WO2014123747A1 - Agrafeuse chirurgicale incurvée - Google Patents

Agrafeuse chirurgicale incurvée Download PDF

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Publication number
WO2014123747A1
WO2014123747A1 PCT/US2014/013825 US2014013825W WO2014123747A1 WO 2014123747 A1 WO2014123747 A1 WO 2014123747A1 US 2014013825 W US2014013825 W US 2014013825W WO 2014123747 A1 WO2014123747 A1 WO 2014123747A1
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WIPO (PCT)
Prior art keywords
instrument
handle portion
curved
blade
stapling head
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PCT/US2014/013825
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English (en)
Inventor
Philip A. LINDEN
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University Hospitals Cleveland Medical Center
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Publication of WO2014123747A1 publication Critical patent/WO2014123747A1/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B17/07207Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously the staples being applied sequentially
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743Type of operation; Specification of treatment sites
    • A61B2017/00809Lung operations
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00946Material properties malleable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00955Material properties thermoplastic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214Stapler heads
    • A61B2017/07221Stapler heads curved

Definitions

  • the present invention relates, in general, to curved surgical stapling instruments for applying surgical staples to tissue and tissue resection and, more particularly, to a circular angled surgical stapling instrument having an design aimed at the resection of spherical tumors.
  • Surgical devices wherein tissue is first grasped or clamped between opposing jaw structure and then joined by means of surgical fasteners are well known in the art.
  • a knife is provided to cut the tissue, which has been joined by the fasteners.
  • the fasteners are typically in the form of surgical staples however, two part polymeric fasteners are also utilized.
  • Instruments for this purpose can comprise two elongated members, which are respectively used to capture or clamp tissue.
  • one of the members carries a cartridge, which houses a plurality of staples arranged in at least two lateral rows while the other member comprises an anvil, which defines a surface for forming the staple legs as the fasteners are driven from the cartridge.
  • this member carries the mating part, e.g. the receiver, to the fasteners driven from the cartridge.
  • a pusher that travels longitudinally through the cartridge carrying member, with the pusher acting upon the staples to sequentially eject them from the cartridge, affects the stapling operation.
  • a knife may travel with the pusher between the staple rows to longitudinally cut and/or open the stapled tissue between the rows of staples.
  • Such instruments are disclosed in U.S. Pat. Nos. 3,079,606 [1] and 3,490,675 [2].
  • a later stapler disclosed in U.S. Pat. No. 3,499,591 [3] applies a double row of staples on each side of the incision. This is accomplished by providing a cartridge assembly in which a cam member moves through an elongate guide path between two sets of staggered staple carrying grooves. Staple drive members are located within the grooves and are positioned in such a manner to be contacted by the longitudinally moving cam to effect ejection of the staples.
  • Other examples of staplers are disclosed in U.S. Pat. Nos. 4,429,695 [4], 5,065,929 [5], and 5,156,614 [6].
  • linear stapling devices Many of the prior art linear stapling devices discussed above include are linear stapling devices and as such have limitations as to the effectiveness when dealing with anatomical features encountered the in body. Additionally, being linear, multiple applications of stapling or cutting may be needed to accomplish the desired result, which can significantly increase the difficulty and length of the surgical procedure and risk to the patient.
  • One particular procedure that this concern is relevant to is lung resection and tumor removal.
  • Lung resection is the surgical removal of all or part of the lung, due to lung cancer or other lung disease. Surgery can provide a cure in some cancer cases, when the tumor is discovered early.
  • a physician will recommend one of the following types of resection, depending on the diagnosis. In the case of cancer, the type of resection will be based on the tumor location, size, and type, as well as the overall health and lung function prior to diagnosis. The type of lung resection used will depend on the location and size of the tumor, and the ability of the remaining lung tissue to compensate for breathing after surgery. Nearly 40% of lung cancers are adenocarcinoma, which usually originates in peripheral lung tissue [7].
