart routinely experiences electrical impulses traversing its many surfaces and ventricles, including the left atrium. Just prior to each heart contraction, the heart depolarizes and repolarizes as electrical currents spread across the heart and throughout the body. In healthy hearts, the surfaces and ventricles of the heart experience an orderly progression of depolarization waves. In unhealthy hearts, such as those experiencing atrial arrhythmia, including for example, ectopic atrial tachycardia, atrial fibrillation, and atrial flutter, the progression of the depolarization wave becomes chaotic. Arrhythmias may persist because of scar tissue or other obstacles to rapid and uniform depolarization. These obstacles may cause depolarization waves to electrically circulate through some parts of the heart more than once. Atrial arrhythmia can create a variety of dangerous conditions, including irregular heart rates, loss of synchronous atrioventricular contractions, and blood flow stasis. These conditions are associated with a variety of ailments, including death.
Catheters are used in a variety of diagnostic and therapeutic medical procedures to diagnose and correct conditions such as atrial arrhythmia, including for example, ectopic atrial tachycardia, atrial fibrillation, and atrial flutter. Typically, in such a procedure, a catheter carrying one or more electrodes is moved through a patient's vasculature to the heart under fluoroscopy-guided observation. The electrodes may be used for mapping, ablation, diagnosis, or other treatments.
When an ablation therapy is desired to alleviate symptoms including atrial arrhythmia, the ablation catheter imparts ablative energy to cardiac tissue to create a lesion in the cardiac tissue. The lesioned tissue is less capable of conducting electrical signals, thereby disrupting undesirable electrical pathways and limiting or preventing stray electrical signals that can lead to arrhythmias. The ablation catheter may utilize ablative energy including, for example, radio-frequency (RF), cryoablation, laser, chemical, and high-intensity focused ultrasound.
Ablation therapies are often delivered by making many individual ablations in a controlled fashion to form a lesion line. To improve conformity of the individual ablations along the lesion line, it is desirable to precisely control the orientation of the catheter and its ablation head when the individual ablations are conducted, the contact force between the ablation head and the targeted tissue, and the ablation period. Thus, ablation therapies require accurate positioning of the ablation catheter as well as precise pressure exertion for optimal ablative-energy transfer into the targeted myocardial tissue. Inaccurate positioning of the ablation head in the myocardia may result in suboptimum ablation or inadvertent ablation of healthy tissue. Excess force between the ablation head and the targeted myocardial tissue may result in excessive ablation, which may permanently damage cardiac muscle and surrounding nerves. On the other hand, when the contact force between the ablation head and the targeted myocardial tissue is below a target force, the efficacy of the ablation therapy may be reduced.
Thus, for a successful outcome, it is not enough to precisely control the applied force of the ablation head against myocardial tissue under conventional fluoroscopy-guided locational observation. Instead, it is important to precisely control both the force exerted by the ablation head against myocardial tissue and the orientation of the ablation catheter in the myocardium. Both are required.
Therefore, there is a need for an improved ablation catheter that is suitable for performing various diagnostic and therapeutic medical procedures to diagnose and correct conditions, such as atrial arrhythmia, where both the orientation of the catheter in the vasculature and the force exerted by the ablation head against myocardial tissue are precisely controlled. The present ablation catheter provides these advantages.
To overcome the shortcomings of conventional methods for tracking the path of an ablation catheter through the vasculature to the target myocardial tissue, an ablation catheter according to the present invention has a spring assembly connected between the distal end of a main catheter body and an ablation head. At least three optical fibers are supported by the catheter body. At least three mirrors, each of whose light reflectivity varies across its surface, is supported by the ablation head. The mirrors face proximally but are spaced distally from the distal face of a corresponding one of the optical fibers.
In use, each of the at least three optical fibers is optically connected to a light source and a light power detector. Light of a defined power emitted by the light source into each optical fiber shines on the corresponding mirror and a percentage of the defined light power (a reflected light percentage) is reflected toward the optical fiber. Then, a percentage of the reflected light percentage is captured by and travels down each optical fiber to a dedicated light power detector connected to a controller.
