Patent Application
20100268028
The present invention relates to devices and methods for guiding surgical instruments during minimally invasive surgical procedures.
Minimally invasive surgical techniques such as endoscopies and laparoscopies are often preferred over traditional open surgeries because the recovery time, pain, and surgery-related complications are typically less with minimally invasive surgical techniques. Rather than cut open large portions of the body in order to access inner cavities, such as the peritoneal cavity, surgeons either rely on natural orifices of the body or create one or more small orifices in which surgical instruments can be inserted to allow surgeons to visualize and operate at the surgical site. Surgeons can then perform a variety of diagnostic procedures, such as visual inspection or removal of a tissue sample for biopsy, or treatment procedures, such as removal of a polyp or tumor or restructuring tissue.
Because of the rise in popularity of minimally invasive surgeries, there has been significant development with respect to the instruments used in such procedures. These instruments need to be suitable for precise placement of a working end at a desired surgical site to allow the surgeon to see the site and/or perform the necessary actions at such site. Oftentimes the instruments either themselves contain a device that allows the surgeon to see the site or else the instruments are used in conjunction with an instrument that can provide visual assistance. At least one of these types of devices, an endoscope, is typically configured with both a lens to visualize the surgical site and a channel through which instruments can be delivered to the surgical site for subsequent use. The instruments themselves can be used to engage and or treat tissue and other portions within the body in a number of different ways to achieve a diagnostic or therapeutic effect.
Minimally invasive procedures typically require that the shaft of any device inserted into the body be flexible to navigate various, often small and nonlinear, shapes within the anatomy while still allowing stability and precision at the working end. During an endoscopy, for example, it can be necessary to navigate a device in a variety of different directions before the device reaches its desired destination, which means it is desirable that any such device be flexible. However, once the device reaches its desired destination, it can also be desirable that the device be strong and stable so that the surgeon can operate with precision. It can be difficult for a device to be sufficiently flexible to navigate through the body but be sufficiently strong to maintain structural integrity and steerability once navigated to its desired surgical location. Furthermore, natural orifices and surgical incisions used to introduce devices into a patient in a minimally invasive procedure are relatively small. Devices used in minimally invasive procedures thus typically need to have a relatively small size to be safely introduced into a patient. The small size of the devices can make them more difficult to navigate through the body with precision and ease.
It can also be desirable to have multiple devices concurrently inserted into a patient during a surgical procedure so the devices can cooperate with each other and/or be quickly used in succession, but the relatively small orifices typically used to introduce the devices can limit the size and number of devices concurrently introduced into a body. Multiple devices can be successively introduced into a patient during a surgical procedure to perform different aspects of a surgical procedure, but the repeated insertion and withdrawal of various instruments into a patient can increase chances of patient injury and increase the length of the surgical procedure.
Accordingly, there remains a need for improved devices and methods for controlling surgical devices used during surgical procedures.
The present invention generally provides methods and devices for guiding surgical instruments during minimally invasive surgical procedures. In one embodiment, a surgical device is provided that includes a flexible elongate shaft having an inner lumen extending therethrough and a support structure coupled to an interior surface of the elongate shaft. A proximal portion of the elongate shaft has a wall with a first thickness, and a distal portion of the elongate shaft has a wall with a second thickness that is larger than the first thickness. The support structure longitudinally extends through the inner lumen of the elongate shaft along a longitudinal length of the elongate shaft.
The support structure can vary in any number of ways. In some embodiments, the support structure can include a flexible central column extending through the inner lumen in the proximal and distal portions of the elongate shaft. At least one strut can radially extend between the central column and the wall in the distal portion of the elongate shaft. A plurality of struts, each of the struts radially extending between the central column and the wall in the distal portion of the elongate shaft, can be spaced substantially equidistantly around the central column. The central column can have at least one cut-out formed therein that extends along a longitudinal length of the central column and that is configured to slidably guide a surgical tool therethrough. The surgical device can optionally include a mating member that is in sliding engagement with the central column. The surgical device can also include an accessory secured to the mating member and configured to receive a surgical instrument therein. The accessory and the mating member can be configured to slide as a unit along the central column. In some embodiments, the support structure can include at least one track extending through the inner lumen in the proximal and distal portions of the elongate shaft. The at least one track can be coupled to an interior surface of the walls in the distal and proximal portions and be configured to engage and guide a surgical instrument disposed through the inner lumen of the elongate shaft. The surgical device can also include an accessory that is configured to slide along the track within the inner lumen of the elongate shaft and that has a passageway for passing a surgical instrument.
