EP1778094A1

EP1778094A1 - A device

Info

Publication number: EP1778094A1
Application number: EP05762872A
Authority: EP
Inventors: Herbert Arnarsson; Richard Hartshorn; Edward Goodwin
Original assignee: Imperial Innovations Ltd; Imperial College Innovations Ltd
Current assignee: Ip2ipo Innovations Ltd
Priority date: 2004-07-27
Filing date: 2005-07-26
Publication date: 2007-05-02
Also published as: WO2006010919A1; GB0416655D0

Abstract

A device for engaging with tissue of a patient, comprising an engagement means for engaging with the tissue, and a support for enabling a user to hold the device the engagement means extending from the support.

Description

A DEVICE

This invention relates to a device for engaging with tissue of a human or animal body, particularly but not exclusively prior to insertion of an instrument into a human or animal body.

It is known that many medical procedures can now be carried out using minimal access techniques. Such minimal access techniques may be used to carry out medical procedures on organs and vessels within the abdomen of a patient. Such procedures are known as laparoscopic procedures or procedures using a laparoscopic approach.

In order to carry out laparoscopic procedures, it is necessary to form one or more perforations through the abdominal wall of a patient. An access port is then inserted into each of the one or more perforations. The port or ports enable a surgeon, or other medical personnel to gain access, through the use of instruments, to the abdominal cavity of the patient.

In order to enable the organs within the abdominal cavity to be accessed more easily via such ports, an operating space is created within the abdominal cavity with or without the use of pressurised gas.

The access ports usually comprise seals, to enable instruments to be inserted through the ports, whilst reducing the amount of gas escaping from the cavity via the port or ports.

It is known to create one or more perforations in the abdominal wall using a sharp trocar inside an access port. The trocar and access port together form a trocar port assembly (TPA) which is forced through the abdominal wall. The TPA is assembled outside the body before use. This process often requires considerable force to be applied to the TPA in order to force it through the abdominal wall.

A known sharp trocar has a spring loaded safety sheath that covers the sharp trocar tip when the trocar is in an aπned condition. The trocar will not spring back unless the sheath is released, or the trocar is again "armed".

In use, the trocar in its armed condition is pressed against the abdominal wall of a patient. The resistance of the abdominal wall causes the sheath to move back to expose the sharp tip. The sharp tip then cleaves the layers of the abdominal wall allowing trocar insertion.

Once, the trocar is inside the abdominal cavity, the safety sheath springs back over the sharp tip due to the reduction or removal of resistance. At this stage it cannot be pushed back. This prevents the sharp tip being exposed inside the abdominal cavity, unless it is re-armed.

The "arming" i.e. the way the safety sheath is released before insertion varies slightly between different known trocars.

One known trocar uses a small tip on the trocar head that is pushed inward when the trocar is pressed against an access port i.e. when the trocar and port are assembled prior to placement.

A second known trocar is armed by pushing a small switch in the trocar. This does not require contact with the port that the trocar places.

Before a perforation is formed through the abdominal wall, a vacuum usually exists in the abdominal cavity. The vacuum makes bowel, mesentery and omentum adhere to the under surface of the abdominal wall. A problem with the known methods of penetrating the abdominal wall, is that due to the adherence of the bowel, mesentery and omentum to the abdominal wall, it is possible to inadvertently pierce bowel, mesentery or omentum whilst the TPA passes through the abdominal wall into the abdominal cavity.

A further problem is that due to the considerable force needed to penetrate the abdominal wall and the variable thickness of the abdominal wall, an "overshoot" of the trocar and port assembly into the abdominal cavity can inadvertently damage any of the above structures. Further, abdominal organs, or the great abdominal vessels can be ruptured when forcing the TPA into the abdominal cavity.

According to a first aspect of the present invention there is provided a device for engaging with tissue of a patient, comprising an engagement means for engaging with the tissue, and a support for enabling a user to hold the device, the engagement means extending from the support.

A device according to the present invention may be engaged with any desired part of a human or animal body. Preferably, however, the device of the present invention is suitable for engagement with the abdominal wall of a patient, and is useful in laparoscopic techniques.

The engagement means may take any desirable shape or form and may be either directly or indirectly engaged with tissue of the patient. In another embodiment, the engagement means lies substantially within a first plane, and the support lies substantially within a second plane, the first and second planes intersecting one another at a non-zero angle.

Preferably, the first and second planes intersect one another at an angle of substantially 90°.

Alternatively, the engagement means comprises a hook shaped portion.

Preferably, the hook shaped portion lies in a plane that extends at an angle of substantially 90° to the support.

Typically, prior to engaging the engagement means with the abdominal wall, an incision is formed in the skin of a patient, and the engagement means is inserted via the incision into the abdominal wall.

The device according to the present invention is particularly useful for providing counter-traction against the movement of the abdominal wall towards the internal organs of the patient during TPA placement.

In addition, the device is particularly suitable for lifting and holding the abdominal wall away from the internal organs, and allowing substantial or complete removal of the abdominal vacuum existing within a human body before any TPA is inserted into the abdominal cavity. Overall, the device according to the present invention provides means for safer control when, creating a perforation using a standard TPA extending through the abdominal wall of a patient.

In use, a user such as a surgeon or other medical personnel, holds the device directly or indirectly via the support and inserts the engagement means into the abdominal wall of the patient. In order to insert the engagement means into the abdominal wall, a force is exerted by the user of the device. However, because the engagement means preferably extends at an angle of 90° to the supporting axis, the force applied to the device will tend to cause transverse movement of the device relative to the patient. This means that the device is not forced into the abdomen or abdominal cavity of a patient.

In an embodiment of the invention where the engagement means extends in a direction that is substantially parallel to the support axis the relative positions of the engagement means and support result in transverse movement of the engagement means within the abdominal wall.

