Japan Patent Office publishes the Examination Handbook for Patent and Utility Model.
The parts about case examples of industrial applicability of the invention (main paragraph of Article 29(1)) are as follows.
Case examples of Examination Guidelines for Patent and Utility Model
3. Cases pertinent to Eligibility for Patent and Industrial Applicability
(Main Paragraph of Article 29(1) of the Patent Act)
3.1 Eligibility for Patent
...(omitted)
3.2 Industrial Applicability
[Case 11] Invention considered to be surgery and therapy (not considered to be methods ofsurgery, therapy or diagnosis of humans)
Title of Invention
Connecting method of gastrostoma tube and nutrient container
What is claimed is:
[Claim 1]
A method for connecting a gastrostoma tube and a nutrient container, the gastrostoma tube being placed to penetrate an abdomen wall and a stomach wall and provided with a connector at the end thereof to be outside of a body, the nutrient container provided with a connector attachable and detachable with respect to the gastroma tube and containing a nutrient therein, wherein the connectors are aligned at the longitudinal axis, and then the connector of the nutrient container is inserted and revolved into the connector of the gastrostoma tube so that the gastrostoma tube and nutrient container engage with each other.
Overview of the description
The present invention relates to a connecting method for a gastrostoma tube and a nutrient container.
In the present invention, the connectors are provided in both of the gastrostoma tube and nutrient container. The both of connectors are aligned at the longtuidnal axes, and the connector of the nutrient container is inserted and revolved into the connector of the gastrostoma tube, thereby both can be steadily engaged.
Therefore, the gastrostoma tube and nutrient container are easily and effectively connected at nursing homes and homes. Also, since the gastrostoma tube and nutrient container can be steadily connected, the nutrient is prevented to be leaked from the connected part of the tubes when opening a clamp and injecting the nutrient into stomach via the gastrostoma tube.
Moreover, the method does not include the process of injecting the nutrient into humans and the process of operating surgery for humans. Thus, the method does not fall under methods of surgery of humans.
Therefore, the method is not considered to be “methods of surgery, therapy or diagnosis of humans".
[Case 12] Invention considered to be surgery (considered to be methods of surgery, therapy or diagnosis of humans)
Title of Invention
Image processing method for identifying direction and position of object
What is claimed is:
[Claim 1]
An image processing method comprising: irradiating X-ray onto a subject to detect an X-ray image; extracting a marker attached to an object from the detected X-ray image; and identifying a direction and position of the object using the extracted marker.
Overview of the description
X-ray image photographed by the X-ray imaging device is subject to threshold processing to extract a marker attached to the object, and based on the direction and position of the extracted marker, the direction and position of the object can be identified in real-time. Thus, the surgical implements such as catheter, guide wire and balloon, and biopsy needle can be guided toward target position, and the position can be confirmed in the stent buried into the patient body.
(Example 1)
An image processing method comprising: irradiating X-ray onto a subject to detect an X-ray image; extracting a marker attached to a stent buried into a body from the detected X-ray image; and identifying a direction and position of the stent using the extracted marker.
(Example 2)
An operating method of an image processing device comprising: receiving an X-ray image from an X-ray imaging device; extracting a marker attached to an object from the received X-ray image; identifying a direction and position of the object using the extracted marker; and displaying the identified direction and position of the object.
(Supplementary Explanation)
The invention of example 1 is for confirming the position of a stent buried into a patient body. Thus, the surgery is not performed such as introducing therapy instruments into patient while performing the invention of example 1. Therefore, the method does not considered to be “methods of surgery, therapy or diagnosis of humans".
[Case 13-1] Invention considered to be surgery (considered to be methods of surgery, therapy or diagnosis of humans)
Title of Invention
A method for the observation of the celom by using an endoscope
What is claimed is:
[Claim 1]
A method for capturing images of the inside of the celom with an endoscope, by way of changing the direction of the view by the operator using the rotation indicator, and rotating the imaging unit whose light axis tilted to the insertional axis of the endoscope.
Overview of the description
This invention relates to an endoscope for optical observation by insertion into the human body. It is especially beneficial to alter the direction of the view of rigid scopes such as laparoscopes that do not have a curve.
The endoscope of this invention has an external cylinder made of stainless pipe for the entire length of the insertion section, and is equipped with a imaging unit with a lens and a solid image sensor. The light axis of the imaging unit is tilted to the axis of the external cylinder and can rotate on the same axis as the external cylinder.
The imaging unit is rotated by a stepping motor. When an operator sends a signal indicating the rotation angle to the stepping motor by using the rotation indicator, the stepping motor rotates according to the signal and the operator can gain the desired visual field.
Since the claimed method does not involve the step with medical doctor’s judgment on the physical condition of a human body such as disease or physical health, the method is not considered to be “methods of diagnosis of humans.”
However, the claimed method includes the step to operate the endoscope inside the human body, by rotating the imaging unit and changing the direction of the view, and it is described in the detailed explanation of the invention that the endoscope is inserted into the human body. Furthermore, the imaging with an endoscope is normally carried out with the endoscope placed inside the human body. Since the claimed method includes a method of surgery of humans as a part of the invention, the method is considered to be “methods of surgery, therapy or diagnosis of humans.”
(Supplementary Explanation)
It should be noted that, if the claim is described as in Example 13-2, the claimed invention is not considered to be “methods of surgery, therapy or diagnosis of humans.”
[Case 13-2] Invention considered to be surgery (not considered to be methods of surgery, therapy or diagnosis of humans)
Title of Invention
A method for controlling the operation of an endoscope
What is claimed is:
[Claim 1]
A method for controlling the operation of an endoscope, wherein means of rotating the imaging unit whose light axis is tilted to the insertional axis of the endoscope is operated by receiving an instruction signal to rotate.
Overview of the description
This invention relates to an endoscope for optical observation by insertion into the human body. It is especially beneficial to alter the direction of the view of rigid scopes such as laparoscopes that do not have a curve.
The endoscope of this invention has an external cylinder made of stainless pipe for the entire length of the insertion section, and is equipped with a imaging unit with a lens and a solid image sensor. The light axis of the imaging unit is tilted to the axis of the external cylinder and can rotate on the same axis as the external cylinder.
The imaging unit is rotated by a stepping motor. When an operator sends a signal indicating the rotation angle to the stepping motor by using the rotation indicator, the stepping motor rotates according to the signal and the operator can gain the desired visual field.
Therefore, the claimed method is considered to be a method for controlling the operation of a medical device since the function of the medical device is represented as a method, and is not considered to be “methods of surgery, therapy or diagnosis of humans.”
(Supplementary Explanation)
The statement of the claim of this example reads “A method for controlling the operation of an endoscope, wherein…” at the front, compared to that of Example 13-1.
Additionally, the subject of the step of “is operated” is “means of rotating the imaging unit whose light axis is tilted to the insertional axis of the endoscope.”
[Case 14-1] Invention considered to be surgery (considered to be methods of surgery, therapy or diagnosis of humans)
Title of Invention
A method for contrast magnetic resonance imaging
What is claimed is:
[Claim 1]
A method for contrast magnetic resonance imaging, wherein an examinee injected with contrast media is imaged with low-resolution real-time mode and then the mode is shifted to the actual high-resolution imaging when the signal strength within the desired domain exceeds the threshold value drastically.
Overview of the description
The present invention relates to a method for magnetic resonance imaging in accordance with the movement of contrast media.
The total dose of contrast media is determined by the patient’s weight, and the change in the infusion rate is determined depending on the part of the body to be imaged and the imaging method. The determined dose of contrast agent and the change in the infusion rate are then read into the power injector, and contrast media is injected into the examinee’s artery or venous during the imaging procedure. In order to obtain the image when the contrast agent reaches the desired domain, a real time image is acquired at low-
resolution mode which enables a high time-resolution monitoring after the start of the contrast media injection. During the real time imaging procedure, the contrast magnetic resonance imaging device will continuously monitor the signal strength within the desired domain, and when the value exceeds the predetermined threshold value, the contrast magnetic resonance imaging device will detect that the contrast media has reached the desired domain and the mode is shifted to the actual imaging procedure of high-resolution setting.
