Patent Application
20110015491
The present invention relates to surgical access devices, such as those used in laparoscopic surgical procedures, typically within the abdominal cavity of the patient. Particularly, the present invention is directed to a surgical access device having at least one device port that is moveable with respect to a housing of the access device.
A variety of surgical access devices are known in the art for maintaining an operative path through an anatomical structure, particularly a patient's abdominal wall, to facilitate insertion of surgical instruments during minimally-invasive (laparoscopic) surgical procedures. Typically, one or more instruments are inserted through such access devices into the peritoneal space, which is insufflated during a procedure, typically with an inert gas such as carbon dioxide. Such access devices maintain the incision opening and minimize trauma through repeated insertion and manipulation of instruments, removal of specimens, and the like. Typically, such access devices are relatively small in size—between about 1.0 and 2.0 centimeters in diameter. Because of size limitations, it is often necessary to utilize multiple access ports in a single procedure, distributed across the abdomen, for example.
Typical access ports are provided with mechanical seals, usually formed from a resilient material. Due to the need for simultaneous use of different instruments, it is often desirable to insert multiple instruments through a single access port. However, with a conventional arrangement, simultaneous insertion of multiple instruments suffers from mutual interference between adjacent instruments and loss of insufflation pressure and gas—loss of the pneumoperitoneum. Accordingly, with previous devices it has proven difficult to achieve desirable results when using multiple instruments through a single access device.
Devices constructed in accordance with the present invention are particularly adapted to use with multiple instruments. The subject devices maintain sealed access through the anatomical structure, such as the abdominal wall, and advantageously stabilize and maintain separation between instruments used simultaneously, avoiding the disadvantages of prior devices.
The subject devices are particularly well suited for use in single-incision laparoscopic surgery or “SILS” procedures. In such procedures, a single incision is formed for access to the operative space, such as through the abdominal wall and into the abdominal cavity. Such procedures advantageously result in minimal to no visible scarring of the patient, particularly when made through the umbilicus. Performance of such procedures suffers from various disadvantages, with adjacent instruments interfering with one another, or promoting loss of insufflation gas. Devices in accordance with the present invention, however, maintain sealed and stabilized access of multiple instruments simultaneously through a common access device, inserted though a single incision.
The purpose and advantages of the present invention will be set forth in and apparent from the description that follows. Additional advantages of the invention will be realized and attained by the devices, and the related methods particularly pointed out in the written description and drawings hereof.
To achieve the above-mentioned and additional advantages, in accordance with one aspect of the invention, a surgical access device for use in laparoscopic surgical procedures is provided, having a housing portion and at least one moveable device port. The housing portion has an axial bore extending therethrough, defining a central axis of the surgical access device. The at least one moveable device port is moveable about an annular path corresponding to an annular seal member. Each moveable device port defines a lumen extending therethrough. Each lumen is substantially parallel to the central axis of the surgical access device.
In accordance with an alternate aspect of the invention, a surgical access device can be configured with a linear path, or alternatively, a path having another shape. In accordance with such aspects, the seal member includes a corresponding shape to maintain sealed access through the surgical access device.
The optional features described herein in connection with a particular embodiment can be incorporated specifically as described, or alternatively such features can be combined in combinations not specifically set forth herein, still in keeping with the spirit of the invention.
The subject surgical access devices can include one substantially axially central stationary device port, or alternatively, more than one such port, held in the housing portion. The stationary device port or ports are preferably restrained from lateral and axial movement, relative to the central axis. Such ports can be completely stationary, or alternatively can be rotatable about a central axis thereof, or alternatively or additionally rotatable about other axes, if desired.
One of the moveable device ports, or more if a plurality thereof is provided, preferably includes a seal member held within a moveable housing. As set forth above, the path, in accordance with one aspect, is annular in configuration. Alternatively, such paths can be provided in alternative shapes, including but not limited to linear, undulating, circular, ovoid, oblong, and so on. The seal member of the moveable device port can be embodied to include a duckbill-type sealing element, configured to seal the lumen of the moveable device port in the absence of an instrument inserted therethrough. Additionally, if so embodied, the seal member of the moveable device port can include an annular seal configured to sealably engage an outer surface of an instrument when inserted therethrough.
In accordance with the invention, a single moveable device port can be provided, or alternatively a plurality of moveable device ports can be provided, such as two, three, four, five, six, seven, eight, nine, ten or more in number.
In accordance with the invention, the circular path can be an annular channel defined by the housing. The annular channel can be configured to restrain the moveable device port from moving in any direction other than along the circular path. Particularly, the moveable device ports can be restrained from radial movement beyond a predetermined region. Additionally or alternatively, the device ports can be restrained from axial movement beyond a predetermined region.
