Patent Application
20080132911
The disclosed technique relates to medical devices in general, and to methods and systems for withdrawal of a fluid sample from the body of a patient, in particular.
In order to diagnose a disease in a patient, a sample of an organic substance, such as a tissue or amniotic fluid is removed from the body of the patient. In case of a solid substance, such as a target tissue, the sample is removed from the body, by employing a biopsy needle. The biopsy needle includes a receptacle to remove the sample. In case of a fluid, such as amniotic fluid, a surgical needle is inserted into the uterus cavity of the uterus of the patient, and a sample of the amniotic fluid is pumped out through a lumen of the surgical needle. The mucous membrane of the vesical surface of the uterus cavity can block the opening of the surgical needle, while the surgical needle passes through the vesical surface to enter the uterus cavity.
A mandrel is inserted in the lumen, when the surgical needle is inserted into the body of the patient, in order to block the opening of the surgical needle, and to prevent entry of undesired tissues and fluids, into the lumen, and thereby prevent contamination of the sample. When the tip of the surgical needle reaches the desired location within the uterus cavity, the mandrel is pulled out of the lumen, and the sample of the amniotic fluid is pumped out. It is desirable for the physical staff to know the location and orientation of the tip of the surgical needle within the body of the patient, in order to minimize physical injury to the tissues surrounding the desired organ.
Methods for determining the location and orientation of the tip of a surgical device, such as a catheter, or a biopsy needle are known in the art. One such method utilizes a sensor wound around the tip of the biopsy needle. The sensor produces an electrical output in response to an electromagnetic filed, according to the location and orientation of the sensor in space. A display displays a representation of the location and orientation of the tip of the biopsy needle, superimposed on an image of the body of the patient, according to the output of the sensor.
Another method utilizes a sensor located within the tip of the catheter, and the sensor detects the location and orientation of the tip of the catheter in a similar manner. Yet another method, utilizes an electron spin resonance (ESR) sample placed within a probe which is inserted into the body of a patient, who is imaged by a magnetic resonance imaging (MRI) apparatus. The location and orientation of the ESR sample is determined according to the frequency of the ESR, in presence of a magnetic field of the MRI.
International Application Publication Number WO 97/29682 to Ben-Haim et al., and entitled “Locatable Biopsy Needle” is directed to a system for determining the trajectory of a biopsy needle while being advanced toward a target tissue within a body. The system includes an ultrasonic imager, a first position sensor, and a second position sensor. The biopsy needle includes an inner portion. The inner portion includes a tissue receptacle. The first position sensor is located distal to the tissue receptacle. The second position sensor is mounted on the ultrasonic imager.
The ultrasonic imager is placed on the body above the target tissue. An image plane of the ultrasonic imager bisects the target tissue. The position of the first position sensor relative to the image plane, can be dynamically determined The actual trajectory over which biopsy needle advances can be determined by storing the positions of the needle during its movement.
U.S. Pat. No. 6,073,043 issued to Schneider and entitled “Measuring Position and Orientation Using Magnetic Fields”, is directed to a system for determining the position and orientation of a catheter. The system includes a plurality of field generation means, a sensor, an amplifier, an analog to digital converter (ADC), a processor, a digital to analog converter (DAC), a multiplexer, and a plurality of driving amplifiers.
Each field generating means includes a pair of B-field generator coils (i.e., magnetic field coils). The sensor is in the form of a coil. The signal processor is in the form of a low pass filter to reduce out of band signals to reach the processor. The sensor is connected to the amplifier. The signal processor is connected to the amplifier and to the ADC. The processor is connected to the ADC and to the DAC. The multiplexer is connected to the DAC and to the driving amplifiers. The driving amplifiers are connected to the field generating means.
The driving amplifiers supply power to each of the B-field generator coils. The sensor receives electromagnetic fields which the field generating means generates. The amplifier amplifies an output of the sensor. The signal processor processes the amplified output of the amplifier. The ADC converts the amplified output from analog to digital format. The processor determines the position and orientation of the sensor, by performing a signal withdrawal method.
