Patent Application
20170281175
The present invention, in some embodiments thereof, relates to surgical tissue staplers and in particular to surgical staplers and endo cutter staplers and to methods of using same during surgeries for sealing and/or cutting a tissue or a bodily organ. Some surgical staplers of the invention are dynamic, being convertible from a non-operational delivery configuration mode, which is applicable for delivery into the body via small-sized passages, to a deployment configuration in which the stapler head is in an operational mode and affords stapling and/or cutting a bodily organ or tissue.
There is a growing trend towards designing surgical tools with smallest possible diameters while keeping, if not also improving, functionality for the surgical practice. In case of minimally invasively introduced laparoscopic tools, smaller diameter may contribute to smaller incisions or cuts made to the skin and soft tissues underneath. In case of natural orifice (e.g., orally) introduction of endoscopic tools, smaller diameter may contribute to the possibility and/or ease to add more tools or other, larger, tools in parallel, via the natural orifice.
In past years this trend also encompasses design efforts of surgical staplers, including disposable or reusable linear staplers and endo cutter staplers. Endoscopic surgical staplers are commonly introduced through laparoscopic ports being 12 mm or more in diameter, so there is a need to provide smaller designs introducible through natural orifices or through laparoscopic ports being 8 mm or less, or even about 6 mm or less in diameter. Some known prior publications focus on new configurations of staples and ways of applying staples (e.g., attaching the staples to and through tissue walls) which allow smaller overall size of the stapler. Such prior publications include: U.S. Pat. Nos. 8,556,935, 8,403,956, 8,365,973, the disclosures of which are fully incorporated herein by reference. However, introducing new staples and methods of anchoring may create unnecessary burden to the surgeons' society and may also increase costs to hospitals and patients.
Therefore, there is a need for surgical staplers and endo cutters having small size during introduction into a patient's body with minimal to no change in current staples and methods of use.
The present invention, in some embodiments thereof, relates to surgical tissue stapler heads, and surgical tissue staplers and to methods of use thereof for fastening, sealing or/and cutting bodily tissues or organs.
The surgical tissue staplers and stapler heads of the invention include a stapling jaw and an anvil jaw positionable to oppose the stapling jaw, the stapling jaw configured to include a first stapling jaw portion and a second stapling jaw portion being relatively positioned so as to be oppositely separated from each other by a longitudinal channel extending therebetween. The first stapling jaw portion includes a first row of tissue fasteners of a first staple size or/and type, and the second stapling jaw portion includes a second row of tissue fasteners of a second staple size or/and type. The surgical stapler device of the invention is preferably convertible during surgery from a delivery configuration in which the surgical stapler's head is non-operable to a deployment operative configuration.
Having asymmetric structure with respect to the first and second jaw portions being different in the number of rows loaded with fasteners and/or the size and/or type of fasteners, affords a particular minimal cross section dimension(s) of the surgical tissue heads and staplers. Consequently, the surgical tissue heads and staplers of the invention provide particular minimal invasive surgical means.
In an aspect of some embodiments, there is provided a (e.g., linear) tissue stapler head, which includes a stapling jaw configured to include a first stapling jaw portion and a second stapling jaw portion being relatively positioned so as to be oppositely separated from each other by a longitudinal channel extending therebetween, the longitudinal channel is sized and configured for allowing a blade having a sharp edge to travel therealong; and an anvil jaw positionable to oppose the stapling jaw.
In some embodiments, the first stapling jaw portion includes a first row of tissue fasteners of a first staple size or/and type adjacent to a first side of the longitudinal channel, and the second stapling jaw portion includes a second row of tissue fasteners of a second staple size or/and type adjacent to a second side of the longitudinal channel.
In some embodiments, the tissue fasteners of the first size or/and type or/and of the second size or/and type have staple legs that are plastically deformable to an inwardly bent form.
In some embodiments, the tissue fasteners of the second size or/and type have a minimal leg length being greater than about 3 mm.
In some embodiments, the tissue fasteners of the first size or/and type have a maximal leg length being less than about 3 mm.
In some embodiments, at least one of the tissue fasteners of the first and second size or/and type includes at least one rigid or elastic prong.
In some embodiments, the second stapling jaw portion has a plurality of rows of tissue fasteners including the second row of tissue fasteners of the second staple size or/and type. In some embodiments, the second stapling jaw portion has a number of rows of tissue fasteners which is greater by at least one than the number of rows of the first stapling jaw portion. In some embodiments, the second stapling jaw portion comprises two rows of tissue fasteners and the first stapling jaw portion comprises one row of tissue fasteners. In some embodiments, the second stapling jaw portion comprises three rows of tissue fasteners and the first stapling jaw portion comprises one row of tissue fasteners. In some embodiments, the second stapling jaw portion comprises three rows of tissue fasteners and the first stapling jaw portion comprises two rows of tissue fasteners.
In some embodiments, the first stapling jaw portion includes suturing means.
