WO2015049391A1 - Laparoscopic system - Google Patents

Laparoscopic system Download PDF

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Publication number
WO2015049391A1
WO2015049391A1 PCT/EP2014/071365 EP2014071365W WO2015049391A1 WO 2015049391 A1 WO2015049391 A1 WO 2015049391A1 EP 2014071365 W EP2014071365 W EP 2014071365W WO 2015049391 A1 WO2015049391 A1 WO 2015049391A1
Authority
WO
WIPO (PCT)
Prior art keywords
trocar
olive
housing
locking surface
lumen
Prior art date
Application number
PCT/EP2014/071365
Other languages
French (fr)
Inventor
Ronan Keating
Barry Russell
Gerard Rabbitte
Original Assignee
Neosurgical Limited
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US14/045,590 external-priority patent/US9668723B2/en
Application filed by Neosurgical Limited filed Critical Neosurgical Limited
Publication of WO2015049391A1 publication Critical patent/WO2015049391A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3417Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421Cannulas
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B2017/348Means for supporting the trocar against the body or retaining the trocar inside the body
    • A61B2017/3482Means for supporting the trocar against the body or retaining the trocar inside the body inside
    • A61B2017/349Trocar with thread on outside
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B2017/348Means for supporting the trocar against the body or retaining the trocar inside the body
    • A61B2017/3492Means for supporting the trocar against the body or retaining the trocar inside the body against the outside of the body

Definitions

  • the present invention relates to laparoscopic systems and in particular to
  • laparoscopic surgical systems configured for cooperation with a trocar.
  • the system may function to provide an anchoring and closure system for use in laparoscopic surgery.
  • an olive or trocar sleeve is provided for a specific trocar type (Hasson) and the two are provided in co-operation with one another prior to any surgical insertion of the trocar into the abdominal wall.
  • This is not always appropriate as not all surgery requires use of an olive at the start of the procedure, particularly off midline when utilizing radially dilating trocars.
  • improved trocar anchoring and subsequent port closure may be required.
  • pneumoperitoneum can cause the trocar to move in the port. Additionally during robotically assisted laparoscopic surgery the importance of maintaining
  • pneumoperitoneum and trocar position is even more critical.
  • the device provides for deployment of a suture and anchor to enable port site closure subsequent to a laparoscopic surgical procedure which may be used to anchor the device during the laparoscopic procedure.
  • Figures 1 A to 1 C show examples of a an olive that may be used in
  • Figures 2A to 2E show further examples of operation of a system such as that shown in Figure 1 .
  • Figure 3A and 3B show examples of an olive in accordance with the present teaching.
  • Figure 4A and 4B show examples of an olive in accordance with the present teaching.
  • Figure 5A and 5B show examples of an olive in accordance with the present teaching.
  • Figures 6A to 6C show example of another system comprising a separately formed locking surface which may be used to positively engage with a received trocar.
  • Figure 7A to 7E show an example of a further embodiment in accordance with the present teaching including locking surfaces configured to positively engage with a received trocar.
  • Figure 8 A to 8F an example of another embodiment in accordance with the present teaching including locking surfaces configured to positively engage with a received trocar.
  • Figure 1 shows a surgical device in the form of an olive 100 for use in laparoscopic surgery.
  • the olive comprises a housing which in use may be anchored to an abdominal wall to define an entry port for presentation of a trocar or surgical devices into the abdominal wall for enabling laparoscopic surgical procedures.
  • the words "olive” and “housing” within the context of the present teaching may be used interchangeably.
  • the olive 100 of Figure 1 comprises an abdominal wall contacting or engaging portion 105 and an outer resting portion 510 which in use will rest against the outer surface of the abdominal wall.
  • the abdominal wall engaging portion 105 extends inwardly from the resting portion 510.
  • the olive 100 defines an aperture in the body of the outer resting portion 510 that extends through to the abdominal wall engaging portion so as to define a lumen 130 for allowing introduction of a trocar 1500 into the abdominal cavity.
  • the olive is intended to be used with suture so as to allow the olive be anchored to the abdominal wall.
  • the suture could also be used for closure of the wound after completion of a surgical procedure.
  • the olive comprises at least one needle guide channel 108 provided in a side wall of the abdominal wall engaging portion 105.
  • the needle guide channel 108 comprises an entry port 108a for a needle driver to be presented to the olive and an exit port 108b from which suture which is coupled to a needle or an anchor may be driven using the needle driver out of and away from the abdominal wall engaging portion 105.
  • the exit port 108b is provided on an outer surface 105b of the
  • the needle guide channel 108 is desirably configured to taper outwardly such that an anchor presented through the guide will be directed into the abdominal wall that is contacting the abdominal wall engaging portion 105.
  • the channel 108 provides a convex path relative to the lumen 130 such that a needle driver will initially be presented towards the lumen 130 on insertion through the entry port 108a and will then be displaced away from the lumen prior to exiting through the exit port 108b.
  • the exit angle relative to the perpendicular is desirably a fixed angle which may be optimally configured between 5 and 30 Q , or more preferably between 10 and 20 Q .
  • suture can be coupled to respective anchors and directed into the abdominal wall.
  • the anchor is desirably biased inwardly through the guide 108 using an anchor driver.
  • the exit hole port 108b is desirably located such that the needle will pass into the subcutaneous layer of the abdominal wall. Desirably application of continued downward pressure using the needle driver will cause the anchor to then pass into the abdominal cavity, pulling suture with it.
  • the orientation of the anchor will typically change orientation from a vertical disposition used in the deployment configuration to a horizontal configuration. This may be assisted by coupling the suture to an anchor at a mid-point of the anchor such that it will pivot relative to the coupling to change its orientation.
  • Anchoring is effected by retracting the deployed suture. This causes the suture to be pulled back into the olive, tightening the anchor against the inner abdominal wall. As the orientation of the needle has changed, it will not tend to retreat back through the abdominal wall through the path it developed on penetration of the wall.
