KR20100109481A - Access device - Google Patents

Abstract

PURPOSE: An approaching device is provided to reduce a chopstick phenomenon by completely performing a laparoscope operation procedure through a port for a surgical procedure. CONSTITUTION: An organization retractor(1000) comprises a flexible member(1100) having an inner surface forming an outer surface and a path for uniting with a body cut-out. An inserted body(2000) is supported inside a path formed by the flexible member. The inserted body comprises at least one instrument opening. The inserted body comprises an outer surface having the size and shape for the deformation of the flexible member so that a part of the path have a predetermined size and shape. The inserted body comprises a cylindrical shaped outer surface. The inserted body comprises a plurality of instrument openings.

Description

Access device {ACCESS DEVICE}

This patent application is incorporated by reference in U.S. Patent Application No. 12 / 479,418, entitled Devices and Methods for Providing Access Into a Body Cavity, filed June 5, 2009. Which is incorporated and claims priority as some consecutive application, which also contains and claims US Provisional Patent Application 61 / 165,080, filed March 31, 2009.

Cross Reference with Related Application

This patent application cross-references and includes the following commonly assigned US patent applications. That is, US Patent Application No. 11 / 398,985, filed April 5, 2006 and published as US20060247673; US Patent Application No. 11/399181, filed April 5, 2006; US Patent Application No. 11/399145, filed April 5, 2006; US Patent Application No. 11/399149, filed April 5, 2006; US Patent Application No. 11/399044, filed April 5, 2006; US Patent Application No. 11/399172, filed April 5, 2006; US Patent Application No. 11/399045, filed April 5, 2006; US Patent Application No. 12 / 242,765, filed September 30, 2008; 12 / 242,711, filed September 30, 2008; US Patent Application No. 12 / 242,721, filed September 30, 2008; US Patent Application No. 12 / 242,383, filed September 30, 2008; US Patent Application No. 12 / 242,333, filed September 30, 2008; US Patent Application No. 12 / 242,353, filed September 30, 2008; US Patent Application No. 12 / 242,381, filed September 30, 2008; US Patent Application No. 12 / 399,625, filed March 6, 2009; US Patent Application No. 12 / 399,633, filed March 6, 2009; US Patent Application No. 12 / 399,547, filed March 6, 2009; US Patent Application No. 12 / 399,656, filed March 6, 2009; US Patent Application No. 12 / 399,482, filed March 6, 2009; US Patent Application No. 12 / 399,473; US Patent Application No. 12 / 110,724, filed April 28, 2008; US Patent Application No. 12 / 109,881, filed April 25, 2008; US Patent Application No. 12/425, filed April 29, 2008; And US patent application Ser. No. 12 / 172,349, filed July 14, 2008.

The present invention relates to an access device such as to provide surgical access into the body cavity.

Surgical treatment by abdominal laparoscopic surgery gained popularity in the late 1980s, when the advantages of laparoscopic removal of the gallbladder over the traditional (laparotomy) procedure became apparent. Reduced postoperative recovery time, markedly reduced postoperative pain and wound infection, and improved cosmetic performance are due to laparoscopic surgery, which is primarily derived from the ability of laparoscopic surgeons to perform surgery using smaller incisions in the body cavity wall. It is a well established advantage of surgical procedures.

Laparoscopic surgery procedures generally include injecting CO 2 gas into the abdominal cavity up to a pressure of about 2.0 mmHg. The abdominal wall is perforated and a 5-10 mm diameter straight tubular cannula or trocar sleeve is then inserted into the abdominal cavity. A laparoscopic surgical telescope connected to the operating room monitor is used to visualize the surgical area and is placed through the trocar sleeve. Laparoscopic instruments (grasper, dissector, scissors, retractor, etc.) are placed through two or more additional trocar sleeves for operation by the surgeon and surgeon assistant (s). .

Recently, so-called "mini-laparoscopy" using straight trocar sleeves and laparoscopy instruments of 2-3 mm diameter has been introduced. In successful cases, mini-laparoscopic surgery allows for further reduction of abdominal wall trauma and improved cosmetic cosmetics. However, instruments used in mini-laparoscopic surgical procedures are generally more expensive and brittle. Due to their performance limitations due to the smaller diameter of these instruments (weak suction-irrigation system, poor durability, reduced video quality), mini-laparoscopic surgical instruments generally have an advantageous anatomical structure (thin Peritoneal wall, less adhesion, minimal inflammation, etc.). These patients represent a small percentage of patients in need of laparoscopic surgical procedures. In addition, smaller 2-3 mm incisions can still cause undesirable cosmetic performance and wound complications (bleeding, infection, pain, keloid formation, etc.).

Since the advantages of smaller and fewer body cavity incisions have been demonstrated, it would be desirable to perform surgery using only a single incision in the navel. The navel is well concealed and is the area through which the thinnest and least amount of blood vessels in the abdominal wall pass. The navel is generally the preferred choice of laparoscopic entry in laparoscopic surgery procedures. The umbilical incision can be easily enlarged (to extract larger specimens) without significantly jeopardizing cosmetic surgery and without increasing the likelihood of wound complications. Placing two or more standard (straight) cannula and laparoscopic surgical instruments next to each other within the navel is a so-called "chopstick" that describes interference between the surgeon's hands, between the surgeon's hand and the instrument, and between the instruments. Produces a chopstick effect. This interference greatly reduces the surgeon's ability to perform the described procedure.

Accordingly, there is a need for instruments and trocar systems that reduce or eliminate the "chopstick effect" while allowing laparoscopic surgery procedures to be fully performed through a surgical port located at the navel or elsewhere.

The present invention generally provides a device that allows surgical access into the body of a patient.

In one embodiment, the medical device includes a tissue retractor and an insert releasably supported in a passage connected to the tissue retractor. The insert may have an outer surface having a size and shape for modifying the flexible member of the tissue retractor to provide at least a portion of the passageway with the desired size and shape.

The insert is in the form of an insert assembly having a generally cylindrical outer surface sized to radially stretch a portion of the tissue retractor to have a generally circular or other suitable cross section having a predetermined diameter or width during insertion into the passage of the insert. Can be.

