Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/34—Trocars; Puncturing needles
  • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
  • A61B17/3421—Cannulas
  • A61B17/3423—Access ports, e.g. toroid shape introducers for instruments or hands
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/02—Access sites
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/02—Access sites
  • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/34—Trocars; Puncturing needles
  • A61B17/3462—Trocars; Puncturing needles with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals
  • A61B2017/3466—Trocars; Puncturing needles with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals for simultaneous sealing of multiple instruments
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/02—Access sites
  • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
  • A61M2039/0264—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body with multiple inlets or multiple outlets
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/02—Access sites
  • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
  • A61M2039/0279—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body for introducing medical instruments into the body, e.g. endoscope, surgical tools

Definitions

• the present invention relates to surgical methods and devices, and in particular to devices and methods for use in mini ma l access surgery, such as laparoscopy and natural orifice endoscopy.
• Minimal access surgery refers to the concept of performing surgical operations via reduced or confined access approaches for the purpose of improving patient outcome and convalescence after surgical intervention.
• Laparoscopic, or "keyhole" surgery is a well-known technique whereby elongate surgical instruments are inserted through one or more narrow incisions (typically 0.5 to 1.5 cm in diameter) in the patient.
• Various instruments can be introduced into the patient in this way, including scissors, graspers, cutters, energy dissection and sealing devices etc. The surgeon may pick and choose such instruments to suit his purpose.
• Laparoscopic surgery has several advantages compared to conventional open surgery. The smaller incisions result in reduced abdominal wall injury and hence lessened postoperative pain and wound complications. Patients typically will also have a shorter recovery time and a better cosmetic outcome.
• An optical device or “laparoscope” provides a suitable imaging mechanism, with currently known types comprising either a charge coupled device (CCD) for insertion directly into the patient or a telescopic lens system that brings the image out of the patient where it can be recorded with a camera.
• CCD charge coupled device
• a fibre optic cable provides light so the laparoscope can be effective and a pump system insufflates the patient with an inert gas (e.g. carbon dioxide), so the instruments have space in which to move.
• an inert gas e.g. carbon dioxide
• a wound protector is often placed into the body wall in order to protect the skin and subcutaneous tissues from microbiological contamination. In cases involving malignancy, this device also acts to shield the wound against tumour cell implantation. For patient benefit, these incisions are often made at the site of one or more of the incisions already made for placement of the laparoscopic trocars.
• the "SILS port” manufactured by Covidien (RTM)
• RTM Covidien
• the "SILS port” comprises a narrow neck of solid plastic with a defined number of holes (three) machined into the plastic. The port is inserted into the incision, and has flanges at either end so that the port is held in place on either side of the incision. Valved tubes can then be inserted through the holes, and elongate surgical instruments inserted through the tubes to allow their access to the patient.
• the general construct of the outer interface is similar in other commercially available ports including those made by Advanced Surgical Concepts, Ethicon Endosurgery, Innovia, Applied Medical and Karl Storz. While some of these devices (by reason of their design and/or material composition) impose strict cylindrical or conical entry and parallel instrumentation, all (including the low profile devices) impose a fulcrum (generally located at the level of the abdominal wall entry site) onto the individual trocars as well as a predetermined, fixed distance (which predisposes to cluttering and clashing of instruments during certain manoeuvres) between the instrument access points. Both of these factors significantly limit the freedom and independence of movement possible by the individual instruments and optic.
• kits that are restrictive in terms of available trocar number (limiting the number of instruments that can be used at any one time) and dimension (limiting the types of instruments that can be used at any one time) and tend to be exclusive of complementary tools that may be already available in a surgery department but made by a different manufacturer. Therefore, when using currently commercially available devices (such as Covidien's, described above) surgeons have to plan ahead within very narrow confines which instruments they will need for each particular part of the procedure. If a part of the procedure requires five instruments, say, and the port allows only four instruments to access the operating field at any one time, further incisions will be necessary. In addition, the surgeon's ability to improvise is lost (or at least hampered).