In an embodiment of the invention where the engagement means comprises a hook shaped portion, the user of the device will apply a rotational force to the device in order to insert the engagement means into the abdominal wall of the patient. In such an embodiment, the force applied to the device will cause rotational movement of the device, which rotational movement takes place within the abdominal wall rather than extending through the abdominal wall.

The term "transverse movement" when used herein to describe movement of the engagement means, describes movement generally across the body of the patient, or in a direction from head to toe (or vice versa) of a patient. In other words, when the device is used to engage with the abdominal wall of a patient, the movement of the engagement means will be generally such that the engagement means moves within the abdominal wall and does not extend into the abdominal cavity or out through the skin of a patient during movement of the engagement means.

Once the engagement means has engaged with the abdominal wall of the patient, the user of the device may lift up the device, and hence the abdominal wall of the patient in order to distance the abdominal wall from organs within the abdominal cavity.

Once the abdominal wall has been lifted, a perforation may be formed in the abdominal wall using perforation means, as will be described in more detail below.

The device of the present invention is particularly useful for allowing perforation of the abdominal wall using perforation means.

Preferably, therefore the device further comprises perforation means.

The perforation means may be in the form of a fine bore needle or Veress needle.

Perforation by a fine bore needle prior to insertion of a TPA allows the vacuum existing in the abdominal cavity of a patient to be removed and the abdominal cavity to be insufflated. The insertion of the fine bore needle into the abdominal wall creates a passage extending through the abdominal wall.

Typically a fine bore needle will have a cross-sectional diameter in the range from 0.5mm to 2mm, and will be approximately 8cm to 15cm long. A Veress needle typically has a diameter of about 2min and is about 8 cm long.

The fine bore needle is used with the device according to the present invention to obliterate the vacuum, insufflate the abdominal cavity with gas and gauge the abdominal wall thickness prior to port placement.

Preferably, the fine bore needle is hollow. This means that, as soon as it enters the abdominal cavity, air is sucked into the abdomen and the vacuum in the abdomen is obliterated. Once a user has confirmed that the needle is within the abdominal cavity and not for example within the bowel, the user may pump gas into the abdomen and insufflate it before placing a TPA into the abdominal cavity by means of a device according to the present invention.

Advantageously, the perforation means is gauged. In use, the perforation means may be inserted through the abdominal wall of a patient and into the abdominal cavity of the patient. On removal of the needle, it is possible to measure the thickness of the abdominal wall by using the gauge on the perforation means.

Because the abdominal wall is held away from the organs and vessels in the abdominal cavity, accidental damage is less likely to occur when perforation means are forced through the abdominal wall to form the perforation.

The device according to the present invention is adapted to support at least a portion of tissue of a patient. Preferably the engagement means comprises one or more tines. Advantageously, the engagement means and the support together foπn a substantially L shaped device.

In other words, the one or more tines each have a tine axis that extends at substantially 90° to the support axis.

Alternatively, the one or more tines each has a tine axis that extends substantially parallel to the support axis.

Advantageously, the engagement means extends in a first direction from the support and comprises a distal blunt end spaced apart from the support, and a proximate end positioned proximate the support.

Advantageously, the proximate end of the engagement means forms a sharp point or edge, which sharp point or edge is adapted to slide transversely into the abdominal wall of a patient on insertion of the device into the abdominal wall.

Preferably, the engagement means comprises a first engagement aim, and the support comprises a first supporting arm, the first engagement arm and the first supporting arm being joined to one another at the proximate end of the engagement means, both the first supporting arm and the first engagement arm lying in a first plane.

The support and the engagement means may be formed separately to one another, but preferably they are integrally formed. Advantageously, the engagement means further comprises a second engagement arm spaced apart from, and substantially parallel to the first engagement arm and lying in the first plane.

Conveniently, the first and second engagement arms are joined together at the distal end of the engagement means to form a substantially U-shaped first engagement portion.

The second engagement arm extends from the distal end of the engagement means towards the proximal end of the engagement means. This means that whilst the first engagement arm extends in a first direction away from the support, the second engagement arm extends from the distal end in the opposite direction towards the supporting means.

Advantageously, the proximate end of the second engagement arm comprises a sharp point or edge.

In other words, the support and the engagement means form a fork in which the first and second engagement arms together form a first tine of the fork which tine "double backs" on itself.

In use, a user may insert the proximate end of the second engagement arm into the abdominal wall of a patient and pull the device in a direction generally parallel to the first and second engagement arms and generally away from the user. This will cause the engagement means to move into the abdominal wall of the patient in a substantially transverse direction.

The depth to which the second engagement arm extends within the abdominal wall is detennined by the distance between the first and second engagement arms. In addition, the extent to which the device may slide through the abdominal wall is determined by the length of the engagement means.

Advantageously, the support comprises a second supporting arm spaced apart from, and substantially parallel to the first supporting arm, the first and second supporting arms lying in a plane substantially orthogonal to the first plane, the engagement means further comprising third and fourth engagement arms spaced apart from, and substantially parallel to one another to form a second engagement portion, the second supporting arm and the third and fourth engagement arms lying in a third plane, which third plane is spaced apart from and substantially parallel to the first plane.

Advantageously, the third engagement arm and the second supporting arm are joined to one another at the proximate end of the engagement means.

Preferably, the third and fourth engagement arms are joined together at the distal end of the engagement means to form a substantially U-shaped second engagement portion.

The fourth engagement arm preferably comprises a sharp point or edge forming the proximate end of the fourth engagement arm.

In other words the third and fourth engagement arms together form a second tine of the fork which tine "double backs" on itself.