The tissue retractor may be a flexible tissue retractor that includes a flexible member, such as a flexible membrane having a first end and a second end, wherein the insert is releasably supported or alternatively within the passageway of the flexible tissue retractor It may be releasably insertable.

In one embodiment, the insert includes an assembly having an inner portion and an outer portion. The outer portion may have a generally cylindrical outer surface configured to engage the inner surface of the passageway of the tissue retractor, the inner portion having a plurality of instrument openings aligned with the outer portion of the insert and the rotatable instrument passageway with respect to the flexible tissue retractor. It may include.

The insert includes an outer body portion sized and shaped to engage and modify a portion of the inner surface of the flexible tissue retractor, a housing at least partially disposed within the outer sleeve, and at least one instrument opening of the upper surface of the housing And at least one seal operatively associated with each appliance opening. The insertion assembly may also include an instrument channel member in the form of a single flexible structure that forms a plurality of tubular instrument channels. Each tubular instrument channel may be independently deformable with respect to the housing and other tubular instrument channels. The instrument channel and instrument opening may be rotatably supported relative to the outer sleeve and the tissue retractor, for example by a bearing member.

In one embodiment, the flexible tissue retractor includes first and second deformable rings, and the insert has a size and shape that passes through at least one of the rings without deforming the rings. The insert can have a size and shape for modifying a portion of the flexible member extending in the middle of the first and second rings.

In one embodiment, an assembly is provided that includes a flexible tissue retractor, an insert, and a sleeve. The sleeve can be positioned in the flexible tissue retractor and the insert can be pressed into the sleeve. The sleeve and insert can be removed together from the retractor without removing the retractor from the incision. The sleeve may be provided to assist in inserting and removing the insert, and the sleeve may be formed of a material having a relatively low coefficient of friction, relatively high burst resistance and / or high toughness.

In one embodiment, a method is provided for accessing a body cavity through an incision. The method includes positioning a tissue retractor in the incision; Releasably positioning an insert having a plurality of instrument openings into the tissue retractor. Positioning the insert may be by pressing the insert into the tissue retractor and may include modifying and / or stretching at least a portion of the tissue retractor. The method includes forming an incision, positioning a tissue retractor within the incision, positioning a sleeve to extend at least partially within the tissue retractor, and positioning an insert having one or more instrument openings into the sleeve. It may include.

In one embodiment, a medical device is provided that includes a tissue retractor and at least one insert having at least one instrument opening, the insert being at a different insertion depth in the passageway of the tissue retractor, for example, by pressing , Position can be set.

In one embodiment, a method for accessing a body cavity includes positioning a flexible tissue retractor in an incision provided with a passage extending through the incision; Releasably positioning a first insert having at least one instrument opening in a passage provided by the flexible tissue retractor; Removing the first insert from the passage provided by the tissue retractor; Positioning a second insert having at least one appliance opening in the passageway. The second insert may have a different number of instrument openings and / or different sizes and / or different shapes than the first insert. The method may also include repositioning the insert to a second depth in the passageway of the retractor.

The invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings.
<Figure 1>
1 is a proximal perspective view showing an access device including an insert having at least one instrument opening releasably supported in a flexible tissue retractor, wherein the proximal end of the insert is below the upper proximal end of the flexible tissue retractor; A diagram shown inserted to be positioned at.
<FIG. 2>
FIG. 2 is a distal perspective view of the insert and flexible tissue retractor shown in FIG. 1, with the distal bottom of the insert being seen from the lower distal opening of the flexible tissue retractor. FIG.
3,
3 is a cross-sectional view of a device of the type shown in FIG. 1.
<Figure 4>
4 is an exploded view of the insert of the type shown in FIG. 1;
<Figure 5>
FIG. 5 is a proximal perspective view showing an alternative access device that includes an insert, an flexible tissue retractor, and an assembly of a sleeve, wherein the sleeve includes a generally annular portion disposed over the proximal end of the flexible tissue retractor And the sleeve is shown to include a generally cylindrical portion extending distally from the annular portion, wherein at least a portion of the generally cylindrical portion of the sleeve is disposed between the insert and the flexible tissue retractor.
6,
FIG. 6 is a cross-sectional view of a device of the type shown in FIG. 5, wherein the generally cylindrical portion extends distal beyond the distal end of the insert and tissue retractor, the distal end of the cylindrical portion being inserted from the tissue retractor; FIG. Is shown as having a generally circumferentially extending rib or ledge shaped member to help withdraw and prevent the insert from being pressed into the body cavity.
<Figure 7>
7 shows one relatively large device opening (e.g. to accommodate a laparoscopic or other relatively large diameter device) and a relatively small device (e.g. a 5 mm gripper, clip applier, etc.) Schematic exploded view of an insert similar to that shown in FIG. 4 but having three instrument openings compared to four instrument openings, comprising two relatively small instrument openings.
<Figure 8>
FIG. 8 is a schematic diagram showing how the insert of FIG. 7 can be inserted into a sleeve (shown in half cross section) and how the insert and sleeve can in turn be inserted into a flexible tissue retractor (also shown in half cross section). .
<Figure 9>
FIG. 9 shows that the insert is inserted into and supported by the sleeve, the sleeve is then supported in the tissue retractor, the sleeve and the retractor are shown in half cross section, and in FIG. 9 the sleeve has a length longer than the axial length of the retractor. So that the sleeve can be positioned at various depths in the retractor, and in FIG. 9 the distal portion of the insert is shown positioned below the abdominal wall, the distal portion of the insert having a retaining feature in the form of an inner lip at the distal end of the sleeve. The adjacent, retaining feature prevents the insert from being pushed through the sleeve into the abdominal cavity and the lip facilitates removal of the insert with the sleeve when the sleeve is withdrawn from the flexible retractor. , Sleeve and tissue retractor drawing.
<Figure 10>
FIG. 10 is a perspective view showing how the sleeve and insert can be removed with one hand fingers gripping the edge of the sleeve and raising the sleeve proximally (upward in FIG. 10), the insert being held by the sleeve, The insert is removed with the sleeve when the sleeve is withdrawn from the retractor and the retractor remains in place at the incision.
<Figure 11>
FIG. 11 is a perspective view illustrating how the specimen and / or the specimen bag may be removed from the body via the flexible retractor when the sleeve and insert are removed from the flexible retractor. FIG.
<Figure 12>
12 is a schematic cross-sectional view of an embodiment in which the insert is disposed in a flexible retractor having an internal retaining feature in the form of an inner lip for retaining the insert to a desired depth in the retractor, for example on a seal mounted above or below the retractor; A diagram showing how the flexible support of the insert in the retractor allows the device extending through the insert to pivot the insert itself to provide an improved range of movement of the device.
Figure 13
FIG. 13 shows a zero closure seal in the form of a duckbill seal at the proximal end of the insert and a seal around the instrument inserted into the instrument channel to seal the instrument access channel when there is no instrument inserted through the channel. A schematic cross-sectional view of an insert, a sleeve, and a retractor, including an appliance seal in the form of a septum seal so as to be effective.

