SURGICAL ACCESS DEVICE WITH FASCIAL CLOSURE SYSTEM

Abstract

A surgical access device is disclosed and includes a housing, a cannula, a guide, and an expandable member. The cannula extends distally from the housing and defines a longitudinal axis. A wall of the cannula includes a first slot defined therein. The guide is engagable with the housing and defines a first channel. The first channel is disposed at a non-parallel angle relative to the longitudinal axis. The expandable member is disposed adjacent a distal portion of the cannula and is transitionable between a collapsed configuration and an expanded configuration. A first surgical instrument is insertable through the first channel of the guide and through the first slot of the cannula.

Claims

1. (canceled)

2. A surgical access device, comprising: a housing; a cannula extending distally from the housing and defining a longitudinal axis, the cannula including a wall defining a first slot; a guide engagable with the housing and defining a first channel that is disposed at a non-parallel angle relative to the longitudinal axis; and a lumen extending through the housing, through the cannula, and through the guide, the lumen being coaxial with the longitudinal axis, wherein a first surgical instrument is insertable through the first channel of the guide and through the first slot of the cannula.

3. The surgical access device according to claim 2, wherein the wall of the cannula defines a second slot.

4. The surgical access device according to claim 3, wherein the first slot of the cannula is disposed at a first distance along the longitudinal axis from the housing, the second slot of the cannula is disposed at a second distance along the longitudinal axis from the housing, the second distance is greater than the first distance.

5. The surgical access device according to claim 2, wherein the first slot is completely bound by the wall of the cannula.

6. The surgical access device according to claim 3, wherein each of the first slot and the second slot is completely bound by the wall of the cannula.

7. The surgical access device according to claim 2, wherein an entirety of the lumen is coaxial with the longitudinal axis.

8. The surgical access device according to claim 2, wherein the first channel includes a proximal end, the housing includes a proximal end, and the proximal end of the first channel extends through the proximal end of the housing.

9. The surgical access device according to claim 2, further including a channel disposed within the wall of the cannula, the cannula including a proximal portion and a distal portion, the channel extending between the proximal portion of the cannula and the distal portion of the cannula.

10. The surgical access device according to claim 2, wherein the cannula includes an inner tube and an outer tube.

11. A surgical access device, comprising: a cannula defining a longitudinal axis, the cannula including a proximal portion, a distal portion, and a wall defining a first slot; a guide disposed in mechanical cooperation with the cannula, the guide defining a first channel that is disposed at a non-parallel angle relative to the longitudinal axis; and a lumen extending through the cannula, and through the guide, the lumen being coaxial with the longitudinal axis, wherein a first surgical instrument is simultaneously insertable through the first channel of the guide and through the first slot of the cannula.

12. The surgical access device according to claim 11, further having an expandable member disposed adjacent the distal portion of the cannula, the expandable member transitionable between a collapsed configuration and an expanded configuration.

13. The surgical access device according to claim 12, wherein the expandable member includes a fixation mesh.

14. The surgical access device according to claim 11, wherein the wall of the cannula is formed from an inner tube and an outer tube.

15. The surgical access device according to claim 14, further having an expandable member disposed adjacent the distal portion of the cannula, the expandable member being a mesh member that expands upon movement of the outer tube distally from a first position to a second position relative to the inner tube.

16. The surgical access device according to claim 11, wherein an entirety of the lumen is coaxial with the longitudinal axis.

17. The surgical access device according to claim 11, wherein the wall of the cannula defines a second slot.

18. The surgical access device according to claim 17, wherein the first slot of the cannula is disposed at a first distance along the longitudinal axis from the guide, the second slot of the cannula is disposed at a second distance along the longitudinal axis from the guide, the second distance is greater than the first distance.

19. The surgical access device according to claim 11, wherein the first slot is completely bound by the wall of the cannula.

20. The surgical access device according to claim 17, wherein each of the first slot and the second slot is completely bound by the wall of the cannula.