In other words, a percentage of the light power emitted by the light source into each optical fiber is reflected by the corresponding mirror toward the distal face of the optical fiber. Then, a lesser percentage of the reflected light percentage is captured by (a captured light percentage) and travels back down the optical fiber to the light power detector. The detector is configured to determine the intensity or power in the reflected and captured light with respect to the defined power of the light emitted by the light source into the optical fiber. The reflected and captured light received by the light power detector has a somewhat lesser power than the originally emitted light. The controller is programmed to determine the difference between the power of the originally emitted light and that of the reflected and captured light received by the detector and to convert that difference into a force imparted to the ablation head in the vasculature.
For example, in a neutral orientation without any axial or lateral forces imparted to the ablation head, the ablation head is aligned along the longitudinal axis of the catheter body with each of the mirrors spaced a first distance from the distal face of the at least three optical fibers. Then, with only an axial force but no lateral force imparted to the ablation head, the ablation head is still axially aligned with the main catheter body, but now the mirrors are at a second, lesser distance from the distal face of each of the at least three optical fibers. Since the mirrors are closer to the distal faces of the optical fibers, the diminution in power of the reflected and captured light that travels back down each of the optical fibers to the dedicated light power detector is less than with the mirror at the first, greater distance from the optical fibers. In other words, the power of the reflected and captured light is greater with the mirrors at a closer distance to the distal face of each of the at least three optical fibers. The controller connected to the light power detectors is programmed to convert the difference in reflected and captured light power with the mirrors spaced at the first and second distances from the distal faces of the at least three optical fibers into a magnitude of the axial force imparted to the ablation head.
Further, according to the present invention, the mirrors are provided with a patterned reflectance that varies along a radius from a central area of reflectance. The patterned reflectance of the mirrors means that the position of the ablation head in an x, y, z coordinate system can be performed with precise accuracy. The patterned reflectance of the mirrors comprises a central area of reflectance having a first light reflectance R1 and at least one annular ring of reflectance having a second light reflectance R2. Reflectance R1 is different than reflectance R2.
In the case without any axial or lateral force imparted to the ablation head, first percentages of the defined light power from each of the mirror reflectances R1 and R2 are reflected toward the distal face of the corresponding optical fiber. Then, second, lesser percentages of the first percentages are captured by and travel down the optical fiber to the light power detector connected to the controller. The first percentages are less than the defined light power that was initially emitted into the optical fiber by the light source and the second percentages are less than the first percentages.
In the situation with only an axial force imparted to the ablation head, the ablation head is still axially aligned with the main catheter body, but the mirrors are spaced a second distance from the distal face of each of the at least three optical fibers. The second distance is less than the first distance. In this orientation, axial force dependent reflected and captured percentages of the defined light power from the mirror reflectances R1 and R2 are received by the controller via each of the optical fibers. The controller then calculates the magnitude of the axial force imparted to the ablation head by comparing reflected and captured percentages of light power from the mirror reflectances R1 and R2 without any axial force to that of the reflected and captured percentages of the defined light power from the mirror reflectances R1 and R2 under the imparted axial force to determine the distance the ablation head has moved along a longitudinal axis, and hence the magnitude of the axial force imparted to the ablation head.
The magnitude of the axial force is based on Hooke's law, which states that the force (F) needed to extend or compress a spring by some distance (x) scales linearly with respect to that distance. That is, Fs=kx, where k is a constant factor characteristic of the spring (i.e., its stiffness), and x is small compared to the total possible deformation of the spring.
