Evaluation of a Balloon-Type Vaginal Endoscope Based on Three-Dimensional Printing Technology for Self-Assessment of Pelvic Organ Prolapse

Round 1

Reviewer 1 Report

The authors have written the paper well, but some more details still need to be corrected before publication.

 

1. The title of the paper is to apply 3D printing technology, and in the paper itself about this procedure is only one sentence and that it is made with FDM and material PLA.

Where in the Introduction Part is it about additive manufacturing and its application in medicine? What has been done so far, how and with what, etc.?

 

2. There is a lot of old literature and don't get me wrong, this should be taken into account, but has no one really done anything in recent times (in the last 5 years from 2015-2020) on the application of additive production in medicine in devices?

 

3. Figures should be better arranged in the text. They should be placed immediately after they are discussed in the text. Eg. Figure 4 is now on page 6, and should be after line 180.

Then the text from lines 181 - 185 and then Figure 5. Etc...

 

4. Does the condom somehow attach to the device? Can it happen that the operator compresses too much air and there is such pressure that the condom flies into the human body?

 

5. Equation (1), units of measurement for d is missing.

 

6. Line 136: when writing 360 deg it is better to put a degree sign.

 

7. Line 150: the camera is washed with water? Is it necessary to disinfect the camera with special liquids?

 

8. Figure 5: Is there something missing in the word end cap? Does that image cover any text?

 

9. The device is made with FDM process: The 3D printer makes the total body of fused deposition modeling (FDM) based on the use of polylactic acid (PLA).

Maybe it should be written with fused deposition modeling?

 

The focus of the work is that it is made with 3D printing, and there is no printer manufacturer, no processing parameters, layer thickness, etc.... If the FDM procedure has been used, why author did not used materials that have better mechanical properties and can go for sterilization. Why was the PLA chosen?

 

10. Line 231-232: Medical approch has been changed - How?

 

11. Conclusion and discussion should be separated.

 

The paper needs to be corrected, and at most the introduction part should be supplemented with references to additive production in medicine and similar or the same applications.

Then, the paper lacks discussion and references from some other authors and how this problem of pelvic organ prolapse is usually resolved. With other cameras, how is it in clinical practice and what has been improved or obtained by this paper?

Author Response

Dear Reviewer #1

 

Thank you for your comments. I revised my manuscript according your kind comments. Please confirm it.

 

Comment #1

The title of the paper is to apply 3D printing technology, and in the paper itself about this procedure is only one sentence and that it is made with FDM and material PLA.

Where in the Introduction Part is it about additive manufacturing and its application in medicine? What has been done so far, how and with what, etc.?

 

Response #1

Thank you for your comments. I added some sentences related to the 3D printer in subsection of Regulation of the airflow;

“Figure 6 shows the mechanical design of the endoscope based on 3D printing technology by using 3D CAD tool of SolidWorks. The diameter of the nozzle is 9.5 mm, and the distance of aluminum is 210 mm. The 3D printer (Sindoh, 3DWOX1 model) makes the total body of fused deposition modeling (FDM) based on the use of polylactic acid (PLA) which is harmless to humans. The thickness of layer is set to 0.15 mm.”

But this study is about the application of 3D printing technology. The main topic is the point-of-care device in healthcare which is related to the observation of pelvic organ prolapse. Thus, I did not describe the 3D printing technology in Introduction. The used 3D printing technology in this study is also the general technology, not the state of the art.

 

 

Comment #2

There is a lot of old literature and don't get me wrong, this should be taken into account, but has no one really done anything in recent times (in the last 5 years from 2015-2020) on the application of additive production in medicine in devices?

 

Response #2

Thank you for your comment and I understand your surprising. I am sure that there is no device like the endoscope type to measure the pelvic organ prolapse in the world. The proposed system is the first step in the world, I am sure.

