Surgical stapling instruments with reinforcement material

Abstract

A buttress material for a surgical stapling instrument, the buttress material attachable to one or both of a cartridge jaw or an anvil jaw of the surgical stapling instrument and configured to reinforce the staple line and containing a bioactive glass material to enhance tissue healing. The buttress material can be impregnated with the bioactive glass or the bioactive glass can be weaved into the buttress material. The bioactive glass can be in a powder form applied to the buttress material or in a fiber form applied to the buttress material.

Description

[0001]

[0002] SURGICAL STAPLING INSTRUMENTS WITH REINFORCEMENT MATERIAL

[0003] BACKGROUND OF THE INVENTION

[0004] This application claims priority from provisional application 63 / 735,349, filed December 18, 2024, the entire contents of which are incorporated herein by reference.

[0005] 1. Field of the Invention

[0006] This application relates to surgical instruments and, more particularly, to surgical instruments having reinforcement material to reinforce the staple line and promote healing.

[0007] 2. Background

[0008] Surgical staplers are used in various medical applications where a device is needed to join and dissect anatomical tissue. However, there are drawbacks and costs associated with use of surgical staplers. Currently, staplers are either fully disposable, reusable or partially reusable. Due to contamination during the surgical procedure, e.g., exposure to the patient’s body fluids, the staplers are required to be sterilized after use, a time consuming and expensive process, with possible risks of infection if not properly sterilized as contaminants adhered to the surgical stapler from a previous use could be transferred to another patient. To avoid the risks of resterilization, some surgical staplers are disposed after use in the surgical procedure. These staplers can be reloaded to fire multiple cartridges of staples, but after the procedure, the staplers are discarded. However, the practice of using single use disposable surgical staplers is costly.

[0009] In certain procedures, high forces are required to fire the staples through tissue into contact with the anvil for formation. This is compounded when multiple rows of staples are fired either simultaneously or sequentially from the stapler. Therefore, powered staplers have been introduced to reduce the force requirements of the user. Such powered staplers have motor driven mechanisms (assemblies) to advance components within the stapler to fire the staples from the cartridge through tissue. Such powered staplers, if reusable, are subject to the same aforementioned costs and risks of resterilization. They suffer from additional drawbacks since the sterilization process and / or heat or chemicals used in the sterilization process can damage the electronic components of the drive assemblies, which may shorten the lifespan of the surgical stapler or adversely affect its function if resterilization compromises the function of the motor or drive assembly. Tf the stapler is disposable, the stapler becomes more costly since the electronic components, which add to the cost of the stapler, are also discarded with the stapler.

[0010] U.S. Patent Nos. 11,331,099, 11,564,685 and 12,357,307 advantageously disclose devices that provide a cost effective, efficient, simple to use and advanced assemblies for powering surgical instruments which overcome the drawbacks of manual actuation without suffering from the disadvantages of current power driven staplers. These devices also advantageously include systems to evaluate various parameters and functionalities to improve operation of the instruments and improve the surgical procedures and outcomes. These devices include user feedback both during and post procedure.

[0011] The use of buttress material between the jaws of surgical stapling instruments is known. These buttress materials reinforce the staple line and reduce the risk of tearing tissue and reduce leakage. It would be advantageous to further enhance the buttress material to provide additional benefits.

[0012] SUMMARY OF THE IINVENTION

[0013] The present invention provides a buttress material for a surgical stapling instrument. The buttress material is attachable to one or both of a cartridge jaw or an anvil jaw of the surgical stapling instrument, the buttress material configured to reinforce the staple line and containing a bioactive glass material to enhance tissue healing.

[0014] In some embodiments, the buttress material is impregnated with the bioactive glass.

[0015] In some embodiments, the bioactive glass is weaved into the buttress material.

[0016] In some embodiments, the bioactive glass is in a powder form applied to the buttress material.

[0017] In some embodiments, the bioactive glass is in a fiber form applied to the buttress material.

[0018] In some embodiments, the bioactive glass is in the form of a coating applied to the buttress material.

[0019] The bioactive glass in some embodiments is applied to a region of the buttress material along a longitudinal length to extend along a staple line. In some embodiments, the bioactive glass extends along the buttress material a sufficient amount to accommodate multiple longitudinal rows of staples so it covers multiple staple rows. Tn some embodiments, the buttress material is attached to one or both of the cartridge jaw or anvil jaw during manufacture so the surgical stapling instrument is packaged with the attached buttress material. In other embodiments, the buttress material is secured to one or both of the cartridge jaw and anvil jaw by a clinician.

[0020] In accordance with another aspect of the present invention, the present invention provides in combination a surgical stapling instrument and a buttress material attachable to one or both of a cartridge jaw or an anvil jaw of the surgical stapling instrument, the buttress material configured to reinforce the staple line and containing a bioactive glass material to enhance tissue healing.

[0021] In some embodiments, the surgical stapling instrument applies linear rows of staples and the buttress material extends along at least multiple rows of staples. In some embodiments, the surgical stapling instrument applies linear rows of staples and the buttress material extends along at least multiple rows of anvil pockets which are configured to receive and bend staples. In some embodiments, the buttress material extends along both multiple rows of staples and multiple rows of anvil pockets.

[0022] In some embodiments, the surgical stapling instrument is powered to provide motor driven staple firing.

[0023] BRIEF DESCRIPTION OF THE DRAWINGS

[0024] So that those having ordinary skill in the art to which the subject invention appertains will more readily understand how to make and use the surgical apparatus disclosed herein, preferred embodiments thereof will be described in detail hereinbelow with reference to the drawings, wherein:

[0025] Figure l is a side view of an example of a surgical stapler which can receive the buttress material of the present invention, the jaws shown in an open position and without the buttress material;

[0026] Figure 2 is a close up view of the jaw assembly of the surgical stapler of Figure 1;

[0027] Figure 3 is a top perspective view of the surgical stapler of Figure 1 showing a power pack being loaded into a compartment in the housing for motor powered firing of the surgical staples;

[0028] Figure 4 is a perspective view of an alternate embodiment of the power pack for motor powered firing of the staples; Figure 5 is a top perspective view of a surgical stapler showing the power pack of Figure 4 being loaded in the compartment in the housing for motor powered firing of the surgical staples;

[0029] Figure 6 is a top perspective view of the buttress material of the present invention prior to attachment to the cartridge jaw;

[0030] Figure 7 is a perspective view showing the buttress material of the present invention attached to both the anvil jaw and cartridge jaw, the jaws shown detached for clarity;

[0031] Figure 8 is a perspective view showing the buttress material of the present invention attached to the cartridge jaw and anvil jaw in an embodiment wherein the anvil jaw pivots with respect to the cartridge jaw, the anvil jaw shown in the open position; and

[0032] Figure 9 is a perspective view of another example of a surgical stapler in which the buttress material of the present invention can be attached.

[0033] DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0034] In some surgical stapling procedures, it is desirable to apply a buttress material to bridge, repair and / or reinforce the staple line of the tissue formed by the staples. The buttress material can prevent the applied staples from pulling through the tissue. It can also reduce the risk of tissue tearing at or near the site of the applied staples. It can further cover the juncture of the tissues to reduce leakage prior to healing. The buttress material can be made of non-ab sorbable or resorbable material to resorb over time.

[0035] The buttress material can be loaded onto the staple jaw, the anvil jaw or onto both the staple and anvil jaw prior to use of the stapler. In other embodiments, the anvil jaw of the stapling instrument and / or the cartridge jaw of the surgical stapler can be provided with an attached buttress material, i.e., packaged / pre-installed with a buttress material already in the anvil and / or cartridge jaws.

[0036] Various buttress materials can be utilized and can include in some embodiments porous and non-porous layers. The buttress can be formed of PGA or other material.

[0037] The present invention provides an enhanced buttress material which increases its clinical effects by including / incorporating a bioactive glass in the buttress material. This bioactive glass is typically composed of silicon dioxide, calcium oxide, sodium oxide and phosphorous pentoxide. The percentage of these compounds can vary. Other compositions are also contemplated, including additional or alternative compounds. Combination of materials in some embodiments can be blended, co-extruded and coated. Provision of the biocompatible bioactive glass in / within or on the buttress material helps the tissue heal (stimulating the body’s natural healing process) as it reacts to host tissue and creates a negative charge to attract calcium and other nutrients. It can be in various forms such as powder or weaved into the buttress material, e.g., weaved into the PGA material. The bioactive glass also has anti-microbial properties as it increases the pH level and increases the osmotic pressure to create an environment hostile to bacteria. That is, it releases ions such as calcium and sodium that can inhibit bacterial growth. The bioactive glass, when implanted / applied to living tissue, induces formation of an interfacial bond between the material and the surrounding tissue, and can act as scaffold for growth of new tissue.

[0038] The bioactive glass can impregnate the buttress material and be applied in a fiber form, powder form or other form for adherence with the buttress material. The bioactive glass is preferably applied to the region of the buttress material along a longitudinal length, so it extends along the staple line(s). With multiple rows of staples applied, the bioactive glass would also be provided along enough of a transverse region of the buttress material to accommodate such multiple rows.

[0039] An example of a surgical instrument which can utilize the buttress material is shown in Figures 1-3; another example is shown in Figure 9. It should be appreciated that the buttress material with bioactive glass can also be used with other surgical staplers such as other linear staplers, circular staplers which apply circular arrays of staples, staplers applying curved rows of staples, etc. The buttress material of the present invention can also be used with robotic driven surgical staplers. The buttress material can also be utilized with non-powered, i.e., manually actuated, surgical staplers.

[0040] Note the term “proximal” as used herein denotes the region closer to the user and the term “distal” as used herein denotes the region further from the user. The terms “top” or “upper” and “bottom” or “lower” refer to the orientation of the instruments as shown in the orientation of the instrument in Figure 3, with the cover being on the top and the handle extending at the bottom.

[0041] Turning first to Figures 1-3, a first embodiment of the surgical stapler and removable power pack are illustrated. In this embodiment, the power pack, which contains a battery, motor, drive mechanism and stapler engagement structure, effects firing of the surgical fasteners (staples). In some embodiments, the power pack does not include a battery, although in preferred embodiments it includes the battery. The power pack can also include a drive mechanism to effect articulation of the instrument jaws. Details of power packs which can be utilized are disclosed in commonly assigned U.S. Patent Nos. U.S. Patent Nos. 11,331,099, 11,564,685 and 12,357,307, the entire contents of each of these are incorporated herein by reference. These patents / publications also disclose more details of the surgical instruments, as well as other surgical instruments, which being incorporated herein by reference, are fully applicable to the surgical staplers disclosed / described herein and the buttress material with bioactive glass of the present invention can be used with those instruments.

[0042] The surgical stapler, also referred to herein as the surgical fastener applying instrument or surgical fastener applier, is designated generally by reference numeral 1 and includes a proximal portion la, a distal portion lb and an elongated or endoscopic portion 6 (also referred to as an elongated tubular portion or shaft) extending between the proximal portion la and the distal portion lb. A handle assembly 2 with a housing 4 (also referred to herein as a handle housing) is positioned at the proximal portion la and has a compartment 5 configured to house and protect internal mechanisms of the stapler including the removable power pack when loaded (mounted) therein. At the distal portion lb are opposing members, i.e., jaws, 8a, 8b, configured to clamp and constrain tissue during operation of the surgical stapler. At least one of the jaws is movable with respect to the other jaw from an open position to receive tissue between the jaws and a closed position to clamp tissue between the jaws. Thus, one of the jaws can be stationary and the other jaw movable with respect to the stationary jaw or alternatively both jaws can move, e g., pivot, toward each other. In the embodiment of Figure 1, jaw 8b, which contains at least one row of surgical fasteners (staples) is movable with respect to non-pivoting (stationary) jaw 8a which contains an anvil with staple forming pockets. In alternate embodiments, the jaw containing the anvil pivots and the jaw containing the fasteners is stationary. Jaws 8a, 8b are collectively referred to herein as jaws 8. The fasteners are fired (advanced) from jaw 8b by linear movement of a firing mechanism which engages staple drivers within the jaw 8b which move transverse to the longitudinal axis, i.e., transverse to the direction of movement of the firing mechanism, to sequentially advance (from proximal to distal) the staples in the linear rows of staples from the jaw 8b and through tissue to engage the anvil pockets on jaw 8a for formation of the staples.

[0043] The elongated tubular member 6 extends distally from the housing 4 and is configured to fit through a surgical port (trocar) used for laparoscopic surgery. With the jaws 8 in the clamped position, the outer diameter of the elongated member 6 is maintained as the cross-sectional dimension of the closed jaws 8 preferably does not exceed the cross-sectional dimension (i.e., diameter) of the tubular member 6.

[0044] The surgical stapler 1 can in some embodiments include a joint 10 that provides for the articulation of the opposing members 8, i.e., pivoting of the jaw assembly (jaws 8) to angular positions with respect to the longitudinal axis of elongated member 6. Articulation can be achieved by linear motion of elongated members extending through the endoscopic portion 6 which are slidable to angle the jaw assembly. A rotational member or knob 12 is configured to rotate, with respect to the handle assembly, the elongated member 6 and connected jaws 8 about the longitudinal axis of the elongated member 6 to change the position of the jaws 8. Articulation is effected by manual manipulation of a lever adjacent the handle 2 or alternatively is effected by a switch to activate a motor driven articulation mechanism. A handle lever 14 (also referred to herein as a clamping handle), linked to an axially movable clamping bar, is pivotable from a first position to a second position closer to stationary handle 16 to effect movement of the jaw 8b toward the jaw 8a from an open (unclamped) position to a clamping position, also referred to as a closed position, of the jaws 8. Release of handle lever 14 returns the jaw 8b to its open position. Stationary handle 16 for grasping by the user is ergonomically designed for comfort of use. In summary, the surgical stapler 1 operates by manual pivoting of the lever 14 toward stationary handle 16 to clamp the tissue between jaws 8, followed by powered firing of the staples from jaw 8b, through the clamped tissue and into contact with the staple forming pockets of the anvil of jaw 8a. Prior to firing, the jaws 8 can be rotated to a desired orientation by rotation of endoscopic portion 6 via knob 12 and / or articulated about joint 10, via movement of the elongated articulation members, to a desired angled position with respect to the longitudinal axis of endoscopic portion 6. In the stapler of Figure 1, articulation is performed by manual manipulation of a lever (not shown) which is operatively connected to an internal elongated member within tubular member 6 which extends to joint 10. A force applied to the internal elongated member pivots / articulates the jaws 8 about the joint 10. In alternate instruments, motor powered articulation is provided.

[0045] The housing 4 of the handle assembly 2 of the surgical stapler is configured to receive the loadable / removable power pack 18 (also referred to herein as a control module) in a compartment 5 as shown in Figure 3. The compartment can include a base and side walls having one or more guides 28 that cooperate with corresponding guiding structures 23 on the outer wall of the housing 19 of power pack 18 for proper alignment of the power pack 18 in the handle assembly 2 during insertion into the compartment 5. Other forms of alignment are also contemplated. The top wall of the power pack 18 is designated by reference numeral 21a and the rear wall by reference numeral 21b.

[0046] The handle assembly 2 includes a cover 25 for opening and closing the compartment 5. The compartment cover 25 is shown as being hingedly attached to the housing 4. The cover 25 is shown pivotably mounted to a top portion of the housing 4 (in the orientation of Figure 3) for top loading of the power pack. Once loaded, the cover 25 is pivoted about a hinge to its closed position. When the cover 25 is in an open position, e.g., as shown in Figure 3, the power pack 18 may be removed from the compartment 5 or inserted into the compartment 5. The cover can have an engagement projection 27 interacting with recess? of the housing (Figure 5).

[0047] When the cover 25 is in a closed position, the seal of the cover 25 is in contact with the rim of the housing 2 such that the compartment 5, and the power pack 18 if inserted into the compartment 5, are sealed from the environment exterior to the surgical stapler. Other seals are provided within the surgical stapler to seal / protect the power pack 18 from contaminants, e.g., body fluids. These seals are discussed in more detail in the abovedisted patents / publication, incorporated herein by reference in their entirety.

[0048] Figure 4 illustrates an alternate embodiment of the power pack, also referred to herein as the control module, designated by reference numeral 30, which includes a motor assembly, removable and rechargeable battery 34 and electronics contained within housing 36. The battery 33 can be recharged outside the stapler when the power pack 30 is removed. The power pack 30 engages the firing rod and the articulation rod (if provided) when loaded into the compartment, and actuation of the firing motor and articulation motor effect firing of staples and articulation, respectively. Details of the power pack engagement members, drive mechanisms, firing components and articulation components are described in detail in the above referenced patents / publication.

[0049] The power pack / control module 30 can be loaded in the surgical instrument, i.e., loaded into the compartment 5, as shown in Figure 5. The control module 30 includes viewing screen 32 to indicate various parameters during the clamping, articulation and firing modes of the instrument, including feedback to the clinician. Examples of such screen and feedback are disclosed in U.S. Patents 12,357,307 and 12,279,770, the entire contents of both patents incorporated herein by reference. Turning now to the buttress material of the present invention, Figure 6 illustrates an embodiment wherein the buttress material 44 is secured to the cartridge jaw 8b which contains rows of staples 41 and a slot 42 for the knife bar to cut tissue between the staple rows. The buttress material is shown prior to attachment to the cartridge jaw 8b. The bioactive glass 43 is contained within buttress material 44 and is provided within a substantial portion, if not the entire portion, of the buttress material 44 so that it covers all staple rows. In this manner, the healing effect, bonding effect and anti-bacterial properties of the bioactive glass are provided along each of the staple lines. The bioactive glass can be applied to the buttress material in various ways, such as impregnated or weaved into it. Buttress material can be provided in two sections to provide a slot or space 45 to accommodate the knife bar or a single section severable by the knife. The buttress material 44 can be attached to the cartridge jaw 8b in manufacture by a plurality of fastening elements 46. It can alternatively be attached by other methods such as snap fit, glueing, etc. It should also be appreciated that buttress material 44 could be attached to the cartridge jaw 8b by a clinician prior to the procedure, rather than pre-attached in manufacture and packaged attached. In such embodiments, a mechanical attachment is preferable. The buttress material, e.g., buttress material 44, can in addition or alternatively be attached to the anvil jaw 8a in manufacture by a plurality of fastening elements (similar to fasteners 46). It can alternatively be attached by other methods such as snap fit, glueing, etc. It should also be appreciated that buttress material could be attached to the anvil jaw ab by a clinician prior to the procedure, rather than pre-attached in manufacture and packaged attached. In such embodiments, a mechanical attachment is preferable.

[0050] Figure 7 illustrates an alternate embodiment wherein the buttress material 44 of the present invention, containing bioactive glass, is attached to the both the cartridge jaw 8b and the anvil jaw 8a. More specifically, buttress material 44 includes buttress material 44b attached to cartridge jaw 8b and buttress material 44a attached to anvil jaw 8a. Buttress material 44a, 44b (collectively buttress material 44) can be of the same material or of different materials and contain the same amount and same type of bioactive glass or a different amount and / or different type of bioactive glass. Anvil and cartridge jaws 8a and 8b are shown detached for clarity.

[0051] Figure 8 illustrates an alternate embodiment wherein the buttress material, containing bioactive glass, is attached to both a cartridge jaw and anvil jaw. In this embodiment, the anvil jaw 58a is pivotable with respect to the cartridge jaw 58b instead of the cartridge jaw being pivotable with respect to the anvil jaw as in the foregoing embodiments. More specifically, buttress material 54b is attached to cartridge jaw 58b and buttress material 54a is attached to anvil jaw 58a. The bioactive glass is contained within buttress material 54a, 54b (collectively buttress material 54) and is provided within a substantial portion, if not the entire portion, of the buttress material 54 so that it covers all staple rows. In this manner, the aforedescribed effects of the bioactive glass is provided along each of the staple lines. Buttress material can be provided in two sections to provide a slot or gap 59 to accommodate the knife bar or a single section severable by the knife. Buttress material 54a, 54b can be of the same material or of different materials and contain the same amount and same type of bioactive glass or a different amount and / or different type of bioactive glass. In an alternate embodiment, the buttress material is attached only to anvil 58a or only to cartridge 58b.

[0052] As stated above, the buttress material of the present invention can be utilized other than with an endoscopic linear stapler such as shown in Figures 1 and 3. Figure 9 provides one example wherein stapler 60 applies linear rows of staples but has a flexible shaft 64. The stapler 60 has a compartment (like compartment 5 described above) in handle housing 68 to receive power pack 18 therein. Movement of handle 61 toward stationary handle 62 pivots cartridge jaw 62b toward anvil jaw 62a to clamp tissue therebetween. Actuation of the motor of power pack 18 fires the surgical staples from cartridge jaw 62b. A rotation knob 66 rotates the flexible shaft 64. Buttress material can be attached, at manufacture or at the time of surgery, to the cartridge jaw 62b and / or the anvil jaw 62a.

[0053] Although the apparatus and methods of the subject disclosure have been described with respect to preferred embodiments, those skilled in the art will readily appreciate that changes and modifications may be made thereto without departing from the spirit and scope of the present disclosure as defined by the appended claims.

[0054] Additionally, persons skilled in the art will understand that the elements and features shown or described in connection with one embodiment may be combined with those of another embodiment without departing from the scope of the present invention and will appreciate further features and advantages of the presently disclosed subject matter based on the description provided.

[0055] Throughout the present invention, terms such as “approximately,” “generally,” “substantially,” and the like should be understood to allow for variations in any numerical range or concept with which they are associated. For example, it is intended that the use of terms such as “approximately” and “generally” should be understood to encompass variations on the order of 25%, or to allow for manufacturing tolerances and / or deviations in design.

[0056] Although terms such as “first,” “second,” “third,” etc., may be used herein to describe various operations, elements, components, regions, and / or sections, these operations, elements, components, regions, and / or sections should not be limited by the use of these terms in that these terms are used to distinguish one operation, element, component, region, or section from another. Thus, unless expressly stated otherwise, a first operation, element, component, region, or section could be termed a second operation, element, component, region, or section without departing from the scope of the present disclosure.

Claims

WHAT TS CLAIMED TS;1. A buttress material for a surgical stapling instrument, the buttress material attachable to one or both of a cartridge j aw or an anvil j aw of the surgical stapling instrument, the buttress material configured to reinforce a staple line and containing a bioactive glass material to enhance tissue healing.

2. The buttress material of claim 1, wherein the buttress material is impregnated with the bioactive glass.

3. The buttress material of claim 1, wherein the bioactive glass is weaved into the buttress material.

4. The buttress material of claim 1, wherein the bioactive glass is in a powder form applied to the buttress material.

5. The buttress material of claim 1, wherein the bioactive glass is in a fiber form applied to the buttress material.

6. The buttress material of claim 1, wherein the bioactive glass is in the form of a coating applied to the buttress material.

7. The buttress material of claim 1, wherein the bioactive glass is applied to a region of the buttress material along a longitudinal length to extend along the staple line.

8. The buttress material of claim 1, wherein the bioactive glass extends along the buttress material a sufficient amount to accommodate multiple longitudinal rows of staples so it covers multiple staple rows.

9. The buttress material of claim 1, wherein the buttress material is attached to one or both of the cartridge jaw or anvil jaw during manufacture so the surgical stapling instrument is packaged with the attached buttress material.

10. The buttress material of claim 1, wherein the buttress material is secured to one or both of the cartridge jaw and anvil jaw by a clinician.

11. The buttress material of claim 1, in combination with the surgical stapling instrument.

12. The buttress material of claim 11, wherein the surgical stapling instrument applies multiple linear rows of staples and the buttress material extends along the multiple rows of staples.

13. The buttress material of claim 11, wherein the surgical stapling instrument applies multiple linear rows of staples and the buttress material extends along the multiple rows of anvil pockets which are configured to receive and bend the staples.

14. The buttress of claim 11, wherein the surgical stapling instrument is powered to provide motor driven staple firing.

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