Continuing, in the situation where both axial and lateral forces are imparted to the ablation head, the ablation head deflects out of both axial and lateral alignment with respect to the main catheter body and the distal faces of each of the optical fibers. Each mirror is now spaced a third distance from the distal face of each of the at least three optical fibers, the third distance being different than the first and second distances. In comparison to the reflected and captured percentages of the defined light power from the mirror reflectances R1 and R2 without any axial force or with only an axial force, axial and lateral force induced reflected and captured percentages of the defined light power from the mirror reflectances R1 and R2 reflect toward the distal face of each of the optical fibers with a different percentage of the reflected light power captured by and traveling along each of the optical fibers to the corresponding light power detector. The controller calculates the magnitude and vector of the axial and lateral forces imparted to the ablation head from the reflected and captured percentages of the defined light power from the reflectances R1 and R2 of each of the at least three mirrors in comparison to those percentages without any axial force or with only an axial force imparted to the ablation head. It is that each of the at least three mirrors have at least the two mirror reflectances R1 and R2 that enables the controller to determine the magnitude of the axial and lateral forces imparted to the ablation head of the catheter. The axial and lateral force vectors are related to the precise pressure being exerted by the ablation head against the targeted myocardial tissue and, in turn, the ablative-energy being transferred into the myocardial tissue.
In addition to determining the amount of force that the ablation head is exerting against body tissue, for example, myocardial tissue, the controller is programmed to use the axial and lateral forces imparted to the ablation head to determine an exact orientational value in an x, y, z coordinate system of the ablation head out of axial alignment with the main catheter body. The controller is programmed to present the orientational and force data in real-time on a visual display.
If desired, each of the at least three mirrors have a patterned reflectance comprising the central area of reflectance having the first light reflectance R1 and at least a first, second, and third annular rings of reflectance having respective second, third and fourth light reflectances R2, R3 and R4 at progressively greater first, second and third radial distances from the central area of reflectance; the mirror reflectances R1, R2, R3 and R4 are different from each other.
In a further embodiment of an ablation catheter according to the present invention, the patterned reflectances comprising the central area of reflectance R1 and the second, third and fourth reflectances R2, R3 and R4 of the respective first, second and third annular rings of reflectance are each divided into quadrants of reflectances; the quadrants of reflectances of each of the mirror reflectances R1, R2, R3 and R4 are different from each other.
Moreover, in another embodiment of an ablation catheter according to the present invention, the patterned reflectance comprising the central area of reflectance R1 and the second, third and fourth reflectances R2, R3 and R4 of the respective first, second and third annular rings of reflectance are each divided into fractional segments of reflectances; the fractional segments of reflectances of each of the mirror reflectances R1, R2, R3 and R4 are different from each other.
If desired, the controller also uses the force data at the ablation head to generate an input signal to an electromechanical vibrator integrated into the catheter's handle so that the surgeon receives force feedback at the hand. This increased feedback to the surgeon helps reduce the risk of damaging vasculature tissue, speeds up medical procedures and reduces contrast fluid and x-ray use. Also, the force data correlates with the contact force between the ablation head and the targeted tissue. Ablation therapies require accurate positioning of the ablation catheter as well as precise pressure exertion for optimal ablative-energy transfer into the targeted myocardial tissue. Excess force between the ablation head and the targeted myocardial tissue may result in excessive ablation, which may permanently damage cardiac muscle and surrounding nerves. Conversely, when the contact force between the ablation head and the myocardial tissue is below a target force, the efficacy of the ablation therapy may be reduced.
Further embodiments of an ablation catheter according to the present invention include push-pull wires extending from the handle connected to a proximal end of the catheter to the ablation head. Manipulation of actuators in the handle move the push-pull wires to selectively deflect the ablation head. As previously discussed, in addition to being programmed to determine the amount of force that the ablation head is exerting against myocardial tissue, the controller is programmed to use the reflected and captured light power percentages of the defined light power from the at least two reflectances R1 and R2 of each of the at least three mirrors in comparison to those percentages without any axial force or with only an axial force imparted to the ablation head to determine an exact orientational value of the ablation head out of axial alignment with the catheter sidewall. In this embodiment, the orientation of the ablation head caused by manipulation of the push-pull wires is first ascertained and then when the ablation head is pressed against myocardial tissue, any added change in the reflected and captured light power percentages of the defined light power from the at least two reflectances R1 and R2 of each of the at least three mirrors in comparison to those percentages without any axial force or with only an axial force imparted to the ablation head is used to calculate the additional force vector resulting from contact with myocardial tissue.
