Instrument Access Device

[0001] This application is a Continuation-In-Part of U.S. application Ser. No. 12/694,888, filed Jan. 27, 2010 which claims the benefit of Provisional Application No. 61/147,625, filed Jan. 27, 2009 and Provisional Application No. 61/147,613 filed Jan. 27, 2009.

[0002] U.S. application Ser. No. 12/694,888 is in turn a Continuation-In-Part of U.S. application Ser. No. 12/133,827, filed Jun. 5, 2008 which claims the benefit of U.S. Provisional Application Nos. 60/924,918, filed Jun. 5, 2007; 60/935,625 filed Aug. 22, 2007; and 60/996,760 filed Dec. 4, 2007.

[0003] This application also claims the benefit of U.S. Provisional Application No. 61/243,295 filed on Sep. 17, 2009. The content of all of the above applications is incorporated herein by reference.

[0004] The invention relates to an instrument insertion device and an instrument access system incorporating the instrument insertion device.

[0005] According to the invention there is provided an instrument access device comprising:

• • [0006] a proximal member for location externally of an opening into a body cavity;
  • [0007] a first instrument receiver for receiving an instrument; and
  • [0008] a second instrument receiver for receiving an instrument.

[0009] In one embodiment the device comprises a first connector extending between the proximal member and the first instrument receiver. There may be a second connector extending between the proximal member and the first instrument receiver.

[0010] In one embodiment at least one of the connectors is substantially rigid.

[0011] In one case a joint between at least one of the connectors and the proximal member which facilitates movement of the connector relative to the proximal member.

[0012] The joint may facilitate pivotal or swivelling movement of the connector.

[0013] In one case the joint is substantially a universal joint.

[0014] In one embodiment the device comprises a formation between the connector and the proximal member to facilitate relative movement between the connector and the proximal member. The formation may comprise a groove.

[0015] In another embodiment the device comprises a spacer for location between the proximal member and the outside of a wound opening. The spacer may be flexible. The spacer may be of flexible material. The spacer may comprise a pad which may comprise foam, rubber, or the like.

[0016] In one aspect of the invention there is provided an instrument access device comprising a proximal member for location externally of an opening into a body cavity, a first instrument receiver for receiving an instrument, a second instrument receiver for receiving an instrument, a proximal mounting for location outside of a wound opening, the proximal member being releasably mounted to the proximal mounting and a flexible spacer for location between the proximal mounting and the outside of a wound opening.

[0017] In one embodiment at least one of the connectors comprises an instrument seal.

[0018] In another embodiment the device comprises a flexible cannula extending from at least one of the connectors. The flexible cannula may be attached to the connector.

[0019] The cannula may be movable relative to the connector. For example, the cannula may be slidable relative to the connector.

[0020] In another embodiment the device comprises a third instrument receiver for receiving an instrument and a third connector extending between the proximal member and the first instrument receiver.

[0021] In a further embodiment the device comprises a port such as an opening in the proximal member which is sized to receive a small instrument or a tube. The opening may be a diameter of from 1 to 5 mm, typically from 2 to 4 mm.

[0022] In one case the opening has a valve means. There may be a cap for the opening.

[0023] In another embodiment at least one of the connectors has an associated seal or valve. The seal may comprise a first valve and a second valve distal of the first valve.

[0024] In one case the first valve comprises a lip-seal valve.

[0025] The second valve may comprise at least two cusps such as a duckbill valve.

[0026] In one case the lipseal is provided in a lipseal housing and the second valve is provided in a second seal housing. The lipseal housing may be movable relative to the second seal housing. The lip seal housing may comprise a cap for the second seal housing. In one case the lipseal housing is removable from the second seal housing. The lipseal housing may be releasably connected to the second seal housing. The lipseal housing may be connected to the second seal housing by a hinge connection such as a strap. The lipseal housing may comprise a reducer cap.

[0027] In one embodiment the device comprises a distal anchoring member for location within a wound interior; and a retractor member extending proximally from the distal anchoring member to retract laterally the sides of a wound opening.

[0028] The retractor member may extend at least between the distal anchoring member and the proximal member. The retractor member may extend in two layers between the distal anchoring member and the proximal member.

[0029] In one case a first end portion of the retractor member is fixed to the proximal member.

