A vaginal tissue capture, fragmentation and safe removal device

Abstract

The present invention relates to a device for capturing, fragmenting, and safely removing tissue from a mammalian body. The device comprises a double-layered bag (80) for receiving a tissue sample (110), a tissue capturer (70) configured to facilitate placement of the tissue sample (110) into the bag (80) and to temporarily hold the bag (80), a cutting tool (20) configured to cut at least a portion of the tissue sample (110) within the bag (80), and a vaginal plug (100) configured to prevent gas leakage during laparoscopic procedures. The tissue capturer (70) is removably attached to the bag (80), and the cutting tool (20) is configured to cut the tissue sample (110) into spiral pieces (112). The device is particularly useful in the context of gynecological procedures, allowing for the safe and efficient removal of tissue samples (110) through a natural vaginal opening.

Description

[0001] A VAGINAL TISSUE CAPTURE, FRAGMENTATION AND SAFE REMOVAL DEVICE

[0002] Background

[0003] The present invention generally relates to a medical device used in minimally invasive surgical procedures, and more specifically, to a device designed for capturing, fragmenting, and safely removing tissue from the body via the vaginal route.

[0004] In the field of medical surgery, particularly gynecological surgery, the removal of tissue from the body is often a desired or even a requisite procedure. This tissue can take the form of a mass, tumor, or organ, some of which may be cancerous, pre-cancerous, or suspected of being cancerous or pre-cancerous. Traditional surgical techniques can remove these through open surgery or minimally invasive approaches.

[0005] One common benign uterine tumor is the fibroid, found in approximately 75% of all women by the age of 50. Fibroids can cause heavy uterine bleeding, infertility, pressure complaints due to mass effect, or pelvic discomfort. In the United States, they account for approximately 210,000 hysterectomies and 50,000 myomectomies annually. Traditional surgery for fibroids involves large open abdominal incisions for hysterectomy or myomectomy. Minimally invasive laparoscopic surgery for hysterectomy and myomectomy can be performed with much smaller abdominal incisions.

[0006] Morcellation is a procedure where tissue is divided into smaller pieces to allow for removal through small incisions. Sharp morcellation with a scalpel or scissors is an old method applied in vaginal and mini-laparotomy hysterectomies. Morcellation with these devices is manually operated, inefficient, and can cause hand fatigue and carpal tunnel syndrome in the surgeon. To overcome these issues, the first electromechanically assisted (powered) morcellator was approved by the United States Food and Drug Administration (FDA) in 1995. This device and subsequent ones have greatly facilitated the removal of large volumes of tissue from the abdomen by the surgeon, thus enabling the removal of tissue through small incisions for minimally invasive surgical procedures. However, the use of power morcellation devices has been limited by the FDA due to concerns about the potential for spreading tumor cells in the abdominal cavity if a patient has a hidden leiomyosarcoma. Even though the FDA has restricted the use of power morcellation devices, based on published evidence, other morcellation techniques, including vaginal and mini laparotomy morcellation, have the potential to spread tissue fragments. Vaginal hysterectomy, mini-laparotomy hysterectomy, mini-laparotomy myomectomy, total laparoscopic hysterectomy, laparoscopic and open supravaginal hysterectomy (cervical amputation), laparoscopic myomectomy (power morcellation) operations require morcellation.

[0007] Uterine sarcomas account for <5% of uterine cancers. Even if early-stage disease is removed in its entirety, leiomyosarcoma has a poor prognosis due to early hematogenous spread. There is no reliable method for the preoperative diagnosis of leiomyosarcoma and it is difficult to distinguish it from benign fibroids. Since frozen sections are considered unreliable to determine the presence of leiomyosarcoma, the diagnosis is made by postoperative tissue analysis. The stage of the disease is increased as a result of the spread of tumor fragments. However, it is not known whether this elevation is similar to the elevation as a result of the natural course of the disease. In addition, even if not malignant, fibroids can spread to surrounding tissues where they grow parasitically and multiply, causing a difficult-to-treat disease called diffuse peritoneal myxomatous disease.