These and other aspects of the present invention will become increasingly more apparent to those skilled in the art by reference to the following detailed description and to the appended drawings.
Turning now to the drawings,
The ablation catheter 12 includes a catheter body 18 which, as an elongate tubular structure, is flexible yet substantially non-compressible along its length. The catheter body 18 connects between the handle 20 and a spring assembly 22 which, in turn, is connected to a distal ablation head 24. As will be described hereinafter, in an exemplary embodiment the handle 20 houses a steering and locking mechanism that provides for selective deflection or steering of the catheter body 18/spring assembly 22/ablation head 24 into any number of disparate orientations within the vasculature of a patient and then for locking the ablation catheter 12 in a desired orientation for performing a medical procedure.
An exemplary catheter body 18 is a tubular member having a main delivery lumen 26 (
The spring assembly 22 is comprised of a cylindrically-shaped intermediate portion 22A that resides between a proximal connector spring assembly portion 22B of a reduced diameter and a distal sleeve 22C. The proximal connector portion 22B has a diameter that is sized to fit into the step 18A of the catheter body 18. When seated against the step 18A, the intermediate connector portion 22A and the proximal connector portion 22B provide a lumen 28 through the spring assembly 22 that is in open communication with the main delivery lumen 26 through the catheter body 18. The distal sleeve of the spring assembly 22 has a diameter that is the same as that of the intermediate portion 22A and is defined by two sections—a first distal sleeve section 22C′ and a second distal sleeve section 22C″.
A coil spring 30 of the spring assembly 22 has its proximal end connected to the first distal sleeve section 22C′ and its distal end is connected to the second distal sleeve section 22C″. The coil spring 30 provides 360° of bending movement of the ablation head 24 secured to the second distal sleeve section 22C″ with respect to the first distal sleeve section 22C′.
Alternately,
A distal lumen 32 extends axially along the proximal head portion 24A, through the intermediate head portion 24B and into the atraumatic tip 24C. The distal lumen 32 is in open communication with the main delivery lumen 26 in the catheter body 12 and the spring assembly lumen 28.
Part-way through the ablation head 24, the distal lumen 32 steps down to a secondary distal lumen 34 that leads to the apex of the atraumatic tip 24C. A plurality of lateral lumens 36 extend radially outwardly from the secondary distal lumen 34 to an outer surface of the intermediate cylindrical portion 24B of the ablation head 24. While two lateral lumens 36 are shown in
For a more thorough understanding of handle assemblies that are useful with the present ablation catheter 12, reference is made to U.S. Design Pat. Nos. D612,044 to Scheibe, D638,934 to Kimmel, D653,335 to Kampa et al. and D653,337 to Kampa et al., all of which are assigned to the assignee of the present invention and incorporated herein by reference.
For a more thorough understanding of push-pull wire systems including their anchoring mechanisms that are useful with the present invention, reference is made to U.S. Pat. Nos. 7,553,305, 8,056,207 and 8,540,697, all to Honebrink et al. and all of which are assigned to the assignee of the present invention and incorporated herein by reference. And, for a more thorough understanding of an anchor for a push-pull wire system, reference is made to U.S. Pat. No. 7,497,853 to Fischer et al., which is assigned to the assignee of the present invention and incorporated herein by reference.
For a more thorough understanding of deflectable catheter steering and locking systems that are useful with the present ablation catheter 12, reference is made to U.S. Pat. No. 7,497,853 to Fischer et al., U.S. Pat. No. 7,588,555 to Pudelko et al., U.S. Pat. No. 7,615,044 to Scheibe et al., U.S. Pat. No. 7,955,314 to Fischer et al., U.S. Pat. No. 8,007,463 to Pudelko et al., U.S. Pat. No. 8,048,026 to Fischer et al., U.S. Pat. No. 8,308,659 to Scheibe et al., U.S. Pat. No. 8,444,626 to Fischer et al., U.S. Pat. No. 8,790,362 to Kimmel et al. and U.S. Pat. No. 9,149,607 to Scheibe et al., all of which are assigned to the assignee of the present invention and incorporated herein by reference.