The surgical device can vary in any other number of ways. For example, the first cross-sectional thickness can have a thickness that is in a range of about 10% to 50% of the second cross-sectional thickness. For another example, the proximal portion of the elongate shaft can be radially compressible.
In another embodiment, a surgical device is provided that includes an overtube having an insertion section with proximal and distal portions. The proximal portion has a flexible wall with a first thickness and a first compressive strength, and the distal portion has a flexible wall with a second thickness greater than the first thickness and a second compressive strength greater than the first compressive strength. A central column extends through the insertion section, is flexible, and is configured to transmit a distally directed force to maneuver the overtube axially. The surgical device can have any number of variations. For example, the overtube can have at least one strut extending radially between the central column and the flexible wall of the distal portion. In some embodiments, the overtube can have a plurality of radial struts extending between the central column and the flexible wall of the distal portion, the plurality of struts defining a plurality of channels in the distal portion equal to the number of struts. The central column can optionally have at least one cut-out formed in an outer surface thereof, the at least one cut-out configured to slidably guide a surgical tool therethrough. For another example, the surgical device can include at least one mating member that is coupled to the central column and that extends through the insertion section of the overtube. An accessory can be coupled to the mating member and extend radially relative to the central column. For yet another example, the central column can have a longitudinal track coupled to an exterior surface thereof, the track being configured to slidably guide a surgical tool therethrough. The central column can have a passageway extending longitudinally therethrough that is configured to slidably receive a surgical tool therein.
In another embodiment, a surgical device is provided that includes an overtube having an insertion section with a proximal portion and a distal portion. The proximal portion has a flexible wall with a first thickness and a first compressive strength, and the distal portion has a flexible wall with a second thickness greater than the first thickness and a second compressive strength greater than the first compressive strength. The surgical device also includes at least one track that is coupled to an interior surface of the overtube and that extends longitudinally along the insertion section. The at least one track is configured to slidably engage a surgical tool disposed through the overtube. The surgical device can vary in any number of ways. In some embodiments, the overtube can have a plurality of tracks coupled to an interior surface thereof. The tracks can be arranged substantially equidistantly around a circumference of the overtube.
In another aspect, a surgical method is provided that includes advancing an overtube into a patient. The overtube has a passageway extending therethrough, has a proximal portion with a wall having a first thickness, and has a distal portion having a wall with a second thickness that is larger than the first thickness. The overtube also has a support structure longitudinally extending through the passageway in the proximal and distal portions of the overtube. The surgical method also includes guiding a flexible surgical instrument through the overtube using the support structure. The method can vary in any number of ways. For example, guiding a flexible surgical instrument through the overtube using the support structure can include engaging the surgical instrument with a continuous track extending through the passageway of the overtube and advancing the surgical instrument along the continuous track. In some embodiments, the continuous track can be in the form of a cut-out formed in a central column longitudinally extending through the overtube and coupled to an interior surface of the wall in the distal portion of the overtube. In other embodiments, the continuous track can be in the form of a rail longitudinally extending through the overtube and coupled to an interior surface of the walls in the proximal and distal portions of the overtube.
The invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which:
Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.
Various exemplary methods and devices are provided for guiding surgical instruments during minimally invasive surgical procedures. In general, a surgical instrument is provided that includes a flexible, cannulated elongate shaft having an inner wall of variable thickness. The inner wall of the shaft can have a first thickness in a proximal portion of the device and can have a second, larger thickness in a distal portion of the instrument. The distal portion of the instrument can thus have increased structural integrity over the proximal portion of the instrument such that the distal portion of the instrument can substantially maintain its shape while the proximal portion of the instrument can collapse or otherwise deform inwards. In this way, the proximal portion of the instrument can occupy less space in a body of a patient and/or less space in an introducer device configured to introduce the instrument into a body of a patient through a natural or artificial access opening, thereby decreasing chances of the instrument harming the patient's body and/or allowing additional surgical devices to be inserted into a patient's body concurrent with the instrument. In an exemplary embodiment, the instrument can include at least one support structure configured to guide at least one surgical device through at least a portion of the cannulated interior of the elongate shaft to help smoothly guide the at least one surgical device through the instrument. The guide mechanism can also help position the at least one surgical device in a predictable position relative to the instrument and to any other surgical devices advanced through the instrument, thereby helping to reduce interference between multiple surgical devices positioned inside and/or outside the instrument.
