Patent Application
20110218445
The invention generally relates to a needle with integrated fibers. Particularly, the invention relates to a small diameter needle for tissue inspection based on optical spectroscopy to diagnose whether tissue is cancerous or not.
Needle interventions are widely used in the field of oncology for taking biopsies of tissue in order to inspect whether tissue is cancerous or not. To make these interventions more reliable feedback of what kind of tissue is in front of the needle is required. A way to achieve this is by making use of optical spectroscopy. This requires integration of fibers into the needle. These fibers are used to deliver light to illuminate the tissue in front of the needle and to collect back the reflected light from the tissue.
However, a problem with this is how to integrate these fibers into the needle without compromising the original functionality of the needle, hence altering the outer part of the needle or the inner part (for instance used to take a tissue sample). This means that the fibers must be integrated inside the needle wall while still being able to construct different fibers arrangements at the distal end of the needle. This is of particular importance, because the fiber arrangement at the tip of the needle determines the sensitivity in the measurement of certain optical properties. For instance the fact that a fiber tip is slanted or the distance between two fibers at the tip, affects the measured signal.
Therefore, needles employing optical fibers are particular suited to provide physiological information of the tissue in front of the needle. Such a needle containing fibers require that these fibers are connected to an optical console. At the console light may be coupled into these fibers to illuminate the tissue in front of the needle, while light, being backscattered from the tissue and coupled back into the fiber, may be detected in the console and further processed. This means that the needle may be connected to the console by the fiber.
This construction has several drawbacks: First of all, the connector fiber part can easily break or being damaged during handling. Furthermore, the connector fiber part makes the sterilization of the needle more difficult hence adding extra costs. Finally, handling by the doctor when setting up the needle for usage is cumbersome because of usually long fibers.
It might be an object of the invention to manufacture a needle having at least one fiber exit at the distal end of the needle, where the fiber does not obstruct the hollow part of the needle if present as well as does not extend beyond the outer cylinder geometry. It might be another object of the invention, to provide a needle which can be used reliably, which will be easily handled, and which can be appropriately sterilized.
These might be achieved by the subject matter according to each of the independent claims. Further embodiments of the present invention are described in the respective dependent claims.
Generally, it is proposed to manufacture a needle consisting of five parts: an inner cylinder tube, an outer hollow cylinder tube, a needle tip part with integrated fiber exit, a connector part, and a holder part.
A needle according to the invention comprises a tip part comprising a through bore in axial direction, a holder part comprising an opening, a shaft comprising an inner tube and an outer tube, wherein distal ends of the inner and outer tubes are connected with the tip part, and proximal ends of the inner and outer tubes are connected with the holder part, and wherein a space is formed between the inner tube and the outer tube, a fiber, the fiber being capable of transmitting light, wherein an end section of the fiber is located in the through bore of the tip part, wherein the fiber is located in the space formed by the inner and outer tubes of the shaft, and wherein the fiber passes through the opening of the holder part.
It should be noted that the hollow spacing between the inner and the outer cylinder is larger than or equal to the outer diameter of the fibers, the inner and the outer cylinder are mounted in the holder part, and the tip part is mounted on the two cylinders.
Advantageously, the use of the two cylinders having different diameters enables an easy way to incorporate the fiber into the needle. Furthermore, the use of a separate tip part enables a large freedom in assembling the illumination and collection fiber end geometries without having to make a complex mount that extends over the entire needle length.
The holder part is provided with a channel to guide the fibers from the tip part, being mounted in between the two cylinders, towards the outside world. This part has as additional functionality to provide strength around the fiber to prevent large bending angles of the fibers at the proximal end of the needle.
The cylinders and the needle tip might be made of metal, wherein the metal might be MRI compatible such as Titanium. The needle tip might also be made of a ceramic material. This has the advantage of being mouldable in various shapes while still allowing for a sharp and robust needle tip. Further, the holder part might be made by plastic injection moulding.
According to one embodiment of the invention, the tip part of the needle further comprises a shaft portion and a bevel forming the tip of the needle, wherein the fiber might be located in the through bore such that the end surface of the fiber is flush with the surface of the bevel.
In case of two fibers, wherein both fibers being capable of transmitting light, an end surface of one of the fibers might be located at a top of the bevel and the other one of the fibers might be located at a bottom of the bevel.
The bevel of the needle is in general slanted in order to allow easy entry into the tissue. Therefore, with ‘bevel’ is meant a geometrical structure allowing for introducing the needle into tissue. Usually, a shaft of a needle includes a circular cross section. The distal end of a needle shaft, in particular of a shaft of a hollow needle, is cut such that an oval surface is formed, which is inclined relative to the longitudinal axis of the shaft. Further, there is defined an angle between the longitudinal axis of the shaft and the inclined surface, i.e. the bevel. The bevel forms a pointed tip at the most distal end of the needle. Furthermore, the edge between the outer surface of the shaft and the inclined surface of the bevel might be sharpened.