21. The surgical access device according to claim 11, further including a housing disposed adjacent the proximal portion of the cannula, wherein the guide is engageable with the housing.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Various embodiments of the present disclosure are illustrated herein with reference to the accompanying drawings, wherein:

[0017] FIG. 1 is a perspective view of a surgical access device including a balloon fixation device of the present disclosure;

[0018] FIG. 1A is a perspective view of the surgical access device of FIG. 1 with a guide separated from a housing of the surgical access device;

[0019] FIG. 2 is a perspective view of the surgical access device of FIG. 1 including a suture passer inserted therethrough;

[0020] FIG. 3 is a side view of the surgical access device of FIG. 1 including a suture passer inserted therethrough;

[0021] FIG. 4 is a perspective view of an inner tube and an outer tube of the surgical access device of FIGS. 1-3 in accordance with an embodiment of the present disclosure;

[0022] FIG. 5 is a perspective view of an inner tube and an outer tube of the surgical access device of FIGS. 1-3 in accordance with another embodiment of the present disclosure;

[0023] FIG. 5A is an enlarged view of the area of detail indicated in FIG. 5;

[0024] FIG. 6 is a perspective view of a distal end of a cannula of a surgical access device in accordance with another embodiment of the present disclosure;

[0025] FIG. 7 is a perspective view of a surgical access device including a fixation mesh device in accordance with another embodiment of the present disclosure;

[0026] FIG. 7A is a perspective view of an inner tube of the surgical access device of FIG. 7;

[0027] FIG. 8 is a perspective view of the surgical access device of FIG. 7 including a suture passer inserted therethrough;

[0028] FIG. 9 is a perspective view of a surgical access device in accordance with another embodiment of the present disclosure including a suture passer extending therethrough and illustrating a fixation mesh in a deployed configuration; and

[0029] FIG. 10 is a side view of a distal end of the surgical access device and suture passer of FIG. 9 illustrating the fixation mesh in an undeployed configuration.

DETAILED DESCRIPTION

[0030] Embodiments of the presently disclosed surgical access device are described in detail with reference to the drawings, wherein like reference numerals designate corresponding elements in each of the several views.

[0031] Various embodiments of a surgical access device are described herein. Generally, the surgical access devices include a fixation device (e.g., a balloon fixation device or a fixation mesh device) configured to engage tissue to help maintain the surgical access device in its position relative to the body during use, and include a fascial closure system which creates an efficient way of closing the incision through which the surgical access device entered the body. FIGS. 1-6 illustrate embodiments of a surgical access device including a balloon fixation device, and FIGS. 7-10 illustrate embodiments of a surgical access device including a fixation mesh device. It is envisioned that the surgical access devices disclosed herein are useful in Hasson techniques, as well as those using blunt, bladeless, bladed and/or optical obturators where the surgical access device is used to gain entry to the abdomen for laparoscopy, for example.

[0032] With initial reference to FIGS. 1-3, a surgical access device 100 is shown. Surgical access device 100 includes a housing 109 and a cannula 200 extending distally from housing 109. The cannula 200 defines a longitudinal axis “A-A.” A guide or suture guide 110 is attached to or configured to selectively engage the housing 109. The guide has an upper flange and a tube extending from the flange. The guide 110 flange and tube define a first channel 112 and a second channel 114 extending therethrough (FIG. 2), and includes a seal 115 (e.g., an O-ring) (FIG. 1A) on the tube configured to engage an inner wall of cannula 200 for establishing a fluid-tight boundary in the cannula that maintains a pneumoperitoneum in a patient. The access device 100 has an instrument seal housing that is removed from the housing 109 before the guide is attached to the access device 100. The housing 109 includes a zero closure seal, such as a duckbill seal, for sealing the passageway of the cannula when no instrument is inserted through it.

[0033] Surgical access device 100 also includes an expandable member or balloon fixation device 300 disposed adjacent a distal end of cannula 200, and at least one slot 250 defined in the cannula 200. As shown in FIGS. 2 and 3, a suture passer “SP” (for example) is insertable through one of channels 112, 114 of guide 110 and through one of slots 250 of cannula 200. Generally, suture passers “SP” are configured to pass a suture through a cannula 200 and to tissue adjacent an incision, for instance.

[0034] Additional description of an access device, guide, and suture passer can be found in U.S. Patent Application Publication No. 2015/003879, filed on Jul. 29, 2014, now U.S. Pat. No. 10,258,324, the entire contents of which being hereby incorporated by reference herein. A sealing member is disposed over the slot 250 in the cannula and can be formed from an elastomeric film or tube disposed over the slot 250.

