Patent Application
20100137681
The present invention relates to methods and apparatus for managing one or more instruments and/or tools used during endoscopic diagnostic and therapeutic procedures. More particularly, the present invention relates to methods and devices used to facilitate instrument management and use during procedures where flexible endoscopic instruments are advanced into a patient body via one or more natural orifices or other access ports.
Endoscopic procedures and surgery typically entail the advancement and use of one or more instruments through the natural orifices and/or other access ports of a patient body and through the tortuous endoscopic pathways to reach the tissue regions of interest. Even procedures performed in body spaces within the patient may entail entry and advancement through one or more openings created in the patient body to gain entry into the desired body space, e.g., entry through a percutaneous opening or a gastrotomy to gain entry into the peritoneal space of the patient.
Because endoscopic surgery may involve the use of multiple instruments through a single conduit into the patient body, efficient management and use of these instruments may be difficult in part not only because of the number of instruments utilized, but also because these multiple instruments typically converge from a single conduit, which may be limited by the cross-sectional profile of the body lumen, organ, orifice, passageway, etc., in which the conduit is disposed. At the same time, advances in therapeutic endoscopy have led to an increase in the complexity of endoscopic operations attempted, as well as the complexity of tools advanced through the working lumens of these conduits.
Because of the number of instruments which converge typically from a single conduit, difficulties may arise in effectively handling and managing the placement, positioning, and use of these multiple instruments in an effective and safe manner.
For example, flexible endoscopes and flexible endoscopic instruments provide the ability for an operator to intubate the patient and to provide therapy to the internal anatomy by way of non-straight access pathways. Typical endoscopes have the ability to steer at the tip and provide light and visualization, gas insufflation, and lens rinsing. Such endoscopes will typically include one or two instrument channels. These instrument channels include an angled interface on the handle of the endoscope having a bend of about 45 degrees on a relatively short section of the handle. One result of this configuration is that any instrument that is to be inserted into the endoscope instrument channel must include a shaft that is flexible over its entire length.
Accordingly, there is a need for methods and devices for facilitating the introduction and management of all the instruments advanced through the relatively small conduits for performing endoscopic procedures.
An endoscopic tissue manipulation assembly may comprise, at least in part, a distal end effector assembly disposed or positionable at a distal end of a flexible and elongate body. Examples are described in further detail in U.S. Pat. Pub. No. 2005/0272977 A1, which is incorporated herein by reference in its entirety. A handle assembly may be connected to a proximal end of the elongate body and include a number of features or controls for articulating and/or manipulating both the elongate body and/or the distal end effector assembly. The elongate body may optionally utilize a plurality of locking or lockable links nested in series along the length of the elongate body which enable the elongate body to transition between a flexible state and a rigidized or shape-locked configuration. Details of such a shape-lockable body may be seen in further detail in U.S. Pat. Nos. 6,783,491; 6,790,173; and 6,837,847, each of which is incorporated herein by reference in its entirety.
One or more various instruments may be passed through the elongate body for deployment through its distal end by introducing the instruments through one or more corresponding tool ports located in the handle assembly. One instrument in particular which may be used to endoscopically visualize procedures and tissue regions of interest may include an endoscope or imaging system having a flexible shaft which may be introduced into the elongate body via a side port, e.g., Y-Port, located along the elongate body and distal to the handle assembly.
Because of the number of different instruments and the different types of tools which may be utilized in the endoscopic tissue manipulation assembly, tool or instrumentation management is one consideration for the practitioner or practitioners to facilitate efficient surgical and/or endoscopic procedures when performed upon a patient. Additionally, the division of responsibility for instrumentation management between one or more practitioners is highly desirable to ensure patient safety and procedure facilitation. Table-mounted or stand-alone instrument support members, such as instrument clamps, stands, or other devices may be used to assist with management of endoscopic access devices, tools, and/or instruments.
Aside from table-mounted or stand-alone instrument supporting members, additional instrument management systems may be employed which a single operator or user may utilize. In a first aspect, a multi-instrument support arm extending proximally from the handle assembly generally comprises a stiffened multi-lumen channel having a straight support channel extending proximally and one or more angled or curved support channels projecting at an angle therefrom support arm. Because the multi-instrument support arm is relatively stiff, it may be engaged to the handle assembly and used to support and separate its respective instruments leaving the operator to hold a single handle during a procedure. Other variations include a pivoting multi-instrument support having one or more individual instrument ports pivotably positioned within an open channel. Still other variations include a manifold that is attachable to the handle assembly and that supports one or more elongated straight docking sections each defining a substantially straight lumen for receiving an instrument shaft in a slidable docking configuration.