  • the olive is then resting against the outer surface of the abdominal wall and is prevented from moving away from that position through the action of the anchors against the inner surface of the abdominal wall. It is self- anchored. The retention of the position is maintained in this configuration by use of a suture cleat 512 within which the suture can be tightened against.
  • first and second needle guide channels 108 are provided, each being adjacent to their respective guide channel.
  • the guide channels 108 are provided opposite to one another, in this configuration each are displaced about 180° away from the other.
  • this suture cleat 512 is an example of a suture securement feature provided adjacent or proximal to each of the entry ports 108a and being useable to secure the suture once tightened against the olive, thereby self-anchoring the olive relative to the abdominal wall.
  • the cleat comprises two opposing faces which when brought together form a double taper to which a suture may be presented and tightened within. In this way the suture securement feature operates as a jam cleat. These faces may be textured or otherwise treated to improve their suture retention properties.
  • the olive may be provided with one or more contoured surfaces providing finger grips 120. These allow an operator to manually manipulate the olive without slipping. As is shown in Figure 5B, these finger grips may comprise one or more projections or ribs 560 that extend beyond the normal surface of the outer resting portion 510 so as to provide a proud contact surface for gripping by an operator.
  • the deployed anchors and sutures may be used to effect a closure of the wound.
  • the suture is released from its suture cleat 512 and the olive is retracted from the abdomen.
  • the surgeon may then tie a knot, and use the still tethered suture to effect a closure of the wound.
  • sutures and/or needle anchors are bioabsorbable so as to allow for their eventual dissolving after the procedure.
  • An alternative method of use would be to deploy the anchors as described above. To close the wound the anchors could be picked by a grasper disposed through a trocar while the spools are in the unlocked position.
  • the anchors are removed through the trocar; the two suture ends are tied or mated and passed through the trocar again to create a closed loop of suture. This joining process could also be completed internally. The olive would then be removed and the suture trimmed and knotted as described above.
  • the longer the length of the abdominal wall engaging portion 105 the less freedom a surgeon has during the laparoscopic procedure to manipulate his laparoscopic tools which are accessing the internal cavity through the device.
  • By maintaining the abdominal wall engaging portion 105 as a shallow element more freedom is provided to the surgeon.
  • Figures 1 to 6 show examples of olives provided in accordance with the present teaching which are also configured to expand to allow presentation of trocars of varying diameter through the lumen defined by the olives.
  • an inner surface of the olive is provided with one or more locking members or locking surfaces which are configured to operably engage with an outer surface of the presented trocar to minimise relative movement between the two.
  • Figure 1 A shows an olive 100 with a trocar locking surfaces 350 which is shaped or contoured to mate with the contours of the trocar 1500 with which the olive is being used.
  • the trocar locking surfaces in this arrangement are integrally formed or molded with the olive and define an arcuate surface that is concave in shape.
  • first and second locking surfaces are provided opposite one another and are biased towards one another. In use these will actively engage with an outer surface of the trocar which is located within the lumen defined by the olive.
  • This biasing of the inner trocar locking surfaces 350 is desirably achieved by the same mechanism that provides for an expansion of the olive. In the illustrated examples this is achieved by provision of first and second expansion struts 550 which are shown in Figure 3.
  • the expansion struts are provided opposite one another and are located substantially 90 degrees out of phase with the locking surfaces 350. In this configuration the outer resting portion 510 of the olive is expandable due to the addition of expansion struts 550.
  • expansion struts allow the inner diameter of the outer resting portion to expand, which in turn allows the trocar locking surfaces 350 to disengage from the contours of the trocar.
  • the expansion struts are also integrally formed with the olive body.
  • the olive of Figure 1 A features a pair of needle entry ports 108 and a pair of suture cleats 512 (shown in Figure 2A) as with previous described arrangements. In this configuration, the suture cleat is achieved by a pan head screw, whereby the suture is pulled into space between the pan head of the screw and the surface of the olive adjacent to the screw head.
  • the screw head provides a substantially flat or planar surface and acts as one half of a cleat once tightened against the olive surface, the olive surface acting as the other half of the cleat.
  • the suture can be placed in the clamp between the flat surface of the screw head and the curved surface of the expandable olive by wrapping the suture around the screw head. This improves the capture efficiency.
  • the suture can be wrapped around the screw head until it overlaps with itself to give enhanced securement.
  • the needle delivery channel 108a is angled such that on the initial part 580 of its trajectory it is angled inwards from the vertical plane, towards the received trocar shaft. This has the advantage of making the needle exit point lower, such that the needle does not have the opportunity to catch at skin level, making the suture entry point lower.
  • FIG. 1 A An expandable olive provided in accordance with the present teaching can be used with a variety of different trocar configurations.
  • the trocar contours are in the form of annular ridges 1590. These annular ridges, as can be seen in Figure13A, taper from a small diameter 1591 to a large diameter 1592, with a step 1593 before the next ridge. This facilitates ease of advancement through the abdominal wall, and provides resistance when the trocar is pulled out, which trocar manufacturers use as a trocar stabilising feature.
  • the trocar locking surfaces 350 sequentially come into contact with the annular ridges to function as a trocar lock.
  • Anchors may be deployed by advancing a driver through the needle entry ports 108 and then providing for a securement of the suture using the suture cleats 512.
  • the trocar may be freely repositioned within the defect or removed from the olive until the user stops squeezing the expansion struts. Effectively a positive action by the user is required to allow the trocar locks to disengage from the trocar.
  • FIG. 1 B shows a similar arrangement to 13A with an olive on a trocar.
  • the trocar contours are in the form of a helical thread 1595.
  • the olive can be threaded onto the trocar with the trocar locking surfaces 350 engaging with the trocar thread.
  • many rotations of the trocar/or olive may be necessary to position each component in the desired location.
  • To quickly move the trocar relative to the olive the operator will disengage the trocar lock by squeezing the expansion struts 550 together. This reduces the biasing force that positively moves the locking surfaces into contact with the trocar.
  • the trocar may be repositioned within the defect or removed from the olive. For fine adjustments of the positioning between the olive and trocar, rotation of the trocar could be used.
  • Figure 1 C shows a similar arrangement to 1 A and 1 B with an olive on a trocar.
  • the trocar contours are in the form of annular rings 1592.
  • the annular rings do not taper like the example in Figure 1 A and have radiused corners. The olive will lock on this configuration trocar, but will not be as secure as the embodiments described in Figures 1 A and 1 B.
  • Figure 3, 4 and 5 show olives which are useable in accordance with the present teaching with different trocars such as those provided with reference numeral 1500 in Figures 2A through 2E.
  • Figure 3 and 5 are similar in construct in that both contain an expansion strut 550.
  • the expansion strut has a number of raised surfaces 560 which act as grips when the expansion strut is squeezed or pinched to disengage the trocar lock.
  • the trocar locking surfaces 350 in Figure 5A have an increased length over that illustrated in 3A, which has the advantage of giving the retained trocar 1500 increased stability, as it removes some of the degrees of freedom the trocar would otherwise have.
  • Figure 4 illustrates a similar olive, but with no expansion struts. This could be used where a trocar has less aggressive steps, for example the trocar illustrated in Figure 1 C. It will be appreciated that this olive is also an expandable housing where the locking surfaces are operably biased into contact with a received trocar. However, the absence of the expansion struts, which extend out from the main olive body, reduces the amount of flex that is provided by this arrangement. The olive in this configuration is a more rigid construct than that of Figures 3 or 5.
  • FIG. 6A to 6C shows another configuration where the trocar locking surfaces 350 are achieved with a formed wire.
  • the olive will lock onto a trocar.
  • the surface of the wire is curved and the wire extends through the expandable housing to define first and second contact points for a received trocar on opposite sides of the lumen.
  • the wire further defines a curved actuation surface 405 located externally to the lumen 107. Compression of the curved actuation surface effects a release of the locking surface from a received trocar. It will be appreciated that in the exemplary configuration this compression is effected by pushing the wire towards the olive with the portion 405. In Figure 6C the wire is shown pushed forward and the locking surfaces 350 are disengaged. This could be achieved by having a flat ground on the wire, such that when the wire is in this position none of the wire enter into the lumen 107. It will also be understood that the profile of the wire may be altered to achieve varying degrees of locking.
  • a round wire will not lock as securely on a stepped trocar as a square or flat wire profile as the round wire has no edges to catch on the trocar steps.
  • this embodiment is illustrated as a wire, it will be understood that this illustration is not limiting as this is an example of the type of locking mechanism that can be used to positively engage with a received trocar while not having to be integrally formed or moulded as part of the olive body. It will be appreciated that by using a locking mechanism such as described in Figure 6, independent control of the engagement of the locking surfaces relative to the movement of the expandable housing is achieved. The locking surfaces can be brought out of contact from a received trocar without requiring a change in the overall diameter of the lumen, which was not possible with the examples of Figures 1 -5.
  • FIG. 6 shows a trocar lock engagement/disengagement feature with reference to an olive which has an expansion strut
  • this type of locking feature could also be applied to an olive of the type illustrated in Figure 4.
  • the illustrated trocar lock engagement/disengagement feature is illustrated as a wire, but this could also be a plastic profile which achieves the same goal. Alternately a profile could also be created which when turned circumferentially will function like a cam to create a trocar locking surface.
  • Figure 7 illustrates an olive which has no expansion features, and is optimally configured to add minimum profile to the trocar it interacts with.
  • the olive features an entry port 107 whereby a trocar may be presented to the lumen and pass into the abdominal cavity.
  • a pair of needle guide channels are also provided in a manner previously described.
  • Trocar locking surfaces 350 which are shaped or contoured to mate with the contours of the trocar 1500 with which the olive is being used.
  • the trocar locking surfaces in this arrangement are integrally formed or molded with the olive and define an arcuate surface that is concave in shape.
  • the trocar locking feature is further defined in this example to have a surface 351 which tapers downwards from the horizontal plane such that the olive of this example is optimally configured for use with a threaded trocar.
  • first and second locking surfaces are provided opposite one another and in use these will actively engage with an outer surface of the trocar which is located within the lumen defined by the olive.
  • the olive also features a second insert moulded portion 740.
  • This second shot material polypropylene
  • the main body portion which may for example be formed from a polycarbonate or clear ABS.
  • the materials are illustrated in Figure 7D, where the main body portions are designated as 175 and the second shot material is designated 775.
  • the main body portion 175 also features a surface 176 which overhangs the lower portion 777 of the second shot material. This in effect creates a mechanical lock to hold the second shot material in place within the main portion 175. As the two materials are dissimilar there is no chemical bond between the main body portion and the second shot material. This creates a zero gap cinch point 750 where the two materials interface opposite the needle guide channel.
  • a lead in area 751 aids in locating the suture at into the zero gap cinch.
  • the suture cinch is illustrated as being on either side of the needle entry channel 108, Ref Figure 7F. This gives the surgeon the option of pulling the suture to either side of the needle entry channel.
  • the suture can be removed from the initial cinch, the olive repositioned and the suture placed in a fresh cinch at the second location.
  • the illustrated example is not intended to be limiting.
  • the suture cinch could for example be positioned at 90° to the current location on the outer edge of the olive which may be a more ergonomic location that the illustrated example.
  • the olive described in this embodiment is ideally moulded in a clear material which has the advantage of giving enhanced visibility of the abdominal wall layers.
  • This is not intended to be limiting.
