Patent Grant
8454592
1. Field of the Invention
The present invention relates to a medical device system, and, more particularly to a medical device system having plural medical devices that are likely to come into contact with one another in a body cavity.
2. Description of the Related Art
In recent years, so-called endoscopic surgery that can minimize invasion in a patient compared with surgical operation involving laparotomy, thoracotomy, and the like has been performed. In particular, laparoscopic surgical operation is widely performed. This laparoscopic surgical operation is an operation performed by using a medical device inserted through a small dissected opening of the skin of a patient. In the laparoscopic surgical operation, after CO2 is injected into an abdominal cavity to form a space necessary for the operation as pneumoperitoneum, a medical device having an elongated insertion portion is inserted through a trocar (a mantle tube) pierced into an epigastria region while the region being observed by an endoscope and the operation is performed.
Japanese Patent Application Laid-Open Publication No. 2004-81277 discloses an endoscope added with a function for detecting, when a surgical device used for the endoscopic surgical operation comes into contact with the endoscope, the contact using an arranged sensor and avoiding the contact.
Japanese Patent Application Laid-Open Publication No. 2004-89591 discloses a medical device having an electric manipulator in the endoscopic surgical operation.
Specifically, the sensor for detecting the contact between the surgical device and the endoscope disclosed in Japanese Patent Application Laid-Open Publication 2004-81277 is a gyro sensor and detects the contact as angular velocity.
In the medical device having the electric manipulator disclosed in Japanese Patent Application Laid-Open Publication No. 2004-89591, medical devices located at distal ends of two manipulators are medical devices to which positive voltage is alternately applied. However, a purpose of this voltage application is to burn and stanch a diseased part.
In order to attain the object, a medical device system according to the present invention includes: first and second medical devices, each of which is used in a body cavity and surfaces of which have conductivity; a first electrode electrically connected to the surface of the first medical device; a second electrode electrically connected to the surface of the second medical device; a resistance measuring unit for measuring an inter-device electric resistance value as electric resistance between the first electrode and the second electrode; a threshold storing unit for storing an inter-device resistance threshold as a predetermined lower limit value of the inter-device resistance value; a determining unit for determining, when the inter-device resistance value is lower than the inter-device resistance threshold, that the first medical device and the second medical device have come into contact with each other; and a warning generating unit for generating a warning when the determining unit determines that the first medical device and the second medical device have come into contact with each other.
Embodiments of the present invention are explained below with reference to the drawings.
<Configuration of a Medical Device System>
A medical device system 1 according to a first embodiment of the present invention as shown in
The first medical device 21 and the second medical device 22 project from a distal end portion of the endoscope 10 inserted in vivo and are used for performing an operation on a living tissue VA in body cavity V. The first medical device 21 and the second medical device 22 are active medical devices that are electrically driven with input information from the respective manual-operation input unit 40a and 40b transmitted to the respective driving units 42a and 42b via the control device 30. The manual-operation input units 40a and 40b are input units for converting three-dimensional motion of operation arms of an input device by a surgeon, i.e., physical displacement of the input device into an electric signal.
The respective manual-operation input units are devices adjusted to the respective medical devices. For example, when the medical devices have two joints, the manual-operation input unit also have two joints. Therefore, the surgeon can apply desired operation to the medical devices by operating the manual-operation input unit. When a motion amount of the medical devices is set small with respect to an actual physical displacement amount of the operation arms of the manual-operation input unit, the surgeon can easily realize extremely fine motion of the medical devices.
Next, as shown in
The first medical device 21 and the second medical device 22 respectively have a knife arm 23 and hand arms 24. The first medical device 21 and the second medical device 22 are active medical devices driven by the driving units 42a and 42b according to instructions from the respective input units 40a and 40b via the control unit 31. The control device 30 includes a threshold storing unit 36 for storing a threshold of inter-device resistance inputted from the input unit 41, a determining unit 34 for determining whether the inter-device resistance is smaller than the threshold of the inter-device resistance stored in the threshold storing unit 36, and a warning generating unit 35 for generating a warning on the basis of the determination of the determining unit 34. The warning generated by the a warning generating unit 35 is transmitted to the surgeon by publicly-known warning such as sound, light, or vibration of a warning unit 43. The warning generated by the warning generating unit 35 is transmitted to the control unit 31 as an electric signal. When the control unit 31 receives the warning signal, the control unit 31 controls to perform contact avoiding operation explained later.