Another method for facilitating instrument management utilizes forming rigid portions of the instrument shafts. The elongate shaft is generally configured as a flexible length so as to traverse through the elongate body and within the patient body via endoluminal pathways. In another aspect, a portion of the elongate shaft extending between the handle and flexible length is configured as a rigid section, and may include a rigid sleeve made, e.g., from stainless steel or some other rigid metal or polymer, which is formed over the portion of the shaft extending from the handle. Alternatively, the rigid portion is formed integrally with the elongate shaft, e.g., as a section reinforced by woven metallic braids or inserts. In use, the flexible length of the elongate shaft is advanced through a tool port and through the handle assembly. The rigid section extending from the handle is advanced at least partially into the tool port such that the handle is supported or held in a linear configuration relative to the tool port and handle assembly by the rigid section.
The interface between the rigid portion(s) of the instrument shaft(s) and the straight sections of the tool port(s) provided in the handle assembly provides the operator with the ability to slidably dock the instruments within the endoscopic access device. The slidable docking interface provides several benefits. For example, the operator is able to release the instrument to use his hand for other purposes without having the instrument drop or flop downward, as would be the case with a flexible shafted instrument. In addition, the slidable docking interface facilitates instrument management using only a single support arm for the endoscopic access device, rather than requiring separate support for each instrument inserted into the device. Further, rigid shafted instruments provide improved force transmission and the slidable docking interface reduces or eliminates the possibility that an exposed shaft will bend or buckle. Still further, having a substantially straight tool port lumen in the handle assembly retains the ability to use flexible shafted instruments, if desired. Finally, having a substantially straight tool port lumen in the handle assembly facilitates insertion of instruments having longer rigid working lengths and/or larger shaft diameters. For example, a typical endoscope has an instrument channel with an inlet having a 45 degree bend. All tools used in the channel must be sufficiently flexible to pass the 45 degree bend. Having a substantially straight lumen provides the ability to use many instruments that could not be used through the instrument channel of a conventional endoscope.
Another variation of the instrument management system includes the provision of a flexible joint or flexible section of the instrument shaft between the handle and a rigid proximal section of the shaft. The flexible joint/section allows the handle to be flexed away from other instruments but retain sufficient rigidity that the handle does not droop. In this manner, the instrument handles are able to be flexed apart to prevent or reduce clashing.
In still another aspect, an endoscopic instrument management manifold is attachable to the handle assembly and provides one or more elongated pathways for passage of a flexible instrument shaft. In several embodiments, the one or more elongated pathways are defined by one or more extension tubes that extend from the proximal end of the handle assembly. In several other embodiments, the elongated pathways are defined by one or more extension tubes that are capable of being manipulated to assume a desired shape or orientation.
With reference to
As shown, the system 10 may comprise a number of various instruments and devices utilized in various combinations with one another to effect any number of different procedures. Accordingly, each of the instruments and devices may require manipulation or some degree of handling by the practitioner.
The elongate body 14 may optionally utilize a plurality of locking or lockable links nested in series along the length of the elongate body 14 which enable the elongate body 14 to transition between a flexible state and a rigidized or shape-locked configuration. Details of such a shape-lockable body may be seen in further detail in U.S. Pat. Nos. 6,783,491; 6,790,173; and 6,837,847, each of which is incorporated herein by reference in its entirety. Alternatively, elongate body 14 may comprise a flexible body which is not rigidizable or shape-lockable but is flexible in the same manner as a conventional endoscopic body, if so desired. Additionally, elongate body 14 may also incorporate additional features that enable any number of therapeutic procedures to be performed endoscopically. Elongate body 14 may be accordingly sized to be introduced per-orally. However, elongate body 14 may also be configured in any number of sizes, for instance, for advancement within and for procedures in the lower gastrointestinal tract, such as the colon.
Elongate body 14, in one variation, may comprise several controllable bending sections along its length to enable any number of configurations for the elongate body 14. Each of these bending sections may be configured to be controllable separately by a user or they may all be configured to be controlled simultaneously via a single controller. Moreover, each of the control sections may be disposed along the length of elongate body 14 in series or they may optionally be separated by non-controllable sections. Moreover, one, several, or all the controllable sections (optionally including the remainder of elongate body 14) may be rigidizable or shape-lockable by the user.
