MXPA01005512A - Laparoscopic sealed access device - Google Patents

Abstract

A hand access device (1) for use in hand assisted laproscopic surgery comprises a substantially tubular inflatable sleeve (5) of pliable gas tight material having a twisted inner sleeve section (12) and an outer sleeve section (12). The device (1) has an inner O-ring (30) for insertion through a wound opening (3) in the abdominal wall (4) and an outer O-ring (31) for location outside of the wound opening. On insertion of a surgeon's arm (2) the sleeve (5) everts while monitoring a reduced lumen (25) seal to the arm (2) and a seal to the wound openings (3).

Description

LAPAROSCOPIC HERMETIC ACCESS DEVICE Field of the Invention The invention relates to a medical device particularly for use in surgery, in order to provide access "... surgically examine the abdomen and maintain a gas tight seal around the arm or an instrument during surgery. Surgery of this type is referred to as a manually assisted laparoscopic surgery or manual access surgery.

BACKGROUND OF THE INVENTION Conventional abdominal surgery requires the creation of an incision in the abdominal wall to allow access to, and visualization of, internal organs and other anatomical structures. These incisions should be large enough to accommodate the surgeons' hands and any instrument to be used by the surgeon during surgery. Traditionally, the size of these incisions has been dictated by the need to see, retract and palpate internal body structures. Although a large incision will provide access to the inside of the abdomen, it will be associated with longer healing times, is more susceptible to infection, and results in unpleasant-looking scars. Alternatives to open surgery exist in the form of endoscopic or laparoscopic surgery. In this method of surgery, the surgeon operates through small incisions through the use of instruments operated remotely. The instruments pass through the abdominal wall through the use of devices called trocars. These working channels typically have a diameter that varies from 5 to 25 millimeters. Vision is provided through the use of a laparoscope, which is typically 20 to 25 centimeters long and uses fiber optic technology or a "CCD camera" to provide the operator with an image of the inside of the abdomen. The abdomen should be inflated with a gas, such as carbon dioxide or nitrogen to maintain a bubble effect and provide a viable workspace for the operator to perform the bare surgery due to lack of space. This insufflation creates a work space known as the pneumoperitoneum. The trocars through which the instruments are inserted are constructed to prevent the loss of gas through them, resulting in a collapse of the pneumoperitoneum. The benefits of laparoscopic surgery are numerous. It has been shown that recovery times are reduced due to the absence of a large incision. This has benefits for the patient, the organization of health care and society. The patient benefits are a reduced stay in the hospital, a mobilization and return to normal activity faster. The benefits of the health care organization are also due to a reduced stay in the hospital, which is often the most expensive aspect of the health care ratio. The benefits of society are a quicker return to work and normal patient activity.

However, not all surgical procedures can be performed laparoscopically. Surgery that requires the removal of specimens of large organs, such as surgery for colon removal, has traditionally been prevented by the small incisions used for the introduction of laparoscopic instruments in surgery. . -_ • * - = - - The other main disadvantages of laparoscopic surgery are due to the complex nature of the technique. Surgeons who want to perform laparoscopic surgery should take a lot of training time to master the technique. The success of laparoscopic surgery depends on the surgeon's experience in manipulating organs and performing delicate tasks through the use of remotely operated instruments. Unfortunately, in laparoscopic surgery, the surgeon isolates himself from the material he works with. This deprives the surgeon of tactile feedback and the ability to feel delicate structures. The most effective instruments of the surgeon, the hand, is reduced to a device that can simply operate instruments that inherently lack dexterity and operability due to constraints in their design, placed by the nature of the narrow channels in the trocars through which they must pass. Another disadvantage of a laparoscope is that the image observed by the surgeon is a two-dimensional image on a video screen. The surgeon loses the three-dimensional perspective of depth and distance and the notion of proximity of other structures during video laparoscopy. These disadvantages have led to long learning curves for practitioners of laparoscopic surgery, requiring highly experienced and coordinated surgical teams and have limited the application of laparoscopic surgery to relatively simple surgical procedures. 5 Recently, new techniques have been developed * >Surgical instruments that combine the advantages of both abietic surgery and laparoscopic surgery. In this new technique, surgery is carried out by using a laparoscopic approach with the addition of a slightly larger incision to allow the surgeon to insert a hand in the abdomen inflated. Frequently, this is referred to as a manually assisted laparoscopic surgery or HALS. The HALS allows surgeons to recover tactile feedback and three-dimensional perspective lost in the conversion of open to laparoscopic procedures. It also allows a quick digital dissection, improved retraction capabilities and simplified hemostasis. There are several publications in the literature that describe procedures carried out through the use of a manually assisted approach. These include total and sub-total colectomy, rectopexy, Nissen fundoplication, gastrectomy, splenectomy, nephrectomy, pancreatectomy and others. Some of these procedures were previously carried out by using an open technique only. During the last few years, several centers have been investigating HALS with surgical device companies and the literature on subject matter has increased. With the advent of For surgical devices to facilitate HALS, it is expected that more open surgical procedures will become HALS procedures. The key to the success of manually assisted laparoscopic surgery will be to provide a device that sealed the edge of the wound and where the arm of a surgeon maintains the required pneumoperitoneum. The device must provide freedom of movement, including rotational, lateral and translational. In addition, it should be possible to use laparoscopic instruments with the device. Several manual access devices have been proposed, however, to date, no manual access device is available that adequately addresses these key issues. US-A-5366478 (Brinkerhoff et al.) Describes a device that claims to be for use during endoscopic surgery. The device has two inflatable toroidal sections connected by a transitional section. It is said that the transitional section works to allow the pae of air from one toroid to the other toroid by the inflation of the device. Each toroidal section contains a flexible reinforcing ring. The reinforcement ring on the external toroid is illustrated in a position that floats above the abdominal wall after inflation. The manner in which the device provides a seal is not clear, however, in any case, it would be difficult to pass an object such as a surgeon's forearm through a lumen in the transitional section, due to the frictional resistance to movement of the surgeon. object in relation to the transitional section. A medical device for forming an external extension of the pneumoperitoneum is described in US-A-5480410 (Cuschieri et al.). The device includes a sealed closure at a trocar puncture site in an abdominal wall. The insufflation gas passes from the body cavity to the closure that inflates it. A number of valve openings are provided in the device to allow access to the interior «Of the closing. * In US-A-5514133 (Golub et al.) An endoscopic surgical apparatus is disclosed to allow a surgeon to access a surgical site through an opening. The apparatus includes two plates, which engage the outer and inner surfaces of the abdominal wall and a sealing member, which inhibits the flow of gas through the opening. It is expected that the seal on this apparatus will not maintain full insufflation of the body cavity since gas can leak gradually through the folding valves and seal. The configuration of the valve also makes the extracorporeal notion of an organ impossible, which is preferred in manually assisted surgery devices. The device also has a complicated construction. In US-A-5526536 (Cartmill) a surgical glove suitable for use in endoscopic surgical procedures is described. The glove has an inflatable cuff section, which when inflated, is said to provide a seal between the surgeon's hand and the body wall. The surgeon's gloved hand must remain in the body cavity to maintain insufflation of the body cavity. Therefore, this device also restricts the actions of the surgeon.