Certain exemplary embodiments will now be described to provide an overall understanding of the principles of structure, function, manufacture, and use of the methods and apparatus disclosed herein. One or more examples of these embodiments are shown in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and shown in the accompanying drawings are non-limiting exemplary embodiments, and the scope of the present invention is defined only by the claims. Features shown or described in connection with one exemplary embodiment may be combined with features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.

The present invention generally allows the insertion of one or more surgical instruments via a single incision surgical access device, for example at various insertion depths, to facilitate handling of the instrument into the patient's body while maintaining infusion, Provided is a medical device, such as a surgical access assembly.

1 is a perspective view of the upper or proximal portion of the access assembly, and FIG. 2 is a perspective view of the lower or distal portion of the access assembly. 1 and 2, in one embodiment the medical device includes a flexible tissue retractor 1000 and at least one device opening 2014 (four device openings 2014 are shown in FIG. 1, and FIG. 2 is shown in FIG. 2). In the form of an access assembly comprising an insert 2000 with four appliance outlets 2016 shown). The instrument opening 2014 may extend through the top surface 2702 of a portion of the insert, and the opening 2014 may be closed or otherwise blocked by the membrane seal 2600, as described in more detail below. It is as follows.

The insert 2000 is shown to be releasably supported in the passage 1104 formed by the flexible member 1100 of the retractor 1000. As used herein, the term "releasably supported" means that the insert can be inserted and removed multiple times from the tissue retractor, including during surgical procedures, without impairing or otherwise degrading the function of the retractor or insert. In one illustrative example, insert 2000 is releasably inserted by pressing the insert (eg, with a thumb or finger) into the passageway of the retractor.

The flexible member 1100 has a generally annular shaped first outer or upper portion 1120 (oriented generally horizontally in FIG. 1) and a generally annular shaped second inner portion 1160 (usually horizontal and FIG. Substantially parallel to portion 1120 at 1) and a generally cylindrically shaped portion 1140 extending axially distal from portion 1120 to portion 1160.

The outer portion 1120 may be connected with the first proximal end 1101 of the flexible member 1100, and the inner portion 1160 may be connected with the second distal end 1103 of the flexible member 110. The outer portion 1120 is disposed outside the patient's body when the flexible retractor is positioned during surgery, and the inner portion 1160 is disposed within the patient, for example within the body cavity, during a surgical procedure. The inner surface of the generally cylindrical portion 1140 may provide most or substantially all of the passageway 1104, while the outer surface of the generally cylindrical portion 1140 may have a flexible retractor (as shown in FIG. 3). 1000 may be in contact with the wall of the incision when positioned during surgery.

The flexible member 1100 can include a single flexible membrane that forms portions 1120, 1140, 1160 and has a first surface 1102 and a second surface 1102. The passage 1104 of the tissue retractor 1000 may be at least partially formed by a portion of the radially inwardly facing first surface 1102 of the generally cylindrical portion 1140. A portion of the second surface 1106 connected with the generally cylindrical portion 1140 may be radially outwardly contacted or otherwise engaged with tissue at the incision point.

The flexible tissue retractor 1000 may also include proximal and distal members for engaging the outer and inner portions of the patient with the outer and inner portions of the retractor. For example, tissue retractor 1000 may include an elastic outer (proximal) deformable ring 1200 and an elastic inner (distal) deformable ring 1400. Rings 1200 and 1400 are shown in phantom in FIGS. 1 and 2, and in cross section in FIG. 3. The flexible member 1100 is shown extending in the middle of the ring 1200 and the ring 1400 such that the member 1100 extends from the ring 1200 to the ring 1400.

3 shows that the distal portion 1160 of the retractor 1000 and the ring 1400 are disposed within the abdominal cavity 40 and the tissue 60 (including a portion of the abdominal wall) engages with the surface 1106 of the flexible retractor. , An access assembly of the flexible retractor 1000 and the insert 2000 located in the incision.

Rings 1200 and 1400 can have any suitable closed or substantially closed configuration, including but not limited to round, oval and elliptical configurations. “Elastic deformable ring can be deformed relatively easily by, for example, pressing the opposite sides of the ring with a finger (and without any additional tools or assistance) so that the ring can be deformed with a body wall (eg an abdominal wall). Means that the inner ring 1400 can be deformed, for example, by pressing together the opposite sides of the ring with a finger, such as an incision through the abdominal wall, When the ring is fully inserted, the inner ring 1400 can elastically return to its undeformed shape.The ring engages with the inner surface of the abdominal wall of the abdominal cavity, thereby retracting the retractor. Help to lock 1000.

The flexible member may comprise a flexible membrane of elastically deformable material such as natural rubber, silicone or a suitable deformable elastomer or elastomeric material. The deformable ring may be attached to the flexible membrane or may be enclosed within the dried end of the membrane. One suitable flexible tissue retractor that includes a flexible member with inner and outer deformable rings is a tissue retractor available from Hako as Hako FF0707.