[0035] Further details of various embodiments of surgical access device 100 are discussed below with reference to FIGS. 4-6. FIG. 4 illustrates an embodiment of a cannula 200a for use with surgical access device 100. Cannula 200a includes an inner tube 220a and an outer tuber 240a. Inner tube 220a is configured to fit within outer tube 240a, and includes at least one slot 230a defined therein. In embodiments, inner tube 220a includes two slots 230a that are 180° offset from each other. In particular, slot 230a is defined by a recessed surface 222a of an outer wall of inner tube 220a. While slot 230a is oval-shaped in the accompanying figures, slot 230a may be any regular or irregular shape, such as circular, rectangular, etc. Further, a film 235a covers slot 230a and may be affixed to recessed surface 222a of inner tube 220a by welding (e.g., ultrasonic welding), for instance, or adhesive bonding. It is envisioned that the outer wall of inner tube 220a and film 235a cooperate to form a flush or nearly flush surface.

[0036] With continued reference to FIG. 4, outer tube 240a is configured to fit over inner tube 220a, has a shorter length than inner tube 220a, and includes at least one slot 250a defined therein. As shown in FIG. 3, outer tube 240a includes two slots 250a that are 180° offset from each other. Each slot 250a is shaped to correspond with slot 230a of inner tube 220a, is covered by a film 255a, and is configured to radially and longitudinally align with slot 230a of inner tube 220a when outer tube 240a and inner tube 220a are engaged.

[0037] Balloon 300 (FIGS. 1-3) is mounted adjacent a distal end of cannula 200a and is transitionable between a collapsed or deflated configuration and an expanded or inflated configuration. In particular, a distal end 302 of balloon 300 is mounted to or adjacent a distal end 221a of inner tube 220a, and a proximal end 304 of balloon 300 is mounted to or adjacent a distal end 241a of outer tube 240a (FIGS. 1 and 4). In this arrangement, air (or another inflation medium) is forced from an inflation port 111 (FIGS. 1-3), between inner tube 220a and outer tube 240a of cannula 200a, out distal end 241a of outer tube 240a (distal end 241a of outer tube 240 is disposed proximally of distal end 221a of inner tube 220a), and into balloon 300 to inflate balloon 300. To deflate balloon 300, the inflation medium is removed from balloon 300, between inner tube 220a and outer tube 240a of cannula 200a, and out of inflation portion 111. Films 235a and 255a help ensure the air/gas from a pressurized environment within the patient does not escape through inner tube 220a or outer tube 240a of cannula 200a. The balloon can be formed as disclosed in U.S. Pat. No. 10,987,128, the entire disclosure of which is hereby incorporated by reference herein.

[0038] In use, a distal portion of cannula 200a is positioned within a patient (e.g., in the abdominal cavity), balloon 300 is inflated through inflation port 111 to help secure cannula 200a with respect to the patient, and a surgical procedure is performed (e.g., by a surgical instrument inserted through a lumen 270a (FIG. 3) of cannula 200a). Following the surgical procedure, the surgical instrument is removed from lumen 270a, and the instrument seal housing is removed from engagement with housing 109, and a portion of guide 110 is inserted through cannula 200a. Next, a suture passer “SP” (FIGS. 2 and 3) is inserted through first channel 112 or second channel 114 of guide 110 and at a non-parallel angle with respect to the longitudinal axis “A-A.” Thus, the suture passer “SP” follows a different pathway from the surgical instruments previously used. First channel 112 is angled such that a distal tip of the suture passer “SP” is moved through a neck of balloon 300 and toward slot 230a of inner tube 220a. Urging the suture passer “SP” distally forces the distal tip of the suture passer “SP” to pierce film 235a covering slot 230a of inner tube 220a, to pierce film 255a covering slot 250a of outer tube 240a, and to extend out from the outer tube 240a. Depending on the shape, size and/or orientation of balloon 300, a physician may opt to insert suture passer “SP” into guide 110 and to patient tissue following deflation of balloon 300 to help prevent the distal tip of the suture passer “SP” from interfering with balloon 300. After the distal tip of the suture passer “SP” is positioned at tissue, the suture passer “SP” can be used to suture tissue, or perform a fascial closure. The cannula can include a single slot. In additional embodiments, the cannula 200a includes more than one set of slots, and an additional suture passer or other device can also be inserted through guide 110 (e.g., through channel 114) and through cannula 200a. This can be done while the first suture passer “SP” is at the tissue, or after the first suture passer “SP” has been removed. Thus, the first channel and second channel of the guide 110 is arranged and shaped so that the suture passer is directed toward a particular slot through the cannula when the guide is properly attached to the access device.

