专利摘要:
Laparascopic morcellation bag and laparascopic morcellation kit including a morcellation bag. The invention relates to a morcellation bag (1) comprising at least one film of plastic material, joined to define a surface (2) of the bag with a first closed end (3a) and a second open end (3b) for inserting surgical pieces (150) and a morcellator (210); characterized in that it is provided with at least one transparent region (5), said transparent region having an area of at least 1 cm2 and a thickness of less than 200μm; said transparent region being made of a material or materials with a total transmittance greater than 80%, a clarity greater than 80% and a veil effect less than 25%. (Machine-translation by Google Translate, not legally binding)
公开号:ES2768103A1
申请号:ES201831245
申请日:2018-12-19
公开日:2020-06-19
发明作者:Maxime Pierrick Fransois Bureau;De Con Inigo Abreu;Martin Carolina Vera
申请人:Deflastrat S L Soc Unipersonal;
IPC主号:
专利说明:

[0003] Object and technical sector of the invention
[0004] The present invention is framed within the technical sector of medical devices and instruments.
[0006] More particularly, the present invention relates to a laparoscopic morcellation bag, as well as a laparoscopic morcellation kit including a morcellation bag, for use, for example and without limitation, in hysterectomy and myomectomy procedures.
[0008] Background of the Invention
[0009] Laparoscopy is a surgical technique that involves the introduction of medical instruments into the patient's pelvic and / or abdominal cavity through at least one small incision that -usually- has a length of between 0.5 and 1.5 cm.
[0011] It is a minimally invasive surgery, which is why it is frequently used, among other applications, in women with gynecological pathologies. For example and without limitation, in interventions of hysterectomy (total or partial removal of the uterus) and myomectomy (removal of fibroids).
[0013] Compared to laparotomy - a surgical intervention that involves opening the abdominal walls and exposing the underlying organs - laparoscopic surgeries have, among others, the following advantages: reduction in hospital stay time, reduction in recovery time and reduced morbidity.
[0015] In order to be able to use surgical procedures based on laparoscopy, it is sometimes necessary to resort to electromechanical morcellation (EEM) procedures. These morcellation procedures consist, roughly speaking, of cutting at least one surgical piece (that is, at least a portion of the patient's tissue) into a smaller piece, using a surgical instrument called a morcellator, so that they can be removed from the patient's body through a small incision made for a trocar, without it being necessary to make additional incisions, or to enlarge the incision or incisions previously made to introduce the medical instruments.
[0017] In 2014, the official US agency Food and Drug Administered (FDA) issued a statement advising against the use of EEM for hysterectomy and myomectomy in women with uterine fibroids with suspected tumor development, due to the risk of involuntary spread of a malignancy. The FDA estimated the risk of hidden sarcoma at 1 in 350.
[0019] In view of this, in the sector there was a need to develop devices that allowed the use of laparoscopic techniques in surgical processes such as hysterectomy and myomectomy, and that, at the same time, eliminated or significantly reduced the risk of involuntary spread of malignant cells. coming from the surgical piece or pieces. This process culminated with the appearance of the so-called “morcellation bags”.
[0021] The morcellation bags are inserted into the patient's pelvic-intestinal cavity in order to carry out morcellation operations inside. In this way, it is possible to confine morcellation in a closed space isolated from the patient's tissues, to avoid the involuntary spread of malignant cells. Some 600,000 hysterectomies are currently performed in the United States, of which 30% are performed by laparoscopic surgery, the procedure of all these operations is currently evolving to be performed with morcellation bags.
[0023] However, currently available morcellation bags have numerous disadvantages.
[0025] Thus, for example, in US patent US 9044210 morcellation bags are disclosed that are necessarily provided with two different open ports (or ports):
[0026] - an open main port, through which the piece or surgical pieces are inserted and the morcellator (apparatus with which morcellation is performed); and
[0027] - an open side port, through which optical devices and insufflation devices are inserted.
[0028] Optical devices allow the medical team to maintain a vision of the interior of the bag in order to carry out morcellation. In this sense, it is especially important that the medical team can determine without error the separation between the morcellator blade and the bag to ensure the integrity of the bag and avoid iatrogenesis (damage by medical acts).
[0030] Insufflation devices are used to inflate the morcellation bag by introducing a gas into it, for example carbon dioxide, to increase its size and leave enough space within the bag for medical equipment to perform morcellation.
[0032] Morcellation bags according to US patent US 9044210 are difficult to use because, for this, it is necessary that the incisions made in the patient's skin coincide with the ports of the bag. In addition, its placement procedure is long and requires the completion of numerous different stages (more than 15), which means that the intervention time is also long and there are many possibilities of making mistakes.
[0034] Likewise, these morcellation bags are not totally hermetic because the open side port, which can become contaminated if it comes into contact with the surgical part or pieces, or pieces of them (which come off during morcellation), necessarily passes again through the patient's abdomen during the process of removing the morcellation bag. This reduces the risk of contamination of the abdomen, compared to the morcellation processes carried out without a bag, but does not completely eliminate it.
[0036] On the other hand, the patent application no US 20160183932 discloses morcellation bags provided with a single open port. These bags have the following drawbacks:
[0038] - To use them, it is necessary to perform a laparotomy in the abdomen, so in most cases, the incision that must be made is large enough to remove the surgical piece or pieces without the need for morcellation; and
[0039] - Optical devices and morcellator must be inserted through the same incision in the abdomen. This reduces lateral vision of the morcellator end more than 70%, in addition to generating many vision dead spots.
[0041] Patent applications Nos. US 20140236167, US 20140236168 and US 20130184536, disclose morcellation bags provided with a single open port, through which the surgical part or parts, the morcellator and the insufflation devices are inserted. In these morcellation bags, the optical devices are inserted by perforating the wall of the bag, using an additional second trocar.
[0043] Drilling the bag inside the patient's abdomen cancels its tightness. Furthermore, the second trocar - when drilling the morcellation bag - comes into contact with the interior thereof, which may be contaminated by the surgical part or pieces, or pieces thereof. During the extraction of said second trocar, the sheath of said device necessarily passes through the abdominal wall, potentially contaminating it.
[0045] Likewise, the optical devices also come into contact with the interior of the morcellation bag without being provided with protection, so they suffer the risk of contamination. This seriously makes it difficult for such optical devices to be reused.
[0047] In fact, this last solution proposed in the state of the art, which consists of introducing the optical devices piercing the wall of the morcellation bag, has been rejected by the FDA health authorities, due to the risk of contamination that it entails.
[0049] Definitions
[0050] Throughout this specification, the “total transmittance” of a material should be understood as the amount of light expressed as a percentage that is transmitted through said material, with respect to the total amount of incident light, measured according to the standard International ASTM 1003, using a transmission beam meter (in English, hazemeter).
[0052] Total transmittance has two components:
[0053] - direct transmittance: that is, the proportion of light that is transmitted through the material without changing its direction; and
[0054] - diffuse transmittance: that is to say, the proportion of light that, when transmitted, is scattered (i.e., its direction varies). This dispersion may be due to both reflections of light on the surface of the material and reflections inside the material.
[0056] Likewise, it should be understood that the “clarity” of a material is the proportion of light transmitted through said material that is scattered at an angle less than 2.5 °, measured according to international standard ASTM 1003, using a beam measurement transmission (in English, hazemeter).
[0058] Finally, it should be understood that the “veil effect” (in English, “haze”) of a material is the proportion of light transmitted through said material that is scattered at an angle greater than 2.5 °, measured according to the standard International ASTM 1003 using a transmission beam measurement (in English, hazemeter).