U.S. Pat. No. 5,882,304 issued to Ehnholm et al., and entitled “Method and Apparatus for Determining Probe Location”, is directed to a system for determining the position of a probe within an anatomy of a patient. The system includes a probe, the lock unit, a position acquisition controller, a gradient controller, and a display. The probe includes an active electron spin resonance (ESR) sample, which exhibits resonance when located in a magnetic field produced by a magnet of a magnetic resonance imaging (MRI) apparatus. The MRI apparatus includes the magnet and a main magnetic field and gradient coils. The lock unit is connected to the probe and to the position acquisition controller. The position acquisition controller is connected to the gradient controller. The display is connected to the position acquisition controller.
The patient is placed in an imaging region of the MRI apparatus. The probe is inserted into a biopsy needle and the biopsy needle is inserted into the anatomy of the patient. The lock unit measures the ESR frequency of the ESR sample, and the local field which acts on the probe. The position acquisition controller acts on the gradient coils through the gradient controller, according to the result of this measurement.
The MRI apparatus produces three gradient magnetic fields. The position of the ESR sample is determined according to the three gradient magnetic fields. In the presence of one of the gradient magnetic fields, the ESR frequency is a function of the position of the ESR sample along that gradient magnetic field. The system determines the coordinates of the probe, by measuring the ESR frequency in three directions. The display displays the position of the probe superimposed on an image of the patient. When the biopsy needle reaches the desired position in the anatomy of the patient, the probe is removed from the biopsy needle, and a biopsy mandrel is inserted in the biopsy needle, in order to withdraw a biopsy sample from the anatomy of the patient.
It is an object of the disclosed technique to provide a novel method and system for navigating a surgical needle toward a target organ of the body of a patient.
In accordance with the disclosed technique, there is thus provided a system for navigating a surgical needle toward a target organ of the body of a patient. The system includes a removable mandrel, a medical positioning system (MPS) sensor, an electromagnetic field generator, and an MPS. The removable mandrel is located within the surgical needle. The removable mandrel can be moved in and moved out of the surgical needle. The MPS sensor is located at the tip of the removable mandrel.
The electromagnetic field generator generates an electromagnetic field. The MPS is coupled with the MPS sensor and with the electromagnetic field generator. The MPS sensor produces an output according to the electromagnetic field. The MPS determines the position of the tip of the removable mandrel in a coordinate system respective of the MPS, according to the output of the MPS sensor. The MPS produces an indication respective of the position of the tip of the removable mandrel, to enable navigation of the surgical needle toward the target organ.
In accordance with another aspect of the disclosed technique, there is thus provided a surgical needle system. The system includes a surgical needle, a removable mandrel, and a medical positioning system (MPS) sensor. The removable mandrel is located within the surgical needle. The MPS sensor is located at the tip of the removable mandrel. The MPS sensor is coupled with an MPS.
The MPS is coupled with an electromagnetic field generator. The electromagnetic field generator generates an electromagnetic field. The MPS sensor produces an output according to the electromagnetic field. The MPS determines the position of the tip of the removable mandrel in a coordinate system respective of the MPS, according to the output of the MPS sensor. The MPS produces an indication respective of the position of the tip of the removable mandrel, to enable navigation of the surgical needle toward the target organ.
In accordance with a further aspect of the disclosed technique, there is thus provided a method for navigating a surgical needle toward a target organ of the body of a patient. The surgical needle includes a removable mandrel there within. The method includes the procedures of coupling a medical positioning system (MPS) sensor with an MPS, generating an electromagnetic field, and producing an output by the MPS sensor. The method further includes the procedures of determining coordinates respective of the position of the tip of the removable mandrel, and producing an indication respective of the position of the tip of the removable mandrel.
The MPS sensor is located at the tip of the removable mandrel. The electromagnetic field is generated by an electromagnetic field generator. The output of the MPS sensor is produced according to the electromagnetic field. The coordinates respective of the position of the tip of the removable mandrel, are determined in a coordinate system respective of the MPS, according to the output of the MPS sensor. The indication respective of the position of the tip of the removable mandrel, is produced according to the determined coordinates, to enable navigation of the surgical needle toward the target organ.