US-A-5522791 (Leyva) describes an abdominal retractor, which retracts an abdominal incision that provides access to a hand in a body cavity. The hand is passed in a sleeve and the other end of the sleeve is mounted on the retractor. US-A-5545179 (Williamson) describes an access assembly, which provides access to surgical devices in a body cavity during surgery. A sealing sleeve is inflated to form a large balloon portion within the body cavity, the balloon portion constricting to remain within the body cavity. It is difficult to retract a surgical instrument through a balloon portion and out of the body cavity, due to the frictional resistance to the movement of the surgical instrument relative to the balloon cuff. US-A-5636645 (Ou) discloses a method for performing laparoscopic surgery, which includes the steps of inserting a gloved hand of the surgeon into a body cavity and sealing the hand in the body tissue surrounding the cavity . This method restricts the actions of the surgeon because the gloved hand of the surgeon must remain in the body cavity seal so that the surrounding tissue maintains insufflation of the body cavity. The seal between the gloved hand of the surgeon and the surrounding tissue should be re-established each time the gloved hand is inserted into the body cavity, if the insufflation of the body cavity should be maintained. US-A-5640977 (Leahy ef al.) Also describes an apparatus and a method for performing minimally invasive laparoscopic surgery. The hand of a surgeon is passed through a cuff to access a body cavity, sealing the cuff around the surgeon's forearm. US-A-5653705 (de la Torre et al.) Discloses an envelope, which is said to provide access for an object to pass through an incision in body tissue, while maintaining insufflation of the body cavity. A first opening in the envelope is sealed around the incision of body tissue and a second opening is sealed around an object passed in the envelope. Devices for use during surgery are also known, which provide access to a surgical site and make an independent seal from the hand of a surgeon. In general, devices of this type are placed predominantly external to a body cavity and are complex, large and bulky. These devices are difficult to use because they are cumbersome and / or due to their complexity. For example, a flexible, fluid-tight envelope that provides access to an object that passes through an incision of body tissue while maintaining insufflation pressure is described in US-A-5672168 (de la Torre et al.) . This is a complex device that includes a first opening secured and sealed to the incision of body tissue and a second opening remote from the incision of body tissue and sealed to the forearm of a surgeon. The device also includes a housing that contains a valve element in the body tissue incision. In US-A-5803921 (Bonadio) an access port device is described for use during a surgical procedure. An object is passed into the sleeve of the device, the device is sealed around the object in the opening of the sleeve and the device is also sealed in the body cavity. US-A-5741298 (MacLeod) describes a method for performing surgery by using a multi-functional access-to pig. The access port has a sealed ring that protects the incision from the body wall from contamination. A sealing cap or surgical glove is connected to the sealing ring to maintain insufflation of the body cavity. This surgical method is also restrictive because the gloved hand of the surgeon must remain sealed in the sealing ring if the insufflation of the body cavity should be maintained. In US-A-5813409 (Leahy ef al.) A surgical apparatus is described for use during manually assisted minimally invasive surgery. A sleeve is mounted at one end to an incision of body tissue. The cuff seals the surgeon's hand to maintain the pneumoperitoneum. Surgical instruments can then be passed to the cuff for the hand of a surgeon inside, which can then be inserted into the incision. This device is relatively large, requires a multi-stage process for its installation and comes in several parts. US-A-5906577 (Beane et al.) Discloses a retractor device for retracting the edges of an incision so as to form an opening into a body cavity. A flexible sleeve is mounted on the retractor and an object passed through the device is sealed to maintain insufflation of the body cavity. This device also consists of many parts of the component that must be assembled carefully. In WO 92/1 1880 (Berry ef al.) A catheter valve for the selective closure of a catheter lumen is exposed. A cuff «Elastomeric is attached between a rotating lid and a cube to form an iris value. The sealing is carried out by rotating the lid in relation to the hub. WO 98/35615 (Crook) describes a device for carrying out a HALS consisting of a wound edge retractor to which a sleeve similar to others mentioned above is attached. This device also consists of several component parts and has a complicated installation procedure. In JP 10-108868 (Tamai, Shitomura) an access port device is described for use during manually assisted laparoscopic surgery. This device consists of a wound retractor component to which an iris valve is attached. The wound retractor component is made of two rings, an inner ring and an outer ring joined by an elastic sleeve to provide a retractable force. The device is inserted into an incision and the surgeon's hand is inserted through the device. The iris valve is then closed around the arm to effect a seal in order to prevent the escape of the insufflation gas. The generally known devices are difficult to use because they are cumbersome and / or due to their complexity.

In addition, tight seals are often not maintained and / or the movement of a surgeon's arm is restricted and / or the device can be released from a wound. Accordingly, there is a need for a sealing device, which provides an effective sealing means for sealing an object that passes through the device and which is convenient and easy to use, compact and clean and can be used repetitively. with a minimum delay and minimum effort.

BRIEF DESCRIPTION OF THE INVENTION According to the invention, a medical device is provided comprising: a sleeve for defining a lumen; the sleeve having a rolled sleeve section, which defines a reduced lumen section; and tension means to facilitate axial extension of the rolled sleeve section. In a particularly preferred embodiment, the sleeve is twisted to provide the rolled sleeve section. More preferably, the sleeve is made of flexible material. In a preferred embodiment, the means for facilitating the axial extension of the rolled sleeve section comprises a chamber for a pressure fluid. In this case, the chamber can be defined by an outer sleeve section and an inner sleeve section.

Preferably, the outer sleeve section is a substantially cylindrical sleeve section and the inner sleeve section is a rolled sleeve section of the same uncoiled diameter as that of the outer sleeve section. In a particularly preferred embodiment, the sleeve is axially returned by itself to define the outer sleeve section and the inner sleeve section. Preferably, the reduced lumen section is of a size smaller than that of an object to be received therein or passed through it. In a particularly preferred embodiment on the clutch of an object in the reduced lumen section and the axial movement of the object in relation thereto, the sleeve returns from the inside out so that the rolled-up inner sleeve section is rolled outwardly. to become an uncoiled outer sleeve section and the outer sleeve section is wound correspondingly inwardly to become a wound inner sleeve section. Preferably, the chamber is impermeable to fluids, ideally, the chamber is inflatable. Preferably, the camera has an access port for inflation of the camera. In a particularly preferred embodiment, the device includes eversion-limiting means for axially limiting the eversion of the sleeve. The device may have a first eversion-limiting means for the external location of the aperture and a second eversion-limiting means for the internal location of the aperture. Preferably, the or each eversion-limiting means is an O-shaped ring, preferably of an elastic material. In one installation, the or each eversion-limiting means is housed in the chamber. The or each eversion-limiting means may be axially movable in the chamber. In another installation, there are two eversion-limiting means and both are independently movable in the chamber. In a further installation, there are two eversion-limiting means and a means of linking between them is provided. The linking means may be of a flexible material. Typically, the linking means comprises a link sleeve. In another embodiment, the eversion-limiting means comprises eversion-limiting means, first and second, attached in different places to the sleeve. Preferably, the first eversion-limiting means is attached to one end of the sleeve and the second eversion-limiting means is attached to another end of the sleeve. In a particularly preferred embodiment, the eversion-limiting means is movable with respect to the rotation of the sleeve. The eversion-limiting means may be rotatable relative to another for the rotation of the sleeve. In one embodiment, the device includes manual means to facilitate the movement of the eversion-limiting means. Preferably, the device includes fixing means for fixing the first eversion-limiting means relative to the second eversion-limiting means. In another embodiment of the invention, the tension means is a mechanical means of tension. In this case, the tension means may comprise a spring means. Preferably, the reduced lumen section is dimensioned to tightly engage an object that passes therethrough. In one aspect, the device is for use in surgery. The device may be a forearm seal for use in the performance of manually assisted laparoscopic surgery. Alternatively, the device is an endoluminal device. The device can be an introducer for introducing an instrument into a body through an opening. The device can also be a blood extractor or an envaginator. In another aspect, the device is a tissue dissector. Alternatively, the device is a trocar seal.