The device thus comprises two engagement portions which are shaped and positioned for insertion into the abdominal wall of a patient. The second and fourth engagement arms are spaced apart from one another and are substantially parallel to one another. This means that when each of the second and fourth engagement arms is inserted into the abdominal wall, the device is securely engaged within the abdominal wall, with any pressures and forces exerted on the abdominal wall by the device being spread across the area between the second and fourth engagement arms. This reduces the possibility that the abdominal wall will tear when the device is used to lift up the abdominal wall.

Preferably, the device further comprises a first handle attachable to the support. The first handle is used to grip the device when engaging the device with the abdominal wall.

Alternatively, the first support is in the form of a handle, the support itself comprising the handle.

Conveniently, the first handle comprises first receiving means for receiving the support. The first receiving means may take any convenient form and may, for example, comprise a slot running longitudinally through the handle. The slot is shaped to receive the supporting means.

Advantageously, the support comprises handle engagement means for attaching the first handle to the support. The handle engagement means may take any convenient form and may, for example, comprise a bolt or screw receivable within an aperture within the handle.

Advantageously, the engagement means allows the position of the first handle relative to the support to be varied, thus allowing the handle position to be varied to suit the user, and also for further reasons which will be described in more detail herein below. In one embodiment, the first handle is attachable to the support by means of a ratchet mechanism.

Conveniently, the device comprises second receiving means, which may be formed in the first handle. The second receiving means may be adapted to receive the perforation means and may take any convenient form, such as a slot running longitudinally through the handle. Preferably the second receiving means comprises a channel extending longitudinally through the handle.

In an embodiment of the invention where the support is formed as a handle, the support may comprise second receiving means, for receiving the perforation means. However, in such embodiments, no first receiving means is required, since the support serves as the handle.

The second receiving means may be formed integrally with or separate from the handle or support.

Advantageously, the device further comprises a second handle which may be used to lift the device during use.

Preferably, the second handle is used to lift the device whilst the position of the first handle is varied.

Once the position of the first handle has been set, the second handle may be removed from the device.

Preferably, the second handle is attachable to the support. Advantageously the second handle is moveable axially within the first receiving means of the first handle.

Preferably, the first handle comprises a first face, and an opposite second face, the first and second faces being axially spaced from one another. The first receiving means extends axially from the first face partially or completely through, the first handle, and the second receiving means extends between the first and second faces.

The support is insertable into the first receiving means at the first face.

Preferably, the support extends through the first handle and emerges at the second face.

In an alternative embodiment, the device comprises a stopper comprising second receiving means, which second receiving means comprises a channel extending axially through the stopper.

Advantageously, the stopper is moveably attachable to the support, and axially off set from the first handle.

In such embodiments, the first handle does not include a second receiving means.

The stopper may be integrally formed with the handle.

Preferably, the device of the present invention is used in conjunction with a trocar and port assembly (TPA). The TPA is receivable within the second receiving means, and axially moveable within the second receiving means. In use of the device, after an initial perforation has been made in the abdominal wall of the patient using the perforation means as described hereinabove, the trocar and port assembly is made to penetrate the abdominal wall by pushing the TPA through the second receiving means so that the trocar and port assembly extends beyond the receiving means between the two engagement portions, and through the abdominal wall into the abdominal cavity.

It is known to design a port forming a TPA₅ having a first port portion and a second port portion, the cross-sectional diameter of the first port portion being smaller than that of a second port portion.

The first port portion may, for example, comprise the trocar. Preferably, the second receiving means is shaped to receive a first port portion, but to prevent the second port portion from being received within the second receiving means.

Alternatively, or in addition, the second engagement means is shaped to receive the TPA such that the trocar is in an armed condition.

Typically, each of the first and second port portions is substantially cylindrical, the first port portion having a first outer diameter, and the second port portion having a second outer diameter.

The first and second port portions could however, have other shapes.

Advantageously, the second receiving means has an inner cross-sectional diameter that is substantially equal to or slightly larger than the first outer diameter, and substantially less than the second outer diameter. Because the dimensions of the second receiving means prevent the second port portion from entering the second receiving means, the extent that the trocar and port assembly can move through the second receiving means and into the abdominal wall is determined by the length of the second receiving means relative to the length of the trocar and port assembly portion, and the position of the first handle relative to the engagement means.

In order to make a perforation through the abdominal wall, the TPA is pushed through the second receiving means into the abdominal wall. Further movement of the TPA is prevented when the second port portion makes contact with the second face of the first handle. By suitably dimensioning the components of the device, the depth of the perforation can be controlled.

In order to take into account different thicknesses of abdominal wall, the position of the first handle relative to the support may be varied. This results in the distance between the first face of the first handle and the surface of the abdominal wall varying in use. This in turn means that for a trocar of predetermined length, the extent of incursion into the abdominal wall may be varied.

By appropriately positioning the handle on the support using the handle engagement means, the extent to which the TPA will extend into the abdominal wall can be controlled.

In embodiments of the invention comprising a stopper, the position of the stopper, and/or the dimensions of the stopper may be varied in order to control the extent to which the TPA will extend into the abdominal wall. In embodiments of the invention comprising first and second engagement portions, the TPA will extend through the second receiving means and continue moving into the abdominal wall and will be positioned between the first and second engagement portions. This provides stability to the device.

The second receiving means may also be used to allow insertion of instruments other than the TPA. For example the perforation means may be inserted into the second receiving means in order to make an initial insertion into the abdominal wall or other tissue of a patient prior to insertion of a TPA.

Advantageously, the device further comprises one or more reducers insertable into the second receiving means, which reducers reduce the effective internal diameter of the second receiving means. This means that an instrument having a narrower cross-sectional diameter such as a very fine needle, may be inserted into the second receiving means in a stable manner.