The disclosed technique will be understood and appreciated more fully from the following detailed description taken in conjunction with the drawings in which:
The disclosed technique overcomes the disadvantages of the prior art by providing a medical positioning system (MPS) sensor located at the tip of a removable mandrel of a surgical needle, and an MPS coupled with the MPS sensor and with an electromagnetic field generator. The surgical needle is employed either to withdraw a sample of a bodily fluid of a target organ of the body of a patient, or to inject a therapeutic substance (e.g., anticarcinogen, anticoagulant) into the target organ. The removable mandrel can be moved in and out of the surgical needle, and it blocks the entrance of undesired bodily substances of the body of a patient, into the surgical needle, while the surgical needle is being advanced into the body of the patient, toward the target organ.
The MPS sensor produces an output according to the electromagnetic field which the electromagnetic field generator generates. The MPS determines the coordinates of the tip of the removable mandrel, in a coordinate system respective of the MPS, according to the output of the MPS sensor. The MPS superimposes a representation of the tip of the removable mandrel, on an image of the target organ, according to the coordinates of the tip of the removable mandrel, to enable withdrawal of the sample of the bodily fluid from the organ, after the removable mandrel is moved out of the surgical needle. The term “position” herein below, refers either to the location, to the orientation or both the location and the orientation, of an object in a three-dimensional coordinate system.
Reference is now made to
The MPS sensor is in the form of an electromagnetic coil (i.e., a wound wire), which produces an electrical output in response to an electromagnetic field. The MPS housing is made of a metal, such as stainless steel, and the like. Removable mandrel 108 is made of a metal, such as stainless steel, plastic, ceramic, and the like. Removable mandrel 108 is in the form of a tube having a bore 120. MPS sensor unit 110 is firmly coupled with the tip of removable mandrel 108 by methods known in the art, such as welding, brazing, employing an adhesive, pressure fit (e.g., MPS sensor unit 110 having a conical shape), and the like. The MPS sensor is coupled with ADC 118 by wires 122 and 124, which pass through bore 120.
Image source 114 is in the form of an imager such as computer tomography (CT), magnetic resonance imager (MRI), positron emission tomography (PET), single photon emission computer tomography (SPECT), ultrasound image detector, infrared image detector, X-ray imager (e.g., C-arm), optical coherence tomography (OCT), and the like. Image source 114 provides a real-time video image (not shown) of an organ (not shown) of the body (not shown) of a patient (not shown), which is acquired during medical operation on the patient. Alternatively, image source 114 is in the form of a database, which includes an image of the organ, which is acquired prior to the medical operation on the patient. Further alternatively, image source 114 includes a still image of the organ.
Image source 114 can produce a two-dimensional image of the target organ. Alternatively, image source 114 can produce a three-dimensional image of the target organ. Further alternatively, image source 114 can produce a right view and a left view of the target organ, thereby enabling a user to perceive a stereoscopic sensation of the image, by viewing the image on display 112 (e.g., by employing a stereoscopic pair of glasses).
An outer diameter of removable mandrel 108 is less than an inner diameter of a lumen 126 of surgical needle 106, to enable movement of removable mandrel 108 within lumen 126, in directions designated by arrows 128 and 130. The outer diameter of removable mandrel 108 and of MPS sensor unit 110 is of such value that MPS sensor unit 110 and removable mandrel 108 can be moved in unison, in directions 128 and 130, while MPS sensor unit 110 physically separates a distal portion 132 of lumen 126 from a proximal portion 134 of lumen 126. In this manner, MPS sensor unit 110 seals against an inner wall 136 of lumen 126, and thereby, fluids and solid materials which are located at distal portion 132, can not reach proximal portion 134. Alternatively, a seal (e.g., an O-ring made of an elastomer—not shown) is coupled with a distal end of MPS sensor unit 110, in order to seal the space between MPS sensor unit 110 and inner wall 136 of lumen 126.