To ablate tissue, the ablation head 24 is configured to electrically conduct a DC energy current or a radio-frequency energy into the targeted tissue. The ablation catheter 12 of the present invention can also be configured for cryoablation, laser ablation, chemical ablation, and ultrasonic ablation of a target tissue. In other embodiments, the power cable 44 is used to provide electrical power to mapping electrodes (not shown), and the like, supported by the ablation head 24.
Preferably, a lubricious coating 48 is provided on the catheter body 18 and the spring assembly 22, but not the ablation head 24. The lubricious coating 48 helps to reduce friction between the ablation catheter 12 and body tissue as the catheter is moved through a vasculature. Suitable coatings for this purpose are described in U.S. Pat. No. 9,255,173 to Edwards, U.S. Pat. No. 9,623,157 to Edwards, U.S. Pat. No. 9,714,361 to Edwards, and U.S. Pat. No. 10,899,944 to Edwards, and in U.S. Pub. Nos. 2014/0275340 to Edwards and 2016/0160078 to Edwards, all of which are assigned to the assignee of the present invention and incorporated herein by reference. Suitable lubricious coatings are also described in U.S. Pat. No. 7,776,956 to Webster at al. and U.S. Pat. No. 9,676,895 to Harkal et al.
An annular inner sleeve 24D extends proximally from the cylindrically-shaped proximal head portion 24A of the ablation head 24 into the spring assembly 22, spaced radially inwardly with respect to the spring 30 and the first distal sleeve section 22C′. A proximal face of the annular inner sleeve 24D supports three proximally facing highly polished mirrors 50A, 50B and 50C (
The ablation catheter 12 and its optical fibers 14, 16 and the third optical fiber (not shown) are detachably connected to an optical connector 56 (
The optical fibers 14, 16 and the third optical fiber (not shown) supported by the ablation catheter 12 are optically connected through the optical connector 56 and the external optical cable 58 to a manifold 60 (
The first light source 74 emits light of a first power through the first circulator 68 into the external optical fiber 62 optically connected to the optical fiber 14 in the ablation catheter 12. Similarly, the second light source 76 emits light of a second power through the second circulator 70 into the external optical fiber 64 optically connected to the optical fiber 16. Further, the third light source 78 emits light of a third power through the third circulator 72 into the external optical fiber 66 optically connected to the third optical fiber not shown in
In various embodiments, the light sources 74, 76 and 78 are single wavelength light sources, narrow-band wavelength light sources or broadband wavelength light sources. However, to prevent light from one optical fiber from being reflected into a different optical fiber and for this power then being measured and input into the controller 86, each optical fiber is irradiated with light of a different wavelength (or band of wavelengths) that does not overlap with the light wavelengths irradiating any of the other optical fibers. The light power detector for each optical fiber is only sensitive to the specific light wavelength of its corresponding light source.
Moreover, as shown in
In another embodiment, there is only one broadband light source that selectively emits light into each optical fiber pair 14/62, 16/64 and the third internal optical fiber/66.
Regardless whether the light sources 74, 76 and 78 are dedicated light sources or the broadband light sources, light reflected by the mirrors 50A, 50B and 50C onto the distal faces of the corresponding optical fibers 14, 16 and the third internal optical fiber (not shown) returns via the optical fibers to the optical connector 56 and the respective external optical fiber 62, 64 and 68 and then the respective circulator 68, 70 and 72.
The circulators 68, 70 and 72 are optically connected to corresponding light power detectors 80, 82 and 84. Each detector analyzes the light it receives to identify the intensity of the light at various powers. As will be described in greater detail hereinafter, this information is forwarded to the controller 86 where the difference in the intensity of the reflected light and then the percentage of the reflected light that is captured by the optical fiber 14, 16 and the third internal optical fiber (not shown) with respect to the intensity of the light originally emitted by the light source into each optical fiber 14, 16 and the third internal optical fiber (not shown) is used to calculate the magnitude of the axial and lateral forces imparted to the ablation head 24 of the catheter 12. The magnitude of the axial and lateral forces imparted to the ablation head 24 in turn is used to calculate the position of the ablation catheter 12 including the ablation head 24 in the vasculature.
