JP2010142655A

Surgical access apparatus

Abstract

Problem to be solved.To provide a surgical access device having a novel configuration. A surgical access device for use during a surgical procedure to provide access to the body, the device for defining a longitudinal axis and being placed outside the body. It comprises an access component having a proximal end and a distal end for extension to the inside of the body. This access component has holes sized to allow the passage of objects through it. The seal 204 is placed in the hole of this access component. This seal comprises textile and elastic materials and defines an internal path 222 sized to form a substantial seal associated with the object inserted through it. [Selection diagram] Fig. 3

JP2010142655A, drawing sheet 1 — Sheet 1 of 17

Term

Projected expiry 25 January 2030.

1 claim: 1 independent, 0 dependent

1
体内へのアクセスを提供するための外科手術用アクセス装置であって、該装置は、以下:長手軸を規定し、体の外側に配置されるための近位端および体の内側に伸長するための遠位端を有するアクセス部材であって、該アクセス部材は、それを通じて物体の通過を可能とするような大きさの穴を有する、アクセス部材;ならびに該アクセス部材の該穴内に配置されるシールであって、該シールは、織物材料およびエラストマー材料を備え、該シールは、それを通じて挿入される物体に関連する実質的なシールを形成するような大きさの内部経路を規定する、シール、を含む、外科手術用アクセス装置。

80 paragraphs, as filed

(Citation of related application) This application claims the priority interests of U.S. Patent Provisional Application No. 60 / 540,421 (filed January 30, 2004) and U.S. Patent Provisional Application No. 60 / 466,005 (filed April 25, 2003). All content of is incorporated herein by reference.

(background) (1. Disclosure field) The present disclosure relates to surgical devices, and more particularly to surgical access devices for use during minimally invasive surgical procedures. The present disclosure further relates to a novel seal assembly for forming a seal around a surgical subject while adapting to the angular manipulation of the surgical subject.

(2. Explanation of related technologies) Minimally invasive surgical procedures, including both endoscopic and laparoscopic procedures, allow surgery to be performed on organs, tissues, and blood vessels far from openings in the tissue. To do. Endoscopic and laparoscopic procedures generally require that any instrument inserted into the body be sealed. That is, for example, in a surgical procedure in which gas is blown into the area of surgery, preparations must be made to ensure that the gas does not enter or leave the body through the incision. These procedures typically use surgical instruments that are introduced into the body through a cannula. The cannula has a housing at its proximal end to which the seal assembly is mounted. This seal assembly provides a substantially fluid-tight seal around this instrument, preserving the integrity of established pneumoperitoneum. This housing extends over the patient's body when the cannula is inserted into the incision, reducing the effective length of the instrument inserted through the cannula and potentially impeding mobility around the surgical site.

The minimally invasive procedure has several advantages over traditional open surgery. These benefits include reduced patient trauma, shorter recovery times, and reduced potential for infection. However, minimally invasive surgery (eg, laparoscopy) has some disadvantages, despite its recent success as a preferred surgical technique and its overall acceptance. In particular, maintaining a seal around a surgical instrument in a cannula can be difficult in certain procedures (eg, in procedures that require extensive operation of elongated endoscopic instruments within a remote site). Proven. In addition, many conventional seal assemblies are not adapted to adapt to instruments of various sizes, while still maintaining the seal around the inserted instrument. Furthermore, known seal assemblies are relatively complex, increasing the length of the housing in which this assembly is confined. As a result, maneuverability on the surgical site and the effective length of the instrument are unfavorably affected.