A person skilled in the art will appreciate that while the methods and devices are described in connection with endoscopic procedures in which the surgical device is delivered through a natural orifice, the methods and devices disclosed herein can be used in numerous surgical procedures and with numerous surgical instruments. By way of non-limiting example, the devices can be used in laparoscopic procedures, in which the device is introduced percutaneously. The methods and devices can also be used in open surgical procedures. Furthermore, the surgical device can be configured to pass through any portion of a body, but in an exemplary embodiment, the surgical device is configured to pass through a tortuous pathway. A person skilled in the art will appreciate that the term “tortuous pathway” as used herein is intended to include a tubular body lumen or organ, e.g., the colon or esophagus. While the methods and devices disclosed herein are described in connection with steering a scoping device, e.g., an endoscope, a laparoscope, and a colonoscope, a person skilled in the art will also appreciate that the methods and devices disclosed herein can be used with any surgical instrument configured to be inserted into a body, such as through a natural orifice, through a puncture hole formed in tissue, and in any other way appreciated by a person skilled in the art. While the surgical instrument can be rigid and/or flexible, in an exemplary embodiment, at least a proximal portion of the surgical instrument is flexible.
The devices discussed herein can be made from any combination of rigid and/or flexible materials, but in an exemplary embodiment the materials are biocompatible and suitable for use in surgical procedures. A person skilled in the art will appreciate that the term “flexible” as used herein is intended to encompass a variety of configurations. Generally, a “flexible” member is one which, to at least some degree of elasticity is capable of bending or deforming without breaking. In an exemplary embodiment, the device or at least portions thereof are composed of at least one biocompatible and flexible material, e.g., plastic, titanium, stainless steel, etc.
The shaft 22 can have any size, shape, and configuration, as will be appreciated by a person skilled in the art. The shaft 22 can be rigid, flexible, or a combination thereof, but in this illustrated embodiment it is flexible along its longitudinal length that corresponds to the longitudinal length 10L of the device. The shaft 22 can vary in longitudinal length depending on the device's intended application. The proximal and distal portions 12, 14 of the shaft 22 can also each have any respective longitudinal length 12L, 14L along the shaft 22 that added together equal the device's longitudinal length 10L. In an exemplary embodiment, the device 10 can have a longitudinal length 10L of about 100 cm, the proximal portion 12 can have a longitudinal length 12L of about 90 cm between the proximal end 16 of the device 10 and an intermediate point 20 of the device 10 located between the proximal and distal ends 16, 18, and the distal portion 14 can have a longitudinal length 14L of about 10 cm between the distal end 18 of the device 10 and the intermediate point 20 of the device 10.
The shaft 22 can be formed from a single component or multiple segments, and can be coiled or non-coiled. The flexibility of the shaft 22, as well as a relatively small diameter of its inner lumen 24, can allow the shaft 22 to be used in endoscopic procedures, whereby the device 10 is introduced translumenally through a natural or artificial orifice. In an exemplary embodiment, the shaft 22 can be substantially cylindrical, which can help ease the device's passage into and through the body and prevent the shaft 22 from harming or getting caught on tissue.
The shaft 22 can have a uniform or non-uniform outer diameter 22D along its longitudinal length. In this illustrated embodiment, the shaft 22 has a uniform outer diameter 22D along its longitudinal length but has a variable inner diameter, e.g., the inner lumen 24 has a variable diameter between the proximal and distal ends 16, 18 of the shaft 22.