[0008] In November 2014, the FDA issued a safety communication warning against the use of laparoscopic morcellators in women undergoing myomectomy or hysterectomy, mostly for the treatment of fibroids. This communication was done because of concerns that the morcellator could spread tumor cells in the abdominal cavity when a patient has a hidden leiomyosarcoma. Also, patients undergoing morcellation have an increased risk of intraabdominal disease.

[0009] Uterine leiomyoma is a smoothly circumscribed and benign tumor originating from the smooth muscle surrounding the uterus. Leiomyomas, which are found in 30% of women in the reproductive age group and 77% of women who have undergone hysterectomy, sometimes have an asymptomatic course, whereas increased uterine bleeding, abdominal pain or urinary symptoms may be observed in some involvements. The indication for treatment in asymptomatic women who are symptomatic or planning to become pregnant is surgical excision of the fibroid. In some cases, hysterectomy, i.e. complete removal of the uterus, is necessary in advanced age and / or in the presence of a uterus containing many leiomyomas. The preferred method of surgery has evolved over the years from open surgery to laparoscopic surgery. Laparoscopic surgery facilitates the surgical recovery process in the patient by reducing the size of the incision. This has an effect that makes it difficult to remove the uterus or large fibroids through small surgical incisions, and a technique called morcellation has been developed to prevent this situation. The technique, also known as ‘Power Morcellation’, is applied by reducing the vaginal or intrauterine tissue with the help of a knife mechanism operated by rotating the vaginal or intrauterine tissue by a power motor and the material reduced by laparoscopic and / or intrauterine route is discharged outside the body. Thus, instead of making a large incision for excision, this technique is combined with minimally invasive surgical methods to accelerate the patient's healing process. Power morcellation was declared risky by the US Food and Drug Administration (FDA) in 2014. The reason for this situation is that it increases the risk of injury to the patient with uncontrolled morcellation and the possibility that fragmented tissues may cause ‘tumor seeding’ by showing adhesion to other locations in the body during tumor tissue removal. In order to prevent these risks, balloon bags were placed around the power morcellators and the idea of isolating the fragmented tissues completely in this bag was implemented and tumor seeding was minimized.

[0010] The Power Morcellation technique has several disadvantages mentioned above. Firstly, since the device works by cutting and shrinking the tumor, it increases the possibility of small parts of the tumor spreading into the uterus or abdomen. This brings the risk of the tumor spreading to a point further away from the primary focus. Another possible problem is that the morcellator connected to the power motor may slip from the cut tissue. If the rotating blade system slips from its place, there is a risk of damaging unwanted tissues and causing complications. In tumor / hysterectomy surgeries where morcellation is not used, laparoscopic or hysteroscopic reduction of the tissues to be surgically removed from the area is required. If these cannot be achieved, these procedures cannot be performed, instead open surgery is performed with a large abdominal incision, which adversely affects the patient's recovery time and increases the risk of complications. Also, the production and design of medical devices brings along several costs. In cases where these costs can be eliminated with simple solutions, hospitals or medical personnel may experience financial difficulties due to excessive resource utilization.

[0011] There are some studies aiming to solve these problems in the known state of the art., Carter et al. (Carter JE, McCarus SD. Laparoscopic myomectomy. Time and cost analysis of power vs. manual morcellation. J Reprod Med. 1997;42(7):383-8) compared 28 patients in terms of manual and power morcellation techniques in their study. According to this study, power morcellators were found to be more successful than manual morcellation technique in terms of both time and material.

[0012] Since 2014, when the use of morcellators was declared risky by the FDA, many studies have been conducted to eliminate these risks.

[0013] Cohen et al. (Cohen SL, Einarsson JI, Wang KC, Brown D, Boruta D, Scheib SA, et al. Contained power morcellation within an insufflated isolation bag. Obstet Gynecol.

[0014] 2014;124(3):491-7.f applied the balloon bag technique. In this technique, a plastic balloon is passed around the tissue to be morcellated and morcellation is performed after it is determined that the tissue is completely inside the bag and thus the risk of tumor budding is eliminated.

[0015] In United States patent application no. US20180161054A1, which is included in the state of the art, discloses a surgical morcellator device with a denticulate shield. In summary, the invention is a morcellator with a specialized shield designed to trap loose tissue fragments and prevent their spread during the morcellation procedure.

[0016] In United States patent no.US11071562B2, which is included in the state of the art, discloses, a reusable universal tissue morcellator system which comprising a morcellator hand piece, a cutter blade has two sets of pin-holes, an obturator has a head with pin- holes to lock it to the morcellator handle, a motor drive unit has a touch screen and manual controls.

[0017] Object of Invention

[0018] The object of the present disclosure is to provide a device and method for capturing, fragmenting, and safely removing tissue from the body via the vaginal route during minimally invasive surgical procedures. Removal of these tissues through the vaginal route does not require the need for abdominal wall incision and prevents the spread of cancer cells during vaginal removal and makes this procedure safer and more effective. It aims to utilize the advantages of minimally invasive surgical methods used in vaginal hysterectomy or myomectomy procedures that require large abdominal incisions in traditional surgical methods.

[0019] The present disclosure aims to address the problem of safely and efficiently removing tissue, such as fibroids and other intra- abdominal tumors, from the body during minimally invasive surgical procedures. Traditional surgical methods often require large abdominal incisions, which can lead to longer recovery times and increased risk of complications. Furthermore, existing morcellation techniques, while enabling the removal of tissue through smaller incisions, carry the risk of spreading cancer cells if the tissue being removed is malignant. The present disclosure seeks to overcome these challenges by providing a device that allows for the safe and efficient removal of tissue through the natural vaginal opening, thereby reducing the risk of spreading cancer cells and eliminating the need for large abdominal incisions.

[0020] Brief Description of Figures

[0021] Figure 1- Multiple angle view of the cutting tool on the vaginal tissue capture, fragmentation, and safe removal device

[0022] Figure 2- A top view of the cutting tool of the device

[0023] Figure 3- A perspective view of the cutting tool of the device Figure 4- A perspective view of the tissue capturer and double layer bag open Figure 5- A perspective view of the double-layer bag in the open state

[0024] Figure 6- A perspective view of the vaginal plug and tissue capturer in the open state Figure 7- Side drawing view of the power transmitter safety stop adapter

[0025] Figure 8- Side view of the rotor, cutting tool and power transmitter safety stopper from the parts of the system

[0026] Figure 9- View of how the vaginal plug, tissue capturer and bag are positioned inside the patient from the side with the bag open

[0027] Figure 10- Side view with tissue cutting tool and bag open

[0028] Figure 11- Side drawing view of all parts of the system, bag, cutting tool, rotor and power transmitter safety stop power adapter

[0029] The reference numbers in the figures are as follows:

[0030] 10. Insert tip

[0031] 12. Helical support

[0032] 14. Blade

[0033] 16. Conical tip

[0034] 18. Metal cylinder

[0035] 20. Cutting tool

[0036] 30. Safety stop power adapter

[0037] 32. Housing

[0038] 34.Rotational platform

[0039] 36. Collars 38. Proximal end

[0040] 40. Recess

[0041] 42. Distal end

[0042] 44. Coupling switch

[0043] 46. Spring

[0044] 50. Rotor

[0045] 52. Threaded connection

[0046] 54. Keyless Chuck

[0047] 56. Clutch torque setting

[0048] 58. Rotational Motor and circuits 60. Handle

[0049] 62. Trigger

[0050] 64. Battery

[0051] 70. Tissue capturer

[0052] 72. Handle

[0053] 74.Booster arm 76.Reinforcement member 78. Atraumatic arm end

[0054] 80. Double layer bag

[0055] 82. Outer layer

[0056] 84. Inner layer 86. Rope

[0057] 88. Tensioner

[0058] 100. Vaginal plug

[0059] 102. Lumen

[0060] 104. Leaf-shaped valve

[0061] 110. Tissue sample

[0062] 112. Spiral pieces

[0063] Detailed Description

[0064] The present invention relates to a device and a system, for capturing, fragmenting, and safely removing tissue from a mammalian body. More specifically, the device comprises a double-layered bag (80) for receiving a tissue sample (110), a tissue capturer (70) configured to facilitate the placement of the tissue sample (110) into the bag (80) and to temporarily hold the bag (80), a cutting tool (20) configured to cut at least a portion of the tissue sample (110) within the bag (80), and a vaginal plug (100) configured to prevent gas leakage during laparoscopic procedures.