[0030] The retractor member may be movable relative to the distal anchoring member. A second end portion of the retractor member may be movable relative to the proximal member.

[0031] In one embodiment the retractor member extends distally from the proximal member to the distal anchoring member, is looped around the distal anchoring member, and extends proximally from the distal anchoring member to the proximal member.

[0032] The proximal member may comprise an inner part and an outer part. The retractor member may extend between the inner part and the outer part.

[0033] In one embodiment the device comprises a mounting member for mounting to the proximal member. The mounting member may be releasably mounted to the proximal member. The mounting member may be mounted to the proximal member in an interference fit arrangement. The mounting member may be mounted to the proximal member in a snap-fit arrangement.

[0034] In one case the device comprises a clamp to clamp the mounting member to the proximal member.

[0035] It will be appreciated that features described with reference to one embodiment of the invention may be utilised with any of the other embodiments.

[0074] Referring to the drawings and initially to FIGS. 1 and 2 there is illustrated an instrument access device 1 according to the invention which in this case comprises three instrument insertion sealing devices according to the invention. The access device 1 comprises a first instrument insertion device 2, a second instrument insertion device 3, and a third instrument insertion device 4. The access device in this case also has two insufflation/desufflation ports 6, 7.

[0075] The insertion device 2 comprises a lipseal 10 through which an instrument 11 is insertable and a second seal member 12 having a passageway extending therethrough, through which the instrument 11 is insertable. The first insertion device 2 also has a reducer cap 15 which has a further lipseal 16 which is smaller than the lipseal 10. To insert large diameter instruments, the cap 15 is removed. To insert smaller diameter instruments the cap 15 is in place.

[0076] Referring to FIGS. 27 and 28 the second seal member 12 may comprise a duckbill valve through which the instrument 11 passes. The duckbill valve 12 provides sealing engagement with the instrument shaft whilst accommodating lateral movement of the instrument as illustrated.

[0077] Alternatively, as illustrated in FIGS. 25 and 26 the second valve may comprise a multicusp valve such as a tricuspid valve 50. In another case as illustrated in FIGS. 29 and 30 the second valve may comprise a foam or gel.

[0078] The lipseal valve 10 is located proximally of the duckbill valve 12 so that a double seal is provided to substantially prevent leakage of insufflation gas.

[0079] The lipseal 10 may be of any suitable material. For example it may be of an elastomeric material, a foam—type material or a gelatinous material. The duckbill valve 12 may be of any suitable material. For example, it may be of a flexible polymeric material.

[0080] The second and third instrument insertion devices 3, 4 may be of the same or different construction as that of the first instrument insertion device 2.

[0081] The instrument access device of the invention is suitable for use during laparoscopic surgery to facilitate instrument access to an insufflated abdominal cavity while maintaining pneumoperitoneum.

[0082] The instrument access device of the invention comprises a first connector 20 for connecting the first instrument insertion device 2 to a connector base 25, a second connector 21 for connecting the second instrument insertion device 3 to the base 25, and a third connector 22 for connecting the third instrument insertion device 4 to the base 25.

[0083] The base 25 is mounted to a proximal ring assembly 26 of a retractor which includes a sleeve 27 which may extend in two layers between a distal anchoring ring (not shown) and the proximal ring assembly 26. One such retractor is described in our US 2005-0090717A, the entire contents of which are incorporated herein by reference. The base 25 has a tab 29 to aid dismounting of the base member 25 from the retractor. A pull ring 30 may be used to aid release of the retractor.

[0084] The instrument insertion devices 2, 3, 4 are arranged in sealing relationship to a body of a patient, in use. The instrument seals 2, 3, 4 are spaced proximally of the proximal ring assembly 26.

[0085] The connectors 20, 21, 22 connect the proximal ring assembly 26 to the instrument seals 2, 3, 4. The connectors 20, 21, 22 may be integral with the connector base 25 and the seals 2, 3, 4 subsequently attached, for ease of manufacture. In addition, instrument seals 2, 3, 4 can be housed in relatively rigid housings for added strength whilst maintaining connector flexibility.