The annular channel is defined within the housing by radially outer and inner channel walls and axially upper and lower channel walls. The axially upper and lower channel walls can be configured to only partially extend radially toward a centerline of the annular channel, permitting passage of instruments through a moveable device port lumen and through the upper and lower channel walls. The annular channel can include a plate formed of a lubricious material on the axially lower channel wall, facilitating movement of the at least one moveable device port. The annular seal member can be compressed by and at least partly positionally secured by the plate.
The annular seal member can include two sealing portions or leaves, extending toward one another about the annular path, and resiliently mutually contacting one another to inhibit flow of insufflation gas though the seal member.
In accordance with a further aspect of the invention, surgical access devices in accordance with the invention can include a body tube extending from a lower end of the housing portion. The body tube, if provided, defines a central lumen extending axially therethrough. At least one engagement feature can optionally be provided on the body tube to facilitate engagement of the surgical access device with an anatomical structure of a patient, such as a portion of the abdominal wall of the patient.
If provided, the at least one engagement feature can be a substantially annular engagement member extending radially outwardly from an outer circumferential wall of the body tube. The annular engagement member can be inflatable with a fluid to expand the volume of the engagement member to promote engagement with the anatomical structure. Accordingly, the annular engagement member can be in communication with an insufflation connection on the surgical access device. A multi-way valve can be provided, interposed between the insufflation connection, an insufflation output into the surgical access device and into at least one engagement member. Accordingly, the engagement members can be inflatable with a gas such as air, or carbon dioxide, or alternatively can be embodied for inflation with a liquid, such as saline.
Surgical access devices can be provided with an insufflation port in fluid communication with the lumen, arranged below the annular seal member, for example, adapted and configured for providing insufflation gas to an operative cavity.
If desired, at least one anchor point on the housing portion can be provided, configured and adapted for engagement with a suture material for tethering to an anatomical structure of a patient. Such anatomical structure can be a portion of the abdominal wall of the patient, for example.
Further, in accordance with another aspect, the invention includes a method of accessing a surgical operative space, comprising the steps of forming an incision through an anatomical structure and inserting a surgical access device through the incision, where the surgical access device has a housing portion having an axial bore extending therethrough, defining a central axis of the surgical access device, and at least one moveable device port, moveable about an annular path corresponding to an annular seal member, each moveable device port defining a lumen extending therethrough, each lumen being substantially parallel to the central axis of the surgical access device. In accordance with this aspect, the operative space can be a patient's abdominal cavity and the anatomical structure can be the patient's abdominal wall. Alternatively, the operative space can be a patient's thoracic cavity, or other area of the body.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and are intended to provide further explanation of the invention.
The accompanying drawings, which are incorporated in and constitute part of this specification, are included to illustrate and provide a further understanding of the invention. Together with the description, the drawings serve to explain the principles of the invention, wherein:
Reference will now be made in detail to the presently preferred embodiments of the invention, examples of which are illustrated in the accompanying drawings.
As set forth hereinabove, the devices and related methods presented herein are particularly suited for laparoscopic procedures, in-particular for single-incision laparoscopic surgeries, or “SILS.” The subject devices provide various advantages, including but not limited to sealed simultaneous insertion of multiple instruments, as well as support and guidance of such instruments. Further, the guidance of such support is adjustable when inserted though a moveable device port.
The housing 110 includes a lower portion 110a, and an upper portion 110b. The upper 110b and lower 110a portions can be formed separately and joined by any suitable technique, including but not limited to a threaded connection, mechanical interlock, such as a bayonet-type lock, press or friction fitting, adhesives, heat, solvent or ultrasonic welding, or the like.
The housing 110 and other elements of surgical access devices in accordance with the invention can be formed of polymeric materials, such as plastics, composites, such as fiber-reinforced plastics, or other materials, for example. Seal members described herein can be formed of any suitable materials, such as polymeric materials including elastomers and composites containing elastomers, or other suitable materials, such as silicone, for example. Surfaces that are preferably easily slideable with respect to others can be formed of a low-friction material such as polytetrafluoroethylene, or the like. The housing and other components can be formed from acrylic materials, or the like. Processes for manufacturing the parts can include, without limitation, injection molding, machining vacuum forming of composite materials, or other techniques.
Within the housing 110 are held one or more moveable device ports 113. As illustrated, two such moveable device ports 113a, 113b are provided and held within the housing, as will be describe in more detail below. The housing optionally includes a central device port 111. The central device port 111 is preferably constrained from movement with respect to the housing 110. In accordance with an alternate aspect, lateral and axial movement are substantially inhibited, while rotation relative to a longitudinal axis of the surgical access device 100 is permitted. Alternatively still, the surgical access device 110 can be configured to permit the central device port 111 to move radially, such as along a linear channel (not illustrated), formed in the central device port supports 112a, 112b. Further, multiple central and/or stationary device ports can be provided, combined with moveable ports, as will be appreciated, and which aspect is within the scope of the invention.
