SYSTEM FOR IMPLANTING IN BONE TISSUE

Abstract

The invention relates a system for implanting an implantable device in bone tissue, a processing unit for such system, a method of implanting an implantable device and a method of providing information for an implanting of an implantable device. In view of the finding that a fat content in cancellous bone is higher than a fat content in compact bone, the lipids fraction, which can be determined by optical means, e.g. spectroscopy, can be used to determine correct screw placement in healthy bone.

Claims

1. A system for implanting an implantable device in tissue, the implantable device having an internal chamber for receiving an optical transmission device, the system comprising: a light detector coupleable to an optical transmission device received in the internal chamber of the implantable device, the light detector configured to receive light reflected by bone tissue in front of the implantable device and detect a spectrum of the reflected light; and a processor configured to: calculate a parameter indicative of a fat content in the bone tissue based on the detected spectrum, compare the calculated parameter with a predetermined value, and output an indication related to the bone tissue based on a result of the compare.

2. The system according to claim 1, wherein the optical transmission device comprises an optical waveguide, a distal end of the waveguide is positioned at a distal end of the optical transmission device and a proximal end of the waveguide is connect to the processor further configured to transmit light from a light source and receive light through the waveguide, wherein the waveguide is configured to (i) transmit light from the processor to the distal end of the optical transmission device to illuminate the bone tissue and (ii) to transmit the light reflected by the bone tissue to the processor.

3. The system according to claim 2, wherein the implantable device comprises a pedicle screw and a stylet integrated with the optical waveguide of the optical transmission device.

4. The system according to claim to claim 3, wherein the stylet is a k-wire configured to be placed into the bone tissue.

5. The system according to claim to claim 2, further comprising a screwing tool configured to couple to the pedicle screw for turning the pedicle screw.

6. The system according to claim 1, wherein the internal chamber has a notch configured to receive a fixating element, and the fixating element is configured to fixate the received optical transmission device to the internal chamber in an axial direction, such that the implantable device has free rotational movement about the optical transmission device.

7. The system according to claim 1, wherein the indication is a warning indicating that the bone tissue reached by the implantable device is compact bone, if the result indicates that the calculated parameter is less than the predetermined value.

8. The system according to claim 1, wherein the indication specifies that the bone tissue reached by the implantable device is cancellous bone, if the result indicates that the calculated parameter is more than the predetermined value.

9. The system according to claim 1, wherein the processor is further configured to set the predetermined value based on a spectrum detected at a portion of tissue with a known bone tissue type.

10. The system according to claim 1, further comprising: a pressure sensitive portion situated at a distal end of the optical transmission device, the pressure sensitive portion forming part of an outer surface of the implantable device, the pressure sensitive portion is configured to exhibit an optical response indicative of an amount of pressure applied to the pressure sensitive portion; and a pressure sensor configured to determine a pressure applied to the pressure sensitive portion and output a signal indicative of said optical response, wherein the light detector is further configured to detect the optical response.

11. The system according to claim 10, wherein the pressure sensitive portion includes one or more of piezochromic material and piezoluminescent material.

12. The system according to claim 1, further comprising a fluid dispenser couplable to the implantable device and configured to dispense a liquid through the implantable device into the bone tissue.

13. An implantation device comprising: a k-wire configured for placement into bone tissue, the k-wire integrated with an optical waveguide; and a pedicle screw having a shaft configured to couple the screw to the k-wire and position a distal end of the waveguide at a tip of the screw, wherein the waveguide is connectable at a proximal end to a processor configured to transmit light, receive light reflected by bone tissue at the tip of the screw and/or k-wire, and translate the reflected light into an indication related to the bone tissue.

14. The device of claim 13, wherein the k-wire and pedicle screw are made of biocompatible material.

15. The device of claim 13, further comprising a screwing tool configured to couple to the screw for turning the screw.

16. A method of implanting an implantable device in tissue, the method comprising: receiving light reflected by bone tissue in front of the implantable device; detecting a spectrum of the reflected light; calculating a parameter indicative of a fat content in the bone tissue based on the detected spectrum; comparing the calculated parameter with a predetermined value; and outputting an indication related to the bone tissue based on a result of the comparing.

