This invention relates to a surgical sealing device suitable for use during a surgical procedure, especially suitable for use during laparoscopic surgery or during hand assisted laparoscopic surgery.
In carrying out a surgical procedure in the region of the abdomen, it is known to form an incision and then retract the incision to provide an access opening. The opening may be sealed with a valve in an effort to prevent insufflation gases from escaping and to maintain pneumoperitoneum. It is however difficult to provide an effective gas seal while providing access for an instrument or for a surgeon's hand.
This invention is directed towards providing a surgical sealing device, which will address these problems.
According to the invention there is provided a surgical sealing device comprising:
In one embodiment of the invention at least one of the sealing members is at least partially of a gelatinous elastomeric material. In one case both sealing members are at least partially of a gelatinous elastomeric material. In another case the material comprises a plasticiser. The plasticiser may be selected from the group consisting of naturally derived oils, synthetic oils and liquid oligomers.
In one case the first sealing valve is biased towards the closed configuration. In one case at least one of the sealing members is of a resilient material to bias the first sealing valve towards the closed configuration.
The first sealing member and the second sealing member may define overlapping portions, which overlap with each other in the closed configuration. In one case at least the overlapping portions of the sealing members are generally planar. In another case the planes of the overlapping portions are slightly offset. In another case the overlapping portions engage with each other in the closed configuration. The engagement force is in one case overcome on insertion of an object, such as a surgeon's hand.
In another embodiment a thin slit is defined between the overlap of the first sealing member over the second sealing member.
The first sealing member may be fixedly attached to the second sealing member. In one case the first sealing member is formed integrally with the second sealing member. In another case the first sealing member is moulded integrally with the second sealing member. In one case the first sealing member comprises an overlap region, which overlaps the second sealing member in the closed configuration, the overlap region comprising a first region attached to the second sealing member and a second region detached from the second sealing member. In one case a thin slit is defined between the second region of the first sealing member and the second sealing member. In another case the slit extends circumferentially through approximately 90°. The ratio of the radial dimension of the slit to the overall radial dimension of the entire first sealing member may be approximately 1:4, in one case approximately 1:8.
In a preferred case in the closed configuration, the second region of the first sealing member engages the second sealing member. In another case the second region of the first sealing member is biased towards engagement with the second sealing member.
The first sealing valve may be configured to be located externally of an internal cavity proximally of an opening to the internal cavity. The first sealing valve may be configured to be located within an internal cavity distally of an opening to the internal cavity.
The first sealing member is in one case substantially planar. The second sealing member is in one case substantially planar.
In a preferred embodiment the device comprises a second sealing valve for sealing around an object passed through an opening to an internal cavity.
The first sealing member may be located distally of the second sealing valve. The first sealing valve may be located proximally of the second sealing valve.
In one case the first sealing valve is longitudinally spaced apart from the second sealing valve. One sealing valve may be configured to be located externally of an internal cavity proximally of an opening to the internal cavity, and the other sealing valve may be configured to be located within the internal cavity distally of the opening.
In another case the first sealing valve is located adjacent and in close proximity to the second sealing valve. Both the first sealing valve and the second sealing valve may be located externally of an internal cavity proximally of an opening to the internal cavity. Both the first sealing valve and the second sealing valve may be located within an internal cavity distally of an opening to the internal cavity.
In one case the second sealing member provides the second sealing valve. In another case the second sealing member has a passageway extending therethrough, through which an object may be inserted to access an internal cavity. The second sealing member may be configured to effect a seal between a sidewall of the passageway and an object inserted through the passageway.
In one case, in the closed configuration, the first sealing member extends across an end of the passageway and overlaps the second sealing member around the entire periphery of the end of the passageway. In one case in the open configuration the first sealing member is retracted to reveal at least part of the end of the passageway.
The second sealing valve may comprise a lip seal valve.