  • the present invention relates, in general, to curved surgical stapling instruments for applying surgical staples to tissue and tissue resection and, more particularly, to a circular angled surgical stapling instrument having an design aimed at the resection of spherical tumors.
  • the invention relates to a surgical instrument, comprising: a) a curved first handle portion comprising a hinge, wherein said hinge connects said first handle portion and a second handle portion, wherein said second handle portion comprises a sickle shaped shaft; b) a stapling head array attached to said curved first handle portion shaped shaft; c) an anvil attached to said sickle shaped shaft, wherein said anvil is aligned to said stapling head, and d) a blade located within said stapling head array.
  • the invention further comprises a firing trigger connected to said curved first handle portion.
  • the invention further comprises a sliding trigger connected to said curved first handle portion.
  • said stapling head array further comprises a plurality of staple slots.
  • said blade is operably coupled to said sliding trigger.
  • the invention further comprises gently curved tips.
  • said curved first handle portion is question mark shaped.
  • said blade is circular.
  • said blade is linear.
  • said instrument comprises a diameter of less than 2 centimeters. In one embodiment, said instrument conforms to a spherical shape.
  • the invention relates to a surgical instrument, comprising: a) a curved first handle portion comprising a hinge, wherein said hinge connects said first handle portion and a second handle portion, wherein said second handle portion comprises a sickle shaped shaft; b) a stapling head array attached to said curved first handle portion shaped shaft wherein said stapling head comprises two rows of staple slots; c) an anvil attached to said sickle shaped shaft, wherein said anvil is aligned to said stapling head, and d) a blade located within said stapling head array between said stapling arrays.
  • the invention further comprises a firing trigger connected to said curved first handle portion.
  • the invention further comprises a sliding trigger connected to said curved first handle portion.
  • said stapling head array further comprises two rows of a plurality of staple slots.
  • said blade is operably coupled to said sliding trigger.
  • the invention further comprises gently curved tips.
  • said curved first handle portion is question mark shaped.
  • said blade is circular.
  • said blade is linear.
  • said instrument comprises a diameter of less than 2 centimeters. In one embodiment, said instrument conforms to a spherical shape.
  • the invention relates to a method for stapling and cutting tissue comprising the steps of: a) providing a stapling and cutting instrument having: i) a curved first handle portion comprising a hinge, wherein said hinge connects said first handle portion and a second handle portion, wherein said second handle portion comprises a sickle shaped shaft; ii) a stapling head array attached to said curved first handle portion shaped shaft; iii) an anvil comprising staple forming pockets attached to said sickle shaped shaft, wherein said anvil is aligned to said stapling head, and iv) a blade located within said stapling head array; b) clamping tissue between said anvil assembly and said head assembly; c) forming said array of staples against said staple forming pockets and; d) penetrating and severing said tissue with said blade.
  • said instrument has gently curved or soft tips.
  • the instrument further comprises a firing trigger connected to said curved first handle portion.
  • the instrument further comprises a sliding trigger comiected to said curved first handle portion.
  • said stapling head array further comprises a plurality of staple slots.
  • said blade is operably coupled to said sliding trigger.
  • the instrument further comprises gently curved tips.
  • said curved first handle portion is question mark shaped.
  • said instrument comprises a diameter of less than 2 centimeters.
  • said instrument confomis to a spherical shape.
  • said blade is circular, hi one embodiment, said blade is linear.
  • said tissue is a lung tumor. In one embodiment, said tissue is a peripheral lung tumor.
  • the gently curved stapler is ideal for thoracoscopic or VATS surgery.
  • said stapler is capable of fitting through a narrow (for example two centimeters) opening and can be maneuvered through the rigid bony skeleton of the chest.
  • a shorter curved version would also be very useful for maneuvering around the branches of the pulmonary artery and veins in the chest, again through the bony skeleton.
  • said stapler has a soft curved tip.