The manual-operation input units 40a and 40b are different depending on a type of an electric driving mechanism for medical devices. As a manual-operation input unit for a biaxially operating medical device, a normal joystick can be used. In a medical device that can perform more complicated operation, the manual operation input unit called operation arms for converting three-dimensional motion of hands of a surgeon to front and back, up and down, and left and right into an electric signal is used. In both the manual-operation input units, the motion of the hands of the surgeon is detected by sensors or the like disposed in the manual-operation input unit. Information concerning physical displacement of the manual-operation input unit is converted into an electric signal.
The manual-operation input units 40a and 40b themselves have not-shown driving mechanisms. By using the manual-operation input units 40a and 40b having the driving mechanisms, contrary to converting the motion of the hands of the surgeon into an electric signal, it is possible to generate force in an opposite direction against operation of the operation arms or the like by the motion of the hands of the surgeon to restrict the motion of the hands of the surgeon or change displacement of the operation arms or the like according to motion of the active medical devices unrelated to the surgeon as explained later.
The control device 30 may have an operation storing unit 32. The operation storing unit 32 stores, together with elapsed time, operation of the first medical device 21 and the second medical device 22 by the operation control unit 33 and displacement of the manual-operation input units 40a and 40b.
Next, an example of the first medical device 21 according to the present embodiment is explained with reference to
A knife arm 23 is inserted through the first medical device 21. A distal end of the first medical device 21 is made of an insulating material for electric insulation from the knife arm 23. However, a surface 21A of the first medical device 21 other than the distal end has conductivity.
The second medical device 22 is also a multi-joint manipulator having a configuration similar to that of the first medical device 21. Therefore, the medical device system 1 according to the present embodiment can detect contact between the first electrode of the first medical device and the second electrode of the second medical device by measuring electric resistance between the first electrode of the first medical device and the second electrode of the second medical device.
<Operation of the Medical Device System>
Next, operation of the medical device system 1 according to the present embodiment is explained with reference to
The flow of the operation of the medical device system 1 according to the present embodiment is explained below according to the flowchart shown in
When the endoscope 10 is inserted into a body cavity V and reaches a target region, the first medical device 21 and the second medical device 22 are projected from the forceps holes 12 to start treatment. In other words, the first medical device 21 and the second medical device 22 are projected from the distal end portion of the endoscope 10 and used. The first medical device 21 and the second medical device 22 may be projected when the endoscope 10 is inserted.
<Step S11>
The threshold storing unit 36 stores an inter-device resistance threshold Rc inputted by the surgeon using the input unit. The inter-device resistance threshold Rc is a predetermined lower limit value as a reference for the determining unit 34 to determine, when inter-device resistance R is smaller than the inter-device resistance threshold Rc, that the first medical device 21 and the second medical device 22 are in contact with each other.
As the inter-device resistance threshold Rc, a value stored by an another storing unit in advance, a value inputted from the surgeon using the input unit 41, or the like is used. For example, the inter-device resistance threshold Rc is desirably 0.1 to 1000 ohms and, particularly desirably 5 to 10 ohms. When the inter-device resistance threshold Rc is smaller than the range, in some cases, it is determined by the determining unit that the first medical device 21 and the second medical device 22 are in non-contact with each other although the medical devices are actually in contact with each other. When the inter-device resistance threshold Rc exceeds the range, in some cases, it is determined that the first medical device 21 and the second medical device 22 are in contact with each other although the medical devices are actually in non-contact with each other.
It is also possible to calculate the inter-device resistance threshold Rc from an inter-device resistance value R1 at the start of operation of the medical device system 1. Specifically, the inter-device resistance value R1 at the start of the operation of the medical device system 1 is a resistance value R1 at the time when the first medical device 21 and the second medical device 22 are in non-contact with each other not only directly but also indirectly via the living tissue VA. It is advisable to set a resistance value of, for example, one tenth of this resistance value R1 as the inter-device resistance threshold Rc.
Depending on a living tissue, since a resistance value thereof is relatively small, when the first medical device 21 and the second medical device 22 indirectly come into contact with each other via the living tissue VA, in some cases, inter-device resistance Rr indicates a low value and the determining unit 34 malfunctions. In this case, the inter-device resistance threshold Rc is set lower than usual. Alternatively, an inter-device resistance value R2 at the time when the first medical device 21 and the second medical device 22 are indirectly in contact with each other via the living tissue VA, which is actually being treated, may be measured by the resistance measuring unit 37 and the inter-device resistance threshold Rc may be calculated from R2.
<Step S12>
Measurement of inter-device resistance value by the resistance detecting unit 37 is started.
It is advisable to set electric current and voltage used for measurement of an inter-device resistance value by the resistance detecting unit 37 to feeble electric current and voltage that do not damage the living tissue VA, for example, 0.1 to 10 V and 0.1 to 500 mA. When the electric current and the voltage are smaller than the ranges, in some cases, accurate resistance measurement is difficult because of noise or the like. When the electric current and the voltage are equal to or larger than the ranges, in some cases, the living tissue VA is damaged.
For the measurement of an inter-device resistance value by the resistance detecting unit 37, it is unnecessary to continuously apply the electric current and the voltage. The electric current and the voltage may be intermittently applied to measure resistance. The measurement of an inter-device resistance value may be performed by any one of driving systems, i.e., constant current driving and constant voltage driving. The measurement of an inter-device resistance value may be performed by an alternating current rather than a direct current.
An inter-device electric resistance value at a stage when the measurement of an inter-device resistance value is started is explained with reference to
R1, R2, and R3 are resistances of a conductive material and are extremely low compared with the resistance R4 of the living tissue VA. In other words, since R4>>R1, R2, and R3, the inter-device resistance value (R1+R2+R4) is substantially (R4).
It is evident that an inter-device resistance value in a state in which the first medical device 21 and the second medical device 22 are not in contact with the living tissue VA is extremely large resistance due to a leak current or the like.
<Step S13>
Physical displacement occurs in the operation arm of the manual-operation input unit 40a because of the operation by the surgeon.
<Step S14>
According to the physical displacement of the manual-operation input unit 40a converted into an electric signal, the operation control unit 33 drives the driving unit 42a and, as shown in
<Step S15>
Next, an inter-device resistance value in the case in which the first medical device 21 and the second medical device 22 come into contact with each other as shown in
When the first medical device 21 comes into contact with the second medical device 22 as shown in
When the inter-device resistance value is higher than the inter-device resistance threshold Rc (NO), the control device 30 returns to step S12 and continues normal control.
<Step S16>
When the inter-device resistance value decreases to be lower than the inter-device resistance threshold Rc, the determining unit 34 determines that the first medical device 21 and the second medical device 22 come into contact with each other and sends a signal to the warning generating unit 35.
<Step S17>
The warning generating unit 35 generates warning according to the determination by the determining unit 34 that the first medical device 21 and the second medical device 22 come into contact with each other. The warning is transmitted to the surgeon by a publicly-known warning method.
<Step S18>
The warning generated by the warning generating unit 35 is transmitted to the control unit 31 as an electric signal. When the control unit 31 receives the warning signal, the control unit 31 controls to perform contact avoiding operation processing explained later.
<Step S19>
When the inter-device resistance value increases to be higher than the inter-device resistance threshold Rc according to contact avoiding operation, i.e., when the contact is released, the control device 30 returns to (I) and continues the normal control until a treatment end instruction is received (YES).
Next, contact avoiding operation is explained with reference to
<Step S19>
The control unit 31 checks whether treatment of any one of contact avoiding operations (a), (b), and (c) selected by the surgeon in advance is performed or the avoiding operation control is not performed when warning is generated by the warning generating unit 35, i.e., when a warning signal is received from the warning generating unit 35.
<Step S20>
The control unit 31 of the medical device system 1 according to the present embodiment can avoid further contact by performing control for stopping the operation of the driving units 42a and 42b when warning is generated by the warning generating unit 35.
Specifically, the control unit 31 cancels all inputs of operations signals by the operation arm of the manual-operation input unit 40a and stops moving operation of the first medical device 21 as shown in
<Step S21>
Since the operation of the first medical device is stopped, damage to the medical device and the like due to further contact are prevented. To continue the treatment again, it is necessary to perform moving operation for safely separating the first medical device 21 from the second medical device 22.
In the medical device system 1 according to the present embodiment, the operation storing unit 32 has stored therein operation information of the driving unit, i.e., operation information of the medical devices. Therefore, the control unit 31 can control, on the basis of the operation information stored by the operation storing unit 32, the driving unit 31 to prohibit further movement in a moving direction in which the first medical device 21 moves before the control unit 31 receives warning, i.e., before contact occurs. Prohibiting the movement means that, even if a moving instruction from the input unit or the like by the surgeon is received, the instruction is cancelled and is not executed.
Therefore, the surgeon can safely separate the first medical device 21 from the second medical device 22 by moving the first medical device 21 in a movable direction different from the moving direction of the first medical device before the contact as shown in
Specifically, for example, when a moving direction of the medical device 21 immediately before the contact is a certain direction vector (+X, −Y, +Z) in a three-dimensional space, the control unit 31 can avoid further contact between the medical devices by prohibiting movement in the (+X, −Y, +Z) direction and allowing the first medical device 21 to move only in an opposite vector direction.
<Step S22>
In the medical device system 1 according to the present embodiment, the operation storing unit 32 has stored therein the operation information of the driving unit, i.e., the operation information of the medical devices. Therefore, as shown in
The surgeon selects a degree of returning the state of the first medical device 21 to the state before the contact occurrence. As a unit for returning the state of the first medical device 21 to the state before the contact occurrence, for example, an operation step unit of the driving unit, a time unit, or the like can be selected. However, for example, it is advisable to return the state of the first medical device 21 to a state two seconds before the contact occurrence.
<Steps S23 and S24>
In the medical device system 1 according to the present embodiment, the operation storing unit 32 has stored therein the operation of the first medical device. Therefore, the control unit 31 can control the driving unit to return the state of the driving unit 42a, i.e., the state of the first medical device 21 to the state before the warning occurrence by the warning generating unit 35, i.e., the state before the contact.
Further, the operation arm of the manual-operation input unit 40a can be returned to a position before the contact in the same manner as the return operation of the first medical device 21. Specifically, the control unit 31 performs control for returning a state of physical displacement of the manual-operation input unit having the driving mechanism to a state before the contact.
The surgeon can resume the operation after checking a returned state of the first medical device 21 according to a state change of the operation arm of the manual-operation input unit 40a. Step S23 and step S24 are simultaneously performed in parallel.
The contact avoiding operation and the returning operation are performed according to selection by the surgeon. The surgeon may select the operations in advance, may select the operation according to a state after contact occurrence, or may select another operation during or after the contact avoiding operation.
In the above explanation, the first medical device 21 moves. However, the same holds true in the case of contact occurrence due to movement of the second medical device 22 and when contact occurs while both the first medical device 21 and the second medical device 22 simultaneously move.
<Combination Examples of the Medical Devices>
Combinations of the medical devices as modifications of the first embodiment are explained with reference to
As explained above, various modifications of the medical devices according to the present embodiment are possible. It is also possible to combine the first medical device 21 and the second medical device 22 with other single or plural medical devices, contact among which does not need to be detected, or detect contact among three or more medical devices. When the contact among the three or more medical devices is detected, surfaces of all the medical devices as contact detection targets are made conductive and inter-device resistance among the medical devices is measured.
<Contact Detection According to a Resistance Ratio Through Use of a Human Body Electrode>
A contact detecting method by the medical device system 1 according to a second embodiment of the present invention is explained with reference to
As shown in
A resistance value at a stage when measurement of the inter-device resistance value and the electrode-to-human body resistance value is started is explained with reference to
The inter-device resistance value between the first electrode 21E and the second electrode 22E is a sum (R1+R2+R4) of the resistance R1 of the first medical device 21 itself, the resistance R2 of the second medical device 22 itself, and the resistance R4 of the living tissue VA. The resistance R4 of the living tissue VA is a value that changes according to, for example, a positional relation between the first medical device 21 and the second medical device 22. R3 and R6 are up resistance from the ground.
An electrode-to-human body resistance value as electric resistance between the second electrode and the human body electrode is a sum (R2+R5) of R5 as electric resistance of the human body and the resistance R2 of the second medical device 22 itself. Therefore, an electric resistance value ratio as a ratio of the inter-device electric resistance value and the electrode-to-human body resistance value is (R1+R2+R4)/(R2+R5). Since R5 as the electric resistance of the human body is higher than the resistance R4 of the living tissue VA, R5>>R4>>R1, R2, R3, and R6.
In a state in which the first medical device 21 and the second medical device 22 are not in contact with the living tissue VA, it is evident that the inter-device electric resistance value is an extremely large value and, as a result, the electric resistance value ratio is also an extremely large value.
Next, an inter-device resistance value in the case in which the first medical device 21 comes into contact with the second medical device 22 is explained with reference to
As shown in
In the medical device system 1 according to the present embodiment, it is possible to determine presence or absence of contact on the basis of a ratio of electric resistances rather than level of electric resistances. Therefore, highly accurate contact detection is possible.
In the present embodiment, the electric resistance between the second electrode and the human body electrode is set as the electrode-to-human body resistance value. However, the same holds true when the electric resistance between the first electrode and the human body electrode is set as the electrode-to-human body resistance value.
<Contact Detection According to Electric Current or Voltage>
According to the first embodiment and the second embodiment, contact between the first medical device 21 and the second medical device 22 is determined according to electric resistance. On the other hand, it is also possible to determine contact between the first medical device 21 and the second medical device 22 according to electric current or voltage.