[0060] General description of the invention
[0061] In order to solve the problems described in relation to the prior art, a first object of the present invention relates to a laparascopic morcellation bag comprising:
[0062] - at least one film of plastic material, joined in a way that defines a surface of the bag;
[0063] - said surface of the bag having a first closed end and a second open end, the second open end being a port for introducing at least one surgical piece and a morcellator,
[0064] said laparascopic morcellation bag being characterized in that it is provided with at least one transparent region, said transparent region having an area of at least 1 cm2 and a thickness of less than 200 gm and said transparent region being made of a material or a combination of materials with a total transmittance greater than 80%, a clarity greater than 80% and a veil effect less than 25%.
[0066] The open end of the morcellation bags, according to the present invention, serves as a port to introduce one or more surgical parts of the patient into the bag and isolate them, thus preventing them from coming into contact with the surface. inside of your abdomen. A trocar is subsequently attached to said open end, that is, a medical device provided with a conduit, which facilitates access of the surgical instruments to the interior of the bag. This trocar is provided with valves sealing (a sealing valve and a non-return valve) as well as a connection to the insufflation device. A morcellator, a surgical device intended to morcel (chop) the surgical pieces, is inserted through the trocar duct.
[0068] On the other hand, the transparent region provided in the morcellation bags according to the present invention allows the optical devices, when coming into direct contact with said transparent region, to maintain a vision of the interior of the bag, without this being necessary pierce its surface. This also avoids the need to provide the bag with a second open port intended for the introduction of optical devices and also avoids that the optical devices have to be introduced through the same open port through which the morcellation pieces and the morcellator are introduced, thus avoiding contamination of the optical devices. Finally, the morcellation bags according to the present invention allow medical personnel to have a continuous view of the interior of the abdominal cavity, even during the extraction of the bag after the morcellation is finished, without blind maneuvers since the optical device is always out of the bag. All this translates into a reduction in waiting and intervention times and a lower risk of error, compared to the morcellation bags of the state of the art.
[0070] In a preferred embodiment of the present invention, the transparent region is made of a material or a combination of materials with a total transmittance greater than 90%, a clarity greater than 90% and a veil effect less than 4%.
[0072] The transparent region provided in the morcellation bag according to the invention preferably has a thickness of 80gm. Also, the transparent region may preferably be made of polyurethane, polyester, polypropylene, polyethylene, polycarbonate, silicone, and / or combinations thereof.
[0074] In another preferred embodiment of the morcellation bag according to the present invention, the second open end of the bag surface is provided with a guide wire. Said guide wire is intended to remain outside the patient's abdomen during the surgical intervention, to facilitate the subsequent removal of the morcellation bag.
[0075] In a further preferred embodiment of the morcellation bag according to the present invention, the second open end of the bag surface is provided with a flexible ring, with a Shore A <90 hardness which gives it a shape memory. This configuration allows the second end to be opened more easily, once the morcellation bag has been inserted inside the patient's abdomen and therefore facilitates the insertion of the surgical piece or pieces, inside said bag .
[0077] In a more preferred embodiment of the invention, the flexible ring is of a color that allows it to be easily distinguished from the patient's organs. The fact that the flexible ring is colored allows it to be easily recognizable inside the patient's abdomen, therefore preventing said ring from being mistaken for a patient's organ. A preferred option is for the flexible ring to be black.
[0079] In another embodiment of the present invention, the flexible ring is attached to a guide wire.
[0081] In another embodiment of the present invention, the flexible ring is replaced by the loop-bent guidewire, said loop forming part of a tie-knot joint.
[0083] This loop, with the tie knot type connection, allows the bag inlet to be closed automatically by pulling the guide wire, preventing the surgical piece from escaping from the bag. The bag entrance is reopened manually once outside the abdomen to allow insertion of the trocar.
[0085] In another embodiment of the laparoscopic morcellation bag according to the invention, the transparent region occupies an area greater than 60% of the total area of the bag surface, preferably an area greater than 80% of the total area of the bag surface and more preferably, an area equal to the total area of the bag surface. In the latter case, the entire surface of the bag is made of transparent material. As it is made entirely of transparent material, it allows you to place the optical devices at any point of the same to see its interior.