The flexible tissue retractor may be provided in one or more sizes, in one example, a length or height of about 15 mm to about 30 mm (measured in the direction of the axis 70 in FIG. 3), and from about 40 mm to about 80 mm Has a maximum diameter corresponding to the diameter of the ring 1200/1400 and an internal passage diameter of about 20 mm to 40 mm. In the figure, the ring is shown having substantially the same diameter, but the diameter of the ring 1200 may be selected to be larger than the diameter of the ring 1400, or the diameter of the ring 1200 is larger than the diameter of the ring 1400. It will be appreciated that it may be small. In one embodiment, a flexible tissue retractor having an internal passage diameter smaller than that required to allow passage of a user's hand and generally less than about 50 mm, provides access to multiple devices but requires a relatively large incision It may be desirable not to.

The flexible tissue retractor 1000 may be formed to have a predetermined self-supporting shape, such as the shape shown in FIG. 1. “Self support may mean that when the retractor 1000 is positioned on a substantially horizontal surface (eg, a flat table top), the retractor may remain unfolded and its passageway 1104 extends substantially vertically. The portions 1120 and 1140 are spaced apart from each other by the portion 1160 by a predetermined distance.

1 to 3, the insert 2000 is pressed into the passage 1104 such that the insert 2000 and the instrument opening 2014 are disposed below the ring 1200 and the annular portion 1120 of the flexible tissue retractor. Or otherwise shown as being located in the passageway. As shown in FIG. 3, a member, such as a retaining feature in the form of an inner lip 1108, may be formed on or otherwise provided to the inner surface of the retractor. Lip 1108 may be positioned to prevent insert 2000 from being pushed into body cavity 40 through retractor 1000.

2 and 3, the distal end of the instrument outlet 2016 and the insert 2000 is shown as extending generally to or below the distal portion 1160 and the distal ring 1400 of the flexible retractor. Thus, the insert 2000 is positioned in the retractor 1000 to provide a low profile so that the instrument inserted into the opening 2014 and outside the outlet 2016 is a pivot point located distal to the upper proximal ring 1200. In, for example, at pivot points located within the incision, can be pivoted with respect to each other and / or with respect to the insert 2000. This low profile configuration allows the seal associated with the instrument passage of the insert 2000 to be present under the ring 1200, in particular in the incision or in the abdominal cavity. Without being bound by theory, placing the seal in the abdominal cavity may help prevent the seal from being folded or otherwise affected by tissue pressure, and tissue may close the instrument passage or alternatively through the instrument passage. It is believed that it can prevent blocking or reducing visibility.

3 and 4, the insert 2000 shown includes an insert assembly. The insert assembly may include an outer body portion 2100, a bearing member 2200, an inversion constraint member 2300, a spacer 2400, an elastomeric device channel member, as described in more detail below. 2500, membrane seal 2600, and inner housing 2700.

The outer body portion 2100 is a generally cylindrical outer surface 2110, an inner surface 2112, a distal ledge 2120 radially inwardly extending from the surface 2112 and a circumferentially extending protrusion 2114. It is shown in a generally cylindrical shell shape with internal surface features.

The outer body portion 2100 may be a generally rigid and hard shell formed of a suitable material, such as polyethylene or other suitable medical grade material, such that when the insert 2000 is inserted into the flexible retractor 1000, the outer body portion ( 2100 is free of any significant degree of deformation, but instead stretches or otherwise extends the flexible retractor to maintain passage 1104 at the desired shape and size, or to provide the passage with the desired size and shape. Acts to expand.

The outer body portion 2100 shown may be inserted into the retractor to deform a portion of the retractor that is spaced apart from and in between the ring 1200 and the ring 1400. The outer body portion 2100 may have a size and shape that allows it to pass through one or both rings 1200 and 1400 without deforming the ring. For example, the outer body portion 2100 may have a generally cylindrical outer surface having an outer diameter less than the inner diameter of the ring 1200, the outer surface radially and circumferentially a portion of the retractor associated with the passage 1104. It may have a size to stretch in the direction. Thus, the insert 2000 can provide a passage 1104 that extends through an incision having a generally circular cross section with a predetermined diameter. The ease of insertion of the flexible retractor is maintained while the passage 1104 is prevented from narrowing or contracting by incision. Moreover, inserts having a generally cylindrical configuration provide a generally circular opening through the retractor, and the circle provides a maximum area per unit perimeter length. The generally circular cross section of the insert also permits easy provision of rotation of a portion of the insert, for example with respect to the outer surface of the insert and / or the retractor.

In one embodiment, the outer diameter of the body portion 2100 may be sized slightly larger than the inner diameter of the passage 1104 when the insert 2000 is not disposed within the passage 1104 and the retractor is standing independently. After the retractor 1000 is inserted into the incision, the insert 2000 can be inserted into the retractor 1000. Insert 2000 may be sized to elongate the retractor to at least slightly enlarge passage 1104, and insert 2000 may frictionally engage the interior surface of passage 1104. Insert 2000 may act to maintain passage 1104 open against the compressive force of the incisions acting on retractor 1000.

The outer body portion 2100 is shown as having a generally cylindrical outer surface, but it can be appreciated that other outer surface shapes can be employed and include generally smooth or faced outer surfaces. Suitable surfaces include, but are not necessarily limited to, oval, oval, ovoid, elongate, and combinations thereof. For example, depending on the procedure to be performed and / or the size of the incision, various inserts having different shapes and sizes of different outer surfaces may be provided to assist in providing or providing a passage 1104 with a predetermined size and shape. It may be desirable to. The size and shape of the outer surface of the body portion 2100 may serve to deform the flexible member to provide a predetermined size and shape in at least a portion of the passageway. In addition, the size and shape of the outer body portion can serve to provide frictional engagement of the inner surface of the passageway 1104 of the flexible retractor with the outer body portion 2100.