The user can employ surgical needle 106 to withdraw a sample of a bodily fluid (e.g., amniotic fluid) from a target organ of the patient (e.g., the uterus cavity of the patient). Alternatively, the user can employ surgical needle 106 to inject a therapeutic substance (e.g., anticarcinogen, anticoagulant), into the target organ. In case surgical needle 106 is employed for collecting a fluid sample, removable mandrel 108 is employed for preventing contamination of the fluid sample. In case surgical needle 106 is employed for injecting a therapeutic substance into the target organ, removable mandrel 108 is employed for flushing out chemical compounds from surgical needle 106.
When the user pierces the skin of the patient with surgical needle 106, in order to reach a selected region of the target organ, which includes the desired bodily fluid, surgical needle 106 passes through various tissues and fluids, which are located in the vicinity of the target organ. In order to perform a reliable assay of the bodily fluid of the target organ, the sample of the bodily fluid should be substantially pure and substantially free of undesired bodily substances (e.g., tissues and fluids) which are located in the vicinity of the target organ.
Before piercing the skin of the patient, the user moves removable mandrel 108 in direction 128 into lumen 126 of surgical needle 106, such that MPS sensor unit 110 is located at distal portion 132. In this manner, MPS sensor unit 110 prevents the undesired substances to reach proximal portion 134 from distal portion 132, and blocks entrance of the undesired substances to proximal portion 134.
The MPS sensor produces an analog electrical output in response to the electromagnetic filed which electromagnetic filed generator 104 generates. ADC 118 converts the analog electrical output to a digital format, and provides this digital output to processor 116. Processor 116 determines the position of the MPS sensor, and thus the tip of removable mandrel 108 in a three-dimensional coordinate system, according to this digital output. Processor 116 produces an indication of the position of the tip of surgical needle 106 according to the position of the MPS sensor, for the user to navigate surgical needle 106 toward the target organ. This indication can be for example, visual, aural, tactile, and the like.
In case of a visual indication, display 112 displays the visual indication. In case the indication is aural, or tactile, the system includes a user interface (not shown), coupled with the processor, to present this indication to the user.
Processor 116 can superimpose a representation (not shown) of the position of the tip of removable mandrel 108, on an image of the target organ which image source 114 provides. Processor 116, then directs display 112 to display a superposition of the representation of the position of the tip of removable mandrel 108 on the image of the target organ. In this manner, the user can view a trajectory of the tip of removable mandrel 108, and distal portion 132, as the user advances surgical needle 106 in the body of the patient, toward the target organ. With the aid of this view, the user can maneuver surgical needle 106 within the body of the patient, in such a manner that the surrounding tissue is minimally severed, and furthermore, the distal portion 132 reaches directly the selected region of the target organ.
The user can employ surgical needle 106 to withdraw a sample of a bodily fluid from the target organ. In this case, when system 100 informs the user that distal portion 132 is located at the selected region of the target organ, the user can pull out removable mandrel 108 from lumen 126 of surgical needle 106, and collect the sample of the bodily fluid in a container (e.g., a vial), by employing a sucking mechanism (e.g., a mechanical pump, an electric pump). It is noted that MPS sensor unit 110 which is located at the tip of removable mandrel 108, blocks entrance of undesired bodily substances to proximal portion 134, thereby preventing contamination of the sample of the bodily fluid of the target organ.
Alternatively, the user can employ the surgical needle to inject a therapeutic substance into the target organ. In this case, when the system informs the user that distal portion of the surgical needle is located at the selected region of the target organ, the user can pull out a removable mandrel which is made of a solid rod, from the lumen of the surgical needle, and then inject the therapeutic substance into the target organ.
It is further noted that surgical needle 106 can be a disposable surgical needle in order to prevent transfer of contagious diseases among different patients. However, removable mandrel 108 together with sensor unit 110 can be used for performing medical operations on different patients. In this case, the probability of transfer of a virus or a bacterium among patients is reduced, for example, by placing a disposable barrier over the removable mandrel (e.g., a polymer sheet such as Latex), by sterilizing the removable mandrel prior to the medical operation, and the like.