BRIEF DESCRIPTION OF THE DRAWINGS The invention will be understood more clearly from the following description thereof, given by way of example only with reference to the accompanying drawings, in which: Figure 1 is a perspective view of a device manual access according to the invention; Figure 2 is a cross-sectional view of the device * -from figure ~ 1; Figures 3 and 4 are a perspective view of the device that is inserted into an incision of the abdominal wall; Figures 5 to 7 are views partially in cross-section, in perspective, of the hand of a surgeon inserting through the device; Figure 8 is a view of the distal end of the device with one hand in place; Figure 9 is a partially cross-sectional view, in perspective, of the hand access device with the hand of a fully inserted surgeon; Figure 10 is a perspective view of the device in an intermediate position in the arm of a surgeon; Figure 11 is a perspective view of a hand access device in position on the arm of a surgeon; Fig. 12 is a cross-sectional view of the device of Fig. 1 1 showing the sealing clutch for the surgeon's arm; Figure 13 is a cross-sectional view of the device of Figures 1 to 10 in a ready position to receive the arm of a surgeon; Figure 14 is a cross-sectional view similar to Figure 13, fully inserted through an incision; Figure 15 was not used. Figure 16 is a perspective view of a tube from which the device can be formed; Figure 17 is a view of the mangupito of Figure 16 partially folded; Figure 18 is a view of the sleeve of Figure 17 in a rolled-up configuration; Figure 19 is a side view of the rolled sleeve; Figures 20 and 21 are perspective views illustrating the insertion of an instrument through an access device of the invention; Figures 22 to 25 are side views of the device of Figure 20 illustrating the steps of inserting the instrument through the device; Figure 26 is a cross-sectional view of an access device with a circular instrument in cross-section in place; Figure 27 is a cross-sectional view of an access device with a non-circular instrument in cross-section in place; Figures 28 and 29 are, respectively, plan and elevational views of a non-coiled sleeve; Figures 30 and 31 are, respectively, plan and elevational views of a rolled sleeve; Figures 32 and 33 are, respectively, plan and elevational views of the sleeve wound with an object extending through the lumen of the sleeve; Figures 34 to 39 are views of the rotation of a tube similar to Figures 28. to 3-3; •. «.- Figures 40 and 41 are a graphic representation of the spirit of rotation plotted against the diameter of the lumen. Figure 42 is a perspective view of a rolled tube with an elongate object passing through it; Figure 43 is an end view of the tube of Figure 42; Figures 44 to 50 are various elevational and plan views illustrating the formation and internal pressurization of a thin walled tube; Figures 51 to 61 are various elevational and plan views illustrating the formation and internal pressurization of a thin-walled rolled tube; Figures 62 to 67 are various cross-sectional end and side views illustrating the translation of an elongate object through a rolled tube; Figure 68 is a perspective view of a manual access device with an integral glove; Figure 69 is a perspective view of the gloved manual access device of Figure 68, in place; Figure 70 is a perspective view of another manual access device with adjustable rotation; Figure 71 is a perspective view of the ring used in the access device of Figure 70; Figure 72 is a plan view of the rings of Figure 5 71; «Auss? Fig. 73 is a cross-sectional view of -? N - detail of the proximal rings of the device of Fig. 71; Fig. 74 is a perspective view of a detail of a seal between the neighboring rings of Fig. 73; Figure 75 is a cross-sectional view of another manual access device with adjustable rotation; Figure 76 is an enlarged sectional view of part of the proximal rings of the device of Figure 75; Figure 77 is a sectional view of the part of the adjacent rings 15 of Figure 76 assembled; Figure 78 is an enlarged cross-sectional view of a sealing mechanism between the proximal rings of Figures 76 and 77; Figure 79 is a perspective view of another manual access device of the invention; Figure 80 is a side view in partially cross section of the device of Figure 79, in use; Figure 81 is an enlarged cross-sectional view of a detail of the device of Figure 80; Figure 82 is a cross-sectional view of a sleeve used to form another manual access device of the invention; Figure 83 is a cross-sectional view of the device formed from the sleeve of Figure 82; Figure 84 is a sectional view. ... c-nsversai of that of figure 83, inflated; The figure ~ - 85 is a ¿. enlarged view of a detail of the device of Figure 84; Figure 86 is a perspective view of another device of the invention; Figure 87 is a perspective view of the device of Figure 86 being adjusted; Figure 88 is a side view, partially in cross section, of the device of Figures 86 and 87; Figure 89 is a view similar to Figure 88 of the partially disassembled device; Figure 90 is a view similar to Figure 88 with the device of Figure 89 reassembled; Figures 91 a and 91 b are cross-sectional views of two devices; Figure 92 is a prospective, partially exploded view of an additional manual access device of the invention; Figure 93 is a perspective, partially exploded view of another manual access device of the invention; Fig. 94 is a view of the device of Fig. 93 in use; Fig. 95 is a perspective, partially exploded view of a further manual access device of the invention; Fig. 96 is a view of the device of Fig. 95 in use; Fig. 97 is a partially exploded perspective view of a still further manual access device of the invention; and Figure 98 is a view of the device of Figure 97, in use; Figures 99 (a) to (e) are side views in cross section of another manual access device according to the invention; Figure 100 is a cross-sectional side view of a still further access device according to the invention; Figure 101 is a perspective, partially exploded view of an additional type of manual access device; Figure 102 is a plan view of a device according to the invention; Figure 103 is an elevational view of the device of Figure 102; Fig. 104 is an elevational cross-sectional view of the device of Fig. 102; Figure 105 is a perspective view of the device of Figure 102; Figures 106 to 109 are views illustrating the device of Figures 102 to 105 with the sleeve in an extended position; Figure 1 is a plan view of a device according to another aspect of the invention; Figure 1 1 1 is an elevational view of the device of Figure 1 10; Figure 1 12 is a cross-sectional view of the device of Figure 1 10; Figure 1 13 is a perspective view of the device of Figure 1 10; Figures 1 14 to 1 17 are views illustrating the device of Figures 1 to 1 in a compressed condition; Figure 1 18 is an enlarged perspective view of another device according to the invention; Figure 1 19 is an enlarged perspective view of the sealing device of Figure 1 18 with the sleeve in an extended position; Figure 120 is a perspective view of the sealing device of Figure 1 18; Figure 121 is a perspective view of the sealing device of Figure 1 18 with the sleeve in an extended position; Figure 122 is a plan view of the sealing device of Figure 1 18 with the sleeve in an extended position; Figure 123 is an elevational view of the sealing device of Figure 1 18 with the sleeve in an extended position; Fig. 124 is a cross-sectional perspective view of the sealing device of Fig. 1 18 with the sleeve in an extended position; Fig. 125 is a perspective view of the sealing device of Fig. 1 18 with the sleeve in an extended position; Figure 126 is a cross-sectional view of another device according to the invention; Figure 127 is a cross-sectional view of the device of Figure 126 with the cuff inflated; Figure 128 is a cross-sectional view of another device according to the invention; and Fig. 129 is a cross-sectional view of the sealing device of Fig. 128 with the sleeve inflated and the tubes axially extended.