Also referring to FIGS. 3 and 4, the inner housing 2700 includes an outer proximal facing top surface 2702 to which the instrument opening 2014 can extend. The inner housing 2700 shown also has a generally cylindrical outer side surface 2710 extending distally from the top surface 2702. The instrument channel member 2500 is shown to be supported within the inner body portion 2700. The instrument channel member 2500 forms a plurality of instrument channels 2550, with each channel 2550 generally extending from and aligned with the distal outlet 2016 from the proximal opening 2014. Membrane seal 2600 is shown to be captured between the proximal end of instrument channel member 2500 and inner housing 2700. Membrane seal 2600 provides a seal to prevent leakage of injection through the instrument opening 2014 prior to insertion of the instrument through the opening. Membrane seal 2600 may be in the form of a thin membrane formed of a flexible material that may be ruptured or otherwise perforated by a surgical instrument. In one embodiment, the seal 2600 comprises a membrane formed of polyurethane having a thickness of less than about 0.25 mm (0.010 inch), in particular the membrane may have a thickness of about 0.15 mm (0.006 inch). Alternatively, a zero closing seal, such as a duckbill seal, or other suitable seal for sealing in the absence of the device may be employed in connection with the opening 2014.

The distal ledge 2120 of the outer body portion 2100 provides an axial thrust support surface (see eg FIG. 3) in which the bearing member 2200 can be rotatably supported. The bearing member 2200 may serve to provide a rotational support for the assembly comprising an inner body portion 2700 and an instrument channel member 2500 such that the assembly is generally through the passage 1104 of the retractor 1000. It may rotate about the outer body portion 2100 about an axis 70 extending in the longitudinal direction (see FIG. 3). Bearing member 2200 may be formed of any suitable material, such as high density polyethylene.

Thus, the bearing member 2200 is an instrument channel member while the insert 2000 is pressed into position in the flexible retractor 1000 while the outer body portion 2100 can be held substantially fixed relative to the retractor 1000. 2500 may be provided to be rotatable in the retractor. Rotation of the member 2500 allows rotational positioning of the instrument opening 2014 and the passages 2550 to provide the desired positioning of one or more instruments extending through the insert 2000.

The device channel member 2500 is shown to include a plurality of device channels 2540, each device channel including a device passageway 2550. The instrument channel member 2500 may advantageously be formed of a single piece of integral structure formed of a deformable elastic material, such as polyisoprene, Kraton or Sanoprene, so that each instrument channel 2540 ) Is independently deformable for the housing 2700 and other instrument channels. Thus, the devices inserted into the device passageway 2550 can be tilted and / or pivoted with respect to each other, increasing the degree of freedom of movement of each device relative to the other devices. If desired, a seal member 2544 or other crimp may be provided at the distal end of each instrument channel 2540 to provide a seal for the instrument located within the instrument channel 2540.

In the figure, the instrument channel 2540 has a generally cylindrical shape and is shown extending distally from the proximal base 2510. The opening 2514 of the base 2510 corresponds to and is generally aligned with the instrument opening 2014 by a recess 2520 formed in the upper surface of the base 2510. Recess 2520 may be positioned to mate with features on the bottom side (distal side) of inner housing 2700.

The protrusions 2114 formed on the inner surface of the outer body portion 2100 can be operatively coupled with features such as circumferentially extending grooves 2714 formed in the outer cylindrical surface 2710 of the inner housing 2700. have. The protrusion 2114 restrains the inner housing 2700 axially (ie, in the proximal and distal directions) with respect to the outer body portion 2100, while the inner body portion 2700 with respect to the outer body portion 2100. Engage with groove 2714 to allow rotation. Alternatively, body portion 2100 may include a groove, and inner housing 2700 may include a protrusion to engage with this groove.

The inversion inhibiting member 2300 may be provided to prevent the device channel 2540 from being "turned over" (eg, in a manner that the shirt sleeve is pulled inwardly outward) when the device is withdrawn from the channel 2540. Member 2300 is shown having a generally disk-shaped body 2320 having apertures 2340 extending therethrough. Each aperture 2340 is on the distal end of the corresponding instrument channel 2540. It may be sized to fit in. The member 2300 may be formed of any suitable material, including, for example, polyisoprene, sanoprene or crayton. Can be tailored to the flexibility of the more proximal portion of, for example, the member 2300 is relatively more flexible than the proximal portion of the insert 2000 (eg, such as the top surface of the housing 2700). Once manufactured, the instrument channel The device inserted in will tend to pivot about a fulcrum connected to the more proximal portion of the insert Alternatively, the member 2300 may be relatively relative to the more proximal portion of the insert 2000. If manufactured to be more rigid, the device will tend to pivot about a support point connected to the member 2300. As shown in Figure 3, the member 2300 is formed between the bearing member 2200 and the spacer 2400. It may be located axially, and the member 2300 may be located radially inward of the distal portion of the inner housing 2700.

5 and 6 show an alternative embodiment of the access device according to the invention. The illustrated access device is shown to include an assembly of flexible tissue retractor 1000 and insert 2000 and sleeve 3000. The flexible tissue retractor 1000 and the insert 2000 may be in any suitable form, including those described above with respect to FIGS. 1-4.

The sleeve 3000 may be provided to help prevent the insert 2000 from being pressed into the body cavity through the retractor 1000, and to help remove the insert 2000 from the retractor 1000. For example, during a surgical procedure, it may be desirable to exchange one or more inserts in tissue retractor 1000 without removing tissue retractor 1000 from the incision. Sleeve 3000 may also be provided to protect retractor 1000 from being torn or otherwise damaged by a device inserted through insert 2000. In one embodiment, multiple inserts 2000 may be provided for a particular procedure, each insert having a different shape, different size, different number of device openings and / or different device opening sizes. Alternatively, it may be desirable to remove the insert 2000 from the retractor located within the incision, such as through the passage of the tissue retractor 1000, to withdraw an instrument, device, tissue or body organ.

5 and 6, the sleeve 3000 can include a generally annular portion 3100 and a generally cylindrical portion 3200. The generally annular portion 3100 is shown having a generally flat distal (bottom) surface 3120 opposite the generally flat proximal (top) surface 3110. Sleeve distal surface 3120 may abut or otherwise contact or face the proximal portion of flexible tissue retractor 1000 when sleeve 3000 is fully positioned relative to retractor 3000 and insert 1000.

