The embodiments relate, in general, to surgical staplers, and, more particularly, to a circular stapler including a discrete staple height adjustment.
In certain types of surgical procedures, the use of surgical staples has become the preferred method of joining tissue and, as such, specially configured surgical staplers have been developed for these applications. For example, intra-luminal or circular staplers have been developed for use in a surgical procedure known as an anastomosis. Circular staplers useful for performing an anastomosis are disclosed, for example, in U.S. Pat. Nos. 5,104,025; 5,205,459; 5,285,945; and 5,309,927, and in U.S. patent application Ser. No. 12/408,905, now U.S. Pat. No. 8,066,167, which are each herein incorporated by reference in their respective entireties.
One form of an anastomosis comprises a surgical procedure wherein sections of intestine are joined together after a diseased portion has been excised. The procedure requires re-joining the ends of the two tubular sections together to form a continuous tubular pathway. Previously, this surgical procedure was a laborious and time consuming operation. The surgeon had to precisely cut and align the ends of the intestine and maintain the alignment while joining the ends with numerous suture stitches. The development of circular staplers has greatly simplified the anastomosis procedure and also decreased the time required to perform an anastomosis.
In general, a conventional circular stapler typically consists of an elongated shaft that has a proximal actuating mechanism and a distal stapling mechanism mounted to the shaft. The distal stapling mechanism commonly consists of a fixed stapling cartridge that contains a plurality of staples configured in a concentric circular array. A round cutting knife is concentrically mounted in the cartridge interior to the staples for axial travel therein. Extending axially from the center of the cartridge is a movable trocar shaft that is adapted to have a staple anvil removably coupled thereto. The anvil is configured to form the ends of the staples as they are driven into it. The distance between a distal face of the staple cartridge and the staple anvil is controlled by an adjustment mechanism mounted to the proximal end of the stapler shaft for controlling the axial movement of the trocar. Tissue clamped between the staple cartridge and the staple anvil is simultaneously stapled and cut when the actuating mechanism is activated by the surgeon.
Generally, in the performance of a surgical anastomotic stapling operation, two pieces of lumen or tubular tissue, e.g., intestinal tissue, are attached together by a ring of staples. The two pieces of tubular tissue may be attached end to end or one piece of tubular tissue may be attached laterally around an opening formed in the side of another piece of tubular tissue. In performing the anastomosis with a stapling instrument, the two pieces of tubular tissue are clamped together between the anvil and the staple cartridge. A staple pusher is advanced to drive the staples into the tissue and form the staples against the anvil. Also, the circular knife is advanced to cut the excess tissue clamped between the anvil and the staple holder. As a result, a donut-shaped section of tissue is severed from each lumen and remains on the anvil shaft. The tubular tissue joined by the circular ring of staples is unclamped by advancing the anvil shaft distally to move the anvil away from the staple holder. The stapling instrument is removed by pulling the anvil through the circular opening between the pieces of tubular tissue attached by the ring of staples.
Further, when performing a lower colon procedure using a circular stapler, the intestine is typically stapled using a conventional surgical stapler with double rows of staples being emplaced on either side of the diseased portion of intestine to be removed. The target section is simultaneously cut as the adjoining end is stapled. After removing the diseased portion, the surgeon typically inserts the anvil into the proximal end of the lumen, proximal of the staple line. This is done by inserting the anvil head into an entry port cut into the proximal lumen by the surgeon. On occasion, the anvil can be placed transanally, by placing the anvil head on the distal end of the stapler and inserting the instrument through the rectum. The surgeon then ties the proximal end of the intestine to the anvil shaft using a suture or other conventional tying device. Next, the surgeon cuts excess tissue adjacent to the tie and the surgeon attaches the anvil to the trocar shaft of the stapler. The surgeon then closes the gap between the anvil and cartridge, thereby clamping the proximal and distal ends of the intestine in the gap. The surgeon next actuates the stapler causing several rows of staples to be driven through both ends of the intestine and formed, thereby joining the ends and forming a tubular pathway. Simultaneously, as the staples are driven and formed, the concentric circular knife blade is driven through the intestinal tissue ends, cutting the ends adjacent to the inner row of staples. The surgeon then withdraws the stapler from the intestine and the procedure is complete.