[0039] FIG. 5 illustrates a further embodiment of a cannula 200b for use with surgical access device 100. Cannula 200b includes an inner tube 220b and an outer tuber 240b. Inner tube 220b is configured to fit within outer tube 240b, and includes at least one slot 230b defined therein. While slot 230b is oval-shaped in the accompanying figures, slot 230b may be any regular or irregular shape, such as circular, rectangular, etc. Inner tube 220b includes a flange 232b surrounding slot 230b. While slot 230b is not covered by a film in the accompanying figures, slot 230b may be covered by a film. Flange 232b (see FIG. 5A) protrudes from inner tube 220b and is configured to engage or nest within a portion of outer tube 240b, as discussed below.

[0040] Outer tube 240b is configured to fit over inner tube 220b, has a shorter length than inner tube 220b, and includes at least one slot 250b defined therein. In embodiments, the inner tube 220b includes two slots 250b that are 180° offset from each other to provide further options to the surgeon during fascial closure. Each slot 250b is shaped to correspond with a slot 230b of inner tube 220b, and is configured to radially and longitudinally align with slot 230b of inner tube 220b when outer tube 240b and inner tube 220b are assembled. Additionally, flange 232b of inner tube 220b is configured to nest within slot 250b of outer tube 240b when outer tube 240b and inner tube 220b are engaged. This helps align the inner tube 220b and the outer tube 240b. Thus, only one film is needed for providing an air-tight or nearly air-tight passage. Additionally, cannula 200b can include a balloon 300 or other expandable structure at or adjacent a distal end thereof.

[0041] FIG. 6 illustrates another embodiment of a cannula 200c for use with surgical access device 100. Cannula 200c includes an elongated tube 220c having channels 240c defined within the wall of elongated tube 220c. Elongated tube 220c extends distally from housing 109, and includes at least one slot 230c defined therein. While slot 230c is oval-shaped in the accompanying figures, slot 230c may be any regular or irregular shape, such as circular, rectangular, etc. In particular, slot 230c is defined by a recessed surface 222c of elongated tube 220c. Further, a film 235c covers slot 230c and may be affixed to recessed surface 222c of elongated tube 220c by welding (e.g., ultrasonic welding), for instance, or adhesive bonding. It is envisioned that an outer surface 221c of elongated tube 220c and film 235c cooperate to form a flush or nearly flush surface.

[0042] Channels 240c extend along a length (e.g., an entire length) of elongated tube 220c and are defined within the wall of elongated tube 220c. In particular, channels 240c extend between outer surface 221c and an inner surface 223c of elongated tube 220c. Channels 240c are in fluid communication with balloon 300, which is mounted adjacent a distal end of elongated tube 220c, such that when air (or another inflation medium) is forced from inflation port 111 of housing 109 through channels 240c, the air flows out of channel openings 242c into balloon 300 and inflates balloon 300. To deflate balloon 300, the inflation medium is removed from balloon 300, proximally through channels 240c, and out of inflation port 111. Film 235c helps ensure the air/gas from the pressurized environment within the patient does not escape through the wall of elongated tube 220c of cannula 200c.

[0043] In embodiments where channels 240c extend an entire length of elongated tube 220c, a distal end 244c of each channel 240c is occluded or blocked to prevent air from escaping therefrom. Including channels 240c that extend an entire length of elongated tube 220c may help optimize manufacturing of cannula 200c. For example, elongated tube 220c can be extruded, and channels 240c extending the length of elongated tube 220c can be formed during the extrusion of elongated tube 220c.

[0044] Additionally, in embodiments where cannula 200c includes two channels 240c and two slots 230c, channels 240c and slots 230c may be angularly offset from each other to prevent interference therebetween. For example, channels 240c and slots 230c can be offset by 90° or another suitable angle.