(wrap up) Accordingly, the present disclosure relates to an access device for use to provide access to the interior of the body during a surgical procedure. The access device includes an access component that defines a longitudinal axis and has a proximal end for being located outside the body and a distal end for extending inside the body. This access component has holes through which it is sized to allow the passage of objects. The seal is placed in the hole of the access component. This seal defines an internal path that includes woven and elastomeric materials and is sized to form a substantial sealing relationship with the object inserted through it. Preferably, the woven material comprises a reticulated woven material, which is generally elongated and extends along the longitudinal axis of the access component. This reticulated woven material can be a tubular reticulated woven material. The seal may include an outer surface containing an elastomeric material that is at least partially located on the outer surface. This outer surface is substantially impermeable to the passage of injected gas. This seal includes an inner surface containing a reticulated woven material that is at least partially placed on the inner surface for fitting with the appliance. The seal can be substantially impermeable to the passage of injectable gas along the substantial length of the seal. Alternatively, the seal may include a porous section adjacent to one end thereof to allow the infusion gas to pass through. The seal is provided within the access component and may define an external path between the seal and the access component. The seal may be secured to the access component in a first position along its longitudinal axis and fixed to the access component in a second position along the longitudinal axis distal to the first position. obtain. This access component may include a channel extending distally in the first position for introduction of the infused gas into the external pathway. The porous section of this seal is adjacent to a second position and allows the injectable gas to pass between the inner and outer paths of the seal. In one embodiment, the seal comprises a compressed region that is expandable to fit into an object in a substantially fluid-tight relationship with the seal. The elastomeric material is immersed in the mesh fabric material of the seal. In another embodiment, the seal comprises a first end and a second end. The first end of the seal is fixed to the access component at a first position along its longitudinal axis. The second end of this seal is adapted for axial movement in response to the movement of the object into the seal's internal path. Preferably, the seal comprises a seal base that is adapted for longitudinal movement with the second end of the seal that is secured to the seal base. In another embodiment, the cannula assembly used in the surgical procedure is disclosed. This cannula assembly defines a longitudinal axis and has a cannula component with longitudinal holes for passage of surgical instruments, with the cannula housing connected to the proximal end of the cannula component. A cannula housing that defines an opening for receiving the device (its openings and holes communicate with each other), and a seal component provided within the cannula component to form a substantial seal with the appliance. Including. This seal component includes a woven material that includes multiple systems and elastomeric materials. This woven material has an elongated shape and a predetermined shape that extends along the longitudinal axis prior to insertion of the instrument. This woven material has a proximal end, a distal end, and an inclined portion in between. This sloping section defines the path for acceptance of the device and is trimmed to form a substantial seal with the device. This woven material includes expandable woven fabrics and is trimmed for expansion during the fitting of the appliance. The elastomeric material is placed adjacent to at least a central portion of the seal component. This central part is adapted to expand upon acceptance of the device. This woven material can have a tubular shape and can be reticulated. This woven material may include a plurality of monofilament systems and a plurality of multifilament systems. The seal component includes an outer surface containing an elastomeric material that is at least partially disposed on the outer surface. This outer surface is substantially impermeable to the passage of injected gas. This seal component includes an inner surface that includes a woven material that is at least partially placed on the inner surface for fitting with the appliance. This elastomeric material can be immersed in the woven material of the seal components. The seal component may include a first end and a second end, the first end of which is secured to the cannula component at a first position along the longitudinal axis. This second end is adapted for axial motion in response to the passage of the instrument through the seal constituent material. The cannula assembly may further include a seal base adapted for longitudinal movement, whereby the second end of the seal component is secured to the seal base. In another preferred embodiment, a surgical access device for providing access to the inside of the body defines a longitudinal axis and has a proximal end for being located outside the body and inside the body. Coaxially within the passage of the access component having an extension to and a distal end for a longitudinal path extended through it, and an access component for defining an external path between the access component and the elongated seal. Includes an elongated seal mounted on top. This seal comprises a woven and elastomeric material and has a longitudinal path for acceptance of the object through it in a substantially sealed relationship with the object. At least one of the access components and the elongated seal defines a port that allows delivery of injectable gas between the external path and the longitudinal path of the seal. This access component may include a gas injection port that allows the passage of injected gas from an external source to an external path, and may define a gas injection port and a channel that communicates with the external path. This elongated seal contains an elastomeric material that is substantially impermeable to the passage of injectable gas. This elongated seal may have a distal end portion lacking an elastomeric material, allowing the infusion gas to pass through the woven material between the external path and the longitudinal path of the seal. This elongated seal may include an expandable fabric that is trimmed for expansion during fitting of the device. The seal component may have a compressed shape for fitting the instrument in the area around the center of this elongated seal. This elongated seal may contain an elastomeric material, at least in its center. This elongated seal may be secured to the inner surface of the access component in a first position along the longitudinal axis. This elongated seal may be secured to the inner surface of the access component in order to form an external path between the elongated seal and the access component in a second position located far from the first position. This port is defined in the access component and is located far from the first location to allow the injectable gas to be expelled from the external path. This elongated seal may define a tubular shape. This elongated seal defines the internal path of the elongated seal, and upon insertion of the device through the internal path, the device is arranged to extend the internal path and form a substantial seal with this path, compression. Has a shaped shape. The access device may also include a zero-closure seal that is attached in connection with the cannula component and is adapted for closure in the absence of equipment. In another alternative embodiment, the surgical access device defines a longitudinal axis as well as proximal and distal ends, through which a path sized to allow passage of an object. Includes access components that have, as well as elongated seals that are placed within the path of the access components. This elongated seal has a proximal end fixed within the access component and a distal end provided for axial movement within the access component. This distal end is movable to a retracted position, allowing the path of the elongated seal to extend to adapt the object in a substantially fluid-tight relationship with the object. Preferably, the elongated seal comprises a woven fabric and can be a tubular reticulated woven fabric. The seal base can be attached to the distal end of the elongated seal and can move between the expanded and retracted positions. In another preferred embodiment, a woven material for sealing is disclosed. This woven material includes a plurality of systems of tubular blades having a polymeric material. Preferably, the tubular blade has a system of between about 48 and about 196, a plurality of monofilament systems with diameters between about 0.001 inch and about 0.007 inch, and about 75 and about 300. Selected from the group consisting of multiple multifilament systems with denier between. This polymeric material is selected from the group consisting of polypropylene, nylon, Teflon®, polyethylene terephthalate (PET) and polyarylether-etherketone (PEEK). In another preferred embodiment, a seal comprising an elastomeric material and a woven material is disclosed. This woven material includes multiple systems of tubular blades. These systems include polymeric materials. This tubular blade has a system of between about 48 and about 196, multiple monofilament systems with diameters between about 0.001 and about 0.007 inches, and between about 75 and about 300. It is selected from the group consisting of a plurality of multifilament systems having denier. Preferably, the seal has a resistance between about 0 lbs and about 10 lbs and a leak rate between about 0 cc / min and about 270 cc / min. This elastomeric material can have a durometer between about 10 shore A and about 80 shore A, and the thickness of the elastomeric material is between about 0.003 inches and about 0.015 inches, about 0 and about. Can have a coverage factor between 1. This seal has a system density for free space between about 10% and about 70%, a compressed area with lengths between about 0.1 and about 2.0 inches, about 0 ° and about 90. It has a blade angle between °, an initial seal diameter between about 3 mm and about 10 mm, and a maximum seal diameter between about 5 mm and about 18 mm. This elastomeric material is polyurethane, polyisoprene, silicone, MonpreneTM, SantopreneTMAnd other thermoplastic elastomers (TPE) can be selected from the group. Preferably, the seal has a diameter between about 4 mm and about 15 mm. This seal can have a minimum diameter and a maximum diameter, whereby the maximum diameter is between about 3 and 5 times the minimum diameter. Methods for gaining access to surgical sites within the body are also disclosed. More specifically, the present invention may relate to the following items. (Item 1)A surgical access device for providing access to the body, the above device being:An access member that defines a longitudinal axis and has a proximal end for placement outside the body and a distal end for extension inside the body, through which the access member allows the passage of an object. Accessory members with holes sized toA seal placed in the hole of the access member, the seal comprising a woven material and an elastomer material, the seal being large enough to form a substantial seal associated with an object inserted through it. Seal, which defines the internal path of theAccess devices for surgery, including. (Item 2)The surgical access device according to item 1, wherein the woven material includes a blade woven material. (Item 3)The surgical access device according to item 2, wherein the seal is generally extended so as to extend along the longitudinal axis of the access member. (Item 4)The surgical access device according to item 3, wherein the blade woven material includes a tubular blade woven material. (Item 5)The surgical access device according to item 1, wherein the seal comprises an outer surface, the elastomeric material is at least partially disposed on the outer surface, and the outer surface is substantially impervious to the injected gas. Access device for surgery. (Item 6)The surgical access device of item 5, wherein the seal comprises an inner surface and the blade fabric material is at least partially disposed on the inner surface to engage the instrument. apparatus. (Item 7)The surgical access device according to item 5, wherein the seal substantially does not allow infused gas to pass along a substantial length of the seal. (Item 8)The surgical access device according to item 7, wherein the seal comprises a perforated section adjacent to one end thereof to allow passage of the injected gas. (Item 9)The surgical access device according to item 8, wherein the seal is installed in the access member to define an external route between the seal and the access member. .. (Item 10)The surgical access device according to item 9, wherein the seal is fixed to the access member at a first position along the longitudinal axis. (Item 11)The surgical access device according to item 10, wherein the seal is fixed to the access member at a second position along a longitudinal axis distal to the first position. apparatus. (Item 12)The surgical access device according to item 11, wherein the access member comprises a channel extending distally from the first position for introduction of an injectable gas into the external pathway. apparatus. (Item 13)The second item of the surgical access device of item 12, wherein the perforated section of the seal allows the infusion gas to pass between the internal and external pathways of the seal. Surgical access device adjacent to the location. (Item 14)The surgical access device of item 3, wherein the seal comprises a compression portion, the compression portion engaging with the object in an expandable, substantially fluid-free relationship. Surgical access device. (Item 15)The surgical access device according to item 3, wherein the elastomer material is impregnated into the blade woven material of the seal. (Item 16)The surgical access device according to item 3, wherein the seal comprises a first end and a second end, the first end having the access at a first position along the longitudinal axis. A surgical access device that is secured to the device and the second end of which is adapted for axial movement in response to the passage of the object through the internal path of the seal. (Item 17)The surgical access device according to item 16, further comprising a seal base adapted for longitudinal movement, the second end of the seal being fixed to the seal base. (Item 18)The surgical access device according to item 2, wherein the blade woven material comprises a plurality of monofilament strands and a plurality of multifilament strands. (Item 19)The surgical access device according to item 1, wherein the seal has a diameter between about 4.5 mm and about 15 mm. (Item 20)The surgical access device according to item 1, wherein the seal has a minimum diameter and a maximum diameter, and the maximum diameter is about 3 times and 5 times larger than the minimum diameter. Surgical access device (Item 21)A cannula assembly for use in surgical procedures, the cannula assembly being described below:a) A cannula component that defines the longitudinal axis, wherein the cannula component defines a longitudinal hole for passage of surgical instruments through it;b) Cannula housing, which defines an opening for receiving the instrument, the cannula housing is coupled to the proximal end of the cannula component so that the opening and the hole communicate with each other. , Cannula housing;c) A seal component that is mounted within the cannula component to form a substantial seal with the instrument, wherein the seal component comprises a woven material, which is a plurality of strands and elastomers. Seal components, including materials,Cannula assembly. (Item 22)The cannula assembly according to item 21, wherein the woven material has an elongated shape extending along the longitudinal axis, and the woven material has a predetermined shape prior to insertion of the device. A cannula assembly in which the woven material has a proximal end, a distal end and a slope portion between them. (Item 23)The cannula assembly according to item 22, wherein the slope portion limits the path for receiving the instrument and the slope portion is arranged to form a substantial seal with them. (Item 24)The cannula assembly according to item 23, wherein the woven material comprises an expandable woven fabric and is arranged to expand when engaged with the appliance. (Item 25)The cannula assembly according to item 21, wherein the elastomeric material is placed adjacent to at least a central portion of the seal component. (Item 26)The cannula assembly according to item 25, wherein the central portion is adapted to expand upon receiving the instrument. (Item 27)The cannula assembly according to item 24, wherein the woven material has a tubular shape. (Item 28)The cannula assembly according to item 21, wherein the woven material comprises a blade woven material. (Item 29)28. The cannula assembly according to item 28, wherein the woven material comprises a plurality of monofilament strands and a plurality of multifilament strands. (Item 30)The cannula according to item 21, wherein the seal component comprises an outer surface, the elastomeric material is at least partially disposed on the outer surface, and the outer surface is substantially impervious to the injected gas. assembly. (Item 31)The cannula assembly according to item 30, wherein the seal component comprises an inner surface and the textile material is at least partially disposed on the inner surface for engagement with the instrument. (Item 32)The cannula assembly according to item 31, wherein the elastomeric material is impregnated in the woven material of the seal component. (Item 33)The cannula assembly according to item 24, wherein the seal component comprises a first end and a second end, the first end being the cannula configuration at a first position along the longitudinal axis. A cannula assembly that is secured to a member and the second end is adapted for axial movement as the instrument passes through the seal component. (Item 34)The cannula assembly according to item 33, further comprising a seal base adapted for longitudinal axis motion, wherein the second end of the seal component is fixed to the seal base. (Item 35)34. The cannula assembly according to item 34, wherein the seal component has a perforated section adjacent to the second end to allow passage of an infusion gas. (Item 36)A surgical access device for providing access to the body, the above device being:An access member that defines a longitudinal axis and has a proximal end for placement outside the body and a distal end for extension inside the body, said access member having a longitudinal path extending through it. Have access members;An elongated seal coaxially attached within the path of the access member, limiting an external path between the access member and the elongated seal, the seal comprising a woven material and an elastomeric material, and the seal An elongated seal, with a longitudinal path for receiving objects through it, in a substantially sealed relationship;The access member and the elongated seal, the at least one access member and the elongated seal, defining a port to allow communication of an injectable gas between the external path and the longitudinal path of the seal. ,A surgical access device. (Item 37)Item 36. The access device according to item 36, wherein the access member includes an injection port to allow the passage of an injection gas from an external source to the external path. (Item 38)The access device according to item 37, wherein the access member defines a channel for connecting the injection port and the external route. (Item 39)The access device according to item 36, wherein the elongated seal comprises an elastomeric material, wherein the elastomeric material is substantially impervious to the injected gas. (Item 40)39. The access device of item 39, wherein the elongated seal comprises a distal end portion lacking the elastomeric material and of an injectable gas passing through the woven material between the external path and the longitudinal path of the seal. An access device that allows passage. (Item 41)36. The access device of item 36, wherein the elongated seal comprises an expandable fabric and is arranged to engage as the device is extended. (Item 42)36. The access device of item 36, wherein the seal component has a compressed shape for engaging the device in a region around the center of the elongated seal. (Item 43)The access device according to item 36, wherein the elongated seal comprises an elastomeric material at least in the center thereof. (Item 44)The access device according to item 36, wherein the elongated seal is fixed to the inner surface of the access member at a first position along the longitudinal axis. (Item 45)The access device according to item 44, wherein the elongated seal is fixed to the inner surface of the access member at a second position located distal to the first position, and the elongated seal and the access member. An access device that forms the above-mentioned external route between and. (Item 46)The access device of item 45, wherein the port is limited to the access member and is located distal to the first position to allow the infusion gas to be released from the external pathway. apparatus. (Item 47)The access device according to item 45, wherein the elongated seal defines a tubular shape. (Item 48)The access device according to item 39, wherein the elastomeric material is combined with the textile material to be bonded, and at least some textile material is exposed to the inner surface of the elongated seal. (Item 49)The access device according to item 36, wherein the elongated seal having a compressed shape defines an internal path of the elongated seal, and when the device is inserted through the internal path, the device is substantially the same. An access device that is aligned to form a seal and extend the internal path. (Item 50)36. The access device of item 36, further comprising a zero closure seal attached to the cannula component, a zero closure valve adapted to close in the absence of the device. (Item 51)The access device according to item 36, wherein the woven material comprises a plurality of monofilament strands and a plurality of multifilament strands. (Item 52)An access device for surgery, the above access device for surgery is as follows:An access member that defines the longitudinal axis and the proximal and distal ends, wherein the access member has a path through it that has a passage and is sized to allow passage of an object through it. Parts; as wellAn elongated seal disposed within the path of the access member, wherein the elongated seal is attached to the proximal end fixed within the access member and distally attached for axial movement within the access member. The distal end can be moved to a contraction position with an end to allow the path of the elongated seal to be extended to accommodate the object in a substantially fluid-free relationship. There is an elongated sticker,A surgical access device. (Item 53)The surgical access device according to item 52, wherein the elongated seal comprises a woven fabric. (Item 54)The surgical access device according to item 52, wherein the elongated seal comprises a tubular blade fabric. (Item 55)52. The surgical access device of item 52, comprising a seal base, wherein the seal base is attached to the distal end of the elongated seal and is movable between an extension position and a contraction position. Surgical access device. (Item 56)A woven material for sealing, wherein the woven material comprises a plurality of strands of tubular blades, said strands comprising a polymeric material, said said tubular blades having strands between about 48 and about 196. And the above strands are below:a) Multiple monofilament strands, the plurality of monofilament strands having diameters between about 0.001 inch and about 0.007 inch (about 0.00254 cm and about 0.0178 cm), and multiple multifilament strands. Has multiple monofilament strands with denier between about 75 and about 300; andb) Multiple monofilament strands, with diameters between about 0.001 inch and about 0.007 inch (about 0.00254 cm and about 0.0178 cm).Strands selected from the group consisting ofA woven material that comprises. (Item 57)The woven material according to item 56, wherein the polymeric material comprises the group consisting of polypropylene, nylon, Teflon®, polyethylene terephthalate (PET) and polyarylether-etherketone (PEEK). The textile material of choice. (Item 58)A seal having an elastomeric material and a woven material with a plurality of strands of tubular blades, said strands comprising a polymeric material, said tubular blade having strands between about 48 strands and about 196, said strands. Has a diameter between about 0.001 inch and about 0.007 inch (about 0.00254 cm and about 0.0178 cm), and multiple multifilament strands have a denier between about 75 and about 300, sticker. (Item 59)The seal of item 58, the seal having drag between about 0 lbs and about 10 lbs (about 0 grams and about 4536 grams) and leakage between about 0 cc / min and about 270 cc / min. A seal with a rate. (Item 60)The seal according to item 59, wherein the elastomeric material is a durometer between about 10 shore A and about 80 shore A, about 0.003 inch and about 0.015 inch (about 0.00762 cm and about 0.0381 cm). It has a thickness of elastomeric material between, and a covering factor between about 0 and about 1, where the seal has a strand density for free space between about 10% and about 70%, about 0.1 inches. And a compression part with a length between about 2.0 inches (about 0.254 cm and about 0.508 cm), a blade angle between about 0 ° and about 90 °, an initial between about 3 mm and about 10 mm A seal with a seal diameter and a maximum seal diameter between about 5 mm and about 18 mm. (Item 61)The seal according to item 58, wherein the elastomeric material is polyurethane, polyisoprene, silicone, Monprene.TM, SantopreneTMA seal selected from the group consisting of, and other thermoplastic elastomers (TPE). (Item 62)The seal according to item 58, wherein the seal has a diameter between about 4 mm and about 15 mm. (Item 63)The seal according to item 58, wherein the seal has a minimum diameter and a maximum diameter, and the maximum diameter is larger than about 3 times and about 5 times the minimum diameter. (Item 64)A method of gaining access to a surgical site in the body, the above method:a) A step of introducing an access device into the incision, wherein the access device has a seal having a textile material and an elastomeric material placed in the holes of the access member;b) Introductory steps, including the step of placing access members and seals through the incision;c) The process of introducing the device into the body through the above seal,Including, methods. (Item 65)The method according to item 64, wherein the step of introducing the device includes the step of expanding the seal. (Item 66)The method of item 65, wherein the seal extends from a minimum diameter to a larger maximum diameter between about 3 and about 5 times the minimum diameter.