But there is the different type such as the ultrasound device. I added the merit and demerit of ultrasound device for observing the pelvic organ prolapse in Discussion;

“5.2 Ultrasound assessment of pelvic organ prolapse

A pelvic ultrasound is a noninvasive diagnostic exam that produces images that are used to assess organs and structures within the female pelvis. A pelvic ultrasound allows quick visualization of the female pelvic organs and structures including the uterus, cervix, vagina, fallopian tubes, and ovaries. A pelvic ultrasound may be performed in your doctor’s office, on an outpatient basis, or as part of your stay in a hospital. Procedures may vary depending on your condition and your hospital’s practices. Although there have been a lot of studies performed, little information is available to help define whether a certain degree of pelvic organ prolapse is clinically relevant. Dietz et al [34] reported that descent of the bladder to >= 10 mm and of the rectum to >= 15 mm below the symphysis pubis are strongly associated with symptoms, and these values are proposed as cut-offs for the diagnosis of significant prolapse based on receiver-operating characteristics statistics.

 

Compared with this, the camera-and-depth-sensors-based proposed system is for the point-of-care device in healthcare. Although the ultrasound device is for diagnosis in the hospital, the user can observe the location at any time by herself when feeling something strange. Furthermore, it is necessary to study particular human anatomy to understand imaging data from the ultrasound device, however, there is no need to have the knowledge and skills in a field related to the medical major when the proposed system is used.”

 

 

Comment #3

Figures should be better arranged in the text. They should be placed immediately after they are discussed in the text. Eg. Figure 4 is now on page 6, and should be after line 180.

Then the text from lines 181 - 185 and then Figure 5. Etc...

 

Response #3

I revised the arrangement of Figures in order to improve the readability. Please confirm it.

 

 

Comment #4

Does the condom somehow attach to the device? Can it happen that the operator compresses too much air and there is such pressure that the condom flies into the human body?

 

Response #4

You can understand that Figure 1 is helpful for recognizing the location for attaching the rubber material at the device. The rubber material is like the balloon. The size of balloon is related to the air amount of air pressure. Our system is similar to the balloon. The proper size of rubber material for the proper air pressure is controlled by the operator because of the self-checking.

 

 

Comment #5

Equation (1), units of measurement for d is missing.

 

Response #5

The unit is mm. You can find the unit of measurement for d is in 134-135 lines.

“The allowable range along the z-axis direction is 0--140 mm, and the resolution of this sensor unit is 0.5 mm. This sensor unit is installed in the primary gun-type part.” Please confirm it.

 

 

Comment #6

Line 136: when writing 360 deg it is better to put a degree sign.

 

Response #6

I revised the deg is the symbol of  as you mentioned. Please confirm it.

 

 

Comment #7

Line 150: the camera is washed with water? Is it necessary to disinfect the camera with special liquids?

 

Response #7

I did not understand this comment. There is no special liquids on the lens of camera in all of experiments. Thus, I think that there is no need to wash the camera.

 

 

Comment #8

Figure 5: Is there something missing in the word end cap? Does that image cover any text?

 

Response #8

Lines 184-188 covers the contents of Figure 5.

 

 

Comment #9

The device is made with FDM process: The 3D printer makes the total body of fused deposition modeling (FDM) based on the use of polylactic acid (PLA).

Maybe it should be written with fused deposition modeling?

 

The focus of the work is that it is made with 3D printing, and there is no printer manufacturer, no processing parameters, layer thickness, etc.... If the FDM procedure has been used, why author did not used materials that have better mechanical properties and can go for sterilization. Why was the PLA chosen?

 

Response #9

Thank you for your comment. I added the related sentences in 3.3 Regulation of the airflow.

“Figure 6 shows the mechanical design of the endoscope based on 3D printing technology by using 3D CAD tool of SolidWorks. The diameter of the nozzle is 9.5 mm, and the distance of aluminum is 210 mm. The 3D printer (Sindoh, 3DWOX1 model) makes the total body of fused deposition modeling (FDM) based on the use of polylactic acid (PLA) which is harmless to humans. The thickness of layer is set to 0.15 mm.