As mentioned above, the inner wall of the shaft 22 can have a variable thickness in the shaft's proximal and distal portions 12, 14 with the distal inner wall 14w having a larger thickness 14t than a thickness 12t of the inner wall 12w in the proximal portion 12. The different sized inner walls 12w, 14w can thus cause the inner lumen 24 to have a first diameter 24P in the proximal portion 12 and a second, smaller diameter 24D in the distal portion 14. The proximal and distal walls 12w, 14w can each have any thickness, but in an exemplary embodiment, the proximal inner wall 12w can have a thickness 12t that is about 25% of the distal inner wall thickness 14t, e.g., the shaft 22 having a proximal inner wall thickness 12t of about 0.25 mm and a distal inner wall thickness 14t of about 1 mm. As illustrated in this embodiment the thicknesses 12t, 14t of the inner walls 12w, 14w can be substantially constant along their respective longitudinal lengths 12L, 14L, although in some embodiments one or both of the thicknesses 12t, 14t of the inner walls 12w, 14w can vary along their respective longitudinal lengths 12L, 14L. Substantially at the intermediate point 20 where the proximal and distal portions 12, 14 meet, the inner wall of the shaft 22 can gradually taper or slope from the larger inner wall 14w thickness 14t to the smaller inner wall 12w thickness 12t around an inner circumference of the inner lumen 24. Alternatively, as illustrated in this embodiment in
With the shaft 22 being flexible in this illustrated embodiment and having the distal inner wall 14w thicker than the proximal inner wall 12w, the distal portion 14 of the shaft 22 can thereby have a compressive strength that is greater than a compressive strength of the proximal portion 12. In this way, the shaft 22 can have enough structural integrity to be advanced through a body, alone or through an introducer device, e.g., a cannula, and to receive at least one surgical instrument in its inner lumen 24. The proximal portion 12 of the shaft 22 can nevertheless be configured to be radially compressible, as illustrated in one embodiment in
As mentioned above, the shaft's inner lumen 24 can be configured to receive at least one surgical instrument therein. The inner lumen 24 can be a cannulated tunnel having any size and shape, but in an exemplary embodiment, the inner lumen 24 is substantially cylindrical and is sized to receive at least one surgical instrument such that the surgical instrument can be slidably movable therein. As mentioned above, at least a portion of the inner lumen 24 can be partitioned to have the channels 26a, 26b, 26c, 26d, which can each be configured to receive and guide at least one surgical instrument through the device 10 in a predictable position relative to the shaft 22 and to any other surgical devices received in the inner lumen 24. Generally, the channels 26a, 26b, 26c, 26d can be defined by the central column 28 and the struts 30a, 30b, 30c, 30d. The central column 28, the struts 30a, 30b, 30c, 30d, and the channels 26a, 26b, 26c, 26d can have a variety of sizes, shapes, and configurations, and are further discussed below.
The central column 28 can be rigid, flexible, or a combination thereof, but as shown in this illustrated embodiment it can be, like the shaft 22, flexible along its longitudinal length that corresponds to the longitudinal length 10L of the device 10, although the column 28 can have any longitudinal length greater or less than the shaft 22 depending on the device's intended application. In an exemplary embodiment, the column 28 can be formed of a flexible material such as polyurethane or polycarbonate to allow the column 28 to flex while also resisting longitudinal compression or buckling. The column 28 can thus be configured to transmit a distally directed force to maneuver the shaft 22 axially, e.g., to advance the shaft 22 through and/or withdraw the shaft 22 from a body. The column 28 can have any cross-sectional shape, e.g., circular (as shown), ovular, rectangular, triangular, etc., that can be the same or variable along the column's longitudinal length. In an exemplary embodiment the column 28 has a shape corresponding to the shape of the shaft's inner lumen 24, e.g., both cylindrical as shown. The column 28 can also have any diameter 28D, which can be the same or different along the column's longitudinal length. In an exemplary embodiment, the column 28 can have a substantially constant diameter 28D, e.g., about 2 mm. The column 28 can be formed from a single component or multiple segments, and can be coiled or non-coiled. Although the column 28 is shown as a solid member, the column 28 can have a central passageway extending longitudinally therethrough or have any number of hollow portions. A central passageway extending longitudinally through a central column can be configured to slidably receive one or more surgical instruments therein.
The struts 30a, 30b, 30c, 30d can also be rigid, flexible, or a combination thereof, but in an exemplary embodiment the struts 30a, 30b, 30c, 30d can be substantially rigid to help provide structural integrity portion of the shaft 22 in which they are located, e.g., the distal portion 14. The struts 30a, 30b, 30c, 30d can have any shape and size same or different from any one or more of the other struts 30a, 30b, 30c, 30d, but in an exemplary embodiment each of the struts 30a, 30b, 30c, 30d can include a linear rod extending substantially perpendicular to the longitudinal axis A of the device between the column 28 and the distal inner wall 14w adjacent to the distal end 18 of the device 10. As will be appreciated by a person skilled in the art, although four struts 30a, 30b, 30c, 30d are shown defining four channels 26a, 26b, 26c, 26d of substantially equal size, the number and location of the struts 30a, 30b, 30c, 30d can vary. In an exemplary embodiment the struts 30a, 30b, 30c, 30d are spaced substantially equidistantly radially around a circumference of the column 28, as shown, to maximize a size of each of the channels 26a, 26b, 26c, 26d. The struts 30a, 30b, 30c, 30d can thus be configured as barriers between the channels 26a, 26b, 26c, 26d to help prevent interference between surgical devices received in different ones of the channels 26a, 26b, 26c, 26d and to more accurately position surgical devices advanced through the inner lumen 24 and distally beyond the device's distal end 18. In an exemplary embodiment, the struts 30a, 30b, 30c, 30d can be integrally formed with the column 28 and the distal inner wall 14w to help prevent the struts 30a, 30b, 30c, 30d from loosening or detaching during use of the device 10.
A person skilled in the art will also appreciate that while the struts 30a, 30b, 30c, 30d in this illustrated embodiment are located in the distal portion 14 of the device 10 to define the channels 26a, 26b, 26c, 26d in the distal portion 14, the struts 30a, 30b, 30c, 30d can be located in the distal and/or proximal portions 14, 12 of the device 10. In some embodiments, the struts 30a, 30b, 30c, 30d can be configured as planar members extending between the column 28 and the distal inner wall 14w along substantially the entire longitudinal length 14L of the distal portion 14 to help more distinctly define the channels 26a, 26b, 26c, 26d in the distal portion 14 and/or along at least a portion of each of the proximal and distal longitudinal lengths 12L, 14L to help define the channels 26a, 26b, 26c, 26d in both the proximal and distal portions 12, 14.
In this illustrated embodiment a number of the channels 26a, 26b, 26c, 26d equals a number of the struts 30a, 30b, 30c, 30d such that each of the channels 26a, 26b, 26c, 26d is defined by two of the struts 30a, 30b, 30c, 30d, but in other embodiments, the number of channels and struts can differ, e.g., the channels 26a, 26b, 26c, 26d can be defined by more than two struts 30a, 30b, 30c, 30d such as if two or more radially aligned struts extend between the column 28 and the inner wall of the shaft 22.
Any surgical device such as a grasper, a scoping device, a cutting instrument, etc., can be slidably received within the instrument's inner lumen 24. A person skilled in the art will appreciate that the term “grasper” as used herein is intended to encompass any surgical instrument that is configured to grab and/or attach to tissue and thereby manipulate the tissue, e.g., forceps, retractors, movable jaws, magnets, adhesives, stay sutures, etc. A person skilled in the art will also appreciate that the term “cutting instrument” as used herein is intended to encompass any surgical instrument that is configured to cut tissue, e.g., a scalpel, a harmonic scalpel, a blunt dissector, a cautery tool configured to cut tissue, scissors, an endoscopic linear cutter, a surgical stapler, etc. As shown in
A person skilled in the art will appreciate that the device 10 can include a proximal handle (not shown) configured to facilitate grasping of the device 10. The handle can have a variety of sizes, shapes, and configurations and be attached to any part(s) of the device 10, e.g., in the proximal portion 12. Non-limiting examples of the handle include finger loops, knobs, an enlarged grip, etc. The handle can form a non-insertion section of the device 10, e.g., a section of the device 10 not configured to be inserted into a body of a patient, while a remainder of the device 10, e.g., the shaft 22, can form an insertion section of the device 10, e.g., a section of the device 10 configured to be inserted into a body of a patient.