The generally cylindrical portion 3200 extends distal from the annular portion 3100 and is shown extending substantially perpendicularly. The generally cylindrical portion 3200 is shown to include a radially outer facing surface 3210 and an inner facing surface 3220. Inner facing surface 3220 provides passage 3104. The generally cylindrical portion 3200 extends at least partially through the flexible tissue retractor 1000, and in FIGS. 5 and 6, the generally cylindrical portion 3200 extends beyond the distal end of the retractor 1000. Extends through 1000.

5 and 6, the insert 2000 is shown to be disposed within the passage 3104 provided by the generally cylindrical portion 3200 of the sleeve 3000. Sleeve portion 3200 is shown, in turn, disposed within flexible tissue retractor 1000. The insert 2000, the sleeve 3000 and the flexible tissue retractor may be assembled in any desired order before or after the tissue retractor is placed in the incision. For example, the insert 2000 may be pressed into the sleeve 3000, and then the sleeve / insert subassembly may be pressed into the retractor 1000 before or after the retractor is positioned in the incision. Alternatively, the sleeve 3000 may be pressed into the retractor or otherwise inserted before or after the retractor is positioned in the incision, and then the insert may be pressed into the sleeve.

Generally, tissue retractor 1000 is modified, for example, by modifying one or both rings 1200/1400 to insert the retractor into the incision, or by using an insertion tool to insert the retractor into the incision. This will be inserted first into the incision. The sleeve 3000 can then be inserted into the retractor 1000, for example by pressing the sleeve into the retractor. The insert 2000 can then be inserted into the sleeve 3000.

Sleeve 3000 is shown to have a member, such as a retention feature, to prevent the insert from being fully pressed into the body cavity through the sleeve / tractor and to help remove the insert 2000 from the retractor. Referring to FIG. 6, the retaining features in the form of generally circumferentially extending ledges or ribs 3300 are shown extending generally radially inward at the distal end of the generally cylindrical portion 3200 of the sleeve 3000. . Lip 3300 may be continuous in the circumferential direction and may be sized and shaped to contactly engage a portion of the insert, such as the distal end of outer body portion 2100.

5 and 6, when insert 2000 and sleeve 3000 are fully inserted into retractor 1000, seal 2544 is located below the distal end of retractor 1000. This arrangement can provide instrument pivot points below the retractor and within the body cavity.

If necessary, the insert 2000 and / or the sleeve 3000 are fully inserted in the proximal direction, shown in FIGS. 5 and 6, to reposition the distal end of the insert 2000 relative to the retractor 1000. It may be partially withdrawn from the configuration. Thus, the position at which the surgical instrument exits the insert 2000 can be changed in a generally continuous manner along the axis 70, and the point at which the instrument exits the insert 2000 is within the passage provided by the retractor. It may be located in a plurality of locations, or in a distal direction below the distal end of the retractor.

If desired, different inserts 2000, different tissue retractors 1000, and / or different sleeves 3000 may be provided in the kit. For example, the kit may include a plurality of tissue retractors 1000 each sized and / or shaped for a different incision size. The kit may include a plurality of inserts 2000 having different instrument opening sizes and / or configurations. The kit may comprise a sleeve with generally cylindrical portions having different lengths and / or diameters.

In order to withdraw the insert 2000 from the retractor 1000 and the incision, a portion of the sleeve 3000, such as the annular portion 3100, may be one hand (eg on opposite sides of the annular portion 3100) or It can be gripped with both hands and the sleeve can be pulled proximally (upward in FIGS. 5 and 6) to withdraw the sleeve 3000 and insert 2000 from the tissue retractor 1000.

The sleeve 3000 may be formed of a nonmetallic plastic or an elastomeric material. The sleeve 3000 may have a thickness between about 0.10 mm (0.004 inches) and 0.64 mm (0.025 inches), and may be formed of a relatively low friction, high tear resistant material having a relatively high elongation before failure, It can be relatively resistant to silicones or other lubricants without compromising quality. One suitable sleeve 3000 may be formed from a sheet or film having a thickness of about 0.13 mm (0.005 inch) to about 0.18 mm (0.007 inch). The sleeve 3000 can be formed to have a lower coefficient of friction than the retractor 1000, and the coefficient of friction of the sleeve 3000 can be less than about 0.25, more specifically less than about 0.20, even more specifically less than about 0.15. .

In one embodiment, the sleeve 3000 may be formed of a relatively rigid nonmetallic plastic or elastomeric material having a hardness higher than the hardness of the tissue retractor and having lower flexibility than the tissue retractor. In other embodiments, the sleeve can be formed of a relatively soft and flexible material. One suitable material from which the sleeve 3000 can be formed is a thermoplastic polyurethane elastomer, such as the Pelethane brand of polyurethane available from Dow Chemical.

Multiple inserts 2000 may be provided, such as two, three or more inserts may be provided in the form of a kit for use in a single surgical procedure. For example, a first insert having two or more device openings may be provided, and a second insert having a plurality of device openings may also be provided. The first and second inserts can have the same number of instrument openings or can have different numbers of instrument openings.

FIG. 7 is a schematic exploded view of an insert 2000 having three device openings 2600 compared to having four device openings as shown in FIG. 1, but similar to that shown in FIG. 4. In FIG. 7, three appliance openings are defined by one relatively large appliance opening (eg, to accommodate a laparoscope or other relatively large diameter device) and relatively (eg, 5 mm gripper, clip applier, etc.). Two relatively small appliance openings for accommodating small diameter devices. As shown in FIG. 7, the instrument channel member 2500 has three instrument channels corresponding to three instrument apertures, one instrument channel being shown to be relatively larger in diameter than the other two instrument channels. The insert 2000 of FIG. 7 may have substantially the same shape and diameter as the insert of FIG. 1. Alternatively, if desired, the inserts can have different diameters and / or different shapes.