 

The designed endoscope has the dimensions of distance x height x width = 420 x 175 x 40 mm, and has a total weight of 400 g. The shape is similar to that of the gun intended for sole use. There is an air cartridge with a 16 g size and an air on/off valve inside the handlebar. When the valve is working, the injected air is moved to a nozzle through the connected tube and airflow hole at the tip.”

 

When most of women needs to use the proposed device, the general 3D printer machine should be able to make the prototype in the house. Then the material for 3D printing should be safe for the human body. Thus, the selected 3D printer in this study is the cheap one, and the material is PLA which is cheap and harmless to human. Further, there is no the direct contact between the device and the human body.

 

 

Comment #10

Line 231-232: Medical approch has been changed - How?

 

Response #10

In this sentence, the word of Medical approach indicates a little change of diagnosis of disease such as pelvic organ prolapse, urinary incontinence, constipation, etc. The detail description is written to the next sentence.

 

 

Comment #11

Conclusion and discussion should be separated.

 

Response #11

Thank you for your comment. According your comment, I separated Discussion and Conclusion. Please confirm it.

 

 

Sincerely

 

Professor, Hieyong Jeong, PhD

Chonnam National University

EMAIL: [email protected]

Author Response File: Author Response.pdf

Reviewer 2 Report

The Paper is sound and well wiritte.

Mabey it would be good to point out a little bit more the scientific contribution of the work, since it seems more a developement topic.

 

Author Response

Dear Reviewer #2

 

Thank you for your review. According to your comments, I revised my manuscript as follows. Please confirm it.

 

Comment #1

The Paper is sound and well written.

Mabey it would be good to point out a little bit more the scientific contribution of the work, since it seems more a developement topic.

 

Response #1

Thank you for your comment. Actually, there is no point-of-care device in healthcare for pelvic organ prolapse by self-checking. Just there are non-surgical methods such as pelvic exercise, pessaries, etc which are not the system. It is very important to develop the device to operate by herself. I am sure that the proposed system of this study is the first step in the world.

 

Sincerely

 

Professor, Hieyong Jeong, PhD

Chonnam National University

EMAIL: [email protected]

Author Response File: Author Response.pdf

Reviewer 3 Report

In this study, Myounjae Jun et al. utilized 3D printer technology to develop a ballon-type vaginal endoscope for self-assessment of pelvic organ prolapse. The proposed endoscope is a practical device setup, which not only behaves portable and flexible features, but also provides great potential for point-of-care applications in pelvic organ prolapse disease. Generally, the experiments/devices were well developed, the logic is reasonable, and the manuscript was carefully prepared. I can recommend this manuscript to be published in “Applied Sciences” after the following several minor questions are solved.

1) As the authors mentioned, the proposed device may find its potential household application. However, how to efficiently tell the pathological features? The clinical categories/stages of POP may be better provided for easier recognition.

2) The current resolution is around 1 mm, I am not sure if it is enough to detect the early stage POP? If not, how to improve the resolution, the authors need to discuss this.

3) What is the maximum depth such endoscope can achieve (higher than 140 mm?)? If the depth distance is enough to detect POP (in case at different locations, especially the inner place of vagina)? And the authors should better mark this parameter in Figure 5.

4) What is the detection limit of such endoscope (i.e., acceptable signal-to-noise level)?

5) Figure 9 is suggested to be improved. The minus values is meaningless.

Author Response

Dear Reviewer #3

 

Thank you for your review. According to your comments, I revised my manuscript as follows. Please confirm it.

 

Comment #1

As the authors mentioned, the proposed device may find its potential household application. However, how to efficiently tell the pathological features? The clinical categories/stages of POP may be better provided for easier recognition.

