1. Technical Field
The present invention relates to surgical cutting and stapling instruments and, in various embodiments, to disposable surgical staple cartridges.
2. Background
Endoscopic surgical instruments are often preferred over traditional open surgical devices since a smaller incision tends to reduce the post-operative recovery time and complications. Generally, these endoscopic surgical instruments include an “end effector”, a handle assembly and an elongated shaft that extends between the end effector and the handle assembly. The end effector is the portion of the instrument configured to engage the tissue in various ways to achieve a desired diagnostic or therapeutic effect (e.g., endocutter, grasper, cutter, staplers, clip applier, access device, drug/gene therapy delivery device, and energy device using ultrasound, RF, laser, etc.).
Two primary design approaches have been used in the past by various medical component manufacturers to reduce the overall cost of endoscopic surgical instruments such as endocutters. While both attempts have been successful at addressing at least some of the user's needs, neither attempt has fully addressed all of those needs.
For example, the first design approach concerned the use of a disposable endocutter devices for each firing. Such endocutter end effectors were fabricated from relatively weak components that can only be fired once before a new end effector is required since the end effector components are markedly deformed after each firing. This type of end effector employed an “I-beam” feature on the knife to prevent the anvil from deflecting away from the cartridge during firing. Since the I-beam is riding on a relatively weak anvil component, the I-beam deforms the portion of the anvil located directly underneath the I-beam feature. This combination of factors allows staple form to be improved while decreasing the forces required to actuate the device because the I-beam is only pulling the anvil material down to the correct position relative to the cartridge where it's needed to form a staple at any given time.
While this approach improves staple form and lowers the force required to cut the tissue and deploy the staples, it has a number of disadvantages. First, having the surgeon dispose of an entire anvil, channel and cartridge after each firing adds a great deal of manufacturing expense. Second, the device often doesn't securely clamp the targeted tissue due to a combination of the relatively weak end effector components and the manner in which the anvil is actually clamped onto the tissue. The third issue is that the relatively weak end effector components can only reliably be used to fire on moderate tissue thicknesses and the components will not function on very thick tissues.
The second primary design approach taken in the past is to make much stronger end effector components that can be used for multiple firings. In this approach, only the cartridge assembly is replaced after each firing. Because the end effector components have to resist multiple firing loads, they are purposefully designed such that they do not deform after each firing. This design concept employs a different set of features on the knife to keep the anvil positioned relative to the cartridge during deployment of the staples to improve staple form. The combination of the stiffer end effector components and a different clamping mechanism allows this type of device to reliably exert high clamping loads so the surgeon can easily manipulate the desired tissue. The stiffer components also allow the end effector to be reliably used on relatively thick tissue samples.
One disadvantage of this approach, however, is that the features on the knife that prevent the anvil from deflecting away from the cartridge are now required to pull a very stiff anvil component down towards the cartridge. The knife is therefore attempting to pull an entire beam down towards the cartridge that is as long as the entire staple line instead of just pulling the anvil down in a localized region as on the previous device. This approach, therefore, generally must generate higher deployment forces due to the increased anvil drag loads on the knife.
U.S. Patent Publication No. US 2007/0175950 A1, entitled “Disposable Staple Cartridge Having an Anvil With Tissue Locator For Use With Surgical Cutting and Fastening Instrument and Modular End Effector System Therefor”, the disclosure of which is herein incorporated by reference in its entirety, discloses various disposable cartridge arrangements that employ a disposable anvil component. Such arrangement effectively address a variety of the shortcomings discussed above, but also include the additional expense of an anvil component. In addition, all of the foregoing arrangements require a separate support channel for supporting the staple cartridge therein. Such support components add to the expense of the surgical instrument.
Consequently, there is a need for a surgical staple cartridges that effectively address many of the shortcomings described above.
The foregoing discussion is intended only to illustrate some of the shortcomings present in the field of the invention at the time, and should not be taken as a disavowal of claim scope.