[0045] In use, a distal portion of cannula 200c is positioned within a patient (e.g., in the abdominal cavity), balloon 300 is inflated through inflation port 111 to help secure cannula 200c with respect to the patient, and a surgical procedure is performed (e.g., by a surgical instrument inserted through a lumen 270c of cannula 200c). Following the surgical procedure, the surgical instrument is removed from lumen 270c, and the instrument seal housing is removed from engagement with housing 109, and a portion of guide 110 is inserted through cannula 200c. Next, a suture passer “SP” (FIGS. 2 and 3) is inserted through first channel 112 or second channel 114 of guide 110 and at a non-parallel angle with respect to the longitudinal axis “A-A.” Thus, the suture passer “SP” follows a different pathway from the surgical instruments previously used. First channel 112 is angled such that a distal tip of the suture passer “SP” is moved toward slot 230c of cannula 200c. Urging the suture passer “SP” distally forces the distal tip of the suture passer “SP” to pierce film 235c covering slot 230c of cannula 200c, and to extend out from the cannula 200c. One or more suture passers “SP” can be used. If cannula 200c includes more than one slot 230c, the slots can be angularly and/or longitudinally offset from one another to accommodate multiple suture passers “SP.” The suture passers “SP” deliver suture to tissue at the incision, so the incision can be closed.

[0046] FIGS. 7-8 illustrate a further embodiment of a cannula 200d for use with surgical access device 100. Cannula 200d includes an inner tube 220d (FIG. 7A), an outer tuber 240d, and a fixation mesh 260d. Inner tube 220d is configured to fit within outer tube 240d, and includes at least one slot 230d defined therein. While slot 230d is oval-shaped in the accompanying figures, slot 230d may be any regular or irregular shape, such as circular, rectangular, etc. In particular, slot 230d is defined by a recessed surface 222d of inner tube 220d. Further, a film 235d covers slot 230d and may be affixed to recessed surface 222d of inner tube 220d by welding (e.g., ultrasonic welding), for instance, or adhesive bonding. It is envisioned that the outer wall of inner tube 220d and film 235d cooperate to form a flush or nearly flush surface. Film 235d helps ensure the insufflation medium (e.g., CO2) from a pressurized environment within the patient does not escape through inner tube 220d of cannula 200d.

[0047] Fixation mesh 260d includes a balloon-like cover and is positioned around (e.g., surrounding the walls of) inner tube 220d. The cover can be formed from an elastomeric film. The film can be molded in a shape to encourage the expansion of the mesh member 260d.

[0048] Outer tube 240d is configured to fit over inner tube 220d, has a shorter length than inner tube 220d, and includes at least one slot 250d defined therein. Slot 250d is shaped to correspond to slot 230d and is configured to radially and longitudinally align with slot 230d of inner tube 220d when outer tube 240d and inner tube 220d are assembled. Two angularly aligned and longitudinally offset slots 250d are provided, as shown in FIG. 7, and will be discussed in further detail below.

[0049] In use, a distal portion of cannula 200d is positioned within a patient (e.g., in the abdominal cavity), fixation mesh 260d is deployed by moving an activation tab 241 distally along the cannula length to expand fixation mesh 260d and to help secure cannula 200d with respect to the patient. In doing this, lower slot 250di of outer tube 240d moves away from slot 230d of inner tube 220d, and upper slot 250d2 of outer tube 240d moves into alignment with slot 230d. A surgical procedure is then performed (e.g., by a surgical instrument inserted through a lumen 270d defined through guide 110 and cannula 200d). Following the surgical procedure, the surgical instrument is removed from lumen 270d, and the instrument seal housing is removed from engagement with housing 109, and a portion of guide 110 is inserted through cannula 200d. Next, a suture passer “SP” (FIGS. 2 and 3) is inserted through first channel 112 or second channel 114 of guide 110 and at a non-parallel angle with respect to the longitudinal axis “A-A.” Thus, the suture passer “SP” follows a different pathway from the surgical instruments previously used. First channel 112 is angled such that a distal tip of the suture passer “SP” is moved toward slot 230d of inner tube 220d. Urging the suture passer “SP” distally forces the distal tip of the suture passer “SP” to pierce film 235d covering slot 230d of inner tube 220d, and extend through slot 250d of outer tube 240d. Depending on the shape, size and/or orientation of fixation mesh 260d, a physician may opt to insert suture passer into patient following the movement of fixation mesh 260d to its pre-deployed or undeployed position to help prevent the distal tip of the suture passer from interfering with a deployed portion of fixation mesh 260d. After the distal tip of the suture passer is positioned at tissue, the suture passer can be used to perform a fascial closure. The suture passer can extend through slot 230d and slot 250di when fixation mesh 260d is not deployed, or through slot 230d and slot 250d2 when fixation mesh 260d is deployed.