Generally, the cut-outs 129 can each be configured to slidably guide a surgical instrument therethrough, as discussed further below. Although three cut-outs 129 are shown, a person skilled in the art will appreciate that the column 128 can have any number of cut-outs 129 formed therein. The cut-outs 129 can have any size, shape, and configuration. The cut-outs 129 can longitudinally extend along any portion of the column 128. As in the illustrated embodiment, the cut-outs 129 can continuously extend along the entire longitudinal length of the column 128, which in this embodiment equals a longitudinal length 100L of the device 100. The cut-outs 129 can have any cross-sectional shape, e.g., c-shaped forming a substantially circular cut-out, and have any size configured to slidably mate with a surgical instrument including a corresponding protrusion configured to be seated in one of the cut-outs 129. The cut-outs 129 in this illustrated embodiment all have the same cross-sectional shape and all extend the longitudinal length of the column 128, but any of the cut-outs 129 can be same or different from any one or more of the other cut-outs 129. The cut-outs 129 can be spaced radially around a circumference of the column 128, equidistantly or nonequidistantly, as shown in this illustrated embodiment.
As shown in another exemplary embodiment in
A surgical instrument 240 can be slidably received in one of the plurality of cut-outs 229 in a variety of ways. In some embodiments, a surgical instrument can include a protrusion on an outer surface thereof that is configured to be slidably seated in one of the cut-outs 229. In the illustrated embodiment, a guide member including a mating member 252 and an accessory 254 can be slidably received in one of the cut-outs 229. Various non-limiting embodiments of a guide member including a mating member and an accessory can be found in U.S. Patent Publication No. 2004/0230095 titled “Medical Apparatus For Use With An Endoscope” filed May 16, 2003, which is hereby incorporated by reference in its entirety. The guide member can be flexible, rigid, or any combination thereof. In an exemplary embodiment, the mating member 252 and the accessory 254 can be rigid, and the flange 256 can be flexible. One suitable material from which the flange 256 can be formed is a thermoplastic elastomer, such as a material designated commercially as Telcar 1025-75 (available from Teknor-Apex, Pawtucket, R.I.).
Generally, the accessory 254 can be in the form of a flexible tubular guide configured to receive and guide a surgical instrument therethrough. The mating member 252 can be configured to facilitate introduction of accessory 254 through the device 200 by providing a means to slide the accessory 254 along the longitudinal length of the column 228 in a controlled manner. The guide member can have any size, shape, and configuration, although in an exemplary embodiment the mating member 252 can have a longitudinal length substantially equal to or greater than a longitudinal length of the central column 228 to allow the mating member 252 to slide along an entire length of the column 228 such that a surgical instrument can be guided along the entire length of the column 228, and the accessory 252 can extend radially relative to the column 228 when the guide member is attached thereto. The mating member 252 and the accessory 254 can be formed as a unitary piece, or they can joined together by any suitable attachment method, as will be appreciated by a person skilled in the art.
The mating member 252 can be operatively coupled to the first cut-out 229a, or any of the other cut-outs 229b, 229c, through interlocking shapes or contours. A shape of the mating member 252 can have a substantially matching shape to a shape of the first cut-out 229a, e.g., both substantially cylindrical as illustrated in this embodiment, so that the mating member 252 can slide along the column 228. Although not shown in this embodiment, there can be a nominal clearance distance between a mating surface of the mating member 252 and a corresponding mating surface of the first cut-out 229a, so that no binding or pinching occurs when sliding one relative to the other. One or both of the column 228 and the mating member 252 can be formed from a flexible, low friction (“slippery”), plastic material, such as polyethylene, Teflon, or polypropylene to provide a low coefficient of friction between the column 228 and the mating member 252 as they slide relative to one another.
In use, once the device 200 has been advanced into a body of a patient, the mating member 252 can be engaged with the first cut-out 229a, or any of the other cutouts 229b, 229c, and the mating member 252 and the accessory 254 can then be advanced any distance along the longitudinal length of the column 228 by sliding engagement with the first cut-out 229a. In an exemplary embodiment, the accessory 254 can be positioned in or near a field of view in a body cavity, e.g., distal to a distal end of the device 200, to perform treatment or diagnosis, such as by advancing a surgical instrument through the accessory 254. A surgical instrument can be engaged with the accessory 254 and guided through an inner lumen of the shaft 222 before and/or after the accessory 254 has been coupled to the device 200.