In some embodiments, the first stapling jaw portion includes tissue bonding means, tissue coagulating means, or tissue adhering means.
In some embodiments, in close proximity between the stapling jaw and the anvil jaw, the first stapling jaw portion faces a first contact surface of the anvil jaw and the second stapling jaw portion faces a second contact surface of the anvil jaw. Optionally, a first distance extending between the first stapling jaw portion and the first contact surface is less than a second distance extending between the second stapling jaw portion and the second contact surface. Optionally, the first contact surface and the second contact surface are distanced apart from each other by a contact surface transition portion located therebetween, the contact surface transition portion includes a rise such that the first contact surface is elevated relative to the second contact surface.
In some embodiments, the tissue stapler head is configured and operative so as to be convertible from a delivery configuration including the stapler head in a non-operational mode and in which the stapler head is passable through a passage enclosing a minimal inner diameter, to a deployment configuration including the stapler head being in an operational mode. Optionally, in the delivery configuration, the stapling jaw and the anvil jaw are consecutively arranged lengthwise relative to each other. Optionally, in the delivery configuration, the stapler head has maximal cross-sectional dimensions including a maximal height, a maximal width, or/and a maximal diameter, each of the dimensions being smaller than the minimal inner diameter of the passage. Optionally, in the delivery configuration, each of the maximal stapler head cross-sectional dimensions is equal to or less than about 8 mm.
In an aspect of some embodiments there is provided a (e.g., linear) tissue stapler, which includes an elongated body having a longitudinal axis, a stapling jaw configured for including a plurality of parallel rows of tissue fasteners, an anvil jaw; and a drive member including a blade having a sharp edge extending between the stapling jaw and the anvil jaw. The blade is optionally shiftable from a horizontal position to a vertical position relative to the longitudinal axis. Optionally, the blade, in the vertical position, is configured to travel along a longitudinal channel extending between oppositely separated portions of the stapling jaw.
In some embodiments, the tissue stapler is configured so as to be selectively convertible from a delivery configuration including a stapler head in a non-operational mode and in which the tissue stapler is passable through a passage enclosing a minimal inner diameter, to a deployment configuration including the stapler head in an operational mode.
In some embodiments, the tissue stapler is configured such that when in the delivery configuration, the blade is in the horizontal position, and when in the deployment configuration, the blade is in the vertical position.
In some embodiments, the tissue stapler is configured such that when in the delivery configuration, the anvil jaw and the stapling jaw are consecutively arranged lengthwise whereby a maximal stapler cross-sectional dimension is less than the minimal inner diameter. In some such embodiments, when in the deployment configuration, the anvil jaw and the stapling jaw are juxtapositionally arranged and form the operational mode stapler head whereby the maximal stapler cross-sectional dimension is equal to or greater than the minimal inner diameter of the passage.
In some embodiments, when converting between the delivery configuration and the deployment configuration, the anvil jaw is actuated for shifting towards the stapling jaw. Optionally, the tissue stapler further includes a pivot around which the anvil jaw swivels during the shifting. Optionally, the pivot is part of the drive member.
In some embodiments, during the shifting, the anvil jaw undergoes a planar displacement being a combination of a planar rotation and a planar translation. Optionally, the planar displacement is effected and maintained via a planar linkage arrangement. Optionally, the planar linkage arrangement includes at least one linkage that includes the blade being rotatable between the horizontal position and the vertical position about a driver-blade joint connecting between the drive member and the blade. Relative rotation between the anvil jaw and the blade may be facilitated about a blade-anvil junction formed between the blade and the anvil jaw.
In some embodiments, the anvil jaw includes a grooved track extending between a proximal side and a distal side thereof below the channel, so as to allow a flange to pass along the grooved track, the flange connects the blade to the anvil jaw to form the blade-anvil junction. Optionally, the blade-anvil junction is positioned proximally to the distal side of the grooved track during the relative rotation between the anvil jaw and the blade when the blade rotates.
In some embodiments, during the conversion of the tissue stapler from the delivery configuration to the deployment configuration, upon the shifting of the blade from the horizontal position to the vertical position and the anvil jaw planar displacement, the stapler is configured such that the anvil jaw shifts distally relative to the blade and thereby opposes the stapling jaw.
In some embodiments, the tissue stapler is configured such that the anvil jaw shifting distally relative to the blade is restricted to motion of the grooved track relative to the flange, whereby the flange is allowed to travel along the grooved track from the blade-anvil junction to a retracted flange location at, or adjacent to, the proximal side of the grooved track. Optionally, the stapler head in the operational mode is configured such that the drive member and the blade are sequentially drivable in a distal direction with the flange along the grooved track from the retracted flange location up to a final flange location located at, or adjacent to, the distal end of the grooved track.
In some embodiments, the tissue stapler is configured to have in the delivery configuration a maximal cross-sectional dimensions including a maximal height, a maximal width and/or a maximal diameter equal to or less than 8 mm.