The method in this example is not considered to be “methods of diagnosis of humans,” since it does not include the steps of medical doctors judging the condition of human diseases or the physical condition of a human body for medical purposes.
In addition because the claim reads “an examinee injected with contrast media” the claimed invention is not defined by the procedure of contrast media injection. However, as the detailed explanation of the invention reads “injected into the examinee’s artery or venous during the imaging procedure,” a surgical treatment of injecting contrast media into blood vessels is practiced during the imaging procedure of the claimed method.
Therefore, although “an examinee injected with contrast media” is stated in the claim as if the contrast media was injected before the imaging, the claimed method is considered to be “methods of surgery, therapy or diagnosis of humans” since a surgical treatment is practiced in working of the claimed method and it includes a method of surgery of humans as a part of the step of the invention.
(Supplementary Explanation)
It should be noted that, if the claim is described as in Example 14-2, the claimed invention is not considered to be “methods of surgery, therapy or diagnosis of humans.”
[Case 14-2] Invention considered to be surgery (not considered to be methods of surgery, therapy or diagnosis of humans)
Title of Invention
A method for controlling a magnetic resonance imaging device
What is claimed is:
[Claim 1]
A method for controlling the operation of a magnetic resonance imaging device, wherein means of shifting to high resolution imaging is operated by the device when the signal strength within the desired domain drastically changes from the threshold value.
Overview of the description
The present invention relates to a method for magnetic resonance imaging in accordance with the movement of contrast media.
The total dose of contrast media is determined by the patient’s weight, and the change in the infusion rate is determined depending on the part of the body to be imaged and the imaging method. The determined dose of contrast agent and the change in the infusion rate are then read into the power injector, and contrast media is injected into the examinee’s artery or venous during the imaging procedure. In order to obtain the image when the contrast agent reaches the desired domain, a real time image is acquired at low-
resolution mode which enables a high time-resolution monitoring after the start of the contrast media injection. During the real time imaging procedure, the contrast magnetic resonance imaging device will continuously monitor the signal strength within the desired domain, and when the value exceeds the predetermined threshold value, the contrast magnetic resonance imaging device will detect that the contrast media has reached the desired domain and the mode is shifted to the actual imaging procedure of high-resolution setting.
Therefore, the claimed method is considered to be a method for controlling the operation of a medical device and is not considered to be “methods of surgery, therapy or diagnosis of humans.”
(Supplementary Explanation)
The statement of the claim of this example reads “A method for controlling the operation of a magnetic resonance imaging device, wherein…” at the front, compared to that of Example 14-1. Additionally, the subject of the step of “is operated” is “magnetic resonance imaging device.”
[Case 15-1] Invention considered to be surgery (considered to be methods of surgery, therapy or diagnosis of humans)
Title of Invention
A method for treating an affected part by micro operation robot
What is claimed is:
[Claim 1]
A method for treating an affected part by using a micro operation robot having at its head optical observing means and incising means and having at its bottom receiving means for receiving manipulator signals from an extracorporeal remote operation device, comprising the steps of;
operating a manipulator in order to give medical treatment to the affected part while viewing the monitor of the remote operation device, receiving a manipulator signal from the remote operation device by the receiving means, and incising the affected part of a patient by an incising means based on the signal received.
Overview of the description
The capsule type micro operation robot of the present invention can, owing to very delicate constitution thereof, perform treatment such as incision, excision, or the like of the affected part by remote control in an organ such as a blood vessel or the like, without excessively burdening the patient.
Accordingly, the claimed method is not considered to be a method for controlling the operation of the medical device.
As a result, the method in this example is nothing but a method of surgery of humans since it corresponds to a method for operating a manipulator and incising the affected part for the treatment of the affected part. Accordingly, the claimed method includes a method of surgery of humans as part of the steps of the invention; thus, the method is considered to be “methods of surgery, therapy or diagnosis of humans”
(Supplementary Explanation)
It should be noted that, if the claim is described as in Example 15-2, the claimed invention is not considered to be “methods of surgery, therapy or diagnosis of humans.”
[Case 15-2] Invention considered to be surgery (not considered to be methods of surgery, therapy or diagnosis of humans)
Title of Invention
A method for controlling the operation of a micro operation robot system
What is claimed is:
[Claim 1]
A method for controlling the operation of a micro operation robot system provided with a micro operation robot and a remote operation device for remote-operating the robot with a manipulator, wherein the robot has at its head an optical observing means and an incising means and at its bottom a receiving means for receiving manipulator signals from the remote operation device, comprising the steps of;
transmitting the signal of the manipulator by the transmitting device to the remote operation device, receiving the manipulator signal from the remote operation device by the receiving means of the robot, and controlling the operation of the incising means of the robot with the manipulator signal received.
Overview of the description
The capsule type micro operation robot of the present invention can, owing to very delicate constitution thereof, perform treatment of the affected part by remote control in an organ such as a blood vessel or the like, without excessively burdening the patient.
Since the matter reading “controlling the operation of the incising means of the robot with the signal received” means that “the incising means” provided with the micro operation robot system is controlled with the manipulator signal received and does not mean so farther that the incising means incise the human body as a result of the operation; thus, the claimed method is judged not to include the step with an influence on the human body by the device.
Therefore, the claimed method is considered to be a method for controlling the operation of a medical device since the function of the medical device is represented as a method, and the method does not include the step with an action of a medical doctor or the step with an influence on the human body by the device. As a result, it is not considered to be “methods of surgery, therapy or diagnosis of humans.”
(Supplementary Explanation)
(1) A micro operation robot system is generally designed to be operated based on a manipulator signal operated by a medical doctor and is assumed to be operated by an action of a medical doctor. However, in case the function of the micro operation robot system is described as a method in a claim, it is considered to be a method for controlling the operation of the micro operation system as long as it does not include the step with an action of a medical doctor and/or the step with an influence on the human body by the device.
(2) Even if the function of the medical device is described as a method in a claim, it should be noted that the claim may not meet the requirement of description or embodiment if the device is not disclosed in the description, as in the case where only a method carried out by the step with an action of a medical doctor is disclosed.
[Case 16-1] Invention considered to be surgery (considered to be methods of surgery, therapy or diagnosis of humans)
Title of Invention
A method for sampling body fluid
What is claimed is:
[Claim 1]
A method for sampling body fluid by a body fluid sampling device provided with a hollow piercing element installed inside housing, a sample extracting tube communicating with the piercing element, and an absorbing means, wherein the piercing element pierces the vein, and the body fluid is absorbed by the piercing element arranged in the vein blood vessel into the sample extracting tube.
Overview of the description
The present invention relates to a method for sampling body fluid such as blood or the like from the human body for analysis or processing. The housing of the body fluid sampling device is placed on the human body and a piercing element is pierced into the surface of the skin. When the device is operated, an absorbing power is applied to the piercing element to absorb the body fluid into the tube.
The step of “the body fluid is absorbed from the piercing element arranged in the vein blood vessel into the sample extracting tube” is judged to include the step with an influence on the human body by the device, as a signal is not received from the human body but body fluid is extracted from the human body.
The claimed method, therefore, is not a method for controlling the operation of the medical device because it includes the step with an action of a medical doctor and the step with an influence on the human body by a device.
The claimed method includes the step of surgical operation of piercing human body with the piercing element. Accordingly, the claimed method includes methods of surgery of humans; thus, the method is considered to be “methods of surgery, therapy or diagnosis of humans.”
(Supplementary Explanation)
It should be noted that, if the claim is described as in Example 16-2, the claimed invention is not considered to be “methods of surgery, therapy or diagnosis of humans.”
[Case 16-2] Invention considered to be surgery (not considered to be methods of surgery, therapy or diagnosis of humans)
Title of Invention
A method for controlling the operation of a body fluid sampling device
What is claimed is:
[Claim 1]
A method for controlling the operation of a body fluid sampling device provided with a hollow piercing element installed inside a housing, a sample extracting tube communicating with the piercing element, a sampling vessel connected with the end of the tube and having a pressure detecting unit inside, and a negative pressure generating unit giving a negative pressure on the sampling vessel, wherein a suppressing means controlling the operation of the negative pressure generating means is operated when the pressure detecting means detects a pressure lower than the predetermined value in the operation of the negative pressure generating unit.