In accordance with general aspects of at least one form, there is provided an integrated surgical fastener cartridge assembly that comprises an elongated channel that is configured for removable attachment to a distal frame portion of a surgical instrument. In at least one form, the elongated channel has an attachment portion that comprises a wedge-shaped portion that is configured for wedging engagement with the distal frame portion. The attachment portion further comprises a locking member for releasably retaining the wedge-shaped portion in wedging engagement with the distal frame portion. The integrated surgical fastener cartridge further comprises a cartridge body that is supported in the elongated channel and operably supports a plurality of tissue fasteners therein.
In accordance with other general aspects of at least one form, there is provided a surgical staple cartridge for use with surgical stapling instruments that have a distal frame portion and an anvil movably supported thereon. In at least one form, the surgical staple cartridge comprises an elongated channel that has a proximal end portion for releasable attachment to the distal frame portion. The proximal end portion of the elongated channel has at least one angled portion that is shaped for wedging engagement with a corresponding complimentary shaped surface on the distal frame portion. A selectively movable locking member is configured for releasable engagement with one of the distal frame portion and the elongated channel such that when the locking member is in an engaged position, the at least one angled portion of the elongated channel is urged proximally into wedging engagement with the corresponding complementary shaped surface on the distal frame portion to releasably affix the elongated channel to the distal frame portion. A staple cartridge is operably supported within the elongated channel and operably supports a plurality of staples therein.
In accordance with still other general aspects of at least one form, there is provided a surgical instrument that comprises a distal frame portion and an integrated surgical staple cartridge assembly. In at least one form, the integrated surgical staple cartridge assembly comprises an elongated channel that has a proximal end portion for releasable attachment to the distal frame portion. The proximal end portion of the elongated channel has at least one angled portion that is shaped for wedging engagement with a corresponding complimentary shaped surface on the distal frame portion. A staple cartridge is operably supported within the elongated channel and operably supports a plurality of surgical staples therein. The surgical instrument further comprises a selectively movable locking member that is configured for releasable engagement with one of the distal frame portion and the elongated channel such that when the locking member is in an engaged position, the at least one angled portion of the elongated channel is urged proximally into wedging engagement with the corresponding complementary shaped surface on the distal frame portion to releasably affix the elongated channel to the distal frame portion.
The above-mentioned and other features and advantages of this invention, and the manner of attaining them, will become more apparent and the invention itself will be better understood by reference to the following description of embodiments of the invention taken in conjunction with the accompanying drawings, wherein:
Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the instruments and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those of ordinary skill 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 various embodiments of the present invention is defined solely by the claims. Reference throughout the specification to “various embodiments,” “some embodiments,” “one embodiment,” or “an embodiment”, or the like, means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in various embodiments,” “in some embodiments,” “in one embodiment”, or “in an embodiment”, or the like, in places throughout the specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. Thus, the particular features, structures, or characteristics illustrated or described in connection with one embodiment may be combined, in whole or in part, with the features structures, or characteristics of one or more other embodiments without limitation. Such modifications and variations are intended to be included within the scope of the various invention embodiments disclosed herein and their respective equivalents.
The terms “proximal” and “distal” are used herein with reference to a clinician manipulating the handle portion of the surgical instrument. The term “proximal” referring to the portion closest to the clinician and the term “distal” referring to the portion located away from the clinician. It will be further appreciated that, for convenience and clarity, spatial terms such as “vertical”, “horizontal”, “up”, “down”, “right” and “left” may be used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and/or absolute.
Various exemplary instruments and methods are provided for performing laparoscopic and minimally invasive surgical procedures. However, the person of ordinary skill in the art will readily appreciate that the various methods and instruments disclosed herein can be used in numerous surgical procedures and applications including, for example, in connection with “open” surgical procedures. As the present Detailed Description proceeds, those of ordinary skill in the art will further appreciate that the various instruments disclosed herein can be inserted into a body in any way, such as through a natural orifice, through an incision or puncture hole formed in tissue, etc. The working portions or end effector portions of the instruments can be inserted directly into a patient's body or can be inserted through an access device such as a trocar that has a working channel through which the end effector and elongated shaft of a surgical instrument can be advanced.