In the example of endoscopic tissue manipulation system 10, elongate body may include a first articulatable section 18 located along elongate body 14. This first section 18 may be configured via handle assembly 16 to bend in a controlled manner within a first and/or second plane relative to elongate body 14. In yet another variation, elongate body 14 may further comprise a second articulatable section 20 located distal of first section 18. Second section 20 may be configured to bend or articulate in multiple planes relative to elongate body 14 and first section 18. In yet another variation, elongate body 14 may further comprise a third articulatable section 22 located distal of second section 20 and third section 22 may be configured to articulate in multiple planes as well, e.g., 4-way articulation, relative to first and second sections 18, 20.
As mentioned above, one or each of the articulatable sections 18, 20, 22 and the rest of elongate body 14 may be configured to lock or shape-lock its configuration into a rigid set shape once the articulation has been desirably configured. Detailed examples of such an apparatus having one or multiple articulatable bending sections which may be selectively rigidized between a flexible configuration and a shape-locked configuration may be seen, e.g., in U.S. Pat. Pub. Nos. 2004/0138525 A1, 2004/0138529 A1, 2004/0249367 A1, and 2005/0065397 A1, each of which is incorporated herein by reference in its entirety. Although three articulatable sections are shown and described, this is not intended to be limiting as any number of articulatable sections may be incorporated into elongate body 14 as practicable and as desired. Moreover, one or multiple sections may be comprised of a series of nested-links which allow the one or more sections 18, 20, 22 to be articulated or deflected relative to one another along their lengths and optionally rigidized to conform and hold any particular shape.
Handle assembly 16 may be attached to the proximal end of elongate body 14 via a permanent or releasable connection. Handle assembly 16 may generally include a handle grip 24 configured to be grasped comfortably by the user and an optional rigidizing control 28 if the elongate body 14 and if one or more of the articulatable sections are to be rigidizable or shape-lockable. Rigidizing control 28 in this variation is shown as a levered mechanism rotatable about a pivot 30. Depressing control 28 relative to handle 24 may compress the internal links within elongate body 14 to thus rigidize or shape-lock a configuration of the body while releasing control 28 relative to handle 24 may in turn release the internal links to allow the elongate body 14 to be in a flexible state. Further examples of rigidizing the elongate body 14 and/or articulatable sections may again be seen in further detail in U.S. Pat. Pub. Nos. 2004/0138525 A1, 2004/0138529 A1, 2004/0249367 A1, and 2005/0065397 A1, incorporated above by reference. Although the rigidizing control 28 is shown as a lever mechanism, this is merely illustrative and is not intended to be limiting as other mechanisms for rigidizing an elongate body, as generally known, may also be utilized and are intended to be within the scope of this disclosure.
Handle assembly 16 may further include a number of articulation controls 26, as described in further detail below, to control the articulation of one or more articulatable sections 18, 20, 22. Handle 16 may also include one or more ports 32 for use as insufflation and/or irrigation ports, as so desired.
Furthermore, one or more various instruments may be passed through elongate body 14 for deployment through distal end 12 by introducing the instruments through one or more corresponding tool ports 34 located in handle assembly 16. As mentioned above, a number of different endoscopic and/or endoluminal instruments having a flexible body may be delivered through system 10 to effect any number of endoscopic procedures.
One example of such an instrument may include an endoscopic tissue manipulation and securement assembly 36, as described in further detail below, which may be introduced into system 10 via instrument lumen 100, as shown in the end view of distal end 12 in
In use, tissue manipulation assembly 40 and helical tissue engager 80 may be advanced distally out from elongate body 14 through their respective lumens 100, 102. Tissue engager 80 may be advanced into contact against a tissue surface and then rotated via its proximal handle 78 until the tissue is engaged. The engaged tissue may be pulled proximally relative to elongate body 14 and tissue manipulation assembly 40 may be actuated via its proximally located handle into an open expanded jaw configuration for receiving the engaged tissue.
Additional instruments may also be introduced through elongate body 14, such as conventional endoscopic instruments including graspers, scissors, needle knives, snares, etc., through a corresponding instrument lumen 104. In one example, an endoscopic instrument 82 having a flexible shaft 84 with a manipulatable handle or control 86 at its proximal end and a scissor mechanism 88 at its distal end may be introduced through the elongate body 14 for performing tasks such as cutting of tissue and/or sutures.