In an alternative embodiment of the invention, rather than the first handle being moveable relative to the support, and comprising second receiving means, the first handle is engageable with the support in a substantially fixed position during use. The device further comprises a stopper moveably engageable with the support and axially offset from the first handle. The stopper comprises an aperture extending axially through the stopper, and comprising the second receiving means.

In this embodiment, the position of the stopper is adjustable to suit the conditions pertaining. During adjustment of the stopper, the first handle may be used to hold the device in a lifted position, thus negating the need for a second handle.

In embodiments of the device in which the support is formed as a handle the stopper may be releasably attached to the handle.

Alternatively, the support comprises an integrally formed stopper.

A stopper could, of course, be present in an embodiment of the invention in which the handle is moveable relative to the support.

The device according to the invention may be formed from any suitable materials, but preferably the engagement means is formed from a metal or metal alloy, and the first and second handles may be formed from metal, plastics materials or rubber or a combination thereof. The reducers may be formed from any suitable material, for example, lightweight stainless steel or durable disposable plastics material.

According to a second aspect of the present invention there is provided a method for engaging and supporting the abdominal wall of a patient using an engagement device comprising an engagement means for engaging with the abdominal wall, and a support for enabling a user to hold the device comprising the step of:

(a) inserting the engagement means into the abdominal wall such that the engagement means moves substantially transversely within the abdominal wall.

Advantageously, the method comprises a further step of (b) pulling the device away from the abdominal cavity of the patient. This has the effect of lifting the abdominal wall away from the abdominal cavity of a patient.

Preferably the method comprises the additional steps of:

(c) inserting a first penetration means into the engagement device;

(d) inserting the first penetration means into and through the tissue via the engagement device;

(e) removing the first penetration means from the tissue; (f) removing the first penetration means from the engagement device.

Advantageously, the first penetration means comprises a fine bore needle. On placement of the fine bore needle into the abdominal wall of a patient, a passage is created within the abdominal wall or tissue which allows air or other gases to flow into or be pumped into the abdominal cavity, thus obliterating any vacuum existing in the abdominal cavity.

Advantageously, the method comprises the further step of: (g) gauging the distance that the penetration means has travelled through the tissue thereby measuring the thickness of the tissue.

Conveniently, the method comprises the further steps of:

(h) inserting a trocar port assembly into the engagement device; (i) inserting the trocar port assembly into the tissue;

(j) removing the trocar from the tissue leaving the port in place; (k) removing the trocar from the engagement device.

Advantageously, the method comprises the further steps of: (1) checking that the port is appropriately positioned; (m) inserting the trocar port assembly into the tissue via the engagement device, causing the TPA to move further into the tissue; and

(n) repeating steps (1) and (m) as necessary until the port is in the appropriate position.

The invention will now be described by way of example only with reference to the accompanying drawings in which:

Figure 1 is a schematic representation of the support and engagement means forming part of a first embodiment of the present invention;

Figure 2 is a schematic representation of the support and engagement means forming part of a second embodiment of the present invention;

Figure 3 is a schematic representation of the support and engagement means forming part of a third embodiment of the present invention; Figure 4 is a schematic representation of the support and engagement means forming part of a fourth embodiments of the present invention;

Figure 5 is a schematic representation of a first handle suitable for use with the first or second embodiments of the present invention;

Figure 6 is an alternative first handle also suitable for use with either the first or second embodiment so the present invention;

Figure 7 is a schematic representation of a first handle suitable for use with the second embodiment of the present invention;

Figure 8 is a schematic representation of a handle suitable for use with the third embodiment of the present invention; Figure 9 is a schematic representation of a reducer forming part of the present invention;

Figure 10 is a schematic representation of a second handle suitable for use with the present invention;

Figure 11 is a schematic representation of the first embodiment of the present invention; Figure 12 is a schematic representation of the second aspect of the present invention;

Figure 13 is an exploded view of the device of Figure 12;

Figures 14 to 17 illustrate a further embodiment of the invention; Figure 18 illustrates yet a further embodiment of the invention;

Figures 19 and 20 are schematic representations of the device of Figures 14 to 17 showing a perforation means in the form of a fine bore needle in place in the device; and

Figure 21 is a schematic representation of another embodiment of the present invention; and

Figure 22 is a schematic representation of a further embodiment of the present invention.

Referring to Figure I₅ a support 16 and engagement means 210 forming part of a first embodiment of the present invention is designated generally by the reference numeral 2. The support and engagement means generally form a fork 2. The engagement means 210 comprises a first engagement portion 4 and second engagement portion 6, each in the form of a tine which engagement portions are spaced apart from one another and are substantially parallel to one another. Each of the first and second engagement portions 4, 6 are generally U-shaped. The first engagement portion comprises first engagement arm 8 and second engagement arm 10, and the second engagement portion comprises third engagement arm 12 and fourth engagement arm 14. The first and second engagement arms are substantially parallel to one another and lie in a first plane, and the third and fourth engagement arms are substantially parallel to one another and lie in a second plane. The support 16 comprises, in this embodiment, first and second support aπns 18, 20 respectively. The first and second support arms are substantially parallel to one another and are joined together so that the support 16 is substantially U-shaped. The first support arm 18 lies in the first plane and the second support arm 20 lies in the second plane.

As can be seen from Figure 1, the engagement means 210, which in this embodiment comprises engagement portions 4, 6 extends from the support

16, which in this example comprises first and second support arms 18, 20.

The engagement means extends from the support 16, in this example generally at an angle of substantially 90° to the support 200. In particular, as can be seen from Figure 1, the first engagement portion 4 intersects with the first support arm 18 at an angle which is substantially 90° and the second engagement portion 6 intersects with the second support arm 20 at an angle that is substantially 90°.