In a further embodiment the device is mountable to a retractor device. In one case the device comprises a mounting element for mounting the device to a retractor device. In another case the mounting element is fixedly attached to the sealing valve. In another case a part of the sealing valve is overmoulded around a part of the mounting element. The mounting element may comprise one or more overmould openings therein. In one case the mounting element comprises an engagement formation for snap-fit mounting of the device to a retractor device.
The mounting element may comprise a ring element.
In one case the device is configured to effect a seal between the device and a retractor device upon mounting of the device to the retractor device. In another case at least one of the sealing members is configured to engage a retractor device upon mounting.
In another embodiment the first sealing valve comprises a biasing member to bias the first sealing valve towards the closed configuration. In one case the biasing member comprises a resilient element extending between the first sealing member and the second sealing member. The resilient element may comprise a spring.
The biasing member may comprise a magnetic element on the first sealing member and a co-operating magnetic element on the second sealing member.
In another case the first sealing valve comprises a biasing member to bias the second region of the first sealing member towards engagement with the second sealing member. In one case the biasing member comprises a resilient element for tensioning the second region of the first sealing member. In another case the resilient element extends between the second region of the first sealing member and the second sealing member.
In one case the first sealing member is hingeably movable relative to the second sealing member between the closed configuration and the open configuration.
The first sealing member may be at least partially curved.
The first sealing member may be at least partially substantially spherical. The second sealing member may be substantially curved.
In the closed configuration, the first sealing member may extend at least partially into the passageway.
In another embodiment the thickness of the second sealing member varies across the width of the second sealing member. In one case the thickness of the second sealing member is at a maximum adjacent the passageway.
The passageway may define a longitudinal axis, and the passageway longitudinal axis may be configured to subtend an acute angle with a longitudinal axis defined by an opening to an internal cavity. In one case the longitudinal axis of the passageway is angled towards the second region of the first sealing member.
In another case the device comprises a closure member for closing the passageway. In one case the closure member comprises a plug.
In one embodiment the second sealing valve comprises a third sealing member having a passageway extending therethrough, through which an object may be inserted to access an internal cavity. In one case the third sealing member is configured to effect a seal between a wall of the passageway and an object inserted through the passageway. In another case the third sealing member is at least partially of a gelatinous elastomeric material.
The second sealing valve may be at least partially inflatable. The second sealing valve may comprise an iris valve.
In a further case the device comprises a third sealing valve for sealing across an opening to an internal cavity. In one case the third sealing valve comprises a fourth sealing member, the second sealing member and the fourth sealing member being movable relative to one another between the closed configuration, in which the second sealing member and the fourth sealing member at least partially overlap one another, and the open configuration. In another case the fourth sealing member is at least partially of a gelatinous elastomeric material.
The mounting element may comprise a screw-thread formation for screw-thread mounting of the device to a retractor device.
In one case the mounting element comprises a sleeve extending proximally of the sealing valve. In one case the sleeve is hookable around a part of a retractor device to mount the device to the retractor device. The sleeve may comprise a mounting ring for hooking around a part of a retractor device.
In another aspect of the invention, there is provided a surgical sealing device comprising:
The invention also provides in a further aspect a surgical sealing device comprising:
In one embodiment the dimensions of the main portion differ from the dimensions of the access portion. In one case the thickness of the access portion is greater than the thickness of the main portion. In another case the access portion is of substantially uniform thickness. In another case the main portion and the access portion are of the same material.
In another embodiment the material properties of the main portion differ from the material properties of the access portion. In one case the main portion and the access portion are of the same dimensions.
The access portion may comprise an accessway extending therethrough, through which an object may be inserted to access an internal cavity. In one case the accessway is defined by a slit in the access portion. In another case the accessway is biased towards a closed configuration. The accessway may be openable upon insertion of an object into the accessway. In another case the accessway is configured to effect a seal between a sidewall of the accessway and an object inserted through the accessway.
According to another aspect, the invention provides a surgical assembly comprising:
In one case the surgical sealing device is mounted to the retractor device.