  • Figure 8 illustrates and olive has no expansion features and again features needle guide channels 108 and a trocar entry port 107.
  • the needle guide channels are disposed with a recessed area 1080 of the outer portion 510.
  • the recessed portion offers the advantage providing a guide whereby the side walls of the recess 1081 serves to guide the user towards the needle guide channel.
  • the user can present the needle sideways through the guide recess 1080 and this arrangement is expected to be easier in terms of locating the needle on the needle channel guide.
  • the olive has trocar locking surfaces which are hidden in the main body portion 510 of Figure 8 A.
  • a pair of finger grips 845 (845A and 845B) can be squeezed once the guide is positioned on a trocar shaft.
  • the trocar lock 810 pivot about the pivot point 820 and rotate the trocar locking surfaces 350 into the trocar entry port 107 to engage with the trocar.
  • the trocar lock is held in position by a ratchet type mechanism whereby the portion 810 and the portion 830 both have teeth which interlock with each other and maintain the trocar lock against the trocar.
  • the portion 830 can be moved by pushing on the surface 835, such that the teeth of the portion 830 are moved away from the teeth of portion 810, allowing the trocar lock to disengage when the surfaces 841 are squeezed together.
  • the olive also features a second insert moulded portion 840.
  • This second shot material polypropylene
  • the main body portion which may for example be formed from a polycarbonate or clear ABS
  • the two materials are dissimilar there is no chemical bond between the main body portion and the second shot material.
  • the cinch becomes more exposed once the trocar locking feature is enabled as illustrated in Figure 8B. While the olive of the present teaching has been described with reference to a needle driver and anchoring system it will be appreciated that an olive which can be used with trocars of differing dimensions may not necessarily be deployed in scenarios that require anchoring.
  • trocar when used in the context of the present teaching should not be limited to a sharp-pointed surgical instrument fitted with a cannula and used especially to insert the cannula into a body cavity as a drainage outlet.
  • trocar when used in the context of the present teaching is intended to define generally a surgical instrument that is used in laparoscopic surgery to allow surgical access within the abdominal cavity through a port provided in the abdominal wall and can include the cannula that functions as that portal.
  • the olive may be fabricated from any suitable material
  • the present inventors have ascertained that fabrication from a polypropylene such as the medium melt-flow-rate polypropylene homopolymer prepared by Borealis Nucleation Technology (BNT) and sold under the trademark Bormed HD850MOTM is particularly advantageous.
  • BNT Borealis Nucleation Technology
  • Bormed HD850MOTM Bormed HD850MOTM
  • This grade of material is found to have the flexibility of generic polypropylenes but is also more impact resistant and harder than most polypropylene grades which enables the flexibility of the hinge/movement function but also is less susceptible to damage when used with threaded trocars which chafe material off softer grades in use. Details of the properties of this polypropylene are provided below:

Abstract

A laparoscopic surgical system configured for cooperation with a trocar is described. In another configuration, which is not necessarily exclusive of the first configuration, the system may function to provide an anchoring and closure system for use in laparoscopic surgery.

Description

Title
LAPAROSCOPIC SYSTEM Field of the Invention
The present invention relates to laparoscopic systems and in particular to
laparoscopic surgical systems configured for cooperation with a trocar. In one another configuration, which is not necessarily exclusive of the first configuration, the system may function to provide an anchoring and closure system for use in laparoscopic surgery.
Background
There are difficulties sometimes associated with the closure of the trocar wound site for example, in laparoscopic procedures. There are difficulties in particular in finding the fascia layer through which a suture must be passed to ensure good and adequate port site closure.
With deeper port sites, such as with an obese patient, it is often more difficult for the surgeon to gain deep access to the fascial layer to securely place a suture therein. In certain instances it may be necessary to cut open the wound to accurately place a suture fixation on the inner fascia layer.
The consequences of inadequate closure may be serious. For example, the patient may be subject to an early or late onset hernia, bowel stricture and/or bleeding from the port site. All of these complications have varying associated morbidities up to and including fatalities in serious undetected bowel strictures. The rate of port site herniation is widely published to be up to 3% for the normal population and double this for the obese cohort. There are therefore a number of problems with current methods of trocar port site closure that need to be addressed, particularly for the obese patient. There are further difficulties in anchoring or otherwise securing laparoscopic surgical devices relative to a laparoscopic surgical port, for example with Hasson type ports. Suture stays can be difficult to manage during Hasson trocar sleeve or olive fixation and can become tangled when removing or adjusting the trocar. These problems also need to be addressed in order to ensure an efficient workflow for the surgeon.
Typically an olive or trocar sleeve is provided for a specific trocar type (Hasson) and the two are provided in co-operation with one another prior to any surgical insertion of the trocar into the abdominal wall. This is not always appropriate as not all surgery requires use of an olive at the start of the procedure, particularly off midline when utilizing radially dilating trocars. However, with excessive trocar manipulation, improved trocar anchoring and subsequent port closure may be required.
Many trocar manufacturers address this by providing ridges or threads on the outer trocar surface to grip or prevent slippage within the tissue. Excessive trocar manipulation can cause damage to the extent that the pressure of the
pneumoperitoneum can cause the trocar to move in the port. Additionally during robotically assisted laparoscopic surgery the importance of maintaining
pneumoperitoneum and trocar position is even more critical.
Summary
These needs and others are addressed by a laparoscopic device in accordance with the claims that follow. In one aspect the device provides for deployment of a suture and anchor to enable port site closure subsequent to a laparoscopic surgical procedure which may be used to anchor the device during the laparoscopic procedure.
By providing an expandable housing whose inner diameter may be varied it is possible in accordance with the present teaching to accommodate surgical instrumentation such as trocars of different dimensions and outer surface features.
These and other features of the present teaching will be better understood with reference to the drawings which follow which are provided to assist in an understanding of the present teaching and are not to be construed as limiting in any fashion.