In other embodiments, the engagement means 210 may extend from a support 16 at any desirable angle.

Figures 2 and 3 show forks 22, 24 respectively for use in second and third embodiments of the present invention. Parts which are common to forks 2, 22, 24 have been given corresponding reference numerals.

Fork 22 shown in Figure 2 additionally comprises attachment means 26 in the form of apertures 26a, 26b, 26c. The purpose of these attachment means will be described in more detail herein below.

Fork 24 shown in Figure 3 comprises bars 28, 30 providing a curve shape to the support 16.

Fork 25 shown in Figure 4 comprises a tapped hole 27, the purpose of which will be explained herein below. Turning now to Figure 5, a first handle forming part of the first embodiment of the present invention is designated generally by the reference numeral 32. The handle comprises first receiving means 34 in the form of a slot extending from a first face 36 to a second face 38 of the handle 32. The receiving means is shaped to receive support 16 of either fork 2 or fork 22, but preferably that of fork 2. The handle 32 comprises second receiving means 40 in the form of an open channel, the purpose of which will be described in more detail herein below.

The handle may be made of any convenient material and in this example is made from hollow stainless steel. Parts 300 of the handle are formed from a no skid rubber surface.

Turning now to Figure 6, an alternative design of a first handle is designated generally by the reference numeral 42. Components of the second handle which correspond to handle 32 have been given corresponding reference numerals.

Handle 42 is also suitable for use in connection with fork 2 or fork 22 but preferably fork 2.

Handle 42 is made from a plastics material.

Handle 42 has a second face 38 that is split into two portions 38a and 38b.

Figure 7 shows another embodiment of a first handle designated generally by the reference numeral 44. Parts of the handle 44 which are common to the handle 32 shown in Figure 4 have been given corresponding reference numerals. The handle 44 is suitable for use with the fork 22 shown in Figure 2. Handle 44 has a removable face (not shown) and an inner face 46. The face 46 is formed with an aperture 48 which enables a pin to be inserted through the face and into one of the apertures 26a, 26b or 26c forming the adjustment means 26 in fork 22. The position of the handle relative to the fork can thus be varied by inserting the pin through a predetermined one of 5 the three apertures 26 a, b or c.

Referring to Figure 8, another first handle is schematically shown and designated generally by the reference numeral 50. The handle 50 comprises a first receiving means 34 which is shaped to fit the curved cross-sectional l o shape of the support of the fork 24.

The handle 50 further comprises second receiving 40 means adapted to receive instruments such as a penetration means in the form of a fine bore needle, or a trocar and port assembly (TPA). If the instrument to be inserted

15 into the receiving means has a significantly narrower cross-sectional diameter than the diameter of the receiving means, then a reducer of the type shown in Figure 9 and designated generally by the reference numeral 54 may be inserted into the receiving means. The reducer comprises a head 56 having an outer diameter which is substantially the same as the inner 0 diameter of the respective receiving means 40, 52 and has an elongate body 58 having a smaller outer diameter. Extending along the body 58 is a bore 60, the inner cross-sectional diameter of which is slightly larger than the instrument to be inserted into the second receiving means 40. In this way, an instrument having significantly smaller dimensions than the receiving 5 means 40, 52 may be securely stably inserted into the receiving means. A reducer is particularly useful when a fine bore needle or Veress needle is received by the second receiving means.

Referring to Figure 10, a second handle is designated generally by the 0 reference numeral 62. The second handle is attachable to the support 16 forming an embodiment of the present invention. One way in which the second handle is attachable to the support 16 is via a tapped hole 27 formed in the support as shown in Figure 4. Such a hole may be formed in any of the supports shown in Figures 1 to 3, and receives a threaded end 63 of the second handle 62.

The second handle is used to pull up the device once the engagement means have engaged into tissue such as the abdominal wall in a patient. This allows the position of the first handle relative to the support to be adjusted. After adjustment of the first handle, the second handle may be removed.

Referring to Figure 11, an embodiment of the invention is designated generally by the reference numeral 64. The device 64 comprises fork 2 as illustrated in Figure 1, first handle 42 as illustrated in Figure 5, and a perforation means in the form of a TPA comprising trocar 66 and port 67 insertable within second receiving means 40. The port 67 comprises a first port portion 68 and a second port portion 70. The TPA is removable from the remainder of the device 64. The TPA can slide transversely out of the second receiving means 40.

In use, when it is required to make an incision, for example, through an abdominal wall of a patient, the device 64 (not including the trocar and port assembly) is engaged with the abdominal wall via a preformed skin incision. This is achieved by gripping the handle 42 and inserting the engagement arm 10, 14 into the abdominal wall via the skin incision. Because of the relative orientation of the engagement arms 10, 14 relative to the support 16, the amis 10, 14 will tend to move transversely within the abdominal wall of the patient. The depth to which the anus 10, 14 are inserted into the abdominal wall will be determined to a large extent by the distance between the engagement arms 10, 14, and engagement aπns 8, 12.

Once the device 64 has engaged with the abdominal wall, the device may be lifted up. This movement also lifts the abdominal wall up away from the organs and vessels within the abdominal cavity. While the device is held in this elevated position, the TPA 66, 67 is forced through the second receiving means 40, through handle 42, and into the abdominal wall. Movement of the TPA 66 and 61 through the second receiving means 40 is limited due to the adjustable length between the second face 38 (or the second portion in Figure 5) of handle 42, and engagement arms 10 or 14. This means that the trocar 66 and port 67 may be forced with substantial pressure through the device and into the abdominal wall, but incursion into the abdominal cavity will be halted once the second port portion 70 makes contact with the handle 42 at its face 38.

