SURGICAL STAPLING KIT FOR STAINLESS FABRIC

专利摘要:
methods and apparatus for releasing tissue treatment composition for stapled tissue. the present invention relates to a surgical stapler including the first and second tissue closure elements and a knife element. the first fabric closure element is configured to receive a plurality of clips. the second fabric closing element comprises an anvil configured to form the clips. a fabric treatment element is positioned between the first and second fabric closure elements. the tissue treatment element comprises a bursting containment bag or deflector that is configured to receive a medical fluid including at least one tissue cell. the fabric treatment element may be of a spiral shape, an annular disc shape, or an elongated cylindrical fit shape. the fabric treatment element may also include outwardly extending flaps. the tissue treatment element may also include an injection port. in use, the staples and; or knife pierce the tissue treatment element to release at least a portion of the medical fluid held by the tissue treatment element.
公开号:BR112012028867B1
申请号:R112012028867-9
申请日:2011-05-10
公开日:2020-09-29
发明作者:John B. Schulte；Rebecca J. Mollere；Patrick D. Dugan；Michael D. Cronin；Jerome R. Morgan；Stuart K. Morgan；Gary B. Mcalister；Tamara S. Vetro Widenhouse；Stephen J. Balek；Joseph P. Schowalter；David A. Witt；Prasanna Malaviya；Frederick E. Shelton Iv
申请人:Ethicon Endo-Surgery, Inc；
IPC主号:

专利说明:

BACKGROUND
[001] Promoting and improving tissue healing is an important aspect of some medical treatments and procedures. For example, promoting and improving tissue healing can lead to shorter recovery times and decrease the opportunity for infections, particularly in a post-surgical setting. Some advances in medical techniques pertaining to systems, methods, and devices to promote and enhance tissue healing in patients are aimed at adding biological components (eg, tissue particles, stem cells, or other types of cells, etc.) to a injury site (eg surgical site, accidental trauma site, etc.) or other defective site (eg, caused by illness or other condition, etc.) to promote tissue regeneration or accelerate tissue healing. When biological components are added to a site, these components can be added independently or as part of a specifically designed matrix or other mixture depending on the health problem being treated and treatment goals. Some examples of cell-based therapy technology are presented in US Publication No. 2008/0311219, entitled "Tissue Fragment Compositions for the Treatment of Incontinence", published on December 18, 2008, the description of which is incorporated herein by reference . Additional examples of technology for cell-based therapy are presented in U.S. Publication No. 2004/0078090, entitled "Biocompatible Scaffolds with Tissue Fragments", published April 22, 2004, the description of which is incorporated herein by reference. Additional examples of technology for cell-based therapy are presented in U.S. Publication No. 2008/0071385, entitled "Conformable Tissue Repair Implant Capable of Injection Delivery", published on March 20, 2008, the description of which is incorporated herein by reference.
[002] Regardless of how active biological components are released or applied to a site, biological components must first be obtained and prepared. One approach to obtaining these biological components is to collect the desired components from a healthy tissue specimen (for example, in an adult human being). Examples of devices and associated methods for collecting and processing harvested tissue are presented in U.S. Publication No. 2004/0193071, entitled "Tissue Collection Device and Methods", published on September 30, 2004, the description of which is incorporated herein by reference. Additional examples of devices and associated methods for collecting and processing harvested tissue are presented in US Publication No. 2005/0038520, entitled "Method and Apparatus for Resurfacing an Articular Surface", published on February 17, 2005, the description of which is incorporated here reference title. Additional examples of devices and associated methods for collecting and processing harvested tissue are provided in US Patent No. 7,611,473, entitled "Tissue Extraction and Maceration Device", issued on November 3, 2009, the description of which is incorporated herein by reference . Additional examples of devices and associated methods for collecting and processing harvested tissue are presented in US Publication No. 2008/0234715, entitled "Tissue Extraction and Collection Device", published on September 25, 2008, the description of which is incorporated herein by reference . Additional examples of devices and associated methods for processing harvested tissue are presented in US Publication No. 2005/0125077, entitled "Viable Tissue Repair Implants and Methods of Use", published on June 9, 2005, the description of which is incorporated herein by way of reference. Additional examples of devices and associated methods for collecting and processing harvested tissue are presented in US Patent No. 5,694,951, entitled "Method for Tissue Removal and Transplantation", issued December 9, 1997, the description of which is incorporated herein by way of of reference. Additional examples of devices and associated methods for collecting and processing harvested tissue are provided in US Patent No. 6,990,982, entitled "Method for Harvesting and Processing Cells from Tissue Fragments", issued January 31, 2006, the description of which is here incorporated as a reference. Additional examples of devices and associated methods for collecting and processing harvested tissue are presented in US Patent No. 7,115,100, entitled "Tissue Biopsy and Processing Device", issued on October 3, 2006, the description of which is incorporated herein by way of reference.
[003] When harvested and properly processed (eg, embedded with a framework, etc.), biological material such as tissue fragments can be applied to an injury site or other type of site within the human body in a variety of ways . Various methods and devices for applying this biological material are presented in one or more of the US Patent references cited above. Additional methods and devices for applying this biological material are presented in U.S. Publication No. 2005/0113736, entitled "Arthroscopic Tissue Scaffold Delivery Device", published on May 26, 2005, the description of which is incorporated herein by reference.
[004] Although a variety of devices and techniques may exist for collecting, processing, and applying biological components to a tissue specimen, it is believed that no one before the inventor (s) designed or used the invention as described in the present invention. BRIEF DESCRIPTION OF THE DRAWINGS
[005] Although the specification ends with claims that specifically indicate and distinctly claim the present invention, it is believed that the present invention will be better understood from the following description of specific examples taken in conjunction with the attached drawings. In the drawings, similar numerals represent similar elements in the various views.
[006] Figure 1 represents a perspective view of an exemplary circular surgical stapler that has a tissue crushing chamber;
[007] Figure 2A represents a partial cross-sectional view of a proximal portion of the stapler shown in figure 1;
[008] Figure 2B represents a partial cross-sectional view of a distal portion of the stapler shown in figure 1;
[009] Figure 3 represents a cross-sectional view of the end effector portion of the stapler shown in figure 1, positioned in a pair of lumens of fabric to be joined in an anastomosis, with the frame of figure 5 positioned between the elements closing;
[0010] Figure 4 represents a partial cross-sectional view of the stapler shown in figure 3, with the end effector closed to secure the ends of the fabric lumens and the framework between the closing elements;
[0011] Figure 5 represents a perspective view of an exemplary framework for use with a circular stapler;
[0012] Figure 6 represents a perspective view of another exemplary framework for use with a circular stapler;
[0013] Figure 7 represents a perspective view of a ruptured fluid compartment for use in performing an anastomosis;
[0014] Figure 8 represents a perspective view of another exemplary rupture fluid compartment for use in performing an anastomosis;
[0015] Figure 9 represents a perspective view of the rupture fluid compartment of figure 8 positioned in an exemplary packaging;
[0016] Figure 10 represents a partial cross-sectional view of the end effector portion of an exemplary circular surgical stapler positioned in a pair of tissue lumens to be joined in an anastomosis, with the fluid compartment of figure 7 positioned between the closing elements;
[0017] Figure 11 represents a partial cross-sectional view of a first closing element exemplifying a circular surgical stapler with a rupture fluid compartment located in the closing element;
[0018] Figure 12 represents a partial cross-sectional view of a second exemplary closing element of a circular surgical stapler with a rupture fluid compartment located in the closing element;
[0019] Figure 13 represents a partial cross-sectional view of the end effector portion of another exemplary circular surgical stapler positioned in a pair of lumens of tissue to be joined in anastomosis, with a rupture fluid compartment located in the second element of closing the end effector;
[0020] Figure 14 represents a partial cross-sectional view of the stapler shown in figure 13, with the stapler in a triggered position to hold the tissue lumens, break the fluid compartment, and cut the tissue lumens;
[0021] Figure 15 represents a partial cross-sectional view of the stapler shown in figure 13, with the stapler having been re-fired so as to further cut the tissue into smaller fragments, and with the fluid compartment emptied;
[0022] Figure 16 represents a top plan view of the grooved knife of the stapler shown in figure 13;
[0023] Figure 17 represents a perspective view of the grooved knife shown in figure 16;
[0024] Figure 18A represents a schematic top plan view of another exemplary framework for use with a circular stapler;
[0025] Figure 18B represents a schematic top plan view of yet another exemplary framework for use with the circular stapler; and
[0026] Figure 18C represents a schematic top plan view of yet another exemplary framework for use with a circular stapler.
[0027] The drawings are not intended to be limiting in any way, and it is envisaged that various embodiments of the invention may be carried out in a variety of other ways, including those not necessarily represented in the drawings. The attached drawings incorporated in, and forming a part of the specification, illustrate various aspects of the present invention, and together with the description serve to explain the principles of the invention; it being understood, however, that this invention is not limited to the precise provisions shown here. DETAILED DESCRIPTION
[0028] The following description of specific examples should not be used to limit the scope of the present invention. Other features, aspects and advantages of the versions presented in the present invention will become evident to those skilled in the art from the following description, which uses illustrations, one of the best ways contemplated for carrying out the invention. As will be understood, the versions described herein may have other different and obvious aspects, all without departing from the invention. Consequently, drawings and descriptions should be considered as illustrative rather than restrictive. I. Exemplary Tissue Treatment Compositions for Use with Surgical Staplers
[0029] Surgical stapling devices can be used to hold tissue, place a plurality of staples in a set on the fabric, and, in some instances, cut the fabric within the set of staples. These stapling devices can apply staples along a circular, linear, arched, or any other desired shape; and can be used, for example, to perform tissue resection or transection, to perform an anastomosis on luminal structures such as intestines, or in any of a variety of surgical procedures. The examples shown and described in the present invention provide a composition for treating tissue as a medicinal fluid that has one or more curing agents for the stapled tissue, as in the staple line (for example, where the closures extend on the tissue), the cut line (for example, where the fabric is cut), and / or elsewhere. The medicinal fluid can include any of a variety of biocompatible materials that accelerate tissue healing, promote tissue regeneration, and / or provide other results. For use in the present invention, the terms "tissue treatment composition", "tissue repair composition", and "medicinal fluid" are to be read interchangeably. It is also to be understood that a composition for treating medicinal tissue or fluid, as referred to in the present invention, can have any suitable consistency, including, but not limited to, the consistency of a slurry.
[0030] A medical fluid as referred to in the present invention can be derived from any biocompatible material, including, but not limited to, synthetic or natural polymers. The consistency of the medicinal fluid can be viscous, or gel-like, that of a slurry composed of microparticles, or any other suitable consistency. Just as an example, any consistency of fluid that may allow injection through a catheter can be used. Medicinal fluid can also provide adhesive characteristics, so that when it is injected into a target site (for example, into a fistula), the fluid coagulates or gels (for example, allowing a plug to be retained within a fistula). The medicinal fluid of the present example is also capable of supporting the migration and proliferation of cells so that healing can occur at a target site in a patient. The fluid is suitable for mixing with biological materials. Examples of medicinal fluid components include, but are not limited to, thrombin, platelet-poor plasma (PPP), platelet-rich plasma (PRP), starch, chitosan, alginate, fibrin, polysaccharide, cellulose, collagen, gelatin adhesive- resorcin-formalin, oxidized cellulose, mollusk-based adhesive, poly (amino acid), agarose, amylose, hyaluronan, polyhydroxy butyrate (PHB), hyaluronic acid, poly (vinyl pyrrolidone) (PVP), poly (vinyl alcohol) ( PVA), polylactide (PLA), polyglycolide (PGA), polycaprolactone (PCL), and their copolymers, VICRYL® (Ethicon, Inc., Somerville, New Jersey, USA), MONOCRYL material, PANACRYL (Ethicon, Inc., Somerville , New Jersey), and / or any other suitable material to be mixed with biological material and introduced into a deficient wound or site, including combinations of materials. Other components, materials, suitable substances, etc., that can be used in a medicinal fluid will be apparent to those skilled in the art, in view of the teachings of the present invention.
[0031] Only by way of example, one or more components in a tissue treatment composition composed of medicinal fluid can comprise at least one viable tissue fragment, which has one or more viable cells that, once applied, can proliferate and integrate with tissue at a target site in a patient. For example, viable cells can migrate out of a tissue particle and multiply into a framework material, which can be positioned at a target site in a patient. These tissue fragments can be collected from the same patient to whom they are reapplied; or they may have been collected from another person or source. The tissue fragments may comprise autogenic tissue, allogeneic tissue, xenogenic tissue, mixtures of any of the aforementioned, and / or any other type (s) of tissue. Tissue fragments may include, for example, one or more of the following tissues or tissue components: stem cells, cartilage tissue, meniscal tissue, ligamentous tissue, tendinous tissue, skin tissue, muscle tissue (for example, from a patient's thigh , etc.), periosteal tissue, pericardial tissue, synovial tissue, adipose tissue, bone marrow, bladder tissue, umbilical tissue, embryonic tissue, vascular tissue, blood and combinations thereof. Obviously, any other suitable type or fabric can be used, including any suitable combination of fabric types. In some versions, the type of tissue used is selected from a type of tissue that most closely resembles the tissue that is close to, or surrounding, the target site (eg, fistula, etc.).
[0032] The tissue to provide at least one viable tissue fragment can be obtained using a variety of tissue biopsy devices or using other types of tissue harvesting devices or techniques. Exemplary biopsy devices include those taught in US Patent No. 5,526,822, entitled "Method and Apparatus for Automated Biopsy and Collection of Soft Tissue", issued June 18, 1996; US Patent No. 6,086,544, entitled "Control Apparatus for an Automated Surgical Biopsy Device", issued July 11, 2000; US Publication No. 2007/0118048, entitled "Remote Thumbwheel for a Surgical Biopsy Device", published on May 24, 2007; Pub. U.S. No. 2008/0214955, entitled "Presentation of Biopsy Sample by Biopsy Device", published September 4, 2008; Non-Provisional US Patent Application. No. 12 / 337,942, entitled "Biopsy Device with Central Thumbwheel", filed on December 18, 2008; and US Non-Provisional Patent Application No. 12 / 483,305, entitled "Tetherless Biopsy Device with Reusable Portion", filed on June 12, 2009. The description of each of the US Patents, US Patent Application Publications, and Applications for US Non-Provisional Patents cited above are incorporated by reference in the present invention. These biopsy devices can be used to extract a plurality of tissue specimens from one or more sites in a single patient. It should also be understood that any suitable device described in any other reference that is cited in the present invention can be used to harvest tissue. Other examples will be apparent to elements skilled in the art in view of the teachings of the present invention. Tissue harvesting sites may include the same sites where the tissue is reapplied as part of the treatment. In addition to or alternatively, the tissue can be harvested from one site and then reapplied elsewhere as part of the treatment. In some versions, the tissue is reapplied to the same patient from whom the tissue was originally harvested. In some other versions, the tissue is applied to a patient that is different from the patient from whom the tissue was originally harvested.
[0033] A tissue specimen can be obtained under aseptic conditions, and then processed under sterile conditions to create a suspension that has at least one fragment of tissue crushed, or finely divided. In other words, the harvested tissue can be diced, crushed or ground, and / or otherwise processed. Specimens of harvested tissue can be crushed and otherwise processed in any of a variety of ways. For example, examples of tissue crushing and processing are described in US Publication No. 2004/0078090, the description of which is incorporated herein by reference. Other examples will be apparent to elements skilled in the art in view of the teachings of the present invention. To ensure tissue viability, agitators or other features of a shredding and / or mixing device can be designed to cut and mix (instead of crushing or compressing) the fabric. In some configurations, tissue specimens can be ground and / or mixed in a standard cell culture medium, either in the presence or absence of serum. Tissue fragments can also come in contact with a matrix digesting enzyme to facilitate cell migration out of the extracellular matrix that surrounds cells. Suitable matrix digesting enzymes that can be used in some environments include, but are not limited to, collagen, chondroitinase, trypsin, elastase, hyaluronidase, peptidase, thermolysin, metalloprotease and protease. The size of each tissue fragment can vary depending on the target site, method for releasing the composition for treatment at the target site, and / or based on several other considerations. For example, the size of the tissue fragment can be chosen to improve the ability of regenerative cells (e.g., fibroblasts) in the tissue fragments to migrate out of those tissue fragments, and / or to limit or prevent the destruction of cell integrity. In some environments, the ideal tissue fragments are between approximately 200 microns and approximately 500 microns in size. As another illustrative example, the ideal tissue fragments can be sized within the range of approximately 0.05 mm3 and approximately 2 mm3; or more particularly between approximately 0.05 mm3 and approximately 1 mm3. Obviously, several other sizes of tissue fragment may be ideal in several different environments.
[0034] In some versions, a medicinal fluid may comprise crushed tissue fragments suspended in a biocompatible vehicle. Suitable vehicles may include, for example, a physiological buffer solution, a high flow gel solution, saline, and water. In the case of gel solutions, the tissue repair composition may be in a high-flow gel form prior to release to the target site, or it may form a gel and remain in place after release to the target site. High-flow gel solutions may comprise one or more gelling materials with or without the addition of water, saline, or physiological buffer solution. Suitable gelling materials include biological and synthetic materials. Exemplifying gelling materials include the following: proteins such as collagen, collagen gel, elastin, thrombin, fibronectin, gelatin, fibrin, tropoelastine, polypeptides, proteoglycan laminin, fibrin glue, fibrin clot, platelet rich plasma clot (PRP), platelet-poor plasma clot (PPP), self-assembled peptide hydrogels; Matrigel or atelocollagen; polysaccharides such as, pectin, cellulose, regenerated oxidized cellulose, chitin, chitosan, agarose, or hyaluronic acid; polynucleotides such as ribonucleic acids or deoxyribonucleic acids; other materials such as alginate, crosslinked alginate, poly (N-isopropyl acrylamide), poly (oxyalkylene), copolymers of poly (ethylene oxide), or poly (propylene oxide), poly (vinyl alcohol), polyacrylate; monostearyl glycerol co-succinate / polyethylene glycol (MGSA / PEG) copolymers and combinations of any of the aforementioned. In addition to providing a high flow vehicle solution for tissue fragments, a gelling agent (s) can also act as an adhesive that anchors the tissue repair composition to a target site. In some versions, an additional adhesive anchoring agent may be included in the medical tissue or fluid repair composition. Also, one or more crosslinking agents can be used in conjunction with one or more gelling agents to crosslink the gelling agent.
[0035] The concentration of tissue fragments in a vehicle and / or one or more components of medicinal fluid can vary depending on the location of the target site, method of releasing the composition for treatment at the target site, and / or for several other reasons. For example, the ratio of tissue fragments to vehicle (by volume) can be in the range of about 2: 1 to about 6: 1, or in the range of about 2: 1 to about 3: 1. The medicinal fluid may also include one or more additional healing agents, such as biological components that accelerate healing and / or tissue regeneration. Such biological components may include, for example, growth factors, proteins, peptides, antibodies, enzymes, platelets, glycoproteins, hormones, cytokines, glycosaminoglycans, nucleic acids, analgesics, viruses, isolated cells, or combinations thereof. The medicinal fluid may also include one or more treatment components that prevent infection, reduce inflammation, prevent or minimize the formation of adhesion, and / or suppress the immune system. In some versions where a framework is used in conjunction with a tissue treatment composition, one or more of these additional biological components or additional treatment components may be provided on and / or within the framework. Similarly, in some versions where a framework plug is used in conjunction with a tissue repair composition, one or more of these additional biological components or additional treatment components may be provided on and / or within the framework plug. Some examples described in the present invention may also include one or more adhesive agents in conjunction with viable tissue fragments.
[0036] As noted above, the harvested tissue can be combined with a framework material and / or other substances as part of a medicinal fluid, as described in the present invention, for administration to the patient. To the extent that the fabric is incorporated into a framework material, it should be understood that any suitable material or combination of materials can be used to provide a framework. By way of example only, the framework material includes a natural material, a synthetic material, a bioabsorbable polymer, a non-woven polymer, other types of polymer, and / or other types of materials or combinations of materials. Examples of suitable biocompatible materials include starch, chitosan, cellulose, agarose, amylose, lignin, hyaluronan, alginate, hyaluronic acid, fibrin glue, fibrin clot, collagen gel, gelatin-resorcin-formalin adhesive, plasma gel rich in platelet (PRP), platelet poor plasma gel (PPP), Matrigel, Monostearoil Glycerol co-Succinate (MGSA), Monostearoil Glycerol co-Succinate / polyethylene glycol (MGSA / PEG), laminin, elastin, proteoglycans, polyhydroxybutyrate ( PHB), poly (vinyl pyrrolidone) (PVP), polylactide (PLA), polyglycolide (PGA), polycaprolactone (PCL), and their copolymers, non-woven VICRYL® (Ethicon, Inc., Somerville, NJ, EDA), material MONOCRYL, fibrin, non-woven poly-L-lactide, and non-woven PANACRYL (Ethicon, Inc., Somerville, NJ, USA). Polymers can include aliphatic polyesters, poly (amino acids), copoly (ether-esters), polyalkylene oxalates, polyamides, tyrosine-derived polycarbonates, poly (iminocarbonates), poly-polyesters, polyoxaesters, polyamidoesters, polyoxyesters containing amine groups, poly (anhydrides) , polyphosphazenes, poly (prolylene fumarate), polyurethane poly (urethane ester), poly (urethane ether) and mixtures and copolymers thereof. Synthetic polymers suitable for use in the examples described in the present invention can also include synthetic biopolymers based on sequences found in collagen, laminin, glycosamino glycans, elastin, thrombin, fibronectin, starches, poly (amino acid), gelatin, alginate, pectin, fibrin , oxidized cellulose, chitin, chitosan, tropoelastine, hyaluronic acid, silk, ribonucleic acids, deoxyribonucleic acids, polypeptides, proteins, polysaccharides, polynucleotides and combinations thereof. Other suitable materials or combinations of materials that can be used will be apparent to those skilled in the art in view of the teachings of the present invention. It should also be understood that fabric mixed with a framework material can have any suitable particle size, and that the resulting mixture can, at least initially, have the consistency of a slurry or have any other suitable consistency. In some versions, the tissue particles include an effective amount of viable cells that can migrate the tissue particle out and popularize the framework. The term "viable" for use in the present invention is to be understood to include a tissue sample that has one or more viable cells.
[0037] In some versions, one or more components in a medical tissue or fluid treatment composition comprises one or more healing agents that promote regeneration at a target site (for example, inside a fistula) and / or accelerate healing of tissue at the target site. Curing agents can include any of a variety of biocompatible materials that accelerate tissue healing and / or promote tissue regeneration. Such biological components may include, for example, growth factors, proteins, peptides, antibodies, enzymes, platelets, glycoproteins, hormones, cytokines, glycosaminoglycans, nucleic acids, analgesics, viruses, isolated cells, or combinations thereof. The medicinal fluid may also include one or more treatment components that prevent infection, reduce inflammation, prevent or minimize the formation of adhesion, and / or suppress the immune system. In some versions where a framework is used in conjunction with a tissue treatment composition, one or more of these additional biological components or additional treatment components may be provided on and / or within the framework. Some examples described in the present invention may also include one or more adhesive agents in conjunction with viable tissue fragments.
[0038] Examples described here relate to the repair (for example, anastomosis) of lumens in a patient. In particular, the examples described herein include devices used in at least part of a process to release compositions for treating medicinal tissue or fluid into a lumen at an anastomosis site. In some versions, the fabric treatment composition is released into the stapled fabric in a staple line, such as through a fluid conduit inside the stapler. In some other versions, the fabric treatment composition is released from a breakable compartment that, for example, can be located on or over the staple end effector and can be broken by being trapped between the stapling head and the anvil, staples, and / or a sharp knife in the stapler. In addition, the fabric treatment composition can be provided in a positionable frame between the stapling head and the stapler anvil. Various examples of such ways in which a medical device can incorporate a tissue treatment composition will be described in more detail below, while additional examples will be apparent to those skilled in the art in view of the teachings of the present invention. Although these examples are described in the context of staplers, it should be understood that the following teachings can be readily applied to various other types of medical devices, including, but not limited to, surgical clip applicators. For example, the instructions of the present invention can be applied to other types of surgical fastener devices, such as surgical splicers used in various procedures such as hernia repair, with the use of a hernia prosthesis (for example, a hernia mesh). As an example, further, the teachings of the present invention can be applied to devices used to cut and coagulate tissue, such as those using RF or ultrasonic energy. Several suitable ways in which the following teachings can be applied to other types of medical devices will be apparent to those skilled in the art. Similarly, while the examples below are described in the context of lumen-tipped anastomosis of tissue, it should be understood that the following teachings can be readily applied to various other types of surgical procedures. Various types of surgical procedures in which the following teachings can be incorporated will be apparent to elements skilled in the art.
[0039] For use in the present invention, the term "fluid communication" (or in some contexts "communication") means that there is a trajectory or route through which a fluid (gas, liquid or other high flow material) can flow between two components, either directly or through one or more intermediate components. Similarly, the term "conduit" encompasses a conduit within or integrated with a valve. In other words, fluid communication between two components means that fluid can flow from one component to another but does not exclude an intermediate component (for example, a valve, etc.) between the two reported components that are in fluid communication. Similarly, two or more components can be in mechanical "communication" with each other, even if intermediate components are interposed between those two or more components. II. Exemplifying Surgical Stapler that has Reservoir to Hold Composition for Tissue Treatment
[0040] Figure 1 represents an exemplary surgical stapler (20) of the type that is used to create an end-to-end anastomosis, as in the intestinal tract after a resection. The stapler (20) may have a construction similar to that shown in, for example, US Patent No. 5,533,661, entitled "Sealing Means for Endoscopic Surgical Anastomosis Stapling Instrument", granted on July 9, 1996, the description of which is incorporated herein as a reference; and / or US Publication No. 2009/0120994, entitled "Surgical Fastening Device with Initiator Impregnation of a Matrix or Buttress to Improve Adhesive Application", published on May 14, 2009, the description of which is incorporated herein by reference. It should be noted that the apparatus and methods described herein can be incorporated into, or otherwise used with, other types of surgical staplers such as a linear stapler. Linear staplers are shown and described in, for example, US Patent No. 5,465,895, entitled "Surgical Stapler Instrument", issued on November 14, 1995, the description of which is incorporated herein by reference; US Patent No. 6,964,363, entitled "Surgical Stapling Instrument having Articulation Joint Support Plates for Supporting a Firing Bar", granted on November 15, 2005, the description of which is incorporated herein by reference; and US Patent No. 6,978,921, entitled "Surgical Stapling Instrument Incorporating an E-beam Firing Mechanism", issued December 27, 2005, the description of which is incorporated herein by reference.
[0041] The circular stapler (20) of the present example has a handle (22), a stem (24) extending distally therefrom, and a circular end effector (26) at a distal end of the stem (24). The circular end effector (26) includes a first fabric closure element (28) (or stapling head) that has a plurality of clips arranged therein in one or more assemblies, and a second fabric closure element (30) which comprises an anvil for disposition of the staples At least one of the fabric closure elements (28 and 30) is movable between an open position to receive the fabric between the closure elements (28 and 30), and a closed position for closing fabric stapling between the closure elements (28 and 30). In the present example, the second closing element (30) is movable in relation to the first closing element (28). Also in the present example, an elongated rod extends between the first and the second closing elements (28 and 30). In this exemplary embodiment, the elongated stem comprises an anvil stem (58), which receives a distal end portion of a column element (68), so that the second closing element (30) can be pulled towards the first closing element (28) by a column element (68), as further described in the present invention. In some other versions, the anvil stem may be received within the distal end of a hollow stem that extends through the first closure member.
[0042] An actionable staple trigger trigger (23) is provided to trigger the stapler (20). In the present example, as shown in figure 1, the trigger (23) is pivotally connected to the cable (22), and is shown in the open position. The trigger (23) can be moved (i.e., pivoted) to the adjacent cable in a closed position (22) to fire the stapler (20). It should be understood that the trigger (23) is merely an example of a feature that can be used to trigger the stapler (20), and that a variety of other types of features or components can be provided to trigger the stapler (20).
[0043] As further described in the present invention, the second fabric closure element (30) is functionally connected to a rotary closure button (32) located on the cable (22). Rotating the closing button (32) moves the second fabric closing element (30) to the closed position shown in figure 4. Rotating the closing button (32) in the opposite direction moves the second closing element (30) back to the open position (figure 3). Certainly, a variety of features or alternative components can be provided to move the second closing element (30) between the open and closed positions.
[0044] The stapler (20) of the present example also includes a reservoir (34) for containing a tissue treatment composition comprising one or more tissue curing agents (for example, one or more viable tissue fragments suspended in one vehicle). In particular, as shown in figure 2A, the reservoir (34) is provided on the cable (22) of the stapler (20) in the present example. It should be understood, however, that the reservoir can be located somewhere else within the stapler (20) or even outside the stapler (20). For example, in some versions, the reservoir is positioned externally to the cable (22), and is functionally connected to the cable (22) or another portion of the stapler (20) to release the fabric treatment composition to the staple line. and / or fabric cut line.
[0045] Although the stapler (20) can be supplied to an end user with the fabric treatment composition pre-loaded in the reservoir (34), the stapler (20) of the present example includes an entry port (36) through the which reservoir (34) can be supplied with a fabric treatment composition (or components of the composition). For example, one or more tissue curing agents, such as viable tissue fragments, and a vehicle (for example, saline or water) and / or framework material, etc., can be injected into the reservoir (34) through the entrance door (36). Alternatively, the stapler (20) can be preloaded with some components of the fabric treatment composition (e.g., a vehicle), while other components such as fragments of viable tissue are injected into the reservoir (34) at the time of use. A valve (38) can also be provided to selectively close the inlet port (36), as shown schematically in figure 2A, so that the inlet port (36) can be closed after the reservoir (34) has been filled with a fabric treatment composition. In the present example, a valve lever (39) is provided to open and close valve 38. As an alternative to using a valve on the inlet port (36), a self-sealing septum can be positioned over the inlet port ( 36) so that the tissue treatment composition (or components thereof) can be injected into the reservoir (34) through the self-healing septum. Other suitable ways in which a medical fluid can be communicated to the reservoir (34) and how the medical fluid can be retained by the reservoir (34) will be apparent to those skilled in the art in view of the teachings of the present invention.
[0046] As further described herein, at least one fluid conduit can also be provided to selectively release tissue curing agent (s) from the reservoir (34) to a location between the first and second closure elements at the time of closing and stapling (and / or immediately before, and / or immediately after) closing and stapling.
[0047] The one or more healing agents inserted in the reservoir (34) may comprise one or more fragments of viable tissue such as, for example, a specimen of muscle tissue from a donor (autologous, allogeneic, and / or xenogenic) with the use of appropriate harvesting tools. Certainly, any type of suitable tissue can be used in addition to or in place of muscle tissue. To facilitate the release of tissue fragments to the stapler and / or cut line, as well as to facilitate the migration of viable tissue fragment cells, the tissue specimen (s) can be finely cut into small fragments before being inserted into the reservoir (34). Cutting the fabric into pieces can be done as the fabric is collected, or alternatively, the fabric can be cut into pieces after it has been harvested and collected from a donor. Cutting the fabric into pieces can be done by a variety of methods, such as using one or more scalpels or a processing tool that automatically divides the fabric into particles of a desired size. Various suitable ways in which tissue can be harvested from a patient will be apparent to those skilled in the art in view of the teachings of the present invention. The viable muscle tissue fragments can then be combined with a fluid carrier, and optionally other tissue healing agents or materials, etc. and injected into the reservoir (34) through the inlet port (36). Alternatively, one or more components of the tissue treatment composition can be inserted into the reservoir (34) separately, instead of being combined externally to the reservoir. It should be understood that any formulation of medicinal fluid described herein can be introduced into the reservoir (34).
[0048] A tissue crusher can be provided inside the stapler (20), as in the reservoir (34), so that the tissue specimens can be crushed into pieces inside the stapler. This configuration can facilitate the processing (for example, crushing, etc.) of viable tissue specimens immediately prior to use. In addition, the number of implements needed would also be reduced. When a crusher is provided in the reservoir (34), the reservoir comprises a crushing chamber for crushing tissue fragments into even smaller fragments and containing the crushed tissue fragments as part of a tissue treatment composition for release to the clamp and / or cut-line.
[0049] As an example, the stapler (20) can include a rotor (44) mounted inside the reservoir (34). The rotor (44) can be configured to crush one or more tissue fragments inserted in the reservoir (34) through the inlet port (36) in order to cut the tissue fragments into even smaller pieces. The rotor (44) can be driven by a motor (45) provided on the cable (22), and an actuator (46) can be provided on the outside of the cable (22) to activate the motor (45) to drive the rotor (44) ) and crush tissue fragments. The cutter (44) will also serve to mix tissue and vehicle fragments (as well as any other curing agents and / or other treatment composition components) into an even more homogeneous tissue treatment composition.
[0050] As an alternative to the motor driven crusher (44) shown in figure 2A, any of a variety of other devices and structures suitable for cutting and dividing tissue into smaller fragments can be provided. These alternative crushers can be operated manually or mechanically. For example, one or more manually operated cutting blades can be located in the reservoir (34) to crush tissue fragments therein.
[0051] Also in the present example, a piston (40) is provided inside the reservoir (34) to expel fluid from the reservoir through a fluid conduit. The piston (40) comprises a cylindrical element dimensioned to fit in a sealing and sliding manner within a corresponding cylindrical portion of the reservoir (34). A sealing ring (41) is provided around the outer circumference of the piston (40) for sealing engagement with the inner wall of the cylindrical portion of the reservoir (34). The piston (40) can be driven mechanically or manually to expel fluid. In the present example, a slide (42) is provided on the outside of the cable (22) and is fixed to the piston (40) through an elongated slot (43) in the cable (22). When sliding the slide (42) in the distal direction, the piston (40) will also be moved distally to expel fluid from the reservoir.
[0052] As can best be seen in figures 2B to 4, the first closing (or fixed) element (28) (also called the stapling head) is located at the distal end of the stem (24), and includes a plurality of ejectors or clamps (51) in one or more circular assemblies. The first closing element (28) also includes a hollow tubular compartment (50) fixedly attached to the distal end (24). The tubular compartment (50) has a funnel shape, and receives a sliding clamp driver (52) that can be advanced and retracted by the trigger operation (23). The clamp driver (52) includes a plurality of finger-like parts (53) configured to engage and drive distally (51) from a clamp holder (54) mounted at the distal end of the tubular compartment (50). The clamp holder (54) includes a plurality of clamp receiving slots in which the clamps (51) are positioned. A cylindrical knife (48) is mounted inside the clamp driver (52), coaxially within the clamp set (51), and can be advanced and retracted by the clamp driver (52).
[0053] The second movable closing element (30) includes a disc-shaped anvil (56) rigidly attached to the distal end of a hollow anvil stem (58). Staple-forming pockets (59) are provided in at least one annular assembly around the periphery of the proximal end wall (57) of the anvil (56). The set of staple-forming pockets (59) complements the set of staple-pockets (51) in the present example, so that the staple-forming pockets (59) will be aligned opposite to the staples (51) on the anvil element (28 ) when the second movable closing element (30) moves from the open position of figure 3 to the closed position shown in figure 4. An anvil wrap (60) is attached to the distal end of the anvil (56) to provide a tip distal trauma to the surgical stapler (20).
[0054] The anvil stem (58) of the present example includes an internal void space (62) that extends axially from the proximal end of the anvil stem (58), ending in an end wall (64). One or more openings (66) are arranged around the periphery of the anvil stem (58), and extend into the void space (62). The openings (66) can be located close to the end wall (64) of the anvil (56), as shown. As further described herein, the tissue treatment composition in the reservoir (34) can be expelled from the inside of the anvil stem (58) through openings (66) in order to release the curing agent (s) in the clamp and / or cut line. The anvil stem (58) can be detachably attached to the column element (68), which is slidably supported by the first closing element (28). The distal end (69) of the column element (68) is inserted into the empty space (62) of the anvil stem (58) to secure the second closing element (30) to the column element (68), as shown in figure 3. One or more seal rings (70) or other seals can be provided around the circumference of the column element (68) to securely and securely secure the column element (68) within the void (62) . In addition, one or more circumferential grooves can be provided around the outer surface of the column element (68) and / or the inner surface of the void (62) to receive the sealing ring (70) therein. To further retain the column element (68) within the void (62), one or more retention characteristics can be provided on the column element (68) and / or anvil stem (58). As an example, and as described in US Patent No. 5,533,661, the column element (68) may have a small diameter portion that defines a shoulder-shaped part that can be engaged by a corresponding structure provided within the empty space (62) of the anvil stem (58) (see, for example, Figure 2 of US Patent No. 5,533,661). Certainly other characteristics for retaining the column element (68) within the void (62) will be apparent to the elements skilled in the art.
[0055] In the present example, the column element (68) is received slidingly inside a hollow central support tube (72) formed in the tubular compartment (50) to allow longitudinal movement of the column element (68) in with respect to the clamp holder (54) mounted on the distal end of the compartment (50). One or more sealing rings (74) or other seals can be provided around the circumference of the column element (68) to position the column element in a sliding and sealing manner within the central support tube (72). One or more circumferential grooves can be provided around the outer surface of the column element (68) to receive sealing rings (74) therein. The distal end of the central support tube (72) abuts against the proximal end surface of the cylindrical knife (48), and the proximal end of the cylindrical knife (48) also includes an opening through which the column element (68 ) extends.
[0056] To facilitate the insertion of the column element (68) into the anvil stem (58), and to facilitate the sliding movement of the column element (68) and the anvil stem (58), the tip of the column (69) has a frustoconical shape. In addition, the column element (68) includes a distal portion (76) that is smaller in diameter than the proximal portion (77) of the column element. A tapered, frustoconical shoulder piece (78) can provide an easy transition between the distal portion (76) and the proximal portion (77) of the column element (68). The outer circumference of at least the anvil stem portion (58) mounted on the column element (68) can be approximately the same as the outer circumference on the proximal portion (78) of the column element (68). In addition, the proximal end wall (80) of the anvil stem (58) is tapered inwardly, as shown, in order to engage in a married manner with the shoulder-shaped piece (78) (see figures 3 and 4). In this way, when the anvil stem (58) is mounted on the distal portion (76) of the column element (68), the resulting assembly will have a generally constant diameter.
[0057] With reference to figures 2A and 2B, a clamp activation element (82) is located inside the rod (24) so as to extend between the trigger (23) and the clamp actuator (52). The clamp activation element (82) is configured to transmit the trigger activation force (23) to the clamp actuator (52) to urge the clamps (51) into the clamp forming pockets (59) in the second closing element (30). The proximal end of the clamp activating element (82) is positioned inside the handle (22) and is coupled to the trigger (23) so that when the trigger (23) is pushed towards the handle (22), the element clip activation mechanism (82) is pushed distally into the stem (24). The distal end of the clamp activating element (82) is configured to engage the clamp actuator (52), so that the distal movement of the clamp activating element (82) results in the firing of the clamps (51). It should therefore be understood that the stapler (50) can fire staples (51) according to the instructions of one or more of US Patent No. 5,533,661, US Patent No. 6,193,129, US Patent No. 5,271,544 , entitled "Surgical anastomosis stapling instrument", issued December 21, 1993, and US Patent No. 7,506,791, entitled "Surgical stapling instrument with mechanical mechanism for limiting maximum tissue compression", granted on March 24, 2009, whose descriptions are hereby incorporated by reference. Obviously, the stapler (50) can alternatively fire staples (51) in any other suitable mode, as will be apparent to those skilled in the art in view of the teachings of the present invention.
[0058] The stapler rod (24) (20) also contains tension elements (84) provided by a pair of elongated flexible bands to transmit tension from the cable (22) to the second closing element (30). The tension elements (84) transmit movement of the cable (22) to allow the second closing element (30) to be adjusted in position relative to the first closing element (30). The distal ends of the tension elements (84) are coupled to the column element (68) by a set of cross pins (86). The ends proximal to the tension elements (84) are coupled to the distal end of a control axis (88) in the cable (22) by a transverse pin (89). The control axis (88) is located inside the cable (22) and is configured for longitudinal movement therein. The proximal end of the control shaft (88) is threadedly coupled with the closing button (32). The closing button (32) is pivotally supported by the proximal end of the cable (22). An internally threaded cylindrical fitting (90) is provided at the end of the closing button (32), and engages in a threaded manner with an elongated threaded rod (92) provided at the proximal end of the control shaft (88). By turning the closing knob (32) counterclockwise (as shown in figure 1), the threaded rod (92) will be pulled proximally by the threaded cylindrical fitting (90), thus moving the control axis ( 88) and the tension elements (84) in the proximal direction. To the extent that the column element (68) and anvil stem (58) are coupled together, the tension elements (84) will likewise pull the column element (68) and the anvil stem (58) into the proximal direction, thus pulling the second closing element (30) towards the first closing element (28) to secure the fabric to be stapled between the first and the second closing elements (28 and 30). Obviously, any other suitable characteristics, components, and methods can be used to pull the second closing element (30) towards the first closing element (28).
[0059] To release the tissue treatment composition (for example, one or more tissue curing agents in a biocompatible fluid vehicle, etc.) from the reservoir (34) at a location between the first and the second closure elements (28 and 30), one or more fluid conduits can be provided inside the stapler (20). In the present example, a fluid conduit (94) extends from a bottom wall of the reservoir (34) through a portion of the cable (22), and through the interior of the rod (24) to an open distal end (96) ) located inside the central support tube (72). As best seen in figures 3 and 4, an empty space (98) extends axially through a portion of the column element (68), and includes an angled portion (99) that communicates between the axial portion of the space void (98) and a hole (100) provided on the outer surface of the proximal portion (77) of the column element (68). The distal portion (76) of the column element (68) includes an opening (102) that communicates with both the void space (98) of the column element (68) and the void space (62) of the anvil stem (58 ) when the latter is mounted on the column element (68). The size, location and configuration of the fluid conduit (94), as well as empty spaces (62 and 98) and the openings in the empty space (62), are merely exemplary. Any of a variety of alternatives can readily be employed to release a fabric treatment composition between the closure elements (28 and 30) although it will not interfere with the stapling and cutting of the fabric by the stapler (20).
[0060] The fluid conduit (94) and column element (68) are configured and positioned so that the distal open end (96) of the fluid conduit (94) is selectively aligned with the orifice (100) on the outside of the column element (68). In particular, in the present example, the fluid conduit (94) is configured so that the distal open end (96) of the fluid conduit will be aligned with the orifice (100) in the column element (68) when the second closing (30) is in the closed position, or closed, shown in figure 4. As described above, the column element (68) is in a proximal position when the second closing element (30) is in the closed position, or closure. In this way, the fluid conduit (94) can be selectively in communication with the empty space (62) of the anvil stem (58) to selectively release fluid from the reservoir (34) to the openings (66) provided around the periphery of the anvil stem (58). As previously mentioned, the openings (66) in the anvil stem (58) can be arranged around the periphery of the anvil stem, proximally and adjacent to the end wall (57) of the anvil (56). In this way, the fluid released from the reservoir (34) can be expelled through the openings (66) in the clamp and / or cutting line. In the present example, the slide (42) is used to selectively expel fluid through the openings (66). In this way, the end user can take the fluid to be expelled before, during or after stapling and / or before, during or after cutting the fabric. The fluid can be expelled at multiple times, such as before stapling and after cutting tissue. In this way, a fluid composition for treating tissue in a reservoir (34) can be propelled through the fluid conduit (94) and selectively expelled through the openings (66), between the first and second closing elements (24 and 25) . When the second closing element (30) is in the open position shown in figure 3, the empty space (98) in the column element (68) will not be in communication with the fluid conduit (94), and therefore the fluid will not be expelled through the openings (66) in the anvil stem (58).
[0061] In some versions, the distal end (96) of the fluid conduit (94) does not need to be precisely aligned with the orifice (100) for the medical fluid to be communicated from the conduit (94) to the void (98). For example, in some versions, the fluid can be communicated from the conduit (94) to the empty space (98) while the distal end (96) of the conduit (94) is positioned longitudinally somewhere between the sealing ring (74) which is distal to the orifice (100) and the sealing ring (74) which is proximal to the orifice (100). Obviously, these two sealing rings (74) can be separated from each other by any suitable longitudinal distance, which can affect the range of longitudinal positions of the column element (68) in relation to the conduit (94) and the medical fluid can be communicated from the conduit (94) to the empty space (98). In some versions, the distal end (96) of the fluid conduit (94) must be aligned with the orifice (100) for the medical fluid to be communicated from the conduit (94) to the void (98). It should be understood that one or more additional sealing rings (not shown) can be positioned around the column element (68) and / or elsewhere to substantially fluidly isolate the distal end (96) of the fluid conduit (94) when the column element (68) is in a distal portion as shown in figure 3.
[0062] In the present example, and as mentioned earlier, a piston (40) is provided within the reservoir (34) to expel a composition for treating medical tissue or fluid (e.g. fragments of viable crushed tissue suspended in a biocompatible vehicle, etc.) from the reservoir (34) through the fluid conduit (94). The piston (40) may comprise, for example, a cylindrical element dimensioned to fit in a sealing and sliding manner within a corresponding cylindrical portion of the reservoir (34). By sliding on the slide (42) in the distal direction, the piston (40) will also move distally and expel fluid from the reservoir (34) through the fluid conduit (94), at least when the distal end is open (96) of the fluid conduit (94) is substantially aligned with the orifice (100) on the outside of the column element (68) or is otherwise properly positioned between the sealing rings (74). Obviously, a tissue treatment composition can be released from the reservoir (34) through the fluid conduit (94) and expelled from the openings (66) in a variety of other ways. For example, a pump capable of being selectively activated can be provided to force the composition for treatment through the conduit (94). Alternatively, the reservoir (34) can be pressurized so that when the distal open end (96) of the fluid conduit (94) is aligned with the orifice (100) on the outside of the column element (68), the composition for treatment will be expelled from the openings (66) provided around the periphery of the anvil stem (58). Other suitable ways in which a tissue treatment composition can be released from the reservoir (34) through the fluid conduit (94) and expelled from the openings (66) will be apparent to those skilled in the art in view of the teachings of the present invention. A. Exemplifying Biocompatible Frameworks for Receiving Composition for Tissue Treatment
[0063] Although a tissue treatment composition can simply be expelled between the closure elements (28 and 30) to release one or more tissue curing agents, etc. in the suture and / or cut line, a biocompatible framework (106) can be used to receive the tissue treatment composition between the closure elements (28 and 30). As shown in figures 3 to 5, the frame (106) comprises an annular disk-shaped element that is positioned between the first and the second closing elements (28 and 30). The disk-shaped frame (106) includes a central opening (108) dimensioned so that the frame (106) can be positioned on the anvil stem (58), between the first and second closing elements (28 and 30), as shown in figure 3. The central opening (108) can be dimensioned to fit firmly, albeit slidingly, on the anvil stem (58). In this way, the framework (106) can be positioned on the anvil stem (58) at any location that does not interfere with the insertion of the end effector (26) in the tissue lumens to be connected or the adjustment of the frill suture around the tissue lumens (as will be described here further). When the second closing element (30) is moved to the closed or closed position shown in figure 4, the frame (106) will slide along the anvil stem (58) until the frame touches against the proximal end wall ( 57) of the anvil (56), with the central opening (108) extending around the anvil stem (58) in substantially the same longitudinal position as the openings (66). The fabric treatment composition can therefore be expelled through the openings (66) around the circumference of the central opening (108), allowing the framework (106) to absorb the fabric treatment composition.
[0064] The diameter of the disk-shaped frame (106) can be chosen so that the frame (106) is stapled between the end walls of the fabric lumens. Thus, when the framework (106) is positioned on the anvil stem (58), the outer perimeter of the framework (106) will extend radially beyond the circular staple line. In other words, the diameter of the frame (106) may be greater than the distance between the most distant clips (51) located on opposite sides of the clip holder (54). In this way, the framework (106) will be held in place between the ends of the fabric by the formed clips.
[0065] While the frame (106) is slid on the anvil stem (58) before attaching the anvil stem to the column element (68) in the present example, the frame (106) includes a radial slot in some versions for allow the frame to be positioned on the anvil stem (58) after the anvil stem (58) has been joined to the column element (68). This gap (not shown) can extend across the entire thickness of the framework (106), from the central opening (108) to the outer circumference of the framework (106).
[0066] When positioned between the first and the second closing elements (28 and 30), the framework (106) is positioned to receive the composition for treating tissue expelled through the openings (66). When the tissue treatment composition includes viable tissue fragments, viable cells can migrate to and / or the framework (106), and thereafter can proliferate and integrate with the tissue surrounding the stapled site. The framework (106) can be porous or non-porous. If desired, the framework (106) can also be bioabsorbable. The scaffold (106) may alternatively be non-bioabsorbable so that it will remain in place and continue to provide support at the clamp location. The frame (106) can also be malleable to allow the frame (106) to adjust to the dimensions and / or configuration of the staple site.
[0067] As an additional example, the framework (106) can be made from any of a variety of materials and methods, such as those described in US Publication No. 2004/0078090, the description of which is incorporated herein by reference. As an example only, the framework (106) can be formed from a biocompatible polymer, injectable gel, ceramic material, autogenic tissue, allogeneic tissue, xenogeneic tissue or combinations thereof. Biocompatible polymers can, for example, be synthetic polymers, natural polymers and combinations thereof. Suitable biocompatible synthetic polymers may include polymers selected from the group consisting of aliphatic polyesters, poly (amino acids), copoly (ether-esters), polyalkylene oxalates, polyamides, tyrosine-derived polycarbonates, poly (iminocarbonates, polyesters, polyoxyesters, polyamidoesters, polyoxyesters, polyoxyesters, polyoxyesters, polyamides). containing amine groups, poly (anhydrides), polyphosphazenes, polyurethanes, poly (urethane ether), poly (urethane ester for example), poly (prolylene fumarate), poly (hydroxy alkanoate and mixtures thereof. Suitable synthetic polymers may also include synthetic biopolymers based on sequences found in collagen laminin, glycosamino glycans, elastin, thrombin, fibronectin, poly (amino acid) starches, gelatin, alginate, pectin, fibrin, oxidized cellulose, chitin, chitosan, tropoelastin, hyaluronic acid, silk, ribonucleic acids , deoxyribonucleic acids, polypeptides, proteins, polynucleotide polysaccharides and combinations of the same the. Suitable biocompatible natural polymers may include, for example, fibrin-based materials, collagen-based materials, hyaluronic acid-based materials, glycoprotein-based materials, cellulose-based materials, silks and combinations thereof. In the present example, the biocompatible framework (106) can comprise freeze-dried fibrin. Still other materials and suitable combinations of materials that can be used to form at least part of the framework (106) will be apparent to those skilled in the art in view of the teachings of the present invention.
[0068] The framework (106) can also be specific to anatomy to promote the regeneration of particular types of cells or structures. For example, it may be desirable to promote the regeneration of a structure such as a sphincter or valve that is resected in a patient (for example, anal sphincter, pyloric sphincter, ielocecal valve, lower esophageal sphincter, etc.). In these examples, the framework (106) can comprise one or more specific tissue components or materials that will particularly promote regeneration of the sphincter or resected valve (or any of a variety of other anatomical structures). In addition or as an alternative, the tissue treatment composition applied to the framework (106) can be anatomically specific, such as a suspension of stem cells that will regenerate a specific anatomical structure (for example, sphincter or valve) when applied to the framework (106) stapled between tissue in a patient.
[0069] Additionally, by way of example, the framework can include one or more components such as fibers that are specifically arranged in the framework in order to direct the regeneration of cells in a particular orientation. In a version shown in the schematic illustration of figure 18A, the framework (120) comprises fibers arranged in one or more circles concentrically ordered around the central opening of the framework (120). This arrangement of the components used to form the framework (120) can help direct cell regeneration in a similar pattern. Obviously, the fibers can be arranged in any number of concentric circles or other patterns. A framework, as shown in figure 18A, can be useful, for example, in the regeneration of a sphincter. Figure 18B schematically represents another version of the framework (130) comprising fibers arranged in a plurality of concentric spirals emanating away from the central opening of the framework (130). Figure 18C schematically represents yet another version of a framework (140) comprising fibers arranged in a plurality of circles arranged around the framework (140). Obviously, fibers can be arranged in any of a variety of orientations, including, for example, a combination of one or more circles (concentric and / or non-concentric) and / or one or more spirals or other shapes to direct cell regeneration in a variety of different orientations.
[0070] It should also be noted that one or more frameworks (106, 120, 130, 140 and 206) can be sent to end users with the stapler (20), as a kit. The frame (s) (106, 120, 130, 140 and 206) can be packed separately in a suitable sterile container (s), or a frame can be supplied pre-installed in a stapler (20) between the first and the second closing elements (28 and 30). B. Exemplifying Use of Surgical Stapler in Combination with Biocompatible Framework
[0071] As mentioned earlier, the circular stapler (20) can be used to perform an anastomosis in which two lumens of tissue are connected by one or more circular staple arrangements. Only as an example, and as shown in figures 3 and 4, the first and second portions of the intestinal lumen (116 and 117), respectively, can be connected to each other after a resection. The stapler (20) can be prepared first for use by positioning the frame (106) of the anvil stem (58) of the second closing element (30), and after that by sliding the anvil stem (58) from end to end of the column element (68) as shown in figures 1-2 (where the framework (106) has been omitted). Consequently, the circular end effector (26) comprising the first and second tissue stapling elements (28 and 30) is inserted into a longitudinal slot (not shown) within the first portion of the intestinal tissue (116), and moved in the position shown adjacent to a tissue opening (116). The second movable closure element (30) is moved to the open position and the second portion of the intestinal tissue (117) is inserted all the way into the second closure element (30), as shown in figure 3. Consequently, each portion of tissue (116 and 117) is fitted with a pucker suture (118) placed around the open ends of the intestinal tissue (116 and 117). Each piece of suture (118) is pulled tightly to close the open ends of the intestinal tissue (116 and 117), and tied for safety reasons.
[0072] After the pucker sutures (118) are tied, the closing knob (32) is rotated so that the second movable closing element (30) is pulled towards the first closing element (28) to a position adjacent to the first closure element (28) to secure the first and second portions of the intestinal tissue (116 and 117) to each other, with the framework (106) trapped between the ends of the tissue (see figure 4). After the second closing element (30) is pulled towards the first closing element (28), and when the distal opening end (96) of the fluid conduit is sufficiently aligned with the hole (100) of the empty space (98) ), a tissue treatment composition in the reservoir (34) is pushed through the fluid conduit (94) so as to be expelled from the anvil stem (58) through openings (66) by pushing the lever (108) on the handle (22) distally towards the circular end effector (26). Alternatively, or in addition, a fabric treatment composition can be expelled through the openings (66) after the tissue portions (116 and 117) and the framework (106) have been trapped between the first and second closure elements (28 and 30). The treatment composition expelled through the openings (66) and containing one or more curing agents will flow radially on and / or through the surface of the framework (106), impregnating the framework (106).
[0073] Consequently, the circular stapling device (20) is triggered by the triggering of the staple discharge trigger (23). The staple ends (51) are pushed out of the staple holder (54), through the first portion of the intestinal tissue (116), through the frame (106) along the dashed staple line (112) (see figure 5), through the second portion of the intestinal tissue (117), and against the staple forming pockets (59) of the anvil (56) to form the staples and staple portions of tissue (116 and 117) together (with framework (106 ) stuck together). The cylindrical knife (48) is also advanced by the staple driver (52), through the first and second portions of intestinal tissue (116 and 117), and through the frame (106) along the dashed line (110) (see figure 5), inside the staple line. The one or more curing agents absorbed in and / or the framework (106) is released along the staple line and the cut line to accelerate tissue healing and / or promote tissue regeneration. It should be noted that the dashed cut line (110) and the clamp line (112) shown in the framework (106) in figure 5 are included for reference only, and do not necessarily represent any structure or feature in the framework.
[0074] The framework (106) will then remain in place between the first and second portions of intestinal tissue (116 and 117). If the framework (106) is made of a bioabsorbable material, the framework (106) will be absorbed over time. If the framework (106) is not made of a bioabsorbable material, it will remain in place as an annular ring and will support the stapled connection between the tissue lumens (116 and 117). Still other suitable means by which the stapler (20) can be used, whether with or without the frame (106), will be apparent to those skilled in the art in view of the teachings of the present invention. C. Alternative Biocompatible Frameworks
[0075] Figure 6 represents another example fabric framework (206) that can be used at the site of the framework (106) described above. The framework (206) of this example can be made of any of a variety of materials mentioned above for framework (106), such as freeze-dried, freezing fibrin, etc., or any other suitable material (s) (s). The biocompatible frame (206) includes an annular disk-shaped portion (214), which has an opening (208) that extends therethrough, and a plurality of radially extending flaps (216) thus extending away the outer circumferential edge of the disk-shaped portion (214). The outer arched edges (217) of the flaps (216) define an outer circumference of the framework (206) that can be dimensioned in a similar way to that described for the framework (106). In this way, the biocompatible framework (206) can be seen as an annular disk-shaped element that has a plurality of radial sections (218) that define flaps (216) with each other.
[0076] The framework (206) can be used in conjunction with a circular stapler as a surgical stapling instrument (20) in the same manner as described above in relation to the framework (106). In particular, the central opening (208) can be dimensioned so that the frame (206) can be positioned on the anvil stem (58), between the first and the second closing elements (28 and 30). The central opening (208) can also be dimensioned to fit firmly, albeit slidingly, on the anvil stem (58).
[0077] The annular disk-shaped portion (214) of the frame (206), however, may have a diameter that is less than the diameter of the cylindrical knife (48) of the stapler (20). In this way, the dashed cut line (210) shown in figure 6 is located outside the disk-shaped portion (214) so that the cut line (210) extends through each of the radially extending flaps (216). When the framework (206) is used to form an anastomosis using a surgical stapler (20) in the manner described above, the radial flaps (216) of the framework (206) will be stapled between the lumens of tissue along the line (212), and the cylindrical knife (48) of the stapler (20) will cut through the frame (206) along the cutting line (210). In this way, the only portions of the frame (206) that remain stapled between the fabric lumens will be the portion of each radial flap (216) that extends between the cut line (210) and the outer arcuate edge (217) of the flap . Since the radial tabs (216) of the framework (206) will be spaced separately around the circumference of the junction between the two lumens of tissue, the framework (206) will not interfere with peristalsis or other expansion or contraction of the lumen in which the anastomosis is formed. Obviously, the versions of the framework (106) described above will not necessarily interfere with peristalsis, once installed. Only by way of example, the material (s) that form (s) some versions of the framework (106) can (s) allow the framework (106) to expand radially and contract freely during peristalsis. It should be understood that the presence and configuration of the flaps (216) may allow a different selection of materials to compose the framework (206) that could otherwise be available to compose the framework (106) (for example, non-elastic materials, etc.).
[0078] Any number of radial flaps (216) can be provided in the biocompatible frame (206). However, it may be desirable in some scenarios to spacing the adjacent flaps (216) away from each other to a degree where the formed clamp does not cross between adjacent flaps (216). In other words, the distance between the adjacent radial flaps (216) on the clamp line (212) can be greater than the length of a formed clamp. It will also be noted that the radial flaps (216) can be any of a variety of sizes and shapes, and the one shown belongs to a modality only. Likewise, although the cuts (218) are shown with an angular width that approximately equals the angular width of the flaps (216), it should be understood that the cuts (218) can have any other suitable angular width; and that the angular width of the cuts (218) can have any type of relationship with the angular width of the flaps (216). In some versions, the cuts (218) are simply radial slits.
[0079] The biocompatible framework (206) can also be used with a conventional circular stapler that is not configured to release fluid medium from a reservoir to the framework. For example, the biocompatible framework (206) can be used with a circular stapler of the type shown and described in US Patent No. 6,193,129, entitled "Cutting Blade for a Surgical Anastomosis Stapling Instrument", issued on February 27, 2001, whose description is hereby incorporated by reference. In some versions, instead of releasing a fabric treatment composition through the stapler (20) to the framework (206), a fabric treatment composition (for example, a suspension of shredded viable tissue fragments, etc.) can be pre-associated with the framework (206). As an example only, the framework (206) can be impregnated and / or coated with a fabric treatment composition before being positioned on the anvil stem of a circular stapler in the manner described above. Only as an example, the framework (206) can be formed from any of the materials and compositions described in US Publication No. 2004/0078090, the description of which is incorporated herein by reference. Similarly, the tissue treatment composition associated with the framework (206) can comprise, for example, any of the biological components and / or other compositions described in US Publication No. 2004/0078090 for application to the frameworks described therein.
[0080] After the framework (206) that has a fabric treatment composition is positioned on the anvil stem of a conventional circular stapler, the fabric lumens to be stapled together can be attached by the first and second closing elements, with the framework (206) positioned between the portions of the fabric to be joined. The stapler is then fired in order to staple and cut the fabric portions and the framework (206). As previously described for using the framework (206) with the stapler (20), the radial flaps (216) of the framework (206) will remain in place between the joined tissue portions in order to allow the joined tissue to expand and contract freely. Other suitable ways in which the framework (206) can be used will be apparent to those skilled in the art in view of the teachings of the present invention. III. Exemplifying Breakable Compartment Containing a Fabric Treatment Composition
[0081] Alternatively, or in addition to releasing a tissue treatment composition from a reservoir to the region between the stapling head and the anvil of a surgical stapler, one or more rupture fluid compartments containing a tissue treatment composition can be provided. The tissue treatment composition can comprise, for example, one or more tissue curing agents such as viable tissue fragments and / or any other medical fluid formulation described in the present invention. In some versions, a tear-away compartment can be configured as a tear-off and biocompatible containment bag configured to be positioned in an aligned manner between the stapling head (first closing element) and the anvil (second closing element) of a surgical stapler. In addition or as an alternative, one or more biocompatible breakable compartments can be located in the end effector of a surgical stapler. The tear-away compartment (s) can be supplied preloaded with a fabric treatment composition and / or can be configured to be supplied with a fabric treatment composition (or components thereof) at the time of use. For example, in some versions, the tear-away compartment (s) may be injected or otherwise filled with one or more fragments of tissue viable at the time of use (for example, injecting fragments of tissue into the tear-away compartment crushed from a patient and suspended in a suitable vehicle). Various examples of how a breakable compartment can be provided will be described in more detail below, while additional examples will be apparent from elements skilled in the art in view of the teachings of the present invention. A. Breakable Containment Bag Exemplifier Positionable between the Stapling Head and the anvil of a Surgical Stapler
[0082] Figure 7 represents an example of a breakable compartment (306) for containing a fabric treatment composition, like the various compositions described above. The compartment (306) comprises a hollow, breakable and biocompatible containment bag configured to be positioned in line between the stapling head (or first closing element) and the anvil (or second closing element) of a circular stapler. The containment bag (306) includes a central opening or groove (308) that is sized so that the containment bag (306) can be positioned on, for example, an anvil stem that extends between the first and the second closing elements of a circular stapler so that the frames (106 and 206) can be mounted on an anvil. The containment bag (306) is breakable so that when positioned between the closing elements of a stapler and filled with a fabric treatment composition, the containment bag (306) will be broken by firing the clips and advancing the knife stapler, which pierces the containment bag (306). In some versions, the containment bag (306) will also break when trapped between the closing elements just before stapling. Breaking the containment bag (306) will result in the release of the fabric treatment composition directly to the clamp and cut lines. A ring annular portion of the containment bag (306) will also remain in place, stuck between the portions of fabric joined by the clips, where this will reinforce the clip line as a support material. If the containment bag (306) is made of bioabsorbable material, the annular ring portion trapped between the joined tissue will be absorbed over time.
[0083] The containment bag (306) can be used in conjunction with, for example, the circular stapler (20) described earlier in the present invention, or any of a variety of other circular staplers such as those shown and described in US Patent no. 6,193,129. Alternatively, and as described below, figure 10 represents a breakable containment bag (306) positioned in line between the first and second closing elements (328 and 330) of an alternative version of a circular stapler (320), during performing an anastomosis. It should be noted that figure 10 represents only the circular end effector portion (326) of the stapler (320). In this example, the stapler (320) has a construction similar to the stapler (20) described above. However, the stapler (320) in this example does not include a shredder, fluid passage, or empty space that extends through the column element (368). Similarly, the openings are not provided in the anvil stem (358) in this example, since the stapler (320) is not configured to release a fabric treatment composition to the staple and / or cut line.
[0084] Like the circular stapler (20) described previously in figures 1 to 4, the surgical stapler (320) shown in figure 10 includes a first closing element (or stapling head) (328) and a second opposite closing element (or anvil) (330) connected to the cable (not shown in figure 10). At least one of the fabric closure elements (328 and 330) is movable between an open position to receive fabric between the closure elements (328 and 330), and a closed position to staple the fabric stuck between the closure elements (328 and 330). The first closing element (328) includes a plurality of clips (351) disposed therein, and the second closing element (330) comprises an anvil (356) which has staple forming pockets (359) forming the clips (351) . In the present example, the second closing element (330) is movable in relation to the first closing element (328) along the longitudinal axis, and an anvil stem (358) extends between the first and second closing elements ( 328 and 330) along this longitudinal axis. As shown in figure 10, the containment bag (306) is configured to be positioned in line with the first and second closing elements (328 and 330) of the stapler (320), mounted on the anvil stem (358).
[0085] The biocompatible containment bag (306) can be configured in any of a variety of formats suitable for housing a fabric treatment composition therein. For example, the containment bag can be configured in the shape of, at least when filled with fluid, a toroid. If the toroid extends around it in a full circle (for example, threaded), a central opening (308) will extend through it and the containment bag (308) can simply be slid on the anvil stem (358) of the stapler (320) before the anvil stem (358) is slid at the distal end of the column element (368). In this way, the biocompatible containment bag (308) can be mounted in line with the anvil stem (358) similar to the way in which the frame (106) described above can be mounted on the anvil stem of a circular stapler. Alternatively, the biocompatible containment bag (306) can be configured as a thread-shaped toroid that has a slit that extends radially from the central opening of the toroid to the outer circumference. In this configuration, the biocompatible containment bag will be configured similar to a lock washer, and can be slid on the anvil stem (358) after the anvil stem (358) has been attached to the column element (368), and even after the end effector (326) has been positioned within a pair of tissue lumens (316 and 317), as shown in figure 10.
[0086] As shown in figure 7, the biocompatible containment bag (306) of the present example is configured as a spiral toroid having an opening (308) that extends through it. The containment bag (306) is similar to the thread-shaped toroid of the slit described above. However, the spiral toroid of figure 7 extends beyond a complete revolution so that the second radial end (312) of the spiral containment bag overlaps the first radial end (310) of the spiral containment bag. In some scenarios, this configuration can ensure the release of the fabric treatment composition around the entire staple line; and it can help to retain the fluid-filled containment bag (306) on the anvil stem (358). The biocompatible containment bag (306) (as well as the containment bag (406) described in detail below) can be made of any of a variety of biocompatible materials, including bioabsorbable materials, that can be formed in a sealable compartment that not only does it contain fluid, it is also breakable. As an example only, the containment bag (306 and 406) can be produced from polyglycololine (PGA), polylactide (PLA), polycaprolactone (PLC), polydioxanone (PDO), poly (lactide-co-glycolide) ( PLGA), poly hydroxy butyrate (PHB), and / or poly hydroxy valerate (PHV). Alternatively, any other suitable material or combination of materials can be used.
[0087] As mentioned earlier, the containment bag (306) is configured to reliably contain a fabric treatment composition. The containment bag (306) can be supplied preloaded with a fabric treatment composition, in which the containment bag (306) can be provided as a sealed sterile structure without a door or other means for adding materials to it. Alternatively, the containment bag (306) can be configured to be filled with a fabric treatment composition (or components thereof) at the time of use. The containment bag (306) can be provided to the end user partially filled with one or more components of a fabric treatment composition (for example, a suitable vehicle solution), and the end user can add additional components at the time of use (for example, crushed viable tissue fragments, collected for example, from patients for whom the containment bag is to be used). Alternatively, the containment bag (306) can be supplied empty to the end user, so that the end user will fill the containment bag (306) with a fabric treatment composition (for example, fill the containment bag with fragments of crushed viable tissue collected from the patient and suspended in a suitable vehicle). To allow the containment bag (306) to be filled with a tissue treatment composition (or components thereof), particularly by an end user such as a surgeon, a sealable port (313) can be provided on the containment bag (306). The sealable door (313) can be positioned at any of a variety of locations in the containment bag (306), and provides an entrance through which the containment bag (306) can be filled with materials such as fabric fragments. The door (313) can have any of a variety of configurations and structures. For example, the port (313) may comprise a self-sealing septum made from a biocompatible material, such as an elastomer suitable for implantation in a patient.
[0088] For the containment bag (306) to be penetrated by clips fired through it, when the containment bag (306) is positioned on the anvil stem (358) as shown in figure 10, the outer perimeter of the containment bag (306) can be extend radially beyond the circular staple line. In other words, the frame diameter (306) can be greater than the distance between the most distant clips (351) located on opposite sides of the clip holder (354). In this way, if it is not broken when trapped between the first and second closing elements, the containment bag (306) will be broken by the clips (351) when the stapler is fired. In addition or as an alternative, the containment bag (306) can be dimensioned so that when the containment bag (306) is positioned on the anvil stem (358) as shown in figure 10, the outer perimeter of the frame (306) it will extend radially outward enough to be cut by the knife (348) but not on the circular staple line. In some of these versions, the containment bag (306) may not be broken by staples, but will be broken by the knife (348) as it cuts through the joined fabric portions located radially into the staple line.
[0089] Although the containment bag (306) can be aligned on the anvil stem (358) at the appropriate location, it may also be desirable to further ensure the proper positioning of the containment bag (306). For example, a biocompatible adhesive can be applied to one or both surfaces of the containment bag (306) (for example, the opposite surfaces of the containment bag (306) that lean against the end walls of the fabric lumen (316 and 317) during use). Alternatively, or in addition, the containment bag (306) can be configured so that it can be sutured to one or both lumens of tissue (316 and 317).
[0090] Figure 8 represents another exemplary biocompatible containment bag (406) that is configured to be attached to one or both lumens of tissue through one or more fixation sutures. The containment bag (406) comprises a spiral toroid similar to the containment bag (306) in figure 7. The containment bag (406) also includes a plurality of suture flaps (414) arranged around the periphery of the containment bag (406). Each suture flap (414) includes an opening (415) extending therethrough. One or more fixation sutures can be placed through the openings (415) to secure the containment bag (406) to one or both lumens before performing an anastomosis. For example, the containment bag (406) can be attached with fixing sutures to the open end of one or both lumens of tissue before insertion of the staple end effector into the tissue lumens. Again, a biocompatible adhesive can also be provided on one or both surfaces of the containment bag (406) to further secure the containment bag (406) to the fabric lumens.
[0091] The containment bag (406) which has a fabric treatment composition contained therein can also be used to perform an anastomosis without the use of a circular stapler. For example, the containment bag (406) can be attached to one or both lumens of fabric using one or more fixation sutures and / or suitable adhesive. After that, a surgeon can then fix the open ends of the tissue lumens using, for example, a conventional suture. The containment bag (406) can be broken to release the fabric treatment composition by the suturing process (for example, by advancing the suture needle through the containment bag (406)) and / or using an implement surgical like a scalpel or claw.
[0092] Figure 9 represents an example of a package (416) for the containment bag (306 and 406). The package (416) may comprise, for example, an envelope made from opposite sheets of sealed material around its periphery. The portions of each sheet may remain unattached along at least one edge of the sheet, in order to provide opposite edges (418 and 419). The edges (418 and 419) can be used to open the package (416) by pulling the edges (418 and 419) in the opposite direction from each other to separate the opposing sheets of material. In the present example, the containment bag (406) can be positioned inside the package (416) so that the door (413), which extends away from an edge of the containment bag (406), is located between the edges (418 and 419). This configuration can allow the end user to fill the containment bag (406) with fluid before opening the package (416). The packaging (416) can be made of any of a variety of materials such as TYVEK.
[0093] As another illustrative example, the breakable containment bag (306 or 406) can be configured in a similar way to the frame (206) and includes an annular toroid-shaped portion (for example, circular or spiral) and a plurality hollow flap portions that extend radially away from the outer circumferential surface of the toroid-shaped portion. This breakable containment bag can be sized so that, after stapling and cutting between the fabric lumens, only the flap portions will remain in place between the fabric lumens.
[0094] Although the breakable containment bags (306 and 406) described and represented in the present invention are designed for use with a circular stapler, a similar type of containment bag can also be configured for use with a linear stapler, as shown and described in US Patent Nos. 5,465,895, 6,964,363, and 6,978,921. As an example, a breakable and biocompatible containment bag that has a sealable door to fill with a fabric treatment composition can be configured as a sheet that can be slid over each or both of the fabric closure elements ( for example, the stapling head and / or the anvil) so that the containment bag will be broken by being trapped between the fabric closure elements, by clips fired through it and / or by a stapler knife that cuts the bag containment. It should also be understood that a surgical stapler and a breakable containment bag can be provided to the end user as a kit that comprises the stapler and breakable containment bag for the end user to assemble these components prior to use. B. Breakable Exemplifying Compartment Located in One or Both of the First and Second Closing Elements of the End Effector of a Surgical Stapler
[0095] As an alternative to using a biocompatible breakable containment bag that can be positioned between the first and second closure elements, or in addition, a biocompatible breakable compartment for fabric treatment compositions can be provided in one or both of the first and second staple closing elements. The breakable compartment (s) can be located so that closing the fabric before stapling and / or firing the staples will perforate the compartment (s) and release the fabric treatment composition a from that.
[0096] Figures 11 and 12 represent the first and second closing elements (528 and 530) of a circular stapler. The first and second closing elements are similar in construction to those shown in figure 10, as well as in figures 1 to 4 (an empty space is missing in the column element (568) to release fluid and openings in the anvil stem (558 ) to expel fluid). In the present example of Figure 11, a biocompatible tear-away compartment (506) for reliably containing a tissue treatment composition is provided in a first closure element (528) as an annular ring-shaped compartment that extends along the distal face (555) of the clamp holder (554). Since, when the stapler is fired, the staples (551) are directed distally away from the distal face (555) of the staple holder (554), the staples (551) will be pushed through the tear-away compartment (506), thus leading the tissue treatment composition to be expelled from the compartment (506) on the staple line.
[0097] Figure 12 shows an exemplary biocompatible breakable compartment (516) for reliably containing a tissue treatment composition in the second closure element (530) as an annular ring-shaped compartment that extends from end to end of proximal end wall (557) of the anvil (556). Since, when the stapler is fired, the staples (551) are directed into staple-forming pockets (559) provided on the proximal end wall (557) of the anvil (556), the staples (551) will be pushed through the compartment breakable (516), thus leading to the tissue treatment composition to be expelled from the compartment (516) in the staple line. One or both of the breakable compartments (506 and 516) for reliably containing the tissue treatment compositions can be provided in a surgical stapler. If both compartments (506 and 516) are provided, each can contain an equal or different fabric treatment composition.
[0098] Breakable compartments (506 and 516) can be provided on the first and second closing elements (528 and 530), respectively, in a variety of ways. For example, each compartment (506 and 516) can simply comprise a biocompatible ring-shaped compartment that is adhesively joined to the indicated end surface (555 and 557) of its respective closing element (528 and 530). In the present example, the doors (513 and 523) are also supplied in breakable compartments (506 and 516), respectively, to allow the end user to fill the compartments (506 and 516) with fabric composition (s). For example, each port (513 and 523) may comprise a self-sealing structure, such as a biocompatible self-sealing septum through which tissue treatment compositions (or components thereof) can be injected using, for example, a syringe. Obviously, the ports (513 and 523) are merely optional. For example, each or both of the breakable compartments (506 and 516) can be pre-filled with medicinal fluid (s). As another illustrative example, one of the breakable compartments (506 and 516) can be supplied pre-filled with one or more fluid medical components; while the other of the breakable compartments (516 and 506) can be filled with one or more fluid medical components through the port (523 and 513), just before application inside the patient.
[0099] It should be understood that one or both breakable compartments (506 and 516) can be formed by applying one or more biocompatible polymeric films (or other similar materials) to the ends of the first and second closing elements (528 and 530). For example, the breakable compartment (506) in the first closing element (528) can be formed by adhering a first layer of polymeric film (507) on the distal end of the first closing element (528), and then adhering selectively a second layer of polymeric film (508) to portions of the first layer of polymeric film (507) so that it forms a fillable fluid space between the first and second layers of polymeric film (507 and 508) that define the compartment ( 506). The first layer of polymeric film (507) can be adhered around at least a portion of the tubular compartment (550) of the first closing element (528), as well as on the distal face (555) of the clamp holder (554) so as to cover the clamps (551) in the clamp holder (554). An inner end portion (510) of the first layer of polymeric film (507) can extend radially into the radial cylindrical knife (548), as shown. The second layer of polymeric film (508) can then be selectively adhered to at least a portion of the first layer of polymeric film (507) which is adhered to the tubular compartment (550), and to the distal end portion (510) of the first layer polymeric film (507). In the present example in Figure 11, the first and second layers of polymeric film (507 and 508) are not adhered to each other where the first layer of polymeric film (507) extends across the distal face (555) of the clamp holder (554). This non-adherent annular region between the first and second layers of polymeric film (507 and 508) thus defines the breakable compartment (506) that can be filled with a fabric treatment composition. The layers of polymeric film (507 and 508) can be adhered to various portions of the closing elements and to each other in any of a variety of ways known to those skilled in the art such as using adhesive, heat welding, and / or ultrasonic welding, etc.
[00100] The breakable compartment (516) in the second closing element (530) can be similarly formed. For example, a first layer of polymeric film (517) can be adhered to the outer surface of the anvil wrap (560), the outer circumference of the anvil (556), and the end wall (557) of the anvil (556) so to extend over staple forming pockets (559). The second polymeric layer (518) can then be selectively adhered to at least a portion of the first polymeric film layer (517) which is adhered to the outer circumference of the anvil (556), and to an outer end portion (520) of the first layer of polymeric film (517) located radially into the end wall (557) of the anvil (556). In the present example in figure 12, the first and second layers of polymeric film (517 and 518) on the second closure element (530) are not adhered to each other where the first layer of polymeric film (517) extends through the wall end (557) of the anvil (556). This non-adherent annular region between the first and second layers of polymeric film (517, and 518) thus defines the compartment (516) that can be filled with a fabric treatment composition.
[00101] It will be understood that the first and second layers of polymeric film (507 and 508) can comprise two separate films or can comprise a single continuous film which is folded to provide the first and second layers of film (507 and 508) . Similarly, the first and second layers of polymeric film (517 and 518) may comprise two separate films or may comprise a single continuous film that is folded to provide the first and second layers of film (517 and 518). As yet another illustrative example, the compartments (506 and / or 516) can be formed using a single layer of polymeric film adhered to the respective first or second closing elements (528 and 530) so that the compartment comprises a non-adherent region between the polymeric film layer and the face of the closing element (528 and 530) to which it is attached.
[00102] Polymeric film layers (507, 508, 517 and 518) can be made from any of a variety of biocompatible materials, including bioabsorbable materials, which can be formed into a film. As an example only, the film layers (507, 508, 517, 518) can be produced from polyglycololine (PGA), polylactide (PLA), polycaprolactone (PLC), polydioxanone (PDO), poly (lactide-co -glycolide) (PLGA), poly hydroxy butyrate (PHB), and / or poly hydroxy valerate (PHV). Alternatively, any other suitable material or combination of materials can be used.
[00103] Breakable compartments (506 and 516) can be filled with compositions for treating fabric using a syringe and needle. For example, the layers of polymeric film used to form the compartments (506 and 516) can be made of a self-sealing material so that a relatively small gauge needle inserted through it to fill the compartments with fluid will not rupture or otherwise affect the integrity of the compartments (506 and 516) and their ability to retain fluid therein. To provide a suitable injection site, a spacer (not shown) can be attached between the first and second layers of polymeric film in order to define a region where the first and second polymeric films are spaced from each other (for example , in locations (513 and 523) in figures 11 and 12, respectively). By providing a small region where the polymeric films are spaced from each other, a hollow injection space is provided to inject the fabric treatment composition. Alternatively, a self-sealing septum or other suitable port may be provided on the anvil (556), in communication with the compartment (506) to fill the compartment with a tissue treatment composition. Other configurations and relationships suitable for breakable compartments (506 and 516) will become apparent to those skilled in the art in view of the teachings of the present invention. C. Breakable Exemplifying Compartment Located on the End Effector of a Surgical Stapler
[00104] Yet another alternative to using a biocompatible breakable containment bag positioned in a line between the first and second closure elements, or in addition, one or more biocompatible breakable compartments for tissue treatment compositions can be provided in the end effector of a surgical stapler. The breakable compartment (s) can be located so that firing a knife to cut joined fabric will pierce the compartment (s) and release the fabric treatment composition therefrom. For example, figures 13 to 15 represent a merely illustrative example of the end effector (626) of a circular stapler. The first and second closing elements (628 and 630) are of similar construction to that shown in figure 10, as well as in figures 1 to 4 (there is no empty space in the column element (568) for the release of fluid and opening in the anvil stem (558) to expel fluid). However, a biocompatible rupture compartment (606) for reliably containing a tissue treatment composition is provided in a chamber (608) defined in the anvil (656) of the second closure element (630). The chamber (608) has an open proximal end, and is located within the set of staple forming pockets (659) that extends around the wall of the proximal end (657) of the anvil (656). The chamber (608) can be supplied in any of a variety of formats, such as the circular bowl-shaped configuration shown in figures 13 to 15, or any other suitable format. The anvil stem (658) extends through the center of the chamber (608), in a spring cavity (616) that extends distally away from the bottom of the chamber (608). Like the previous examples, the anvil (658) can be used to operationally join the second closing element (630) to a column element (668) of the first closing element (628).
[00105] The compartment (606) may comprise a flexible collapsible containment bag sized and configured to fit the chamber (608). Thus, in the present example in figures 13 to 15, the compartment (306) comprises a toroid (thread-shaped) positioned in the chamber (608), with the anvil stem (658) extending through the central opening of the toroid. Obviously, any of a variety of other formats can be employed for the compartment (606). To facilitate the release of the tissue treatment composition from the compartment (606) when the compartment is ruptured, a fluid treatment composition can be pressurized into the compartment (606). Pressurization can be provided in a variety of ways. In the present example, the compartment (606) is pressurized by spring through a pressure plate pulled proximally (610). The pressure plate (610) of this example comprises an annular disk-shaped element positioned at the bottom (i.e., distal end surface) of the chamber (608), with the anvil stem (658) extending through a central opening (611) on the pressure plate (610). The pressure plate (610), including its opening (611), is dimensioned so that the pressure plate (610) can slide in a proximal direction (towards the first closing element (628)) along of the anvil stem (658). The pressure plate (610) is spring-drawn towards the first closing element (628) by a spring (618) that extends around the distal end of the anvil stem (658) within the spring cavity (616) . Obviously, the pressure plate (610) can be pulled in any other suitable way using any other suitable features or components.
[00106] To retain the compartment (306) inside the anvil chamber (608) (656), a stationary retaining plate (612) is also provided in the present example. The retaining plate (612) comprises an annular disk-shaped element positioned on the anvil stem (658), not shown. A shoulder-shaped part (614) is provided on the anvil stem (658) so that the retaining plate (612) rests on the shoulder-shaped part (614) inside the chamber (608). The breakable compartment (306) is located inside the anvil chamber (608) between the pressure plate (610) and the retaining plate (612). The spring (608) pushes the pressure plate (610) against the housing (606).
[00107] The retaining plate (612) of the present example also includes a plurality of slits (613) extending through the thickness of the retaining plate (612) and arranged at an angle around the circumference of the adjacent plate (612) its outer periphery. As described in more detail below, the slits (613) are dimensioned and configured so that the plurality of sharp points (649) provided in the circular knife (648) of the first closing element (628) can be advanced through slits (613) ) to break the compartment (606) and release the tissue treatment composition contained therein. The fabric treatment composition will then flow through the slits (613), with the spring-drawn pressure plate (610) helping to expel the treatment composition from the ruptured compartment (606). As a merely illustrative alternative for providing slits (613) in the retaining plate (612), the retaining plate (612) can be dimensioned so that the sharp points provided in the knife (648) to break through the housing (606) can be advanced beyond the outer circumference of the retaining plate (612) and into the compartment (606). The compartment (606) can be made of any of a variety of biocompatible materials, including bioabsorbable materials, which can be formed in a sealable compartment that will not only contain the fluid but will also be tearable. As an example only, the compartment (606) can be made of polyglycololine (PGA), polylactide (PLA), polycaprolactone (PLC), polydioxanone (PDO), poly (lactide-co-glycolide) (PLGA), poly hydroxy butyrate (PHB), and / or poly hydroxy valerate (PHV). Alternatively, any other suitable material or combination of materials can be used to form the housing (606).
[00108] The cutting knife (648) can be provided in the first closing element (628) in the manner described above with respect to figures 1 to 4. To allow the knife (648) to break the compartment (606), a plurality of sharp points (649) are provided in the knife (648) so as to extend distally away from the cutting edge (655) of the knife (648). The sharp points (649) are located to be aligned with the slits (613) in the retaining plate (612) of the second closing element (630). In this way, when the stapler is fired and the knife (648) cuts through the portions of the joined fabric lumens (116 and 117) inside the staple line, the sharp points (649) on the knife (648) will pass through the slits ( 613) of the retaining plate (612) to break the compartment (606). Sharp points (649) can also be added to the cutting edge (655) of a circular knife of the type shown in figure 3. This embodiment is shown, for example, in US Patent No. 6,193,129, the description of which is incorporated herein into reference title. It should be noted that additional sharp points can be provided on the knife that is shown in US Patent No. 6,193,129, if desired, to facilitate piercing the compartment and releasing the fabric treatment composition around the entire cut and lines staple.
[00109] In the present example in figures 13 to 17, the cutting knife (648) does not only have a plurality of sharp points (649) that extend distally away from the cutting edge (655), the knife (648) also is grooved. Therefore, the cutting edge (655) is also grooved to provide a longer and more irregular cutting edge, compared to a conventional circular knife on a surgical stapler. In this way, the cutting edge (655) will crush the cut fabric into smaller pieces than the circular cutting edge shown in the knife (48) of figure 3. The resulting fabric fragments can combine with the fabric treatment composition (which can also contain viable tissue fragments) expelled from the compartment (606) to promote tissue healing and regeneration. The tissue treatment composition in the compartment (606) can also contain one or more agents (e.g., fibrin, etc.) that help to hold the tissue fragments cut by the knife (648) on the cut line. In this way, viable cells can migrate from the cut tissue fragments to the tissue surrounding the cut and staple lines.
[00110] Any of a variety of other non-circular and irregular shapes can be used for the cutting knife (648) in place of, or in addition to, the grooved arrangement shown in figures 16 to 17. For example, the cutting edge (655) of the cutting knife (648) can be configured in the shape of a star, a hexagon, an octagon, a polygon, or any other non-circular shape. In other examples, the cutting knife (648) can be configured so that a plurality of cutting edges (655) are provided, in any of a variety of one or more geometric shapes, with some of the cutting edges (655) arranged radially into the outer perimeter of the cutting knife (648). In still other examples, the cutting edge (655) can be serrated. In the present example, the sharp points (649) extend distally away from the cut line (655) in the inner fold of each groove. Obviously, the sharp points (649) can be located at any of a variety of other locations on the knife (648), so that they can be aligned with the slits (613) in the retaining plate (612). Other suitable configurations will be apparent to those elements skilled in the art in view of the teachings of the present invention.
[00111] An exemplary use of a stapler that has a breakable compartment (606) located on the end effector (626) to perform an anastomosis is shown sequentially in figures 13 to 15, in which the two lumens of tissue (116 and 117) they are joined by one or more circular sets of clamps (651). The stapler can be provided to the end user with a compartment (606) already filled with a fabric treatment composition. Alternatively, the compartment (606) can be empty or only partially filled with one or more components of the fabric treatment composition. The end user (for example, a surgeon) can then fill the compartment (606) (or add additional materials to it) by, for example, injecting material (for example, fragments of viable tissue crushed into a vehicle, etc.) through one or more slits (613) in the retaining plate (612) or in any other suitable way. The compartment (606) can be made from a self-sealing material so that a sufficiently small gauge needle inserted through it to fill the compartment with fluid will not rupture or otherwise affect the integrity of the compartment (606) and its ability to retain fluid in it. Alternatively, a self-sealing septum or other suitable port may be provided on the anvil (656), in communication with the compartment (606) to fill the compartment with a tissue treatment composition.
[00112] After the first and second closing elements (628 and 630) have been joined to each other (if provided to the end user in uneven form), the circular end effector (626) comprising the first and second closing elements of tissue (628 and 630) can be inserted into a longitudinal slit (not shown) within the first portion of intestinal tissue (116), and moved in the position shown adjacent to an open end of the tissue (116). The movable closure element (630) can be moved to the open position and the second portion of intestinal tissue (117) can be inserted above the second closure element (630), as shown in figure 13. Consequently, each portion of tissue (116 and 117) can be adjusted with a frill suture placed around the open ends of the intestinal tissue (116 and 117), as previously described.
[00113] After the ruffled threads are tied, the second movable closing element (630) is pulled toward the first closing element (628) to a position adjacent to the first closing element (628) to secure the first and second portions of intestinal tissue (116 and 117) to each other. As previously described, this can be done, for example, by rotating a closing button or using another mechanism provided in the stapler. Since the ends of the fabric lumens are trapped between the first and second closing elements (628 and 630) (for example, similar to what is shown in figure 4, with or without a frame positioned between the ends of the fabric lumens ), the circular stapling device is triggered by activating a trigger provided on a clamp cable. The ends of the staples (651) are pushed distally out of the staple holder (654), through the first portion of intestinal tissue (116), through the second portion of tissue (117), and against the staple forming pockets (659 ) of the anvil (656) to form the staples and secure the tissue portions (116 and 117) as shown in figure 14.
[00114] The knife (648) is also advanced by the staple driver (652), through the first and second portions of the intestinal tissue (116 and 117), inside the staple line. The sharp points (649) that extend distally away from the cut edge (655) of the knife (648) will pass through the slits (613) of the stationary retaining plate (612) in the anvil (656), and will pierce the compartment (606 ) as shown in figure 14. The spring-drawn pressure plate (610) will then propel the fabric treatment composition out of the compartment (606), through the slits (613). In addition, the grooved cutting edge (655) of knife (648) will cut the portions of tissue lumens (116 and 117) located between the staple line and the anvil stem (658) into small fragments. The retaining plate (612) can also act as a stop or cutting surface, against which the knife (648) will cut the fabric. To further crush the fabric fragments, the knife (648) can cut back and forth any number of times to further crush the fabric fragments into even smaller pieces. This can be accomplished, for example, by releasing the trigger from the stapler so that the cutting edge (655) of the knife (648) will be moved proximally away from the retaining plate (612), while still maintaining the closing (628 and 630) in the closed position with the stapled tissue trapped between them, and thereafter firing the stapler again so as to move the cutting edge (655) distally against the retaining plate (612). This can be repeated any number of times to crush the tissue cut into conveniently small fragments. The tissue fragments will combine with the tissue treatment composition released from the compartment (606) in the region between the first and second closure elements (628 and 630), so that the tissue treatment composition and the crushed viable tissue fragments will be applied along the tissue lumens and around the cut line to accelerate tissue healing and promote tissue regeneration. Other suitable ways in which a stapler having an end effector (626) as described above can be used will be apparent to elements skilled in the art in view of the teachings of the present invention.
[00115] Although several devices and components have been discussed in detail above, it must be understood that the components, characteristics, configurations and methods of use of the devices discussed are not limited to the contexts provided above. In particular, the components, characteristics, configurations and methods of use described in the context of one or more devices can be incorporated into any of the other devices. In addition, not limited to the additional description provided below, the appropriate, additional, and alternative components, features, configurations, and methods of using the devices, as well as various ways in which the teachings of the present invention can be combined and exchanged, will be apparent to elements skilled in the art in view of the teachings of the present invention.
[00116] Versions of the devices described above can be activated by mechanical and electromechanical means (for example, with the use of one or more electric motors, solenoids, etc.). However, other modes of operation may also be suitable including, but not limited to, hydraulic actuation, etc. Various suitable ways in which these alternative forms of actuation can be provided in a device as described above will be apparent to those skilled in the art in view of the teachings of the present invention.
[00117] The versions of the devices described above can have several types of construction. Only by way of example, can any of the devices described herein, or components thereof, be constructed of suitable metals, ceramics and plastics, or combinations thereof. In addition, although it is not necessary, the construction of the devices described here can be configured to be compatible with or optimize their use with various imaging technologies. For example, a device configured for use with RMI can be constructed from all non-ferromagnetic materials. Also, for example, when using optional imaging technologies with devices described here, certain configurations may include modifications to construction materials so that portions or the entire device can readily appear in a resulting image. Various suitable ways in which these other modifications to the construction of the devices described herein can be carried out as will be apparent to elements skilled in the art in view of the teachings of the present invention.
[00118] Versions of the devices described above may have application in conventional medical treatments and procedures conducted by a medical professional, as well as application in medical treatments and procedures assisted by robotics.
[00119] Versions of the above can be designed to be discarded after a single use, or they can be designed for use multiple times. The versions can, in either or both cases, be reconditioned for reuse after at least one use. Reconditioning can include any combination of steps to disassemble the device, followed by cleaning or replacing particular parts, and subsequent reassembly. In particular, some versions of the device can be disassembled, in any number of particular parts or parts of the device can be selectively replaced or removed in any combination. With the cleaning and / or replacement of particular parts, some versions of the device can be reassembled for subsequent use in a reconditioning facility, or by a user immediately before a surgical procedure. Those skilled in the art will understand that the reconditioning of a device can use a variety of techniques for disassembly, cleaning / replacement, and reassembly. The use of such techniques, and the resulting reconditioned device, are all within the scope of the present patent application.
[00120] Just as an example, the versions described here can be sterilized before and / or after a procedure. In a sterilization technique, the device is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and device can then be placed in a radiation field, such as gamma radiation, X-rays or high-energy electrons. , which can penetrate the container. Radiation can kill bacteria on the device and the container. The sterile device can then be stored in a sterile container for later use. The device can also be sterilized using any other known technique, including, but not limited to, beta or gamma radiation, ethylene oxide or water vapor.
[00121] In view of the presentation and description of several versions in the present disclosure, additional adaptations of the methods and systems described in this document can be made through appropriate modifications made by an element skilled in the art, without departing from the scope of the present invention. Several potential modifications have been mentioned and others will be evident to those skilled in the art. For example, the examples, versions, geometry, materials, dimensions, proportions, steps and the like discussed above are illustrative only and are not mandatory. Consequently, the scope of the present invention must be considered in accordance with the terms of the following claims and it is understood that it is not limited to the details of the structure and operation shown and described in the specification and drawings.