Reference is now made to
MPS sensor unit 172 includes an MPS sensor (not shown) and an MPS housing (not shown), similar to the MPS sensor and the MPS housing of sensor unit 110, as described herein above in connection with
Processor 180 is coupled with electromagnetic field generator 166, display 176, image source 178, and with ADC 182. Receiver 164 is coupled with ADC 182. MPS sensor unit 172 is coupled with the tip of removable mandrel 170 in a similar manner of coupling of MPS sensor unit 110 with removable mandrel 108, as described herein above in connection with
Transmitter 168 is physically coupled with removable mandrel 170 and with MPS sensor unit 172, and electrically coupled with the MPS sensor. Transmitter 168 is located at the tip of removable mandrel 170. In this case, removable mandrel 170 is in the form of a solid rod. Alternatively, transmitter 168 is located at a proximal end of the removable mandrel, in which case the transmitter is coupled with the MPS sensor by a pair of wires which pass through a bore of the removable mandrel. Further alternatively, transmitter 168 can be integrated with MPS sensor unit 172. System 160 operates similar to system 100, except that the MPS sensor is coupled with MPS 162 by a wireless link.
Reference is now made to
Alternatively, device 210 can include a transmitter (not shown), similar to transmitter 168 (
Each of an outer diameter of removable mandrel 214, and a wire diameter of MPS sensor 216 is of such value that MPS sensor 216 and outer surface 220 of removable mandrel 214 seal against an inside wall 222 of a lumen 224 of surgical needle 212. In this manner, the tip of removable mandrel 214 blocks entrance of undesired bodily substances from a distal portion 226 of lumen 224 to a proximal portion 228 of lumen 224. Hence, device 210 enables withdrawal of a substantially uncontaminated sample of a bodily fluid from a target organ (not shown) of the body (not shown) of a patient (not shown).
In the example set forth in
Reference is now made to
The MPS housing includes a housing bore there within (i.e., the MPS housing is in the form of a tube). An inner diameter of the housing bore is substantially equal to an outer diameter of removable mandrel 258. An inside wall (not shown) of the housing bore is coupled with an outer surface 260 of removable mandrel 258, by fastening methods known in the art, such as welding, brazing, by employing an adhesive, and the like. Radiopaque marker 256 is in the form of a metallic foil, which is visible in an X-ray image thereof (i.e., radiopaque marker 256 fluoresces under X-ray). Each of a housing outside diameter of the MPS housing, an inside wall diameter of an inside wall 262 of a lumen 264 of surgical needle 252, and a marker outer diameter of radiopaque marker 256 is of such value that MPS sensor unit 254 seals against inside wall 262, while an assembly of removable mandrel 258, MPS sensor unit 254 and radiopaque marker 256 move within lumen 264.
The MPS sensor is coupled with an MPS (not shown). A processor (not shown) superimposes a representation of a position of the tip of removable mandrel 258 on a real-time image (e.g., an X-ray image—not shown) of a target organ (not shown) of the body (not shown) of a patient (not shown). The processor directs a display (not shown) to display this X-ray image, along with a real-time image of radiopaque marker 256.
In the example set forth in
Reference is now made to
A mandrel outer surface 298 of removable mandrel 296 includes an undercut 300. MPS sensor unit 294 is similar to MPS sensor unit 254 (
In the example set forth in
Reference is now made to
In procedure 332, an electromagnetic field is generated by an electromagnetic field generator. With reference to
In procedure 334, an output is produced by the MPS sensor according to the electromagnetic field. With reference to
In procedure 336, the coordinates respective of the position of the tip of the removable mandrel is determined, in a coordinate system respective of the MPS, according to the output of the MPS sensor. With reference to
In procedure 338, an indication of the position of the tip of the removable mandrel is produced, to enable navigation of the surgical needle toward the target organ. With reference to
It will be appreciated by persons skilled in the art that the disclosed technique is not limited to what has been particularly shown and described hereinabove. Rather the scope of the disclosed technique is defined only by the claims, which follow.
| Number | Date | Country | |
|---|---|---|---|
| 60861118 | Nov 2006 | US |