Turning to the Drawings wherein like numerals denote like components throughout the several views,
As shown in
As is known, the closure trigger 26 is actuated first. Once the clinician is satisfied with the positioning of the end effector 100, the clinician may draw back the closure trigger 26 to its fully closed, locked position proximate to the pistol grip 24. Then, the firing trigger 28 is actuated. The firing trigger 28 springedly returns when the clinician removes pressure. A release button 30 when depressed on the proximal end of the handle portion 20 releases any locked closure trigger 26.
As will be discussed in further detail below, the integrated cartridge and channel assembly 120 is detachably coupled to a frame 50 that protrudes from the handle portion 20. The frame 50 is enclosed within a movable closure tube assembly 40 that is configured to operably interface with the closure trigger 26 on one end and the anvil 200 on the other end. When the closure tube 32 is moved proximally on the frame 50 by the closure trigger 26, the anvil 200 opens, pivoting away from the integrated cartridge and channel assembly 120. As the present Detailed Description proceeds, those of ordinary skill in the art will recognize that the various embodiments of the integrated cartridge and channel assembly 120 of the present invention may be employed with a variety of known surgical instruments designed to sever and staple tissue. Thus, the protection afforded to the various embodiments of the present invention disclosed herein and their respective equivalents should not be limited to the specific surgical instrument arrangement disclosed herein. For example, various embodiments of the present invention may be successfully employed with surgical instruments with articulatable end effectors or non-articulatable end effectors, instruments that have powered closure and firing features, instruments that have manually operated closure and firing features, instruments that are attached to robots or other automated control equipment, etc.
Turning to
The instrument 10 further includes a firing bar 80 that is configured to longitudinally translate through the shaft assembly 14 and through a firing slot 54 in the frame 50. The firing bar 80 has a distal end portion 82 that has a sharpened cutting edge 84 formed thereon for severing tissue. A variety of firing bar configurations are known and may be adapted for use in connection with the integrated cartridge and channel assembly 120 without departing from the spirit and scope of the present invention.
In operation, the distal end portion 82 of the firing bar 80 actuates the integrated cartridge and channel assembly 120 as the firing bar 80 is driven distally therethrough. A wedge sled 90 is driven distally by the distal end portion 82 of the firing bar 80. The wedge sled 90 upwardly cams the staple drivers 126 to force out the staples 124 into deforming contact with the closed anvil 200 while the cutting edge 84 of the distal end 82 portion of the firing bar 80 severs clamped tissue. The firing bar 80 is movably supported within the shaft assembly 14 such that it passes through the integrated cartridge and channel assembly 120 when the instrument 10 is fired (e.g., actuated).
As can be seen in
In various non-limiting embodiments, the elongated channel 123 has an attachment portion 130 that has at least one wedge-shaped attachment portion 132 thereon. In the embodiments depicted in
As can be seen in
In various non-limiting embodiments, the elongated channel 323 has an attachment portion 430 that has at least one wedge-shaped attachment portion 432 and a proximally protruding attachment segment 450. In the embodiments depicted in
As can be seen in
To attach the integrated cartridge and channel assembly 320 to the frame 50′, the attachment segment 450 is inserted between the tangs 440 until the wedge shaped attachment portions 432 engage the corresponding angle attachment surfaces 56′ on the frame 50′. See
Various integrated cartridge and channel assembly embodiments of the present invention may be easily attached to and detached from the surgical instrument without the need for any tools or addition instruments. The devices disclosed herein can 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 inventions 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.
Any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated materials does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.
While this invention has been described as having exemplary designs, the present invention may be further modified within the spirit and scope of the disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains.
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Number | Date | Country | |
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20120234896 A1 | Sep 2012 | US |