To endoscopically visualize procedures and tissue regions of interest, an endoscope or imaging system 90 having a flexible shaft 92 may be introduced into the elongate body 14 via a side port, e.g., Y-Port 96, located along the elongate body 14 and distal to handle assembly 16, as shown in
Endoscope 90 may be introduced directly through handle assembly 16 in other variations; however, positioning the imaging system 90 through a distally located Y-Port 96 relative to handle assembly 16 may allow for a longer length of the shaft 92 to be introduced through visualization lumen 98 into the patient body. As elongate body 14 is advanced into the patient body, e.g., per-orally and into the stomach, the Y-Port 96 remains outside the patient body.
Also shown is helical tissue engager 80 disposed upon flexible shaft 76 and endoscopic instrument 88, e.g., endoscopic scissors, disposed upon flexible shaft 84, removed from elongate body 14 and handle assembly 16. Further shown is endoscope 90 with endoscope shaft 92 removed from Y-Port 96.
As mentioned above, tissue manipulation assembly 40 is further described in detail in U.S. patent application Ser. No. 11/070,863 filed Mar. 1, 2005 and published as U.S. Pat. Pub. 2005/0251166 A1. An illustrative side view of one example is shown in
Tissue manipulation assembly 40 is located at the distal end of tubular body 38 and is generally used to contact and form tissue folds, as mentioned above.
Launch tube 54 may extend from handle 42, through tubular body 38, and distally from the end of tubular body 38 where a distal end of launch tube 54 is pivotally connected to upper jaw member 48 at launch tube pivot 56. A distal portion of launch tube 54 may be pivoted into position within a channel or groove defined in upper jaw member 48, to facilitate a low-profile configuration of tissue manipulation assembly 40. When articulated, either via launch tube 54 or other mechanism, as described further below, jaw members 46, 48 may be urged into an open configuration to receive tissue in jaw opening 58 between the jaw members 46, 48.
Launch tube 54 may be advanced from its proximal end at handle 42 such that the portion of launch tube 54, which extends distally from body 38, is forced to rotate at hinge or pivot 56 and reconfigure itself such that the exposed portion forms a curved or arcuate shape that positions the launch tube opening perpendicularly relative to upper jaw member 48, as shown in
Once the tissue has been engaged between jaw members 46, 48, a needle deployment assembly 60 may be urged through handle 42 and out through launch tube 54 by introducing needle deployment assembly 60 into the handle 42 and through tubular body 38 such that the needle assembly 66 is advanced from the launch tube and into or through approximated tissue. The needle deployment assembly 60 may pass through lower jaw member 46 via needle assembly opening defined in lower jaw member 46 to pierce through the grasped tissue. Once the needle assembly 66 has been passed through the engaged tissue, a distal and proximal tissue anchor 70, 72 of the anchor assembly 68 may be deployed or ejected on one or opposing sides of a tissue fold for securing the tissue.
Anchor assembly 68 is normally positioned within the distal portion of tubular sheath 64 which extends from needle assembly control or housing 62. Once the anchor assembly 68 has been fully deployed from sheath 64, the spent needle deployment assembly 60 may be removed from assembly 36 and another needle deployment assembly may be introduced without having to remove assembly 36 from the patient. The length of sheath 64 is such that it may be passed entirely through the length of tubular body 38 to enable the deployment of needle assembly 66 into and/or through the tissue.
Because of the number of different instruments and the different types of tools which may be utilized in endoscopic tissue manipulation system 10, tool or instrumentation management is one consideration for the practitioner or practitioners to facilitate efficient surgical and/or endoscopic procedures when performed upon a patient. Additionally, the division of responsibility for instrumentation management between one or more practitioners is highly desirable to ensure patient safety and procedure facilitation. Several device management systems are described in U.S. patent application Ser. No. 12/138,348 (Attorney Docket No. USGINZ05600), filed Jun. 12, 2008, which was previously incorporated by reference herein. The systems described in the foregoing application include trays, stands, tables, clamps, belts, and other supports used to support or hold the endoscopic tissue manipulation system 10 or one or more portions of the system.