FIG. 8 illustrates how the insert of FIG. 7 can be inserted into a sleeve 3000 (shown in half cross section), and the insert 2000 and sleeve 3000 are also flexible tissue retractor 1000 (half cross section). It is a schematic diagram showing how it can be inserted into. As noted above, the sleeve 3000 may include a retaining feature in the form of a generally circumferential ledge or lip 3300, which is generally at the distal end of the generally cylindrical portion 3200 of the sleeve 3000. It is shown to extend radially inward. Lip 3300 may be continuous in the circumferential direction and may be sized and shaped to be in contact with a portion of the insert, such as the distal end of outer body portion 2100 of the insert. If desired, the sleeve 3000 may be formed of a relatively elastic material, and the inner diameter of the portion 3200 of the sleeve 3000 may be of the insert (eg, having a diameter slightly smaller than that of the insert 2000). Sized to engage the outer diameter, the insert can be releasably positioned at multiple insertion depths within the portion 3200. In this way, the insert 2000 can be positioned at multiple insertion depths for the flexible tissue retractor, and the feature 3300 is operable to prevent the insert from being inadvertently pushed into the body cavity.

9 shows a tissue retractor 1000 disposed within the incision of tissue 60, with the insert 2000 being releasably supported in the sleeve 3000, in turn the sleeve 3000 being the tissue retractor 1000. Is releasably supported. The insert 2000 is shown disposed at the distal end of the sleeve 3000, the distal end of the insert being adjacent to the member / retaining lip 3300 of the sleeve.

9 also shows that the sleeve 3000 can have an axial length that is longer than the axial length of the retractor 1000. If desired, the sleeve can be positioned at various depths in the retractor so that the distal end of the sleeve (ie, the distal end of the cylindrical portion 3200) can be located proximal or distal of the distal end of the retractor. In FIG. 9, the distal end of the sleeve is disposed (below) at the distal end of the distal end of tissue retractor 1000, such that the instrument outlet 2016 of the insert 2000 is positioned below the abdominal wall. Retention features (eg, lip member 3300) prevent the insert from being inadvertently pushed into the abdominal cavity 60A. Feature 3300 also facilitates removal of sleeve 3000 and insert 2000 when sleeve is withdrawn proximally from flexible retractor 1000. Thus, the retractor may remain in the incision after removal of the sleeve 3000 carrying the insert.

FIG. 10 illustrates how sleeve 3000 and insert 2000 may be removed with one hand finger gripping the edge of portion 3100 of sleeve 3000 and raising the sleeve proximally (upward in FIG. 10). In a perspective view showing the possibility of the insertion, the insert is carried and held by the sleeve 3000. The insert is shown to be removed with the sleeve when the sleeve is withdrawn from the retractor 1000 and the retractor remains in place at the incision of the tissue 60.

11 shows that the specimen and / or the specimen bag 5000 are inserted through, for example, the passage of the retractor when the sleeve 3000 and the insert 2000 are removed from the passage provided by the flexible retractor 1000. FIG. 11 is a perspective view showing how the gripper device 6000 is removed from the body cavity (eg, the abdominal cavity 60A) in the proximal direction (upward in FIG. 11) through the passage of the flexible retractor 1000.

12 shows a schematic cross-sectional view of an embodiment in which an insert 2000 is disposed within the flexible retractor 1000 without using the sleeve 3000. The flexible retractor 1000 is shown having internal retention features in the form of internal ribs or ribs 1108 for retaining the insert 2000 at a desired depth within the retractor. In FIG. 12, the lip 1108 is positioned about halfway along the length of the passage provided by the retractor 1000 such that the distal end of the insert 2000 is positioned about halfway along the length of the passage of the retractor. It is.

FIG. 12 illustrates an instrument channel of an insert 2000 that may be employed to provide an improved range of movement of the instrument, for example compared to a seal mounted above or below the retractor and a range of movement provided by the instrument support. How the flexible support of the insert in the flexible retractor 1000 allows the device 7000 (e.g., a device for manipulating / gripping the laparoscopic or tissue) extended through it to pivot the insert 2000 itself. Show how you do it.

FIG. 13 provides a schematic cross-sectional view of an assembly that includes an insert 2000, a sleeve 3000, and a retractor 1000, the insert (to seal the instrument access channel when the instrument is not inserted through the channel). A zero closure seal in the form of a duckbill seal 2630 connected to the proximal end of the instrument access channel and a diaphragm seal 2640 in operative connection with the distal end of the instrument access channel for sealing against the instrument inserted into the instrument channel. Including the seal. Alternatively, seal 2640 may be provided at the proximal end of the insert and seal 2630 may be provided at the distal end of the insert.

The device disclosed herein may be designed to be disposed of after a single use or may be designed to be used multiple times. In either case, however, the device may be reinstated for reuse after at least one use. Restoration may include any combination of disassembly of the device, subsequent cleaning or replacement of the particular fragment, and subsequent reassembly. In particular, the device may be disassembled and any number of specific pieces or parts of the device may be selectively replaced or removed in any combination. Upon cleaning and / or replacing a particular part, the device can be reassembled for subsequent use by the surgical team at the restoration facility or immediately before the surgical procedure. Those skilled in the art will appreciate that reinstatement of the device may utilize various techniques for disassembly, cleaning / replacement and reassembly. Such techniques and the use of the restored devices obtained are all within the scope of the present application.

Preferably, the invention described herein will be treated prior to surgical treatment. First, new or used equipment is obtained and cleaned if necessary. The device can then be disinfected. In one disinfection technique, the device is placed in a closed and sealed container such as a plastic or TYVEK bag. The vessel and device are then placed in a radiation region that can penetrate the vessel, such as gamma radiation, x-rays, or high energy electrons. The radiation kills bacteria on the device and in the container. The sterilized device can then be stored in the sterilized container. The sealed container keeps the device sterilized until the container is opened at the medical facility.

It is desirable for the device to be disinfected. This can be done in a number of ways known to those skilled in the art, including beta or gamma radiation, ethylene oxide, steam, and liquid baths (eg, cold soaking).

Those skilled in the art will recognize further features and advantages of the present invention based on the embodiments described above. Accordingly, the invention is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety.