Also, unlike the devices 10, 100, 200, the device 300 in this illustrated embodiment does not include a support structure in the form of a central column extending therethrough. The device 300 instead includes a support structure in the form of at least one track 360 extending through the inner lumen 24 in the proximal and distal portions 312, 314 of the shaft 322. Although the device 300 is shown including three tracks 360 equidistantly spaced around a circumference of the device 300 in the inner lumen 324, the device 300 can include any number of tracks arranged in any way in the inner lumen 324. The tracks 360 can have any size, shape, and configuration, same or different from any one or more of the other tracks 360. The tracks 360 can longitudinally extend along any portion of the shaft 322 and/or the end cap 315. As in the illustrated embodiment, the tracks 360 can continuously extend along the substantially the entire longitudinal lengths of the proximal and distal portions 312, 314.
The device 300 can optionally include openings 361 formed in a sidewall thereof that are configured to allow passage of surgical instruments therethrough. The openings 361 can have any size, shape, and configuration. Although three oblong openings 361 are shown, the device 300 can have any number of openings 361, and the openings 361 can have any shape same or different from any of the other openings 361. Each of the openings 361 can be associated with one of the tracks 360 such that a surgical instrument inserted through one of the openings 361 can engage and slide through the track 360 associated with that opening 361. The openings 361 can thus facilitate engagement of surgical instruments with the tracks 360 by easing distal advancement of a surgical instrument into the lumen 324 and into engagement with a track 360. The openings 361 can be particularly helpful in embodiments such as the one illustrated in
As shown, the tracks 360 can include a rail 362 and a flange 364. One terminal end of the flange 364 can attach to an inner surface of the device 300, e.g., be molded to inner walls 312w, 314w of the proximal and distal portions 312, 314, while the other terminal end of the flange 364 can attach to the rail 362. The flanges 364 can be flexible to allow surgical devices to be seated in the rails 362 with increased freedom of movement. The rails 362 can be configured similar to the column cut-outs 129, 229 discussed above and be configured to slidably receive a surgical instrument therein and allow the surgical instrument to be glided therethrough. As shown in one embodiment in
The embodiment shown in
In some embodiments, at least one track configured to guide a surgical instrument through an inner lumen of a surgical device can have a low profile, e.g., have a rail in a direct contact with a surface of the inner lumen without a flange coupled therebetween. Such a low profile track can help conserve space within the inner lumen such that larger and/or more surgical instruments can be more easily inserted therethrough.
Although the tracks discussed above are coupled to an inner surface of the elongate shaft within the inner lumen, in some embodiments one or more tracks can be coupled to an outer surface of the elongate shaft and radially extend outward therefrom. The tracks, having rails with or without flanges coupling the rails to an outer surface of the shaft, can otherwise be configured in any way as discussed above. Having one or more tracks coupled to an outer rather than inner surface of the shaft can help provide an unobstructed inner lumen for a surgical device, such as a scoping device that can be configured to provide visualization of the device's insertion into a body and/or of any surgical devices glided through any of the outer surface tracks.
The outer sheath 670 can be fixedly or removably disposed over the shaft 622, and over the tracks 660 in this embodiment having the tracks 660 radially extending outward from the shaft 622. Generally, the sheath 670 can be configured to form a barrier between an external environment and the shaft 622 to help protect the shaft 622 from fluid and/or other debris that could damage or interfere with proper functioning of the shaft 622 and/or a surgical instrument disposed therein. Non-limiting examples of a sheath can be found in U.S. patent application Ser. No. 12/111,425 titled “Methods and Devices for Maintaining Visibility” filed Apr. 29, 2008, which is hereby incorporated by reference in its entirety.
As will be appreciated by a person skilled in the art, the sheath 670 can have a variety of shapes, sizes and configurations. The sheath 670 can be formed from a variety of materials, e.g., C-Flex® available from Consolidated Polymer Technologies of Clearwater, Fla., and can be formed from a fluid impermeable, biocompatible material. The sheath 670 can be optically clear, translucent, opaque, or any combination thereof. An optically clear sheath can minimize obstruction of the viewing path of a scoping device received in the steering platform 670. If optically clear, the sheath can be formed from non-magnifying 1× material so as to be substantially non-modifying of the view provided by a scoping device disposed therein.