During the above-described surgical procedures, it is desirable to properly form staples within a range of staple heights such that they are retained in the tissue and prevent leakage and bleeding and to achieve “tissue-to-tissue” contact which promotes tissue healing. In general, by controlling the distance or gap between the anvil and the cartridge, better stapling and healing results may be achieved. While some surgical staplers are equipped with a visual readout indicating staple height, a surgeon may need to focus on many different items during surgery. Further, once the anvil has been properly positioned, it is necessary that the anvil not move during firing, otherwise proper staple formation could be adversely affected.
The foregoing discussion is intended only to illustrate the present field and should not be taken as a disavowal of claim scope.
In various embodiments, a surgical stapling head assembly is provided. In at least one embodiment, the surgical stapling head assembly can comprise a staple cartridge for supporting one or more surgical staples, a core movable relative to the staple cartridge, at least one staple driver for engaging and driving the staples from the staple cartridge, and a casing configured to at least partially hold the staple cartridge and movably receive the core and the at least one staple driver. In these embodiments, the at least one staple driver can extend from the core. Further, in these embodiments, the casing can further comprise at least one retention member that is configured to move from a first position to a second position when sufficient external force is applied to the retention member. Moreover, in these embodiments, when the at least one retention member is at the second position, the at least one staple driver is prevented from driving the staples from the staple cartridge.
In various embodiments, a surgical stapler is provided. In at least one embodiment, the surgical stapler can comprise a body, a stapling head assembly, a drive system, an anvil, and an anvil adjustment assembly. In these embodiments, the body can comprise a handle portion and a shaft portion extending from the handle portion. Further, in these embodiments, the stapling head assembly can be releasably coupled to the shaft portion. Additionally, in these embodiments, the stapling head assembly can comprise a staple cartridge for supporting one or more surgical staples, a core movable relative to the staple cartridge, at least one staple driver for engaging and driving the staples from the staple cartridge, and a casing configured to at least partially hold the staple cartridge and movably receive the core and the at least one staple driver. Also, in these embodiments, the at least one staple driver can extend from the core. Further, in these embodiments, the casing can further comprise at least one retention member that is configured to move from a first position to a second position when sufficient external force is applied to the retention member. Moreover, in these embodiments, when the at least one retention member is at the second position, the at least one staple driver is prevented from driving the staples from the staple cartridge. Additionally, in these embodiments, the drive system may be configured to apply drive motions to the staple driver. Further, in these embodiments, the anvil may be movably supported relative to the staple cartridge for axial movement toward and away from the staple cartridge. Also, in these embodiments, the anvil adjustment assembly may be configured to selectively adjust an axial position of the anvil relative to the staple cartridge.
In at least one embodiment, a surgical stapling head assembly is provided that can comprise a staple cartridge for supporting one or more surgical staples, a core movable relative to the staple cartridge, at least one staple driver extending from the core and for engaging and driving the staples from the staple cartridge, a casing configured to at least partially hold the staple cartridge and movably receive the core and the at least one staple driver, and lockout means for preventing the at least one staple driver from driving staples from the staple cartridge.
The novel features of the embodiments described herein are set forth with particularity in the appended claims. The embodiments, however, both as to organization and methods of operation may be better understood by reference to the following description, taken in conjunction with the accompanying drawings as follows.
Certain 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 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 embodiments and that the scope of these embodiments is defined solely by the claims. The features illustrated or described in connection with one embodiment may be combined with the features of other embodiments. Further, where an ordering of steps in a process is indicated, such ordering may be rearranged or the steps may be carried out contemporaneously as desired unless illogical or the listed order is explicitly required. Such modifications and variations are intended to be included within the scope of the appended claims.
In the following description, like reference characters designate like or corresponding parts throughout the several views. Also in the following description, it is to be understood that terms such as “forward,” “rearward,” “front,” “back,” “right,” “left,” “over,” “under,” “upwardly,” “downwardly,” “proximally,” “distally,” and the like are words of convenience and are not to be construed as limiting terms. The description below is for the purpose of describing various embodiments and is not intended to limit the appended claims.