[0065] In some aspects of the device, the tissue capturer (70) is removably attached to the bag (80), and the cutting tool (20) is configured to cut the tissue sample (110) into spiral pieces (112). The tissue capturer (70) may be configured to expand and contract within the pelvic region to facilitate the placement and temporary holding of the bag (80). The tissue capturer (70) may comprise at least one atraumatic arm end (78) that is removably attached to pockets (90) located near the opening of the bag (80), thereby facilitating the placement and temporary holding of the bag (80) in the pelvic region.

[0066] The capturer (70), which may include a handle (72), one or more booster arms (74) or reinforcement members (76) that are separate from the bag (80). The cutting tool (20) may comprise a metal cylinder (18), an insert tip (10), a conical tip (16) for directing and contacting the tissue sample (110) and a helical support (12) for maintaining the blade (14) in a parallel orientation to the axis of the cutting tool (20). This conical tip (16) can facilitate the precise placement of the cutting tool (20) within the tissue sample (110), thereby enhancing the accuracy and efficiency of the tissue cutting process. The conical tip (16) may also provide a contact surface for the tissue sample (110), which can help to stabilize the cutting tool (20) during the cutting process and prevent unwanted movement or displacement of the cutting tool (20).

[0067] The helical support (12) can provide structural support to the blade (14), thereby enhancing the stability and durability of the cutting tool (20). The helical support (12) can also help to maintain the blade (14) in a parallel orientation to the axis of the cutting tool (20), which can facilitate a uniform and consistent cutting action across the tissue sample (HO).

[0068] The double-layered bag (80) may be made of a material resistant to cutting and puncturing, such as poly-paraphenylene terephthalamide. The vaginal plug (100) may comprise a lumen (102) for the passage of instruments into the pelvic cavity, and at least one leaf-shaped valve (104) for preventing gas leakage.

[0069] In some cases, the device may further comprise a safety stop power adapter (30) configured to transmit rotational motion from a rotor (50) to the cutting tool (20), and to cease transmission of rotational motion when resistance or pressure from the tissue sample (110) decreases. This ensures safe and controlled operation of the cutting tool (20).

[0070] The safety stop power adapter (30) is a mechanism that transfers the rotation movement coming from the rotor (50) or manually to the insert tip (10), starts to work with the pressure or resistance created by the tissue sample (110), and stops transferring the rotation movement when the resistance decreases. Figure 7 shows a proximal end (38) which transmits the rotational movement and is connected to the rotor (50), a distal end (42) of circular cross-section with a triple wave standing in the housing, a proximal end (38) which receives the rotational movement from the distal end (42) with a hexagonal wave and a recess (40) which allows the proximal end (38) of the insert tip (10) to enter into its circular cross-sectional surface. The safety stop power adapter (30) comprises a cylindrical housing (32) which allows the system to be closed, a spring (46) which prevents the proximal ends (38) of the adapter (30) from coming into contact with each other in the absence of pressure, and collars (36) which restrict the axial movement of the distal (42) and proximal ends (38), preventing the distal end (42) and proximal end (38) from leaving the adapter (30). The components of the adapter (30) may be made of hard, strong, durable metal. The pattern of the coupling ends may vary. The resistance of the spring (46), diameters, size of the fittings may vary. This part (30) serves to ensure the formation of the coupling connection with the pressure while processing the tissue sample and the rotation of the sharp tip when the cutting of the tissue sample is completed, and the pressure is reduced.

[0071] The device and the system, of the present disclosure provide a technical advantage in that they allow for the safe and efficient removal of tissue from a mammalian body. The cutting tool's (20) ability to cut the tissue sample (110) into spiral pieces (112) facilitates the removal of the tissue through a natural body opening, such as the vagina, thereby minimizing the risk of spreading cancer cells and making the procedure safer and more effective. The double-layered bag (80), made of a material resistant to cutting and puncturing, provides a secure containment for the tissue sample (110), preventing the spread of potentially harmful biological materials within the patient's body cavity. The tissue capturer (70), which is removably attached to the bag (80), allows for easy manipulation of the bag (80) and placement of the tissue sample (110) therein. The vaginal plug (100) prevents gas leakage during laparoscopic procedures, further enhancing the safety and efficiency of the procedure.

[0072] In some aspects, the device includes a double-layered bag (80) for receiving a tissue sample (110). The bag may have an outer layer (82) and an inner layer (84). The outer layer (82) and the inner layer (84) may be made of a material that is resistant to cutting and puncturing, such as poly-paraphenylene terephthalamide. This material can provide a secure containment for the tissue sample (110), preventing the spread of potentially harmful biological materials within the patient's body cavity during the tissue removal process.

[0073] In some cases, the tissue capturer (70) is removably attached to the bag (80). This allows for easy manipulation of the bag and placement of the tissue sample therein. The tissue capturer (70) can be configured to facilitate the placement of the tissue sample (110) into the bag (80) and to temporarily hold the bag. Once the tissue sample (110) is placed into the bag (80), the tissue capturer (70) can be easily detached from the bag (80), allowing for the subsequent steps of the tissue removal process to be carried out.

[0074] In some aspects, the tissue capturer (70) is configured to expand and contract within the pelvic region. This ability to expand and contract can facilitate the placement of the tissue sample (110) into the bag (80) and the temporary holding of the bag. The tissue capturer (70) may include at least one atraumatic arm end (78) that is removably attached to pockets (90) located near the opening of the bag (80). This configuration allows the tissue capturer (70) to be easily detached from the bag (80) after the tissue sample (110) has been placed into the bag, thereby facilitating the subsequent steps of the tissue removal process.

[0075] In some aspects, the tissue capturer (70) can be introduced into the pelvic cavity through a cannula with a hollow center. The capturer (70) part can be partially folded and can partially protrude from the cannula when it expands into a conical shape. The atraumatic arm ends (78) of the tissue capturer (70) fit into the pockets (90) at the end of the double -layered bag (80), keeping the bag (80) open. When the mouth of the bag (80) is closed by pulling a string, the tissue capturer (70) can be easily separated from the bag (80). This configuration allows for easy manipulation of the bag (80) and placement of the tissue sample (110) therein, thereby facilitating the subsequent steps of the tissue removal process.

[0076] The vaginal plug (100) may be configured to prevent gas leakage during laparoscopic procedures. This can be particularly beneficial in maintaining the insufflation of the pelvic cavity during the tissue removal process, thereby enhancing the visibility and accessibility of the surgical field. The vaginal plug (100) may comprise a lumen (102) for the passage of instruments into the pelvic cavity. This lumen (102) can facilitate the introduction and removal of various surgical instruments, such as the tissue capturer (70) and the cutting tool (20), thereby enhancing the versatility and convenience of the device.

[0077] The leaf-shaped valve (104) can provide a seal against the escape of insufflation gas from the pelvic cavity through the vaginal opening. The leaf-shaped valve (104) can be designed to open to allow the passage of instruments through the lumen (102), and to close to prevent gas leakage when no instrument is present in the lumen (102). This can help to maintain the insufflation pressure within the pelvic cavity during the tissue removal process, thereby enhancing the safety and efficiency of the procedure.

[0078] In some embodiments, the vaginal plug (100) may be made of a flexible and biocompatible material, such as silicone, which can conform to the shape of the vaginal opening and provide a comfortable and secure fit. The vaginal plug (100) may also be designed for easy insertion and removal, and may be reusable or disposable, depending on the specific requirements of the procedure.

[0079] The tissue sample (110) that is placed into the bag (80) may comprise a myoma, uterus, fallopian tube, and ovary. These tissues are typically found in the pelvic region of a mammalian body and may be subject to various medical conditions that necessitate their removal. For instance, a myoma, also known as a fibroid, is a benign tumor that develops in or around the uterus and can cause symptoms such as heavy menstrual bleeding, pelvic pain, and fertility problems. Similarly, conditions such as ovarian cysts, endometriosis, and uterine prolapse may require the removal of the ovary, fallopian tube, or uterus, respectively.

[0080] In some cases, the tissue sample (110) may comprise a myoma. Myomas are common benign tumors that can cause various symptoms and complications, depending on their size and location. The ability to safely and efficiently remove myomas through a natural body opening, such as the vagina, can provide a technical advantage in terms of reducing the risk of complications and improving patient recovery times. In other cases, the tissue sample (110) may comprise a uterus. Conditions such as uterine fibroids, endometriosis, and uterine prolapse may necessitate the removal of the uterus. The disclosed device, system, and method can facilitate the safe and efficient removal of the uterus through a natural body opening, thereby minimizing the risk of spreading cancer cells and making the procedure safer and more effective.

[0081] In yet other cases, the tissue sample (110) may comprise a fallopian tube or an ovary. Conditions such as ectopic pregnancy, ovarian cysts, and ovarian cancer may necessitate the removal of the fallopian tube or ovary. The disclosed device, system, and method can facilitate the safe and efficient removal of these tissues through a natural body opening, thereby minimizing the risk of spreading cancer cells and making the procedure safer and more effective.

[0082] In some aspects, the method for capturing, fragmenting, and safely removing tissue from a mammalian body may include several steps. Initially, a portion of a double-layered bag (80) may be introduced into a pelvic cavity of a patient through the patient's vagina. This bag (80) may be made of a material resistant to cutting and puncturing, such as polyparaphenylene terephthalamide, providing a secure containment for the tissue sample (110) and preventing the spread of potentially harmful biological materials within the patient's body cavity.

[0083] Subsequently, a tissue sample (110) may be placed into an inner part of the bag (80). The tissue sample (110) may comprise a myoma, uterus, fallopian tube, and ovary, depending on the specific medical condition necessitating the tissue removal. The mouth of the bag (80) may then be closed, for instance, by sliding a knot and string, thereby securing the tissue sample (110) within the bag (80).

[0084] Following this, a cutting tool (20) may be introduced into an inner part of the tissue container through the vagina. This cutting tool (20) may comprise a conical tip (16) for directing and contacting the tissue sample (110) and a helical support (12) for maintaining the blade (14) in a parallel orientation to the axis of the cutting tool (20). This configuration of the cutting tool (20) can facilitate a uniform and consistent cutting action across the tissue sample (110).

[0085] The cutting tool (20) may be configured to cut at least a portion of the tissue sample (110) within the bag (80). In some cases, the cutting tool (20) may be configured to cut the tissue sample (110) into spiral pieces (112), facilitating the efficient fragmentation and removal of the tissue sample (110) from the patient's body.

[0086] Finally, the tissue sample (110) may be removed from the inner part of the tissue container through the vagina using the cutting tool (20). This removal process may be facilitated by the spiral pieces (112) of the tissue sample (110), which can be easily extracted through a natural body opening, such as the vagina, thereby minimizing the risk of spreading cancer cells and making the procedure safer and more effective.

[0087] In summary, the disclosed method provides a technical advantage in that it allows for the safe and efficient removal of various types of tissue samples, including myomas, uteruses, fallopian tubes, and ovaries, from a mammalian body. The ability to cut the tissue sample into spiral pieces facilitates the removal of the tissue through a natural body opening, thereby minimizing the risk of spreading cancer cells and making the procedure safer and more effective. The double-layered bag (80), made of a material resistant to cutting and puncturing, provides a secure containment for the tissue sample (110), preventing the spread of potentially harmful biological materials within the patient's body cavity. The vaginal plug (100) prevents gas leakage during laparoscopic procedures, further enhancing the safety and efficiency of the procedure.

[0088] In some cases, the cutting tool (20) can be operated manually, without the use of a rotor (50). This variation allows for greater control over the cutting process, as the rotational motion for the cutting tool (20) can be provided by the operator's hand, using a handle attached to the cutting tool (20). This manual operation of the cutting tool (20) can be particularly advantageous in situations where precise control over the cutting process is desired, such as when dealing with delicate or sensitive tissues. Furthermore, the device includes a vaginal plug (100) configured to prevent gas leakage during laparoscopic procedures. This feature enhances the safety and efficiency of the procedure by maintaining the insufflation of the pelvic cavity, thereby enhancing the visibility and accessibility of the surgical field.

[0089] For a better understanding of the invention there are some reference numerals included in the figures but not in the main object of the claims. The functions of these features can be explained as follows.

[0090] Rotational platform (34) is a part inside the rotating parts to provide easy rotation and prevent axle slipping. Coupling switch (44) is a spanner to enable easy assembly with the part of the rotor. Threaded connection (52), also known as adjustable jaws, is a retractable jaw for catching the distal end. Keyless Chuck (54) is a holder that allows the user to mount and hold different tools such as drill.

Claims

CLAIMS1. A device for capturing, fragmenting, and safely removing tissue from a mammalian body, the device comprising: a double-layered bag (80) for receiving a tissue sample (110), the bag having an outer layer (82) and an inner layer (84); a tissue capturer (70) configured to facilitate placement of the tissue sample (110) into the bag (80) and to temporarily hold the bag (80); a cutting tool (20) configured to cut at least a portion of the tissue sample (110) within the bag; and a vaginal plug (100) configured to prevent gas leakage during laparoscopic procedures, wherein the device is characterized in that the tissue capturer (70) is removably attached to the bag (80), and the cutting tool (20) is configured to cut the tissue sample (110) into spiral pieces (112).

2. The device of claim 1, wherein the tissue capturer (70) is configured to expand and contract within the pelvic region to facilitate the placement and temporary holding of the bag (80).

3. The device of claims 1 or 2, wherein the tissue capturer (70) comprises at least one atraumatic arm end (78) that is removably attached to pockets (90) located near the opening of the bag (80).

4. The device of claims 1 to 3, wherein the cutting tool (20) comprises a conical tip (16) for directing and contacting the tissue sample (110) and a helical support (12) for maintaining the blade (14) in a parallel orientation to the axis of the cutting tool (20).

5. The device of claims 1 to 4, wherein the double-layered bag (80) comprises an inner layer (84) and an outer layer (82) which are made of a material resistant to cutting and puncturing, such as poly-paraphenylene terephthalamide.

6. The device of claims 1 to 5, wherein the double-layered bag (80) is made of any of selected from at least one polyethylene, polyurethane, polypropylene, PET, PETG, aramid and para-aramids.

7. The device of claims 1 to 6, wherein the vaginal plug (100) comprises a lumen (102) for the passage of instruments into the pelvic cavity, and at least one leaf-shaped valve (104) for preventing gas leakage.

8. The device of claims 1 to 7, further comprising a safety stop power adapter (30) configured to transmit rotational motion from a rotor (50) to the cutting tool (20), and to cease transmission of rotational motion when resistance or pressure from the tissue sample (110) decreases.

9. A system for capturing, fragmenting, and safely removing tissue from a mammalian body, the system comprising:a double-layered bag (80) for receiving a tissue sample (110), the bag having an outer layer (82) and an inner layer (84);a tissue capturer (70) configured to facilitate placement of the tissue sample (110) into the bag (80) and to temporarily hold the bag (80);a cutting tool (20) configured to cut at least a portion of the tissue sample within the bag (80);a vaginal plug (100) configured to prevent gas leakage during laparoscopic procedures; anda safety stop power transfer (30) configured to transfer rotational motion from a rotor (50) to the cutting tool (20),wherein the system is characterized in that the tissue capturer (70) is removably attached to the bag (80), and the cutting tool (20) is configured to cut the tissue sample (110) into spiral pieces (112).

10. The system of claim 9, wherein the tissue capturer (70) comprises at least one atraumatic arm end (78) that is removably attached to pockets (90) located near theopening of the bag (80), thereby facilitating the placement and temporary holding of the bag (80) in the pelvic region.

11. The system of claims 9 or 10, further comprising a safety stop power adapter (30) configured to transmit rotational motion from a rotor (50) to the cutting tool (20), and to cease transmission of rotational motion when resistance or pressure from the tissue sample (110) decreases, thereby ensuring safe and controlled operation of the cutting tool (20).

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