Source: https://patents.google.com/patent/US8932288B2/en
Timestamp: 2018-07-20 07:13:01
Document Index: 251804225

Matched Legal Cases: ['Application No. 60', 'Application No. 200980125027', 'Application No. 06710474', 'Application No. 06710474', 'Application No. 06795186', 'Application No. 06795186', 'Application No. 08826173', 'Application No. 11158967', 'Application No. 11158967', 'Application No. 06795186', 'Application No. 09746251', 'Application No. 11158967', 'Application No. 2007', 'Application No. 2011509074', 'Application No. 2007', 'Application No. 20068007106', 'Application No. 200980125027', 'Application No. 200980125027']

US8932288B2 - Medical apparatus system having optical fiber load sensing capability - Google Patents
Medical apparatus system having optical fiber load sensing capability Download PDF
US8932288B2
US8932288B2 US13096647 US201113096647A US8932288B2 US 8932288 B2 US8932288 B2 US 8932288B2 US 13096647 US13096647 US 13096647 US 201113096647 A US201113096647 A US 201113096647A US 8932288 B2 US8932288 B2 US 8932288B2
Active, expires 2027-06-30
US13096647
US20120179068A1 (en )
Nicolas Aeby
St Jude Medical International Holding SARL
St Jude Medical GVA SARL
A61B19/46—
A61B2019/547—
A61B2562/0266—Optical strain gauges
An apparatus and method for diagnosis or treatment of a vessel or organ. The apparatus includes a deformable body such as a catheter having a tissue ablation end effector and an irrigation channel in fluid communication therewith. At least two sensors are disposed within a distal extremity of the deformable body, the sensors being responsive to a wave in a specified range of frequency to detect deformations resulting from a contact force applied to the distal extremity. A microprocessor can be operatively coupled with the sensors to receive outputs therefrom, the microprocessor being configured to resolve a multi-dimensional force vector corresponding to the contact force. In one embodiment, the sensors are fiber Bragg grating sensors, and the wave is injected into the fiber Bragg grating strain sensors from a laser diode.
The present application is a continuation of U.S. patent application Ser. No. 11/436,926, filed May 15, 2006 now U.S. Pat. No. 8,075,498, which is a continuation-in-part of U.S. patent application Ser. No. 11/237,053, filed Sep. 28, 2005 now U.S. Pat. No. 8,182,433, which claims the benefit of U.S. Provisional Application No. 60/704,825, filed Aug. 1, 2005 and which also claims priority from European Patent Application No. EP 05004852.9 filed Mar. 4, 2005, all of which are hereby incorporated by reference herein.
FIG. 3 is a section according to of FIG. 2;
Proximal end 2 preferably includes storage device 2a, such as a memory chip, RFID tag or bar code label, which stores data that may be used in computing a multi-dimensional force vector, as described herein after. Alternatively, storage device 2 a need not be affixed to proximal end 2, but instead could be a separate item, e.g., packaging, individually associated with each catheter. Proximal end 2 may be manipulated manually or automatically to cause a desired amount of articulation or flexion of distal extremity 5 using mechanisms which are per se known in the art, such as pull wires or suitably configured electroactive polymers. Catheter 1 also may be advanced, retracted and turned manually or automatically.
Preferably, catheter 1 comprises a liquid crystal polymer (“LCP”) that has a small positive or even negative coefficient of thermal expansion in the direction of extrusion. A variety of liquid crystal polymers are known in the art and such materials may be coated with parylene or a metallic coating to enhance resistance to fluid absorption.