The retractor device may have a distal end and a proximal end, and the surgical sealing device may be located adjacent to the distal end of the retractor device. The retractor device may have a distal end and a proximal end, and the surgical sealing device may be located adjacent to the proximal end of the retractor device.
The invention provides in another aspect a method of accessing an internal cavity through an opening to the internal cavity, the method comprising the steps of:—
In one embodiment of the invention the method comprises the step of biasing the first sealing valve towards the closed configuration.
The first sealing valve may be arranged within the opening. In one case the first sealing valve is arranged externally of the internal cavity proximally of the opening. In another case the first sealing valve is arranged within the internal cavity distally of the opening.
In a preferred case the method comprises the steps of:
The second sealing valve may be arranged proximally of the first sealing valve.
The second sealing valve may be arranged within the opening. The second sealing valve may be arranged externally of the internal cavity proximally of the opening. The second sealing valve may be arranged within the internal cavity distally of the opening.
In another case the second sealing valve has a passageway extending therethrough, and the method comprises the step of inserting the object through the passageway to access the internal cavity. In one case the method comprises the step of effecting a seal between a sidewall of the passageway and the object.
The method may comprise the step of retracting the sides of the opening to the internal cavity. In one case the method comprises the step of mounting the sealing valve to a retractor device. In another case the method comprises the step of effecting a seal between the sealing valve and the retractor device. The object passed through the opening may comprise a surgeon's hand and/or forearm. The object passed through the opening may comprise a surgical instrument.
In one case the second sealing valve is arranged distally of the first sealing valve.
The method may comprise the step of closing the passageway.
In another embodiment the method comprises the step of at least partially inflating the second sealing valve to seal around the object. In a further embodiment the method comprises the step of twisting the second sealing valve to seal around the object.
The invention also provides in another aspect a method of accessing an internal cavity through an opening to the internal cavity, the method comprising the steps of:—
In a further aspect of the invention there is provided a method of accessing an internal cavity through an opening to the internal cavity, the method comprising the steps of:—
In one embodiment the sealing member is at least partially of a gelatinous elastomeric material.
In one case the object comprises a laparoscopic instrument.
The object may comprise a sharp distal tip for piercing the sealing member.
In one case the passageway created through the sealing member comprises a pinhole through the sealing member.
The invention will be more clearly understood from the following description of some embodiments thereof, given by way of example only, with reference to the accompanying drawings, in which:—
FIGS. 17 to 21 are cross-sectional, side views of other surgical sealing devices according to the invention;
FIGS. 50 to 53 are partially cross sectional, side views of the device of
FIGS. 65 to 67 are perspective views from below of further surgical sealing devices according to the invention;
Referring to the drawings and initially to FIGS. 1 to 8 thereof, there is illustrated a surgical sealing device 1 according to the invention, which is suitable for use during a surgical procedure, such as a laparoscopic procedure or a hand-assisted laparoscopic procedure.
The device 1 may in the case of a laparoscopic procedure be employed to effect a seal around a laparoscopic instrument inserted through the device 1 into an abdomen to maintain insufflation gas pressure within the abdomen. In the case of a hand-assisted laparoscopic procedure, the device 1 may be employed to effect a seal around a surgeon's hand or forearm inserted through the device 1 into the abdomen to maintain insufflation gas pressure within the abdomen.
The device 1 comprises a planar first sealing member 5 and a planar second sealing member 6. The second sealing member 6 has a passageway 2 extending therethrough through which an object, such as a laparoscopic instrument or a surgeon's hand/forearm 3, may be inserted to access an interior space, such as an insufflated abdomen 4. The planar first sealing member 5 may be employed to seal the passageway 2.
In this case, the first sealing member 5 is provided in the form of a flap member of an elastic material. The flap member 5 is movable relative to the second sealing member 6 between a closed configuration sealing the passageway 2 (
In this case the first sealing member 5 and the second sealing member 6 are formed integrally, in this case moulded integrally. In the closed configuration, the first sealing member 5 overlaps the second sealing member 6 around the entire periphery of the distal end opening of the passageway 2. In this region of overlap, the first sealing member 5 is fixedly attached to the second sealing member 6 at an attachment region 7, and is detached from the second sealing member 6 at a detachment region 8. As illustrated in FIGS. 2 to 6, the detachment region 8 is in the form of a very thin slit or gap. The slip/gap 8 extends circumferentially through approximately 90°, and has a radial dimension approximately ¼ of the radial width of the first sealing member 5, and approximately {fraction (1/8)} of the radial width of the second sealing member 6. In the closed configuration, the insufflation gas pressure within the abdomen 4 forces the detachment region 8 to engage against the second sealing member 6 around the distal end of the passageway 2. This results in the thin slit/gap being closed down to prevent leakage of insufflation gas out of the abdomen 4.
Because the region 8 is detached from the second sealing member 6, this arrangement enables the region 8 to be retracted when an object is inserted through the passageway 2, which results in the slit/gap becoming large enough for the object to exit the passageway 2 and access the abdomen 4. As the object passes through the passageway 2, the object engages the region 8 and forces the region 8 aside. In this manner, the region 8 is retracted.
Because the first sealing member 5 and the second sealing member 6 overlap in the closed configuration, a seal is created across the wound opening which prevents loss of insufflation gases from the abdomen 4. The overlapping first and second sealing members 5, 6 thus provide a first sealing valve for sealing across the wound opening.
The elastic biasing nature of the flap member 5 biases the flap member 5 towards the closed configuration to prevent leakage of insufflation gas out of the abdomen 4, when the surgeon withdraws the object, such as the hand/forearm 3 out of the abdomen 4. In particular the resilience of the material of the flap member 5 biases the flap member 5 towards the closed configuration. In addition, the gas pressure within the abdomen 4 acts on the flap member 5 to force the flap member 5 towards the closed configuration.
The sidewall of the passageway 2 is of an elastic material, and the passageway 2 typically has a smaller diameter than an object to be inserted therethrough. The material defining the passageway 2 thus creates a seal between the sidewall of the passageway 2 and the object, defining an interference fit between the sidewall and the object (
In the case of laparoscopic surgery, the passageway 2 is sized to seal around a laparoscopic instrument inserted therethrough. The passageway 2 may therefore be sized as a pinhole through the second sealing member 6. In certain cases, the second sealing member 6 may be formed with no hole therethrough, and the passageway 2 may be created in-situ by the surgeon piercing the second sealing member 6 with the instrument and forcing the instrument through the second sealing member 6.
In the case of hand-assisted laparoscopic surgery, the passageway 2 is sized to seal around a hand or forearm of the surgeon.
As illustrated in
However it will be appreciated that the first sealing valve may alternatively be provided proximally of the second sealing valve.
The sealing device 1 may be mounted to a wound retractor device 10, as illustrated in
The device 1 is in this case a combined overlap/lipseal valve for hand assisted laparoscopy (HALS).
The device 1 may be a single piece moulded gel component. The first and second sealing members 5, 6 are both formed of a gel material. The gel material may include an elastomer, such as silicone or latex. The gel material may also include an oil, and/or a foam.
In one embodiment the device 1 is of a gelatinous elastomeric material. An extensive review of gelatinous elastomeric materials is included in U.S. Pat. No. 5,994,450 (Pierce), the entire contents of which are incorporated herein by reference. One such group of gelatinous elastomers may comprise a triblock copolymer A-B-A wherein A is selected from the group consisting of monoalkenylarene polymers and B is a hydrogenated polymer including a plurality of isoprene monomers and a plurality of butadiene monomers. The material includes a plasticiser which may be selected from the group consisting of naturally derived oils, synthetic oils and liquid oligomers. For the device of this embodiment of the invention the gelatinous elastomeric material is formulated to have high tear strength and high flexibility.