Brief Description of the Drawings The present teaching will now be described with reference to the accompanying drawings in which:
Figures 1 A to 1 C show examples of a an olive that may be used in
accordance with the present teaching to provide for a closure of a laparoscopic port with locking surfaces configured to positively engage with a received trocar.
Figures 2A to 2E show further examples of operation of a system such as that shown in Figure 1 .
Figure 3A and 3B show examples of an olive in accordance with the present teaching.
Figure 4A and 4B show examples of an olive in accordance with the present teaching.
Figure 5A and 5B show examples of an olive in accordance with the present teaching.
Figures 6A to 6C show example of another system comprising a separately formed locking surface which may be used to positively engage with a received trocar.
Figure 7A to 7E show an example of a further embodiment in accordance with the present teaching including locking surfaces configured to positively engage with a received trocar.
Figure 8 A to 8F an example of another embodiment in accordance with the present teaching including locking surfaces configured to positively engage with a received trocar.
Detailed description of the drawings
Figure 1 shows a surgical device in the form of an olive 100 for use in laparoscopic surgery. As shown, the olive comprises a housing which in use may be anchored to an abdominal wall to define an entry port for presentation of a trocar or surgical devices into the abdominal wall for enabling laparoscopic surgical procedures. The words "olive" and "housing" within the context of the present teaching may be used interchangeably. The olive 100 of Figure 1 comprises an abdominal wall contacting or engaging portion 105 and an outer resting portion 510 which in use will rest against the outer surface of the abdominal wall.
In this exemplary arrangement the abdominal wall engaging portion 105 extends inwardly from the resting portion 510. The olive 100 defines an aperture in the body of the outer resting portion 510 that extends through to the abdominal wall engaging portion so as to define a lumen 130 for allowing introduction of a trocar 1500 into the abdominal cavity.
In this configuration, the olive is intended to be used with suture so as to allow the olive be anchored to the abdominal wall. The suture could also be used for closure of the wound after completion of a surgical procedure. To facilitate the delivery of suture, the olive comprises at least one needle guide channel 108 provided in a side wall of the abdominal wall engaging portion 105. The needle guide channel 108 comprises an entry port 108a for a needle driver to be presented to the olive and an exit port 108b from which suture which is coupled to a needle or an anchor may be driven using the needle driver out of and away from the abdominal wall engaging portion 105. The exit port 108b is provided on an outer surface 105b of the
abdominal wall engaging portion 105. The needle guide channel 108 is desirably configured to taper outwardly such that an anchor presented through the guide will be directed into the abdominal wall that is contacting the abdominal wall engaging portion 105. In a first configuration the channel 108 provides a convex path relative to the lumen 130 such that a needle driver will initially be presented towards the lumen 130 on insertion through the entry port 108a and will then be displaced away from the lumen prior to exiting through the exit port 108b.
The exit angle relative to the perpendicular is desirably a fixed angle which may be optimally configured between 5 and 30Q, or more preferably between 10 and 20Q. By providing a needle guide channel, suture can be coupled to respective anchors and directed into the abdominal wall. The anchor is desirably biased inwardly through the guide 108 using an anchor driver. The exit hole port 108b is desirably located such that the needle will pass into the subcutaneous layer of the abdominal wall. Desirably application of continued downward pressure using the needle driver will cause the anchor to then pass into the abdominal cavity, pulling suture with it.
On passage of the anchor into the abdominal cavity it will desirably hang, suspended on its suture, after the anchor driver is removed. The orientation of the anchor will typically change orientation from a vertical disposition used in the deployment configuration to a horizontal configuration. This may be assisted by coupling the suture to an anchor at a mid-point of the anchor such that it will pivot relative to the coupling to change its orientation. Anchoring is effected by retracting the deployed suture. This causes the suture to be pulled back into the olive, tightening the anchor against the inner abdominal wall. As the orientation of the needle has changed, it will not tend to retreat back through the abdominal wall through the path it developed on penetration of the wall. The olive is then resting against the outer surface of the abdominal wall and is prevented from moving away from that position through the action of the anchors against the inner surface of the abdominal wall. It is self- anchored. The retention of the position is maintained in this configuration by use of a suture cleat 512 within which the suture can be tightened against. In the
configuration of Figure 1 , first and second needle guide channels 108 are provided, each being adjacent to their respective guide channel. The guide channels 108 are provided opposite to one another, in this configuration each are displaced about 180° away from the other.
It will be understood that this suture cleat 512 is an example of a suture securement feature provided adjacent or proximal to each of the entry ports 108a and being useable to secure the suture once tightened against the olive, thereby self-anchoring the olive relative to the abdominal wall. The cleat comprises two opposing faces which when brought together form a double taper to which a suture may be presented and tightened within. In this way the suture securement feature operates as a jam cleat. These faces may be textured or otherwise treated to improve their suture retention properties. The olive may be provided with one or more contoured surfaces providing finger grips 120. These allow an operator to manually manipulate the olive without slipping. As is shown in Figure 5B, these finger grips may comprise one or more projections or ribs 560 that extend beyond the normal surface of the outer resting portion 510 so as to provide a proud contact surface for gripping by an operator.
On completion of the surgical procedure, the deployed anchors and sutures may be used to effect a closure of the wound. The suture is released from its suture cleat 512 and the olive is retracted from the abdomen. The surgeon may then tie a knot, and use the still tethered suture to effect a closure of the wound. Desirably sutures and/or needle anchors are bioabsorbable so as to allow for their eventual dissolving after the procedure. An alternative method of use would be to deploy the anchors as described above. To close the wound the anchors could be picked by a grasper disposed through a trocar while the spools are in the unlocked position. The anchors are removed through the trocar; the two suture ends are tied or mated and passed through the trocar again to create a closed loop of suture. This joining process could also be completed internally. The olive would then be removed and the suture trimmed and knotted as described above.