  • said stapler is used for severing and stapling of the superior pulmonary vein, shown performed by a standard stapler that may preferentially be done with an embodiment of the current invention.
  • a shorter curved version of the instrument would also be very useful for maneuvering around the branches of the pulmonary artery and veins in the chest, through the bony skeleton.
  • a small curved circular stapler provides the advantage of positioning within small opening compared to linear staplers.
  • additional advantages of using small curved circular stapler compared to a linear stapler include less chest wall bleeding, less pain, and faster recovery.
  • the device 1 has several parts including a curved first handle portion 2 comprising a hinge 3, wherein said hinge 3 connects said first handle portion 2 and a second handle portion, wherein said second handle portion comprises a sickle shaped shaft 6; b) a stapling head array 9 located in the inside face of said curved first handle portion shaped shaft 4 to near the tip of curved first handle portion shaped shaft 5; c) an anvil located in the inside face of said sickle shaped shaft of said second handle portion 6 and to near the tip of curved second handle portion shaped shaft 7, wherein said anvil is aligned to said stapling head, and d) a blade 10 located within said stapling head array 9.
  • the stapling head array 9 further comprises a cutting blade within said stapling head array, hi one embodiment, the invention further comprises a firing trigger connected to said curved first handle portion 2.
  • the curved first handle portion 2 is question mark shaped.
  • the instrument conforms to a spherical shape.
  • the tips of the device (5 and 7) comprise blunt tips.
  • the tips of the device (5 and 7) comprise gentle curved tips.
  • surgical stapler device 1 comprises set of jaws 11 wherein said inside face of said curved first handle portion shaped shaft 4 and the inside face of said sickle shaped shaft of said second handle portion 6 meet when the device 1 is closed or is closed with tissue between said faces.
  • the device is designed with a small diameter (40mm inside curve) with 150° blade and dual row staples. In one embodiment, the device is designed with a small diameter (40mm inside curve) with 150° blade and single row staples. In one embodiment, the device is designed with a small diameter (40mm inside curve) with 180° blade and dual row staples. In one embodiment, the device is designed with a small diameter (40mni inside curve) with 180° blade and single row staples. In one embodiment, the device is designed with a small diameter (40mm inside curve) with 220° blade and dual row staples. In one embodiment, the device is designed with a small diameter (40mm inside curve) with 220° blade and single row staples.
  • the device is designed with a large diameter (60mm inside curve) with 150° blade and dual row staples. In one embodiment, the device is designed with a large diameter (60mm inside curve) with 150° blade and single row staples. In one embodiment, the device is designed with a large diameter (60mm inside curve) with 180° blade and dual row staples. In one embodiment, the device is designed with a large diameter (60mm inside curve) with 180° blade and single row staples. In one embodiment, the device is designed with a large diameter (60mm inside curve) with 220° blade and dual row staples. In one embodiment, the device is designed with a large diameter (60mm inside curve) with 220° blade and single row staples.
  • each staple 12 comprises a single piece of a bio-compatible, resilient thermoplastic material having a base member 15 and two substantially parallel legs 16 extending perpendicular from the base member to sharp ends 17 for allowing the legs to pierce body tissue.
  • the staples 12 may be made from a bio-compatible, resilient thermoplastic material that is also bio-absorbable. As shown, the staples 12 extend longitudinally within the lower jaw 13 and are formed together with removable tangs 18 between each staple.
  • the lower jaw 13 includes an ejector system for ejecting the staples 12 from the lower jaw, through layers of body tissue 20 and against the upper jaw 14.
  • the one embodiment of the system includes a platform 21 for ejecting the staples 12 upon being moved towards the upper jaw 14, cams 22 for moving the platform towards the upper jaw uponbeing rotated, and an ejection bar 23 for rotating the cams upon being longitudinally moved within the lower jaw 13.
  • the ejection bar 23 has teeth 24 on a top surface thereof that engage teeth 25 on the rotatable cams 22, such that as the ejection bar is longitudinally moved towards a distal end of the lower jaw 13, the cams are rotated counter-clockwise to raise the staple ejection platform 21.
  • the ejection bar 23 is longitudinally moved by one of the triggers on the proximal end of the first handle portion of the stapler.
  • the upper jaw 14 includes longitudinal chambers 26, and the plurality of recesses 27 for receiving and forming the ends 17 of the ejected staples 12 communicate with the chambers.
  • the longitudinal chambers 26 receive elongated ultrasonic horns 28, while the recesses 27 receive ultrasonic anvils 29.
  • the anvils 29 and the walls of the recesses 27 receive and guide the ends 17 of the ejected staples 12, such that the ends overlap between the anvil 29 and the horn 28 after passing through the layers of body tissue 20, as shown in Figure 12.
  • lung tumor is used throughout the specification to describe both benign and malignant growths of tissue in or on the lung organ. These include, but are not limited to: Benign tumors: Adenoma, Benign metastasizing leiomyoma, Clear cell (sugar) tumor, Diffuse pulmonary lymphangiomatosis, Granular cell tumor, Hamartoma, Multiple pulmonary leiomyomatous hamartomas, Hemangioma, Hemangiomatosis, Inflammatory pseudotumor, Langerhans cell histiocytosis, Leiomyoma, Lipoma, Lymphangiomyomatosis, Micronodular pneumocyte hyperplasia, Paraganglioma, Sclerosing hemangioma, Solitary fibrous tumor, and Squamous papilloma; Dysplasia/carcinoma in situ: Dysplasia-general, Bronchioalveolar atypical adenomatous hyperp
  • mesothelioma Adenoid cystic carcinoma, Adenosquamous carcinoma, Bronchioloalveolar carcinoma, Epithelial-myoepithelial carcinoma, Giant cell carcinoma, Large cell undifferentiated carcinoma, Large cell neuroendocrine carcinoma, Lymphoepithelioma-like carcinoma, Metastastic tumors to lung, Metastatic endometrial stromal sarcoma, Micropapillary adenocarcinoma, Mucoepidermoid carcinoma, Pleomorphic carcinoma, Pulmonary blastoma, Sebaceous carcinoma, Small cell carcinoma, Spindle cell carcinoma, Squamous cell carcinoma, Early lung carcinoma of hilar type, and Early squamous cell carcinoma of peripheral type; Carcinoid and related tumors: Carcinoid tumor, Central carcinoid tumor, Peripheral carcinoid tumor, Atypical carcinoid tumor, and Tumorlet; Lymphoma and lymphoid infiltrates: BALT lymphoma,
  • peripheral lung tumor is used throughout the specification to describe
  • lung resection is used throughout the specification to describe the removal of part of a lung tissue.
  • Wedge resection or segmentectomy is used throughout the specification to describe the removal of an area of lung smaller than a lobe, usually the tumor and a small area of healthy lung tissue around it. This is a treatment used for early-stage cancer and sometimes to remove a piece of lung where cancer is suspected but not proven.
  • VATS video-assisted thoracoscopic surgery
  • VATS video-assisted thoracoscopic surgery
  • the surgeon is able to view the instruments that are being used along with the anatomy on which the surgeon is operating.
  • the camera and instruments are inserted through separate holes in the chest wall also known as "ports".
  • these small ports may be advantageous because the chance for infection and wound dehiscence could be drastically reduced. This allows for a faster recovery by the patient and a greater chance for the wound to heal.
  • these small ports may be advantageous in reducing chest wall bleeding, reducing pain, and consequently lead to a faster recovery.
  • VATS Video-assisted
  • lobectomy is used throughout the specification to describe a lobectomy using video-assisted thoracic surgery.
  • a minimally invasive approach called VATS (video-assisted thoracic surgery).
  • VATS video-assisted thoracic surgery
  • several tiny incisions are made in the chest through which the surgeon inserts instruments as well as a small video camera that projects images onto a computer monitor.
  • the surgeon uses the images from the computer monitor as a guide during surgery. It may be possible to perform any of the resections (wedge, segmentectomy, lobectomy, pneumonectomy) described above.
  • the term "effective,” as that term is used in the specification and/or claims, means adequate to accomplish a desired, or hoped for result.
  • the term "patient” or “subject” refers to a living mammalian organism, such as a human, monkey, cow, sheep, goat, dog, cat, mouse, rat, guinea pig, or transgenic species thereof In certain embodiments, the patient or subject is a primate. Non-limiting examples of human subjects are adults, juveniles, infants and fetuses.
  • Prevention includes: (1) inhibiting the onset of a disease in a subject or patient which may be at risk and/or predisposed to the disease but does not yet experience or display any or all of the pathology or symptomatology of the disease, and/or (2) slowing the onset of the pathology or symptomatology of a disease in a subject or patient which may be at risk and/or predisposed to the disease but does not yet experience or display any or all of the pathology or symptomatology of the disease.
  • the terms “treat” and “treating” are not limited to the case where the subject (e.g. patient) is cured and the disease is eradicated. Rather, the present invention also contemplates treatment that merely reduces symptoms, improves (to some degree) and/or delays disease progression. It is not intended that the present invention be limited to instances wherein a disease or affliction is cured. It is sufficient that symptoms are reduced.
  • Subject refers to any mammal, preferably a human patient, livestock, or domestic pet. DESCRIPTION OF THE FIGURES
  • Figure 1 shows one embodiment of the present invention.
  • the device 1 has several parts including a curved first handle portion 2 comprising a hinge 3, wherein said hinge 3 connects said first handle portion 2 and a second handle portion, wherein said second handle portion comprises a sickle shaped shaft 6; b) a stapling head array 9 located in the inside face of said curved first handle portion shaped shaft 4 to near the tip of curved first handle portion shaped shaft 5; c) an anvil located in the inside face of said sickle shaped shaft of said second hand portion 6 and to near the tip of curved second handle portion shaped shaft 7, wherein said anvil is aligned to said stapling head, and d) a blade 10 located within said stapling head array 9.
  • the stapling head array 9 further comprises a cutting blade within said stapling head array.
  • the invention further comprises a firing trigger connected to said curved first handle portion 2.
  • the curved first handle portion 2 is question mark shaped.
  • the instrument conforms to a spherical shape.
  • the tips of the device (5 and 7) comprise blunt tips. In a preferred embodiment, the tips of the device (5 and 7) comprise gentle curved tips.
  • Figure 2 shows the articulation of one embodiment of the curved stapler with a tissue sample with a central 1cm tumor.
  • the stapler effectively, upon two applications, provides margins for a 5 cm diameter tissue resection, effectively stapling and cutting for the removal of the tissues.
  • Figure 3 shows the articulation of one embodiment of the curved stapler with a tissue sample with a central 2cm tumor.
  • the stapler effectively, upon three applications, provides margins for approximately 6cm diameter tissue resection, effectively stapling and cutting for the removal of the tissues.
  • Figure 4 shows a tip detail with the stapler in a closed position in the process of removing a 6 cm tissue sample surrounding a 2 cm tumor.
  • Figure 5 shows a tip detail with the stapler in an open position in the process of removing a 6 cm tissue sample surrounding a 2 cm tumor.
  • Figure 6 shows a close-up open position view of the stapling/cutting array 9 with the blade recessed, with 6 rows of staples (3 pass device) and a view with the blade 10 exposed.
  • Figure 7 shows the carrier component displaying the curve detail for medium tissue sample (approximately 6 cm). This involves six rows of staples and a cutting track for multiple cuts.
  • Figure 8 shows the hammer component 8 displaying the curve detail for medium tissue sample (for example approximately 6 centimeters). Seen are the six rows of staple deforming features.