 

Response #1

Thank you for your comment. I added standardization of the description of pelvic organ prolapse to understand the present level for physical exam in the Section of Discussion. As you can see the conventional method, I am sure that you feel like the necessity of this kind of system because the conventional method is only based on the visual observation of medical doctors.

 

 

Comment #2

The current resolution is around 1 mm, I am not sure if it is enough to detect the early stage POP? If not, how to improve the resolution, the authors need to discuss this.

 

Response #2

Thank you for your comment. I added that the setting resolution of sensor is enough to measure the prolapse of stage 0 in the Section of Discussion. Because the prolapse of stage 1 appears less than 1 cm from the vagina, it is necessary to perform the self-checking from stage 0 when feeling something strange. This self-check is connected to prevent the POP from getting worse through the active response and precaution such as exercise, pessaries, etc.

 

 

Comment #3

What is the maximum depth such endoscope can achieve (higher than 140 mm?)? If the depth distance is enough to detect POP (in case at different locations, especially the inner place of vagina)? And the authors should better mark this parameter in Figure 5.

 

Response #3

Thank you for your comment. I added that the setting depth length of endoscope is enough to measure the vagina in the Section of Discussion. Through the results of conventional method, we can get the information of total vaginal length of 10 cm in the medical field. The developed device has the depth length of 14 cm, thus it is enough. Then, the description for the sliding length of 14 cm in Figure 5 is changed according to your comments.

 

 

Comment #4

What is the detection limit of such endoscope (i.e., acceptable signal-to-noise level)?

 

Response #4

Thank you for your good comment. In fact, there is no limit to measure the prolapse with the proposed system because the conventional method is based on the human visual observation. The possible problem is the relationship between the safety and the air pressure for inserting. The high-level air pressure is helpful for inserting the endoscope to the vagina, but there is existed a little danger for the rubber material to be exploded through the high-level air pressure. Although the boundary of air pressure cannot be decided in this study because there is no practical test, we are sure that there is not a serious danger through the pre-test by using the proposed system.

 

 

Comment #5

Figure 9 is suggested to be improved. The minus values is meaningless.

 

Response #5

Thank you for your comment. As you mentioned, Figure 9 was revised. But the minus side is still existed because the minus value indicates the direction of prolapse. Thus, I think that the minus values is meaningful.

 

Sincerely

 

Professor, Hieyong Jeong, PhD

Chonnam National University

EMAIL: [email protected]

 

Author Response File: Author Response.pdf

Round 2

Reviewer 1 Report

1. Figures are not again arranged in parallel with the text when they are written about. The first Figure is placed at the beginning of page 3, and should be below the first paragraph in Chapter 2. Etc.

 

 

2. Although a value and its dimensions are written in the text, it is correct to put a label, name, and unit of measurement of each label in the equation after each equation. Readers will not go to the text to search what it is and what the unit of measurement is. It's a simple rule. And the authors need to correct that.

 

 

The rest is more or less corrected and after arranging the figures and equations, it can be published.

Author Response

Dear Reviewer #1

 

Thank you for your comments. I rearranged all of Figures and added the unit of measurement for each parameter in equations. Please confirm it.

 

Comment #1

Figures are not again arranged in parallel with the text when they are written about. The first Figure is placed at the beginning of page 3, and should be below the first paragraph in Chapter 2. Etc.

 

Response #1

Thank you for your comment. I rearranged all of Figures with related sentences. Please confirm it.

 

 

Comment #2

Although a value and its dimensions are written in the text, it is correct to put a label, name, and unit of measurement of each label in the equation after each equation. Readers will not go to the text to search what it is and what the unit of measurement is. It's a simple rule. And the authors need to correct that.

 

Response #2

Thank you for your comment. I added some sentences which are related to the unit of measurement. Please confirm it.

 

Although you have busy schedules, I would like to give you big thank to review my manuscript.

 

Sincerely

 

Professor, Hieyong Jeong, PhD

Chonnam National University

EMAIL: [email protected]

Author Response File: Author Response.pdf