The materials required to form a suitable gel material are available, for example, from the company Edizone L.C. of Utah, USA. The gel material preferably has the properties of high tear strength to resist tearing of the attachment of the first sealing member 5 to the second sealing member 6, and high flexibility to enable the first sealing member 5 to be retracted for passage of an object through the passageway 2 into the abdomen 4.
During moulding, a thin plate is located between the first sealing member 5 and the second sealing member 6. This thin plate prevents the first sealing member 5 being fully moulded to the second sealing member 6. As a result the first sealing member 5 is moulded to the second sealing member 6 at a first region which is the attachment region 7, and remains un-moulded to the second sealing member 6 at a second region which is the detachment region 8. This thin plate defines the thin slit/gap 8 between the sealing members 5, 6.
In certain applications the device may alternatively be formed as a single piece moulded rubber or elastomeric component.
There is a lipseal hole 2 through which an object, such as hand can pass, due to the highly elastic nature of the material. An overlap flap 5 is integrally moulded underneath, and covering, the lipseal hole 2. The overlap flap 5 is essentially joined to/integral with the main body of the lipseal apart from a slit which in this case extends radially. Because of the elastic nature of the material, the object, such as the hand can displace the overlap flap 5 and push through the slit. In use, the slit is closed by the gas pressure acting upwardly on the flap 5. On insertion of an object the slit can be opened just sufficiently to allow the object to pass therethrough with no substantial loss of gas pressure. The lipseal 2 now seals to the object, such as the surgeon's wrist, maintaining pneumoperitoneum. When the object, such as the hand/forearm 3 is removed, the overlap flap 5 returns to its original position blocking the lipseal hole 2.
In the case where the surgical sealing device of the invention is employed during laparoscopic surgery, the second sealing member 6 may alternatively be formed as a continuous single block of gel with no passageway extending therethrough. When the device is mounted across a wound opening sealing the opening, the surgeon may pierce the second sealing member 6, for example with a laparoscopic instrument having a sharp distal tip to create the passageway through the second sealing member 6 in situ by pushing the instrument through the second sealing member 6.
The ring 20 includes a series of oblong openings or slots 21 therein, in both the vertical and horizontal planes. The slots 21 assist in obtaining a secure attachment of the device 1 to the ring 20 (
One method of attaching the device 1 to the ring 20 is by overmoulding a part of the second sealing member 6 around parts of the ring 20. The slots 21 thus provide pathways for the second sealing member 6 to mould around parts of the ring 20 to fixedly attach the device 1 to the ring 20.
Because the first and second sealing members 5, 6 are moulded integrally, the process of moulding the device 1 and attaching the device 1 to the ring 20 may be performed in a single moulding step.
It will be appreciated that the device 1 may be fixedly attached to the mounting ring 20 in a variety of possible alternative ways. For example, the device 1 may be securely attached to the ring 20 using an adhesive or any other suitable fixing means.
The ring 20 includes a downwardly extending rim 22 having an inwardly protruding engagement lip 23. The lip 23 is particularly suitable for mounting the ring 20 and the overmoulded device 1 to a retractor device in a snap-fit manner. For example, in the case of the wound retractor device 27 of
As illustrated in
The mounting ring may be mounted to a wound retractor device in any suitable manner. For example, screw-thread formations 31 may be provided on the ring 30, and co-operating screw-thread formations 33 may be provided on the wound protector device 32, as illustrated in
In
In this case, the first sealing member 5 includes a hemispherical portion 41. In the closed configuration, the hemispherical portion 41 extends partially into the passageway 2 to achieve a particularly effective seal.
To ensure that the first sealing member 5 engages the second sealing member 6 around the entire periphery of the distal end of the passageway 2 in the closed configuration, the thickness of the second sealing member 6 may vary across the width of the second sealing member 6. A variety of possible configurations for the second sealing member 6 are illustrated in FIGS. 17 to 19. By arranging for the thickness of the second sealing member 6 to be at a maximum adjacent the passageway 2, the sealing effect may be enhanced.
By arranging for the proximal side of the second sealing member 6 to curve proximally away from the distal end of the passageway 2 (
In the embodiments of
The passageway 2 may be arranged so that the passageway longitudinal axis A-A subtends an acute angle with the longitudinal axis B-B of the wound opening, and the passageway 2 is angled towards the detachment region 8, as illustrated in
In this manner, the passageway 2 effectively guides the instrument or surgeon's hand in the direction of the detachment region 8 of the first sealing member 5. This assists in a faster and smoother insertion through the passageway 2 and retraction of the first sealing member 5.
An additional sealing member 50 may be provided integrally moulded with the second sealing member 6, as illustrated in
In this case, the fourth sealing member 50 is of the same gelatinous elastomeric material as the first and second sealing members 5, 6, and may be integrally formed.
A biassing member may be provided to bias the first sealing member 5 towards the closed configuration. For example,
FIGS. 24 to 26 illustrate another surgical sealing device 70 according to the invention, which is similar to the device 1 of FIGS. 1 to 8, and similar elements in FIGS. 24 to 26 are assigned the same reference numerals.
In this case, the device 70 comprises a plug 71 for insertion into the passageway 2 to close the passageway 2. By closing the passageway 2 with the plug 71, this acts as a further seal to prevent loss of insufflation gases, for example during initial insufflation of the abdomen 4.
The plug 71 is attached by means of a cord to the second sealing member 6.
Referring now to
Referring to FIGS. 28 to 30, there is illustrated another surgical sealing device 200 according to the invention. The device 200 is formed from a highly elastomeric material, such as a silicone based gel. The first sealing member 202 and the second sealing member 203 have relatively thin outer portions. At the attachment region 201, the sealing members 202, 203 have a relatively thick central portion. The central portion has a detachment region slit 205 therein which extends obliquely with respect to the axis of an incision to provide enhanced sealing between the marginal edge of the accessway defined by the slit 205 and an object passing therethrough, as illustrated in
Referring to FIGS. 31 to 35, there is illustrated a surgical sealing device 101 according to the invention for use in a surgical procedure, such as laparoscopic surgery or hand assisted laparoscopic surgery. The device 101 comprises a first sealing member 102 and a second sealing member 103 which have a normally closed configuration (
The sealing members 102, 103 have respective overlapping portions 106, 107 which overlap with each other in the closed configuration. The sealing members 102, 103 are generally planar, with the planes of the overlapping portions 106, 107 being slightly offset. The overlapping portions 106, 107 are at least partially engaged with one another in the closed configuration. In this case, the sealing members 102, 103 are of a resilient and elastomeric sheet material such as rubber, silicone or latex. The engagement force between the overlapping portions 106, 107 is overcome by the insertion of an object, such as a surgeon's hand.
In this case the sealing members 102, 103 are each mounted to a mounting ring in the form of an O-ring 110. A sleeve 112 extends proximally from the mounting O-ring 110.
Referring to
The sealing members 102, 103 are, in this case, of an elastic material such as a gel, neoprene, rubber or silicone which may optionally have facings 121, 122 on the non-engaged side. Indeed, there may be a facing on the engaged side to enhance the engagement. In this case, the facings may have some adhesive or tackiness properties.
Referring to
Referring to
Referring to FIGS. 39 to 41, the overlap valve 1100 is located just inside an incision. The valve 1100 is coupled to a retractor located in the incision at a surgical site, such as in an abdominal wall 141.
The retractor may be of any suitable construction such as the retractors described in our US patent application published under No. 2001/0037053A, and/or U.S. Pat. No. 6,582,364, and/or U.S. patent application Ser. No. 10/678,653, the whole contents of which are incorporated herein by reference.
In this case, the retractor has a distal ring 142 and a proximal ring 143 with a retracting sleeve 144 extending therebetween, as illustrated. The retractor also has a proximal guide or mounting ring 145. In this case, the proximal ring 143 is located in a recess in the guide-mounting ring 145, however various other constructions are possible. The valve sleeve 112 is mounted to the retractor, in this case to the mounting ring 145. The distal end of the valve sleeve 112 has a reinforcing mounting ring 146 to facilitate coupling, as shown. In particular the reinforcing ring 146 may be hooked around the mounting ring 145 to mount the device 1100 to the retractor.
The lip seal 1000 is attached to the mounting ring 45 of the retractor.
Referring to
The first sealing overlap valve 1100 is located within the abdomen distally of the wound opening, and the second sealing lip seal valve 160 is located externally of the abdomen proximally of the wound opening. As illustrated, the first sealing valve 1100 is longitudinally spaced apart from the second sealing valve 160.
Referring to
In this case, the second sealing valve lip seal 1000 is located just proximal of, adjacent and in close proximity to the first sealing overlap valve 1100. The lip seal 1000 may be attached to the mounting ring 110 of the overlap valve 1100. One advantage of this arrangement is the very low profile of the device. Both the first sealing valve 1100 and the second sealing valve 1000 are located, in use, within the abdomen distally of the wound opening, and adjacent to the distal end of the wound retractor device.
Referring to
The first sealing valve 1100 is located adjacent and in close proximity to the second sealing valve 1000. Both the first sealing valve 1100 and the second sealing valve 1000 are located, in use, externally of the abdomen proximally of the wound opening, and adjacent to the proximal end of the wound retractor device.
As an alternative, one or both of the sealing valves may be located within the wound opening.
In
Referring to
The mounting ring 145 provides a platform for mounting a second sealing valve 250, such as an iris-type valve to the retractor 140. In this case, the valve 250 may be regarded as a primary valve and the overlap valve as a secondary valve.
In use, the space beneath the abdominal wall 141 is insufflated. The primary valve 250 is normally closed and is opened for insertion of an object, such as a laparoscopic instrument or a surgeon's hand/forearm 105. On opening of the valve 250 the secondary overlap valve holds back the pressure of the gas inside the abdomen (
The valve system of the invention is easy to use by a surgeon and yet avoids substantial gas leakage. Because the valve 250 is sealed to a surgeon's arm, the secondary overlap valve can be readily and safely opened to allow access into the abdominal cavity. The secondary overlap valve provides an effective seal against gas leakage while a surgeon seals his arm to the primary valve 250. Upon opening of the secondary overlap valve, the primary valve 250 then provides the primary seal against gas leakage.
In this case, the sealing members 102, 103 are of a gel material. However it will be appreciated that the sealing members 102, 103 may alternatively be provided in the form of any suitable elastic material, for example neoprene.
Referring to
Referring to FIGS. 57 to 59, there is illustrated another surgical assembly which is similar to that of
In some of the described embodiments above the first sealing overlap valve is located adjacent to a distal end of the incision. It is also possible to provide the first sealing overlap valve externally of the abdomen proximally of the wound opening. For example, as illustrated in
Various other mounting arrangements are possible. For example, as illustrated in
Referring to
The sealing members 303, 304 are of an elastomeric gel material. The sealing members 303, 304 may therefore be manipulated to align the two passageways 303, 304, and thereby facilitate passage of an object, such as a laparoscopic instrument or a surgeon's hand/forearm, through the device 300 to access the abdomen.
Each passageway 303, 304 is in the form of a lip-seal, and is capable of effecting a gas-tight seal between the wall of the passageway 303, 304 and the object inserted therethrough. Thus insufflation gas is prevented from escaping from the abdomen while the object is inserted through the passageways 303, 304.
In
In this case, the first sealing member 5 is attached to the second sealing member 6 at the attachment region 7 by means of a hinge arrangement. The first sealing member 5 is thus movable in a hinging motion relative to the second sealing member 6 between the open and closed configurations.
For enhanced sealing in the closed configuration, a biasing member may be provided to bias the detachment region 8 of the first sealing member 5 towards engagement with the second sealing member 6, and thus bias the device 320 towards the closed configuration. A suitable biasing member is a magnetic element 321 on the first sealing member 5 and a co-operating magnetic element 322 on the second sealing member 6, as illustrated in
Alternative biassing members include velcro strips, or a latch.
FIGS. 67 to 70 illustrate another surgical sealing device 330 according to the invention, which is similar to the device 1 of FIGS. 1 to 8, and similar elements in FIGS. 67 to 70 are assigned the same reference numerals.
In this case, the first sealing member 5 is attached to the second sealing member 6 by means of a resilient cantilever arm 331. The arm 331 acts as a leaf-spring to bias the first sealing member 5 towards engagement with the distal end opening of the passageway 2, and thus bias the device 330 towards the closed configuration.
The first sealing member 5 has a partially spherical, curved portion 332 which partially extends into the passageway 2 in the closed configuration.
Referring to
In this case the first sealing member 5 is provided in the form of a substantially spherical ball. In the closed configuration, the sphere 5 engages the distal end opening of the passageway 2 to effect a gas-tight seal. Part of the sphere 5 extends into the passageway 2 in the closed configuration.
The sphere 5 is attached to the distal side of the second sealing member 6 by means of two resilient cords 341. The cords 341 act as spring members to bias the sphere 5 towards engagement with the distal end opening of the passageway 2, and thus bias the device 340 towards the closed configuration.
It will be appreciated that the first sealing member 5 may be attached to the second sealing member 6 in a variety of possible arrangements. For example, a single resilient cord 341 may extend from the sphere 5 through the passageway 2 and be attached to the proximal side of the second sealing member 6, as illustrated in
Referring to FIGS. 75 to 82, there is illustrated another surgical sealing device 400 according to the invention for use in a surgical procedure such as a laparoscopic procedure or a hand assisted laparoscopic surgery. The device 400 comprises a sealing valve body having a proximal side 402 and a distal side 403. The sealing valve body also has a main portion 404 and an access portion 405, which in this case is approximately central of the sealing body. The access portion 405 has an accessway for passage of an object, such as a surgeon's hand/forearm or an instrument therethrough to access an internal surgical cavity. In this case the accessway is defined by a slit 406 in the sealing body, the slit 406 in this case extending from the proximal side 402 to the distal side 403 of the sealing body. The accessway 406 is biased towards a normally closed configuration as illustrated in
The access portion 405 has different dimensions and/or properties to those of the main portion 404. In this case, for ease of manufacture the sealing body is all of the same material and the differences are in the thickness of the sealing body.
In this case, the access portion 405 of the sealing body is substantially thicker than the main portion 404 of the sealing body. Thus, the use of material is optimised and the weight of the sealing body is optimised without any sacrifice in the sealing properties. The access portion 405 has substantially uniform thickness across its width.
In use, when the sealing body is deployed over a retracted incision and the body cavity insufflated, the sealing body bows upwardly as illustrated in
The sealing body may be of any suitable material such as an elastomeric material. It may comprise silicone, latex, rubber, neoprene or like and may be in the form of a gel.
Referring to
In this case, the retractor 410 has a distal ring 413 and a proximal ring 414 with a retracting sleeve 415 extending therebetween, as illustrated. The retractor 410 also has a proximal guide or mounting ring 416. In this case, the proximal ring 414 is located in a recess in the guide/mounting ring 416, however various other constructions are possible. In
Referring to
The device 400 of the invention provides sealed access without risk of gas leakage from the abdominal cavity.
It will be appreciated that in an alternative embodiment, the main portion and the access portion may be of the same dimensions, with different material properties between the access portion and the main portion. For example to achieve a greater sealing effect at the access portion than at the main portion.
The invention is not limited to the embodiments hereinbefore described, with reference to the accompanying drawings, which may be varied in construction and detail.
Number | Date | Country | |
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60511135 | Oct 2003 | US | |
60511075 | Oct 2003 | US | |
60517075 | Nov 2003 | US | |
60582801 | Jun 2004 | US |