17. The method according to claim 16, where the indication is a warning indicating that the bone tissue reached by the implantable device is compact bone, if the result indicates that the calculated parameter is less than the predetermined value.

18. The method according to claim 16, wherein the indication specifies that the bone tissue reached by the implantable device is cancellous bone, if the result indicates that the calculated parameter is more than the predetermined value.

19. The method according to claim 16, further comprising setting the predetermined value based on a spectrum detected at a portion of tissue with a known bone tissue type.

20. A non-transitory computer readable medium storing instructions executable, which, when executed by a processor, causes the processor to carry out the method of claim 16.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0051] In the following drawings:

[0052] FIG. 1 shows a principle concept of a pedicle screw,

[0053] FIG. 2 shows two pedicle screws placed in a vertebra,

[0054] FIG. 3 shows a combination of a pedicle screw, an optical transmission device and a processing unit in accordance with an embodiment of the invention,

[0055] FIG. 4 shows a portion of a pedicle screw in accordance with another embodiment of the invention,

[0056] FIG. 5 shows a system for implanting an implantable device in accordance with another embodiment of the invention,

[0057] FIG. 6 shows a log plot of the absorption spectra of blood, water and fat,

[0058] FIG. 7 shows intrinsic fluorescence curves for collagen, elastin, NADH and FAD,

[0059] FIG. 8 shows a diagram illustrating an equivalent circuit for measuring tissue impedance,

[0060] FIG. 9 shows a part of an arrangement including a pedicle screw, an optical transmission device with a pressure sensitive portion and adjacent tissue in accordance with another embodiment of the invention, and

[0061] FIG. 10 shows a flow diagram illustrating a method of assisting in implanting an implantable device in accordance with an embodiment of the invention.

DETAILED DESCRIPTION OF EMBODIMENTS

[0062] FIG. 1 shows a principle concept of a pedicle screw 1. The pedicle screw 1 includes a body 2, a neck 3 and a head 4. The body 2 is provided with a thread having a pitch 5, and outer diameter 6 and an inner diameter 7, such that the thread depth is the difference between the outer diameter 6 and the inner diameter 7.

[0063] FIG. 2 shows two pedicle screws 1 placed in a vertebra 10 together with a tool 11 for screwing the screw 1 into the bone.

[0064] As the skilled person is familiar with the general concepts of a pedicle screw as an example of an implantable device for being implanted into bone tissue and other such implantable devices for bone tissue, the tools already conventionally used in such context and the concepts of conventional placing the implantable devices into the bone tissue, further explanation thereof is not provided here.

[0065] FIG. 3 shows a combination of a pedicle screw 100, an optical transmission device 101 and a processing unit 102 in accordance with an embodiment of the invention.

[0066] The pedicle screw 100 has a hollow shaft 103, into which an optical stylet 104 of the optical transmission device 101 is inserted such that the optical stylet 104 extends to the distal tip of the screw 100. The stylet 104 and the whole optical transmission device 101 contain a waveguide such as an optical fiber that is connected to a processing unit 102 (an optical console) that is capable of sending and receiving light. The received light is spectrally analyzed allowing tissue discrimination at the tip of the screw 100. For instance techniques like diffuse reflectance spectroscopy, fluorescence spectroscopy, RAMAN spectroscopy, OCT can be applied.

[0067] Specifically, the received light is used for a determination of the parameter indicative for the fat content of the (bone) tissue in front of the tip of the screw 100 and the optical stylet 101, which, in turn, is used for determining whether the bone tissue is that of the soft(er) part of the bone or that of the hard(er) part of the bone, thereby allowing for a navigation assistance in placing the screw 100.