Overview of the description
The present invention relates to a method for sampling body fluid such as blood or the like from a human body for analysis or processing. The housing of the body fluid sampling device is placed on a human body and a piercing element is used to pierce the surface of the skin. When the device is operated, an absorbing power is applied to the piercing element to absorb the body fluid into the tube for sampling. In this invention, as the pressure detecting means and the suppressing means are provided in the sampling vessel, it becomes possible to avoid endangering a human body by preventing the application of a higher absorbing pressure than required.
The matter reading “a suppressing means controlling the operation of the negative pressure generating means is operated when the pressure detecting means detects a pressure lower than the predetermined value in the operation of the negative pressure generating unit” means that the “suppressing means” provided with the body fluid sampling device is operated and does not mean so farther that the volume of the body fluid absorbed is changed as a result of the operation of the suppressing means, and the claimed method is judged not to include the step with an influence on the human body by the device.
Therefore, the claimed method is considered to be a method for controlling the operation of a medical device since the function of the medical device is represented as a method, and the method does not include the step with an action of a medical doctor or the step with an influence on the human body by the device. As a result, the method is not considered to be “methods of surgery, therapy or diagnosis of humans.”
[Case 17-1] Invention considered to be surgery (considered to be methods of surgery, therapy or diagnosis of humans)
Title of Invention
A method for displaying superimposed images of an object being cut and a cutting device
What is claimed is:
[Claim 1]
A method for displaying superimposed images of the three-dimensional data of an object being cut and the three-dimensional data of a cutting device, comprising
a step of : obtaining the three-dimensional data of an object to be cut and a cutting device with markers attached;
a step of detecting the position of the markers on the object to be cut and the cutting device; and
a step of making a connection between the three-dimensional data of the object being cut and the three-dimensional data of the cutting device by calculating the relative positional data of the object being cut and the cutting device.
Overview of the description
The present invention relates to a method for displaying superimposed images of an object being cut and a cutting device.
During a surgical operation for cutting a bone or treating a decayed tooth, the images of the bone or the tooth and the cutting device can be displayed as superimposed images on a screen placed adjacent to a surgeon, thereby providing the surgeon with information regarding the progress of the surgical procedure. By observing the images on the screen, the surgeon can check accurately of the situation of cutting, even sections that are difficult to visually recognize, and hence can carry out the surgery appropriately.
Therefore, the claimed method includes a method of surgery or therapy of humans as a part of the steps of the invention. Thus the method is considered to be "methods of surgery, therapy or diagnosis of humans."
(Supplementary Explanation)
It should be noted that, if the claim is described as in Example 17-2, the claimed invention is not considered to be "methods of surgery, therapy or diagnosis of humans."
[Case 17-2] Invention considered to be surgery (not considered to be methods of surgery, therapy or diagnosis of humans)
Title of Invention
A method for controlling a device for displaying superimposed images of an object being cut and a cutting device
What is claimed is:
[Claim 1]
A method for controlling an operation of a device for displaying superimposed images of the three-dimensional data of an object being cut and the three-dimensional data of a cutting device, comprising;
a step for obtaining the three-dimensional data of an object to be cut and a cutting device with markers attached by a means to obtain the image data,
a step for detecting the position of the markers on the object to be cut and the cutting device by a means to detect a position of the markers, and
a step for making a connection between the three-dimensional data of the object being cut and the three-dimensional data of the cutting device with calculating the relative positioning data of the object being cut and the cutting device by a means to make a connection.
Overview of the description
The present invention relates to a method for displaying superimposed images of an object being cut and a cutting device.
During a surgical operation for cutting a bone or treating a caries tooth, the images of the bone or the tooth can be displayed as superimposed images on a screen adjacent to a surgeon, thereby providing the surgeon with information regarding the progress of the surgical procedure. By observing the images on the screen, the surgeon can check accurately of the situation of cutting, even sections that are difficult to visually recognize, and hence can carry out the surgery appropriately.
Therefore, the claimed method is considered to be a method for controlling the operation of a medical device and is not considered to be “methods of surgery, therapy or diagnosis of humans.”
(Supplementary Explanation)
The statement of the claim of this example reads “A method for controlling an operation of a device for…” at the beginning, compared to that of Example 17-1.
Additionally, the subjects of the steps are “a means to obtain the image data”, “a means to detect the position of the markers” and “a means to make a connection.”
[Case 18-1] Invention considered to be therapy (considered to be methods of surgery, therapy or diagnosis of humans)
Title of Invention
A method for X-ray irradiation
What is claimed is:
[Claim 1]
A method for irradiating X-rays onto the human body by changing the tube voltage and the tube current of the X-ray generator each time the generator rotates one lap inside the gantry.
Overview of the description
The present invention relates to a method for treatment of the human body by X-ray therapy with confirming the X-ray therapy process by monitoring the X-ray image of the affected area.
The device used in the current invention places the X-ray generator and the X-ray detector in opposite positions inside the gantry, and rotates one lap around the circumference of the gantry maintaining the opposite positions. The X-ray generator which is used for treatment of the human body and imaging procedures sets the appropriate tube voltage and tube current for treatment at the time of treatment and sets the appropriate tube voltage and tube current for image processing at the time of imaging. The X-ray device used in this invention has a control function for controlling the operation of the X-ray generator and the X-ray detector, and their rotation, detects the rotating position of the X-ray generator, and changes the tube voltage and tube current each time it rotates one lap around the circumference.
In the present invention the treatment and the imaging procedures are switched over each time the X-ray generator and the X-ray detector rotates one lap inside the gantry. At the time of treatment the X-ray will be irradiated to the affected area at the appropriate tube voltage and tube current value for treatment procedures while the X-ray generator is rotating one lap around the circumference. Just before the start of the next lap, the value of the tube voltage and tube current is changed to the appropriate value for imaging. During the next lap, the X-ray will be irradiated to the affected area at the appropriate tube voltage and tube current value for imaging, the X-ray that penetrate the affected area are detected by the X-ray detector, and image reconstruction is performed.
Additionally since the claimed method does not include the steps with an action of a medical doctor judging the condition of human diseases or the physical condition of a human body for medical purposes, it is not considered to be “methods of diagnosis of humans.”
According to the detailed explanation of this invention, by changing the tube voltage and tube current of the X-ray generator, the treatment and imaging is repeated alternately; thus the steps to irradiate X-rays onto the human body by changing the tube voltage and tube current of the X-ray generator include a step of therapy of humans. Therefore, the claimed method is considered to be “methods of surgery, therapy or diagnosis of humans.”
(Supplementary Explanation)
It should be noted that, if the claim is described as in Example 18-2, the claimed invention is not considered to be “methods of surgery, therapy or diagnosis of humans.”
[Case 18-2] Invention considered to be therapy (not considered to be methods of surgery, therapy or diagnosis of humans)
Title of Invention
A method for operating an X-ray device
What is claimed is:
[Claim 1]
A method for controlling the X-ray generator by control means of the X-ray device; wherein the control means change the tube voltage and the tube current of the said X-ray generator each time the generator rotates one lap inside the gantry.
Overview of the description
The present invention relates to a method for treatment of the human body by X-ray therapy with confirming the X-ray therapy process by monitoring the X-ray image of the affected area.
The device used in the current invention places the X-ray generator and the X-ray detector in opposite positions inside the gantry, and rotates one lap around the circumference of the gantry maintaining the opposite positions. The X-ray generator which is used for treatment of the human body and imaging procedures sets the appropriate tube voltage and tube current for treatment at the time of treatment and sets the appropriate tube voltage and tube current for image processing at the time of imaging. The X-ray device used in this invention has a control function for controlling the operation of the X-ray generator and the X-ray detector, and their rotation, detects the rotating position of the X-ray generator, and changes the tube voltage and tube current each time it rotates one lap around the circumference.