• US 5524644 and EP 2363105 disclose wound retracting ports for protecting an incised wound from exposure to bacterial and other harmful contaminants of a simpler design, in which there is an impermeable pliable sleeve for insertion into the incision and having resilient annular members connected to each end; one of these is formed to engage the inner edge of the wound, with a portion of the sleeve above the wound being rolled onto the other annular member to draw the remaining sleeve portion contiguous with opposite sides of the wound.
• the present invention seeks to address these and other problems
• the invention provides a port for m i n i m a l a ccess surgery via an incision in a patient, comprising a substantially cylindrical sleeve formed of a flexible membrane material and having a first, open end and a second, closed end; a first resilient ring arrangement around said sleeve at said open end, and a second resilient ring arrangement around said sleeve and located on it between said first resilient ring arrangement and said closed end, wherein the second resilient ring arrangement is adapted, in use, to be rolled around itself and the sleeve to roll up any flexible membrane material extending between said first and second resilient ring arrangements, so as to draw both the first and second resilient ring arrangements into close engagement against respective sides of the incision.
• Such an arrangement may in some embodiments be of unitary construction and hence relatively inexpensive (unitary in this context indicates that the port is a one-piece, integrated device that is not made from separate components and cannot be taken apart without causing the destruction of the port). It is easy to use and, as will become clearer below, capable of performing the functions of both a wound retractor/port and a seal in one, avoiding the connection problems of some prior devices (thus, in describing embodiments of the invention herein, the word "port” should be construed broadly, so as to encompass a device which performs the function of a port and a seal).
• such a device provides all the functions associated with the arrangements of US 5524644 and EP 2363105, but may also provide two layers of sleeve material adjacent the incision, effectively doubling the thickness of the sleeve, therefore providing additional protection against contamination as well as against device damage and parietal wall trauma that may occur during instrumentation insertion, withdrawal and exchange (especially with respect to sharp instrumentation).
• the sleeve is elastically resilient and all formed of the same material suitable for surgical use, such as a polyolefin or polyisoprene, natural or synthetic rubber or silicone and, as is known in the art, substantially transparent or translucent.
• a polyolefin or polyisoprene such as a polyolefin or polyisoprene, natural or synthetic rubber or silicone and, as is known in the art, substantially transparent or translucent.
• the flexible nature of the device means it may be used to provide a robust, secure and hermetic sealing of an incision through which such a device has been installed while providing, at its upper surface, entry points to allow the insertion of instruments and connection tubing for gas sufflation.
• the material may alternatively be substantially opaque, for situations when it is desirable to exclude ambient light from the wound area.
• the ring arrangements may be formed of a resilient material such as an elastomer, which is flexible (optionally different to the material of the sleeve) and either joined to the sleeve arrangement by the application of heat or a suitable adhesive, or they may be seated in annular pockets formed in the sleeve.
• the ring arrangements may be formed of the same material as the sleeve, and may therefore be moulded or otherwise incorporated into the sleeve in a simple, single manufacturing step.
• one or both of the ring arrangements is/are of larger diameter than that of the incision, with the second resilient ring arrangement having a diameter greater than the diameter of the incision. This enables a user readily to recognise which way round the device should be used, and can be assisted by providing that one of the ring arrangements is of a different colour to the other.
• the second ring arrangement may be inserted into the incision and located against the inside of the incision, whilst the first ring arrangement may be located outside the incision.
• the elastic sleeve can be stretched to insert the lowermost ring into the wound incision and then its elasticity draws the two ring arrangements taut against the two sides of the incision.
• the second ring arrangement is capable of being able to be rolled around itself, to "roll up" sleeve material and draw the two ring arrangements into close contact with opposing sides of the incision.
• the ring arrangements are sufficiently flexible to also allow either or both rings to be stretched over the outer component of a standard wound protector or other device placed around (on either internal or external aspect) or through an incision or natural orifice.
• the device may also be used in association with a flat sterile drape based around a single ring for insertion into an incision in order to provide tension on the drape so that this construct acts as a wound retractor as well as a simple wound protector.