权利要求:
Claims (15)
[0001]
1. Surgical stapling kit for stapling tissue, comprising: (a) a stapling instrument, comprising: (i) a handle (20), (ii) a first closure element (28), in which the first closure element closure is configured to receive a plurality of clips, and (iii) a second closing element (30) opposite the first closing element, wherein the second closing element comprises an anvil to form the clips, in which one or both of the first or second closing elements (28, 30) are coupled with the cable (20), at least one of the closing elements (28, 30) is movable between an open position for receiving fabric and a closed position for stapling fabric between the closing elements; and (b) a rupture and biocompatible tissue treatment element, wherein the tissue treatment element is configured to receive and retain a tissue treatment composition comprising a medicinal fluid, wherein the tissue treatment element is further configured to be positioned between the first and second closure elements (28, 30) so that when the fabric is attached and stapled between the closure elements, the fabric treatment element releases at least a portion of the fluid treatment composition of fabric retained by the fabric treatment element in which the stapling instrument comprises a circular stapler (20, 320), in which the first closure element (28) is configured to receive a plurality of staples in at least one circular matrix, in which the stapling instrument also comprises an elongated axis (58, 358) that extends between the first and the second closing element, and in which the element The fabric treatment element is configured to be slidable on the axis, where the fabric treatment element comprises a toroid sized so that when the fabric treatment element is positioned on the axis and the fabric is fastened and stapled between the fabric elements. closing, the fabric treatment element will be broken by the clips; characterized by the fact that the toroid (306, 406) is a spiral toroid (306, 406) that defines a central opening (308, 408) configured to receive the axis.
[0002]
2. Surgical stapling kit, according to claim 1, characterized by the fact that the fabric treatment element comprises a breakable containment bag (306, 406).
[0003]
3. Surgical stapling kit according to claim 2, characterized in that the containment bag (306) includes a self-sealing port (313) for adding one or more medicinal fluids to the containment bag.
[0004]
4. Surgical stapling kit, according to claim 1, characterized by the fact that a biocompatible adhesive is provided on one or both surfaces of the tissue treatment element, so that the tissue treatment element can be attached to the fabric before the tissue treatment element is positioned in line with the first and second closure elements (28, 30) of the stapling instrument.
[0005]
5. Kit for surgical stapling, according to claim 1, characterized by the fact that the stapling instrument still comprises a knife (48) that is movable in a functional way between the first and second closing elements (28, 30), in which when the fabric is secured and stapled between the first and second closure elements (28, 30), the knife (48) passes through the fabric and the fabric treatment element.
[0006]
6. Surgical kit according to claim 1, characterized by the fact that the tissue treatment element is supplied in a sealed package (416) separate from the stapling instrument and is positioned between the first and second closing elements (28 , 30) after receiving a tissue treatment composition.
[0007]
7. Surgical kit according to claim 1, characterized in that the tissue treatment element is generally disk-shaped and includes a plurality of flaps (414) extending radially outwardly.
[0008]
Surgical kit according to claim 1, characterized in that the tissue treatment element contains at least one tissue cell configured to form a sphincter, wherein the tissue treatment element comprises a plurality of fibers arranged in a pattern selected from the group consisting of concentric circles, spirals, or spheres (120, 130, 140).
[0009]
9. Surgical kit according to claim 1, characterized by the fact that it also comprises: a reservoir (34) for storing a tissue treatment composition; and a fluid conduit (94) configured to distribute the tissue treatment composition of the reservoir (34) to a location between the first and the second closure elements (28, 30).
[0010]
10. Surgical kit, according to claim 9, characterized by the fact that the reservoir (34) is positioned within the portion of the cable (22).
[0011]
Surgical kit according to claim 9 or 10, characterized in that the fluid conduit comprises a first fluid passage (94) extending from the reservoir (34) and a second fluid passage (98, 62 ) within said elongated axis (58, 358), wherein the first fluid passage (94) is selectively in fluid communication with the second fluid passage (98, 62) to selectively deliver the reservoir tissue treatment composition ( 34) to a location between the first and second closing elements.
[0012]
12. Surgical kit, according to claim 11, characterized by the fact that the first fluid passage is in communication with the second fluid passage when at least one of the closing elements is moved to its closed position and in which the first passage of fluid is out of communication with the second passage when at least one of the closing elements is moved to its open position.
[0013]
Surgical kit according to any one of claims 9 to 12, characterized in that the reservoir (34) comprises an entrance port (36) configured to receive a tissue treatment composition.
[0014]
Surgical kit according to any of claims 9 to 13, characterized in that the reservoir (34) comprises a piston (40) operable to expel the tissue treatment composition from the reservoir (34) through the conduit fluid (94).
[0015]
15. Surgical kit, according to claim 14, characterized by the fact that it comprises a slider (42) outside the cable portion (22), in which the slider (42) is fixed to the piston (40) through an elongated slot (43) in the cable portion (22) and is operable to selectively drive the piston (40) to expel a tissue treatment composition from the reservoir.

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同族专利:

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公开号 | 公开日

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US20110282446A1|2011-11-17|

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US8646674B2|2014-02-11|

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AU2011251987B2|2013-10-10|

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WO2011143183A2|2011-11-17|

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CA2799195C|2018-05-22|

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EP2568887A2|2013-03-20|

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CN102892361B|2016-04-06|

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BR112012028867A2|2016-07-26|

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CA2799195A1|2011-11-17|

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EP2568887B1|2014-04-16|

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AU2011251987A1|2012-11-15|

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JP5797746B2|2015-10-21|

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JP2013526341A|2013-06-24|

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PL2568887T3|2014-09-30|

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WO2011143183A3|2012-01-05|

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CN102892361A|2013-01-23|

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法律状态:
2018-12-26| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|

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2019-08-13| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|

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2020-02-27| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application according art. 36 industrial patent law|

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2020-06-23| B09A| Decision: intention to grant|

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2020-09-29| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 10/05/2011, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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US12/777,424|2010-05-11|

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US12/777,424|US8646674B2|2010-05-11|2010-05-11|Methods and apparatus for delivering tissue treatment compositions to stapled tissue|

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PCT/US2011/035876|WO2011143183A2|2010-05-11|2011-05-10|Methods and apparatus for delivering tissue treatment compositions to stapled tissue|

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