The various embodiments generally relate to various surgical staplers configured to seal tissue and, in at least one embodiment, cut tissue also. Such surgical staplers may be configured to function through a natural orifice, such as the anus, mouth and/or vagina, or through an incision cut through a body wall. Further, such surgical staplers may be designed as endoscopic tools, including laparoscopic tools. One exemplary type of surgical stapler may be found in U.S. application Ser. No. 12/635,415, entitled SURGICAL STAPLER WITH DISCRETE STAPLE HEIGHT ADJUSTMENT AND TACTILE FEEDBACK, filed on Dec. 10, 2009, now U.S. Pat. No. 8,136,712, incorporated herein by reference in its entirety.
Focusing now on one non-limiting embodiment, as can be seen in
When the trigger 90 is activated, a drive system may be actuated within the body 10 so that staples 31 (see
Referring to
Referring to
Referring to
Focusing now on the adjustment of the anvil 50 and referring to
Referring to
Further, referring to
Referring now to
As mentioned above, in various embodiments, the adjustment shaft 70 may be configured to move the anvil 50 to at least one predetermined distance from the stapling head 30. In more detail, and focusing now on
Continuing, the circle drawn in dashed lines in
Further, each dwell portion 74b′, 74b″, and 74b′″ may be at a different longitudinal position along anvil adjustment shaft 70 to provide predetermined, discrete staple forming heights. For example, referring to
Focusing now on
Referring to
In more detail, referring again to
Referring to
Similarly, referring still to
In various embodiments, referring to
While at least one embodiment described above show the delimiters 76′, 76″, and/or 76′″ as being formed as bumps or protrusions in the screw surface 74, the delimiters may also take the form of indentations in the screw surface. Also, the delimiters may be a separate piece from the adjustment shaft 70 such that they may be attached thereto. In any event, the delimiters may provide tactile feedback to a user as the user rotates the shaft 70. Further, while a delimiter is shown as separating the ramp portion 74a from the first dwell portion 74b′, and so on, the screw surface may not include a dwell portion or dwell portions. In such embodiments, the screw surface may comprise multiple ramp portions separated, at desired intervals, by at least one delimiter. Accordingly, a user may be informed, via tactile feedback, when an appropriate staple forming height, between the anvil 50 and staple cartridge 33 (see, e.g.,
In addition to tactile feedback, the surgical stapler 1 may include visual reference indicia to provide a user with an indication of when the aforementioned staple forming height(s) have been reached. For example, referring now to
Additionally, while at least one embodiment described above has illustrated the screw surface 74 as being defined by a channel formed in anvil adjustment shaft 70, the screw surface may, in at least one embodiment, alternatively be defined by a thread projecting from the anvil adjustment shaft 70. In such embodiments, pin 75 may be employed or another thread mating component may be used to engage the screw surface, such as a fork projecting from the inside of body 10.
Further, while the screw surface 74 discussed above is described as being a part of anvil adjustment shaft 70, it is to be understood that such screw surface could alternatively be a part of the body 10. In such embodiments, an engagement portion, such as a pin or other thread engaging component, would likewise be fixed to the adjustment shaft 70 instead of to the body 10. In any event, rotation of the shaft 70 may cause a screw surface to rotate with respect to an engagement portion such that the shaft 70 and, hence, the anvil 50 translate with respect to the body 10 and/or stapling head 30.
In various embodiments, as mentioned above and referring to
Referring now to
Further, referring to
In various embodiments, and as mentioned above, the surgical stapler may be straight instead of curved, as described above. Accordingly, referring now to
Also, referring now to
It should be appreciated that the straight stapler 101 and the curved stapler 1, discussed above (see
In at least one exemplary experiment, the aforementioned minimization of part count was accomplished by comparing each component to a part criteria list to see if that part was needed. The only ones remaining were those listed above and required for assembly reasons, possessed unique material properties, or which moved with respect to other parts in the stapler.