In an aspect of some embodiments, there is provided a method of surgically fastening or/and cutting a bodily tissue or organ inside a body of a subject. In some embodiments, the method includes at least one of the following steps (not necessarily in same order):
compressing the removable body part via the first row of tissue fasteners, and compressing the remaining body part via the second row of tissue fasteners, such that adjacent the cutting line the removable body part has a smaller thickness than the remaining body part.
In some embodiments, the passing the blade and the releasing the first and second rows of tissue fasteners effects dissecting of the bodily tissue or organ along the cutting line into a removable body part sealed with the first row of tissue fasteners, and a remaining body part sealed with the second row of tissue fasteners.
In some embodiments, the actuating of the stapler head further includes compressing the stapling jaw towards the anvil jaw to thereby inwardly bend staple legs of the tissue fasteners over the bodily tissue or organ.
The tissue stapler head may further include a drive member including the blade, and is configured for driving the blade to travel along the longitudinal channel.
In an aspect of some embodiments there is provided a method of surgically fastening and cutting a bodily tissue or organ inside a body, the method includes at least one of the following steps (not necessarily in same order):
In some embodiments, the dividing the bodily tissue or organ includes stapling the first body part with at least one row of the tissue fasteners of the first size or/and type, and stapling the second body part with at least one row of the tissue fasteners of the second size or/and type.
In an aspect of some embodiments there is provided a method of surgically fastening and cutting a bodily tissue or organ inside a body, the method includes at least one of the following steps (not necessarily in same order):
In some embodiments, the operating the tissue stapler is followed by converting the tissue stapler from a delivery configuration to a deployment configuration having the stapler head in an operational mode.
Unless otherwise defined, all technical and/or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and/or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.
Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.
In the drawings:
The present invention, in some embodiments thereof, relates to surgical tissue stapler heads, and surgical tissue staplers and to methods of use thereof for fastening, sealing or/and cutting bodily tissues or organs.
According to some embodiments, the tissue staplers of the invention are configured so as to be selectively convertible from a delivery configuration including a stapler head in a non-operational mode and in which the linear tissue stapler is passable through a passage enclosing a minimal inner diameter, to a deployment configuration including the stapler head in an operational mode.
According to some embodiments, the surgical tissue staplers and stapler heads of the invention are particular minimal in cross sectional dimensions, thus affording introduction into the body in a minimal invasive manner.
As will be explained in more details below, in some embodiments, some particular minimal cross sectional dimensions of the surgical tissue staplers and stapler heads of the invention are afforded by the convertible properties of the surgical tissue heads or/and by the asymmetric structure of the surgical tissue head, being sufficient for allowing delivery thereof via the abovementioned passage.
The following preferred embodiments may be described in the context of exemplary laparoscopic surgical procedures for ease of description and understanding. However, the invention is not limited to the specifically described devices and methods, and may be adapted to various clinical applications without departing from the overall scope of the invention. For example, devices and related methods including concepts described herein may be used for other surgical procedures such as, but not limited to: single-port laparoscopy, endoscopy, and NOTES (“Natural Orifice Translumenal Endoscopic Surgery”) assisted endoscopic or laparoscopic surgeries.
Provided immediately below is a “Definition” section, where certain terms related to the invention are defined specifically.
The term “surgical stapler” as used herein refers to a medical device which is used to place surgical fasteners.
The terms “surgical fastener”, “tissue fastener”, “surgical staples” or “tissue staples”, as used herein are interchangeable and refer to any pronged artifact that can pierce through tissue layers for fixating or bonding them together. A surgical fastener may include one leg or a plurality of legs, possibly linked one with the other via a leg bridge; each leg is pronged at its end and sized to pass through a plurality of soft tissue layers. Surgical fasteners or staples types include, but are not limited to, those that are elastic and capable to bounce from a stressed configuration (e.g., by stretching or compressing its legs open or close) to a nominal less stressed configuration during deployment, those that are rigid enough in order to preclude deformation during deployment, or those that are plastically deformable during deployment, as in the case of surgical tissue staples, where the legs are forced to bend to a fixedly deformed closed configuration, and are commonly used to close wounds or openings in place of sutures.
Surgical staplers may be designed for open surgeries or for endoscopic or laparoscopic surgeries, may or may not include tissue cutting means, and may be disposable or reusable. The surgical staplers are optionally loaded with disposable cartridges containing the fasteners (e.g., staples). The stapler line may be straight, curved or circular.
A surgical stapler as other types of staples can include two opposing jaws pivotally movable one with the other: a “stapling jaw” which houses the cartridge/staples and optionally includes means to push staples to protrude towards the opposing jaw, an “anvil jaw”, having a number of recesses or grooves corresponding in number and position to the staples in “stapling jaw”. Upon grasping and compressing a tissue with the jaws, each staple favorably penetrates through the tissue with each of its two pronged legs which are then inwardly bent as they press against the corresponding anvil recesses.