The sheath 670 can have any shape. In this illustrated embodiment, the sheath 670 has an elongate tubular shape having an open proximal end, an open distal end, and an inner pathway extending longitudinally between its proximal and distal ends. The sheath 670 can be disposed around and receive the device 600 within its inner pathway. The sheath's distal and/or proximal ends (not shown) can be respectively secured to the shaft's distal and/or proximal ends (not shown) so as to form a fluid-sealed barrier around the shaft 622. In some embodiments, the sheath 670 can be coupled to the device 600 using an attachment mechanism configured to engage the sheath 670, e.g., at the sheath's proximal end, such as a clip, a clamp, adhesive, a groove, a hook, or any other coupling mechanism appreciated by a person skilled in the art. The attachment mechanism can be located on the shaft 622, the device's handle (not shown), and/or on an introducer device used to introduce the device 600 with the sheath 670 positioned therearound into a body cavity.
The size of the sheath 670 can vary, and the sheath 670 can have a size and shape that can correspond with the size and shape of the shaft 622, with the tracks 670 extending outwardly therefrom, when the sheath 670 is disposed therearound (with or without stretching or flexing of the sheath 670). The sheath 670 can also have any thickness, e.g., 0.015 in. thick. In some embodiments, an internal sheath (not shown) can be disposed inside the inner lumen 624 of the shaft 622. The internal sheath can be flexible and can be made from any material, such as a braided nylon tube, expanded PTFE (polytetrafluoroethylene), or other flexible lubricious, thin-walled material.
As illustrated in
In use, any of the surgical devices having a central column or at least one track as described herein can be introduced into a body of a patient for use in a surgical procedure. The device can be introduced in a variety of ways, such as through a natural orifice, an incision, and/or a trocar, as will be appreciated by a person skilled in the art.
The support structure can help transmit a distally directed force applied to the device 800, e.g., from outside the body of the patient 802, to help distally advance the device 800 through the esophagus 804. The distal portion of the overtube 822 can expand the esophagus 804 as necessary to accommodate the diameter of the device 800 at least in a distal portion thereof to help move the distal portion therethrough, thereby also allowing the trailing proximal portion of the overtube 822 to be distally advanced through the esophagus 822. Where the proximal portion is positioned within the esophagus 804, the esophagus 804 can naturally relax, e.g., contract radially inward to its normal, unexpanded state, with the overtube's thinner proximal portion correspondingly contracting radially inward. Any portion of the overtube's proximal portion in a collapsed position can contact an inner wall of the esophagus 804, although some or all of the proximal portion positioned in the esophagus 804 can sufficiently contract to not contact the esophagus 804. When the overtube's distal portion distally exits the esophagus 804 and enters the stomach 806, only the thinner proximal portion of the overtube 822 can be disposed in the esophagus, thereby allowing an entire longitudinal length of the esophagus 804 to relax and experience minimal or no force from the device 800 inserted therethrough. The esophagus 804 and/or the overtube's proximal portion can nevertheless each radially expand outward as necessary to accommodate any one or more surgical tools advanced through the overtube 822. Similarly, the support structure can help transmit a proximally directed force applied to the device 800 to help proximally withdraw the device 800 from the stomach 806 and/or the esophagus 804.
A person skilled in the art will appreciate that the present invention has application in conventional endoscopic and open surgical instrumentation as well application in robotic-assisted surgery.
The devices disclosed herein can also be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces and subsequent reassembly. In particular, the device can be disassembled, and any number of the particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a device can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.
Preferably, the invention described herein will be processed before surgery. First, a new or used instrument is obtained and if necessary cleaned. The instrument can then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and instrument are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation kills bacteria on the instrument and in the container. The sterilized instrument can then be stored in the sterile container. The sealed container keeps the instrument sterile until it is opened in the medical facility.
It is preferred that device is sterilized. This can be done by any number of ways known to those skilled in the art including beta or gamma radiation, ethylene oxide, steam, and a liquid bath (e.g., cold soak).
One skilled in the art will appreciate further features and advantages of the invention based on the above-described embodiments. 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.