Preferred embodiments of the present disclosure are better understood by reference to the drawings below.<figref num="1">FIG. 1 is a perspective view of an access device according to an embodiment of the present disclosure.</figref><figref num="2">FIG. 2 is a second perspective view of an access device according to the embodiment of FIG. 1 having a cross-sectional portion showing the inside of the cannula.</figref><figref num="3">FIG. 3 is a cross-sectional view of the side surface of the access device according to the embodiments of FIGS. 1 and 2.</figref><figref num="4">FIG. 4A is an enlarged cross-sectional view having a removed portion of the access device according to the embodiments of FIGS. 1 to 3. FIG. 4B is an enlarged cross-sectional view showing the components of the seal connection in the cannula according to the embodiments of FIGS. 1-4A.</figref><figref num="5">FIG. 5 is a side view of the seal assembly of the access device according to the embodiments of FIGS. 1 to 4B.</figref><figref num="6">FIG. 6 is an enlarged separation view in the cross section of FIG. 5, and details the components of the seal of the access device according to the embodiments of FIGS. 1 to 5.</figref><figref num="7">FIG. 7 is a chart showing a preferred range of various design parameters for forming a seal for an access device according to the embodiments of FIGS. 1-6.</figref><figref num="8">FIG. 8 is a schematic side view of a mandrel used in a preferred process to form a seal according to the embodiments of FIGS. 1-6.</figref><figref num="9">FIG. 9 is a schematic plan view of the mold used in the preferred process to form the seal according to the embodiments of FIGS. 1-6.</figref><figref num="10">FIG. 10 is a cross-sectional view of an access device according to a further embodiment of the present disclosure.</figref><figref num="11">FIG. 11 is a cross-sectional view of an access device according to a further embodiment of the present disclosure.</figref><figref num="12">FIG. 12 is a side sectional view of an access device according to another embodiment of the present disclosure.</figref><figref num="13">FIG. 13 is a side view of the seal assembly of the access device according to the embodiment of FIG.</figref><figref num="14">FIG. 14 is an enlarged separation view of the sealed assembly according to the embodiments of FIGS. 12 and 13 in cross section of the area to be compressed.</figref><figref num="15">FIG. 15 is a side sectional view of another embodiment of the access device of the present disclosure.</figref><figref num="16">FIG. 16 is a cross-sectional view of a side surface of an access component of an access device according to the embodiment of FIG.</figref>

(Detailed description of preferred embodiments) The access device of the present disclosure provides a substantial seal between the patient's body cavity and external air during insertion of an object through this device. In addition, the access devices of the present disclosure can accommodate objects of varying diameter (eg, instruments of about 4.5 mm to about 15 mm or more) and, when inserted, use each instrument to provide a gastight seal. .. This flexibility of this access device greatly facilitates endoscopic surgery, which often requires different instruments of different diameters during a single surgical procedure.

This device comprises a seal assembly. The seal assembly is inserted through the trocar and / or cannula assembly while maintaining a substantial fluid sealing interface around instruments that maintain air integrity in the surgical procedure from gas and / or fluid leaks. Allows the introduction and operation of various types of instruments adapted for. Specifically, the seal assembly provides off-axis manipulation of the surgical instrument, as well as angular manipulation of the surgical instrument associated with the seal axis. This feature of the present disclosure preferably minimizes the inflow and outflow of gas and / or fluid into and / or out of the body cavity. Examples of instruments include clip appliers, traps, anatomists, retractors, staplers, laser probes, photographic devices, endoscopes and laparoscopes, tubes and the like. Such instruments are collectively referred to herein as "instruments or instruments".

The access device may also be adapted to receive and form a seal around the physician's arm or hand during the hand-based laparoscopic procedure.

With reference to the figures here, in these figures, parts with similar reference numbers are the same or substantially similar over several figures, and FIGS. 1 to 6 are access according to the embodiments of the present disclosure. The device will be described. For exemplary purposes, this access device is described for a cannula assembly that is adapted for introduction intraperitoneally, typically utilizing a trocar, during a laparoscopic surgical procedure. However, this access device is suitable within any device (eg, catheter, trocar assembly, etc.) suitable for the introduction and passage of surgical objects into the intrinsic tissue through an incision or through an innate body opening. It is recognized that it can be an endoscopic portal, a hand access device, etc.).

The cannula assembly 100 is described here with reference to FIGS. 3, 4A and 4B in conjunction with FIGS. 1 to 2. The cannula assembly 100 comprises a generally tubular component similar to a conventional cannula that is suitable for the intended purpose of accessing the body cavity and allows the introduction of instruments through it. The cannula assembly 100 is specifically adapted for use in laparoscopic surgery. Here, this abdominal cavity is a suitable gas (eg, CO).2) Is injected, resulting in a cavity wall from the internal organs there. The cannula assembly 100 is typically used with a closure assembly (eg, a sharp-tipped trocar), which is an elongated instrument located within the cannula assembly 100. In FIG. 2, it is shown that the closure 1000 is partially introduced into the cannula assembly 100. The closure assembly 1000 can have sharp, smooth, or tapered ends for separating or expanding tissue, such as being utilized to pass through abdominal tissue and intraperitoneally. Facilitates the introduction of the cannula assembly 100. Once access to the abdominal cavity is achieved, the closure assembly 1000 is removed from the cannula assembly 100, allowing the introduction of surgical instruments used to perform this procedure.

In one preferred embodiment, the access device (ie, cannula assembly 100) includes a cannula sleeve 102 having a proximal end 101 and a distal end 103, and a cannula housing 104 attached to the proximal end 101 of the sleeve 102. The cannula sleeve 102 defines a longitudinal axis "a" that extends along the length of the sleeve 102. The sleeve 102 further defines an internal longitudinal path 106 that is sized to allow passage of surgical instruments. The sleeve 102 incorporates a sleeve flange 108 (FIG. 3) that is integrally formed at the proximal end 101. The sleeve 102 can be a work piece of stainless alloy or another suitable rigid material (eg, a polymeric material). The sleeve 102 can be transparent or opaque. The diameter of the sleeve 102 can vary, but is typically in the range of 5 mm to 15 mm. The sleeve flange 108 has a seal support 202 that is either completely formed with the sleeve flange 108 or attached to the sleeve flange 108. The sleeve flange 108 further includes at least one outer peripheral groove or outer peripheral slot 110 within its outer surface. The outer slot 110 mates or collaborates with the cannula housing 104 and the corresponding structure to secure the cannula sleeve 102 and the cannula housing 104.

As best shown in FIGS. 3, 4A and 4B, the cannula housing 104 is connected to the sleeve flange 108 of the cannula sleeve 102. In one preferred embodiment, this connection is achieved through ultrasonic welding, adhesives, bonding agents and the like. Alternatively, the cannula housing 104 and the sleeve flange 108 can be connected through a bionette, screw-in or snap-fit coupling, eg, the retaining 116 of the cannula housing 104 that is received within slot 110 of the sleeve flange 108. To capture. The O-ring 118 is preferably located between the bearing surface 120 inside the cannula housing 104 and the bearing surface 122 outside the sleeve flange 108, and the cannula housing 104 and sleeve flange 108 during use in the laparoscopic procedure. Minimize gas leakage between and.

The valve support 114 is provided between the cannula housing 104 and the sleeve flange 108. The support 114 includes an inner column 124 and an outer collar 126 that are coaxially arranged around the inner column 124. The valve support 114 has a distal end 113 and a proximal end 115. The outer collar 126 is provided to the inner surface of the sleeve flange 108 and may be fixed there using an adhesive, adhesive, or the like. As best shown in FIG. 4A, this O-ring 118 is located between the outer collar 126, the cannula housing 104 and the ancillary leg 127 of the sleeve flange 108. The elastic valve 128 is supported within the valve support 114. The elastic valve 128 includes an outer peripheral ledge 130 fitted by the proximal end 115 of the inner column 124, is secured to the inner planar surface 132 of the main housing 104, and the elastic valve 128 is supported inside the inner column 124. .. The valve 128 can be in the shape of a common duck beak and defines an internal slit 134 that opens to allow passage of the object and closes in the absence of the object. This valve 128 is the desired zero closure valve or slit seal and is adapted to close in the absence of surgical objects, thereby blocking the passage of infused gas through the cannula assembly 100. Alternatively, the valve 128 can be a flat disc-shaped valve, a balloon valve, a flapper valve, a conical valve, and the like. In one preferred embodiment, valve 128 is a U.S. patent application number 10/165, by the same applicant. A fibrous seal disclosed in 133 (filed June 6, 2002, which is incorporated herein by reference in its entirety). The seal disclosed in the '133 application can be a flat bulkhead seal with a first layer of elastic material and a second fiber layer paralleled in relation to the first layer. Still further, the valve 128 is preferably a fibrous seal and is trimmed as desired to have a region to be compressed. The fibers are preferably constructed of a material that forms a compression or closure. The seal can also be molded with an elastic material to have a compression section. Other arrangements for valve 128 are also envisioned.

Desirably, the cannula housing 104 includes a port 136 for connecting a stopcock to the cannula housing 104, as best shown in FIG. This stopcock leads to an external source of injectable gas for introducing the injectable gas into the patient's body cavity through the cannula sleeve 102. The port 136 communicates with a channel 138 defined adjacent to the inside of the sleeve flange 108 of the cannula sleeve 102 (FIGS. 3, 4A and 4B). Channel 138 is open to longitudinal path 106 of cannula sleeve 102.

Here, the seal assembly 200 of the cannula assembly 100 is discussed in detail with reference to FIGS. 3 to 6 together with FIGS. 1 to 2. The seal assembly 200 comprises an elongated seal 204 extending from the seal support 202. As best shown in FIGS. 4A and 4B, the seal support 202 has an internal opening 205 and an external trough 206 defined between walls 208, 210 extending inside and above the seal support 202. It is a general annular component having (Fig. 4B). The distal end 113 of the valve support 114 is shaped to be received in the external trough 206. The proximal end of the elongated seal 204 is located between the external trough 206 and the distal end 113 of the valve support 114 and is provided with the seal 204 as discussed and discussed. Alternatively, or in addition, the seal 204 may be glued or adhered to the seal support 202 and / or the sleeve flange 108. The seal support 202 is located within the internal boundary of the sleeve flange 108 of the cannula sleeve 102 when in the assembly conditions of the device. The seal support 202 may include a separation portion attached to the cannula sleeve 102 or sleeve flange 108, or a portion formed integrally with the sleeve flange 108 or cannula sleeve 102. In either case, the seal support 202 is preferably placed to allow the flow of injected gas through channel 138.

The elongated seal 204 contains an elastomeric material, a fibrous material, and / or a combination of these materials. The fibrous material may include fibrous materials, woven fabrics, knit materials, non-woven fabrics. In a preferred embodiment, the elongated seal 204 incorporates the tubular reticulated fiber material 212, as best shown in FIGS. 5-6. This tubular blade fiber is a strand of polyethylene, polypropylene, polyethylene, nylon, polyamide, polyglycolic acid, polyethylene terephthalate (PET), glycolide-lactide copolymer, polyaryl ether-ether ketone and / or these strands. Can include combinations. Metal strands (eg, stainless alloys, MP35N, nitinol and / or Titanium) can also be used to form fibrous materials. As used herein, the terms "strand", "yarn" or end include both monofilament and multifilament.

A variant of the tubular blade is envisioned. The tubular blades are of various blade types with a number of strands (also called "yarn ends" or "ends"), blade angles, strand diameters, and denier, selected according to the desired characteristics of the textile material. Can be mentioned. The tubular braided woven material for the seal preferably has a strand, comprising a polymeric material and having strands between about 48 and about 196. This strand is preferably a plurality of monofilament strands having a diameter between about 0.001 and about 0.007 inches, and a plurality of multifilament strands having a denier between about 75 and about 300.

Examples of preferred alternatives to braided textile materials are listed below: 1) 144 braided strands with 72 strands containing 0.003 inch PET (polyethylene terephthalate) monofilaments and 72 strands containing 100 denier PET multifilaments.

2) 144 braided strands with 72 strands containing 0.005 inch PET monofilaments and 72 strands containing 100 denier PET multifilaments.

3) 144 braided strands of 0.003 inch PET or PEEK monofilament In the embodiments shown in FIGS. 1-6, the elongated seal 204 comprises a composite structure that incorporates the tubular blade 212 and the elastomeric material 214. The elastomer is attached to the outer surface of the blade, formed on it, or otherwise applied, and preferably extends approximately the entire length of the tubular blade. Processes intended for imparting elastomers include spraying, dipping, injection molding, compression molding and extrusion processes, including simultaneous extrusion, drawing molding, corrugated molding, such as with reduced pressure or pressure. Preferably, the elastomer is formed such that the elastomer impregnates the fabric of the tubular blade, leaving at least one portion of the fabric strand exposed to the inner surface of the blade 212. The elastomeric material 214 may include polyurethane, polyisoprene, or any suitable elastomer or elastic material. Other suitable elastomeric materials include polyurethane, silicone, polyisoprene, momprene, sanoprene, thermoplastic elastomers (TPE), material rubbers and any suitable material.

In one preferred embodiment of the elongated seal 204, the woven material comprises a tubular blade having 144 strands of 0.003 inch PEEK molded with polyisoprene. The polyisoprene alone had a coefficient of friction of about 0.9, while the composite structure had a coefficient of friction of about 0.16.

Further, with respect to FIGS. 3-6, one preferred embodiment of the elongated seal 204 is shown. The elongated seal 204 defines a seal shaft "b", which coincides with the shaft "a" of the cannula assembly 100. The elongated seal 204 is a tubular blade 212, which extends to the length of the seal 204 above, and an elastomeric material that is attached to, formed on, or otherwise attached to the tubular blade 212. Take in 214 and. The elongated seal 204 further comprises a cannula tip 216 secured to the distal end of the elongated seal 204. In a preferred embodiment, the cannula tip 216 is glued directly to the elongated seal 204 or is formed during the molding process. Desirably, the elongated seal 204 has a degree of play in the longitudinal direction. It can be installed inside the cannula sleeve 102 with slack). Upon insertion of the instrument through the elongated seal 204 and radial expansion of the tubular blade 212, the elongated seal 204 shrinks in the longitudinal direction. The attachment of the elongated seal 204 with play eliminates excessive strain on the elongated seal 204 and facilitates expansion of the elongated seal 204.

The elongated seal 204 is slightly curved or circular bow that is inclined inward from the proximal end of the elongated seal 204 to the center 220 and then outwardly from the center 220 to the distal end of the elongated seal 204. Prescribe a state profile. This slanted, constricted form is produced during the manufacture of tubular blades and elastomer assemblies. The tubular blade 212 and / or the elastomeric material 214 may be formed in a curved shape and then joined to each other. Alternatively, the curved shape can be formed in the process of joining tubular blades and elastomers of constant diameter.

In the embodiments shown in FIGS. 1-6, the seal 204 has a circular concave shape (ie, a curve with one radius). In other embodiments, curves with more than one radius may be used. The geometry and shape of this elongated seal 204 affects sealing, tearing and pushing forces. In general, shorter seal lengths reduce the chance of tearing and provide lower insertion force. The shape of the elongated seal 204 should balance sufficient sealing with a pushing force. The elongated seal 204 is aligned so that the seal area around the center 220 is positioned to engage the instrument. The shape of the elongated seal 204 and the position of engagement with the instrument define the approach angle of the tip of the instrument with respect to the seal 204. An approach angle approaching 0 ° (ie, the tangent to the surface of the seal) reduces tearing and pushing force. Longer morphologies, gradually tapered morphologies, circular concave morphologies, or hyperbolic morphologies are preferred, because such morphologies result in lower approach angles and reduce tearing and pushing forces. Is. The fibrous material, the elastomeric material, or both are preferably preformed into a constricted shape or an hourglass shape. Preferably, the seal 204 has an elongated shape that the blade 212 naturally takes under tension. This is because it facilitates the manufacturing process.