The terms “linear tissue stapler”, “linear stapler” and “surgical linear stapler” as used herein refer to a surgical stapler loaded with two or more staggered straight rows of staples, commonly used in abdominal surgery, thoracic surgery, gynecology, and pediatric surgery. Linear tissue staplers may be reusable or disposable, with distinctive designs for open surgeries and for endoscopic surgeries.
The terms “endocutter”, “endo-cutter”, “endo cutter stapler” and “cutting stapler” as used herein refer to a stapler with a blade provided between staples rows used for resection and transection of organs or tissues. Common cutting staplers are loaded with two groups of staples rows (each with a single row, or double or triple staggered rows, or more, or any combination thereof) and simultaneously cuts and divides tissue between the two groups of rows in parallel to closing cut tissue ends with staples.
The present invention, in some embodiments thereof, relates to surgical fasteners appliers and in particular to surgical linear staplers and endo cutter staplers.
Reference is made to
In an attempt to provide an endo cutter stapler for treating tissues including thick muscular tissues in sub-abdominal locations, yet still allowing passage through small endoscopic channels, the present invention discloses concept of linear (endo cutter) tissue staplers comprising at least one of the following attributes:
1. the stapler is convertible from a delivery configuration, in which the anvil jaw and the stapling jaw are arranged such that the maximal stapler cross-sectional dimension is smaller or less than the minimal inner diameter of a small laparoscopic channel, to a deployment configuration, in which the anvil jaw and the stapling jaw are arranged such that they form an operational stapler head with a maximal cross-sectional dimension equal to or greater than the channel minimal inner diameter.
2. the stapler head is asymmetric in the sense that quantity, type, size or/and distribution of tissue fasteners (e.g., staples) is different from two sides of the blade and elongated channel (e.g., in a form of a ‘2+1’, or ‘3+1’, or ‘3+2’ type). In some such embodiments, stapler head readily incorporates or/and is configured to include a first stapling jaw portion/side and a second stapling jaw portion/side. In some embodiments, the second stapling jaw portion is configured to apply tissue fasteners in similar size and quantity as in large endo cutter staplers, and a first stapling jaw portion/side configured to apply tissue fasteners in much smaller size and/or quantity, thereby decreasing substantially the cross-sectional dimension of the stapler head in corresponding side of the stapler head relative to longitudinal channel. In some embodiments, the stapler head is asymmetric in the sense that at least the rows of tissue fasteners adjacent to each side of the longitudinal channel are different one from the other in the type and/or size of staples. It should be recognized that in surgical procedures involving withdrawal of cut tissues, each of tissue remaining within the body and tissue removed from the body may be treated in a different manner. Specifically, for tissue remaining within the body it is necessary that the cut end would be fastened and sealed in a sufficient manner that eliminate untightened spaces yet loose enough to exclude over-compression and necrosis. For the removed tissue part, the cut end may be fastened in a much less strict manner in terms of untightened spaces, and that would allow further compression of the tissue to a minimal thickness, hence even a single row with smaller staples may be used. The surgical tissue stapler and stapler head of the invention, being of ‘2+1’, or ‘3+1’, or ‘3+2’ type provides a solution to those surgical requirements. It should be further recognized that the particular stapler's head type as disclosed herein affords uniquely minimal invasive delivery into the body.
3. in order to further minimize its size during delivery, the stapling jaw cover can be provided retracted (proximally) and configured to slide distally over the staples rows. The cover can be provided fixated to the blade and runners therefore functioning as a drive member instead of housing a driver mechanism slidable therein.
Thus, according to one aspect of the present invention, there is provided a linear tissue stapler head, comprising: a stapling jaw configured to include a first stapling jaw portion and a second stapling jaw portion being relatively positioned so as to be oppositely separated from each other by a longitudinal channel extending therebetween, the longitudinal channel is sized and configured for allowing a blade having a sharp edge to travel therealong; and an anvil jaw positionable to oppose the stapling jaw; wherein the first stapling jaw portion includes a first row of tissue fasteners of a first staple size or/and type adjacent to a first side of the longitudinal channel, and the second stapling jaw portion includes a second row of tissue fasteners of a second staple size or/and type adjacent to a second side of the longitudinal channel.
According to some embodiments, the second stapling jaw portion has a plurality of rows of tissue fasteners including the second row of tissue fasteners of the second staple size or/and type. According to some embodiments, a plurality of rows of tissue fasteners is two rows or three rows. First and second stapling jaw portions are optionally different one from the other with respect to at least the staples size or/and type of the rows adjacent to each side of the longitudinal channel. Namely, at least the single row immediately adjacent one side of the longitudinal channel is different than the other single row immediately adjacent the other side of the longitudinal channel, such that each of these two rows comprises a different size/type of tissue fasteners. According to some embodiments, first and second stapling jaw portions are different one from the other with respect the entire size or/and type of staples. In some embodiments, the second stapling jaw portion has a number of rows of tissue fasteners which is greater by at least one, than the number of rows of the first stapling jaw portion. In some embodiments, the second stapling jaw portion has a number of rows of tissue fasteners which is greater by one or two than the number of rows of the first stapling jaw portion. In some embodiments, the second stapling jaw portion has two rows of tissue fasteners of the second staple size or/and type and the first stapling jaw portion has one row of tissue fasteners of a first staple size or/and type. In some embodiments, the second stapling jaw portion has three rows of tissue fasteners of the second staple size or/and type and the first stapling jaw portion has one row of tissue fasteners of a first staple size or/and type. In some embodiments, the second stapling jaw portion has three rows of tissue fasteners of the second staple size or/and type and the first stapling jaw portion has two rows of tissue fasteners of a first staple size or/and type.