Turning to Figures 12 and 13, another embodiment of the invention is designated generally by the reference numeral 72. The device 72 comprises a first handle 44 of the type shown in Figure 6, a fork 22 of the type shown in Figure 2, a second handle 62 of the type shown in Figure 9 and a TPA 66.

The detachable side portion 74 comprises a pin 78 which is engageable in any one of apertures 26a, 26b or 26c. The position of the handle 44 relative to the fork 22 may thus be varied by varying the aperture 26a, b or c with which a pin 78 engages.

In the illustrated embodiments, the handle has three different positions relative to the fork, although in other embodiments there may be more than three different positions, or there may be infinitely variable positions. In the embodiments shown in Figures 13 and 14, the second handle is used to lift up the device once the engagement arms 10, 14 have engaged with the abdominal wall and whilst the position of the first handle is adjusted. Once the first handle has been appropriately positioned, the second handle is detached from the device.

In each of the embodiments shown in Figures 11, 12 and 13, the fork comprises two engagement portions 4, 6 in the form of tήies. This means that when the trocar enters the abdominal wall, the TPA passes between the engagement portions 4, 6. The engagement portions 4, 6 provide a stable area through which the trocar passes, and spread out forces and pressures applied by the device across an area of the abdominal wall. This prevents or reduces the chances of, tearing of the abdominal wall.

When the trocar has formed the incision, it may be simply removed from the remainder of the device by pulling the trocar out from the abdominal wall and port, and then sliding the port away from the device.

Referring now to Figures 14 to 17, a further embodiment of the present invention is shown designated generally by the reference numeral 100. The device 100 comprises a fork 102 and a support 104. A first handle 106 is attached to the support 104. The device 100 further comprises a stopper 108 moveably attached to the support 104. The position of the stopper 108 may be varied to suit the conditions pertaining at the time. The stopper comprises receiving means 110 for receiving penetration means such as a trocar port assembly 112. In the embodiment illustrated in Figures 14 to 17, first handle 106 has a fixed position relative to the support 104, and the stopper 108 is moveable relative to the support.

The receiving means 110 is in the form of an aperture, and serves the same purpose as the second receiving means described hereinabove with reference to Figures 1 to 12. In other words, the second receiving means, as defined hereinabove, is no longer contained within the first handle, but instead forms part of the moveable stopper 108.

In Figure 17 the port 112 which forms part of the standard trocar and port assembly is shown. This is representative of the port being in situ, before it is slid forwards from the device, but after the trocar has been removed.

The first handle 106 may be used to hold the device in a lifted position while the position of the stopper is being altered. This means that the embodiment shown in Figures 14 to 16 does not require a second handle.

Figure 18 illustrates a device similar to that shown in Figures 14 to 17, and similar parts have been given corresponding reference numerals for ease of reference. The device 180 comprises a TPA comprising a trocar 182 and a port 184. The port comprises a first port portion 186 and a second port portion 188.

One way of using the device according to the present invention will now be further described with particular reference to Figure 12.

A user begins by making a standard sldn incision into the abdominal wall.

Engagement arms 10 and 14 are then caused to slide horizontally via the skin incision into an abdominal wall for a distance of about 3 to 4 cm. Other ways of inserting the engagement means into an abdominal wall could also be used, for example, engagement means could be in the form of a retractor, or the engagement means could simply be stapled to the abdominal surface thus negating the need for the device to slide relative to the abdominal wall.

The first handle 32 is then attached to the support 16.

The abdominal wall is lifted up using the handle 32. This step is carried out to counteract the inward movement of the trocar port assembly to be later on inserted into the abdominal wall, and to increase the distance from the TPA from any internal structures.

A long scaled fine bore needle is then inserted via the second receiving means 40 using reducers 54 to appropriately reduce the diameter of the second receiving means. This step removes the vacuum existing within the abdominal cavity and also enables the user of the device to gauge the thickness of the abdominal wall.

The fine bore needle is then removed and the distance that it has travelled is gauged.

This is achieved by using a gauged needle, thus allowing the abdominal wall thickness to be measured.

A knowledge of this distance is used to adjust the first handle on the support to appropriately allow for the thickness of the abdominal wall.

Whilst the first handle 44 is being adjusted, the second handle 62 can be used to maintain the lift of the abdominal wall. In certain embodiments of the second handle, for example in embodiments shown in Figures 14 to 17, no second handle is required.

A standard trocar port assembly (TPA) is then inserted into the device by the second receiving means. The TPA is then inserted in a safe controlled manner into the abdominal cavity.

The trocar is then withdrawn leaving the port in place and complete entry of the port into the abdominal cavity via the abdominal wall is verifed with laparoscope.

If the port has not reached the abdominal cavity, i.e., if it is still within the layers of the abdominal wall, the trocar 66 is replaced and both trocar and port are inserted another 1 cm or so before being checked again with the laparoscope. This step is repeated as necessary until the port is positioned appropriately within the abdominal cavity. The port then slides away from the first handle 32 via the second receiving means 40 and the engagement portions 4, 6 are withdrawn from the abdominal wall.

In another embodiment of the invention, the TPA could pass completely through the device. The device would then need to dis-assembled or be hinged in order to remove the device from the patient after insertion of the TPA.

Referring to Figures 19 and 20, the device 100 shown and described hereinabove with reference to Figures 14 to 17 is shown. The receiving means 110 is shown receiving a reducer 120 which is adapted to fit within the receiving means 110. The reducer comprises an inner bore 122 having a diameter which is substantially smaller than ϋie diameter of the receiving means 110. The reducer is adapted to receive a fine bore needle 124 in the inner bore 122, and to hold the needle stably within the device 100. The fine bore needle is scaled so that it is possible to gauge the thickness of the abdominal wall of the patient as mentioned hereinabove.