[0068] FIG. 4 shows a portion a pedicle screw 110 in accordance with another embodiment of the invention. As discussed already with respect to FIG. 3, the pedicle screw 110 includes a hollow shaft, such that there is an internal chamber 111 inside the pedicle screw 110 extending through the pedicle screw 110. Into such internal chamber 111, the optical transmission device or optical waveguide may be inserted (not shown here), such that optical measurements at the tip (or other parts) of the pedicle screw 110 can be performed. The pedicle screw 110 is further provided with openings 112 branching off from the internal chamber 111. The openings 112 allow, for example, for fluids to be injected through the pedicle screw 110 into the surrounding (bone) tissue (not shown).

[0069] In a further preferred embodiment (not shown), the internal chamber 111 may be provided with a notch for example adjacent its rear portion. In the notch, a fixating element such as a small screw may be provided. When a stylet 104 has been introduced into the internal chamber 111, the fixating element may be used to fixate the stylet in the axial direction. However, the fixation is such that a free rotational movement of the pedical screw 110 about the stylet 104 is still possible, thus avoiding twisting of the stylet 104 during implantation of the screw.

[0070] FIG. 5 shows a system 120 for implanting an implantable device (not shown) in accordance with another embodiment of the invention.

[0071] The probe 124 contains two light guides 128. These light guides 128 of the probe 124 are connected to an optical console 121. These light guides are understood to be for instance optical fibers or other optical waveguides. Specifically, in the present embodiment, the system comprises a light source 122 in the form of a halogen broadband light source with an embedded shutter, the probe 124 (or optical transmission device) which is to be inserted in the implantable device (not shown) and an optical detector 123. The optical detector 123 can resolve light with a wavelength substantially in the visible and infrared regions of the wavelength spectrum, such as from 400 nm to 1700 nm. The combination of light source 122 and detector 123 allows for diffuse reflectance (DRS) and fluorescence measurements of the tissue 127 in front of the distal end of the waveguides 128. For a detailed discussion on DRS measurements, incorporating reference is made to R. Nachabe, B. H. W. Hendriks, M. V. D. Voort, A. E, and H. J. C. M. Sterenborg, “Estimation of biological chromophores using diffuse optical spectroscopy: benefit of extending the UV-VIS wavelength range to include 1000 to 1600 nm,” (Optics Express, vol. 18, 2010, pp. 879-888) and R. Nachabe, B. H. W. Hendriks, A. E. Desjardins, M. van der Voort, M. B. van der Mark, and H. J. C. M. Sterenborg, “Estimation of lipid and water concentrations in scattering media with diffuse optical spectroscopy from 900 to 1600 nm,” (Journal of Biomedical Optics, vol. 15, May. 2010, pp. 037015-10). From these DRS measurements, tissue transitions can be deduced, wherein furthermore specifically a parameter indicative of a fat content of the tissue can be obtained.

[0072] Although diffuse reflectance spectroscopy is described above to extract tissue properties, other optical methods can also be envisioned like diffuse optical tomography by employing a plurality of optical fibers, differential path length spectroscopy, fluorescence and Raman spectroscopy. Additionally, acquisition of optical data could be done via a probe that is contact with the tissue or via a non-contact probe.

[0073] A processor 125, to which data storage 125 is connected, transforms the measured spectra in the detector 123 into physiological parameters that are indicative of the tissue state for the source-detector fiber combination. To determine whether a certain tissue is in front of the probe (or implantable device), the signal for the source-detector pair can be compared with a look-up-table. Another way is to translate the measured parameters into physiological parameters and define ranges for these parameters for each tissue type. Incorporating referral is made to Duck, F. A., “Physical properties of tissue: A comprehensive reference book” (1990, Academic Press, Harcourt Brace Jovanovich, Publishers), where methods based on classification and regression tree (CART) analyses are described for classifying tissue based on these physiological parameters.