Claims (39)

As a medical device,
A tissue retractor comprising a flexible member having an outer surface for engaging the body incision and an inner surface defining a passageway; And
And an insert releasably supported in the passageway formed by the flexible member and including at least one instrument opening. The method of claim 1,
The insert comprises an outer surface having a size and shape for deforming the flexible member such that at least a portion of the passageway has a predetermined size and shape. The method of claim 1,
The insert includes a generally cylindrical outer surface sized to extend radially such that the flexible member has a generally circular cross section of a predetermined diameter upon insertion of the insert into the passageway. The method of claim 1,
The insert includes a plurality of device openings. The method of claim 1,
The insert includes an assembly comprising an outer portion and an inner portion, the inner portion being rotatable relative to the outer portion. The method of claim 1,
And the outer portion of the insert frictionally engages the inner surface of the flexible member. The method of claim 1,
And a feature for limiting axial movement of the insert into the body cavity. As a medical device,
A flexible tissue retractor having an outer surface for engaging the body incision and an inner surface for forming a body access passageway; And
An insert configured to be inserted into the flexible tissue retractor,
The insert is
An outer sleeve sized and shaped to engage and modify a portion of the inner surface of the flexible tissue retractor;
A housing having an upper surface at least partially disposed within said outer sleeve and comprising a plurality of instrument openings, and
A medical device comprising at least one seal associated with each device opening. The method of claim 8,
The insert further comprises an instrument channel member comprising a plurality of tubular instrument channels, each tubular instrument channel substantially aligned with an instrument opening in the housing. 10. The method of claim 9,
And the housing and the instrument channel member are rotatably supported relative to the outer sleeve. The method of claim 10,
The device channel member is of a single flexible structure, wherein each tubular device channel is independently deformable with respect to the housing and other tubular device channels. The method of claim 11,
And a flip-back suppressing member having a plurality of openings therethrough, wherein the tubular instrument channel extends axially through each of the openings of the flip-back suppressing member. As a medical device,
A flexible tissue retractor having a first end, a second end, and a flexible member extending in the middle of the first and second ends; And
An insert comprising a plurality of instrument openings and configured to be releasably inserted into a flexible member intermediate between the first and second ends of the retractor,
The flexible tissue retractor comprises a first deformable ring connected with a first end of the tissue retractor and a second deformable ring connected with a second end of the tissue retractor,
And the insert is sized and shaped to deform a portion of the flexible member intermediate of the first and second deformable rings. The method of claim 13,
The insert is sized to pass through the first deformable ring without deformation of the first deformable ring. As a medical device,
A flexible tissue retractor having an outer surface for engaging the body incision and an inner surface defining a passageway;
A sleeve in which at least a portion may be located in the passageway; And
A medical device comprising an insert including at least one instrument opening and releasably supported within the passageway. 16. The method of claim 15,
At least a portion of the sleeve is disposed between a portion of the interior surface of the flexible tissue retractor and a portion of the insert. 16. The method of claim 15,
The sleeve includes a generally cylindrical portion sized to be positioned in a passageway between the portion of the flexible member and the portion of the insert. 16. The method of claim 15,
The insert and sleeve are removable together from the passageway of the flexible tissue retractor. 16. The method of claim 15,
And the sleeve is located in a passageway between the outer surface of the insert and a portion of the inner surface of the flexible member, wherein the sleeve comprises a material having a hardness lower than the hardness of the outer surface of the insert. 16. The method of claim 15,
The sleeve includes a feature for limiting axial movement of the insert through the sleeve. 16. The method of claim 15,
And the sleeve has an axial length longer than the axial length of the insert. 16. The method of claim 15,
And the sleeve has an axial length longer than the axial length of the passageway of the retractor. As a way to access the body cavity through the incision,
Positioning a tissue retractor within the incision; And
Releasably positioning an insert having a plurality of instrument openings into the tissue retractor. The method of claim 23, wherein
Positioning the insert comprises pressing the insert into a tissue retractor. The method of claim 23, wherein
Positioning the insert includes modifying at least a portion of the tissue retractor through the incision. The method of claim 23, wherein
And removing the insert from the tissue retractor without removing the tissue retractor from the incision. As a way to access the body cavity,
Making an incision;
Positioning a tissue retractor within the incision;
Positioning a sleeve to extend at least partially within the tissue retractor; And
Positioning an insert having at least one device opening into the sleeve. The method of claim 27,
Positioning the tissue retractor within the incision is performed prior to inserting the sleeve into the retractor. The method of claim 27,
And removing the insert without removing the tissue retractor from the incision. The method of claim 27,
Removing the insert and sleeve together from the tissue retractor. As a medical device,
A tissue retractor comprising a flexible member having an outer surface for engaging the body incision and an inner surface defining a passageway; And
At least one insert having at least one instrument opening and releasably supported in a passage formed by the flexible member,
And the insert is positionable at a different insertion depth in the passageway formed by the flexible member. The method of claim 31, wherein
And the insert is positionable at an insertion depth where the proximal end of the insert is located distal to the proximal end of the flexible member. The method of claim 31, wherein
And the insert is positionable at an insertion depth where the distal end of the insert is located distal to the distal end of the flexible member. The method of claim 31, wherein
A medical device comprising at least first and second inserts, each insert releasably supportable in a passageway, said inserts being interchangeable with each other. The method of claim 34, wherein
Wherein the first and second inserts are interchangeable within the passageway without removing the flexible member from the body incision. As a way to access the body cavity through the incision,
Positioning the flexible tissue retractor in the incision providing a passageway extending through the incision;
Releasably positioning a first insert having at least one instrument opening in a passage provided by the flexible tissue retractor;
Removing the first insert from the passage provided by the tissue retractor; And
Positioning a second insert having at least one instrument opening in the passageway. The method of claim 36,
Positioning at least one of the first and second inserts includes pressing the insert into a tissue retractor. The method of claim 36,
Positioning a removable sleeve in the passage, wherein at least a portion of the sleeve is accessible to the body cavity through an incision disposed between the insert and a portion of the flexible tissue retractor. As a way to access the body cavity through the incision,
Positioning the flexible tissue retractor in the incision providing a passageway extending through the incision;
Releasably positioning an insert having at least one instrument opening at a first depth of the passage provided by the flexible tissue retractor; And
Repositioning the insert to a second depth within the passageway.

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