Referring now to Figure 21 a device according to another embodiment of the present invention is designated generally by the reference numeral 300. Parts of the device 300 which correspond to parts of the devices shown in earlier figures have been given corresponding reference numerals for ease of reference.

The device 300 comprises a support 16 and an engagement means 210. The engagement means comprises a first engagement portion 4 and a second engagement portion 6 each in the form of a tine. The engagement means 210 extends from the support 16 in such a way that the tine axis (x;y) of each tine 4, 6 is substantially parallel to the support axis (z) of the support 16.

The device 300 further comprises second receiving means 40 adapted to receive an instrument such as a penetration instrument. In this embodiment, the second receiving means 40 is adapted to receive a trocar and port assembly (TPA).

As can be seen from Figure 21 the second receiving means 40 is attached to the support 16, which in this example is in the form of a handle. The second receiving means 40 may be integrally formed with the support 16, or may be separately formed. When the second receiving means is separately formed from the support 16 it may be attached to the handle 16 by any convenient method such as the use of an adhesive or by the use of engagement pins for example. The shape of the second receiving means 40 and its position relative to the engagement portions 4, 6 will deteπnine the depth to which a trocar forming the trocar port assembly is able to be inserted into the abdominal wall of the patient. The second engagement means 40 thus also serves as a stopper.

In different situations, it may be desirable for the trocar to extend by different amounts into the abdominal wall of the patient.

A particular device 300 may therefore be made with dimensions suitable for the circumstances. In other words the device 300 may be made in a range of different sizes and dimensions so that the combined thicknesses of the second receiving means 40 and the support 16 relative to the engagement means will determine the extend to which a trocar will extend into the abdominal wall of the patient. A device 300 having suitable dimensions for particular circumferences may then be chosen from the range of differently sized devices 300.

Alternatively, the dimensions of a particular device 300 may be altered by attaching removal stopper portions 310 of varying thickness to the second receiving means 40. One or more removal stopper portions 310 may be attached to the second receiving means 40 in any convenient way, such as by using clips. The presence of one or more removable stoppers will limit the possible movement of a trocar passing through the U-shaped channel formed in the second receiving means.

Referring now to Figure 22 a further embodiment of the device according to the present invention is designated generally by the reference numeral 400. The device comprises a support 16 and an engagement means 210. The engagement means is in the form of a hook, which hook lies in a plane that lies substantially at right angles to the axis of the support 16. The device further comprises second receiving means 40 for receiving a trocar port assembly 66, 67.

In the embodiment shown in Figure 22, it is not necessary for a user to apply force to the trocar 47, 66, 67 in order to cause the trocar to be inserted into an abdominal wall of a patient. Instead, the device further comprises a first handle in the form of a trigger 420 operatively connected to a ratchet mechanism, operation of the trigger activates the ratchet mechanism, causing the second receiving means, including the trocar port assembly held therein, to move generally in the direction of the arrow 430.

In use, the device 400 will be placed on the outer surface of the abdominal wall of the patient such that the engagement means 210 is in contact with the outer surface of the abdominal wall. A user of the device will apply rotational force to the device causing the engagement means 21 to enter into the abdominal wall of the patient and thus engage with the abdominal wall of the patient. The user may then lift the device away from the abdominal cavity of the patient and thus be in a position ready to use the device.

As mentioned above, the second receiving means and hence the trocar port assembly are connected to the support 16 of the device 400 by means of a ratchet mechanism. The ratchet mechanism is activated by operating the trigger 420 that forms a first handle. During use of the device a user may further support the device by holding onto a second handle 450.

Activation of trigger 420 causes the trocar port assembly to move towards the abdominal wall. The shape and dimensions of the second receiving means 40 are such that the trocar port assembly will be held in an armed position. Once the port 66 is moved such that it is in contact with the outer surface of the abdominal wall, the resistance of the abdominal wall to further movement of the trocar will cause the sheath to move back to expose the sharp tip 440 of the trocar 66. The sharp tip then cleaves the layers of the abdominal wall allowing trocar insertion.

Claims

1. A device for engaging with tissue of a patient, comprising an engagement means for engaging with the tissue, and a support for enabling a user to hold the device, the engagement means extending from the support.

2. A device according to Claim I₅ wherein the engagement means comprises one or more tines.

3. A device according to Claim 1 or Claim 2, wherein the support comprises a support axis, and the engagement means extends from the support in a direction that forms an angle of substantially 90° from the support axis.

4. A device according to Claim 1 or Claim 2, wherein the engagement means lie at least partially within a first plane, and the support lies substantially within a second plane, the first and second planes intersecting one another at a non-zero angle.

5. A device according to Claim 4, wherein the first and second planes intersect one another at an angle of substantially 90°.

6. A device according to any one of the preceding claims, wherein the engagement means extends in a first direction from the support, and comprises a distal blunt end spaced apart from the support, and a proximate end positioned proximate the support.

7. A device according to Claim 6 wherein the proximate end of the engagement means forms a sharp point or edge.

8. A device according to any one of the preceding claims, wherein the engagement means comprises a first engagement arm, and the support comprises a first supporting arm, the first engagement ann and the first supporting arm being joined to one another at the proximate end of the engagement means, both the first supporting arm and the first engagement arm lying in a first plane.

9. A device according to Claim 8, wherein the engagement means further comprises a second engagement ann spaced apart from and substantially parallel to the first engagement arm, and lying in the first plane.

10. A device according to Claim 9, wherein the first and second engagement arms are joined together at the distal end of the engagement means to form a substantially U-shaped first engagement portion.

11. A device according to Claim 9 or Claim 10, wherein the proximate end of the second engagement ann comprises a sharp point or edge.