[0050] In some embodiments, inner tube 220d and outer tube 240d of cannula 200d include more than one angularly offset sets of slots to accommodate more than one suture passer.

[0051] FIGS. 9 and 10 illustrate another embodiment of a cannula 200e for the surgical access device 100. Cannula 200e includes an elongated tube 220e, and a fixation mesh 260e. Elongated tube 220e includes at least one slot 230e (e.g., an oval-, round-, rectangular-, or other-shaped slot) defined therein. In contrast to the embodiment of cannula 200d discussed above with regard to FIGS. 7 and 8, slot 230e is not covered by a film, but a film may be provided in other embodiments.

[0052] Fixation mesh 260e can include a balloon-like cover and is positioned around (e.g., surrounding the wall of) elongated tube 220e. Further, fixation mesh 260e covers a substantial portion of the length of cannula 200e, and can be adhered or affixed to a flange 205e of cannula 200e in an air-tight manner to provide an air-tight seal therebetween. In this regard, fixation mesh 260e helps ensure the air/gas from a pressurized environment within the patient does not escape through elongated tube 220e of cannula 200e.

[0053] In use, a distal portion of cannula 200e is positioned within a patient (e.g., in the abdominal cavity), fixation mesh 260e is deployed by moving flange 205e distally along the cannula length. This expands fixation mesh 260e to help secure cannula 200e with respect to the patient. A surgical procedure is performed (e.g., by a surgical instrument inserted through a lumen 270e defined through guide 110 and cannula 200e). Following the surgical procedure, the surgical instrument is removed from lumen 270e, and the instrument seal housing is removed from engagement with housing 109, and a portion of guide 110 is inserted through cannula 200d. Next, a suture passer “SP” (FIGS. 2 and 3) is inserted through first channel 112 or second channel 114 of guide 110 and at a non-parallel angle with respect to the longitudinal axis “A-A.” Thus, the suture passer “SP” follows a different pathway from the surgical instruments previously used. First channel 112 is angled such that a distal tip of the suture passer “SP” is moved adjacent slot 230e of elongated tube 220e at a non-parallel angle with respect to the longitudinal axis “A-A.” Urging the suture passer “SP” distally forces the distal tip of the suture passer “SP” to pierce fixation mesh 260e, and to thereby extend out from cannula 200e. A physician may opt to insert suture passer “SP” into patient following the movement of fixation mesh 260e to its pre-deployed or undeployed position or may pass the suture passer through fixation mesh 260e while it is in the deployed state. After the distal tip of the suture passer “SP” is positioned within tissue, the suture passer “SP” can be used to perform a fascial closure or other closure or suturing of tissue. Additionally, in embodiments where elongated tube 220e of cannula 200e includes more than one angularly offset slot, a second suture passer can also be inserted through cannula 200e.

[0054] The present disclosure also includes methods of performing a surgical procedure including using the fixation device (e.g., inflatable member 300 or fixation mesh 260d, 260e) to secure the surgical access device 100 within tissue, performing a surgical procedure through the cannula, removing a seal housing from housing 109, mounting guide 100 to housing 109, inserting a distal portion of a suture passer through channel 112, 114 of guide 110 and through a slot in the cannula 200, and performing a fascial closure or other procedure on tissue. As noted above, depending on the particular embodiment of the surgical access device 100, the fixation device can remain inflated/deployed during the fascial closure, or the fixation device can be deflated/undeployed while the fascial closure is performed.

[0055] While the above description contains many specifics, these specifics should not be construed as limitations on the scope of the present disclosure, but merely as illustrations of various embodiments thereof. Therefore, the above description should not be construed as limiting, but merely as exemplifications of various embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto