The invention relates to an access port and port sleeve arrangement for use in laparoscopic surgical procedures and the like. Laparoscopic surgery, often termed ‘key-hole’ surgery conventionally involves making, typically two or more, small incisions in a patient and inserting an access port into each of those incisions. One or more of the known access ports may allow the introduction of an insufflation gas so that a surgeon has room to undertake a procedure, for example by inflating the abdominal cavity of a patient. The access port further includes an opening through which is inserted a surgical tool during the procedure. Such apertures are generally self-sealing so when a tool is not present in the aperture, little insufflation gas pressure is lost through the port.
The known access ports have a stem which is inserted into a patient, for carrying a head of the access port typically having a self sealing aperture and insufflation gas valves etc. The stems need to be long enough to reach through bodily tissues of large or obese patients and so these stems are usually and needlessly too long for many patients. In addition, the stems are usually pointed so that they can be inserted easily into an incision. As a result of their length and pointed end of the stem, there is a possibility that internal trauma may occur if the stem is forced against internal tissues.
The inventor has realised that there is a need for an access port which avoids or mitigates internal trauma.
Commercially available access ports are, by necessity cumbersome and bulky. The ports usually have a means for insufflating the patient, as well as a self-sealing aperture. The ports are designed for use during surgery, and then removal when surgery is finished. Some surgical procedures require two or more sessions spaced hours or days apart. When an access port is reintroduced into a patient for further surgical procedures, for example, to check on the initial surgery, that reintroduction can cause additional trauma at the re-entry area.
The inventor has realised also that there is a need for a port which can be left in the patient for further surgical sessions, but the present devices mentioned above are not suitable for that purpose. A particular shortcoming of present designs is that they protrude into the body in use and protrude above the line of the body significantly, making them potentially very uncomfortable for the patient if the patient were to lie on the port or knock the head of the port on an obstruction. The necessary rigidity of the port also makes them dangerous if they were left in place.
The inventor has further realised that a device that can facilitate removal and reinsertion of an access port, and which could be left in place until all surgical sessions were complete, would be of great benefit to a patient and surgical staff.
Embodiments of the invention address the problems mentioned above. The access port of the present invention, in embodiments, employs a length adjustable stem, for example a telescopic stem principle, so that the conventional stem of the port is replaced by a length adjustable sleeve arrangement and this sleeve arrangement allows the internal length of the port (conventionally the stem portion) to be adjusted to the dimension of the patient's bodily tissues, for example the abdominal wall, so there is less chance of accidental internal trauma. The sleeve can be at least partially removeable from the head of the port so that the sleeve can be left in the patient if required, for example either to be reconnected later or to allow access to the surgical site for other instruments inserted through the sleeve. A removable cap can be used to seal the body cavity from the external environment. In addition, the same length adjustable principle can be applied to a stand-alone sleeve which is positioned generally inside the body without the head of an access port, which sleeve has little material protruding above the patient's body line and so can remain in the patient after an initial surgical procedure session, providing a ready reinsertion point, for example, for known access ports.
The present invention provides a laparoscopic access port having a head portion for use generally externally of a patient, and a sleeve portion extending along an axis and for inserting generally into the body of a patient in the direction of the axis, said port being adjustable in overall length in the direction of the axis, the sleeve portion comprising a shank attached or attachable to the head and a flanged piece moveable relative to the shank by means of a mechanism for causing the overall length of the port to adjust, the mechanism being operable externally of the patient at or adjacent the head.
The head, or part of the head, and sleeve may be separable.
The invention provides also a sleeve insertable at least partially into a patient, the sleeve being suitable for either complementary connection to the head of an access port or for removably supporting the head of a laparoscopic access port in use.
In an embodiment, said sleeve (in its stand-alone form or the sleeve attached or attachable to the head of an access port) includes a first seal member for preventing or inhibiting the escape of insufflation gases, in use, and a second seal member for preventing or inhibiting the escape of said gases, acting between the sleeve and the patient in the form of a flange or flanged piece.
In an embodiment, said sleeve is generally tubular, including a first tubular piece forming the shank and a second tubular piece forming the flanged piece, one of said tubular piece being relatively moveable within the other to adjust the overall length of the port.
Preferably the first or second tubular piece has a thread and the other of the first or second tubular pieces has a complementary thread or thread- following formation such that the movement of the second tubular piece causes said overall length adjustment.
Preferably the rotation of the second tubular piece is caused by a manually rotatable third tubular piece forming part of the mechanism and extending from the head such that the third tubular piece can be rotated externally of the patient in use.
Preferably said third tubular piece extends at least partially within the second tubular piece, which in turn is at least partially within the first tubular piece.
Preferably the third tubular piece includes at least one axially extending slot for accepting a detent formed on or in the second tubular piece for allowing the detent of second tubular piece to move axially in the slot under the influence of the thread.
Preferably, the flanged piece includes a distal end at which is formed a flange, optionally being formed from flexible material.
Preferably the sleeve further includes a one-way movement mechanism operable so that the shank and flanged piece can move only toward each other, in turn so that the flange of the flanged piece and the head can only move toward each other.
More preferably the one-way mechanism includes complementary formations on the shank and flanged piece which allow them only to come closer together.
In an embodiment the shank and flanged tubular piece of the sleeve include cooperating means to prevent or restrain their relative movement, for example during insertion of the sleeve.
Preferably said means to prevent or restrain relative movement includes a bayonet type mechanism.
Preferably the bayonet type mechanism includes one or more studs on one of the shank or flanged piece slideable in a complementary channel or channels in the other of the shank or flanged piece, the channel or channels including an area which allows the relative sliding of the shank and flanged piece and an area that does not.
Preferably the area of the channel or channels which allows said sliding together has sides which extend generally parallel to the axis and the area that does not has sides which extend obliquely to the axis.
In an embodiment, the flanged piece has at least one flexible draw tab for holding the flange in place while the shank is moved toward or over the flanged piece.
Preferably the draw tab comprises two draw tabs, which are tensioned in use to pull the shank or flanged piece together.
Preferably each draw tab is held in place in use to thereby hold the inner and outer flanges in place relative to each other.
The port may further include a plug or cap to substantially seal the port after the head of the access port is removed or partially removed.
In an embodiment, the access port further includes an introduction tool which includes a shoulder, in use engageable with the second tubular piece.
Preferably the access port includes at least one ear at or adjacent the head for allowing securing of the head by means of suture.
The invention extends to a combination of a sleeve for insertion into a patient optionally with features mentioned above, supporting a laparoscopic access port head and arranged such that the access port head is removable from the sleeve. The sleeve, if a stand-alone sleeve, can allow multiple reinsertions of the head onto the sleeve, or if the sleeve is attachable to the head of a port then the sleeve allows reconnection of the head at a later time while the sleeve stays in the patient.
The invention further extends to a method of using medical equipment, comprising or including the following steps in any suitable order:
a) inserting a sleeve into a patient for holding or supporting a laparoscopic access port head,
b) inserting a laparoscopic access port head into the sleeve or attaching a laparoscopic access port head to the sleeve;
c) optionally inserting and removing a surgical tool into the access port;
d) removing the laparoscopic access port or port head from the patient but not the sleeve;
e) optionally, reintroducing the laparoscopic access port into the port or re-attaching a laparoscopic access port head to the sleeve; and
f) removing at least a portion of the sleeve.
Preferably, the step of inserting the sleeve is followed by securing the sleeve in place, by means the bringing together of inner and outer flanges of the sleeve.
Preferably the sleeve may be sealed with out without the inserted or attached head, by means of the sealing cap fitted to an exterior portion of the sleeve, or fitted to the head.
Although, there are many ways of putting the invention into effect, by way of example only, embodiments of the invention are described below, with reference to the drawings, wherein:
a shows a pictorial view the first embodiment of the invention;
b and 2c show partial enlarged views of the first embodiment shown in
a shows a pictorial view of a second embodiment of the invention;
b shows a partial enlarged view of the second embodiment;
a and 4b show side views of a third embodiment of a sleeve according to the invention;
a, b and 6 show sectional views of the third embodiment;
a to 15c show yet further embodiments of the invention.
Referring to
The access port sleeve 10 is shown in more detail in
The inner flange 14 in use sits against the inner wall of a body cavity C (as shown in
Referring additionally to
Referring additionally to
A captive plug 30 is illustrated in
In general the internal diameter of the aperture 8 will be in the order of 7.5 mm to 14 mm to allow the insertion of a laparoscopic access port which in turn is capable of receiving laparoscopic surgical tools of a diameter of 5 mm to 11 mm. Whilst the sizes mentioned above are typical of presently used apparatus, it will be appreciated that other sizes may be employed for example smaller sizes may be used for paediatric surgery.
In use the sleeve 10 is pushed through an incision in the patient P by collapsing the inner flange 14 and forcing the sleeve 12 into the incision. As the inner flange 14 enters the cavity C the flange will resiliently return to its planar shape as illustrated in
When the access port 50 is removed the plug 30 can be inserted into the channel 8 so as to avoid infection entering the cavity C via the channel 8.
A second embodiment of the invention is shown in
b shows a one-way ratchet mechanism which is similar to the to ratchet mechanism shown in
In use the flanges can be brought together as described above. When it is desired to seal the channel 8, the plug 30 is pushed into the channel 8 and the clasp 104 is moved down relative to the straps 102 to prevent the plug from coming out.
In a refinement, the lower tubular piece 13 is slightly longer than the upper tubular piece 11. This means that the upper tubular piece cannot be inadvertently forced to protrude into a body cavity beyond the flange 14, so reducing the likelihood of damaging internal organs and the like.
A third embodiment of the invention is shown in
Referring to
The sleeve 110 includes an inner flange 114 and an outer flange 116, which perform sealing functions as described above. The outer tubular piece 111 has a cap 130, which is used for sealing the sleeve when not used for laparoscopic access. The cap 130 has a tether 132.
a and 5b show sections of the tube when they are partially collapsed. Such a partial collapsed state may provide the correct dimension between the inner and outer flanges, for example if the patient is overweight.