• the ring arrangements can also be sufficiently flexible to be deformed enough not only to allow their straight insertion into a wound or natural orifice (or indeed other hollow device placed into either an incision or natural orifice) but also that the second ring arrangement can be passed through the first ring arrangement to leave two nested cylinders of sleeve material, one inside the other, with the second ring arrangement at one end, the first ring arrangement at the other end, and with the closed end of the sleeve extending through and beyond the first ring arrangement.
• the outermost sleeve in cooperation with the two ring arrangements, is then able to function as a port, similar to those of the prior art, but with an internal sleeve which functions to both provide additional protection to the incision and also as an access point for introducing instruments and/or trocars - these can pierce the closed end of the sleeve, the dimension, configuration or resilient material of which may be sufficient to provide an airtight seal against the introduced items, or a suitable tie may be used to improve the air seal.
• such ports provide instrument access points that allow great freedom of movement of instruments which extend through the gap defined by the sleeve inside the patient.
• the inner sleeve With the upper ring passed through the lower ring, the inner sleeve is also free to move in the gap between it and the outer sleeve.
• attachments may be disposed around the sleeve and between said second resilient ring arrangement and said closed end, and adapted, in use, to releasably attach to said second resilient ring arrangement and to enable tensioning of the flexible membrane material between the second resilient ring arrangement and the attachments.
• attachments could be formed around the sleeve in the form of small hooks or the like which are adapted to engage with the sleeve material wound round the first ring arrangement or with the ring arrangement, or there may be a ring of adhesive: a user simply draws the inner sleeve tight and then engages the attachments which then hold the inner sleeve in position against the inside of the outer sleeve.
• the invention provides a method of performing minimal access surgery via an incision in a patient using a port as described, comprising passing the second resilient ring arrangement through the first resilient ring arrangement to create two nested cylinders of flexible membrane material, and inserting the first resilient ring arrangement through the incision into the patient.
• the internal diameter of the port can be adjusted so as to fit an incision of a certain diameter, and/or to hold the incision at a certain diameter, as is known in the art.
• the sleeve material extending from the second ring arrangement to the closed end may be formed of a different material as that extending between the ring arrangements, so as to improve the seal, for example. It is additionally advantageous that the second, closed end of the sleeve defines a plurality of instrument access points, each point comprising a tubular extension of the sleeve, so that instruments/trocars may be inserted through the closed end through the closed ends of these tubular extensions (or the ends of these extensions may simply be cut off to allow insertion).
• the tubular extensions may be "stepped", i.e. have sections of different diameters (usually decreasing in the direction away from the ring arrangements) or more gradually tapered.
• the conduits may include discrete rings, internal ribbing and/or valves to ensure maximised efficiency of gas-sealing during instrument usage. Because the closed end will extend outside of the patient (especially in association with the positive pressure induced by sufflation of gas into the patient's body cavity or viscus), the fulcrum point for the instrument is moved away from the level of the parietal wall . This means that any trocar inserted into the device initially remains extrinsic to the patient, and this may minimise the risk of organ or visceral injury. Furthermore, the added lever effect improves the angulation possible for synchronous or isolated instrument movement (an effect also enhanced by the thinness, elasticity and flexibility of the material). BRIEF DESCRIPTION OF THE DRAWINGS
• Figures la and lb are schematic views, in elevation and plan view respectively, of an embodiment of the present invention, shown prior to use;
• Figures 2a and 2b are schematic elevation views of the embodiment of Figures la and lb at different stages of use, and
• Figure 3 shows a modification to the devices of Figures 1 and 2.
• Figures la and lb show a surgical access port 2 in its "opened out” form, prior to being prepared for use on a patient. It comprises a first ring arrangement 4 and a second ring arrangement 6 joined by a cylindrical tube of flexible material 8; this tube 8 continues beyond the second ring arrangement 6 to form a cap 10 at one end.
• the cap 10 has a number of extensions 12 as conduits for instrument or trocar insertion (the number and disposition of these conduits may be varied as necessary, and any discrepancies between the views in Figures la and lb ignored).
• the cap end of the tube is closed, as manufactured, whilst the other end of the tube, defined by the first ring arrangement 4 is open. Both ring arrangements are resiliently flexible so that they can be easily deformed by manual pressure, and will then "snap" or spring back into their original, substantially circular shape.