The novel alignment of the elongated seal 204 has many advantages. The elongated seal 204 seals around the instrument inserted into the passage 106. The seal 204 is located in the passage 106 of the cannula sleeve 102 and not in the cannula housing 104, whereby the cannula housing 104 has a lower profile. The lower profile of this cannula housing 104 efficiently extends to the useful length of the instrument inserted within the cannula assembly 100.

In addition, it is preferable to minimize the drag of the seal on the instrument so as to facilitate the operation of the instrument through the cannula assembly 100. The seal 204 preferably contains a woven material and is aligned to facilitate insertion of the instrument. Preferably, the woven material engages the instrument upon insertion. In embodiments that incorporate a composite of an elastomeric material and a woven fabric, the elastomeric material is preferably, at least partially, impregnated into the woven fabric material, whereby the seal 204 is on its outer surface and is largely elastomeric. It is a material, and on its inner surface, most have woven strands. The seal 204 may be entirely an elastomeric material on its outer surface and may be predominantly a woven fiber on its inner surface. The woven strands engage the instrument upon insertion to minimize contact with the elastomeric material. Contact with the elastomeric material tends to increase the frictional force with the instrument. However, it is contemplated that the elastomeric material can be formed on the inner surface of the elongated seal 204. In certain embodiments, lubricants, dressings and / or other materials may be used to reduce friction.

Even when the woven strands are exposed on the inner surface of the seal 204, the composite structure of certain preferred embodiments also reduces the tendency of the instrument to catch the woven strands. Without relying on any particular theory of operation, the elastomeric material holds the strands in place, reducing the tendency of the instrument to catch the strands.

The elongated tubular shape of the seal 204 in certain preferred embodiments engages the device along the longitudinal axis "b" of the seal 204, increasing the contact area with the device and improving sealing. .. The woven material provides sufficient elasticity to seal an instrument of a predetermined size. This woven material can be aligned to provide good sealing characteristics in the absence of any elastomeric material. The elastomeric material of certain preferred embodiments further provides sealing and resilience to the seal 204.

The elongated seal 204 defines an internal passage 222 within the passage 106 of the cannula sleeve 102, which opens towards the underlying body cavity to allow passage of the instrument. When the device is inserted, the textile and elastomeric materials described above expand to pass through the device while establishing a sealed relationship with the object. In the absence of the instrument, the seal 204 returns to the normal constricted form of the seal 204 under the influence of the elasticity of the elastomer 204 and the textile material.

The elongated seal 204 is coaxially aligned within the cannula sleeve 102 to define an outer passage 224 between the elongated seal 204 and the inner surface of the cannula sleeve 102. This outer passage 224 communicates with channel 138 and port 136. The elongated seal 204 further defines the gap 226 (FIG. 4), or the portion adjacent to the cannula tip 216 lacking this elastomer. This gap 226 allows the passage of inhaled gas between the outer and inner passages 224 of the elongated seal 204. The inhaled gas is introduced from the port 136 through the channel 138, through the outer passage 224, through the gap 226 into the body cavity, and expands this body cavity. Alternatively, or in addition, the gap 226 allows the inspiratory gas to pass from the outer passage 224 to the inner passage 222 and from the inner passage 222 to the outer passage 224 so that the pressures at the two locations are substantially the same to provide the seal. Adjust to instruments of various sizes. The gap 226 may be provided during the molding process or may be the result of a removal step in which the elastomer is removed after molding to define the gap 226. The gap 226 can be made by drilling or forming slits in the outer elastomeric material 214. It is further envisioned that the cannula sleeve 102 may provide an opening in the outer wall of the cannula sleeve 102 in contact with the outer passage 224 to allow the passage of gas through the abdominal cavity. This feature is discussed in detail below herein.

The suction pressure can enhance the sealing capacity of the elongated seal 204 by allowing the inspiratory gas to pass through the outer passage 224 between the elongated seal 204 and the cannula sleeve 102. When this feature is utilized, thin-walled woven materials and lower Durometer elastomeric materials are preferred. As an alternative to the gap 226, one or more slits can be formed in the elongated seal 204 and are aligned to open only when exposed to a given pressure to inflate the seal. As another alternative, the elongated seal 204 lacks an opening (s) so that the outer passage 224 constricts the inner passage 222 of the elongated seal 204 and seals between the instruments to be inserted. Inflated to form. In this alternative, the inhaled gas is cannulated with the seal 204 without inflating the seal by providing a gas release structure (eg, through the gap 226 above or in the form of an opening in the wall of the cannula sleeve 102). Can be introduced between the sleeve 102.

In certain preferred embodiments, the access device comprises a fixation device at the distal end of the cannula sleeve. This fixed device is preferably disclosed in a particular embodiment of US Pat. No. 5,232,451, or in a particular embodiment of US Provisional Application No. 60 / 512,389 (filed October 17, 2003). Anchors are provided (both of these disclosures are incorporated herein by reference). In the alternative, balloon anchors according to a particular embodiment of U.S. Pat. No. 5,697,946 or 5,468,248 (both of which are incorporated herein by reference) are used. Can be done.

The access device according to the disclosure of the present invention is specific for features such as skin seals or anchors (eg, International Application No. WO 02/096307 (this disclosure is incorporated herein by reference)). (Discussed in embodiments) can be further incorporated. This access device may be used with an easily expandable sleeve as disclosed in specific embodiments of US Pat. Nos. 5,431,676 and 5,183,464 (these disclosures are incorporated by reference). In a further embodiment, the cannula sleeve is threaded onto this outer surface, or as disclosed in a particular embodiment of US Pat. No. 6,224,608, the disclosure of which is incorporated herein by reference. , Can be provided with fabric on this outer surface. The cannula housing may specify other structures for use as loops, flanges, or suture anchors. Those skilled in the art will appreciate that all these features are within this disclosure.

In one preferred process of manufacture, the tubular braided woven material 212 comprises multiple monofilaments and, for example, multifilament polyethylene terephthalate (PET) fibers braided on a braiding machine to form a nearly tubular shape. Prescribe. Braiders for forming the tubular braided woven material are commercially available. For example, a Steeger machine made by Steeger can be used (Koerting Nachf. Wilhelm Steeger in). Germany). Preferably, the tubular blade is formed in a tubular shape, which defines a diameter close to the maximum diameter of the elongated seal 204 in use. The tubular braided woven material 212 is then placed over the mandrel or pin, which extends the mandrel or pin throughout the interior of the tubular blade 212. The mandrel has a shape that, in its final state, closely matches the internal passage 222 of the elongated seal 204, as shown in FIG. 5 (ie, the shape of this mandrel generally has the desired final result shown in FIG. Corresponds to the tubular blade 212). FIG. 8 shows a suitable mandrel 300 that forms the desired hourglass shape. The tubular blade 212 is installed under tension to match the blade to the shape of the mandrel. The shaped or tilted tubular blade 212 then undergoes a molding process to impart an elastomeric material 214 on at least the outer surface of the tubular blade 212. This preferred molding process is achieved, for example, via an injection molding process or a compression molding process. FIG. 9 illustrates the lower half of the mold 400 used to apply the elastomeric material. The mold 400 defines a mold cavity 402 that corresponds to the general arrangement of the tubular blade 212 (virtually shown) and preferably receives the blade 212 along with the mandrel 300. The mold 400 receives an elastomeric material, providing a slight clearance 404 around the perimeter of the cavity 402. The upper half of the mold 400 is equal to the lower half shown in FIG.

In one preferred injection molding process, the shaped or tilted tubular blade 212 and mandrel described above have a shape that generally corresponds to the shaped blade 212, as discussed above herein. Positioned in the part. The molten elastomer is injected into the mold around the tubular blade 212. Upon curing, the elastomeric coating 214 binds to the outer surface of the blade 212. As will be appreciated, the molten elastomer can move into the gaps of the blade 212 and completely impregnate the blade 212. However, this preferred process prevents complete contact of the molten elastomer with the inner surface of the tubular blade 212. This is preferably achieved by applying sufficient tension to the tubular blade 212 to increase contact with the mandrel, thereby reducing the diameter of the blade 212 (which is the blade). (Increases the density of the elastomer) to minimize the transfer of elastomer to the inner surface of the tubular blade 212. At least one portion of the strand of the tubular blade is exposed to the inner surface of the tubular blade 212. Lubricating coatings can be applied to the inner surface of this tubular blade to further reduce the insertion force. Lubricating dressings containing hydrogels and medical fluids can be used. Preferred materials for injection molding include thermoplastic elastomers (TPE). Any suitable elastomer can be used.

Alternatively, a compression molding process can be utilized to form the elastomeric material 214. Following one preferred process, the tubular blade 212 and mandrel 300 described above are placed in a compression mold (eg, mold 400 in FIG. 9) having a mold cavity that matches the desired shape for the tubular blade 212. Heat and pressure are then applied so that the molten elastomer is compressed within the tubular blade 212 to cover at least the outer surface of the tubular blade 212 and impregnate the gaps in the braided woven material. .. Pressure can be applied using mechanical pressure and / or decompression. Preferably, complete communication of the molten elastomer to the inner surface of the tubular blade 212 is avoided and these advantages are discussed above herein. Any suitable elastomer can be used. One preferred elastomer for compression molding is polyisoprene.

It is envisioned that during either the injection molding process or the compression molding process, the cannula tip 216 can be positioned within the mold and secured to the tubular blade 212 throughout the overmolding process. It is also assumed that the cannula tip 216 is formed by injection molding on the blade 212 when the elastomer is injected or continuously before and after the elastomer is injected. .. In addition, the cavity 402 of the mold 400 may include space for the elastomeric material to be built up, forming an elastomeric feature on the seal assembly 200. The tubular blade 212 preferably extends beyond the end of this mold to clamp and / or pull the tubular blade 212.

Again, with respect to FIGS. 3-6, the proximal end of the elongated seal 204 has a peripheral flange 218. The flange 218 is monolithically formed from the elastomeric material 214, for example, during an injection molding process or a compression molding process. The perimeter flange 218 is received within the trough 206 of the seal support 202 and may be secured within the trough 206 by the use of an adhesive, adhesive or the like. As discussed above in the specification, the distal end 113 of the column 124 inside the valve support 114 engages the flange 218 and along the proximal end of the woven material 212, trough 206. By fixing the flange 218 inside, the peripheral flange 218 is fixed inside the seal support 202.

In yet another preferred method, the tubular blade 212 may be immersed in a pool of elastomeric material. A preferred elastomer is urethane. The urethane is carried to the inner surface of the tubular blade 212, and forms a urethane layer on the inner surface of the tubular blade 212. The tubular blade 212 is then flipped so that the elastomeric material is largely disposed outside the tubular blade 212. The tubular blade 212 is installed along the length of the tubular blade 212 under tension to form a constricted shape, forming the blade and applying heat to the assembly. The assembly is cured with a constant tension to define the desired bent form of the elongated seal 204.

Alternatively, according to another process, the elastomeric jackets can be formed separately in the desired, slanted or tapered form and then glued to or otherwise attached to the outer surface of the tubular blade 212. Combined to provide the desired tapered morphology to the tubular blade 212.

In another embodiment, the tubular blade 212 may comprise either monofilament fibers or a combination of monofilament fibers and multifilament fibers, which are wrapped in strands such as elastomer strands.

Regardless of the above process used, the elastomeric material 214 serves as an additional barrier to inhaled gas. The elastomeric material 214 also provides the additional elasticity of the elongated seal 204. The blade extends upon receiving the instrument to form a fluid-tight seal against the instrument, and the blade returns to its initial narrowed alignment following removal of the instrument. The elastomeric material 214 also extends upon receiving the instrument and returns to its original narrowed alignment upon removal of the instrument.

It is further contemplated that the elastomeric material may be applied to cover the inner surface of the tubular blade 212 in addition to the elastomeric material 214 on the outer surface of the blade 212. Preferably, the inner layer has a relatively high durometer to minimize resistance to the inserted instrument, while the outer layer preferably has a relatively low durometer. The inner layer may incorporate protrusions to fill any gap between the elongated seal 204 and the inserted instrument. The inner and outer elastomeric materials can be formed using injection molding, extrusion or co-extrusion processes, injection imprinting and compression molding.

As discussed herein, the tubular fabric 212 can also be formed by the weaving process. This woven fabric is initially woven into a tube-like structure by "warp threads" running in the long axis direction of the seal and "weft threads" running in the opposite direction. At least the weft in the center of the seal contains a LYCRA (registered trademark of IUDuPont and Nemours Company) strands. This LYCRA strand forms a constricted structure for this seal. This LYCRA helps to facilitate the establishment of a seal around the appliance and controls the puckering of the fabric, which can cause leaks. Weaving of various materials is contemplated, including 80 denier PET, 20 denier PET, etc., where the entire weft is composed entirely of LYCRA or less than the entire weft is composed of LYCRA. Some strands of PTFE or polypropylene can be mixed between various other longitudinal warp threads to reduce friction and facilitate the passage of equipment through the woven seal. Further planned. Due to their respective properties, PTFE and polypropylene have low frictional characteristics. Desirably, the seal comprises a woven woven material and an elastomeric material. The woven fabric may further include folds defined within the tubular fabric. This fold may tend to eliminate the gap and other pathways between the elongated seal 204 and the surgical instrument.

Other alignment and manufacturing methods for the elongated seal 204 are also envisioned. Some exemplary alignment and manufacturing processes for woven materials are discussed below.

(Example of braiding) (1) The spool winds up 72 spools of unlubricated, clear 0.003 inch polyester (PET) monofilament with a winding device (eg, a Fletcher spool winder). This winding device should be properly stretched. 72 warp threads of 100 denier PET without lubricant / sizing treatment and PET of 100 denier (36 warp threads have high interweaving) are wound up with a total of 144 warp threads. The low tension spring system is then loaded with both sets of 72 spools of the 144 carrier machine. The spools are stacked in a manner that creates a woven fabric with alternating monofilament and multifilament warp threads. The blades are manufactured without mandrel with a pick count of 28 picks per inch. "Picks per inch" is defined herein as the number of intersections between warp threads per inch of fabric. This yields 144 warp tubes with a diameter of approximately 3-4 mm with 70% coverage. The tube is then impregnated with a polymer to create a composite seal structure using any of the methods discussed above. This composite tube has the ability to stretch 400-500% in the radial direction. The length of the braided tube is reduced by 15-20 when the original diameter is stretched to 500%.

(2) The spool winds up 72 spools of clear 0.03 inch Teflon® (PTFE) without spool lubricant. 72 warp threads of 100 denier PET without lubricant / sizing treatment and PET of 100 denier (36 warp threads have high interweaving) are wound with a total of 144 warp threads. The low tension spring system is then loaded with both sets of 72 spools of the 144 carrier machine. The spools are stacked in a manner that creates a woven fabric with alternating monofilament and multifilament warp threads. The blades are manufactured without mandrel with a pick count of 28 picks per inch. This yields 144 warp tubes with a diameter of approximately 3-4 mm with 70% coverage. The tube is then impregnated with polymer to create a composite seal structure (using any method discussed above). This composite tube has the ability to stretch 400-500% in the radial direction. The length of the braided tube is reduced by 15-20 when the original diameter is stretched to 500%. The PTFE monofilament produces an internal surface with low drag against the seal so as to reduce force indentation.

(3) The spool winds up 144 spools of clear, unlubricated 0.003 inch polyester (PET). The low tension spring system is then loaded with both sets of 144 spools of the 144 carrier machine. The blades are manufactured without mandrel with a pick count of 29 picks per inch. This yields 144 warp tubes with a diameter of approximately 3-4 mm with 60% coverage. The tube is then impregnated with polymer to create a composite seal structure (using any method discussed above). This composite tube has the ability to stretch 400-500% in the radial direction. The length of the braided tube is reduced by 15-20 when the original diameter is stretched to 500%. This 100% monofilament blade has higher abrasion resistance and is less prone to tearing due to the increased stiffness of the monofilament added to the fabric.

(Example of weaving) (1) A narrow woven loom is set up with 200 denier PTFE filaments with a warp density of 50 threads per inch in the warp direction. This loom is configured to weave a continuous tube. Weave 40 denier spandex weft yarn in the fabric with a constant weft density of 150 picks per inch. By manipulating the weft yarn tension, the woven tube "force" or squeezing force can be selectively adjusted.

(2) A narrow woven loom is set up with 200 denier PTFE filaments with a warp density of 50 threads per inch in the warp direction. This loom is configured to weave a continuous tube. Weave 80 denier spandex weft yarn in the fabric with a constant weft density of 60 picks per inch. This weft yarn tension can be manipulated to change the "force" or squeezing force of the woven tube.

(3) A narrow woven loom is set up with 200 denier PTFE filaments with a warp density of 50 threads per inch in the warp direction. This loom is configured to weave a continuous tube. Weave 40 denier spandex weft yarn in the fabric with a variable filling density of 50-150 picks per inch. This weft yarn tension can be manipulated to change the woven tube "force" or squeezing force for a given controlled woven length.

(Four) A narrow woven loom is set up with 200 denier PTFE filaments with a warp density of 50 ends per inch in the warp direction. This loom is configured to weave a continuous tube. Weave 40 denier spandex weft yarn in the fabric with a constant weft density of 150 picks per inch. The diameter of this tube can be adjusted by varying the warp density. Longer, lower density fabrics can be smaller in diameter, then reduce weft yarn tension and reduce force.

(Example of knit) (1) A 1-inch head circular knitting machine from Lamb Knitting Corporation with 36 stitches per inch was set to knit tubes using 200 denier polyester yarn. The higher the needle density, the denser the fabric. Higher density fabrics tend to resist piercing and tearing. Knit fabrics are more physically flexible than blades. The knit construction is an elastic reinforcing material that can adapt to the seal shape and tensile openings if it is required to allow the tool to pass through this tube.

(2) A 1-inch head Lamb circular knitting machine with 36 stitches per inch was set to knit tubes using 200 denier Teflon® yarn. The higher the needle density, the denser the fabric. Higher density fabrics tend to resist piercing and tearing. Push the tool with reduced Teflon (registered trademark) through the drag.

(3) The warp knitting machine of the double needle bar was set to knit the tube. This warp knitting machine has 28 stitches per bar and PET 200D yarn. Higher needle densities result in higher density tube fabrics. This warp knitting structure is an elastic reinforcing material that can be adapted to the seal shape and tension openings required to allow the tool to pass through the tube.

In the use of this device (eg, in laparoscopic surgery), the underlying body cavity (eg, the abdominal cavity) is known to enlarge the body cavity and in it to separate the abdominal wall from the underlying organs. Inhaled. With the obstructor 1000 positioned therein, the cannula assembly 100 is advanced into the abdominal tissue and punctures the abdominal wall. The obstructor 1000 is removed, but the cannula assembly 100 is left in the incision. The surgical instrument is advanced into the cannula assembly 100, opens the valve 128, and enters the internal passage 222 of the elongated seal 204. The device is advanced by engaging the elongated seal 204 with the device and extends outward to form a fluid-tight seal around the outer surface of the device. This device is utilized to carry out the desired procedure. The configuration of the elongated seal 204 allows the seal to move in relation to the axis "a". Because this instrument is operated during surgery. As discussed below in connection with FIGS. 10 and 11, the area of the seal 204 that engages with the device is larger for devices with larger diameters compared to devices with smaller diameters. During the above procedure, the inhaled gas is introduced through the outer passage 224. This gas passes through the gap 226 of the elongated seal 204 and enters the body cavity to maintain inhalation of this body cavity. This inhaled gas also passes through the gap 226 of the elongated seal 204 from the outer passage 224 to the inner passage 222 and from the inner passage 212 to the outer passage 224 as the instrument is taken in and out, and the outer passage of the elongated seal 204. Make the pressure between 224 and the internal passage 222 substantially the same.

The present disclosure considers changes to the structure of this seal. For example, the woven material of this elongated seal can be constructed from any suitable woven structure. The woven material of the elongated seal 204 has a suitable snag resistance, a suitable seal, and produces a moderate pushing force (pushing force) when inserting and removing the instrument. In this property, the woven material has certain properties that act on tear resistance, sealing and indentation forces, material coefficients, strand (also known as yarn) size and type, density, power, and The outer shape of the woven structure can be mentioned.

As discussed in more detail herein below, the elongated seal 204 is arranged in a compressed shape (eg, an annular concave shape, a double curved shape, or a drum shape), resulting in one of the seals. The portion engages with the instrument as it is inserted into this seal. This woven structure is preferably selected so that the strands extend significantly along the longitudinal axis of the elongated seal 204 to reduce tearing. Since these textile materials have lower permeability and larger sealing around the fixture, a textile structure with a winding fluid path should be selected.

The fabric is preferably formed from a plurality of polymer strands that are compatible with instruments that are inserted without pocketing. The strands for this fabric can be metal (eg, stainless steel, MP25N, nitinol and / or titanium). Pocketing is the formation of indentations in a fabric when engaged by an instrument, which tends to cause larger tears in the fabric. A material with a lower modulus of elasticity is desirable because of its larger sealing properties, but a material with a higher modulus is desirable because of its lower indentation force and lower tearing. The strands of this fabric preferably have a coefficient greater than or equal to 700,000 PSI due to acceptable pocketing and tearing. The smaller the size of the strands that form the fabric, the greater sealing and lower indentation force was achieved. However, multifilament strands greater than 100 denier and monofilament strands larger than 0.003 inch in diameter are desired for acceptable tear resistance.

A woven fabric that is tighter and has a higher cover is desirable. Tighter or dense fabrics have lower transmission (cc / cm ^)2/ Minutes). Higher density fabrics produce a stronger, better sealing structure with less tearing. Higher density, tighter fabrics have smaller holes and prevent tearing, while more meshed fabrics allow the instrument to "poke through" these holes and tears. A more denser fabric is formed from more strands. Materials with higher fabric densities produce less indentation force as this instrument tends to slide on the strand surface. This is surprising because greater friction than usual results in greater surface contact.

Preferably, when the instrument is inserted and the seal is extended to its maximum size, the density of this fabric is greater than 48 strands per inch (also known as "ends per inch"). , Smaller than 200 strands. The number of ends per inch is measured around the entire circumference of the fabric. If the number of ends per square inch is too large, this compressed or drum-shaped shape can be formed without packer ring, which tends to cause leakage. To increase the density of this fabric, a larger number of smaller yarns may be used, while improving the fabric's ability to form compressed or drum-shaped shapes. However, multifilament strands greater than 100 denier and monofilament strands larger than 0.003 inch in diameter are desirable for acceptable tear resistance.

The fabric preferably has sufficient "power" to create an effective seal without increasing the indentation force and tearing to unacceptable levels. "Power" defines the level of "pushing force (squeeze force)" of the seal applied to the instrument inserted into the seal. If the power level of the fabric is high, this seal pushes out this device with greater force. Higher power improves the sealing around this device.

The woven material may consist of multifilament strands, monofilament strands, or a combination of multifilament strands and monofilament strands. cc / cm ^2When defined by / min, the permeability of this woven material is lower for multifilament woven fabrics than for monofilament. Multifilament strands create high resistance to fluid and greater sealing, while monofilaments create less resistance to fluid and leak more. Monofilaments have greater resistance to tearing when compared to multifilaments.

Runners can be used in textile structures (eg, knits, fabrics, blades) to extend in the axial direction of the seal and reduce the length of the seal. Runners greatly improve tear resistance. The runner preferably comprises a higher coefficient monofilament of, for example, polypropylene, PEEK, polyester, nylon or other suitable material. This runner also adds radial stiffness to the fabric structure. This stiffness reduces pocketing and tearing. The runner increases the strand surface engaged by the instrument and then reduces the indentation force.

This elongated seal is preferably formed from a composite structure of a woven material and an elastic material (preferably including an elastomeric material). This elastomeric material may be composed of any suitable material. This elastomeric material is used to cover and shape the "zones" of the seal. The fabric of the elastomer material 214 and the tubular blade 212 forms a composite structure. The sum of the components (ie, textile and elastomeric materials) defines the final seal outline, creates power for sealing, and has a significant effect of pushing force and tear resistance. This elastomeric material preserves the tubular woven structure and facilitates reducing the chance of tearing.

Elastomer materials with higher durometers (units of hardness) above 70 Shore A tend to produce better seals. The adhesive surface properties decrease as creep is reduced and the durometer is increased. Higher durometer elastomeric materials result in seals with higher power and better sealing. Thicker films of elastomeric material also give rise to additional power for sealing. However, these features must be balanced against greater indentation forces.

It is desirable that the surface of the strands of the tubular blade 212 be available or presented on the inner surface of the elongated seal 204 in order to contact the instrument and reduce the indentation force. A harder, higher coefficient polymer is used to make the strands, which tend to be very smooth and reduce friction when compared to elastomeric materials.

This elastomeric material must substantially fill the "gap" of the woven material in order to produce a film or film over the entire woven surface. The complete film ensures that the fluid does not pass through the seal. Seals with thinner walls are desirable because such seals provide less space for fluid to flow out.

This composite seal structure should be flexible and compatible enough to move with the device, which improves sealing and reduces the chances of pocketing and tearing. These properties depend on the fabric structure, strand type, elastomeric material type, and seal geometry. Therefore, this woven structure, strand type, elastomeric material type, and seal bonding structure should be selected to form a seal with the desired sealing and tearing. Thinner and more submissive woven and elastomeric material composite structures also reduce indentation forces.

FIG. 7 is a blueprint showing a three-dimensional envelope for a preferred seal composite structure. In all cases, the X-axis, Y-axis, and Z-axis variables are adjusted, compensated, and exchanged to create the design volume (dv) for optimal seal design. Others of dv also produce working seals, but with less attractive working properties such as greater pushing force, lower tear resistance, additional leakage, or other properties discussed above. Desired work including drag or pushing force (0-10 lbs) and leakage rate (0-270 cc / min) to obtain optimum properties for sealing (quantitative values such as load, durometer, volume fraction) Limited by the required value. The work requirement value of the elongated seal 104 is included in the Z-axis variable. The variables on this X-axis are (1) the seal diameter from the initial diameter to the extended diameter and (2) the number of yarns in the seal. The Y-axis variables are (1) durometer, (2) surface coverage factor, (3) yarn density for free space, (4) polymer thickness, (5) seal zone geometry and (6) blade. The angle. The X-axis and Y-axis variables are optimized to yield the desired Z-axis parameters for the elongated seal 204.

In the design volume shown above, the preferred sealing structure is 0-5 lbs drag, 0-270 cc leakage rate per minute, 10-80 Shore A elastomeric material durometer, ASTM D1894 between 0.07 and 0.5 (plastic film). And sheet) friction properties, 0 to 1 coverage factor, 10 to 70% strand density for free space, 0.003 to 0.015 inch elastomer material thickness, 2 to 0.1 inch compression area length, 0 to 90 It has a blade angle of °, a seal diameter extended from the initial seal diameter of 3-18 mm, and a strand count of 30-200.

More preferred sealing structures are 0.5-1.5 pound drag (when used with larger size instruments with a diameter of about 10-14 mm), 0-120 cc leakage rate per minute, 10-30 Shore A. Elastomer material durometer, coefficient of friction of 0.07 to 0.18, coverage factor of about 1, density of 70 to 100%, thickness of elastomer material of 0.003 to 0.010 inches, length of compression area of 0.5 to 1.5 inches, 0 to 60 ° It has a blade angle of, a seal diameter extended from the initial seal diameter of 4-15 mm, and a strand count of 100-160.

10 to 11 show alternative embodiments of the present disclosure. The access device 250 is substantially similar to the embodiments of FIGS. 1-6, but incorporates a seal base 252 located within the cannula sleeve 102 adjacent to the distal end of the cannula sleeve. The seal base 252 is secured to the distal end of the elongated seal 204 in the same manner as discussed above in connection with the cannula tip 216, with the extension position shown in FIG. 9 and the contraction position shown in FIG. Attached for axial movement within the cannula sleeve 102 between and. Specifically, the seal base 252 includes an opposed key 254, and the opposed key 254 is received by the internal recess 256 of the cannula sleeve 102. Desirably, the recess 256 does not extend to the outer surface of the cannula sleeve 102. The key 254 allows axial movement of the seal base 252 and the distal ends of the elongated seal 204 beyond the recess 256. In this fashion, the elongated seal 204 can be fully stretched (ie, substantially lacking excess slack material) when mounted within the cannula sleeve 102. FIG. 10 shows the arrangement of the elongated seal 204 and the seal base 252 when a relatively small diameter instrument is placed within the access device 100. As shown, the region of the elongated seal 204 around the center 220 forms a fluid leak-free relationship with this instrument while the seal base 252 is in the first location. With reference to FIG. 11, upon insertion of a larger diameter instrument, the seal base 252, in the proximal contraction motion, the region of the elongated seal 204 around the center 220 provides a fluid-free seal around this instrument. Move to allow expansion while maintaining further. The area of seal 204 that engages this device is larger in FIG. 11 when compared to that in FIG. The access device 250 may also include a bulkhead seal 258 attached to the proximal end of the cannula housing 104 to provide additional sealing performance. The bulkhead seal 258 is any of the seal arrangements described above in this specification. obtain. Open both the indicated bulkhead seal 258 and the duckbill valve to fit the instrument inserted into the access device.To.

Figures 12-14 show a cannula assembly according to an alternative embodiment of the present disclosure. The elongated seal 500 comprises a proximal flange 502, a tubular component 504 extending from the proximal flange 502, and a cannula tip 506 attached to the distal end of the tubular component 504. Tubular component 504 comprises a blade fabric 505 with an external elastomer coating 508. The proximal flange 502 can be formed integrally with the elastomeric coating 508 or attached to the proximal end of the tubular component 504. The elongated seal 500 has a general hourglass shape that tapers inward from the proximal end to the structure 510 and taps outward from the structure 510 to the distal end of the tubular component 504. This drum-shaped structure is formed during the manufacturing process by placing a tubular blade on the corresponding drum-shaped mandrel and forming an elastomeric material on the blade by any of the techniques discussed above herein. To do.

In a preferred embodiment, the elastomeric coating 508 incorporates a pair of ribbed portions 512 adjacent to the structure 510. The rib portion 512 provides a region where the thickness of the elastomer is thickened and effectively increases the elastic force of the central portion 510 of the tubular component 504. This increased elastic force ensures the formation of a fluid leak-free seal around the device and facilitates the central portion 510 to return to its original diameter after the device is removed. The rib portion 512 may be incorporated (compressed or injected) into the mold to accommodate the recesses sized to receive the overflowing elastomer. Alternatively, the rib portion 512 may separate the elastomeric strip adhered to the outer surface of the central portion 510 of the elongated seal 500.

Figures 15-16 show a cannula assembly according to an alternative embodiment. The cannula sleeve 102 includes an external screw 150 formed on its outer surface. The screw 150 facilitates the insertion of the cannula assembly 100 within the tissue site. Specifically, the rotational movement of the cannula assembly 100 engages the screw 150 with the tissue and causes it to move forward in the body cavity. Although the threads 150 are shown as continuous, the threads 150 include partially blocked thread segments that are even more effective in advancing the cannula assembly 100 within the tissue.

The cannula sleeve 102 may also have an opening 170 on its outer surface. The opening 170 allows the passage of infused gas between the exterior space (limited between the elongated seal 500 and the cannula sleeve 102) and the abdominal cavity, maintains gas infusion within the body cavity, and / or gas. Allows the pressure of the external space to enter and exit the external space to connect with the abdominal cavity to be equalized to the pressure of the internal path of the elongated seal 504. In this embodiment, the elongated seal may be totally impermeable to the injected gas.

The present invention will be specifically shown and described with respect to preferred embodiments, but it is possible that various modifications and modifications in shape and detail can be made within the scope of the invention without departing from the spirit and spirit of the invention. Understood by those skilled in the art. For example, one of ordinary skill in the art may devise alternatives for attaching slit seals or elongated seals, which are contemplated herein. In addition, the slit seal can be removed and an elongated seal can be placed to block the path through the cannula sleeve. In a further embodiment, it is a different means for introducing the injectable gas, such as a pathway incorporated into a cannula sleeve or a fixed pathway. In other embodiments, the blade or other textile material is formed into layers, and the ends of the layers are sewn together or otherwise combined together to form a tubular shape. In a further embodiment, this elastic portion extends only over the top of the woven material. In a further embodiment, the elastomeric material is removed and the textile material is used as the basis for forming a seal with an instrument. Therefore, modifications such as those suggested above (but not limited to these) should be considered within the scope of the present invention.

100 Cannula assembly102 Cannula sleeve104 Cannula housing108 Sleeve flange110 Outer slot114 Valve support128 Elastic valve136 port200 Seal assembly202 202 Seal support204 sticker212 Tubular blade1000 Obstructor

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Citations
Document	Relation	Office	Cited during
JP2013099533A	Cited by	Japan	Search report
JP2001112770A	Cites	Japan	Examiner
JP2001128985A	Cites	Japan	Examiner
US6447489B1	Cites	United States of America	Examiner

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US2004143263A1	United States of America	A1	2004-07-22
CA2513983A1	Canada	A1	2004-08-12
WO2004066927A2	World Intellectual Property Organization (WIPO)	A2	2004-08-12
AU2004212894A1	Australia	A1	2004-09-02
AU2004212990A1	Australia	A1	2004-09-02
CA2516444A1	Canada	A1	2004-09-02
CA2516451A1	Canada	A1	2004-09-02
WO2004073488A2	World Intellectual Property Organization (WIPO)	A2	2004-09-02
WO2004073753A2	World Intellectual Property Organization (WIPO)	A2	2004-09-02
WO2004080290A2	World Intellectual Property Organization (WIPO)	A2	2004-09-23
US2004193213A1	United States of America	A1	2004-09-30
WO2004073753A3	World Intellectual Property Organization (WIPO)	A3	2004-10-07
AU2004226371A1	Australia	A1	2004-10-14
CA2519461A1	Canada	A1	2004-10-14
WO2004086987A1	World Intellectual Property Organization (WIPO)	A1	2004-10-14
WO2004066927A3	World Intellectual Property Organization (WIPO)	A3	2004-11-04
AU2004233871A1	Australia	A1	2004-11-11
AU2004234014A1	Australia	A1	2004-11-11
CA2522617A1	Canada	A1	2004-11-11
CA2522766A1	Canada	A1	2004-11-11
WO2004096012A2	World Intellectual Property Organization (WIPO)	A2	2004-11-11
WO2004096295A2	World Intellectual Property Organization (WIPO)	A2	2004-11-11
US2004229496A1	United States of America	A1	2004-11-18
US2004230262A1	United States of America	A1	2004-11-18
US2004254426A1	United States of America	A1	2004-12-16
US2005021026A1	United States of America	A1	2005-01-27
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WO2004096012A3	World Intellectual Property Organization (WIPO)	A3	2005-03-24
EP1523942A2	European Patent Office (EPO)	A2	2005-04-20
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EP1523942A3	European Patent Office (EPO)	A3	2005-06-22
WO2004073488A3	World Intellectual Property Organization (WIPO)	A3	2005-09-22
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WO2004080290A3	World Intellectual Property Organization (WIPO)	A3	2005-11-03
EP1594392A2	European Patent Office (EPO)	A2	2005-11-16
EP1596743A2	European Patent Office (EPO)	A2	2005-11-23
EP1605840A1	European Patent Office (EPO)	A1	2005-12-21
EP1608272A2	European Patent Office (EPO)	A2	2005-12-28
EP1615673A2	European Patent Office (EPO)	A2	2006-01-18
EP1617755A2	European Patent Office (EPO)	A2	2006-01-25
WO2004096295A3	World Intellectual Property Organization (WIPO)	A3	2006-03-30
EP1587443A4	European Patent Office (EPO)	A4	2006-04-05
JP2006518255A	Japan	A	2006-08-10
JP2006518262A	Japan	A	2006-08-10
US2006184182A1	United States of America	A1	2006-08-17
US2006188545A1	United States of America	A1	2006-08-24
US7104834B2	United States of America	B2	2006-09-12
JP2006521185A	Japan	A	2006-09-21
US2006241655A1	United States of America	A1	2006-10-26
JP2006524552A	Japan	A	2006-11-02
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EP1596743A4	European Patent Office (EPO)	A4	2007-01-24
US2007055107A1	United States of America	A1	2007-03-08
US2007142832A1	United States of America	A1	2007-06-21
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US2007156140A1	United States of America	A1	2007-07-05
EP1594392A4	European Patent Office (EPO)	A4	2007-08-08
JP2007525242A	Japan	A	2007-09-06
US7296722B2	United States of America	B2	2007-11-20
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US2008054046A1	United States of America	A1	2008-03-06
EP1596743B1	European Patent Office (EPO)	B1	2008-04-09
DE602004012972D1	Germany	D1	2008-05-21
ES2300746T3	Spain	T3	2008-06-16
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DE602004012972T2	Germany	T2	2009-06-10
US7559449B2	United States of America	B2	2009-07-14
AU2004212894B2	Australia	B2	2009-10-22
AU2004226371B2	Australia	B2	2009-10-29
AU2004212990B2	Australia	B2	2009-12-10
AU2004234014B2	Australia	B2	2010-01-28
US7655007B2	United States of America	B2	2010-02-02
AU2004233871B2	Australia	B2	2010-02-18
AU2010200346A1	Australia	A1	2010-02-18
US7699205B2	United States of America	B2	2010-04-20
JP4460576B2	Japan	B2	2010-05-12
JP2010104812A	Japan	A	2010-05-13
JP2010104813A	Japan	A	2010-05-13
AU2010201670A1	Australia	A1	2010-05-20
JP2010110649A	Japan	A	2010-05-20
US2010130971A1	United States of America	A1	2010-05-27
JP4469843B2	Japan	B2	2010-06-02
AU2010201946A1	Australia	A1	2010-06-03
JP2010142655AThis record	Japan	A	2010-07-01
US2010170931A1	United States of America	A1	2010-07-08
US2010170933A1	United States of America	A1	2010-07-08
US2010222747A1	United States of America	A1	2010-09-02
AU2004234014C1	Australia	C1	2010-09-16
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EP1615673A4	European Patent Office (EPO)	A4	2010-09-22
JP4557972B2	Japan	B2	2010-10-06
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EP1605840B1	European Patent Office (EPO)	B1	2011-01-05
DE602004030891D1	Germany	D1	2011-02-17
EP2292173A1	European Patent Office (EPO)	A1	2011-03-09
ES2354613T3	Spain	T3	2011-03-16

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2012-07-20	Written withdrawal of applicationJAPANESE INTERMEDIATE CODE: A761A761	A761
2012-06-15	Written amendmentJAPANESE INTERMEDIATE CODE: A523A521	A521
2012-01-18	Written permission of extension of timeJAPANESE INTERMEDIATE CODE: A602A602	A602
2012-01-13	Written request for extension of timeJAPANESE INTERMEDIATE CODE: A601A601	A601
2011-12-16	Notification of reasons for refusalJAPANESE INTERMEDIATE CODE: A131A131	A131
2011-01-19	Written amendmentJAPANESE INTERMEDIATE CODE: A523A521	A521