12. A device according to any one of Claims 9 to 11, wherein the support comprises a second supporting ann spaced apart from, and substantially parallel to the first supporting ann, the first and second supporting arms lying in a plane substantially orthogonal to the first plane, the engagement means further comprising third and fourth engagement amis spaced apart from, and substantially parallel to one another to fonn a second engagement portion, the second supporting ann and the third and fourth engagement arms lying in a third plane which third plane is spaced apart from, and substantially parallel to the first plane.

13. A device according to Claim 12, wherein the third engagement arm. and the second supporting arm are joined to one another at the proximate end of the engagement means.

14. A device according to Claim 12 or Claim 13, wherein the third and fourth engagement arms are joined together at the distal end of the engagement means to form a substantially U-shaped second engagement portion.

15. A device according to any one of Claims 12, 13 or 14, wherein the fourth engagement arm preferably comprises a sharp point or edge forming the proximate end of the fourth engagement means.

16. A device according to Claim 1 or Claim 2, wherein the support comprises a support axis, and the engagement means extends from the support in a direction that is substantially parallel to the support axis.

17. A device according to Claim 1 or Claim 2, wherein the engagement means comprises a hook shaped portion.

18. A device according to Claim 17, wherein the hook shaped portion lies in a plane that extends at an angle of substantially 90° to the support axis.

19. A device according to any one of the preceding claims, wherein the support and the engagement means are foπned integrally with one another.

20. A device according to any one of the preceding claims, wherem the device further comprises a first handle.

21. A device according to Claim 20, wherein the support comprises handle engagement means for attaching the first handle to the support.

22. A device according to Claim 20 or Claim 21, wherein the first handle comprises first receiving means for receiving the support.

23. A device according to any one of Claims 20 to 22, wherein the first handle comprises a first face, and an opposite second face, the first and second faces being axially spaced apart from one another.

24. A device according to Claim 23, wherein the first receiving means extends axially from the first face, partially or completely through the first handle, and the second receiving means extends between the first and second faces.

25. A device according to any one of Claims 20 to 24, wherein the first handle is moveably attachable to the support.

26. A device according to Claim 25 wherein the first handle is moveably attachable to the support by a ratchet mechanism.

27. A device according to any one of the preceding claims, further comprising second receiving means.

28. A device according to Claim 27, wherein the second receiving means comprises a channel extending longitudinally through the first handle.

29. A device according to any one of the preceding claims further comprising a second handle.

30. A device according to Claim 29 when dependent on Claim 22 or any claim dependent thereon wherein the second handle is attachable to the support and is moveable axially within the first receiving means.

31. A device according to Claim 27 or any claim dependent thereon, further comprising a stopperthe second receiving means comprising a channel extending axially through the stopper.

32. A device according to Claim 31 wherein the stopper is moveably attachable to the support, and axially offset from the first handle.

33. A device according to Claim 27, or any claim dependent thereon wherein the second receiving means is adapted to receive a trocar port assembly.

34. A device according to Claim 33, wherein a port forming part of a trocar and port assembly (TPA) is receivable within the second receiving means, and axially moveable within the second receiving means.

35. A device according to Claim 34, wherein the second receiving means is shaped to receive a first port portion but to prevent a second port portion from being received within the second receiving means.

36. A device according to Claim 35, wherein the first port portion is substantially cylindrical, and the inner cross-sectional diameter of the second receiving means is substantially equal to the outer diameter of the first port portion; and the second port portion is substantially cylindrical and the cross-sectional inner diameter of the second receiving means is substantially less than an outer diameter of the second port portion.

37. A device according to Claim 27 or any claim dependent thereon, further comprising one or more reducers for reducing the cross-sectional dimensions of the second receiving means.

38. A device according to any one of the preceding claims further comprising perforation means.

39. A device according to Claim 38 wherein the perforation means comprises a fine bore needle.

40. A device according to Claim 38 or Claim 39 wherein the perforation means is hollow.

41. A device according to any one of Claims 38, 39 or 40 wherein the perforation means is gauged.

42. A device according to any one of Claims 38 to 41 when dependent on Claim 27 or Claim 37, wherein the perforation means is receivably in the second receiving means.

43. A method for engaging and supporting the abdominal wall of a patient using a device comprising an engagement means for engaging with the abdominal wall, and a support for enabling a user to hold the device, the engagement means extending from the support, the method comprising the steps of:

44. A method according to Claim 43 comprising the further step of: (b) pulling the device away from the abdominal cavity of the patient.

45. A method according to Claim 43 or Claim 44 comprising the additional steps of:

(c) inserting a first penetration means into the engagement device;

(d) inserting the first penetration means into and through the abdominal wall via the engagement device;

(e) removing the first penetration means from the abdominal wall; (f) removing the first penetration means from the engagement device.

46. A method according to any one of Claims 43 to 45 comprising the further step of: (g) gauging the distance that the penetration means has travelled through the tissue, thereby measuring the thickness of the tissue.

47. A method according to any one of Claims 43 to 46 comprising the further steps of: (h) inserting a trocar port assembly into the engagement device;

(i) inserting the trocar port assembly into the abdominal wall;

(j) removing the trocar from the tissue leaving the port in place;

(k) removing the trocar from the engagement device.

48. A method according to any one of Claims 43 to 47 comprising the further steps of:

(1) checking that the port is appropriately positioned; (m) inserting the trocar port assembly into the abdominal wall via the engagement device, causing the TPA to move further into the abdominal wall; and (n) repeating steps (1) and (m) as necessary until the port is in an appropriate position.

49. A method for engaging and supporting the abdominal wall of a patient using a device according to any one of Claims 1 to 42.

50. A device substantially as hereinbefore described with reference to the accompanying drawings.

51. A method substantially as hereinbefore described with reference to the accompanying drawings.