Reference is made to
When in the deployment configuration, anvil jaw 3 and stapling jaw 2 are juxtapositionally arranged and oppose each other, one above the other, forming the operational stapler head such that the maximal stapler cross-sectional dimension is greater than or equal to minimal inner diameter 4. Minimal inner diameter 4 may be about 8 mm or less, optionally about 6 mm or less, optionally about 4 mm or less, or higher, or lower, or an intermediate size. Each possibility represents a separate embodiment of the invention. Stapling head 1 maximal cross-sectional dimension in the deployment configuration may be a maximal height, a maximal width and/or a maximal diameter, and is optionally equal to or greater than about 5 mm, optionally equal to or greater than about 7 mm, optionally equal to or greater than about 8 mm, optionally equal to or greater than about 12 mm, or higher, or lower, or an intermediate value. Each possibility represents a separate embodiment of the invention.
Stapling jaw 2 is configured to include a first stapling jaw portion B and a second stapling jaw portion A being relatively positioned so as to be oppositely separated from each other by a longitudinal channel 7 extending therebetween. First stapling jaw portion B includes a first row of tissue fasteners and second stapling jaw portion A includes a second row of tissue fasteners, optionally adjacent/closest to longitudinal channel 7, out of a number of rows of tissue fasteners (not necessarily of same size or/and type). First stapling jaw portion B includes a first row of tissue fasteners of a first staple size or/and type and is positioned adjacent to a first side of longitudinal channel 7. Second stapling jaw portion A includes a second row of tissue fasteners of a second staple size or/and type and is positioned adjacent to a second side of the longitudinal channel 7. In the figures, stapling jaw 2 includes a total of four rows of tissue staples, and a drive member 5 in the form of a slidable cover provided with a blade 6 having a sharp edge. Drive member 5 is configured to travel along longitudinal channel 7 extending therebetween the separated opposing portions of stapling jaw 2. In some embodiments and as shown, first stapling jaw portion B contains a single row of small tissue fasteners 8 and second stapling jaw portion A contains three staggered rows of large tissue staples 9. First stapling jaw portion B may contain a single row of small tissue fasteners 8 and second stapling jaw portion A may contain two staggered rows of large tissue staples 9. Optionally, the number of small tissue staples 8 is greater than the number of large tissue staples 9 per each row, optionally being further compacted together along the row. In some embodiments, the tissue fasteners of the second row of tissue fasteners have a second size or/and type of tissue fasteners. In some embodiments, the second size or/and type of tissue fasteners have a minimal leg length being greater than about 3 mm. In some embodiments, the tissue fasteners of the first row of tissue fasteners have a first size or/and type of tissue fasteners. In some embodiments, the first size or/and type of tissue fasteners have a maximal leg length being less than about 3 mm.
A minimal leg size of the large tissue staples 9 legs is optionally greater than 3 mm in length, optionally about 3.5 mm, or optionally about 3.8 mm, or optionally about 4.1 mm. A maximal leg size of the small tissue staples 8 legs is optionally smaller than 3 mm in length, optionally about 2.5 mm or optionally about 2 mm. Optionally, additionally or alternatively, a minimal leg size of large tissue staples 9 legs is optionally equal to or greater than 1.5 mm, optionally equal to or greater than 2 mm, in length, whereas a maximal leg size of small tissue staples 8 legs is optionally smaller by at least 0.2 mm, optionally by at least 0.5 mm, optionally by at least 1 mm, optionally by at least 1.5 mm, than the minimal leg size of large tissue staples 9.
Drive member 5 comprises a number of runners (as, for example, runners 121 shown in
Linear tissue stapler 30 is convertible from a delivery configuration (shown in
When in the deployment configuration (
The maximal stapler cross-sectional dimension 39′ in the deployment configuration is equal to or greater than minimal inner diameter 38. Cross-sectional dimensions 39 and 39′ may be a maximal height, a maximal width and/or a maximal diameter. The maximal stapler cross-sectional dimension in the deployment configuration is equal to or greater than about 3 mm, optionally equal to or greater than about 5 mm, optionally equal to or greater than about 8 mm, optionally equal to or greater than about 12 mm, optionally equal to or greater than about 20 mm, optionally equal to or greater than about 30 mm, or higher, or lower, or an intermediate value. Each possibility represents a separate embodiment of the invention.