[0086] In use, a wound opening is created in a tissue wall, and the distal anchoring ring is inserted through the wound opening into the wound interior. The proximal ring assembly 26 is located externally of the wound opening, with the retractor member extending proximally from the distal anchoring member through the wound opening. The second end of the retractor member is pulled proximally relative to the proximal ring assembly 26 to retract laterally the sides of the wound opening. Instruments may then be inserted through the instrument seals 2, 3, 4, extended through the connectors 20, 21, 22, and extended through the retracted wound opening and into the wound interior.

[0087] Referring especially to FIGS. 1 to 6 in this case the connectors 20, 21, 22 are of a substantially rigid material to aid stability as instruments are inserted and withdrawn.

[0088] In the embodiment of FIGS. 1 and 2 the valve assemblies 2, 3, 4 are fixed to their connectors 20, 21, 22 and at least some of the connectors have internal extended flexible cannulae 60, 61 which can be manipulated for ease of positioning of an instrument. One of the connectors may have a more rigid cannula 62 to guide some types of instruments.

[0089] In the case of the devices of FIGS. 1 and 2 one or more of the cannulae 60, 61, 62 may be fixed at the proximal end. Alternatively, as illustrated in FIGS. 3 and 4 one or more and in the case illustrated all of the cannulae 60, 61, 62 are slidably movable relative to the connectors 20, 21, 22.

[0090] Referring now to FIGS. 5 and 6 in this case cannulae 70, 71, 72 extend from the connectors 20, 21, 22 and the proximal seals are provided at the proximal ends of the cannulae 70, 71, 72. One or more of the cannulae 70, 71, 72 may be at least partially flexible. Indeed some or all of the cannulae may be rigid.

[0091] Referring especially to FIGS. 7 to 12 a joint between at least one and in this case all of the connectors 20, 21, 22 and the proximal member 25 facilitates movement of the connector(s) relative to the member 25. Referring to FIGS. 7 and 8 in one case the joint comprises a groove 80 or area of reduced thickness to accommodate pivotal or swivelling movement. The arrangement may have an integral bias to return the connector to one position (FIGS. 7, 8(a)). FIGS. 10(a) and 10(b) illustrate a joint 85 which is similar to that of FIGS. 8(a) and 8(b). Alternatively, the joint may comprise a flexible extension leg 87 to facilitate flexible movement.

[0092] Referring to FIGS. 11 and 12 in this case there is a ball and socket type joint 90 between the connector and the proximal member 25 to facilitate movement in many directions.

[0093] Referring to FIGS. 13 to 15 in one case there is a spacer 100, for example comprising a pad of flexible material such as foam or rubber which is interposed between the proximal ring assembly 26 and the body outside the wound opening. The pad 100 is sufficiently flexible to allow swivelling or pivotal movement of the device in situ to provide even a greater freedom of movement. In addition, because the proximal ring assembly 26 is spaced away from the body the retractor sleeve 27 can be more easily manipulated and does not become trapped at the proximal end. The pad 100 may also assist in reducing trauma and bruising during surgery.

[0094] FIGS. 18 and 19 illustrate the use of the tab 29 in demounting the instrument access device from the retractor base, the base 25 being detached from the proximal ring assembly 26.

[0095] Referring now to FIGS. 19 to 22 there is illustrated another instrument access device which in this case has a port or hole 110 to facilitate insertion of a small instrument 111 or tube 112. The port 110 has closure cap 113. In this case the port 110 is provided in the proximal member 25. The port has a relatively small diameter, typically 3 to 5 mm and can be used to allow escape of smoke which may be generated during the procedure such as a cauterisation procedure. The tube 112 may have a luer connector 115 at the proximal end which may be attached to a vacuum/suction source. The tube may also be used for blood removal and/or irrigation/cleaning. The port 110 can also be used for desufflation and/or insufflation.

[0096] Referring to FIGS. 31 to 35 there is illustrated another instrument access device 200 according to the invention which is similar to the devices described above and like parts are assigned the same reference numerals. In this case the access device comprises a first instrument insertion device 201, a second instrument insertion device 202, a third instrument insertion device 203, and a fourth instrument insertion device 204. The first instrument insertion device 201 can accommodate an instrument of up to 10 mm diameter and has a reducer cap 15 which, when closed, converts the insertion device to accommodate an instrument of up to 5 mm diameter. The second, third and fourth instrument insertion devices 202, 203, 204 can all accommodate instruments of up to 5 mm diameter.

[0097] The device 200 of FIGS. 31 to 35 is particularly suitable for use in a method of performing a laproscopic surgical procedure as described in our US2009/0036745A, the entire contents of which are incorporated herein by reference. The three instrument insertion devices 202, 203, 204 extend in a direction towards a surgeon performing the procedure. The pull tab 29 can be used as a reference in this aspect, pointing away from the surgeon. The arrangement of the insertion devices is ergonomically efficient as the surgeon can readily manipulate tissue retraction and camera instruments inserted through the devices 202, 203, 204. The larger device 204 points away from the surgeon as it may be used only occasionally during the procedure, for example in removing dissected tissue. In this way the available space is optimised. One example of a procedure using the device of FIGS. 31 to 35 is a cholecystectomy.

[0098] Referring to FIGS. 36 to 40 there is illustrated another instrument access device 250 according to the invention which is similar to the devices described above and like parts are assigned the same reference numerals. In this case the access device comprises first, second and third instrument insertion devices 251, 252, 253 respectively. The first instrument insertion device 251 can accommodate an instrument of up to 10 mm diameter and has a reducer cap 15 which, when closed, can convert to accommodate an instrument of up to 5 mm diameter. The second and third instrument insertion devices 252, 253 can all accommodate instruments of up to 5 mm diameter.

[0099] The device 250 of FIGS. 36 to 40 is particularly suitable for use in surgical procedures which require the use of larger diameter instruments such as a morcellator (which is used for example in gynecological procedures such as uterus removal), or instruments for tissue specimen removal, gastric banding, endocath bag delivery (which are used for larger organs such as a kidney. Larger organs/tissue specimens can be removed by detaching the access device from the retractor base.

[0100] In the case of the access devices of FIGS. 31 to 40 an incision of typically 10 to 25 mm in length is made. The devices allow procedures to be carried out laparoscopically which would not otherwise be possible through such a small incision.

[0101] Referring to FIGS. 41 to 45 there is illustrated another instrument access device 300 according to the invention which is similar to the devices described above and like parts are assigned the same reference numerals. In this case the access device comprises first, second, third, fourth and fifth instrument insertion devices 301, 302, 303, 304, 305 respectively. The first instrument insertion device 301 can accommodate instruments of up to 10 mm diameter. The device 301 has a reducer cap 15 which, when closed, can convert to accommodate an instrument of up to 5 mm diameter. The second instrument insertion device 302 can accommodate instruments of up to 15 mm diameter. The device 302 has a reducer cap 15 which, when closed, can convert to accommodate an instrument of up to 5 mm diameter. The third instrument insertion device 303 can accommodate instruments of up to 12 mm diameter. The device 303 has a reducer cap 15 which, when closed, can convert to accommodate an instrument of up to 5 mm diameter. The fourth and fifth instrument insertion devices 304, 305 can accommodate instruments of up to 5 mm diameter.

[0102] The device 300 of FIGS. 41 to 48 is particularly suitable for use in complex procedures which require multiple instruments. One such procedure is Nissen fundiplication which is a surgical procedure used to treat gastroesophageal reflux disease (GERD). In the case of the device of FIGS. 41 to 48 an incision of typically 20 to 60 mm in length is made. The device allows complex procedures to be carried out laproscopically which would not otherwise be possible.

[0103] A base part of the access device of FIGS. 41 to 45 is illustrated in FIGS. 46 to 48. The valves/seals have been omitted in these drawings. The connector or receiver leg parts of the instrument insertion devices 301, 302, 303, 304, 305 are assigned the reference numerals 311, 312, 313, 314, 315 respectively. Access holes 316, 317 for the insufflation/desufflation ports 6, 7 are also illustrated. The base part is of a relatively flexible material and in this case is reinforced by a reinforcing ring 320 of a more rigid material. The reinforcing ring 320 is embedded in the base using overmoulding.

[0104] The instrument insertion devices may be coded such as by indicia or colour coding to indicate a particular instrument size that may be used with a particular device size. For example, the colour blue may be used to indicate use with an instrument of up to 5 mm in size, white for up to 10 mm instruments, grey for up to 12 mm instruments, and orange for up to 15 mm instruments.

[0105] It will be appreciated that features described with reference to one embodiment of the invention may be utilised with any of the other embodiments.

[0106] The invention is not limited to the embodiments hereinbefore described which may be varied in detail.