It will be appreciated that the longer the length of the abdominal wall engaging portion 105, the less freedom a surgeon has during the laparoscopic procedure to manipulate his laparoscopic tools which are accessing the internal cavity through the device. By maintaining the abdominal wall engaging portion 105 as a shallow element more freedom is provided to the surgeon.
Figures 1 to 6 show examples of olives provided in accordance with the present teaching which are also configured to expand to allow presentation of trocars of varying diameter through the lumen defined by the olives. In these configurations, an inner surface of the olive is provided with one or more locking members or locking surfaces which are configured to operably engage with an outer surface of the presented trocar to minimise relative movement between the two. The same reference numerals will be used for similar parts. Figure 1 A shows an olive 100 with a trocar locking surfaces 350 which is shaped or contoured to mate with the contours of the trocar 1500 with which the olive is being used. The trocar locking surfaces in this arrangement are integrally formed or molded with the olive and define an arcuate surface that is concave in shape. In this configuration first and second locking surfaces are provided opposite one another and are biased towards one another. In use these will actively engage with an outer surface of the trocar which is located within the lumen defined by the olive. This biasing of the inner trocar locking surfaces 350 is desirably achieved by the same mechanism that provides for an expansion of the olive. In the illustrated examples this is achieved by provision of first and second expansion struts 550 which are shown in Figure 3. The expansion struts are provided opposite one another and are located substantially 90 degrees out of phase with the locking surfaces 350. In this configuration the outer resting portion 510 of the olive is expandable due to the addition of expansion struts 550. These expansion struts allow the inner diameter of the outer resting portion to expand, which in turn allows the trocar locking surfaces 350 to disengage from the contours of the trocar. In these examples the expansion struts are also integrally formed with the olive body. The olive of Figure 1 A features a pair of needle entry ports 108 and a pair of suture cleats 512 (shown in Figure 2A) as with previous described arrangements. In this configuration, the suture cleat is achieved by a pan head screw, whereby the suture is pulled into space between the pan head of the screw and the surface of the olive adjacent to the screw head. The screw head provides a substantially flat or planar surface and acts as one half of a cleat once tightened against the olive surface, the olive surface acting as the other half of the cleat. The suture can be placed in the clamp between the flat surface of the screw head and the curved surface of the expandable olive by wrapping the suture around the screw head. This improves the capture efficiency. The suture can be wrapped around the screw head until it overlaps with itself to give enhanced securement.
It will be seen that the needle delivery channel 108a is angled such that on the initial part 580 of its trajectory it is angled inwards from the vertical plane, towards the received trocar shaft. This has the advantage of making the needle exit point lower, such that the needle does not have the opportunity to catch at skin level, making the suture entry point lower.
An expandable olive provided in accordance with the present teaching can be used with a variety of different trocar configurations. In the example of Figure 1 A the trocar contours are in the form of annular ridges 1590. These annular ridges, as can be seen in Figure13A, taper from a small diameter 1591 to a large diameter 1592, with a step 1593 before the next ridge. This facilitates ease of advancement through the abdominal wall, and provides resistance when the trocar is pulled out, which trocar manufacturers use as a trocar stabilising feature. When the trocar is moved through the olive 100, the trocar locking surfaces 350 sequentially come into contact with the annular ridges to function as a trocar lock. As the trocar and olive are moved relative to one another such that the trocar progresses through the olive, the change in diameter of the ridges effects a flex in shape of the expandable olive so as to allow the trocar locking surfaces 350 pass over each ridge, but movement in the opposite direction is prevented by the trocar locking surfaces surface engaging with the step on the trocar. This could advantageously be used to position a trocar in a defect with the olive in the desired location such that it will not be possible for the trocar to pull out of the defect until the olive trocar lock is disengaged. Anchors may be deployed by advancing a driver through the needle entry ports 108 and then providing for a securement of the suture using the suture cleats 512. This anchors the olive relative to the abdominal wall and prevents the trocar from being removed. To disengage the trocar lock the user squeezes the expansion struts 550 together. This is achieved using a pinching movement by the user. The trocar may be freely repositioned within the defect or removed from the olive until the user stops squeezing the expansion struts. Effectively a positive action by the user is required to allow the trocar locks to disengage from the trocar.
Figure 1 B shows a similar arrangement to 13A with an olive on a trocar. Here the trocar contours are in the form of a helical thread 1595. In this instance the olive can be threaded onto the trocar with the trocar locking surfaces 350 engaging with the trocar thread. It will be appreciated that many rotations of the trocar/or olive may be necessary to position each component in the desired location. To quickly move the trocar relative to the olive the operator will disengage the trocar lock by squeezing the expansion struts 550 together. This reduces the biasing force that positively moves the locking surfaces into contact with the trocar. The trocar may be repositioned within the defect or removed from the olive. For fine adjustments of the positioning between the olive and trocar, rotation of the trocar could be used.
Figure 1 C shows a similar arrangement to 1 A and 1 B with an olive on a trocar. Here the trocar contours are in the form of annular rings 1592. In this configuration the annular rings do not taper like the example in Figure 1 A and have radiused corners. The olive will lock on this configuration trocar, but will not be as secure as the embodiments described in Figures 1 A and 1 B.
Figure 3, 4 and 5 show olives which are useable in accordance with the present teaching with different trocars such as those provided with reference numeral 1500 in Figures 2A through 2E. Figure 3 and 5 are similar in construct in that both contain an expansion strut 550. In Figure 5 the expansion strut has a number of raised surfaces 560 which act as grips when the expansion strut is squeezed or pinched to disengage the trocar lock. The trocar locking surfaces 350 in Figure 5A have an increased length over that illustrated in 3A, which has the advantage of giving the retained trocar 1500 increased stability, as it removes some of the degrees of freedom the trocar would otherwise have.