The maximal stapler or stapling head cross-sectional dimensions in the delivery configuration may be a maximal height, a maximal width and/or a maximal diameter. The maximal stapler cross-sectional dimension in the delivery configuration is equal to or less than about 20 mm, optionally equal to or less than about 15 mm, optionally equal to or less than about 10 mm, optionally equal to or less than about 8 mm, optionally equal to or less than about 6 mm, optionally equal to or less than about 4 mm, or lower, or an intermediate value.
Reference is made to
Stapling jaw 44 is optionally coupled to shaft distal end 42 and lying distally thereto in both delivery configuration and deployment configuration. Anvil jaw 43 is configured to swivel towards stapling jaw 44 when shifting between the delivery configuration and the deployment configuration as shown in
Linear tissue stapler 50 (
Stapling jaw 54 is optionally coupled to shaft distal end 52 and lying distally thereto in both delivery configuration and deployment configuration. Anvil jaw 53 is configured to revolve around a point 56 located thereon on the shifting as shown in
Linear tissue stapler 60 (
Stapling jaw 64 is optionally coupled to shaft distal end 62 and lying distally thereto in both delivery configuration and deployment configuration. Anvil jaw 63 is configured to slide proximally and/or distally when shifting between the delivery configuration and the deployment configuration, for example along a track 65 provided thereon or along part of shaft 61. Anvil jaw 63 may then interlock with shaft distal end 62 and/or with stapling jaw 64 in the deployment configuration to form the operational stapler head distally adjacent shaft distal end 62. Stapling jaw 64 and anvil jaw 63 are then movable with respect to each other from an open position, wherein the jaws are spaced apart, to a closed position, wherein the jaws are in close approximation to one another. The maximal stapler cross-sectional dimension in the deployment configuration is equal to or greater than minimal inner diameter, and may be a maximal height, a maximal width and/or a maximal diameter. The maximal stapler cross-sectional dimension in the deployment configuration is equal to or greater than about 3 mm, optionally equal to or greater than about 5 mm, optionally equal to or greater than about 8 mm, optionally equal to or greater than about 12 mm, optionally equal to or greater than about 20 mm, optionally equal to or greater than about 30 mm, or higher, or lower, or an intermediate value. Each possibility represents a separate embodiment of the invention.
Stapling jaw 74 is optionally coupled to shaft distal end 72 and lying distally thereto in both delivery configuration and deployment configuration. Anvil jaw 73 is configured to swivel towards stapling jaw 74 (as shown in
Reference is now made to
Stapling jaw 104 is an extension of shaft distal end 102, optionally coupled thereto or unitary with it, and lying distally thereto in both delivery configuration and deployment configuration. When shifting between the delivery configuration and the deployment configuration, anvil jaw 103 goes through a planar translation derived from a parallelogram linkage coupling mechanism and then undergoes a sliding motion until docking in a predetermined posture below stapling jaw 104. Anvil jaw 103 may then interlock with shaft distal end 102 and/or with stapling jaw 104 to form an operational stapler head. Stapling jaw 104 and anvil jaw 103 are then movable with respect to each other from an open position (shown in
Upon shifting from the delivery configuration to the deployment configuration, anvil jaw 103 undergoes a planar displacement, which combines a planar rotation and a planar translation. The planar displacement is effected and maintained by a planar linkage arrangement in which blade 107 performs as one of its linkages, and anvil jaw 103 performs as a second linkage. Blade 107 is rotatable between the horizontal position and the vertical position about a driver-blade joint 110 connecting between drive member 106 and blade 107. A relative rotation between anvil jaw 103 and blade 107 is facilitated about a blade-anvil junction 111 provided therebetween.
Anvil jaw 103 includes a grooved track 112, extending between a proximal side 113 and a distal side 114 thereof. Grooved track 112 allows a blade flange 115 to pass there along. Blade flange 115 connects blade 107 to anvil jaw 103 to form a blade-anvil junction 111, which is stationed proximally to distal side 114 of grooved track 112 and throughout which most or all the relative rotation between anvil jaw 103 and blade 107 during blade rotation occurs. Upon the shifting of blade 107 to the vertical position and the planar displacement of anvil jaw 103, the stapler is configured such that anvil jaw 103 shifts distally relative to blade 107 until complete docking in opposition to the stapling jaw 104, as shown in
In some embodiments, stapler 100 is configured such that shifting from delivery configuration to deployment configuration includes anvil jaw 103 shifting distally relative to blade 107, thereby opposing stapling jaw 104. Shifting from delivery configuration to deployment configuration is optionally actuated by pushing an actuator flange 116 to travel distally along a length of shaft 101. Actuator flange 116 is coupled to anvil jaw 103 through a first inclined slot 117. In the delivery configuration, actuator flange 116 is located at the lower end of slot 117. Upon forcing actuator flange 116 to move distally, anvil jaw 103 pushes blade 107 to rotate up to the vertical position which in turn forces the distal portion of anvil jaw 103 to move downwards in parallel to its distal motion. Anvil jaw 103 is kept substantially parallel to shaft 101 during its planar translation due to the orientation and dimension of slot 117 thus facilitating a chosen inclined upward motion of actuator flange 116 therealong.
In some embodiments of the present disclosure, there is provided a linear tissue stapler head comprising a stapling jaw, an anvil jaw, and a drive member provided with a blade having a sharp edge, the blade extending between the jaws. The drive member is configured to travel along a longitudinal channel between separated opposing portions of the stapling jaw. The longitudinal channel is sized and configured for allowing a blade having a sharp edge to travel therealong. The stapling jaw comprises a first stapling jaw portion containing a single row of tissue fasteners (e.g., similar to single row 206 shown in
Reference is made to
As previously mentioned, in typical instances where a surgical procedure involves withdrawal of cut tissues, it is of primarily importance that the tissue remained within the body would be fastened and sealed at the cut end in an efficient manner, and in a manner that prevents over compression and necrosis, while the removed tissue part can be subjected to less efficient tissue preserving fixating procedures. The present surgical stapler fulfils those requirements which are commonly met in medicinal practice.
Optionally, first stapling jaw portion includes the tissue bonding means, tissue coagulating means, or tissue adhering means.
As used herein the terms “tissue bonding means”, “tissue coagulating means”, or “tissue adhering means” are interchangeable and relate to means or procedures used to stop bleeding. Suitable tissue bonding means include, but are not limited to means within which argon gas or high frequency energy may pass or means of hot probes.
When stapling jaw and anvil jaw are in the closed position or are in close proximity, as shown, first stapling jaw portion 130 faces a first contact surface 136 of anvil jaw 103 and second stapling jaw portion 131 faces a second contact surface 137 of anvil jaw 103. A first distance, extending between first stapling jaw portion 130 and first contact surface 136 is smaller or less than a second distance, being the distance extending between second stapling jaw portion 131 and second contact surface 137, due to the smaller size of staples 133 of first stapling jaw portion 130 as to remaining staples of second stapling jaw portion 131. According to some embodiments, the first contact surface and the second contact surface are distanced apart from each other by a contact surface transition portion located therebetween. Contact surface transition portion between first contact surface 136 and second contact surface 137 includes a rise 138 such that the first contact surface is elevated relative to the second contact surface.
Due to the asymmetric nature of the stapler head structure, structural means may be provided in order to improve firmness and/or structural stability (e.g., stability to torsion, bending and/or shearing forces). In designing such structural means, thought should also be made to the different compression pressures generated between first stapling jaw portion 130 and first contact surface 136 and between second stapling jaw portion 131 and second contact surface 137 during compression and stapling. As shown, blade 107 adds firmness to the stapling head, especially as it further advances distally, due to its two points connection to drive member 106 and anvil jaw 103 at driver-blade joint 110 and blade-anvil junction 111, respectively, with stapling jaw 104 arrested therebetween. Nevertheless, blade 107 is off-centered and closer to first stapling jaw portion 130, therefore a support 139 is also provided between the jaws, off-centered towards second stapling jaw portion 131 in a prescribed proportion to diminish torsions upon tissue compression and stapling.
A further aspect of the present invention provides a method of surgically fastening or/and cutting a bodily tissue or organ inside a body of a subject. The method may include at least one of the following steps (not necessarily in same order):
According to yet a further aspect of the present invention there is provided a method of surgically fastening and cutting a bodily tissue or organ inside a body. The method may include at least one of the following steps (not necessarily in same order):
According to yet another aspect, the present invention provides a method of surgically fastening and cutting a bodily tissue or organ inside a body. The method may include at least one of the following steps (not necessarily in same order):
Reference is now made to
Stapling jaw 303 and anvil jaw 304 can then be emerged out of passage 301 within the body, allowing for linear tissue stapler 300 to be converted (inside the body) from the delivery configuration to a deployment configuration (as shown in
According to some embodiments, passing the blade and releasing the first row 310 and second row 308 of tissue fasteners effects dissecting of the tissue BT along cutting line 312 into a removable body part 318 sealed with first row 310 of tissue fasteners, and a remaining body part 320 sealed with second row 308 or/and remaining rows 306 of tissue fasteners.
Optionally, alternatively or additionally, length of staples bridge 322 of the first size or/and type is smaller than length of staples bridge 324 of the second size or/and type, or/and optionally distance between tissue fasteners along first row 310 is smaller than distance between tissue fasteners along second row 308, optionally resulting in stacking of a greater number of tissue fasteners in first row 310 than in second row 308 of tissue fasteners.