For example, in
Electric current, voltage, and resistance may be used for contact detection in combination.
<Division of a Conductive Area on the Surface of the Medical Device>
Next, as a modification of the medical device 21 or 22 according to the present embodiment, the medical device 21 or 22 with an area having conductivity of the surface thereof divided is explained with reference to
A conductive area 51A on the surface of the first medical device 21 shown in
It goes without saying that, by dividing a conductive area on the surface of the not-shown second medical device 22 in the same manner, a contact place of the second medical device 22 is also known. The surgeon can more safely take contact avoiding measures.
The conductive area 51A on the surface of the first medical device 21 shown in
When the medical device 21 or 22 has multi-link structure, an electrode may be formed for each of links. The medical device 21 or 22 having a large number of divided conductive surface areas can obtain more detailed information concerning a contact place.
<Associated Operation with an Electric Knife>
Next,
An electric knife device is used for performing treatment such as dissection, coagulation, and hemostasis for a living tissue. The electric knife device includes the electric knife control unit 44b, the not-shown high-frequency power supply connected to the electric knife control unit 44b, and the electric knife 44a. The electric knife device supplies high-frequency power from the high-frequency power supply to the electric knife 44a, which is brought into contact with the living tissue, and cauterizes the living tissue with energy of the high-frequency power.
When contact occurs between the medical devices 21 and 22 during treatment by the electric knife 44a, a high-frequency current flows through an unexpected path. Therefore, in the medical device system 1 according to the present embodiment, when contact occurs between the medical devices during use of the electric knife 44a provided in the medical device 21 or 22, the control unit 31 performs control for controlling the electric knife control unit 44b to stop or reduce output of the electric knife 44a.
As shown in
Since a stray current due to a high-frequency current flows in the body cavity V of the patient during use of the electric knife 44a, it is difficult to measure inter-device electric resistance and the like. Therefore, high-frequency current application to the electric knife 44a and inter-device electric resistance measurement are performed to be timed to coincide with each other. Specifically, ON/OFF of the high-frequency current of the electric knife 44a is periodically repeated and inter-device current resistance is measured only while the high-frequency current of the electric knife 44a is OFF. Although an ON/OFF period of the high-frequency current is not specifically limited, about 1 to 1000 ms is desirable. Control is difficult when the ON/OFF period is smaller than the range. When the ON/OFF period exceeds the range, detection of contact between the medical devices is delayed.
In the medical device system 1 according to the present embodiment, when contact between the medical devices occurs, the output of the electric knife 44a stops or falls. Therefore, it is possible to more safely perform treatment.
The present invention is not limited to the embodiments above. Various modifications, alterations, and the like are possible in a range in which the gist of the present invention is not changed.
| Number | Date | Country | Kind |
|---|---|---|---|
| 2007-237046 | Sep 2007 | JP | national |
This application is a continuation application of PCT/JP2008/056948 filed on Apr. 8, 2008 and claims benefit of Japanese Application No. 2007-237046 filed in Japan on Sep. 12, 2007, the entire contents of which are incorporated herein by this reference.
| Number | Name | Date | Kind |
|---|---|---|---|
| 6402737 | Tajima et al. | Jun 2002 | B1 |
| 7171286 | Wang et al. | Jan 2007 | B2 |
| 20030216715 | Moll et al. | Nov 2003 | A1 |
| 20040059322 | Kawai et al. | Mar 2004 | A1 |
| 20050267335 | Okada et al. | Dec 2005 | A1 |
| 20070013336 | Nowlin et al. | Jan 2007 | A1 |
| 20090163907 | Jarrard et al. | Jun 2009 | A1 |
| 20090192524 | Itkowitz et al. | Jul 2009 | A1 |
| 20090209809 | Schaller et al. | Aug 2009 | A1 |
| 20100168517 | Shim et al. | Jul 2010 | A1 |
| Number | Date | Country |
|---|---|---|
| 1 607 037 | Dec 2005 | EP |
| 08-275958 | Oct 1996 | JP |
| 2002-336269 | Nov 2002 | JP |
| 2004-081277 | Mar 2004 | JP |
| 2004-89591 | Mar 2004 | JP |
| 2005-334237 | Dec 2005 | JP |
| 2007-029232 | Feb 2007 | JP |
| Entry |
|---|
| International Search Report dated May 13, 2008, in PCT/JP2008/056948. |
| Number | Date | Country | |
|---|---|---|---|
| 20100168744 A1 | Jul 2010 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/JP2008/056948 | Apr 2008 | US |
| Child | 12722149 | US |