In the present invention the treatment and the imaging procedures are switched over each time the X-ray generator and the X-ray detector rotates one lap inside the gantry. At the time of treatment the X-ray will be irradiated to the affected area at the appropriate tube voltage and tube current value for treatment procedures while the X-ray generator is rotating one lap around the circumference. Just before the start of the next lap, the value of the tube voltage and tube current is changed to the appropriate value for imaging. During the next lap, the X-ray will be irradiated to the affected area at the appropriate tube voltage and tube current value for imaging, the X-ray that penetrate the affected area are detected by the X-ray detector, and image reconstruction is performed.
Therefore, the claimed method is considered to be a method for controlling the operation of a medical device and is not considered to be “methods of surgery, therapy or diagnosis of humans.”
[Case 19-1] Invention considered to be therapy (considered to be methods of surgery, therapy or diagnosis of humans)
Title of Invention
A method for the treatment of cancer
What is claimed is:
[Claim 1]
A method for treatment of cancer using;
a micro capsule X which contains an anti-cancer agent and releases the agent when disintegrated by a convergence supersonic wave, and
an apparatus having means to obtain the image data showing the position of the tumor, means to focus the convergence supersonic wave on the position of the tumor, and means to irradiate the convergence supersonic wave onto the micro capsule X.
Overview of the description
This invention is directed to a method for treatment of cancer comprising injecting a micro capsule X with a anti-cancer agent inside into the blood vessel, destroying the micro capsule X in the body, and making the anticancer agent work efficiently on the tumor.
Since the convergence supersonic wave is focused onto the position of the tumor, only the micro capsule that has reached the tumor is disintegrated and thus the anti-cancer agent can be effectively administered to the tumor.
Thus the method is considered to be "methods of surgery, therapy or diagnosis of humans".
(Supplementary Explanation)
It should be noted that, if the claim is described as in Example 19-2, the claimed invention is not considered to be “methods of surgery, therapy or diagnosis of humans.”
[Case 19-2] Invention considered to be therapy (not considered to be methods of surgery, therapy or diagnosis of humans)
Title of Invention
A system for cancer treatment
What is claimed is:
[Claim 1]
A cancer treatment system comprising;
a micro capsule X which contains an anti-cancer agent and releases the agent when disintegrated by a convergence supersonic wave, and
an apparatus having means to obtain the image data showing the position of the tumor, means to focus the convergence supersonic wave on the position of the tumor, and means to irradiate the convergence supersonic wave onto the micro capsule X.
Overview of the description
The present invention relates to a system for effectively administering an anti-cancer agent to the tumor.
Since the convergence supersonic wave is focused onto the position of the tumor when the micro capsule X which contains an anti-cancer agent and has been injected into the blood vessel disintegrates inside the human body, only the micro capsule that has reached the tumor is disintegrated and thus the anti-cancer agent can be effectively administered to the tumor.
[Case 20-1] Invention considered to be therapy (considered to be methods of surgery, therapy or diagnosis of humans)
Title of Invention
A method for giving electrical stimulus by a pacemaker
What is claimed is:
[Claim 1]
A method for giving an electrical stimulus by a pacemaker, comprising;
a step of comparing a heart rate detected by a detecting unit with a threshold value stored in a memory device, and, when the heart rate is lower than the threshold value,
a step of reading out an average heart rate in a steady state from the memory device,
a step of calculating the difference between the average heart rate and the detected heart rate,
a step of setting a pulse generating interval value in accordance with the difference,
a step of a pulse generating unit’s giving stimulus to the ventricle of the heart with the pulse generating interval having been set, and a step of keeping the heart rate steady.
Overview of the description
Since the pacemaker constantly analyzes an electric signal from a myocardium to give a stimulus to the ventricle of the heart with a signal most fitted to the state of the heart, the maintenance of the optimum heart rate is made possible without a switching operation of the output signal.
The method in this example is considered to be a method of therapy of humans, since it corresponds to a method for curing diseases by giving a stimulus to the ventricle of the patient’s heart with pacemaker pulses and maintaining an optimum heart rate. Accordingly, the claimed method includes a method of therapy of humans as a part of the steps of the invention; thus, the method is considered to be “methods of surgery, therapy or diagnosis of humans.”
(Supplementary Explanation)
It should be noted that, if the claim is described as in Example 20-2 to 20-4, the claimed invention is not considered to be “methods of surgery, therapy or diagnosis of humans.”
[Case 20-2] Invention considered to be therapy (not considered to be methods of surgery, therapy or diagnosis of humans)
Title of Invention
A method for controlling a pacemaker
What is claimed is:
[Claim 1]
A method for controlling a pacemaker, comprising;
a step of comparing a heart rate detected at a detecting unit with a threshold value stored in a memory, and, when the heart rate is lower than the threshold value,
a step of reading out an average heart rate in a steady state from the memory,
a step of calculating the difference between the average heart rate and the detected heart rate, and
a step of setting a pulse generating interval value in accordance with the difference.
Overview of the description
Since the pacemaker constantly analyzes an electric signal from a myocardium to set a generating interval of the pulses most fitted to the state, the maintenance of an optimum heart rate is made possible.
Additionally, no step involves the step with an action of a medical doctor on a human body or the step with an influence on a human body by a device.
Therefore, the claimed method is considered to be a method for controlling the operation of a medical device and is not considered to be “methods of surgery, therapy or diagnosis of humans.”
[Case 20-3] Invention considered to be therapy (not considered to be methods of surgery, therapy or diagnosis of humans)
Title of Invention
A method for controlling a pacemaker
What is claimed is:
[Claim 1]
A method for controlling a pacemaker, comprising;
a step of comparing a heart rate detected at a detecting unit with a threshold value stored in a memory, and, when the heart rate is lower than the threshold value,
a step of reading out an average heart rate at a steady state from the memory,
a step of calculating the difference between the average heart rate and the detected heart rate,
a step of setting a pulse generating interval value in accordance with the difference, and
a step of the pulse generating means’ generating pulses for giving stimulus to the ventricle of the heart with the pulse generating interval.
Overview of the description
Since the pacemaker constantly analyzes electrical signals from the myocardium to set the generating interval of the pulses most fitted to the state, the maintenance of an optimum heart rate is made possible.
The matter reading “the pulse generating means’ generating pulses for giving stimulus to the ventricle of the heart with the pulse generating interval” means that “the pulse generating means” provided with the pacemaker generates pulses, but it does not mean so farther that the generated pulses give stimulus to the ventricle of the heart as the direct result of the pulses being generated; thus, it is judged not to have the step with an influence on the human body by the device.
It should be further noted that pulses “for giving stimulus to the ventricle of the heart” does not depict the step with an influence on the human body, since it specifies the state and/or the character of the pulse and differs from an influence on the human body of giving stimulus to the ventricle of the heart.
Therefore, the claimed method is considered to be a method for controlling the operation of a medical device since the function of the medical device is represented as a method and does not include the step with an action of a medical doctor or the step with an influence on the human body by the device. As a result, the method is not considered to be “methods of surgery, therapy or diagnosis of humans.”
(Supplementary Explanation)
A pacemaker is generally designed to be placed and operated in the human body by nature and is assumed to operate in a human body. However, in case the function of the pacemaker is described as a method in a claim, it is considered to be a method for controlling the operation of the pacemaker as long as the method does not include the step with an action of a medical doctor and/or the step with an influence on the human body by the device.
[Case 20-4] Invention considered to be therapy (not considered to be methods of surgery, therapy or diagnosis of humans)
Title of Invention
A method for controlling the operation of a pacemaker
What is claimed is:
[Claim 1]
A method for controlling the operation of a pacemaker; wherein means for comparing a heart rate detected in a detecting unit with a threshold value stored in a memory is operated, and, when the heart rate is lower than the threshold value, means for reading out an average heart rate at a steady state from the memory is operated, means for calculating the difference between the average heart rate and the detected heart rate is operated, means for setting the pulse generating interval value in accordance with the difference is operated, and pulse generating means for generating pulses for giving stimulus to the ventricle of the heart with a set pulse generating interval is operated.
Overview of the description
Since the pacemaker constantly analyzes electrical signals from a myocardium to set the pulse-generating interval best fitted to the state of the heart, the maintenance of the optimum heart rate is made possible.