Each of the following terms written in singular grammatical form: ‘a’, ‘an’, and ‘the’, as used herein, means ‘at least one’, or ‘one or more’. Use of the phrase ‘one or more’ herein does not alter this intended meaning of ‘a’, ‘an’, or ‘the’. Accordingly, the terms ‘a’, ‘an’, and ‘the’, as used herein, may also refer to, and encompass, a plurality of the stated entity or object, unless otherwise specifically defined or stated herein, or, unless the context clearly dictates otherwise. For example, the phrases: ‘a unit’, ‘a device’, ‘an assembly’, ‘a mechanism’, ‘a component’, ‘an element’, and ‘a step or procedure’, as used herein, may also refer to, and encompass, a plurality of units, a plurality of devices, a plurality of assemblies, a plurality of mechanisms, a plurality of components, a plurality of elements, and, a plurality of steps or procedures, respectively.
Each of the following terms: ‘includes’, ‘including’, ‘has’, ‘having’, ‘comprises’, and ‘comprising’, and, their linguistic/grammatical variants, derivatives, or/and conjugates, as used herein, means ‘including, but not limited to’, and is to be taken as specifying the stated component(s), feature(s), characteristic(s), parameter(s), integer(s), or step(s), and does not preclude addition of one or more additional component(s), feature(s), characteristic(s), parameter(s), integer(s), step(s), or groups thereof. Each of these terms is considered equivalent in meaning to the phrase ‘consisting essentially of.’ Each of the phrases ‘consisting of’ and ‘consists of’, as used herein, means ‘including and limited to.’ The phrase ‘consisting essentially of’, as used herein, means that the stated entity or item (system, system unit, system sub-unit, device, assembly, sub-assembly, mechanism, structure, component, element, or, peripheral equipment, utility, accessory, or material, method or process, step or procedure, sub-step or sub-procedure), which is an entirety or part of an exemplary embodiment of the disclosed invention, or/and which is used for implementing an exemplary embodiment of the disclosed invention, may include at least one additional ‘feature or characteristic’ being a system unit, system sub-unit, device, assembly, sub-assembly, mechanism, structure, component, or element, or, peripheral equipment, utility, accessory, or material, step or procedure, sub-step or sub-procedure), but only if each such additional ‘feature or characteristic’ does not materially alter the basic novel and inventive characteristics or special technical features, of the claimed entity or item.
The term ‘method’, as used herein, refers to steps, procedures, manners, means, or/and techniques, for accomplishing a given task including, but not limited to, those steps, procedures, manners, means, or/and techniques, either known to, or readily developed from known steps, procedures, manners, means, or/and techniques, by practitioners in the relevant field(s) of the disclosed invention.
Throughout this disclosure, a numerical value of a parameter, feature, characteristic, object, or dimension, may be stated or described in terms of a numerical range format. Such a numerical range format, as used herein, illustrates implementation of some exemplary embodiments of the invention, and does not inflexibly limit the scope of the exemplary embodiments of the invention. Accordingly, a stated or described numerical range also refers to, and encompasses, all possible sub-ranges and individual numerical values (where a numerical value may be expressed as a whole, integral, or fractional number) within that stated or described numerical range. For example, a stated or described numerical range ‘from 1 to 6’ also refers to, and encompasses, all possible sub-ranges, such as ‘from 1 to 3’, ‘from 1 to 4’, ‘from 1 to 5’, ‘from 2 to 4’, ‘from 2 to 6’, ‘from 3 to 6’, etc., and individual numerical values, such as ‘1’, ‘1.3’, ‘2’, ‘2.8’, ‘3’, ‘3.5’, ‘4’, ‘4.6’, ‘5’, ‘5.2’, and ‘6’, within the stated or described numerical range of ‘from 1 to 6’. This applies regardless of the numerical breadth, extent, or size, of the stated or described numerical range.
Moreover, for stating or describing a numerical range, the phrase ‘in a range of between about a first numerical value and about a second numerical value’, is considered equivalent to, and meaning the same as, the phrase ‘in a range of from about a first numerical value to about a second numerical value’, and, thus, the two equivalently meaning phrases may be used interchangeably. For example, for stating or describing the numerical range of room temperature, the phrase ‘room temperature refers to a temperature in a range of between about 20° C. and about 25° C.’, and is considered equivalent to, and meaning the same as, the phrase ‘room temperature refers to a temperature in a range of from about 20° C. to about 25° C.’
The term ‘about’, as used herein, refers to ±10% of the stated numerical value.
It is to be fully understood that certain aspects, characteristics, and features, of the invention, which are, for clarity, illustratively described and presented in the context or format of a plurality of separate embodiments, may also be illustratively described and presented in any suitable combination or sub-combination in the context or format of a single embodiment. Conversely, various aspects, characteristics, and features, of the invention which are illustratively described and presented in combination or sub combination in the context or format of a single embodiment, may also be illustratively described and presented in the context or format of a plurality of separate embodiments.
Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.
All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting.
This application claims the benefit of priority under 35 USC 119(e) of U.S. Provisional Patent Application No. 62/050,476, filed Sep. 15, 2014, entitled “ENDOSCOPIC CUTTER STAPLERS AND METHODS”, the content of which is incorporated herein by reference in its entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IB2015/057083 | 9/15/2015 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62050476 | Sep 2014 | US |