In that manner, the first or central area of light reflectivity 92 has a first light reflectivity R1. A first annular band or ring 94 at a first radial distance from the central area of light reflectivity 92 has a second light reflectivity R2, which is different than the first light reflectivity R1. A second annular ring 96 at a second radial distance from the central area of light reflectivity 92 has a third light reflectivity R3, which is different than the first light reflectivity R1 of the central area 92 and the second light reflectivity R2 of the first annular ring 94. This pattern continues radially across the reflective surface 90 of each of the mirrors 50A, 50B and 50C to an outermost annular ring 98 having an nth light reflectivity Rn that is different than the first, second and third light reflectivities R1, R2 and R3 of the respective central area 92, first annular ring 94 and second annular ring 96.
The pattern of varying reflectance of the reflective surface 90 of each of the mirrors 50A, 50B and 50C can be fabricated in the following ways:
a) patterned surface roughening by a laser robotically directed onto the regions to be roughened and controlled by software;
b) surface roughening by applying photoresist, patterning the photoresist using a mask, removing photoresist in the required areas and etching those areas to roughen the reflective surface 90; and
c) depositing either reflection or anti-reflection coatings onto the mirror 50A, 50B and 50C and then selectively removing the coating in the required area using masking techniques.
It is noted that the reflective surface 90 of the mirrors 50A, 50B and 50C shown in
Specifically, the first light reflectivity R1 of the central area of light reflectivity 92 is divided into a first quadrant 92A of the first light reflectivity R1A, a second quadrant 92B of the first light reflectivity R1B, a third quadrant 92C of the first light reflectivity R1C, and a fourth quadrant 92D of the first light reflectivity R1D. Each of the light reflectivities R1A, R1B, R1C and R1D of the respective quadrants 92A, 92B, 92C and 92D is different than the other light reflectivities. The respective light reflectivities are input into the programmable memory of the controller 86.
Similarly, the second light reflectivity R2 of the first ring of light reflectivity 94 is divided into a first quadrant 94A of the second light reflectivity R2A, a second quadrant 94B of the second light reflectivity R2B, a third quadrant 94C of the second light reflectivity R2C, and a fourth quadrant 94D of the second light reflectivity R2D. Each of the light reflectivities R2A, R2B, R2C and R2D of the respective quadrants 94A, 94B, 94C and 94D is different with respect to each other and with respect to the light reflectivities R1A, R1B, R1C and R1D of the respective quadrants 92A, 92B, 92C and 92D of the central area of light reflectivity 92. The respective light reflectivities are input into the programmable memory of the controller 86.
Further, the third light reflectivity R3 of the second ring of light reflectivity 96 is divided into a first quadrant 96A of the third light reflectivity R3A, a second quadrant 96B of the third light reflectivity R3B, a third quadrant 96C of the third light reflectivity R3C, and a fourth quadrant 96D of the third light reflectivity R3D. Each of the light reflectivities R3A, R3B, R3C and R3D of the respective quadrants 96A, 96B, 96C and 96D is different with respect to each other and with respect to the light reflectivities R2A, R2B, R2C and R2D of the respective quadrants 94A, 94B, 94C and 94D of the first ring of light reflectivity 94 and with respect to the light reflectivities R1A, R1B, R1C and R1D of the respective quadrants 92A, 92B, 92C and 92D of the central area of light reflectivity 92. The respective light reflectivities are input into the programmable memory of the controller 86.