The matter reading “pulse generating means for generating pulses for giving stimulus to the ventricle of the heart is operated” means that “the pulse generating means” provided with the medical device is operated, but it does not mean so farther that the generated pulses give stimulus to the ventricle of the heart as the direct result of “the pulse generating means” being operated and the claimed method is judged not to include the step with an influence on the human body.
Therefore, the claimed method is considered to be a method for controlling the operation of a medical device since the function of the medical device is represented as a method, and does not include the step with an action of a medical doctor on the human body or the step with an influence on the human body by the device. As a result, the method is not considered to be “methods of surgery, therapy or diagnosis of humans.”
[Case 21-1] Invention considered to be therapy (considered to be methods of surgery, therapy or diagnosis of humans)
Title of Invention
A method for retinal stimulation using an artificial eye system
What is claimed is:
[Claim 1]
A method for giving stimulus to a retina by an artificial eye system provided with an extracorporeal device composed of a visor device having an image receiving element and a light emitting element, and an extracorporeal image processing device, and an intraocular devices having a light receiving element, a signal processing circuit and an electrode, comprising;
a step of making a picture signal by processing an outside picture image obtained from the image receiving element of the visor device,
a step of converting the picture signal into an optical signal for transmitting from the light emitting element of the visor device to the light receiving element of the intraocular devices,
a step of receiving the optical signal by the light receiving element of the intraocular devices installed inside the oculus,
a step of converting the received signal into a signal for use in electrical stimulation by the signal processing circuit of the intraocular devices, and
a step of transmitting the signal for use in the electrical stimulation to an electrode for retina to transfer the signal to the retina, wherein stimulus of the picture information is given to the retina of the patient by the artificial eye system.
Overview of the description
The artificial eye system of the present invention can transfer the signal of the artificial picture information to the retina of a visually handicapped patient through an electrode for retina buried in the retina, by combining the image receiving element, the light emitting element, the light receiving element, and the signal processing circuit.
In addition, the matter reading “stimulus of the picture information is given to the retina of the patient” depicts the step with an influence on the human body by the device giving stimulus to the retina of the patient.
The claimed method, therefore, is not considered to be a method for controlling the operation of the medical device.
The method in this example is considered to be a method of therapy of humans, since it corresponds to a method for recovering the visual functions of a patient to cure diseases by transferring the signal for use in the electrical stimulation to the retina of a patient with the artificial eye system.
Accordingly, the claimed method includes a method of therapy of humans as a part of the steps of the invention; thus, it is considered to be “methods of surgery, therapy or diagnosis of humans.”
(Supplementary Explanation)
It should be noted that, if the claim is described as in Example 21-2, the claimed invention is not considered to be “methods of surgery, therapy or diagnosis of humans.”
[Case 21-2] Invention considered to be therapy (not considered to be methods of surgery, therapy or diagnosis of humans)
Title of Invention
A method for controlling an artificial eye system
What is claimed is:
[Claim 1]
A method for controlling an artificial eye system provided with an extracorporeal device composed of a visor device having an image receiving element and a light emitting element, and an extracorporeal image processing device, and an intraocular device having a light receiving element, a signal processing circuit and an electrode, comprising;
a step of making a picture signal by processing an outside picture image by the image receiving element of the visor device,
a step of converting the picture signal into an optical signal for transmitting from the light emitting element of the visor device to the light receiving element of the device for intraocular use,
a step of receiving the optical signal by the light receiving element of the devices for intraocular use,
a step of converting the received signal into a signal for use in the electrical stimulation for transferring to the retina by the signal processing circuit of the device for intraocular use, and
a step of transmitting the signal for use in the electrical stimulation to the electrode buried in the retina.
Overview of the description
The artificial eye system of the present invention can transfer the signal of the artificial picture information to the retina of a visually handicapped patient through an electrode buried in the retina, by combining the image receiving element, the light emitting element, the light receiving element, and the signal processing circuit.
Since the matter reading “transmitting the signal for use in the electrical stimulation to the electrode buried in the retina” means that the device for intraocular use transmits signals for use in electrical stimulation and does not mean so farther as transferring the signal for use in the electrical stimulation to the retina as the result of the transmission, the claimed method is judged not to include the step with an influence on the human body by the device.
It should be noted that the matter reading “buried in the retina” in the above step specifies the state and/or the character of the electrode in the artificial eye system and is distinguished from the step with the action of a medical doctor burying the electrode in the retina or from the step with an influence on the human body by the device.
Therefore, the claimed method is considered to be a method for controlling the operation of the medical device since the function of the medical device is represented as a method and does not include the step with an action of a medical doctor on the human body or the step with an influence on the human body by the device. As a result, it is not considered to be “methods of surgery, therapy or diagnosis of humans.”
[Case 22-1] Invention considered to be therapy (considered to be methods of surgery, therapy or diagnosis of humans)
Title of Invention
A method for regenerating cartilage
What is claimed is:
[Claim 1]
A method for regenerating cartilage wherein a material wherein the A-cells is embedded in gel formed by the biocompatible polymeric material Z is transplanted to a joint of humans.
Overview of the description
It was found that transplantation of a material wherein the A-cells is embedded in gel formed by the biocompatible polymeric material Z to a joint of humans has a remarkable cartilage regenerating effect.
(Supplementary Explanation)
It should be noted that, if the claim is described as in Example 22-2, the claimed invention is not considered to be “methods of surgery, therapy or diagnosis of humans.”
[Case 22-2] Invention considered to be therapy (not considered to be methods of surgery, therapy or diagnosis of humans)
Title of Invention
An implant material for cartilage regeneration
What is claimed is:
[Claim 1]
An implant material for regenerating a cartilage consisting of biocompatible polymeric material Z and A-cells wherein the A-cells are embedded in gel formed by the biocompatible polymeric material Z, characterized in that the implant is transplanted to a joint of humans.
Overview of the description
It was found that transplantation of a material wherein the A-cells is embedded in gel formed by the biocompatible polymeric material Z to a joint of humans has a remarkable cartilage regenerating effect.
[Case 23-1] Invention considered to be therapy (considered to be methods of surgery, therapy or diagnosis of humans)
Title of Invention
A method for the treatment of cardiac infarction
What is claimed is:
[Claim 1]
A method for treating cardiac infarction wherein A-cells and cell growth factor W are combined to be administrated to the site of cardiac infarction of humans.
Overview of the description
It was found that the infarct area was reduced and cardiac function was recovered by injecting a combination of A-cells and cell growth factor W to the site of cardiac infarction of humans.
Therefore, the claimed invention falls under “methods of surgery, therapy or diagnosis of humans.”
(Supplementary Explanation)
It should be noted that, if the claim is described as in Example 23-2, the claimed invention is not considered to be “methods of surgery, therapy or diagnosis of humans.”
[Case 23-2] Invention considered to be therapy (not considered to be methods of surgery, therapy or diagnosis of humans)
Title of Invention
A composition for treatment of cardiac infarction
What is claimed is:
[Claim 1]
A composition for treating cardiac infarction containing A-cells and cell growth factor W as active ingredients, characterized in that the composition is administrated to the site of cardiac infarction of humans.
Overview of the description
It was found that the infarct area was reduced and cardiac function was recovered by injecting a combination of A-cells and cell growth factor W to the site of cardiac infarction of humans.
[Case 24-1] Invention considered to be data collection (not considered to be methods of surgery, therapy or diagnosis of humans)
Title of Invention
A method for X-ray CT scanning
What is claimed is:
[Claim 1]
A method for imaging by controlling the respective parts of an X-ray CT scanner by control means, comprising;
a step of exposing X-rays to the human body by controlling X-ray generating means,
a step of detecting the X-rays permeated through the human body by controlling X-ray detecting means, and
a step of performing reconstruction of the detected data and converting such detected data into picture data for display.
Overview of the description
The present invention relates to a method for imaging by controlling an X-ray CT scanner for picking up an image of a human body, and a picture image thereof can be accurately displayed on account of the reconstruction of the detected data.
(Supplementary Explanation)
Since the matter reading “exposing X-rays to the human body” includes the step with an influence on the human body by the device, the claimed method is not considered to be a method for controlling the operation of the medical device.
[Case 24-2] Invention considered to be data collection (not considered to be methods of surgery, therapy or diagnosis of humans)
Title of Invention
A method for controlling an X-ray CT scanner
What is claimed is:
[Claim 1]
A method for controlling the respective parts of an X-ray CT scanner by control means, comprising;
a step of generating X-rays by controlling X-ray generating means,
a step of detecting X-
rays permeated through the human body by controlling X-ray detecting means, and
a step of performing reconstruction of the data detected and converting the detected data into picture data for display.
Overview of the description
The present invention relates to a method of controlling an X-ray CT scanner for picking up an image of a human body, and a picture image thereof can be accurately displayed on account of reconstruction of the detected data.
Since the matter reading “generating X-rays by controlling X-ray generating means” means that the “X-ray generating means” belonging to the X-ray CT scanner generates X-rays and does not mean so farther that the human body is exposed by the X-rays; thus, the claimed method is judged not to include the step with an influence on the human body by the device.
Furthermore, the matter reading “detecting X-rays permeated through the human body by controlling X-ray detecting means” represents the function that the “X-ray detecting means” provided to the X-ray CT Scanner receives a signal (X-ray) permeated through a human body. As a result, the claimed method is judged not to include the step with an action of a medical doctor or the step with an influence on a human body by the device.
Therefore, the claimed method is considered to be a method for controlling the operation of a medical device since the function of the medical device is represented as a method, and the method does not include the step with an action of a medical doctor or the step with an influence on the human body by the device. Accordingly, the method is not considered to be “methods of surgery, therapy or diagnosis of humans.”
[Case 25-1] Invention considered to be data collection (not considered to be methods of surgery, therapy or diagnosis of humans)
Title of Invention
A method for magnetic resonance imaging
What is claimed is:
[Claim 1]
A method for magnetic resonance imaging by a magnetic resonance imaging device comprising;
a step of repeating pulse sequences while sequentially changing the intensity of the gradient magnetic field in the phase encode direction in the order from lower to higher, wherein the pulse sequence is carried out by irradiating 90o pulse to the imaging objective region while generating a gradient magnetic field in the slice direction,
a step of generating a predetermined quantity of the gradient magnetic field in the phase encode direction,
a step of irradiating 180o pulse to the region while generating the gradient magnetic field in the slice direction, and
a step of detecting a magnetic resonance signal from the pertinent region while generating the gradient magnetic field in the lead-out direction.
Overview of the description
The magnetic resonance imaging device of the present invention acquires magnetic resonance signals in the order of phase encode from low to high when the human body is imaged by the spin-echo method.
(Supplementary Explanation)
Since the matters reading “irradiating 90o pulse to the imaging objective region while generating a gradient magnetic field in the slice direction” and “irradiating 180o pulse to the region while generating the gradient magnetic field in the slice direction” include the step with an influence on the human body by the device, the claimed method is not considered to be a method for controlling the operation of the medical device.
[Case 25-2] Invention considered to be data collection (not considered to be methods of surgery, therapy or diagnosis of humans)
Title of Invention
A method for controlling magnetic resonance imaging device
What is claimed is:
[Claim 1]
A method for controlling the operation of a magnetic resonance imaging device in which the control means of the magnetic resonance imaging device controls a transmitting and receiving circuit, a RF coil, and a gradient coil, comprising;
a step of repeating pulse sequences while sequentially changing the intensity of the gradient magnetic field in the phase encode direction in the order from low to high, wherein the pulse sequence is carried out by a RF coil transmitting a 90o pulse toward a uniform magnetic field space while the gradient coil is generating the gradient magnetic field in the slice direction,
a step of a gradient coil generating a predetermined quantity of the gradient magnetic field in the phase encode direction,
a step of a RF coil transmitting an 180o pulse while the gradient coil is generating a gradient magnetic field in the slice direction, and
a step of a RF coil receiving a magnetic resonance signal from a human body while a gradient coil is generating a gradient magnetic field in the read-out direction.
Overview of the description
The magnetic resonance imaging device of the present invention acquires magnetic resonance signals in the order of the phase encode from low to high when a human body is imaged by a spin-echo method.
The matters reading “a RF coil transmitting a 90o pulse toward a uniform magnetic field space while the gradient coil is generating the gradient magnetic field” and “a RF coil transmitting 180o pulse while the gradient coil is generating the gradient magnetic field” mean that “the RF coils” provided with the magnetic resonance imaging device transmit pulses; however, this does not mean so farther that the generated pulses are exposed to the human body as a result of generating pulses. Accordingly, the claimed method is judged not to include the step with an influence on the human body by the device.
Furthermore, the matter reading “the RF coil receiving a magnetic resonance signal from the human body” represents the function that “the RF coil” receives a signal (magnetic resonance signal) from the human body; thus, the claimed method is judged not to include the step with an influence on the human body by the device.
Therefore, the claimed method is considered to be a method for controlling the operation of a medical device since the function of the medical device is represented as a method, and the method does not include the step with an action of a medical doctor or the step with an influence on the human body by the device. As a result, the method is not considered to be “methods of surgery, therapy or diagnosis of humans.”
[Case 26] Invention considered to be data collection (not considered to be methods of surgery, therapy or diagnosis of humans)
Title of Invention
A method for nuclear medicine imaging
What is claimed is:
[Claim 1]
A method for nuclear medicine imaging comprising;
a step of performing SPECT imaging synchronized with the cardiac cycle on the examinee’s heart administered with a radioactive agent,
a step of performing ultrasonic
Doppler imaging synchronized with the cardiac cycle on the examinee’s heart without contrast agent, and
a step of superimposing of the SPECT image and the ultrasonic
Doppler image that have the same time phase of the heartbeat.
Overview of the description
The present invention relates to the superimposed image display of a SPECT (Single photon emission computed tomography) image which is a type of a nuclear medicine image and a supersonic Doppler myocardial image.
Firstly with regard to the myocardial SPECT imaging, a radioactive agent that contains gamma emitters such as Technetium is administered to the vain of the examinee, and 45 minutes later, the examinee is moved to the bed of the SPECT device. An electrocardiogram device is attached to the examinee and the SPECT imaging is performed in synchronization with the heartbeat.
Next, in order to avoid excess strain on the examinee’s heart, further use of radioactive agent are avoided and an electrocardiogram device is attached to the examinee and the Doppler myocardial imaging is performed in synchronization with the heartbeat.
The SPECT images and supersonic Doppler images that have the same time phase of the heartbeat are displayed in a superimposed display format.
The superimposed image displays enable the evaluation of cardiac ischemia, and because of the synchronization with the heartbeat, inconsistency in the data appearance due to pulsation can be avoided.
Therefore, the claimed method is not considered to be “methods of surgery, therapy or diagnosis of humans.”
(Supplementary Explanation)
Since the claimed method does not represent the function of the medical device but the steps with an action of a doctor, the method is not deemed as “methods for controlling the operation of a medical device.”
[Case 27-1] Invention considered to be methods for treating samples that have been extracted from the human body (considered to be methods of surgery, therapy or diagnosis of human)
Title of Invention
A method for measuring hematocrit values of blood
What is claimed is:
[Claim 1]
A method for optically measuring hematocrit values of blood, the method comprising; irradiating the blood with light comprising a selected range of wavelengths; and calculating the hematocrit value based on the strength of the reflection from the blood.
Overview of the description
The present invention relates to a method of measuring the blood hematocrit value, by utilizing the light absorbing characteristic of each element in blood, and calculating the blood hematocrit value.
This invention enables the measuring of the hematocrit value of blood flowing in the blood circuit during dialysis treatment. During a dialysis treatment the fluid removal rate has to be controlled so that the patient does not experience any blood pressure drop or shock. The hematocrit value of blood flowing in the blood circuit which is a parameter closely related to the rate of change of the circulating blood volume, which is a control factor for the fluid removal rate, can be calculated without direct contact with the circulating blood.
Other than measuring the hematocrit value of the blood during dialysis treatment, the present invention enables conducting of various tests such as anemia tests. In such cases, the extracted blood is housed in a test container, the blood housed in the test container is irradiated with light comprising a selected range of optical wavelengths, and the blood hematocrit value which is an indicator for anemia is calculated based on the strength of the reflection from the blood.