• Figures 2a and 2b illustrate both the preparation of the device 2 of Figure la for use on a patient, and how the device is adapted in use to fit tightly.
• the second ring 6 is pushed through the first ring 4, turning the tube 8 inside out but creating a double cylinder of sleeve material (nested one inside the other) and leaving the extensions 12 protruding from the mouth of the first ring 4 (apart from one, shorter extension (such as may be used for gas sufflation) which, as shown in Figure 2b, is within the sleeve 8 and slightly distorting its shape).
• the second ring 6 is deformed again so it can be introduced into a wound incision (the patient's body wall, in which the wound is incised, is depicted at 14), and when fully inserted its resilience opens the ring 6 out to its original shape, to lie inside the wound and against the inside of the patient's body (the outside of the patient's body is depicted as 16, the interior of the patient's body cavity is depicted as 18); of course, this ring 6 is suitably larger in diameter than the wound so as to seat against it and not pull out in normal use.
• the user can now grasp the first ring 4 and the extensions 12 and pull the device 2 so that the ring 6 inside the patient's body seats firmly against the body wall, inside the patient, as shown in Figure 2a.
• the first ring 4 outside the patient can be rolled over and over on itself to roll up the excess tube material, until the first ring 4, wrapped in several turns of the tube material, abuts against the outside of the patient's body, and the cap 10 and extensions 12 project away from the patient's body, as shown in Figure 2b.
• Now pulling the tube of material still extending between the rings 4, 6 tight thus holds the device 2 firmly in place in the wound, and provides a contamination-resistant barrier for the edges of the wound incision in similar manner to known wound protecting devices.
• the cap 12 is formed of a flexible and elastic (yet durable) material, this advantageously allows greater freedom of movement of instruments at a relatively less fixed point of insertion. Furthermore, the projection of the cap 10 and the extensions 12 a distance away from the patient body provides significant ergonomic advantage in terms of allowing greater relative movement at the tips of instruments in synchronous use. It also offers an improved safety profile as any trocars placed within such a device would be in fact be placed extra-corporeally (or outside the patient body cavity) and so minimise any potential injury due to trocar misplacement.
• the first ring arrangement 4 may consist of two rings (not shown) ; this is to facilitate the rolling up step, and this could equally be achieved using a single ring provided with lugs, or with an oblate or pointed cross section, for example (not shown) and the ring(s) may be hollow and/or provided with shaped inserts to assist in rolling (or prevent unwanted unrolling) as are known in the art.
• the cap 10 of tube material and the extensions 12 are left protruding out through the first ring 4, and these seal the open wound from the atmosphere.
• the surgical instruments and/or trocars can be pushed through the material of the cap 10 to access the wound (this can of course be done prior to placement of the device in the patient so that the entire construct is inserted at one time into the patient or the device can be placed first and thereafter trocar and instruments positioned or some combination of the two can be performed).
• the material of the cap 10 is simply punctured or cut to allow insertion of the instruments.
• the instruments may be inserted through the ends of the extensions 10; if the end of an extension is cut off, the instrument may be passed down the extension, and provided the diameter of the extension is appropriate, the resilient flexibility of the material of the tube 8 and the extensions 10 will act so as to grip the outside of the introduced instrument (not shown) and make a seal against it, thus maintaining the contamination-resistant properties of the seal, !f needed, ties can be used to further secure the extensions to the sides of the instrument or trocar which has been introduced, although it is advantageous to rely on the resilience of the extensions themselves to perform this function without needing additional parts.
• a particular advantage of the device 2 is that the instruments are shielded from the edges of the wound by two layers of sleeve material. Not only does this provide additional protection to the wound, also any rubbing takes place between the layers of sleeve material, and there is less risk of the instrument abrading a single sleeve, as in known devices, and possibly damaging the wound edges.
• the ring arrangements 4, 6 are disposed in pockets formed in the material of the sleeve 8; alternatively the rings may be attached to the sleeve 8 by heat sealing or a suitable adhesive or one or both rings may be manufactured within the material of the device by rolling, plication or some other method.
• the rings may have configurations of colour and/or shape/texture for easy use and orientation of the device, and many other variations will be apparent to the skilled person.
• some type of releasable attachment 20 may be provided on the cap 10 to be releasably attachable to the rolled up material on the first ring 4, or vice versa, to hold the material of the cap 10 against the material of the sleeve 8 inside the edges of the wound; these attachments 20 could be adhesive, hooks, or any other suitable attaching device formed on or provided on the cap 10, and/or ring 4.
• the sleeve material may be lightweight and translucent, which allows ambient light to help illuminate the activity taking place inside the patient (and to see the colour of the ring arrangements contained within pockets in the sleeve material), but the material may be opaque if desired (to limit light leakage, for example).
• the material of the sleeve 8 is the same as that of the cap 10 (since they are formed as a unitary item), however the two may be of different materials, and/or of different thicknesses for different applications.
• the device 2 may be formed of an opaque and of a stiffer and much more robust material, such as a surgical rubber, and is then a unitary device formed of the same material throughout.
• the rings 4, 6 are formed of the same material as the sleeve 8, and can be created by moulding the entire device 2 in one step.
• the device 2 operates in exactly the same way as described above, but once the second ring 6 has been passed through the first ring 4, the second ring 6 placed inside the patient and the first ring 4 rolled down, the resilience of the material acts to hold the first ring 4 in place and prevent unrolling.
• the diameter of the second ring 6 is larger than that of the first ring 4 in order to hold its position inside the incision.
• the use of a stiffer material reduces the ability of the device to act as a wound retractor by relative twisting (so the device 2 would have to be of similar diameter to the incision), but is beneficial because it provides very robust physical protection to the wound edges and, subject to suitable sterilisation, could be re-used.
• the device 2 could be manufactured in a range of diameters.
• Figure 3 shows a modification to the device 2" of Figures 1 and 2 in which the extensions 12" are formed as cylinders as before, but now they are stepped in diameter (two steps are shown in Figure 3, but there could be more than two, as many as are reasonable and practical) .
• This arrangement is advantageous because it allows different diameter tools to be used (if the very end of the cap shown is cut off, a relatively small diameter instrument or trocar can be introduced, whereas if the extension is cut at the first step then a larger diameter trocar or instrument can be introduced) and allows separate ties to be used to improve sealing, if desired.
• the Figures illustrate an embodiment in which the length of the cylindrical sleeve 8 is greater than the distance between the inside 18 of the patient's body and the outside 16 at the location of the incision (the "body thickness").
• the sleeve may be elastic and shorter than the body thickness, in which case the device has to be stretched to seat the ring arrangements against the opposite edges of the wound - but then the same elasticity of the sleeve may act advantageously to hold the device 2 tightly thereagainst - the rolling of the sleeve could then additionally tauten the ring arrangements against the patient's body.
• the access device can be used simply by stretching the lower ring directly onto the external aspect of any standard wound protector or protector-retractor already placed into a surgical incision.
• it can be directly applied to the external aspect of a ring, mount, strut or stent placed either in or around either an incision or natural orifice.
• the lower ring catches around the exterior of the secondary device and the upper ring takes up position just above so that the interior of the other device (and hence incision or orifice) is securely sealed and made useful for laparoscopic or endoscopic working.
• some additional material such as a sterile drape can be captured between the lower ring of the port device and another externally or internally placed mount or ring so that additional wound protection or retraction may be incorporated into the surgical device construct.
• the device disclosed here is fit for the purposes described above and also for providing an access port that can be placed across or within a variety of already available and in development proctoscopes, anorectoscopes and anal strut/stent systems as well as externally placed rings and mounts. It also has potential applications for thoracoscopic procedures and other minimal invasive operations.

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• Heart & Thoracic Surgery (AREA)
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• Animal Behavior & Ethology (AREA)
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• 2012
  • 2012-08-14 GB GB1214515.7A patent/GB2504962A/en not_active Withdrawn
• 2013
  • 2013-08-13 EP EP13752606.7A patent/EP2884919A2/de not_active Withdrawn
  • 2013-08-13 WO PCT/EP2013/066860 patent/WO2014026960A2/en active Application Filing

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