DETAILED DESCRIPTION OF THE INVENTION In a first preferred embodiment of the invention and referring in particular to figures 1 to 6, there is illustrated a manual access device 1 according to the invention, which, in this case, is to be used as a seal for sealing the forearm 2 of a surgeon at the entrance through a wound opening 3, for example, in an abdominal wall 4. Referring in particular to figures 16 to 19, the sealing device 1 comprises a substantially tubular sleeve 5 of flexible gas-tight material formed from a tube 10, such as a suitable, biocompatible plastic material. The tube 10 is returned axially by itself to define an outer sleeve section 1 1 and an inner sleeve section 12. The tube 10 is rotated so that the axially opposite data indicators 15, 16 are circumferentially separated as illustrated in Figure 18. The inner and outer sleeve sections 1 1, 12 define between them a sealed inflatable chamber 20. The internal sleeve section 12 defines a lumen 25 and, upon inflating fa chamber 20, inner sleeve section 12 sealingly clutches an object that extends or passes through lumen 25. The manual access device includes an eversion-limiting means for sleeve 5. The eversion-limiting means is provided, in this case, by a first ring in the form of O 30, which is attached to the sleeve 5 and a second O-ring 31, which is attached to an axially separated location in the sleeve 5. The inner ring in shape of O 30 is of an elastomeric, resilient material, suitable for joining the ring 30 so as to facilitate insertion into a wound 3 as illustrated in Figures 3 and 4. As a surgeon inserts his forearm 2 through the lumen 25 of l device 1, the inner sleeve section 12 rotates together with the arm 2 and in turn, the outer sleeve section 1 1, returns from the inside outwards. An effective seal is maintained around the forearm of the surgeon 2 and the sealed integrity of the body cavity being operated is maintained. To facilitate the insertion of the surgeon's arm 2, lubrication may be used. In this case, the device 1 is pre-rotated and can be inflated before or during its use.

A protective wound section 35 of the sealing device between the rings 30, 31 can be made of a plastic sheet material having a greater flexibility than the main body of the sleeve 5. In this way, when the sleeve 5 is inflated, the section protector 35 is adjusted to conform to the irregular shape of wound 3 and provide a "Make it airtight to the opening of the wound 3. In addition, the inner ring 30 is attracted against the inner wall surrounding the wound 3, after the sleeve 5 is inflated. The installation also facilitates the lubricated rotation of the protective section 35, which facilitates the insertion of the arm 33 of a surgeon. The O-shaped inner ring 30 may have a larger diameter than the O-shaped outer ring 31 to create a taper effect. This installation promotes a pressure differential that helps the insertion of the arm of a surgeon 2 that acts against internal abdominal pressure. The invention provides a device that allows laparoscopic surgeons to insert their hand into the abdominal space during laparoscopic surgery and retrieve tactile feedback, three-dimensional perspective and the general use of the hand as an operative tool as it was in open surgery. The device is easy to insert into a small incision and easy to remove from the same incision. The device facilitates movement within the device so that the device is not an obstacle to the performance of the surgery. An effective seal is provided for both the operator's forearm and the edges of the wound to prevent the escape of gases used to maintain the pneumoperitoneum. In addition, the device allows the removal of specimens of organs from the abdominal cavity through the device, for the purpose of either removing them completely from the body or to perform a surgical procedure on them while temporarily removed from the body or extracorporealized. A further object of the invention is to allow the operator to remove the hand from the device and leave the device in place without compromising the pneumoperitoneum. The device 1 consists of a double-layer polymeric sleeve 5 through which the operator can extend a hand 2 in the abdomen. The device 1 is held in place in the abdominal incision 3 by an installation of rings 30, 31 that can be attached to the outer layer of the sleeve 5. The rings 30, 31 provide an anchor for the polymeric sleeve 5 when it is in the abdominal incision 3. A stopcock valve 26 and an inflation bulb allow the device to inflate through an inflation tube 27 which leads to the chamber 20 when it is in poon in the incision. When the device 1 is in its correct poon and inflated, the lumen 25 is closed and the device is sealed against the edges of the incision 3, thus preventing the escape of gas from the pneumoperitoneum to the outside, either through the device or between the device and the edges of the incision. If the operator's hand is inside the sleeve 5 when it is inflated, the lumen 25 will close around the arm 2 and make a seal in such a way that no gas escapes from the pneumoperitoneum.