Access channel 108 for accepting a laparoscopic access port can be readily seen formed within inner diameters of the two tubular pieces 111 and 113. Two flexible draw tabs 134 can be seen. These are integrally moulded with the inner tubular piece 113 and extend through openings 117 in the outer flange 116. The tabs 134 can be gripped and pulled through the openings 117 from the outside to hold the inner piece 113, while the outer tubular piece 111 is pushed toward the inner piece 113. This action brings the two tubular pieces together. The openings 117 include a gripping mechanism for one-way movement of the tabs 134 therethrough so that the two tubular pieces are held together by tension of the tabs and cannot come apart once they have been forced together.
A modification is shown in
Inner flange 114 is resiliently fitted to the inner end of the moulded tube and the draw tabs 134 are integrally formed on the outer end of this tube. The tube wall includes the channel 115 which has a majority of its length extending parallel to the axis C. At the outer end of the tube 119 the channel extends obliquely to the axis. A similar mirror-image channel (not shown) is provided on the opposite side of the tube.
The outer tubular piece 111 and cap 130 in more detail. The outer tube 111 includes a pair of studs 118, slideable in the channels 115 mentioned above. The studs and channels form a bayonet fitting which restricts the coming together of the two tubular pieces 111 and 113 when the studs are located in the outer oblique end 119 of the channel 115. When the outer tubular piece 111 is then rotated about axis C relative to the inner tubular piece 113, the studs can be moved into a position in the channel, which allows the tubular pieces to come together. It will be noted that the openings 117 are wider than the tabs 134 to allow said relative rotation of the tubular pieces.
The embodiments described above refer to a sleeve which can accommodate a conventional access port. However, in an alternative design a sleeve having a similar arrangement to the sleeves described above may form part of a surgical access port.
Such a combined port and sleeve 200 is illustrated in the sectional views of the fourth embodiment shown
Referring in particular to
In use, as illustrated in
Following insertion, the inner and outer pieces are relatively rotated to remove the influence of the bayonet restraint. Draw tabs 217 are pulled in the direction of arrow A and as a result, the inner piece 213 is drawn toward an outer piece 211 of the sleeve 210. A one way movement mechanism 217 stops the tabs from sliding backwards. As described previously, flanges 214 and 216 on the inner and outer parts, come closer together to minimise the leakage of insufflation gases. The flanges are formed from elastomeric material.
At this stage, cap 230 can be removed and an instrument (not shown) can be pushed through the seal 218 into the aperture 208 and on, into the patient P.
After surgery, the instrument is removed and the port arrangement 200 can be removed. In this embodiment, the head 250 can be removed from the sleeve 210, whilst the sleeve remains in the patient. Thus the sleeve can remain in the patient for further access to the surgical site in subsequent surgical operations, or for observations, or drainage, or suchlike, in a similar manner to the sleeves described above.
In
Referring to
The generally tubular sleeve 410 has two main parts—a shank 411 generally rotatably attached to the head 450, and a moveable flanged piece 413, which is moveable relative to shank 411 to adjust the overall length X (including the head) of the port 400. A mechanism is described below for causing said movement.
The head 450 is divided into two parts—a lower part 440 which is rotatably attached to the shank 411 and a removable part 460, which can be detached, as shown in
As illustrated in
Once inserted a flange 414 helps to hold the port in place as described above and provides a radially inwardly facing seal around bore 408 to aid prevention of the escape of insufflation gases when a laparoscopic tool is being used in the bore 408. Sutures stitched into the skin of a patient, can be attached to ears 412 to aid the securing of the port 400 in place on/in the patient's body. The ears include tapering slots 415 for capturing and securing the sutures in place.
a is a longitudinal section through
Referring to
Various alternatives to the above embodiments are described below with reference to
Referring to
Referring to
It will be readily apparent to the skilled addressee that further modifications, alterations and additions to the embodiments described above are possible. For example, suitable alternatives to the materials used could be employed. Thus, the flexible silicon elastomer described could be replaced by other suitable biocompatible material i.e. material which is safe for use within a patient's body cavity. The sleeves 10, 100, 110, 210, 410, 510, 610 and 710 could be manufactured from other plastics materials, or metals or ceramic materials. It is possible that the sleeves could be made completely or partially from biodegradable material so that disposal is made less expensive, or from material which can be cleaned and reused. Plastics materials described could include a bactericide to reduce the likelihood of infection. The inner and outer flanges are illustrated as being generally planar and parallel, although it is envisaged that for some applications the shape of the flanges could be altered. For example, the outer flange could be shaped to fit a particular curved body part and thus avoid protruding too far above the skin of a patient. A circular channel 8, 108, 208, 408 and flanges 14, 114, 214, 414 and 16, 116, 216 are preferred but it will be appreciated that other shapes, for example hexagonal, could be used. The terms tube and tubular are intended to embrace such non-circular shapes.
Number | Date | Country | Kind |
---|---|---|---|
0909393.1 | May 2009 | GB | national |
0918565.3 | Oct 2009 | GB | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
---|---|---|---|---|
PCT/GB2010/050884 | 5/27/2010 | WO | 00 | 1/30/2012 |