In various embodiments, a stapling head assembly may be configured to include a lockout feature such that during insertion into a portion of surgical stapler, the staple drivers are resisted or prevented from unintentionally firing or driving the staples from a staple cartridge. In more detail, referring now to
Thus, in more detail, the stapling head assembly 230 may comprise a staple cartridge 233 for supporting one or more surgical staples (not shown; however, see staples 31 in
Referring to
As shown in
As discussed in more detail below, the retention members 237 may be configured move from a first position to a second position when sufficient external force is applied to the retention member, such as that provided by the shaft portion 12 of a surgical stapler 1 (see
In at least one embodiment, to provide additional locking ability to the stapling head assembly 230, the core 235 may further comprise a recess 240 sized and configured to receive the retention members 237 when the retention members 237 are in the second position. For example, referring to
As noted above, in various embodiments, the retention members 237 may be resiliently deflectable. In other words, the retention members 237 may be configured to deflect resiliently such that after deflecting due to external forces, they may spring back or otherwise return to their original positions. In more detail, the retention members 237 may each comprise a cantilevered arm formed in the casing 239. In such embodiments, referring to
In at least one embodiment, the retention members 237 may be unitary and integrally formed with the casing 239 such that the casing 239 and the retention members 237 are formed and/or molded from the same piece of material. In such embodiments, the casing 239 may be made from a plastic material, such as Nylon, Polycarbonate, Polyetherimide (PEI) or PolyEtherEther-Ketone (PEEK), for example. Additionally, in at least one embodiment, the core may be made from a plastic material, such as Nylon, Polycarbonate, Polyetherimide (PEI) or PolyEtherEther-Ketone (PEEK), for example.
In at least one embodiment, the operation of the retention members 237 interacting with the core 235 and/or recess 240 may be understood with reference with
Other styles of stapling head assemblies may include various features discussed above. For example, in at least one embodiment and referring to
While the embodiments have been described, it should be apparent, however, that various modifications, alterations and adaptations to the embodiments may occur to persons skilled in the art with the attainment of some or all of the advantages of the various embodiments. For example, according to various embodiments, a single component or step may be replaced by multiple components or steps, and multiple components or steps may be replaced by a single component or step, to perform a given function or functions or accomplish a given objective. Further, the various components described above may be made from a variety of materials. For example, the components may be made from any combination of metal, plastic, and/or a biocompatible material. Moreover, various components, such as the trigger, drive band, and anvil adjustment band may be made and bent or folded from sheet metal. This application is therefore intended to cover all such modifications, alterations and adaptations without departing from the scope and spirit of the appended claims.
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 devices can be reconditioned for reuse after at least one use. Reconditioning can include a combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the devices can be disassembled, and any number of 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 devices can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those of ordinary skill in the art will appreciate that the reconditioning of a device can utilize a variety of different 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.
The devices described herein may 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 higher 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 material 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.
This application is a divisional application claiming priority under 35 U.S.C. § 121 to U.S. patent application Ser. No. 14/324,772, entitled SURGICAL STAPLING HEAD ASSEMBLY WITH FIRING LOCKOUT FOR A SURGICAL STAPLER, filed Jul. 7, 2014, which issued on Jan. 12, 2016 as U.S. Pat. No. 9,232,945, which is a continuation application claiming priority under 35 U.S.C. § 120 of U.S. patent application Ser. No. 13/718,405, entitled SURGICAL STAPLING HEAD ASSEMBLY WITH FIRING LOCKOUT FOR A SURGICAL STAPLER, filed on Dec. 18, 2012, which issued on Aug. 5, 2014 as U.S. Pat. No. 8,794,497, which is a continuation application claiming priority under 35 U.S.C. § 120 from U.S. patent application Ser. No. 12/878,065, entitled SURGICAL STAPLING HEAD ASSEMBLY WITH FIRING LOCKOUT FOR A SURGICAL STAPLER, filed on Sep. 9, 2010, which issued on Jan. 29, 2013 as U.S. Pat. No. 8,360,296, the entire disclosures of which are incorporated by reference herein.
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