Accordingly the claimed method is deemed as “methods of surgery, therapy or diagnosis of humans,” since it corresponds to a method to analyze a sample which has been extracted from the human body on the assumption that the sample is to be returned to the same human body for medical treatment purposes.
(Supplementary Explanation)
It should be noted that, if the claim is described as in Example 27-2 and 27-3, the claimed invention is not considered to be “methods of surgery, therapy or diagnosis of humans.”
[Case 27-2] Invention considered to be methods for treating samples that have been extracted from the human body (not considered to be methods of surgery, therapy or diagnosis of human)
Title of Invention
A method for measuring hematocrit values of extracted blood
What is claimed is:
[Claim 1]
A method for optically measuring hematocrit values of blood which is housed in a test container, the method comprising;
irradiating the blood with light comprising a selected range of wavelengths; and calculating the hematocrit value based on the strength of the reflection from the blood.
Overview of the description
The present invention relates to a method of measuring the blood hematocrit value, by utilizing the light absorbing characteristic of each element in blood, and calculating the blood hematocrit value.
This invention enables the measuring of the hematocrit value of blood flowing in the blood circuit during dialysis treatment. During a dialysis treatment the fluid removal rate has to be controlled so that the patient does not experience any blood pressure drop or shock. The hematocrit value of blood flowing in the blood circuit which is a parameter closely related to the rate of change of the circulating blood volume, which is a control factor for the fluid removal rate, can be calculated without direct contact with the circulating blood.
Other than measuring the hematocrit value of the blood during dialysis treatment, the present invention enables conducting of various tests such as anemia tests. In such cases, the extracted blood is housed in a test container, the blood housed in the test container is irradiated with light comprising a selected range of optical wavelengths, and the blood hematocrit value which is an indicator for anemia is calculated based on the strength of the reflection from the blood.
In addition, the blood which is housed in a test container is discarded without returning to human body.
[Case 27-3] Invention considered to be methods for treating samples that have been extracted from the human body (not considered to be methods of surgery, therapy or diagnosis of human)
Title of Invention
A method for controlling the operation of a blood hematocrit measuring device
What is claimed is:
[Claim 1]
A method for controlling the operation of a device for optically measuring blood hematocrit value, wherein;
means of irradiating the blood with light comprising a selected range of wavelengths is operated; and means of calculating the hematocrit value based on the strength of the reflection from the blood is operated.
Overview of the description
The present invention relates to a method of measuring the blood hematocrit value, by utilizing the light absorbing characteristic of each element in blood, and calculating the blood hematocrit value.
This invention enables the measuring of the hematocrit value of blood flowing in the blood circuit during dialysis treatment. During a dialysis treatment the fluid removal rate has to be controlled so that the patient does not experience any blood pressure drop or shock. The hematocrit value of blood flowing in the blood circuit which is a parameter closely related to the rate of change of the circulating blood volume, which is a control factor for the fluid removal rate, can be calculated without direct contact with the circulating blood.
Other than measuring the hematocrit value of the blood during dialysis treatment, the present invention enables conducting of various tests such as anemia tests. In such cases, the extracted blood is housed in a test container, the blood housed in the test container is irradiated with light comprising a selected range of optical wavelengths, and the blood hematocrit value which is an indicator for anemia is calculated based on the strength of the reflection from the blood.
The matter reading “means of irradiating the blood with light comprising a selected
range of wavelengths is operated” means that “the means of irradiating with light comprising a selected range of wavelengths” provided with the blood purifying instrument is operated, but it does not mean so further that the light is irradiated to the human body as a result of the “the means of irradiating with light comprising a selected range of wavelengths” being operated and it is judged not to include the step with an influence on the human body by the device.
Therefore, the claimed method is considered to be a method for controlling the operation of a medical device since the function of the medical device is represented as a method and does not include the step with an action of a medical doctor on the human body or the step with an influence on the human body by the device. As a result, the method is not considered to be “methods of surgery, therapy or diagnosis of humans.”
[Case 28-1] Invention considered to be methods for treating samples that have been extracted from the human body (considered to be methods of surgery, therapy or diagnosis of human)
Title of Invention
A method for blood purification
What is claimed is:
[Claim 1]
A method for blood purification by a blood purifying device provided with a blood removal line, a blood return line, a blood plasma separation apparatus to separate the blood introduced through the blood removal line into the blood cell and blood plasma, an absorptive apparatus to remove any disease virus from the separated blood plasma, a pressure sensor to detect the pressure of the blood removal line and blood return line, and a blood pump, comprising;
a step of removing blood via the blood removal line,
a step of separating the blood cell and the blood plasma,
a step of removing any disease virus from the separated blood plasma,
a step of mixing the blood cells with the blood plasma with the disease virus removed,
a step of returning blood via the blood return line, and
a step of controlling the flow of blood from the blood pump according to the pressure of the blood removal line and blood return line.
Overview of the description
The blood purifying device of the present invention can perform the treatment safely and continuously by controlling the flow of blood from the blood pump according to the pressure of the blood removal line and blood return line when removing any disease virus such as bilirubin from the blood.
The blood purifying device of this case forms an extracorporeal circuit. During operation of the blood purifying device, the blood is continuously circulated in the human body and extracorporeal circuit. The matters reading “separating the blood cell and the blood plasma,” “removing any disease virus from the separated blood plasma” and “mixing the blood cells with the blood plasma with the disease virus removed” mean that separating blood into the blood cell and the blood plasma, removing any disease virus from the separated blood plasma, and mixing the blood cells with the blood plasma with the disease virus removed are performed in an extracorporeal circuit; thus are deemed as the steps with an influence on the human body by a device. The blood, blood plasma and blood cells are continuously circulated in the human body and extracorporeal circuit. Thus, each of the steps is
a step with an influence on the human body by a device.
The matter reading “controlling the flow of blood from the blood pump according to the pressure of the blood removal line and blood return line” means that the flow of blood from the blood pump is controlled; thus are deemed as the step with an influence on the human body by a device.
Therefore, the claimed method is not considered to be a method for controlling the operation of a medical device.
Since the method in this case relates to a method of treating the blood in an extracorporeal circuit and is a method of treating samples which have been extracted from the human body on the assumption that the sample is to be returned to the same body for medical treatment purposes, the method is considered to be “method of surgery, therapy, or diagnosis of humans.”
(Supplementary Explanation)
It should be noted that, if the claim is described as in Example 28-2, the claimed invention is not considered to be “methods of surgery, therapy or diagnosis of humans.”
[Case 28-2] Invention considered to be methods for treating samples that have been extracted from the human body (not considered to be methods of surgery, therapy or diagnosis of human)
Title of Invention
A method for controlling the operation of a blood purifying device
What is claimed is:
[Claim 1]
A method for controlling the operation of a blood purifying device provided with a blood removal line, a blood return line, a blood plasma separation apparatus to separate the blood introduced through the blood removal line into the blood cell and blood plasma, an absorptive apparatus to remove any disease virus separated from the blood plasma, a pressure sensor to detect the pressure of the blood removal line and blood return line, and a blood pump, wherein a means controlling the flow of the blood pump is operated according to the output from the pressure sensor.
Overview of the description
The blood purifying device of the present invention can perform the treatment safely and continuously by controlling the flow of blood from the blood pump according to the pressure of the blood removal line and blood return line when removing any disease virus such as bilirubin from the blood.
The matter reading “a means controlling the flow of the blood pump is operated according to the output from the pressure sensor” means that “the means controlling the flow of the blood pump” provided with the blood purifying device is operated, but it does not mean so further that there is a change in the blood output from the pump as a result, and it is judged not to include the step with an influence on the human body by the device.
Therefore, the claimed method is considered to be a method for controlling the operation of a medical device since the function of the medical device is represented as a method and does not include the step of an action by a medical doctor on the human body or the step of giving an influence on the human body by the device. As a result, the method is not considered to be “methods of surgery, therapy or diagnosis of humans.”
[Case 29-1] Invention considered to be methods for treating samples that have been extracted from the human body (considered to be methods of surgery, therapy or diagnosis of human)
Title of Invention
A method for Gene therapy
What is claimed is:
[Claim 1]
A method of reducing a cancer by administering the vector Z including both the DNA encoding protein X and the DNA encoding protein Y into a human body.
Overview of the description
It was found that a cancer would be reduced as a result of suppression of angiogenesis particular to cancer tissues and simultaneously stimulation of immunity by administering the claimed recombinant vector into a human body.
[Case 29-2] Invention considered to be methods for treating samples that have been extracted from the human body (not considered to be methods of surgery, therapy or diagnosis of human)
Title of Invention
A method for manufacturing cell formulation for gene therapy
What is claimed is:
[Claim 1]
A method for manufacturing cell formulation for cancer therapy by introducing genes with vector Z including both the DNA encoding protein X and the DNA encoding protein Y into a cell W extracted from a human body
Overview of the description
It was found that a cancer would be reduced as a result of suppression of angiogenesis particular to cancer tissues and simultaneously stimulation of immunity by the recombinant cell medicine for cancer therapy obtained by the claimed method.
The cells obtained from a donor who is a relative of the patient could be used.
However, it is the most preferable to use the cells from the patient himself or herself in view of compatibility.
[Case 30-1] Invention considered to be methods for treating samples that have been extracted from the human body (not considered to be methods of surgery, therapy or diagnosis of human)
Title of Invention
A method of inducing differentiation of cells
What is claimed is:
[Claim 1]
A method of inducing differentiation of an human induced pluripotent stem cells to a neural stem cells wherein the human induced pluripotent stem cells are cultured in serum-free medium and in the presence of X cell growth factor.
Overview of the description
It was found that the the differentiation of human induced pluripotent stem cells (hereinafter abbreviated as “iPS cells”) to neural stem cells was induced by culturing them in serum-free medium and in the presence of X cell growth factor.
Moreover, taking into consideration of immunological compatibility, it is preferable to use iPS cells derived from somatic cells of the same patient. The neural stem cells differentiated from human iPS cells can be used as a therapeutic agent for degenerative neurological disorder.
[Case 30-2] Invention considered to be methods for treating samples that have been extracted from the human body (not considered to be methods of surgery, therapy or diagnosis of human)
Title of Invention
A method of separating and purifying differentiation-induced cells
What is claimed is:
[Claim 1]
A method of separating and purifying neural stem cells from a cell population including them differentiated from human iPS cells, the said method comprising the steps of;
(a) separating the neural stem cells by using separation membrane M, and
(b) culturing the cells separated in (a) in the medium containing compound P.
Overview of the description
It was found that the separation membrane M selectively absorbed the neural stem cells. Moreover, it has been publicly known that compound P is useful for maintaining pluripotency of the neural stem cells and for proliferation of them.
Thus, it is possible to obtain high-purity neural stem cells by separating the neural stem cells from the cell population containing undifferentiated human iPS cells and purifying them by using the separation membrane M, and by culturing them in the medium containing compound P. The high-purity neural stem cells can be used as a safer therapeutic agent for degenerative neurological disorder.
[Case 30-3] Invention considered to be methods for treating samples that have been extracted from the human body (not considered to be methods of surgery, therapy or diagnosis of human)
Title of Invention
A method of analyzing a ratio of separated and purified cells
What is claimed is:
[Claim 1]
A method of analyzing a ratio of neural stem cells within a cell population including separated and purified neural stem cells derived from human iPS cells, the said method comprising the steps of;
(a) measuring the expression level of cell marker A and cell marker B in the said cell population using a labeled antibody respectively, and
(b) determining the ratio of the neural stem cells based on the said expression level, wherein the cell marker A consists of the amino-acid sequence of SEQ ID NO:1.
Overview of the description
It was found that the cell marker A was specifically expressed in the neural stem cells and consisted of the amino acid sequence of SEQ ID NO:1. An antibody which binds to the cell marker A was also produced. Moreover, the cell marker B is publicly known as a cell marker widely expressing in the overall stem cells.
Thus, it is possible to measure the expression level of the cell marker A and the cell marker B using a labeled antibody respectively,, and to analyze the ratio of the neural stem cells in a cell population derived from the human iPS cells by deciding a determining the the expression level of the cell marker A to that of the cell marker B, which allows safer treatment of degenerative neurological disorder.
[Case 31-1] Invention considered to be assisting device (not considered to be methods of surgery, therapy or diagnosis of human)
Title of Invention
A method for judging a motion state of walking
What is claimed is:
[Claim 1]
A method for judging walking conditions with a power assisting equipment coupled to a leg of a worker to reduce his burden comprising,
a step of measuring myogenic potential of the leg of the worker by a sensor attached to a leg part of the power assisting equipment, and
a step of judging the walking conditions based on the measured myogenic potential.
Overview of the description
This invention relates to a method for judging walking conditions using the power assisting equipment used to reduce a burden of a worker who involves in hard work. The power assisting equipment is appropriately controlled based on the result of judgment of walking conditions. ("A worker," described in the claims is defined as a person who involves in hard work in the detailed explanation of the invention. It is not supposed that the power assisting equipment of this invention assists movements of those who lost muscle strength and those who lost physical motor function for medical purposes.)
According to the detailed explanation of this invention, since “a worker” is defined as a person who involves in hard work and it is not supposed that the power assisting equipment of this invention assists for the medical purpose movements of those who lost muscle strength and those who lost physical motor function, the claimed method does not fall under the method of therapy of humans.
Therefore, the claimed method is not considered to be “methods of surgery, therapy or diagnosis of humans.”
[Case 31-2] Invention considered to be assisting device (not considered to be methods of surgery, therapy or diagnosis of human)
Title of Invention
A method for controlling a power assisting device
What is claimed is:
[Claim 1]
A method for controlling a power assisting equipment coupled to a worker to reduce his burden comprising,
a step of measuring myogenic potential of an arm or a leg of the worker by a sensor attached to the power assisting equipment, and
a step of moving the arm or the leg of the worker by driving a motor attached to the power assisting equipment based on the measured myogenic potential.
Overview of the description
This invention relates to a method of appropriately controlling the power assisting equipment used to reduce a burden of a worker who involves in hard work based on the myogenic potential of an arm or a leg of the worker. ("A worker," described in the claims is defined as a person who involves in hard work in the detailed explanation of the invention.
It is not supposed that the power assisting equipment of this invention assists movements of those who lost muscle strength and those who lost physical motor function for medical purposes.)
According to the detailed explanation of this invention, since “a worker” is defined as a person who involves in hard work and it is not supposed that the power assisting equipment of this invention assists for the medical purpose movements of those who lost muscle strength and those who lost physical motor function, the method for controlling the power assisting equipment of this invention does not fall under “methods of surgery, therapy or diagnosis of humans.”
[Case 31-3] Invention considered to be assisting device (not considered to be methods of surgery, therapy or diagnosis of human)
Title of Invention
A method for power assisting
What is claimed is:
[Claim 1]
A power assisting method to assist movements of a worker by a power assisting equipment coupled to workers to reduce their burden comprising,
a step of measuring myogenic potential of an arm or a leg of the worker by a sensor attached to the power assisting equipment, and
a step of moving the arm or the leg of the workers by driving a motor attached to the power assisting equipment based on the measured myogenic potential.
Overview of the description
This invention relates to a method of appropriately controlling the power assisting equipment using judgment results of a judgment made by the power assisting equipment used to reduce a burden of a worker who involves in hard work. This invention relates to a method for controlling a power assisting equipment used to reduce a burden of a worker who involves in hard work based on the myogenic potential of an arm or an leg of the worker and assisting movements of the worker. ("A worker," described in the claims is defined as a person who involves in hard work in the detailed explanation of the invention.
It is not supposed that the power assisting equipment of this invention assists movements of those who lost muscle strength and those who lost physical motor function for medical purposes.)
According to the detailed explanation of this invention, since “a worker” is defined as a person who involves in hard work and it is not supposed that the power assisting equipment of this invention assists for the medical purpose movements of those who lost muscle strength and those who lost physical motor function, the power assisting method of this invention does not fall under “methods of surgery, therapy or diagnosis of humans.”