[0074] Apart from the tissue sensing, the illumination fiber 128 is partly covered by an on pressure color changing material (not shown, see FIG. 9). Part of the light in the illumination fiber 128 is reflected by this color changing material and received by the console 121. The reflected wavelength depends on the applied pressure. By measuring for instance the wavelength where the peak intensity of the reflected light is located, the pressure that was exercised on the on pressure changing material can now be deduced. In this way not only the tissue properties can be deduced but also the pressure that is exercised on the screw while being inserted can be determined. Apart from the optical spectroscopy measurements that provide information the tissue in front of the screw this pressure sensing material provide also information that can be used as additional confirmation. When the screw is in the softer interior of the bone the pressure found will be lower than that when the screw is near or in the boundary of the bone. Furthermore, the hardness of the bone marrow can be assessed. Based on the measured pressure the physician can decide whether or not additional measures must be taken, for instance injecting material via the ports of the screw that enforces the inside of the bone (see FIG. 4).

[0075] An example of extracting the physiological parameter is by fitting the acquired spectra using a custom made Matlab 7.9.0 (Mathworks, Natick, Mass.) algorithm. In this algorithm, a widely accepted analytical model was implemented, namely the model introduced by T. J. Farrel, M. S. Patterson and B. C. Wilson, “A diffusion theory model of spatially resolved, steady-state diffuse reflectance for the non-invasive determination of tissue optical properties,” (Med. Phys. 19 (1992) p. 879-888), which is hereby incorporated by reference in entirety. The input arguments for the model of Farrel et al. are the absorption coefficient μ.sub.a(λ), the reduced scattering coefficient μ.sub.s′(λ) and the center-to-center distance between the emitting and collecting fibers at the tip of the probe. For a complete description of the diffusion theory model, referral is made to the paper of Farrel et al.

[0076] In the following, the model will be explained briefly. The formulas are mainly based on the work of Nachabé et al. mentioned above (R. Nachabé, B. H. W. Hendriks, M. V. D. Voort, A. E, and H. J. C. M. Sterenborg, “Estimation of biological chromophores using diffuse optical spectroscopy. benefit of extending the UV-VIS wavelength range to include 1000 to 1600 nm,” (Optics Express, vol. 18, 2010, pp. 879-888)), which is hereby incorporated by reference in entirety, and furthermore reference is made in this context also to R. Nachabe, B. H. W. Hendriks, A. E. Desjardins, M. van der Voort, M. B. van der Mark, and H. J. C. M. Sterenborg, “Estimation of lipid and water concentrations in scattering media with diffuse optical spectroscopy from 900 to 1600 nm,” (Journal of Biomedical Optics, vol. 15, May 2010, pp. 037015-10), which is hereby incorporated by reference in entirety.

[0077] A double power law function can be used to describe the wavelength dependence of the reduced scattering coefficient, where the wavelength λ is expressed in nm and is normalized to a wavelength value of λ.sub.0=800 nm. The parameter a corresponds to the reduced scattering amplitude at this specific wavelength.

[00001]$\begin{array}{cc}{\mu }_s^{\prime }\left(\lambda \right)=a({{\rho }_{\mathrm{MR}}\left(\frac{\lambda }{{\lambda }_0}\right)}^{-b}+\left(1-{\rho }_{\mathrm{MR}}\right)\left(\frac{\lambda }{{\lambda }_0}{j}^{-4}\right)\left[{\mathrm{cm}}^{-1}\right]& \left(\mathrm{Eq}.1\right)\end{array}$

[0078] In this equation the reduced scattering coefficient is expressed as the sum of Mie and Rayleigh scattering where ρ.sub.MR is the Mie-to-total reduced scattering fraction. The reduced scattering slope of the Mie scattering is denoted as b and is related to the particle size.

[0079] For a homogeneous distribution of absorbers, the total light absorption coefficient μ.sub.a(λ) can be computed as products of the extinction coefficients and volume fraction of the absorbers (see FIG. 6, which shows a log plot of the absorption spectra of blood (hemoglobin (line 130), oxygenated hemoglobin (line 131), water (line 132) and fat (line 133), with the abscissa indicating the wavelength in nm and the ordinate showing μ.sub.a(λ) in cm.sup.−1)):

μ.sub.a.sup.Total=f.sub.1μ.sub.a.sup.1+f.sub.2μ.sub.a.sup.2+f.sub.3μ.sub.a.sup.3+ . . .   (Eq.2)

[0080] Instead of modeling the absorption coefficient μ.sub.a(λ) as the sum of absorption coefficients weighted by the respective concentrations of the four chromophores of interest, it was decided to express the tissue absorption coefficient as

μ.sub.a.sup.Tissue(λ)=C(λ)v.sub.Bloodμ.sub.a.sup.Blood(λ)+v.sub.WLμ.sub.a.sup.WL(λ)[cm.sup.−1]  (Eq.3)

where μ.sub.a.sup.Blood(λ) corresponds to the absorption by blood and μ.sub.a.sup.WL(λ) corresponds to absorption by water and lipid together in the probed volume. The volume fraction of water and lipid is v.sub.WL=[Lipid]+[H.sub.2O], whereas v.sub.Blood represents the blood volume fraction for a concentration of hemoglobin in whole blood of 150 mg/ml.

[0081] The factor C is a wavelength dependent correction factor that accounts for the effect of pigment packaging and alters for the shape of the absorption spectrum. This effect can be explained by the fact that blood in tissue is confined to a very small fraction of the overall volume, namely blood vessels. Red blood cells near the center of the vessel therefore absorb less light than those at the periphery. Effectively, when distributed homogeneously within the tissue, fewer red blood cells would produce the same absorption as the actual number of red blood cells distributed in discrete vessels. The correction factor can be described as

[00002]$\begin{array}{cc}C\left(\lambda \right)=\frac{1-\exp \left(-2R{\mu }_a^{\mathrm{Blood}}\left(\lambda \right)\right)}{2R{\mu }_a^{\mathrm{Blood}}\left(\lambda \right)},& \left(\mathrm{Eq}.4\right)\end{array}$

where R denotes the average vessel radius expressed in cm. The absorption coefficient related to blood is given by

[00003]$\begin{array}{cc}\text{?}\left(\lambda \right)-{\alpha }_{\mathrm{BL}}{\mu }_a^{{\mathrm{HbO}}_2}\left(\lambda \right)+\left(1-{\alpha }_{\mathrm{BL}}\right){\mu }_a^{\mathrm{Hb}}\left(\lambda \right)\left[{\text{?}}^{-1}\right],\text{?}\text{indicates text missing or illegible when filed}& \left(\mathrm{Eq}.5\right)\end{array}$

where μ.sub.a.sup.HbO.sup.2(λ) and μ.sub.a.sup.Hb(λ) represent the basic extinction coefficient spectra of oxygenated hemoglobin HbO.sub.2 and deoxygenated hemoglobin Hb, respectively. The oxygenated hemoglobin fraction in the total amount of hemoglobin is noted as α.sub.BL=[HbO.sub.2]/([hbO.sub.2]+[Hb]) and is commonly known as the blood oxygen saturation. The absorption due to the presence of water and lipid in the measured tissue is defined as

μ.sub.a.sup.WL(λ)=α.sub.WLμ.sub.a.sup.Lipid(λ)+(1−α.sub.WL)μ.sub.a.sup.H.sup.2.sup.O(λ)[cm.sup.−1]  (Eq.6)

[0082] In this case the concentration of lipid related to the total concentration of lipid and water together can be written as α.sub.WF=[Lipid]/([Lipid]+[H.sub.2O]), where [Lipid] and [H.sub.2O], correspond to the concentration of lipid (density of 0.86 g/ml) and water, respectively.

[0083] This way of relating the water and lipid parameters in the expression of the absorption coefficient is defined in Eq.6, rather than estimating separately the water and lipid volume fraction corresponding to a minimization of the covariance of the basic functions for fitting, thus resulting in a more stable fit (see, also for further explanation and validation of this theorem the above mentioned papers by R. Nachabe et al.).

[0084] Other optical absorbers could also be incorporated into this algorithm, such as: lycopene, vitamin A, β-carotene, bile, or black tar (or any absorbing substance related to smoking).

[0085] Another way to discriminate differences in spectra is by making use of a principal component analysis. This method allows classification of differences in spectra and thus allows discrimination between tissues. It is also possible to extract features from the spectra.

[0086] Apart from diffuse reflectance one could also measure fluorescence spectra. Then for instance parameters like collagen, elastin, NADH and FAD could also be measured (see FIG. 7, which shows intrinsic fluorescence curves for collagen (line 140), elastin (line 141), NADH (line 142) and FAD (line 143), with the abscissa providing the wavelength in nm and the ordinate giving the fluorescence intensity in arbitrary units). The ratio NADH/FAD, which is called the optical redox parameter, is of interest because it is an indicator for the metabolic state of the tissue (see M. Müller and B. H. W. Hendriks, “Recovering intrinsic fluorescence by Monte Carlo modeling”, (J. Biomed. Optics vol. 18 (2013) p. 027009-1 to 027009-13) and references therein), which can also be used to discriminate tissues.

[0087] FIG. 8 shows a diagram illustrating an equivalent circuit for measuring tissue impedance.

[0088] Dielectric properties (permittivity ε′ and conductivity σ) of an unknown sample (e.g. pedicle, vertebral body, spinal nerve and spinal cord) can be calculated from measurements of the impedance of the probe against the unknown sample using the following relationships where so is the permittivity of free space

[00004]$\begin{array}{cc}{\mathrm{.Math.}}^{\prime }=\frac{C}{K}\sigma =\frac{G{\mathrm{.Math.}}_0}{K}& \left(\mathrm{Eq}.7+8\right)\end{array}$

where C and G are the fringing capacitance and conductance of the probe. The characteristic parameters of the probe can be calculated from measurements of the impedance components of the probe in air and in a standard sample (water or salt solution).

[0089] In the case of biological samples, the dielectric properties of the materials are a measure of their interaction with electromagnetic fields and varies significantly based on the type of tissue (see the table below based on Duck, F. A., “Physical properties of tissue: A comprehensive reference book” (1990 Academic Press, Harcourt Brace Jovanovich, Publishers) and C. Gabriel, et al. “Compilation of dielectric properties of body tissues at RF and microwave frequencies” (Radiofrequency Radiation Standards NATO ASI Series Volume 274, 1995, pp 187-196)). Frequency dependent dielectric properties of the tissues can be measured using several impedance matching techniques i.e. Wien-bridge oscillators. A suitably calibrated probe can be used to measure the tissue impedance in frequency ranges from 10 Hz to 20 GHz. The phenomenon is equivalent to a frequency dependent capacitor in series with a resistor (see FIG. 8 showing an electrode component 150 with a constant phase element 151 in series with a tissue component including a resistance 153 in series with a parallel provision of a further resistance 154 and another constant phase element 155). Both components can be approximated by negative power functions of frequency i.e. their absolute values decrease with increasing frequency.

TABLE-US-00001 Tissue Type Tissue Conductivity (S/m) Bone-Cancellous 0.07 Bone-Marrow 0.05 Cartilage 0.18 Cerebro Spinal Fluid 2.0 Fat 0.04 Muscle 0.375 Blood 0.7 Nerve 0.03

[0090] FIG. 9 shows a part of an arrangement including a pedicle screw 160, an optical transmission device 161 with a pressure sensitive portion 162 and adjacent tissue 163 in accordance with another embodiment of the invention.

[0091] Due to the insertion or implanting of the pedicle screw 160, of which only the tip is shown, a pressure exists between the pressure sensitive portion 162 of the optical transmission device 161 (which is fixed against axial movement in the screw 160) and the adjacent tissue 163 (e.g. bone).

[0092] Pressure can be sensed with an optical signal using, for example, photonic crystals. Photonic crystals may be formed by a combination of at least 2 material types, where one has a high dielectric constant and the other has a low dielectric constant (for example air). The material has a periodic pattern in the refractive indices, with a typical length scale of 100-1000 nm allowing interaction with visible light, described by the Bragg reflection. Changing this periodical pattern, for example by pressure or stretch, will change this interaction, observable by a difference in the reflected wavelength (color). The material class is highly adjustable, so the range and sensitivity can be tuned towards the requirements of the application (see, for example, E. Yablonovitch, “Photonic Crystals: Semiconductors of Light” (Scientific American ISSN: 0036-8733 Vol: 285 (6) 2001 Page: 46-55); C. G. Schäfer, et al. “Reversible Light, Thermo., and Mechano-Responsive Elastomeric Polymer Opal Films” (Chemistry of Materials, 2013, 25, pp 2309-2318) and O. L. J. Pursiainen, et al. “Nanoparticle-tuned structural color from polymer opals” (Optics Express ISSN: 1094-4087, Vol: 15 2007, Page: 9553).

[0093] Examples of pressure sensitive photonic crystal materials include nanopores filled with air in a polymer matrix, for example poly(alkyl-methacrylate) matrix with monodisperse spherical nanopores in a highly ordered pattern, commercialized by the Canadian company Opalux and also nanospheres in a polymer matrix, for example hard crosslinked polystyrene (PS) spheres coated with a thin polymethyl-methacrylate (PMMA) inter-layer which anchors the outer shell composed of soft polyethylacrylate (PEA) (see, O. L. J. Pursiainen, et al. “Nanoparticle-tuned structural color from polymer opals” (Optics Express ISSN: 1094-4087, Vol: 15 2007, Page: 9553)).

[0094] Pressure induced color changing material can also be made of liquid crystals, for example developed by the Fraunhofer Institute (see, A. Seeboth, et al. “Piezochromic Polymer Materials Displaying Pressure Changes in Bar-Ranges” (American Journal of Materials Science 2011, volume 1, page 139-134). Currently, however, this material is not yet commercially available.

[0095] Furthermore optical pressure sensing can also be done by using dye-doped polymers (see, Y. Sagara, et al. “Mechanically induced luminescence changes in molecular assemblies” (Nature chemistry 2009, volume 1, page 605-610)) or light emitting materials (see, M-J. Teng, et al. “Reversible Tuning Luminescent Color and Emission Intensity: A Dipeptide-Based Light-Emitting Material” (Advanced materials 2012, volume 24, page 1255-1261).

[0096] In any case, the skilled person will appreciate that the pressure sensitive portion 162 may be provided by any suitable means, including piezochromic and piezoluminescent materials.

[0097] The use of pressure sensing in this way includes as advantages a high simplicity (no electronic components, no labor-intensive electronic assembly), therefore possible cost reduction; a possibility for further miniaturization (no limitation due to electrical cables or interconnects), mechanical flexibility and MR, EM and RF compatibility.

[0098] Furthermore, there is the possibility to integrate multi sensing modalities on the interventional device. This may lead to distributed sensing along the interventional devices shaft, sensing a variety of parameters with only one device, or a combination of both. FIG. 10 shows a flow diagram illustrating a method of assisting in implanting an implantable device in accordance with an embodiment of the invention.

[0099] In a preparation step 201, an optical waveguide is provided in an internal chamber of the implantable device, the optical waveguide being arranged for transmitting light from a proximal end of the optical transmission device to a distal end to illuminate tissue and for transmitting light reflected by and/or scattered in the tissue from the distal end of the optical transmission device to the proximal end.

[0100] During the actual implanting procedure, in an illuminating step 203 light is transmitted from a proximal end of the optical transmission device to a distal end to illuminate tissue.

[0101] In a reflecting step 205, light reflected by and/or scattered in the tissue is transmitted from the distal end of the optical transmission device to the proximal end. In a reception step 207, the light reflected by and/or scattered in the tissue is received and at least a part of the spectrum thereof is detected.

[0102] Based on the detected spectrum, in a calculation step 209, a parameter indicative for a fat content in the tissue is calculated.

[0103] In a comparison step 211, the calculated parameter indicative for the fat content is compared with a predetermined value and in an output step 213, a signal indicative of a result of the comparing is outputted.

[0104] During the procedure, a loop including steps 203 to 213 is repeated as long as needed.

[0105] After the insertion or implanting is provided, the optical transmission device may be removed from the implanted device.

[0106] In an embodiment of the present invention, at least one optical sensor is incorporated (inserted) into a pedicle screw capable of performing measurements near the screw. The sensor is in communication with a console that based on the sensed data is able to determine the tissue type near the screw. In this way, when the screw is advanced, the tissue sensing allows the physician to avoid misplacement of the screw.

[0107] In a preferred modification of the embodiment as the sensor an optical stylet is provided inside the center of the pedicle screw including of a waveguide capable of sending to and receiving light from the tip of the screw that based on optical spectroscopy allows tissue discrimination at the tip of the screw. This tissue information is provided to the physician during the screw placement due to which screw misplacement can be avoided.

[0108] A further aspect of the embodiment is that at least one of the distal ends of the fiber that is in contact with the tissue is covered by a pressure sensitive material that changes color upon application of pressure. The pressure load on the material at the tip results in a well-defined color change from which the pressure can be deduced. The color change is detected by the optical console used to perform the optical spectroscopy for tissue discrimination.

[0109] In a further aspect of the embodiment, the pedicle screw contains openings to the side that are in connection to the top portion of the pedicle screw. In this way fluids like biocompatible cement can be injected through the screw into the surrounding tissue. Such fluids may be cement that hardens upon injection or curable resin. The curing can be done for instance by heat, chemically or by light (such as UV hardening). Due to this curing of an injected fluid the fixation of the screw can be improved. During the curing phase the hardness of the curable resin can be interrogated with the color changing material on pressure at the fiber tip.

[0110] In a further modification, the sensing part can be integrated in any other part of the pedicle screw placement system such as the K-wire. As is known in the art, in certain procedures it may be needed to first place a K-wire in the bone, following which the pedicle screw to be implanted may be slided over this K-wire which can be removed after the screw has been placed.

[0111] In particular and in the context of an advantageous embodiment, the invention relates to pedicle screw system including a screw being of a biocompatible material and containing at least one optical waveguide, a biocompatible k-wire integrated with optical waveguide, wherein a distal end of the optical waveguide is positioned near the tip of the screw and a proximal end of the waveguide is connected to an optical console capable of sending and receiving light, pressure sensitive material that changes color upon application of pressure coated at least partly on the distal end of the waveguide, a console capable of sending light in the waveguide and able to receive the light that has interacted with the color changing material and with the tissue near the screw tip, a monitor connected to the console, wherein the console is capable of translating the received light (1) into tissue specific parameters and (2) into the amount of pressure exercised on the screw tip based on the color of the color changing material.

[0112] In a more preferred modification of the embodiment the pedicle screw has openings to allow fluids being injected through the screw. These fluids can for instance but not limited to be self-hardening cement or curable resins such as UV hardening resin.

[0113] In an even further preferred modification of the embodiment the pedicle screw system is equipped with impedance sensors for tissue discrimination.

[0114] In a further embodiment, the invention provides for a pedicle screw placement device including of a pedicle screw, a screwdriver, a stylet inside the pedicle screw allowing tissue sensing at the tip of the screw and an optical console capable of analyzing the optical signal and providing a feedback signal to the physician indicative for tissue in front of the screw.

[0115] While the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and not restrictive; the invention is not limited to the disclosed embodiments.

[0116] Other variations to the disclosed embodiments can be understood and effected by those skilled in the art in practicing the claimed invention, from a study of the drawings, the disclosure, and the appended claims.

[0117] In the claims, the word “comprising” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality.

[0118] A single processor, device or other unit may fulfill the functions of several items recited in the claims. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage.

[0119] Operations like determining, calculating, comparing and outputting (e.g. outputting a signal) can be implemented as program code means of a computer program and/or as dedicated hardware.

[0120] A computer program may be stored and/or distributed on a suitable medium, such as an optical storage medium or a solid-state medium, supplied together with or as part of other hardware, but may also be distributed in other forms, such as via the Internet or other wired or wireless telecommunication systems.

[0121] Any reference signs in the claims should not be construed as limiting the scope.