This pattern continues across the reflective surface 90 of each of the mirrors 50A′, 50B′ and 50C′ to the nth light reflectivity Rn of the outermost ring of light reflectivity 98. The nth light reflectivity Rn of the outermost ring of light reflectivity 98 is divided into a first quadrant 98A of the nth light reflectivity RnA, a second quadrant 98B of the nth light reflectivity RnB, a third quadrant 98C of the nth light reflectivity RnC, and a fourth quadrant 98D of the nth light reflectivity RnD. Each of the light reflectivities RnA, RnB, RnC and RnD of the respective quadrants 98A, 98B, 98C and 98D is different with respect to each other and with respect to the light reflectivities R3A, R3B, R3C and R3D of the respective quadrants 96A, 96B, 96C and 96D of the second ring of light reflectivity 96, with respect to the light reflectivities R2A, R2B, R2C and R2D of the respective quadrants 94A, 94B, 94C and 94D of the first ring of light reflectivity 94 and with respect to the light reflectivities R1A, R1B, R1C and R1D of the respective quadrants 92A, 92B, 92C and 92D of the central area of light reflectivity 92. This pattern continues across the reflective surface 90 of each of the mirrors 50A′, 50B′ and 50C′ for as many rings of light reflectivity as each mirror has. The respective light reflectivities are input into the programmable memory of the controller 86.
This is illustrated in
Since the light beams 102 from the optical fibers 14, 16 still encompass the central area of light reflectivity 92 (R1) and the first ring of light reflectivity 94 (R2), different reflected percentages will reflect off each of those surfaces 92, 94 of each mirror 50A, 50B and 50C. Then, a percentage of the reflected percentage 102A off each of the central area of light reflectivity 92 (R1) and the first ring of light reflectivity 94 (R2) of each mirror 50A, 50B and 50C is captured by each of the optical fibers 14, 16 and the third internal optical fiber (not shown), and travels along those internal optical fibers through the optical connector 56 to the external optical fibers 62, 64 and 66 optically connected to the respective light power detectors 80, 82 and 84 and then the controller 86 shown in
Similar principals apply regarding the reflectances of the light reflectivities R1, R2, R3 and Rn of the respective central area 92, the first annular ring 94, the second annular ring 96 and the nth annular ring 98 for the mirrors 50A, 50B and 50C shown in
Referring still to
While line 116 has a smaller diameter than line 110 in
Similar principals apply regarding the reflectances of the light reflectivities R3 and Rn of the respective second annular ring 96 to the nth annular ring 98 of the mirrors 50A, 50B and 50C shown in
Thus, any change in the percentage of light captured by the three internal optical fibers 14, 16 and the third optical fiber (not shown) following reflection from the reflective surfaces 90 of the respective mirrors 50A, 50B and 50C back to the distal faces 14A, 16A of the optical fibers 14, 16 and the third optical fiber (not shown) with respect to the percentages of light captured with the catheter 12 in the first state without an axial force being applied to the ablation head 24 or with respect to the reflected percentages of light captured with the catheter 12 in the second state with only an axial force but no lateral force being imparted to the ablation head 24 is indicative of forces of different axial and lateral magnitudes being applied to the ablation head. Then, relative change of the percentages of light captured by each of the internal optical fibers 14, 16 and the third optical fiber (not shown) is converted by the controller 86 into a value related to the force that the ablation head 24 is exerting against body tissue. The controller 86 is also programmed to calculate a spatial orientation in an x, y, z coordinate system of the ablation head 24 in the vasculature from the relative change of the percentage of light captured by each of the internal optical fibers 14, 16 and the third optical fiber (not shown).
Moreover, change in the percentage of light captured by the three internal optical fibers 14, 16 and the third optical fiber (not shown) following reflection from the reflective surfaces 90 of their respective mirrors 50A, 50B and 50C back to the distal faces 14A, 16A of the optical fibers 14, 16 is with respect to the reflective surfaces shown in
Further, the present invention can be practiced with an ablation catheter having a plurality of optical fibers, for example, more than three optical fibers. Moreover, the three or more optical fibers need not be evenly spaced about the circumference of the annular inner sleeve 24D extending proximally from the cylindrically-shaped proximal head portion 24A of the ablation head 24. So long as the controller 86 is programmed with information related to the relative positions of the plurality of optical fibers and their corresponding mirror, the optical principals described above apply.