Several of the instrument management system embodiments described herein and in the '348 application referenced above facilitate use of the endoscopic access system by the operator in either a “hands on tools” mode with the system retained in the stand or support arm, or a “hand on scope/hand on tool” mode in which the operator holds the handle 24 in one hand and an instrument with the other hand. Those skilled in the art will recognize that the “hands on tools” mode corresponds generally with the manner in which laparoscopic procedures are typically performed, while the “hand on scope/hand on tool” mode corresponds generally with the manner in which endoscopic procedures are performed. Each of these modes of use are facilitated using the instrument management systems described herein. For example, many surgical instrument holders are configured to clamp onto the shaft of a 5 mm or 10 mm instruments. By providing a 5 mm or 10 mm cylindrical post on the handle 24 of an endoscopic access system, the handle 24 may be selectively clamped onto and removed from the instrument holder by the operator. In this way, the operator can simply place the post in the holder and lock it in place to use the system in a “hands on tools” mode, or remove it from the holder and use the system in a “hand on handle/hand on tool” mode.
Aside from or in addition to table-mounted or stand-alone instrument supporting members, additional instrument management systems may be employed which a single operator or user may utilize. One example is shown in
Another instrument management system is shown in
As shown in the partial cross-sectional view of
In an alternative configuration, portions of or the entire support arm 190 is formed of a relatively flexible material, such as a rubber or polymeric material. The flexibility of the support arm 190 allows instruments having relatively rigid shafts to pass through the instrument lumens 198, 200, 202 despite the presence of any non-linear portions of the lumens. For example, the support arm 190 is sufficiently flexible that the support channels 194, 196 are able to flex in response to the rigid instrument shaft as it passes through any non-linear portions of the lumen.
Another example of a multi-instrument support arm 210 is shown in the perspective view of
In yet another variation, a pivoting multi-instrument support 220 is illustrated as generally having a support arm 222 with a fanned or angled lumen enclosure 224 extending therefrom, as shown in
Turning to
Another method for facilitating instrument management utilizes forming rigid portions of the instrument shafts. An example is shown in the side view of
In use, the flexible length of elongate shaft 252 may be advanced through a tool port 34 and through handle assembly 16. Rigid section 254 extending from handle 42 may be advanced at least partially into tool port 34, as shown in
Additionally, one or more visual markings or indicators 260 may be provided along the length of rigid section 254, as shown in
In addition to the various device and instrument management tools and systems described above, tool ports 34 in handle assembly 16 may also be configured to facilitate device management. As shown in the end and top views of handle assembly 16 in
Several of the features of the tools and systems described above in relation to
As shown in
In addition to the other instrument management tools and systems described herein, another mechanism for reducing or eliminating clashing of instrument handles is shown in
Turning next to
The instrument management manifolds 400 shown in
Turning to
In some embodiments, the instrument management manifold 400 is transformable so that the relative positions of the lumens may be altered. For example, a manifold 400a, 400b having the jointed or other malleable structure is able to be bent or otherwise deformed to meet specific procedural needs. For example, the lumens defined by the manifolds 400a, 400b may be positioned straight and relatively close together during insertion of tools through the manifolds and/or the endoscopic manipulation system 10 (see, e.g.,
Positionable or bent manifold lumens also are advantageous with regard to the relative hand positions of the clinician manipulating the tools or instruments 402 and what is displayed on a visualization monitor. A phenomenon of “switching” occurs when an endoscopic delivery device is steered into a retroflexed position. The retroflexed position of the device causes the image to turn upside down and reversed. For example, compare
The “switching” phenomenon is corrected using the instrument management manifolds 400 in the following ways, as shown in
In some embodiments, the endoscopic instrument manifold 400 has a construction that allows it to telescope. See
In still other embodiments, the instrument 402 inserted into a manifold 400 is adapted to interlock with the manifold 400 entrance, preferably at the instrument handle. See
The foregoing descriptions of instrument management tools and systems includes descriptions of several components (and embodiments of components) that may be used in a standalone manner or in combination with other components. For example, a preferred embodiment of an instrument management system suitable for use with the endoscopic tissue manipulation system 10 shown in
Although a number of illustrative variations are described above, it will be apparent to those skilled in the art that various changes and modifications may be made thereto without departing from the scope of the invention. Moreover, although specific configurations and applications may be shown, it is intended that the various features may be utilized in various combinations and in various types of procedures as practicable. It is intended in the appended claims to cover all such changes and modifications that fall within the true spirit and scope of the invention.
This application claims benefit of priority to U.S. Provisional Patent Application No. 61/116,955, filed on Nov. 21, 2008, the content of which is incorporated herein by reference in its entirety. This application also relates to U.S. patent application Ser. No. 12/138,348 (Attorney Docket No. USGINZ05600), filed Jun. 12, 2008, the content of which is also incorporated herein by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 61116955 | Nov 2008 | US |