With reference to
The annular seal member 214, which can be embodied in other configurations, such as linear configurations, permits repositioning or translation of an instrument therethrough, while maintaining a sealed closure across the remainder of the seal member 214. As seen in
The annular seal member 214 can be formed by molding, such as injection molding, or another suitable process, such as a vacuum lamination process, for example. Materials suitable for construction of the seal member can include, for example, elastomers or composites such as fiber-reinforced polymers, for example. The seal member 214 can be provided with features such as gussets or stays to prevent inversion of the seal under high insufflation pressures.
Further, in the illustrated embodiment, as well as in other embodiments discussed hereinbelow, a valve 129 is provided for insufflation of the operative space, such as the abdominal cavity, during a procedure. A fluid conduit is connected to the valve 129 from a surgical insufflator, for example. The valve 129 is then opened to permit entry of insufflation gas, rotated to release insufflation gas to the surroundings, or as discussed in more detail below, to inflate anchor elements for securing the position of the surgical access device.
Further optional features that can advantageously be applied to devices in accordance with the invention include suture tie-down points or anchor points 119 provided in connection with the housing 110.
With reference to
As seen in
With reference to
Similarly, with reference to
As best seen in the cross-sectional view of
As mentioned above, a compression plate 216, preferably formed of a relatively low friction material, such as a lubricious material, defines the face of the axially lower channel wall and facilitates movement of the moveable device ports 113. The annular seal member 214, is held below the compression plate 216, between the plate 216 and the lower housing portion 110a.
The cross-sectional view of
Moreover, each of the moveable device ports 113 can include a seal element in connection therewith to further seal between the device port 113 and the annular seal member 214, such as may be necessary when an instrument is inserted therethrough. When an instrument is inserted through the annular seal member 214 so-called “cat-eyeing” may occur, and may result in small amounts of gas loss. Accordingly, a seal member filling the space between the moveable device port 113 and the annular seal member 214 may be desirable. Such additional seal member can be embodied as a skirt formed of a resilient material and shaped to interface with the arcuately concave surface of the upper face of the annular seal member 214, for example.
As embodied, the surgical access device 1400 includes a unitary housing 110 and body tube 120, but it is to be understood that a separable configuration can be effected as with above-described embodiments, and vice versa. In
In the illustrated embodiment, the anchor elements 1426, 1428 are substantially annular in configuration and are inflatable by introduction of insufflation gas by way of a multi-way valve 1429, fill tube 1424 and one or more internal fill channels 1629 (See
In accordance with an alternate aspect of the invention, a surgical access device can configured with a linear path, or a path having another shape. In accordance with such aspects, the seal member, corresponding to seal member 214, is shaped to match with the moveable device port channel, such as channel 115, to maintain sealed access through the surgical access device. As mentioned above, the central device port 111 can be configured as a radially moveable device port in such a manner.
Devices in accordance with the invention are dimensioned similarly to other devices in the art, but sufficiently large to include all required elements. In accordance with one aspect, the body tube of surgical access devices of the invention has about a 2.5 centimeter outer diameter. The inner device ports, such as the stationary and moveable device ports, can be sized to accommodate a range of instrument diameters, such as instruments of about 5.0 mm in diameter to about 10.0 mm in diameter, but not limited to this range. The subject access devices can simultaneously include device ports of multiple sizes, as desired or required. Instruments that can be inserted through the subject access devices include any surgical instrument suitably sized, including but not limited to endoscopes, graspers, dissectors, staplers, and the like.
In accordance with a further aspect of the invention, a plurality of moveable device ports can be provided between inner and outer channel walls, as illustrated in the above embodiments. A surgical access device can include such moveable device ports, and be configured such that movement of one or more rotational elements, such as one or more rings held on the housing, effects arcuate translation of one or more moveable device ports along the channel. Such an embodiment can include one ring that simultaneously moves all moveable device ports, or alternatively, separate rings for each device port, for example. Such a configuration can be embodied as a planetary-type gear arrangement, with mutual frictional engagement, or alternatively gear teeth to enhance engagement and response to a call for movement.
Further, in accordance with another aspect, the invention further includes a method of accessing a surgical operative space, comprising the steps of forming an incision through an anatomical structure and inserting a surgical access device through the incision, where the surgical access device has a housing portion having an axial bore extending therethrough, defining a central axis of the surgical access device, and at least one moveable device port, moveable about an annular path corresponding to an annular seal member, each moveable device port defining a lumen extending therethrough, each lumen being substantially parallel to the central axis of the surgical access device. In accordance with this aspect, the operative space can be a patient's abdominal cavity and the anatomical structure can be the patient's abdominal wall.
The devices and related methods of the present invention, as described above and shown in the drawings, provide for surgical access devices with superior properties including enhanced control and reduced interference from surgical instruments being used simultaneously during a surgical procedure, particularly single-incision procedures.
It will be apparent to those skilled in the art that various modifications and variations can be made to the devices, and related methods of the present invention without departing from the spirit or scope of the invention. Thus, it is intended that the present invention include modifications and variations that are within the scope of the appended claims and their equivalents.