The hand of the operator 2 does not need to be inside the device 1 when it is inflated. The operator's hand can be inserted into the abdominal cavity through the device 1 after it has been inflated. This is possible due to the way in which the device is built. The device is assembled in such a way that it effectively seals around the arm 2¿ * s¡n constricting the arm 2 or preventing movement of the arm. Using the device, the complete rotational, angular and transverse movement of a surgeon's arm is allowed. The device 1 is easily inserted into the abdominal incision before being used. The device 1 in the incision 3 without distortion. A hand is easily inserted through the lumen 25 of the device either in its inflated or uninflated state. The device 1 is rapidly inflated and makes a seal around the operator's arm 2 to facilitate the creation of the pneumoperitoneum. Referring to figures 20 to 27, another access device 40 is illustrated which is similar to that described above with reference to figures 1 to 19 and similar parts are assigned the same numerical references. In this case, the device 40 is used for the insertion of an instrument 41. The instrument 41 can be of any suitable cross section such as circular (figure 26) or square (figure 27). The device 40 operates in exactly the same manner as the device 1 described above. The principles underlying this invention will be clearer from the following description with reference to Figures 28 to 67. Figure 28 illustrates a thin-walled tube of flexible material. It can be considered as a number of longitudinal elements, typical of which is the element A-B. Clearly there is a lumen that passes through the tube, the diameter of which is the diameter of the tube. Rotation of one end of the tube relative to the other end around the axis of the tube, causes the tube to rotate in the - ^ configuration shown in figure 30. * ----. • - - # * • "The element AB is now tilted towards the axis of the tube but a straight element remains, it is clear that the element AB in figure 30 Therefore, it follows that a force must be applied to the element to cause this elongation.In the absence of such a force, the elongation of the element AB would not occur and the length The total length of the tube would be reduced (not shown) in order to accommodate the change in geometry.In the angles of rotation of less than 180 °, the element will not intersect the axis of the tube, its midpoint being the point of the Proximity closest to the axis The sum of all elements at their midpoints is what defines the minimum diameter of the lumen formed, reduced This diameter can be calculated by knowing the diameter of the original tube and the angle of rotation. takes the form of a configuration n Fitted, narrow or hourglass. This profile is not determined by the shape of any individual elements or elements but it is the effect of a section in the plane of the tube axis taken through all the elements. Before proceeding to the effects of introducing an object into the reduced lumen, particular attention should be paid to the elements as they appear in the plan view of Figure 29. All the elements are straight. Clearly, if an object of smaller diameter were introduced than the reduced lumen in the reduced lumen, the object could pass without contacting the wall of the reduced lumen. Therefore, it would not be possible for the tube to hold or create a seal towards the object. In order to accommodate the introduction of a larger object (diameter), it is necessary that each element be deformed or curved outwards, thus forming an increased lumen. This can be clearly seen in Figure 32, All elements are now deformed. As before, there is an apparent increase in the length of the elements. Also as before, in the absence of a force to lengthen the elements, the total length of the tube will be reduced to accommodate the change in geometry (figure 33). Therefore, it will be understood that the lumen has been increased to accommodate the introduced object without adjustment of the tube material and that the tube is in intimate contact with the object introduced over at least part of its length. The application of an axial force to the tube will cause the now deformed elements to try to straighten. Because the tube elements do not lie in the plane of the applied axial force, there will be a corresponding force, radially inward. This tendency to straighten the elements will be restricted by the presence of an object in the lumen. Accordingly, the radially inward component of the applied force will act on the inserted object, creating a pressure or gripping force between the tube and the inserted object.

Referring to Figures 34 to 39, the hollow cylindrical tube shown in Figure 35 is considered. The cylinder wall defines a lumen through its center. It is considered a linear element A-B. If the top edge of the tube is rotated through a certain angle, point A will move to the position shown in figures 36 and 37. Element A-B will define -even a straight line. The tube will be nominally distorted into an hourglass shape with a reduced lumen at the average height. The diameter of the lumen in the neck of the tube depends on the angle of rotation.

When the top edge rotates through 180 °, the lumen will close to a null diameter. In any horizontal plane through a twisted tube, the material must be gathered and, therefore, under compressive cycle, be tensed. If the tube height remains unchanged, then the element A-B is a twisted tube, being longer than in a flat tube, having to be under tensile axial tension. If the tube is free of axial constriction, the total length of the tube will be reduced. Angle of turn vs. lumen diameter Figure 41 shows the diameter of the lumen (D2) as a ratio of the diameter of the tube (D1) for the angles of rotation (E) from 0o to 180 °. The diameter of the lumen (D2) is calculated from: D2 = D1 cos (E / 2) As can be seen, the diameter of the lumen is independent of the length of the tube. Obieto lengthened, passed through the twisted tube As can be seen from figures 41, 42 and 43, the angle of rotation necessary to collapse the lumen of a tube for the diameter of an elongated object passed through it, depends on the ratio of the diameter of the tube to the diameter of the elongated object. The angle of rotation can be calculated from: E = 2. { cos "1 (D2 / D1).} where E is the angle of rotation, D1 is the diameter of the tube, and. >; - * D2 is the diameter of the elongated object. Although illustrated in a circular profile, a tube of sufficiently docile material will conform to many non-recursive profiles. For such profile D2 is taken as the smallest diameter that can be inscribed within the profile. Double-walled blood vessel under internal pressure Referring to Figs. 44 to 50, a thin walled tube is considered as shown in Fig. 45a. One end of the tube is bent backwards by itself as shown in figure 47 and the free ends are joined together. What is defined is essentially a double-walled tube (or two coaxial tubes joined together at their ends) with a closed volume between the two walls. One way to extend the thin walled tube in an axial direction is by introducing a pressurized fluid into the closed volume. This causes the inner tube to be subjected to axial resistance to traction and resistance to the traction cycle. The inner tube will be subjected to axial resistance to traction and resistance to the compressive cycle. As a result, the diameter of the lumen is reduced and the lumen collapses in a nominally duckbill configuration but constrained by the external tube, Figure 50.

The greater control of the lumen can be obtained by introducing a twist in the tube. The tube shown in Figure 52 is rotated as shown in Figure 54. One end of the tube is bent backwards by itself, as shown in Figure 56, and the free ends are joined together. This configuration defines two coaxial beakers, which lie together in their bases and in a common vertex. However, the common vertex is not constrained to remain in this configuration. In reality, the inner and outer tubes are free to behave as individual tubes each with half of the original twist and as such the composite tube can better defined as two coaxial pipes as hourglass, as shown in figure 59, each containing half of the total original turn. As both internal and external tubes narrow, each one is subjected to resistance to the compressive cycle. Next, a pressurized fluid is introduced into the closed volume. The introduction of pressurized fluid extends the inner and outer tubes in an axial direction, reducing the diameter of the lumen. The external tube is a narrow tube in the shape of an hourglass with resistance to the compressive cycle. The introduction of the pressurized fluid also induces resistance to the traction cycle, negating the resistance to the compressive cycle induced by the rotation. Therefore, to stay in this helical configuration, the tube must have compressive strengths cycle and since the pressurized fluid overcomes these compressive strengths, the tube is straightened and assumes a nominally cylindrical configuration, Figure 61. Since the inner and outer tubes are joined together, as the outer tube straightens, the inner tube rotates more in response. Since the outer tube does not now have any rotation, the inner tube must have all the rotation. If the original total rotation was 180 °, then the lumen would close completely. Additionally, the material defining the inner tube will be central within the diameter of the outer tube. For brevity, this configuration will be called * an Cyclops. Translation of an elongated object through a Cyclops Consider the installation illustrated in Figure 62. An axis is passed through a Cyclops with the lumen in mutual contact with the axis. He Cyclops outer tube rests in mutual contact with a fixed surface. Consider the points of contact A, between the Cyclops and the fixed surface, and B, between the axis and the lumen of the Cyclops. As the axis moves, as shown in Figure 64, point A remains fixed while the guide end of the lumen is unrolled. Since the Cyclops does not change total length, the hanging end of the outer tube is rolled as illustrated. It will be apparent that the axis moves towards the right turn as much as the Cyclops. This is exactly the movement of a caterpillar tractor. From this point of view, a Cyclops could be considered as a three-dimensional caterpillar tractor. Since points A and B in the Cyclops are not move in relation to their corresponding positions in the axis and the surface is fixed, there is no frictional resistance to the translation of the axis. In Figure 66, the Cyclops has moved to the right in approximately its own length. The material that had originally formed the inner tube has been unwound to become the tube external and vice versa. In other words, the Cyclops has been reversed. Since the inner tube of the Cyclops is in a helical configuration and since the point B remains in contact with the same point, the shaft rotates about its axis as shown by arrow C (in this case, about 120 °) . In order to obtain this translation the resistance required to be overcome is that generated as the end .guía ^ and pendant -of Cyclops deform as they are unwound and wound, respectively. Referring to figures 68 and 69, another access device 50 is illustrated, which in this case, has an integral glove 51 or an annex thereto to receive the hand of a surgeon. Referring to Figures 70 to 74, another manual access device 55 according to the invention is illustrated. The device 55 is similar to that described above except that in this case the rotation is adjustable in situ. In this case, the sleeve 5 has an inner ring 56 similar to the ring 30 and an outer ring assembly comprising two intermeshing rings 57, 58 which are rotatable with each other to adjust the rotation in the sleeve 5. The rings 57, 58 are they snap together and a seal 60 is used to prevent air discharge. The seal 60 has an upper part 61 which is housed in a female recess 62 in the ring 57 and a sealing portion 62 which extends to sealingly engage a protruding part 63 of the outer ring 58. Referring to FIGS. 75 and 78 , another adjustable turning device 70 is illustrated, which is similar to the device 55 of figures 70 to 74 and similar parts are assigned the same numerical references. In this case, the click projections 79, 80 are engaged in an assembly of the mounting rings 57, 58. To ensure a gas-tight seal between the rings 57, 58, an elastomeric sealing ring 81 is provided. The sealing ring 81 is housed in a recess in the male part 82 of the outer mounting ring 59 and projects into the space between the two rings 57, 58, in an assembly for engagement against an integral projection 92 of the lower ring 58 The seals on the mounting ring 93, 94 are used to mount the sleeve 5 on the external and internal mounting rings 57, 58, respectively. In each of the devices 55, 70, the mounting ring 57 includes a side port 95 having a passage 96 for the entry of an inflation gas into the sleeve 5. The mounting rings 57, 58 are rotatable with each other for rotating the sleeve 5 and thus reduce the diameter of the lumen 25 defined by the sleeve 5. The relative rotation is effected by the clamping of the opposite handles 97, 98 on the mounting rings 57, 58 and the rotation thereof. This causes the sleeve 5 to rotate from a configuration 28 where there is no rotation for, for example, a 90 ° turn or a 180 ° turn in which the lumen 25 is closed. Therefore, the sleeve 5 can be pre-rotated. or turning during a surgical procedure. In use, sleeve 5 straightens and O-ring 56 is inserted through a wound opening 3. A surgeon then inserts his hand through the sleeve 5. The rings 57, 58 are relatively rotated to rotate into the sleeve 5 and thus reduce the diameter of the lumen. The sleeve 5 is then inflated by the introduction of pressurized gas through the inlet port 95. This causes the sleeve 5 to extend in the axial direction and the diameter of the lumen 25 to be reduced, further improving the seal. The surgical procedure is then carried out. At the end of the surgical procedure, a combination of deflation and / or straightening of the sleeve 5 is used to allow the surgeon to remove his hand. In this way, if required, the gas seal can be maintained as a surgeon withdraws his hand and when the hand is removed completely. An advantage of this sealing device is that it is adjustable to the site and in situ to suit a particular patient, surgeon and / or procedure. The mounting rings 57, 58 jump with each other as they rotate relative to one another. It is desirable to have a small frictional force acting between the surfaces as they rotate with each other, to facilitate operation of the device 55, 70 and also to maintain the desired sealing contact between the two rings 57, 58. Referring to FIGS. to 81, another surgical device 100 according to the invention is illustrated. In this case, an inner ring 101 has clutch means in the form of a radially and axially extending tip seal 105 for engaging an internal wall of a patient in the wound opening. This facilitates the positive location and clutch of the device 100, in use. Referring to figures 82 to 85, another device is illustrated 109. In this case, an inner liner or bag 1 10, extending between the outer and inner rings 1 1 1, 1 12, is provided to ensure that the inside of the inflated sleeve 5 is sealed while the rings 1 1 1, 1 12 turn on each other. Referring to Figures 86 to 88, another surgical device 20 according to the invention is illustrated. The device 1 comprises a first O-shaped ring 201, a first external mounting means in the form of an O-shaped ring 202 mounted on a first receiver 203 and a second mounting means in the form of a shaped ring of O 205 mounted on a second receiver 206. The receivers 203, 206 are, in this case, interconnectable, as illustrated, and a fourth O-shaped ring 207 is provided between the receivers 203, 206 in the assembly. A hose 210 of flexible, foldable plastic material extends from the second external receiver 206 to the first external receiver 203. The receivers 203, 206 are removable as illustrated in FIG. 87 to facilitate relative rotation between them in the direction of the arrows to vary the degree of rotation in the sleeve 210. Referring to figures 89 and 90, another surgical device 220 is illustrated, which is similar to the device 200. In this case, the O-ring 205 is Removable from the receiver 206 to facilitate the adjustment of the length of the sleeve 210. Upon removal of the O-shaped ring 205, the sleeve 210 is adjusted to a desired length d. In this way, a single device 220 can be used for a variety of abdomen thicknesses. The diameter of the lumen defined by the twist does not need to be changed to provide a range of abdomen sizes. The excess sleeve can be cut or wrapped around the ring seal in the form of O 205.

Referring to Figures 91 a and 91 b, an assembly of two surgical devices 250, 260 is illustrated. The device 250 is a forearm seal and the device 260 is a protective wound retractor that is assembled in an external sealing device 250. The sealing device 250 provides an external sealed access port through which a surgeon can insert his forearm or- for the insertion of an instrument or the like. Referring to figure 92, a modified manual access device 155 according to the invention is illustrated. In this case, an inner ring 156 is closed in a pocket 157 in the sleeve 5 while an outer ring 158 is free to move between the walls of the sleeve. Referring to Figures 93 and 94, another manual access device 160 is shown in which the eversion-limiting rings 161, 162 are free to move axially inside the sleeve 5. The device is used as described above, clipping the outer ring 161 the exterior of the abdominal wall after insertion to limit eversion in the incision. The inner ring 162 is free between the walls of the sleeve 5 when the sleeve returns from the inside out completely to the wound as illustrated in Figure 94. Upon removal of a surgeon's arm, the eversion of the sleeve outwardly is limited by the clutch of the ring 162 against the inside of the abdominal wall. An advantage of this installation is that the same device can be used for a wide range of different abdomen thicknesses.

Referring to Figures 95 and 96, another manual access device 1 65 is illustrated, which is again similar to those described above. In this case, the inner and outer rings 166, 167 are not attached to the sleeve 5, however, a linking section 168 of flexible material extends between the rings 166, 167. "t Referring now to Figures 97 and 98, Another manual access device 1 70 according to the invention is illustrated. In this case, an inner ring 171 is held in a desired axial position in the sleeve 5 by adhesive tapes 173. An outer ring 172 is poised to move axially within the sleeve. Referring to Figure 99, another medical device 700 according to the invention is illustrated, which is similar to those described above and similar parts are assigned the same numerical references. The device includes a protective device to protect the connection between the rings 30, 31. The protector protects the sleeve section 35 which engages with the incision from the axial force to the traction. This facilitates improved compliance at the margins of the incision and improved retraction and sealing. In this case, the protector is in the form of a film 701 which is of a caliber lighter than that of the main sleeve 5. There is a hole 702 in the main sleeve 5 which allows air to enter the chamber 706 between the main sleeve 5 and the film 701. The hole 702 can be covered by a valve such as a non-return flap valve 705. The protective film 701 is shown deflated in Figure 99a. After inflation swells out as illustrated in Figure 99b and better compliance to the incision is achieved as illustrated in Figure 99c. This installation can then be used to allow deflation of the inner sleeve for improved access, as illustrated in Figure 99d. Referring to Fig. 100, in this case, the protector is provided by a compressible foam - like the sleeve 750. The foam may include reinforcing means 751, as illustrated in Fig. 101. It will be appreciated that the protector can be of any suitable material. Referring to FIGS. 1 10 to 1 17, a sealing device 300 according to the invention is illustrated. For a clear understanding of the principles underlying this invention, reference will be made to Figures 102 to 109, which illustrate a simple sealing device 250. The sealing device 250 comprises a tubular sleeve 251 of flexible material mounted on a first end. to a first mounting means and mounted at a second end to a second mounting means. The first mounting means is an elastic ring 252, the second mounting means is an elastic ring 253. The sleeve 251 defines a lumen 254. The rings 252, 253 are rotated together to cause the sleeve 251 to rotate, thereby reducing the diameter of the lumen 254. The sleeve 251 is illustrated in a twisted, flaccid position in Figures 102 to 105. The rings 252, 253 move away from each other in the axial direction, thereby extending the sleeve 251 and further reducing the diameter of the sleeve 251. lumen, figures 106 to 1 09. The sleeve 251 is sealed around an object that passes through the lumen 254: (i) ai the rings 252, 253 rotate with each other, thus rotating the sleeve 1 and reducing the diameter of the lumen 254; or (ii) by distancing the rings 252, 253 from each other in the axial direction, thereby extending the sleeve 1 and reducing the diameter of the lumen 254; or (iii) through a combination of (i) and (ii). Referring to Figures 1 to 17, the sealing device 300 is illustrated which is similar to the sealing device 250 of the figures. 102 to 109 and similar parts are assigned the same numerical references. In this case, elastic supports 305 are connected between the first elastic ring and the second elastic ring. As the two rings move together, the supports 305 curve outward in a looping manner. This causes the twisted sleeve to take a flaccid configuration that increases the diameter of the lumen, figures 1 14 a 117. The material properties of the supports 305 cause them to extend when they are released. The supports 305 return to their straight positions parallel to the axis of the sleeve, figures 1 10 to 1 13. The extension of the supports 305 moves the two rings away from one another in the axial direction and extends the sleeve, thus reducing the diameter of the lumen . In this case, the sleeve is pre-rotated and the elastic rings are constricted by supports 305 to remain in the twisted position. The elastic rings can not rotate with each other. Referring to Figures 1 18 to 125, there is illustrated another medical device 400 that forms a trocar seal. In this case, a coiled spring 401 is placed between two elastic rings 402, 403 with a sleeve 404 therebetween. The upper end of the coil spring _ ^, 401 is held against the underside of the first ring 402 and the lower end of the coil spring 401 is held against the upper side of the second ring 403. The coil spring 401 and the sealing sleeve 404 They lock inside a shelter. The housing comprises a rigid casing having an upper part 407 and a lower part 408 which are separable from each other and a tubular, flexible elastomeric sleeve 409 extending therebetween. The elastomeric sleeve 409 is sealed to the upper part of the casing and to the lower part of the casing in order to join the upper part and the lower part. This installation 5 facilitates the movement of the wound spring 401 from a compressed position to an extended position, the spring 401 remaining enclosed within the housing. When the coil spring 401 is compressed, the two rings 402, 403 move together. This causes the twisted sleeve to take a flaccid configuration, increasing the diameter of the lumen. This compresses the elastomeric sleeve so that the upper and lower parts of the envelope are adjacent to each other. When the coil spring 401 is released, it moves to an extended position. This causes the two rings to move away from one another, extending the twisted sleeve 5 and reducing the diameter of the lumen. The elastomeric sleeve extends to a position in which the upper and lower parts of the envelope are distant from each other. The device 400 is used to seal a cannula. Referring to Figures 126 and 127, a sealing device 500 according to the invention is illustrated. In this case, a twisted tubular sleeve 501 ^ is mounted at an end of one end of a rigid tube 502 and at the other end of the other end of the rigid tube 502, with a volume enclosed 503 between the sleeve 501 and the walls 502. The hose 501 is inflated as air passes through a port 504 in the tube 502 and towards the enclosed volume 505. Inflation of the sleeve 501 extends the sleeve 501 in the axial direction, thus reducing the diameter of the lumen . Referring to Figures 128 and 129 there is illustrated a sealing device 600 which is similar to the sealing device 500 of Figures 126 and 127. One end of a twisted tubular sleeve 601 is mounted to a first rigid tube 602, the other end of the the twisted sleeve 501 is mounted to a second rigid tube 603. The rigid tubes 602, 603 partially overlap and are movable in an axial direction with respect to each other, so that when the sleeve inflates and extends in the axial direction, the tubes they move axially away from each other in a "trombone-like" action, reducing the diameter of the lumen. The tubes are constricted at the overlapping ends so that they always overlap at least partially. Reference is also made to the appropriate alternatives and modifications outlined in our parallel applications of reference WO 00/321 16A, WO 00/321 1 8A, WO 00/35356A, WO 00/321 19A, WO 00 / 32120A, the contents integers of which are incorporated herein by reference. The invention is not limited to the embodiments described hereinabove, which may vary in construction and detail.

Claims (65)

1. CLAIMS 1. A medical sealing device, characterized in that the device comprises: a sleeve defining a lumen; the sleeve having a helical sleeve section, the helical sleeve section defining at least a portion of the lumen; and tension means for the axial tension of the helical sleeve section in order to axially extend the helical sleeve section and thereby reduce the cross-sectional area of the lumen portion defined by the helical sleeve section of a first lumen configuration open to a second sealing configuration to seal the clutch of the helical sleeve section to an object in the lumen. A device according to claim 1, characterized in that the sleeve is rotated to provide the twisted sleeve section. 3. A device according to claim 1 or 2, characterized in that the sleeve is made of flexible material. A device according to claim 1, characterized in that the tension means for the axial tension of the twisted sleeve section comprises a chamber for a pressurizing fluid. A device according to claim 4, characterized in that the chamber is defined by an outer sleeve section and an internal sleeve section. 6. A device according to claim 5, characterized in that the outer sleeve section is substantially cylindrical and the inner sleeve section is rotated and is of the same diameter without twisting as the outer sleeve section. 7. A device according to claim 6, characterized in that the sleeve is returned axially by itself to; defining the outer sleeve section and the inner sleeve section, the inner sleeve section comprising the twisted sleeve section. A device according to claim 7, characterized in that after the axial tension of the twisted sleeve section, the sleeve can be turned from the inside outwards so that part of the twisted inner sleeve section is rolled out to become part of the sleeve. the outer sleeve section without turning. 9. A device according to any of the claims 7 or 8, characterized by the clutch of an object in the portion of the lumen of the twisted sleeve section and the axial movement of the object relative to the twisted sleeve section, the sleeve can be turned from the inside outwards so that the The twisted inner sleeve section is rolled out to become an outer sleeve section without rotating and the non-twisted outer sleeve section is inwardly wound inwardly to become a twisted inner sleeve section. 10. A device according to any of claims 4 to 9, characterized in that the chamber is impermeable to fluids. eleven . A device according to any of claims 4 to 10, characterized in that the camera is inflatable. 12. A device according to any of claims 4 to 11, characterized in that the camera has an access port for inflation of the camera. A device according to any of claims 8 to 12, characterized in that it includes eversion-limiting means for axially limiting the eversion of the sleeve. 14. A device according to claim 13, characterized in that the eversion-limiting means is housed in the chamber. 15. A device according to claim 14, characterized in that the eversion-limiting means is axially movable in the chamber. 16. A device according to any of claims 13 to 15, characterized in that it includes a first eversion-limiting means for the external location of a body opening and a second eversion-limiting means for the internal location of a body opening. 17. A device according to claims 15 and 16, characterized in that both the eversion-limiting means are movable independently in the chamber. 18. A device according to claims 15 and 16, characterized in that a linking means is provided between the two eversion-limiting means. 19. A device according to claim 18, characterized in that the linking means is made of flexible material. 20. A device according to claim 18 or 19, characterized in that the linking means comprises a link sleeve. twenty-one . A device according to any of claims 3 to 20, characterized in that the or each eversion-limiting means is an O-ring. 22. A device according to claim 21, characterized in that the O-ring is made of an elastic material. . 23. A device according to claim 21 or 22, characterized in that each eversion-limiting means is an O-ring. 24. A device according to claim 23, characterized in that the O-rings are of different diameters. 25. A device according to any of the claims 21 to 24, characterized in that it comprises an internal ring in the form of an O, the O-ring having an internal clutch means for engaging with an internal wall of an opening. 26. A device according to claim 25, characterized in that the clutch means is a tip seal. 27. A device according to any of claims 13 to 26, characterized in that the eversion-limiting means comprises eversion-limiting means, first and second, attached at different places in the sleeve. A device according to claim 27, characterized in that the first eversion-limiting means is attached to one end of the sleeve and the second eversion-limiting means is attached to another end of the sleeve. 29. A device according to claim 27 or 28, characterized in that the eversion-limiting means is movable relative to each other to rotate the sleeve. • - • - < --- • 30. A device according to claim 29, characterized in that the eversion-limiting means are rotatable relative to each other to rotate the sleeve. 31 A device according to claim 29 or 30, characterized in that it includes handling means to facilitate the movement of the eversion-limiting means. 32. A device according to any of claims 29 to 31, characterized in that fixing means for fixing the first eversion-limiting means relative to the second eversion-limiting means. A device according to any of the preceding claims, characterized by an outer ring assembly comprising two mounting rings that are rotatable with each other. 34. A device according to claim 33, characterized in that the mounting rings are inter-engagable. 35. A device according to claim 34, characterized in that the mounting rings are engaged by clicking adjustment. 36. A device according to any of claims 33 to 35, characterized in that a seal is provided between the mounting rings. 37. A device according to claim 36, characterized in that the seal has an upper part that is housed in a mounting ring and a sealing part that extends to hermetically engage the other mounting ring. 38. A device according to claim 36, characterized in that the seal comprises a liner or bag extending between the mounting rings. 39. A device according to any of claims 33 to 38, characterized in that a mounting ring includes an input port in fluid communication with the sleeve. 40. A device according to any of claims 33 to 39, characterized in that each mounting ring includes handle means. 41. A device according to any of the preceding claims, characterized in that it includes protective means for protecting the sleeve portion from the axial tensile force. 42. A device according to claim 41, characterized in that the protector comprises a film defining a chamber, together with the sleeve portion to which it is attached. 43. A device according to claim 42, characterized in that the protective film is of a material of lighter caliber than that of the sleeve portion. 44. A device according to claim 42 or 43, characterized in that an access hole is provided between the sleeve and the chamber. 45. A device according to claim 44, characterized in that the orifice is covered by a valve means. 46. A device according to claim 45, characterized in that the valve means is a non-return flap valve. 47. A device according to claim 41, characterized R-L because the protector is made of a material similar to compressible foam. 48. A device according to claim 47, characterized in that the protective foam material includes reinforcing means. 49. A device according to any of claims 10 to 4, characterized in that it comprises an external rigid tube to which the sleeve is attached. 50. A device according to claim 49, characterized in that the tube comprises rigid tube sections that are axially movable relative to each other. 15 51. A device according to any of the preceding claims, characterized in that it has connecting means for connecting the device to another medical device. 52. A device according to claim 51, characterized in that one of the devices is a forearm seal and the other 20 device is a protective wound retractor. 53. A device according to claim 1, 2 or 3, characterized in that the tension means is a mechanical means of tension. 54. A device according to claim 53, characterized in that the tension means comprises a spring means. 55. A device according to any of the preceding claims, characterized in that in the second sealing configuration, the twisted sleeve portion of the lumen is dimensioned to hermetically engage an object passing through it. 56. A device according to any of the preceding claims, characterized in that it is used in surgery. 57. A device according to any of the preceding claims, characterized in that it is used in laparoscopic surgery. 58. A device according to any of the preceding claims, characterized in that the device is a forearm seal that is used to perform manually assisted laparoscopic surgery. 59. A device according to any of claims 1 to 55, characterized in that the device is an endoluminal device. 60. A device according to any of the claims 1 to 55, characterized in that the device is an introducer for introducing an instrument into a body through an opening. 61 A device according to any of claims 1 to 55, characterized in that the device is a blood extractor. 62. A device according to any of the claims 1 to 55, characterized in that the device is an envaginator. 63. A device according to any of claims 1 to 55, characterized in that the device is a tissue dissector. 64. A device according to any of claims 1 to 55, characterized in that the device is a trocar seal. 65. A device according to any of claims 1 to 57, characterized in that the device is an instrument port / cannula.