METHOD FOR CONTROLLING THE VISCOSITY OF ORTHOPEDIC BONE CEMENT
20180177540 · 2018-06-28
Assignee
- UNIVERSITÉ DE STRASBOURG (Strsbourg, FR)
- Centre National De La Recherche Scientifique (Paris, FR)
- INSTITUT NATIONAL DES SCIENCES APPLIQUÉES (Strasbiurg, FR)
Inventors
- Nicole LEPOUTRE (Strasbourg, FR)
- Laurence MEYLHEUC (Bergbieten, FR)
- Gabriela Iuliana BARA (Illkirch, FR)
- Bernard Bayle (Strasbourg, FR)
Cpc classification
A61B2017/8844
HUMAN NECESSITIES
A61B2090/064
HUMAN NECESSITIES
International classification
Abstract
Some embodiments are directed to a method for controlling the viscosity of orthopedic bone cement during its curing in percutaneous vertebroplasty by allowing a controlled heating and/or cooling of the cement during the injection that leads to a dynamic and full control of the viscosity of the cement during the injection.
Claims
1. A method for a dynamic control of the viscosity of an orthopedic bone cement during curing by acting on a bone cement temperature in percutaneous vertebroplasty, within an injection device that includes a syringe, a percutaneous needle connected to the syringe via a pipe, including an active heat exchanger, the method comprising: A. defining the time t.sub.o, time at which the radiologist starts the mixing process of the bone cement; B. filling the syringe with the prepared bone cement; C. defining for the bone cement a target viscosity * to be reached or maintained, the target viscosity * being in the range [.sub.min.sub.max], .sub.min being the minimal threshold viscosity of the cement which has to be reached for beginning the injection and .sub.max being the maximum threshold viscosity of the cement above which the injection is no longer possible; D. beginning the injection of the bone cement into the vertebra; E. at instant t during the injection: e1) measuring an effective temperature T of the bone cement at an outlet of the active heat exchanger and measuring an effective temperature T.sub.i of the bone cement at an inlet of the active heat exchanger; e2) computing the pressure drop P=P.sub.oP.sub.i along the pipe between the outlet of the syringe and a given intermediate point, P.sub.o being the pressure measured at the outlet of the syringe and P.sub.i being the pressure measured at the given intermediate point on the pipe, the length between those two points being denoted as L.sub.sensor; e3) computing a flow rate Q of the bone cement in the pipe; e4) computing a shear rate {dot over ()}.sub.p at the wall of the pipe as a function of the flow rate Q, the cross-section dimensions of the pipe and the intrinsic physical parameters of the cement; e5) calculating the instant viscosity (t,T,{dot over ()}.sub.P) if Q is nonzero, as a function of time t, temperature T, pressure drop P and shear rate {dot over ()}.sub.p, itself function of the flow rate Q; .sub.0(t,T) if Q has a zero value, as a function of time t and temperature T. e6) computing a set point temperature T(*)t associated to the target viscosity * and the instant viscosity , * being function of the flow rate Q and the time t; e7) calculating the difference .sub.T between the previously determined set point temperature T(*)t and the effective temperature at the outlet of the heat exchanger T; e8) controlling the cooling or the heating of the bone cement throughout the control of the active heat exchanger as a function of .sub.T; F. at instant t+t, repeating step E until the end of the injection, unless the instant viscosity (t,T,{dot over ()}.sub.P) and/or .sub.0(t,T) has reached the maximum threshold viscosity .sub.max.
2. The method according to claim 1, wherein step F further comprises the redefinition of the target viscosity * before repeating step E until the end of the injection, unless the instant viscosity (t,T,{dot over ()}.sub.P) and/or .sub.0(t,T)has reached the maximum threshold viscosity .sub.max.
3. The method according to claim 1, wherein the step e2) of computing the pressure drop P is realized between the outlet of the syringe and the outlet of the needle.
4. The method according to claim 1, wherein the step e2) of computing the pressure drop P is realized between the outlet of the syringe and the outlet of the active heat exchanger.
5. The method according to claim 1, wherein the instant viscosity (t,T,{dot over ()}.sub.p), if the flow rate is nonzero, is calculated according to modified Power Law as defined by formula (2) in the case of a pipe having a cylindrical geometry of radius r:
6. The method according to claim 1, wherein the instant viscosity (t) is calculated according to the differential equation (5):
{dot over ()}(t,T,{dot over ()}.sub.p)=f((t,T,{dot over ()}.sub.p)) (5) wherein the time derivative fi of the viscosity is defined as a function the instant viscosity .