[0087] In a further embodiment of the invention, the bag surface is folded into an accordion. This specific type of folding makes it possible for the morcellation bag automatically expands once it has been inserted into the patient's abdominal cavity.
[0089] According to the present invention, the bag surface preferably has a rounded shape. In this way, the presence of folds and spikes that may disturb the vision when supporting the optical devices against the transparent region of the inflated morcellation bag is avoided.
[0091] In another embodiment of the present invention, the surface of the bag is telescopically folded. This type of folding ensures that the morcellation bag expands automatically once it has been inserted into the patient's abdominal cavity and also facilitates complete sterilization of the bag, that is, down to the bottom of the bag , in case of sterilization with ethylene oxide gas.
[0093] In a preferred embodiment of the invention, the morcellation bag is provided with at least one recess comprising an open outer mouth, a lateral surface hermetically attached to the surface of the bag, and a closed bottom, in turn hermetically attached to said lateral surface, the closed bottom also being provided with a transparent region of an area of at least 1 cm2 and a thickness of less than 200 gm and said transparent region being made of a material or a combination of materials with a total transmittance greater than 80% , a clarity of over 80% and a veil effect of less than 25%.
[0095] In this embodiment of the invention, described in the previous paragraph, the recess is tube-shaped and is intended to house the optical devices inside. Said recess has a closed bottom provided with a transparent surface that allows the optical devices to see the inside of the bag, without it being necessary to make any opening or hole to the surface of the bag. Also, the recess is completely hermetic to avoid any possible contamination of the optical devices.
[0097] The previously described cavities also improve the vision of the interior of the bag in those cases where the inner wall of the morcellation bag becomes dirty and help to fix the optical devices, limiting their movement.
[0098] The lateral surface of the recess is generally tubular in shape. However, the present invention also contemplates the possibility that said lateral surface is trapezoidal.
[0100] This trapezoidal embodiment facilitates the introduction of the optical devices and limits their movement once they have been inserted into the cavity. In addition, the fact that the mouth of the cavity is narrower than the bottom of the cavity means that, when inflating the morcellation bag, the resulting pressure fits the cavity to the optical devices through the mouth of the cavity, helping to retain better said optical devices and further limiting their movement.
[0102] In a preferred embodiment of the invention, the recess is provided with at least one protruding tongue. Said tab or tabs facilitate the introduction of the optical devices into the cavity, once the morcellation bag has been inserted into the patient's abdominal cavity.
[0104] In another preferred embodiment of the invention the width of the second open end of the bag is between 17 and 20 cm. This width is considered sufficient to be able to introduce the vast majority of the surgical pieces obtained in this type of procedure into the morcellation bag. In fact, it is estimated that the largest surgical piece to insert into the morcellation bag would be a uterus, weighing approximately 1 kg and about 15 cm in diameter.
[0106] Also, in a last preferred embodiment of the invention, the bag surface has an elastic shore rigidity greater than A70, an elongation at break greater than 100%, a mechanical resistance to rupture greater than 40MPa and a temperature of continuous use greater 115 ° C.
[0108] A second object of the present invention relates to a laparoscopic morcellation kit comprising:
[0110] - a laparascopic morcellation bag according to the first aspect of the invention;
[0111] and
[0112] - an introducer tube containing the laparascopic morcellation bag folded inside.
[0114] In a preferred embodiment of the present invention, the laparoscopic morcellation kit comprises a trocar with a diameter of between 15 to 20 mm and a length of between 70 and 100 mm, said trocar also being provided with a connection socket for insufflation devices .
[0116] Throughout the description, reference will only be made for simplicity to the fact that the morcellation bag is provided with a single transparent region. It is important to note, however, that the present invention also expressly contemplates the possibility that the morcellation bag is provided with two or more different transparent regions or that the entire bag is transparent.
[0118] Also, throughout the description, reference will only be made, for simplicity, to a single cavity (in those embodiments of the invention that are provided with this element). It is important to note, however, that the present invention also expressly contemplates the possibility that the morcellation bag is provided with two or more different cavities.
[0120] Below to facilitate a better understanding of this specification and forming an integral part thereof, a series of figures are attached in which, by way of illustration and not limitation, several different embodiments of the present invention have been represented.
[0122] Brief description of the figures
[0124] Figure 1: It is a plan view of a morcellation bag according to a first embodiment of the present invention;
[0126] Figure 2A: is an exploded perspective view of a first embodiment of a morcellation kit according to the present invention;
[0127] Figure 2B: It is a perspective view of the morcellation kit shown in Fig. 2a, which also includes a trocar. This figure also shows the folded morcellation bag inside the introducer tube; and
[0129] Figures 3A to 3G: They are schematic views showing the method of using a morcellation kit according to the present invention.
[0131] Description of a preferred embodiment
[0133] Throughout the present description, as well as in the figures, the elements with the same or similar functions will be designated with the same numerical references.
[0135] Figure 1 shows a first embodiment of a laparoscopic morcellation bag 1, according to the present invention.
[0137] Bag 1 is made, in this specific embodiment of the invention, from a polyurethane (TPU) sheet with a thickness of 80gm, an elastic rigidity of Shore A87 (measured according to international standard DIN 53505), an elongation at 550% breakage (measured according to the international standard DIN EN ISO 527), a mechanical resistance to break of 60MPa (measured according to the international standard DIN EN ISO 527) and a continuous use temperature of 130 ° C . Said polyurethane sheet is joined at its periphery to define a U-shaped bag surface 2 which also has a first closed end 3a and a second open end 3b.
[0139] In this embodiment of the invention, the width of the open end 3b is 18cm.
[0141] The open end 3b is further provided with a flexible ring 6 of the strap type, with shape memory, which facilitates its opening. A monofilament guide wire 4 is also attached to the open end 3b to facilitate the correct manipulation of the bag 1, once it has been introduced into the patient's pelvic and / or abdominal cavity, as well as its subsequent extraction from said cavity.
[0143] In this embodiment of the invention, at the closed end 3a a recess 7 is provided, comprising a lateral surface 7b, hermetically attached to the surface 2, of the closed end 3a of the bag 1. The lateral surface 7b has, in this embodiment of the invention, a tubular shape and has an open end, external to the bag 1, that defines the open mouth 7a and a closed bottom 7c.
[0145] In this embodiment of the invention, the recess 7 has a depth of between 3 and 6 cm.
[0147] Bag 1 has at least one transparent region 5, the optical properties of this transparent region 5 being the following: total transmittance greater than 90%, clarity greater than 90% and veil effect (haze) less than 4%
[0149] In this specific embodiment of the invention, the transparent region 5 is located in the closed bottom 7c.
[0151] In other possible embodiments of the invention the transparent region 5 may be:
[0152] - in addition to the closed bottom 7c, in other parts of the surface 2 of the bag 1 - in addition to the closed bottom 7c, in all the surface 2 of the bag 1
[0153] - in that bag 1 that does not have a hole 7, in at least part of the surface 2 of bag 1
[0154] - in that bag 1 that does not have a hole 7, in the entire surface 2 of bag 1
[0156] In this specific embodiment of the invention, the bag surface 2, the side surface 7b, the closed bottom 7c and the transparent region 5 provided in said closed bottom 7c are made from the same polyurethane (TPU) sheet. However, the present invention also contemplates the possibility that at least two of said components: surface 2, lateral surface 7b, closed bottom 7c and / or transparent region 5, are made of a different material.
[0158] Also, two brightly colored tabs 8a, 8b are in contact with the mouth 7a of the recess 7. The fact that the tabs 8a, 8b are made of bright colors allows them to be more easily identified during the insertion operation. of the optics in the hollow.
[0159] Figure 2A shows a first embodiment of a morcellation kit, according to the present invention, which comprises a laparoscopic morcellation bag 1 as shown in Figure 1 and an introducer tube 9.
[0161] In the embodiment shown in said Figure 2A, the introducer tube 9 has an outer diameter of 18mm, a length of 20cm and is provided with a bevel 9b at one of its ends to facilitate its insertion through an incision in the abdomen. The tube 9 is further provided with sealing means at the opposite end, which include a plug 9a. Preferably, in the plug 9a a sealing valve and a non-return valve are provided. In this way, once the bag is inserted, tube 9 can be used as a trocar for a clamp.
[0163] More preferably, the sealing valve is provided in the part of the plug 9a that is outside the tube 9, while the non-return valve is provided in the part of the plug 9a that is inside the tube 9 .
[0165] Figure 2B shows a second embodiment of a morcellation kit, according to the present invention. In this embodiment, the surface 2 of the laparoscopic morcellation bag 1, as well as the flexible ring 6, are conveniently folded and arranged inside the introducer tube 9.
[0167] The kit of Figure 2B further comprises a trocar 10 provided with a socket 10a for the connection of insufflation devices (not visible in the figures). The trocar 10 further comprises a rigid sheath 10b which, in this particular embodiment of the invention, has an outer diameter of 20mm and an inner diameter of 18mm.
[0169] Figures 3A to 3G show, schematically and not necessarily to scale, the method of using a morcellation kit, according to the present invention, during a laparoscopic intervention.
[0171] More particularly, Figure 3A shows a patient 100 who is to undergo laparoscopic intervention. In said intervention, a first hole 110 is made in the iliac fossa and three secondary holes, through these secondary holes, respectively, three trocars 120a, 120b and 120c used for the introduction of surgical instruments during laparoscopic intervention and a optical device 130, which enables the medical team to maintain a view of the interior of the pelvic-abdominal cavity of patient 100 during the operation.
[0173] The morcellation bag 1 is inserted into the patient's pelvic-abdominal cavity preferably through hole 110, previously made, since this allows a better overview of the interior of said cavity (as it is the most distant point from the optical device 130, located in the peri umbilical region).
[0175] For this, C02 is insufflated inside the patient's pelvic-abdominal cavity through a connection socket to insufflation devices (not visible in the figures), provided in at least one of the trocars 120a, 120b or 120c . Once said cavity has swollen, the introducer tube 9 that houses inside and folded into an accordion, introduces the morcellation bag 1 by pushing with first preferably open tweezers 140. The free end of the guide wire 4 is left outside the patient, to facilitate the subsequent extraction of the laparoscopic morcellation bag 1.
[0177] Figure 3B schematically illustrates the process of inserting a surgical piece 150 into the morcellation bag 1, once said bag 1 has entered the interior 160 of the pelvic-abdominal cavity.
[0179] To carry out this process, the surgical piece 150 is manipulated with second tweezers 170 and inserted into the morcellation bag 1, through the open end 3b of the latter, which is kept open with the help of third tweezers. 180, while the medical team observes the interior 160 of the pelvic-abdominal cavity thanks to the optical device 130.
[0181] Figure 3C schematically illustrates the way in which, once the surgical piece 150 has been introduced inside the morcellation bag 1, the open end 3b of said bag 1 is taken out, pulling the guide wire 4, so that it comes out through the hole 110, made in the abdominal wall 200. To facilitate the extraction of the open end 3b from the bag, C02 can optionally be insufflated through the socket provided in the trocar 120c. Once said open end 3b has exited to the outside, the trocar 10 is inserted through it.
[0182] Figure 3D schematically illustrates the way in which the optical device 130 is placed inside the recess 7 of the morcellation bag 1. To carry out this operation, the tabs 8a and 8b are pulled by means of two additional clamps 190a and 190b while the optical device 130 is pushed into the recess 7.
[0184] In Figure 3E, the optical device 130 is shown resting on a point on the surface 2 of the bag that is located outside the recess 7 of the morcellation bag 1. This is because, in this particular case, the entire surface 2 of the bag 1 is transparent, so it is not necessary to expressly place the optical device 130 in the transparent region 5 of the closed bottom 7c. To carry out this operation, bag 1 is inflated with C02 through trocar 10 and the patient's abdomen is emptied, allowing C02 to evacuate through one of the intakes provided in trocars 120a, 120b or 120c.
[0186] However, as shown in Fig. 3F, it would also be possible to insert the optical device 130 into the recess 7, bringing it into contact with the transparent region 5 of the closed bottom 7c. In this particular case, C02 would be blown into the patient's abdomen through the intakes provided on trocars 120a, 120b or 120c.
[0188] Figure 3F schematically shows the morcellation operation. At this stage, the surgical piece 150 is cut using a morcellator 210 that is inserted through the trocar 10.
[0190] Figure 3G schematically shows the final extraction operation from bag 1. At this stage, morcellation bag 1 is emptied of C02 by opening the trocar valve 10 and / or by removing trocar 10 and C02 is blown into the abdomen by through the trocar 120c socket, to dilate the pelvic-abdominal cavity. This causes bag 1 to collapse. The morcellation bag 1 is subsequently removed by pulling on the outside of said bag 1.
[0192] Numerical references of the figures
[0194] (1) Morcellation bag;
[0195] (2) Surface of the bag;
[0196] (3a) First end of the bag (closed end);
[0197] (3b) Second end of the bag (open end);
[0198] (4) Guide wire;
[0199] (5) Transparent region;
[0200] (6) Flexible ring;
[0201] (7) Hollowness;
[0202] (7a) Open outer mouth of the cavity;
[0203] (7b) Surface of the cavity;
[0204] (7c) Closed bottom of the hole;
[0205] (8a, 8b) reeds;
[0206] (9) Introducer tube;
[0207] (9a) Cover of the introducer tube;
[0208] (9b) Bevel of the introducer tube;
[0209] (10) Trocar;
[0210] (10a) Connection socket to the insufflation devices;
[0211] (10b) Trocar sheath;
[0212] (100) Patient;
[0213] (110) hole in the iliac fossa;
[0214] (120a, 120b) trocars used in laparoscopic intervention;
[0215] (120c) trocar with air intake
[0216] (130) optical device;
[0217] (140) First open clamp;
[0218] (150) Surgical Piece;
[0219] (160) Interior of the patient's pelvic-abdominal cavity;
[0220] (170) Second forceps for manipulating the surgical piece;
[0221] (180) Third clamps, used to hold open end 3b of the bag; (190a, 190b) additional clamps, used to pull the tabs;
[0222] (200) abdominal wall;
[0223] (210) morcellator.
权利要求:
Claims (17)
[1]
1. Laparascopic morcellation bag (1) comprising:
- at least one film of plastic material, joined in a way that defines a surface (2) of the bag (1);
- said surface (2) of the bag (1) having a first closed end (3a) and a second open end (3b), the second open end (3b) being a port for introducing at least one surgical piece and a morcellator ,
said laparascopic morcellation bag (1) being characterized in that it is provided with at least one transparent region (5), said transparent region (5) having an area of at least 1 cm2 and a thickness of less than 200pm and said transparent region being made (5) of a material or a combination of materials with a total transmittance greater than 80%, a clarity greater than 80% and a veil effect less than 25%.
[2]
2. Laparascopic morcellation bag (1) according to claim 1, in which the transparent region (5) is made of a material or a combination of materials with a total transmittance greater than 90%, a clarity greater than 90% and a veil effect less than 4%.
[3]
Laparoscopic morcellation bag (1) according to any of the preceding claims, in which the transparent region (5) has a thickness of 80pm.
[4]
Laparoscopic morcellation bag (1) according to any of the preceding claims, in which the transparent region (5) is made of polyurethane, polyester, polypropylene, polyethylene, polycarbonate, silicone and / or combinations thereof.
[5]
5. Laparoscopic morcellation bag (1) according to any of the preceding claims, in which the second open end (3b) of the bag surface is provided with a guide wire (4).
[6]
6. Laparoscopic morcellation bag (1) according to any of claims 1 to 4, wherein the second open end (3b) of the bag surface is provided with a flexible ring (6), with a Shore A <90 hardness and shape memory.
[7]
7. Laparoscopic morcellation bag (1) according to claim 6, wherein the flexible ring (6) is attached to a guide wire (4).
[8]
8. Laparascopic morcellation bag (1) according to claim 5, in which the guide wire (4) is folded into a loop surrounding the second open end (3b) of the bag surface (2), said loop forming part. of a tight knot type union.
[9]
9. Laparoscopic morcellation bag (1) according to any of the preceding claims, wherein the transparent region (5) occupies an area greater than 60% of the total area of the bag surface (2).
[10]
10. Laparascopic morcellation bag (1) according to any one of the preceding claims, wherein the bag surface (2) has an elastic shore rigidity greater than A70, an elongation at break greater than 100%, a mechanical resistance to break greater than 40MPa and a continuous use temperature greater than 115 ° C.
[11]
11. Laparascopic morcellation bag (1) according to any of the preceding claims, wherein the bag surface (2) has a rounded shape.
[12]
12. Laparoscopic morcellation bag (1) according to any of the preceding claims, in which it is provided with at least one recess (7) comprising an open external mouth (7a), a lateral surface (7b) hermetically attached to the surface (2) bag and a closed bottom (7c) hermetically attached to said lateral surface (7b), the closed bottom also being provided with a transparent region (5) with an area of at least 1 cm2 and a thickness of less than 200 gm and said transparent region (5) being made of a material or a combination of materials with a total transmittance greater than 80%, a clarity greater than 80% and a veil effect less than 25%.
[13]
13. Laparascopic morcellation bag (1) according to claim 11, wherein the lateral surface (7b) of the recess (7) is tubular or trapezoidal in shape.
[14]
14. Laparoscopic morcellation bag (1) according to any of claims 11 and 12, wherein the recess (7) is provided with at least one protruding tongue (8a, 8b).
[15]
15. Laparascopic morcellation kit, characterized in that it comprises:
- a laparascopic morcellation bag (1) according to any of claims 1 to 14; and
- an introducer tube (9) containing the laparascopic morcellation bag (1) folded inside.
[16]
16. Laparascopic morcellation kit according to claim 15, characterized in that the introducer tube (9) is provided with sealing means comprising a plug (9a), said valve and a non-return valve being provided in said plug.
[17]
17. Laparascopic morcellation kit according to claim 15, characterized in that you are also provided with a trocar (10) with a diameter of between 15 to 20mm and a length of between 70 and 100mm, said trocar (10) also being provided with a socket (10a) for connection to insufflation devices.
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同族专利:
公开号 | 公开日
WO2020128127A2|2020-06-25|
US20220061830A1|2022-03-03|
ES2768103B2|2021-04-26|
EP3900640A2|2021-10-27|
WO2020128127A8|2020-09-03|
WO2020128127A3|2020-12-17|
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法律状态:
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优先权:
申请号 | 申请日 | 专利标题
ES201831245A|ES2768103B2|2018-12-19|2018-12-19|LAPARASCOPIC MORCELLATION BAG AND LAPARASCOPIC MORCELLATION KIT INCLUDING A MORCELLATION BAG|ES201831245A| ES2768103B2|2018-12-19|2018-12-19|LAPARASCOPIC MORCELLATION BAG AND LAPARASCOPIC MORCELLATION KIT INCLUDING A MORCELLATION BAG|
EP19856446.0A| EP3900640A2|2018-12-19|2019-12-17|Laparoscopic morcellation bag and laparoscopic morcellation kit including a moircellation bag|
US17/415,767| US20220061830A1|2018-12-19|2019-12-17|Laparoscopic Morcellation Bag and Laparoscopic Morcellation Kit Including a Morcellation Bag|
PCT/ES2019/070853| WO2020128127A2|2018-12-19|2019-12-17|Laparoscopic morcellation bag and laparoscopic morcellation kit including a morcellation bag|
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