In various embodiments of the present ablation catheter 12, the optical fibers 14, 16 are a step index optical fiber, a graded index optical fiber or a photonic crystal optical fiber. In other embodiments of the ablation catheter 12, the optical fibers 14, 16 are a single-mode optical fiber, a multi-mode optical fiber, or a dual clad optical fiber. Still, in other embodiments of the ablation catheter 12, a lens is placed between the distal face 14A, 16A of the optical fiber 14, 16 and the mirrors 50A, 50B to focus the light beam on the reflective surface 90 of the mirror.
In one embodiment of the present ablation catheter 12, the proximal end of the optical fibers 14, 16 and the third internal optical fiber (not shown) are uniformly illuminated by the light sources 74, 76 and 78 to equally excite all bound modes so that the near-field pattern of the emerging light at the distal face 14A, 16A of each of the optical fibers 14, 16 approximates the refractive index profile of the optical fiber. In another embodiment, the light shining from each of the optical fibers 14, 16 and the third internal optical fiber (not shown) passes through a mode scrambler to achieve a uniformly distributed light beam.
Referring back to
As previously described, during movement of the ablation catheter 12 through the vasculature (both forward and rearward movement), frictional feedback from the surface of the shaft of the catheter dominates the tactile feel in the surgeon's hand while tactile perception of the force acting at the ablation head 24 is minimal. Therefore, there is a risk of vessel injury including perforation due to the force of the catheter 12 including its ablation head 24 against vasculature tissue.
To overcome this, axial and lateral forces applied to the ablation head 24 are not only fed back to the controller 86 for presentation by the display 88 as described above, but the controller also sends a haptic or tactile feedback signal to an electromechanical actuator (not shown) integrated into the handle 20. Haptic or tactile feedback is the use of vibration patterns to convey information to a user or operator. Haptic feedback uses the controller 86 to send haptic feedback signals to the electromechanical actuator, which can be felt by the surgeon holding the handle 20. Exemplary electromechanical actuators include a vibration motor, an eccentric rotating mass (ERM) actuator driven by an electronic circuit, a linear resonant actuator, and a piezoelectric actuator.
In the ablation catheter system 10 of the present invention, an exemplary embodiment has the vibration increase in frequency or amplitude depending on the calculated force of the ablation head 24 against vasculature tissue. Further, the vibrational frequency can be varied to indicate the direction of the force while the amplitude of the vibration can be varied to indicate the magnitude of the axial and lateral force vectors. That way, the surgeon feels the magnitude and direction of the axial and lateral force vectors in his hand as the ablation head 24 of the catheter 12 is moved through the vasculature during a medical procedure.
This haptic or tactile feedback to the surgeon helps reduce the risk of damaging tissue, speeds up the medical procedure and reduces contrast and x-ray use. Also, the haptic or tactile feedback correlates with the contact force of the ablation head against myocardial tissue as ablative energy is imparted to cardiac tissue to create a lesion in the cardiac tissue. The force data at the individual ablations also conveys information on the degree to which the cardiac tissue has been ablated. As discussed above, inaccurate positioning of the ablation head in the myocardia may result in suboptimum ablation or inadvertent ablation of healthy tissue. Excess force between the ablation catheter head and the targeted myocardial tissue may result in excessive ablation, which may permanently damage cardiac muscle and surrounding nerves. Conversely, when the contact force between the ablation head and the targeted myocardial tissue is below a target force, the efficacy of the ablation therapy may be reduced.
It is appreciated that various modifications to the inventive concepts described herein may be apparent to those of ordinary skill in the art without departing from the spirit and scope of the present invention as defined by the appended claims.
This application claims priority to U.S. provisional application Ser. No. 63/217,985, filed on Jul. 2, 2021.
| Number | Name | Date | Kind |
|---|---|---|---|
| 20110087112 | Leo | Apr 2011 | A1 |
| 20140046194 | Erdman | Feb 2014 | A1 |
| 20170100606 | Lilge | Apr 2017 | A1 |
| 20200402228 | Talbert | Dec 2020 | A1 |
| Number | Date | Country | |
|---|---|---|---|
| 20230000437 A1 | Jan 2023 | US |
| Number | Date | Country | |
|---|---|---|---|
| 63217985 | Jul 2021 | US |