7. The method according to claim 1, wherein the set point temperature T(*)t is calculated according to a chosen control strategy either via
8. The method according to claim 1, wherein the step of measuring the flow rate Q of the bone cement in the pipe comprises a step of measuring a moving speed V.sub.pist of the piston of the syringe, the piston being driven to vary the volume of the cement in the syringe, the volumetric flow Q being then given by Q=V.sub.pist..r.sup.2.
9. The method according to claim 1, wherein the controlling e8) of the active heat exchanger realizes the cooling or heating of the bone cement as a function of .sub.T throughout a temperature regulation scheme composed of two nested closed loops, where: a temperature controller C.sub.T uses the difference .sub.T between the previously determined set point temperature T(*)t and the effective temperature T to compute the current reference I* of the active heat exchanger, the current reference I* being limited by a current saturation block, a current controller C.sub.I uses the difference .sub.I between the current reference I* and the effective input current I to compute the input voltage U of a power supply H driving the active heat exchanger.
10. The method according to claim 4, wherein the intravertebral pressure P.sub.vertebra is computed according to formula (1):
11. The method according to claim 2, wherein the step e2) of computing the pressure drop P is realized between the outlet of the syringe and the outlet of the needle.
12. The method according to claim 2, wherein the step e2) of computing the pressure drop P is realized between the outlet of the syringe and the outlet of the active heat exchanger.
13. The method according to claim 2, wherein the instant viscosity (t,T,{dot over ()}.sub.p), if the flow rate is nonzero, is calculated according to modified Power Law as defined by formula (2) in the case of a pipe having a cylindrical geometry of radius r:
14. The method according to claim 2, wherein the instant viscosity (t) is calculated according to the differential equation (5):
{dot over ()}(t,T,{dot over ()}.sub.p)=f((t,T,{dot over ()}.sub.p)) (5) wherein the time derivative of the viscosity is defined as a function the instant viscosity .
15. The method according to claim 3, wherein the instant viscosity (t) is calculated according to the differential equation (5):
{dot over ()}(t,T,{dot over ()}.sub.p)=f((t,T,{dot over ()}.sub.p)) wherein the time derivative 1) of the viscosity is defined as a function the instant viscosity .
16. The method according to claim 4, wherein the instant viscosity (t) is calculated according to the differential equation (5):
{dot over ()}(t,T,{dot over ()}.sub.p)=f((t,T,{dot over ()}.sub.p)) wherein the time derivative 3 of the viscosity is defined as a function the instant viscosity .
17. The method according to claim 2, wherein the set point temperature T(*)t is calculated according to a chosen control strategy either via
18. The method according to claim 3, wherein the set point temperature T(*)t is calculated according to a chosen control strategy either via
19. The method according to claim 4, wherein the set point temperature T(*)t is calculated according to a chosen control strategy either via
20. The method according to claim 5, wherein the set point temperature T(*)t is calculated according to a chosen control strategy either via
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0123] Other features and advantages of some embodiments will become more clearly apparent on reading the following description, given with reference to the appended figures, which illustrate non-limiting examples of possible or preferable realizations (
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[0139] For the sake of clarity, identical or similar elements have been referenced with identical reference symbols in all or most of the figures.
DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS
[0140] For purposes of understanding the principles of some embodiments, reference will now be made to the realizations illustrated in the drawings and the accompanying text.
[0141] An advantage of the method of some embodiments is to control the cement viscosity. A regulation scheme composed of three nested closed-loops may be used for realizing the controlling e8) of the active heat exchanger of an injection device, as shown by
[0142] A. after defining for the bone cement to be injected the target viscosity * to be reached or maintained, the target viscosity * being included in the range [.sub.min.sub.max], .sub.min being the minimal threshold viscosity of the cement which has to be reached for beginning the injection and .sub.max being the maximum threshold viscosity of the cement above which the injection is not possible anymore;
[0143] B. the set point temperature T*(t) associated to the target viscosity * is computed according to the method of some embodiments (step e6) in the temperature set point generation block in the viscosity loop of
[0144] C. the value of the set point temperature T*(t) is injected in the temperature regulation loop that is illustrated on
[0145] D. the current reference I* is limited by a current saturation block,
[0146] E. the current is also controlled in a closed loop control (current loop), in which a current controller C.sub.T uses the difference .sub.I between the current reference I* and the effective input current I to compute the input voltage U of a power supply H driving the active heat exchanger (current loop).
[0147] Now concerning the injection device 1 that may be used in the method of some embodiments,
[0148] On the fixed part of the device, a mounting base has also been designed to support the syringe. The syringe itself is fixed to the mounting base by using a specific sheath that will be more precisely illustrated and detailed below (see
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[0151] The overall dimensions of the injection device 1 as a whole are approximately 500100100 mm for a mass of approximately 5.5 kg. It can provide a service load of 2 kN. This can generate a pressure of about 100 bar on the cement 12 in the syringe 7, and will allow to inject a fluid with a viscosity up to 2000 Pa.Math.s at a flow rate of 33 mm.sup.3/s considering the pressure drop of a 1500 2.5 mm cylinder (equivalent to a typical cement near the end of its solidification injected in a typical large section injection needle plugged into a short channel).
[0152] A master device 11, illustrated on
[0153] The control of the injection is done via a rotating knob 111 located on the master device that returns the pressure information in the form of a force feedback. Should the physician release the knob during the injection, an integrated spring returns the interface in a neutral position.
[0154] As regards the active thermal regulation, which is realized in the method some embodiments by an active heat exchanger 13,
[0163] The active thermal regulation may also be alternatively realized by a deported active heating/cooling heat exchanger 15 put on a closed water circuit 16 with a water-to-cement heat exchanger 13 located on the pipe 17 of the injection device 1, according to a second realization of some embodiments. Such a deported device allows a remote control of the viscosity of the cement during the intervention, thus protecting the radiologist during the cement injection phase by keeping her/him outside the radiation area.
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[0165] The deported heat exchanger 15 of
[0171] As the orientation of the fan/sink couple has an impact on the performance on the heat sinks dissipation in free airflow, the fans 154 have been placed in a geometry designed to provide a more efficient forced airflow.
[0172] The water circuit 16 shown on
[0173] The water-to-cement heat exchanger 13 shown on
[0174] Now concerning the passive thermal exchange,
[0178] As such, the sheath 71 has been machined out of a 316L stainless steel in order to provide a high mechanical resistance and to resist to various chemical products, including biologic fluids and asepsis solutions. The sheath 71 provides some space around the syringe that may filled with an eutectic mixture known for its ability to exchange heat at constant temperatures, thus ensuring that the syringe 71 is kept cool during most of the injection.
[0179] The assembly (sheath) is also equipped with a fixation 9 at the back that interfaces with the mounting base 10 on the injector. A nut 72 and screw system is used to put in and extract the disposable syringe that contains the cement.
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[0182] Now concerning pressure measurements of the cement along the cement pipe 17,
[0183] The best or better way to measure the intravertebral pressure would be to integrate a pressure sensor at the tip of the needle, but it would be very constraining in terms of design. Thus, in the frame of some embodiments, the value of this pressure is obtained indirectly, using a pressure measurement in the cement channel.
[0184] Considering the flow of a cement with varying rheological parameters K and n in a cylindrical pipe of length L.sub.vertebra and of radius r, and given the known sensor position distant from the pipe inlet by a distance L.sub.sensor, the Poiseuille flow leads to equation (6):
[0185] Assuming that the flow rate is high enough, the cement viscosity at the sensor is substantially equal to the cement at the outlet of the pipe. This provide then equation (7):
[0186] As shown by the equations, the knowledge of at least one pressure outside the injection pressure is mandatory. However, as pressure sensors are too expensive to be integrated as a disposable component, there is a need for a reusable pressure sensor that could be carried over several interventions. Also because of sterility issues, the sensor should not have any internal interface with the cement in order to be cleanable.
[0187] For this purpose, reusable pressure sensors have been developed in the frame of some embodiments, in which the sensing area of a standard pressure sensor is immersed in an incompressible fluid that would transfer the pressure.
[0188] According to a first advantageous embodiment of such a pressure sensor 19 (as shown on
[0189] According to a second advantageous embodiment of such a pressure sensor 20 (as shown on
[0190] According to a third advantageous embodiment of such a pressure sensor 21 (as shown on
LIST OF THE CITED REFERENCES
[0191] [1] A. Gangi, S. Guth, J. Imbert, H. Marin, and J.-L. Dietemann, Percutaneous vertebroplasty: indications, technique, and results. Radiographics, vol. 23, March 2003. [0192] [2] US 2013/0190680 of Baroud: US patent application filed on Mar. 8, 2013 by the SOCPRA S.E.C and published on Jul. 25, 2013. [0193] [3] US 2009/0062808 of Wolf: US patent application filed on March 2008 by Wolf (as inventor and applicant) and claiming the priority of a provisional application dated Sep. 5, 2007, and published on Mar. 5, 2009. [0194] [4] U.S. Pat. No. 8,523,871 of Truckai et al.: US granted patent filed on Apr. 3, 2008 by Truckai et al. (as inventors and applicants) and claiming the priority of four provisional applications dated Apr. 3, 2007, and granted on Oct. 9, 2008. [0195] [5] N. Lepoutre, G. Bara, L. Meylheuc, et B. Bayle, Phase Space Identification Method for Modeling the Viscosity of Bone Cement, in Control Conference (ECC), 2016 European, Juin-Juillet 2016.