Figure 4 illustrates a similar olive, but with no expansion struts. This could be used where a trocar has less aggressive steps, for example the trocar illustrated in Figure 1 C. It will be appreciated that this olive is also an expandable housing where the locking surfaces are operably biased into contact with a received trocar. However, the absence of the expansion struts, which extend out from the main olive body, reduces the amount of flex that is provided by this arrangement. The olive in this configuration is a more rigid construct than that of Figures 3 or 5.
In the arrangement of Figures 1 -5, the engagement surfaces are integrally formed with the olive housing. Figure 6A to 6C shows another configuration where the trocar locking surfaces 350 are achieved with a formed wire. In the configuration shown in Figure 6B the olive will lock onto a trocar. It will be appreciated that the surface of the wire is curved and the wire extends through the expandable housing to define first and second contact points for a received trocar on opposite sides of the lumen.
The wire further defines a curved actuation surface 405 located externally to the lumen 107. Compression of the curved actuation surface effects a release of the locking surface from a received trocar. It will be appreciated that in the exemplary configuration this compression is effected by pushing the wire towards the olive with the portion 405. In Figure 6C the wire is shown pushed forward and the locking surfaces 350 are disengaged. This could be achieved by having a flat ground on the wire, such that when the wire is in this position none of the wire enter into the lumen 107. It will also be understood that the profile of the wire may be altered to achieve varying degrees of locking. For example a round wire will not lock as securely on a stepped trocar as a square or flat wire profile as the round wire has no edges to catch on the trocar steps. While this embodiment is illustrated as a wire, it will be understood that this illustration is not limiting as this is an example of the type of locking mechanism that can be used to positively engage with a received trocar while not having to be integrally formed or moulded as part of the olive body. It will be appreciated that by using a locking mechanism such as described in Figure 6, independent control of the engagement of the locking surfaces relative to the movement of the expandable housing is achieved. The locking surfaces can be brought out of contact from a received trocar without requiring a change in the overall diameter of the lumen, which was not possible with the examples of Figures 1 -5. In this way, while Figure 6 shows a trocar lock engagement/disengagement feature with reference to an olive which has an expansion strut, this type of locking feature could also be applied to an olive of the type illustrated in Figure 4. Again the illustrated trocar lock engagement/disengagement feature is illustrated as a wire, but this could also be a plastic profile which achieves the same goal. Alternately a profile could also be created which when turned circumferentially will function like a cam to create a trocar locking surface.
Figure 7 illustrates an olive which has no expansion features, and is optimally configured to add minimum profile to the trocar it interacts with. As with previous arrangements the olive features an entry port 107 whereby a trocar may be presented to the lumen and pass into the abdominal cavity. A pair of needle guide channels are also provided in a manner previously described. Trocar locking surfaces 350 which are shaped or contoured to mate with the contours of the trocar 1500 with which the olive is being used. The trocar locking surfaces in this arrangement are integrally formed or molded with the olive and define an arcuate surface that is concave in shape. The trocar locking feature is further defined in this example to have a surface 351 which tapers downwards from the horizontal plane such that the olive of this example is optimally configured for use with a threaded trocar. In this configuration first and second locking surfaces are provided opposite one another and in use these will actively engage with an outer surface of the trocar which is located within the lumen defined by the olive.
In the example of Figure 7, the olive also features a second insert moulded portion 740. This second shot material (polypropylene) is non-compatible with the main body portion (which may for example be formed from a polycarbonate or clear ABS). The materials are illustrated in Figure 7D, where the main body portions are designated as 175 and the second shot material is designated 775. The main body portion 175 also features a surface 176 which overhangs the lower portion 777 of the second shot material. This in effect creates a mechanical lock to hold the second shot material in place within the main portion 175. As the two materials are dissimilar there is no chemical bond between the main body portion and the second shot material. This creates a zero gap cinch point 750 where the two materials interface opposite the needle guide channel. A lead in area 751 (Figure 7E) aids in locating the suture at into the zero gap cinch. In this embodiment the suture cinch is illustrated as being on either side of the needle entry channel 108, Ref Figure 7F. This gives the surgeon the option of pulling the suture to either side of the needle entry channel. In addition if repositioning of the olive is required, the suture can be removed from the initial cinch, the olive repositioned and the suture placed in a fresh cinch at the second location. The illustrated example is not intended to be limiting. The suture cinch could for example be positioned at 90° to the current location on the outer edge of the olive which may be a more ergonomic location that the illustrated example.
The olive described in this embodiment is ideally moulded in a clear material which has the advantage of giving enhanced visibility of the abdominal wall layers. However this is not intended to be limiting.
Figure 8 illustrates and olive has no expansion features and again features needle guide channels 108 and a trocar entry port 107. The needle guide channels are disposed with a recessed area 1080 of the outer portion 510. The recessed portion offers the advantage providing a guide whereby the side walls of the recess 1081 serves to guide the user towards the needle guide channel. The user can present the needle sideways through the guide recess 1080 and this arrangement is expected to be easier in terms of locating the needle on the needle channel guide. The olive has trocar locking surfaces which are hidden in the main body portion 510 of Figure 8 A. A pair of finger grips 845 (845A and 845B) can be squeezed once the guide is positioned on a trocar shaft. This causes the trocar lock 810 to pivot about the pivot point 820 and rotate the trocar locking surfaces 350 into the trocar entry port 107 to engage with the trocar. The trocar lock is held in position by a ratchet type mechanism whereby the portion 810 and the portion 830 both have teeth which interlock with each other and maintain the trocar lock against the trocar. The portion 830 can be moved by pushing on the surface 835, such that the teeth of the portion 830 are moved away from the teeth of portion 810, allowing the trocar lock to disengage when the surfaces 841 are squeezed together.
The olive also features a second insert moulded portion 840. This second shot material (polypropylene) is non-compatible with the main body portion (which may for example be formed from a polycarbonate or clear ABS) but held in place by a mechanical lock. As the two materials are dissimilar there is no chemical bond between the main body portion and the second shot material. This creates a zero gap cinch point 850 where the two materials interface. In addition the cinch becomes more exposed once the trocar locking feature is enabled as illustrated in Figure 8B. While the olive of the present teaching has been described with reference to a needle driver and anchoring system it will be appreciated that an olive which can be used with trocars of differing dimensions may not necessarily be deployed in scenarios that require anchoring. As such the provision of features that assist in the anchoring of the olive or the closure of a wound post-surgery should not be considered as essential to the present teaching. It will be appreciated that the word trocar when used in the context of the present teaching should not be limited to a sharp-pointed surgical instrument fitted with a cannula and used especially to insert the cannula into a body cavity as a drainage outlet. The term trocar when used in the context of the present teaching is intended to define generally a surgical instrument that is used in laparoscopic surgery to allow surgical access within the abdominal cavity through a port provided in the abdominal wall and can include the cannula that functions as that portal.
While the olive may be fabricated from any suitable material, the present inventors have ascertained that fabrication from a polypropylene such as the medium melt-flow-rate polypropylene homopolymer prepared by Borealis Nucleation Technology (BNT) and sold under the trademark Bormed HD850MO™ is particularly advantageous. This grade of material is found to have the flexibility of generic polypropylenes but is also more impact resistant and harder than most polypropylene grades which enables the flexibility of the hinge/movement function but also is less susceptible to damage when used with threaded trocars which chafe material off softer grades in use. Details of the properties of this polypropylene are provided below:
Physical Properties Typical Value Test Method
Density 910 kg/m3 IS0 1 183
Melt Flow Rate (230 °C/2, 16 kg) 8 g/1 Omin ISO 1 133
Tensile Modulus (1 mm/min) 1 .800 MPa ISO 527-2 Tensile Strain at Yield (50 mm/min) 7,5 % ISO 527-2 Tensile Stress at Yield (50 mm/min) 38 MPa ISO 527-2
Heat Deflection Temperature (0,45 MPa) 1 12 °C ISO 75-2
Charpy Impact Strength, notched (23 °C) 5,5 kJ/m2 ISO 179/1 eA
Hardness, Rockwell (R-scale) 105 ISO 2039-2
While preferred arrangements have been described in an effort to assist in an understanding of the teaching of the present invention it will be appreciated that it is not intended to limit the present teaching to that described and modifications can be made without departing from the scope of the invention.
It will be appreciated that the exemplary arrangements or examples of devices have been described with reference to the Figures attached hereto. Where a feature or element is described with reference to one Figure, it will be understood that the feature or element could be used with or interchanged for features or elements described with reference to another Figure or example. The person of skill in the art, when reviewing the present teaching, will understand that it is not intended to limit the present teaching to the specifics of the illustrated exemplary arrangements as modifications can be made without departing from the scope of the present teaching.
The words comprises/comprising when used in this specification are to specify the presence of stated features, integers, steps or components but does not preclude the presence or addition of one or more other features, integers , steps, components or groups thereof.

Claims

Claims
1 . A laparoscopic system configured for engagement with an aperture provided in an
abdominal wall, the system comprising:
a housing defining a lumen for receipt of surgical instrumentation, the lumen dimensioned for receiving a trocar and wherein the system further comprises at least one locking surface configured to operably engage with a received trocar.
2. The system of claim 1 wherein the at least one locking surface is operably biased into positive contact with the received trocar.
3. The system of claim 1 or 2 comprising first and second locking surfaces provided on opposite sides of the lumen.
4. The system of claim 3 wherein each of the first and second locking surfaces comprise an arcuate surface which operably contacts an outer surface of the trocar.
5. The system of any preceding claim comprising at least one expansion strut, the at least one expansion strut being operably pinchable by an operator to facilitate disengagement of the locking surface from the received trocar.
6. The system of claim 5 comprising first and second expansion struts provided on opposite sides of the lumen to one another.
7. The system of any preceding claim wherein the at least one locking surface is integrally formed with the housing.
8. The system of any one of claims 1 to 6 wherein the at least one locking surface is formed separately to the housing.
9. The system of any preceding claim wherein the at least one locking surface comprises a curved surface for contacting with the received trocar.
10. The system of any preceding claim wherein the at least one locking surface comprises a wire.
1 1 . The system of claim 10 wherein the wire extends through the housing to define first and second contact points for a received trocar on opposite sides of the lumen.
12. The system of claim 10 or 1 1 wherein the wire defines a curved actuation surface
located externally to the lumen.
13. The system of claim 12 wherein compression of the curved actuation surface operably effects a release of the locking surface from a received trocar.
14. The system of any preceding claim 1 comprising an actuator coupled to the at least one locking surface, the actuator comprising a cam surface and wherein the locking surface is activated by rotation of the cam surface.
15. The system of any preceding claim comprising first and second dissimilar materials, the materials being located relative to one another to define a cinch within which suture may be secured.
16. The system of claim 15 wherein at least one of the dissimilar materials is held in the housing by a mechanical lock.
17. The system of any preceding claim wherein at least a portion of the trocar locking
surfaces are disposed within the housing.
18. The system of any preceding claim wherein the at least one trocar locking surface is pivotable relative to the housing into the lumen, a pivot action being effected by a squeeze action.
19. The system of claim 17 comprising a ratchet mechanism configured to operably maintain the at least one trocar locking surface against a received trocar.
20. The system of claim 19 wherein the ratchet can be released to allow the trocar to be repositioned.
21 . The system of any preceding claim wherein the housing comprises at least one needle guide channel.
22. The system of claim 21 wherein the housing defines a recess with a side wall which operably guides a user towards the needle guide channel.
PCT/EP2014/071365 2013-10-03 2014-10-06 Laparoscopic system WO2015049391A1 (en)

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