[ ɛ 1 , t ɛ 2 , t ɛ 3 , t Δ ⁢ ⁢ T t ] = [ C ɛ 0 0 C ɛ ⁢ ⁢ T 0 C ɛ 0 C ɛ ⁢ ⁢ T 0 0 C ɛ C ɛ ⁢ ⁢ T 0 0 0 C T ] · ( [ λ 1 , t λ 2 , t λ 3 , t λ 4 , t ] - [ λ 1 , r λ 2 , r λ 3 , r λ 4 ⁢ r ] ) ( 1.1 ) ɛ t = C - ( λ ⁢ t - λ ⁢ r ) ( 1.1 ⁢ a )
Where: r—time when reference (zero) measurement is set
t—time relative to reference time
λi,r, i=1,4—reference wavelengths of Bragg-gratings
λi,t, i=1,4—wavelengths of Bragg-gratings at time t
εi,t, i=1,3—total strain values at time t
ΔTt—Temperature change at time t
Cε—coefficient of linearity between the wavelength and strain
CεT—coefficient of temperature compensation of the Bragg-grating
CT—coefficient of linearity between the wavelength and temperature
λT—Matrix (vector) of Bragg-gratings reference wavelengths
λt—Matrix (vector) of Bragg-gratings wavelengths at time t
εt—Matrix (vector) of total strain and temperature changes
C—Strain transducer and compensation matrix
The total strain includes a component due to thermal expansion of the distal extremity arising from the difference between the measured temperature of the distal extremity and a predetermined reference temperature. The elastic strain, which is a function of the applied force, therefore may be calculated using:
[ ɛ el ⁢ ⁢ 1 , t ɛ el ⁢ ⁢ 2 , t ɛ el ⁢ ⁢ 3 , t ] = [ ❘ 1 0 0 - α Tc 0 1 0 - α Tc 0 0 1 - α Tc ] · [ ɛ 1 , t ɛ 2 , t ɛ 3 , t Δ ⁢ ⁢ T t ] ( 1.2 ) ɛ el , t = α T - ɛ t ( 1.2 ⁢ a )
Where: εeli,t, i=1,3—elastic strain values at time t
αT—Thermal expansion coefficient of catheter material (PEEK)
εel,t—Matrix (vector) of elastic strain at time t
αT—Temperature reduction matrix
εel,t=αT ·C·(λt−λT) (1.3)
[ ɛ el ⁢ ⁢ 1 , t ɛ el ⁢ ⁢ 2 , t ɛ el ⁢ ⁢ 3 , t ] = [ 1 y 1 - x 1 1 y 2 - x 2 1 y 3 - x 3 ] · [ 1 E ten · A 0 0 0 1 E flex · I x 0 0 0 1 E flex · I y ] · [ N z , t M x , t M y , t ] ( 2.1 ) ⁢ ɛ el , t = G · δ · I F , t ( 2.1 ⁢ a )
Where: xi and yi, i=1,3—coordinates of Bragg-gratings with respect to center of gravity of the catheter cross-section
Eten—Equivalent tension/compression Young modulus of catheter
Eflex—Equivalent flexural Young modulus of catheter
Ix—Moment of inertia with respect to x axis
Iy—Moment of inertia with respect to y axis
Nz,t—Normal force in direction of z axis at time t
Mx,t—Bending moment with respect to x axis at time t
My,t—Bending moment with respect to y axis at time t
G—Geometry matrix
δ—Matrix of flexibility
IF,t—Matrix (vector) of internal forces at time t
Equation (2.1) may be rearranged to solve for the internal forces as a function of the elastic strain. The elastic strain from equation (1.3) may then be substituted into the rearranged matrix system to compute the internal forces as a function of the elastic strain, as shown in Equation (2.3) below:
( 2.1 ) ⇒ [ N z , t M x , t M y , t ] = [ E ten · A 0 0 0 E flex · I x 0 0 0 E flex · I y ] · [ 1 y 1 - x 1 1 y 2 - x 2 1 y 3 - x 3 ] - 1 · [ ɛ el ⁢ ⁢ 1 , t ɛ el ⁢ ⁢ 2 , t ɛ el ⁢ ⁢ 3 , t ] ( 2.2 ) ⁢ ( 2.1 ⁢ a ) ⇒ I F , t = S · G - 1 · ɛ el , t ⁢ ⁢ ⁢ Where ⁢ : ( 2.2 ⁢ a ) ⁢ S = δ - 1 - Stiffness ⁢ ⁢ matrix ⁢ ⁢ ⁢ ( 1.3 ) ⋀ ( 2.1 ⁢ a ) ⇒ I F , t = S · G - 1 · α T · C · ( λ t - λ r ) ( 2.3 )
[ F x , t F y , t F z , t ] = [ 0 0 - 1 d 0 1 d 0 - 1 0 0 ] · [ N z , t M x , t M y , t ] ( 3.1 ) F t = d · I F , t ( 3.1 ⁢ a )
Where: Fx,t—Touching external transversal force at time t, in direction of x axis (with opposite sense)
Fy,t—Touching external transversal force at time t, in direction of y axis (with opposite sense)
Fz,t—Touching external normal force at time t, in direction of z axis (with opposite sense, compression is positive)
d—distance between the touching point of lateral forces and the cross-section with sensors (along z axis)
Ft—Matrix of touching external forces at time t
d—matrix of conversion
Ft=d·S·S·G 1−αT ·C·(λt−λt) (3.2)
Ft =K λ·(λt−λT)=K λ−λt−FT (3.3)
Where: Kλ—Force transducer matrix, K λ=d·S·G −1·αT ·C (3.4)
Fr—Reference force matrix (vector), Fr =K λ,·λT (3.5)
Solution of equations (3.1) to (3.5) provides the normal and transverse forces applied to the external surface of the deformable body, i.e., Fnorm,t=Fz,1 and
Ftrans,t=square root (F2 x,t+F2 y,t). The angle γ1 of application of the transverse force may be computed from Table I:
Fx,t Fy,t γt
≧0 ≧0 arcsin(Fy,t/Ftran,t)
<0 ≧0 Π − arcsin(Fy,t/Ftran,t)
<0 <0 Π − arcsin(Fy,t/Ftran,t)
≧0 <0 2 * Π + arcsin(Fy,t/Ftran,t)
F(t)=K(λ(t)−λ0) (4.0)
λ0 is the vector of wavelengths [λ0 1, λ0 2, λ0 3] measured for the individual sensors with zero applied force, and
K is a matrix computed when the deformable body is subjected to the series of known forces.
During the calibration step of manufacture, the catheter is subjected to the following forces in series: (1) a purely axial force of known magnitude F′; (2) a lateral force of known magnitude F″; and (3) a lateral force of known magnitude F′″ applied 90 degrees to the orientation of force F″. When all of the forces F′, F″, F′″ and wavelengths are known, the force-to-strain conversion matrix K may be computed as:
K=F(λ(t)−λ0)−1 (5.0)
[ F x F x ′ F x ″ F y F y ′ F y ″ F z F z ′ F z ″ ] ⁡ [ ( λ 1 - λ 1 0 ) ( λ 1 ′ - λ 1 0 ) ( λ 1 ″ - λ 1 0 ) ( λ 2 - λ 2 0 ) ( λ 2 ′ - λ 2 0 ) ( λ 2 ″ - λ 2 0 ) ( λ 3 - λ 3 0 ) ( λ 3 ′ - λ 3 0 ) ( λ 3 ″ - λ 3 0 ) ] - 1 = [ a 11 a 13 a 13 a 21 a 22 a 23 a 31 a 32 a 33 ] ( 5.1 )
Force-to-strain conversion matrix K then may be stored in storage device 2a associated with the corresponding device, as described herein above. The values of the force-to-conversion matrix then may be input to console 3 when the catheter is coupled to the console using a bar code reader, input pad or direct electrical connection through cable 4. Once matrix K is provided for a given distal extremity, the normal force, transverse force and angle of application of the transverse force may be computed as described above and using Table I.
In FIG. 9, reflection intensity sensors comprise connection zones 25 within optical fibers 7. Under the effect of a strain caused by deformation of the distal extremity, or a temperature variation, connection zones 25 modulate the amplitude of the optical wave 26 that is transmitted and/or reflected. The variation in intensity of the reflected light is measured by apparatus, which is per se known. An additional optical fiber also may be provided to perform temperature measurement. In FIG. 10, microbending intensity sensors comprise connection zones 27 disposed along the length of optical fibers 7. Connection zones 27 may be obtained by introducing microbendings in the fibers. Under the effect of a strain caused by deformation of the distal extremity, or a temperature variation, connection zones 27 modulate the amplitude of the optical wave 28 that is transmitted and/or reflected. The variation in intensity of the reflected light is measured by apparatus, which is per se known.
Referring now to FIGS. 18 and 19, subassembly 60 disposed within distal extremity 56 of apparatus 50 is described. Subassembly 60 comprises irrigation tube 61 coupled at proximal end 52 to an infusion port (not shown) and at distal end 62 to irrigation ports 58 of front end 63.
Front end 63 preferably is metallic and acts as an ablation electrode, and includes irrigation ports 58 in fluid communication with the interior of irrigation tube 61, so that fluid injected via the infusion port exits through irrigation ports 58.
As described above, apparatus 50 may be configured to include the capability to deflect the distal extremity of catheter 51 using any of variety of well-known mechanisms, such as pull-wires. More particularly, referring to FIG. 21, an illustrative embodiment of a deflectable catheter shaft suitable for use with subassembly 60 of FIGS. 18 and 19 is described.
1. An apparatus for diagnosis or treatment of a vessel or organ, comprising:
a deformable body that defines a longitudinal axis and having a distal extremity, said distal extremity including a tissue ablation end effector having irrigation ports;
at least one irrigation channel disposed within said deformable body, said at least one irrigation channel being in fluid communication with said irrigation ports;
at least two optical fiber sensors disposed within said distal extremity to detect deformations imposed on said deformable body resulting from a contact force applied to said distal extremity, said optical fiber sensors being responsive to a wave in a specified range of frequency to detect said deformation; and
a microprocessor operatively coupled with said at least two optical fiber sensors and adapted to receive outputs therefrom, said microprocessor being configured to resolve a multi-dimensional force vector from said outputs, said multi-dimensional force vector corresponding to said contact force applied to said distal extremity and including an axial component that is substantially parallel with said longitudinal axis.
2. The apparatus of claim 1 wherein said at least two optical fiber sensors are fiber Bragg grating strain sensors.
3. The apparatus of claim 2, wherein said wave is injected into said fiber Bragg grating strain sensors from a laser diode.
4. The apparatus of claim 1, further comprising a controller operatively coupled with said outputs from said at least two optical fiber sensors, said controller being programmed to control operation of said tissue ablation end effector based on said outputs.
5. The apparatus of claim 4, further comprising an actuator operatively coupled with said controller and with said deformable body proximal to said distal extremity, said controller being programmed to control said actuator for manipulation of said deformable body.
6. The apparatus of claim 4 wherein said controller is configured to enable energization of said tissue ablation end effector when a magnitude of said multi-dimensional force vector exceeds a predetermined minimum value.
7. The apparatus of claim 1, wherein a direction of said multi-dimensional force vector ranges from a purely axial force to a purely lateral force.
8. The apparatus of claim 1, wherein said at least two optical fiber sensors are at least three optical fiber sensors that measure deformations imposed on the deformable body to be measured at three or more non-planar points.
9. The apparatus of claim 1, wherein said tissue ablation end effector is a radiofrequency ablation electrode.
US13096647 2005-03-04 2011-04-28 Medical apparatus system having optical fiber load sensing capability Active 2027-06-30 US8932288B2 (en)
EPEP050048529 2005-03-04
EP05004852 2005-03-04
EP050048529 2005-03-04
US70482505 true 2005-08-01 2005-08-01
US11237053 US8182433B2 (en) 2005-03-04 2005-09-28 Medical apparatus system having optical fiber load sensing capability
US11436926 US8075498B2 (en) 2005-03-04 2006-05-15 Medical apparatus system having optical fiber load sensing capability
US13096647 US8932288B2 (en) 2005-03-04 2011-04-28 Medical apparatus system having optical fiber load sensing capability
US14573666 US9907618B2 (en) 2005-03-04 2014-12-17 Medical apparatus system having optical fiber sensing capability
US11436926 Continuation US8075498B2 (en) 2005-03-04 2006-05-15 Medical apparatus system having optical fiber load sensing capability
US14573666 Continuation US9907618B2 (en) 2005-03-04 2014-12-17 Medical apparatus system having optical fiber sensing capability
US20120179068A1 true US20120179068A1 (en) 2012-07-12
US8932288B2 true US8932288B2 (en) 2015-01-13
ID=37492415
US11436926 Active 2029-02-16 US8075498B2 (en) 2005-03-04 2006-05-15 Medical apparatus system having optical fiber load sensing capability
US13096647 Active 2027-06-30 US8932288B2 (en) 2005-03-04 2011-04-28 Medical apparatus system having optical fiber load sensing capability
US13308196 Active 2025-11-12 US8961436B2 (en) 2005-03-04 2011-11-30 Medical apparatus system having optical fiber load sensing capability
US14573666 Active 2026-11-01 US9907618B2 (en) 2005-03-04 2014-12-17 Medical apparatus system having optical fiber sensing capability
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