The wording ‘top of the bevel’ should indicate an area being part of the surface of the bevel, which area is located adjacent to the distal edge between the bevel and the shaft. That is, a fiber which is located at the top of the bevel might be located at the long axis of the oval surface of the bevel, near the distal edge, i.e. the pointed tip.
On the other hand, ‘bottom of the bevel’ means the area being part of the surface of the bevel, which area is located diametric to the top of the bevel. That is, the fiber which is located at the bottom of the bevel might be on or near or adjacent beside the long axis of the oval surface of the bevel near the proximal edge between bevel and shaft.
However, the wording ‘bevel’ might also include similar structures at the tip of the needle, which structures are useful for introducing the needle into a tissue. For example, the bevel might be a convex or concave surface, or the bevel might be a combination of several small surfaces, wherein these surfaces are connected to each other by steps or edges. It might also be possible that the cross section of the shaft is not completely cut by the bevel, such that an area remains which is blunt, i.e. is perpendicularly orientated relative to the longitudinal axis of the shaft. Such a ‘blunt’ end might include rounded edges or might also form a rounded leading edge. As another example, a sharp edge might be formed by two or more slanted surfaces being symmetrically or asymmetrically arranged to form the tip of the needle.
It should be noted that the bevel might form an acute angle with the shaft, such that the needle includes a pointed tip. Preferably, the acute angle might be approximately 20°.
According to one embodiment of the invention, the shaft of the needle has an outer diameter, and the end surfaces of the fibers are arranged at a distance to each other, wherein the distance between the end surfaces is greater than the diameter. Preferably, the distance between the fiber ends is greater than the diameter of the shaft. For example, the distance is more than 1.1 times greater than the diameter. Particularly, the distance is more than 1.25 times greater than the diameter. Preferably, the distance is more than 1.5 times greater than the diameter.
Depending on the intended use of the needle, the outer diameter of the needle might be 2.108 mm for a brain biopsy needle, between 1.27 mm and 2.108 mm for a common biopsy needle or a neuro puncture needle, between 0.711 mm and 2.108 mm for a fine aspiration needle, between 0.711 mm and 1.473 mm for an epidural needle, and might be 2.108 mm or smaller for a needle electrode.
According to a further embodiment of the invention, the needle further comprises a third fiber which is capable of transmitting light, wherein an end surface of the third fiber is located at the bottom of the bevel in the vicinity of the end surface of the other one of the fibers. In this case, the other one of the fiber and the third fiber might be located beside the long axis of the bevel surface.
For example, with a needle diameter of 1.3 mm it might be possible that the distance between the fiber at the top of the bevel and one of the fibers at the bottom of the bevel might be 2.46 mm, and the distance between the two fibers at the bottom of the bevel might be 0.37 mm.
It is noted that the distances are measured from the central axis of one of the fibers to the central axis of the other one of the fibers.
According to yet another embodiment of the invention, the needle further comprises a connector part, wherein a proximal end section of the fiber is located in the connector part for connection with a fiber cable located between the needle and a console including a light source and a light detector. With this, the proximal fiber end is rigidly mounted on the needle. In other words, there will be no fiber section leading out of the holder part of the needle.
Advantageously, the manufacturing, sterilization and handling of the needle is significantly simplified, the separate fiber cable can be made more robust since this part may be reused, and the workflow for setting up the equipment becomes easier since this separate fiber cable can be setup beforehand, i.e. the needle need not to be unpacked from its sterile environment.
To produce a needle according to the invention, it is proposed that the corresponding method generally comprises the steps of manufacturing the tip part including forming at least one through bore in axial direction, positioning and fixing an end section of at least one fiber in a respective through bore, connecting distal ends of the inner tube and the outer tube with the tip part, such that the at least one fiber is located in a space formed between the inner and outer tubes, passing the at least one fiber through an opening of the holder part, and connecting proximal ends of the inner tube and the outer tube with the holder part.
The method might further comprise the step of polishing the surface of the bevel and the end surface of the at least one fiber such that the end surface of the at least one fiber is flush with the surface of the bevel.
According to an embodiment of the invention, the fixing of the at least one fiber in the respective through bore might be provided by gluing, and the connecting of the inner and outer tubes with at least one of the tip part and the holder part, might be provided by welding or by gluing.
According to a further embodiment of the invention, the method may further comprise the step of fixing a proximal end of the at least one fiber in a connector part located at the holder part, so that the fiber is rigidly mounted in the fiber.
According to another embodiment of the invention, the needle with fibers might be used in a system for optical tissue inspection, wherein the system further comprises a light source connected with one of the fibers of the needle, a light detector connected with another one of the fibers of the needle, wherein light coming from the light source and being emitted from the end surface of the one of the fibers can be detected by the light detector when entering the other one of the fibers, a processing unit for processing the data from the light detector, and a monitor for visualization of the processed data. Between the needle and the light source and/or the light detector, a separate fiber cable may be provided.
In such a system, the fiber distal ends in the needle slanted bevel, as mentioned above, provide at least one source-detector fiber pair with a distance A that is larger than the outer diameter of the needle D, wherein A>1.1 D or even A>1.25 D, and preferably A>1.5 D. If b is the tip angle of the needle bevel the following equation might count
In the case that the needle is provided with a fiber at the top of the bevel, and with two fibers at the bottom of the bevel, the fiber at the top might serve as a light source emitting light into surrounding tissue, and the two other fibers might be two detector fibers collecting reflected light. It should be noted, that other combinations are also possible regarding attaching the fibers to the light source and detector, respectively.
The invention might also be related to a computer program for the processing unit of the system according to the invention. The computer program is preferably loaded into a working memory of a data processor. However, the computer program may also be presented over a network like the worldwide web and can be downloaded into the working memory of a data processor from such a network. The computer program might control the emitting of light, might process the signals coming from the light detector at the proximal end of the detector fiber(s). These data might then be visualized at a monitor.
It has to be noted that embodiments of the invention are described with reference to different subject matters. In particular, some embodiments are described with reference to method steps whereas other embodiments are described with reference to devices or systems. However, a person skilled in the art will gather from the above and the following description that, unless other notified, in addition to any combination of features belonging to one type of subject matter also any combination between features relating to different subject matters is considered to be disclosed with this application.
The aspects defined above and further aspects, features and advantages of the present invention can also be derived from the examples of embodiments to be described hereinafter and are explained with reference to examples of embodiments. The invention will be described in more detail hereinafter with reference to examples of embodiments but to which the invention is not limited.
The illustration in the drawings is schematically only and not to scale. It is noted in different figures, similar elements are provided with the same reference signs.
As illustrated in
In this embodiment, the fiber 130 which runs from the distal end, i.e. the surface of the bevel 120, through the shaft 110 to the holder part 160, passes through an opening of the holder part 160 out of the needle.
It is noted that the dimensions mentioned above, are exemplary and not intended to limit the scope of the invention. With the mentioned dimensions, it is intended to provide an order of magnitude and relations for a needle for tissue inspection based on optical spectroscopy.
In
The tip part 200 includes a shaft portion having a thicker section 210 and a thinner section 212. Between said shaft sections, a step or shoulder 214 is formed. The tip part further comprises a bevel 220 with a top 222 and a bottom 224, wherein the top is a surface area near the pointed tip 226 of the tip part 200. Parallel to the longitudinal axis of the shaft portion, there are provided three small through bores or channels 230, 240 and 250. Each of said small through bores is formed such that an opening of each bore is at the bevel surface 220 and the other opening of the bore is in the surface of the shoulder 214, which surface is orientated substantially perpendicular to the longitudinal axis of the shaft portion. The bores 230, 240 and 250 are dimensioned so that a fiber might fit into that bore, wherein the fiber might additionally be fixed by gluing.
As depict in
Finally, the tip part 200 includes a channel 260 along the centre axis of the shaft portion. Such a channel 260 might serve to deliver, for example, drugs or to extract substances from the tissue in which the needle is positioned.
An important part of the needle is the needle tip (see
The tip, fibers and both tubes, once assembled, is fixed to a needle holder. Inside the holder the inner tube is connected with a connector to which for instance a syringe or other tubing can be fixed. In this way volumes of fluid can be dispensed through the channel 354 of the inner tube and tip part, without interaction with the fibers. The needle holder 360 also contains separate exit 362 for the fibers. After assembling tip, fibers, tubes and holder, the bevel 320 of the needle (i.e. the needle tip) is polished to obtain a proper surface quality for the fibers.
Further, the system comprises a light source 332, a light detector 242, a processing unit 370 and a monitor 380. The processing unit 370 is capable of controlling the light source 332 to emit light into the fiber 330 such that light will be emitted through the distal end surface of the fiber 330 at the top of the bevel 320 into surrounding tissue. Depending on what kind of tissue is in front of the bevel, more or less of the emitted light will be reflected in the direction of the bottom of the bevel, to be received be the other fiber 340. Through the fiber 340, the light will be led to the light detector 342, which detector is adapted to transform the light into electrical signals. These electrical signals will be send by, for example, wire to the processing unit. The processing unit will process the data corresponding to the electrical signals, so that the processed data might be visualized on a monitor 380. Based on said visualized data, it might be possible to diagnose whether or not a tissue is cancerous.
To couple the needle 400 with the fiber cable 490, there is provided a connector part 470 at the needle 400, and a correspondingly formed connector part 480 at the fiber cable 490. As depicted in the detail view in
During connection of the connector parts 470, 480, the pin like element 484 will be accommodated in the recess of the connector part 470, and the smaller end portion 472 will engage in the hollow portion 482 of the counter connector part 480. Flush with the blunt front surface 486 of the connector part 480, there is positioned at least one fiber end. The corresponding end(s) of the fiber(s) in the needle are located in the end surface of the recess of the connector part 470. Therefore, an appropriate and reliable connection between the two connector parts and thus between the fibers of the needle and the fiber cable is easily realized.
It is noted that a rigid connector 470 on the needle can either connect one fiber in the needle or a multiple number. In
The construction according to the invention has the following advantages, namely that manufacturing, sterilization and handling of the needle is significantly simplified, that the separate fiber cable can be made more robust since this part is being reused, and that the workflow for setting up the equipment becomes easier since this separate fiber cable can be setup beforehand, i.e. the needle need not to be unpacked from its sterile environment.
Beside that there is only one connector present on the needle, also multiple connectors are envisioned. The connector may also provide connection to other signals such as electrical signals.
Step S1 of the method according to the invention, is the manufacturing of the tip part, wherein this manufacturing includes forming of at least one through bore in axial direction.
Step S2 is the positioning of an end section of at least one fiber in a respective through bore, wherein said positioning might include the fixing of the at least one fiber by, for example, gluing.
Step S3 is the connecting of the distal ends of the inner tube and the outer tube with the tip part, such that the at least one fiber is located in a space formed between the inner and outer tubes.
Step S4 is the connecting of the proximal ends of the inner tube and the outer tube with the holder part, wherein the at least one fiber will be passed through an opening of the holder part.
Step S5 is the fixating of the proximal end of the at least one fiber by means of a connector part mounted at the holder part.
Step S6 of the method according to the invention, is the polishing of the surface of the bevel and of the end surface of the at least one fiber such that the end surface of the at least one fiber is flush with the surface of the bevel.
In the following, exemplary needles according to the invention will be described with respect to their outer diameter, their insertion length, and their preferred use.
A biopsy needle might have an outer diameter of 1.27 mm up to 2.108 mm, might be inserted into tissue with 100 mm to 150 mm of its length, and might be used in soft tissue core biopsies in the neck, the head, the breast, the prostate, and the liver.
A fine aspiration needle of soft tissue might have an outer diameter between 0.711 mm and 2.108 mm, might be inserted into soft tissue with 100 mm to 150 mm of its length, and might be used for aspiration of soft tissue.
A brain biopsy needle might have an outer diameter of 2.108 mm, might be inserted into tissue with 150 mm up to 250 mm of its length, and might be used for diagnostic brain biopsies.
A neuro puncture needle might have an outer diameter of 1.27 mm up to 2.108 mm, might be inserted into tissue with 150 mm to 200 mm of its length, wherein such needles allow a non-traumatic approach to lesions in the brain.
An epidural needle might have an outer diameter between 0.711 mm and 1.473 mm, might be inserted into tissue with a length of up to 150 mm, and might be used for treatments in the spinal cord area such as steroid injections in the epidural space.
Finally, a needle electrode might have an outer diameter of 2.108 mm and smaller, might be inserted into tissue up to 250 mm of its length, and might be used for radiofrequency ablation for instance of tumors.
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. 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. 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. A single processor 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 measured cannot be used to advantage. A computer program may be stored/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. Any reference signs in the claims should not be construed as limiting the scope.
100, 300, 400 needle
110 shaft
120, 220, 320 bevel
210 thicker section of shaft portion
212 thinner section of shaft portion
214 shoulder
222 top of the bevel
224 bottom of the bevel
130, 230, 240, 250, fiber
200, 310 tip part
330, 340 fiber
332 light source
342 light detector
350 outer tube
352 inner tube
260, 354 channel
356 space between inner and outer tubes
160, 360, 460 holder part
362 opening
370 processing unit
380 monitor
470, 480 connector part
472 smaller end portion
482 hollow portion
484 pin like element
486 front surface
490 fiber cable
| Number | Date | Country | Kind |
|---|---|---|---|
| 08169427.5 | Nov 2008 | EP | regional |
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/IB2009/052539 | 6/15/2009 | WO | 00 | 5/13/2011 |