  • Figure 9 shows one version of the curves stapler wherein the curve of the stapler is gentler. In this version, more passes may need to be made to provide the same margins about a tumor, however, the gentler curve may allow for increased flexibility within the chest cavity.
  • the tips (5 and 7) of the device 1 comprise gentle curved tips.
  • Figure 10 shows an underside view of the device creating margins about a tumor.
  • the tips (5 and 7) of the device 1 comprise gentle curved tips
  • Figure 11 is a further enlarged side sectional view of one embodiment of a portion of the jaws 11 of the surgical stapler of Figure 1, showing the jaws in a closed position clamping two layers of body tissue to be joined.
  • Figure 12 is the side sectional view of the portion of the jaws 11 of the surgical stapler of Figure 1, showing the jaws in a closed position driving staples through the two layers of body tissue.
  • Figure 13 shows an illustration of one embodiment of the device articulated around a peripheral lung tumor, first pass.
  • Figure 14A&B shows an illustration of one procedure, severing and stapling of the superior pulmonary vein, shown performed by a standard stapler Figure 14A that may preferentially be done with an embodiment of the current invention, Figure 14B.
  • a shorter curved version of the instrument would also be very useful for maneuvering around the branches of the pulmonary artery and veins in the chest, through the bony skeleton for example in Figure 14B.
  • the reference does not describe any cutting action of the surgical stapler.
  • the reference also does not describe the curved shape stapler design of the present invention.
  • the current invention describes a curved (i.e. question mark shaped) surgical stapler designed for resection of peripheral lung tumors.
  • a figure of the device is shown in Figure 1.
  • Various surgical staplers as either linear or round are currently available. Linear staplers are poorly designed for peripheral lung tumor resection. A wide margin is paramount when resecting a lung tumor that may not be visible or easily palpable, even with video assisted surgery. Repeat applications of a linear stapler can lead to inadequate (or even positive) margins.
  • the present invention is a stapler that is curved such that it fits through a small (2 cm) thoracoscopy incision, and conforms to the typical spherical shape of a lung tumor.
  • an appropriately sized stapler of this design is able to encompass up to one-half of the circumference of the tumor with the first fired release of staples.
  • the curved shape allows for more even and reliable margins to be obtained on nonlinear (i.e. spherical) tumors.
  • the curved or question mark design would require just two applications to completely encompass and remove the lesion. Fewer stapler applications would lessen the risk of poor lung healing and the incidence of prolonged air leaks.
  • the surgical stapler has parallel rows of staples with a slot for a cutting means to travel between the rows of staples.
  • This type of surgical stapler minimizes bleeding by applying the outside rows of staples to layers of surrounding tissue as the cutting means pierces through the tissue in between the staples.
  • the stapler includes a hinge and a cutting knife capable of cutting between two separate rows of staple.
  • a stapler designed specifically for lung resection may cut on the specimen side only, allowing for increased ease of indicating the cut edge of the specimen for margin assessment by pathology.
  • the use of malleable materials in the stapler allows for conformation of the stapler to suit the size and shape of individual tumors.
  • Such a stapler would better allow for larger and even margins when resecting a spherical tumor.
  • a gently curved stapler may allow for greater flexibility and maneuverability in the chest when passing a long stapler through the rigid bony skeleton of the chest.
  • Such a gentle curved design when applied to vascular height (for example 2.5 millimeters) staplers, may also allow for an easier passage around the pulmonary artery and vein branches as required during lung lobectomy.
  • using such a stapler in a thoracoscopic surgery may reduce chest wall bleeding, reduce pain, and result in a shorter recovery from surgery.
  • Linear staplers are currently used for peripheral lung tumor resection, but are poorly designed for such a task. Paramount to lung tumor resection is obtaining wide margins on a tumor that may not be visible and may not be easily palpable. Repeat applications of a linear stapler can lead to inadequate or positive margins.
  • the concept of the current invention is a stapler that is curved, with several possible configurations ranging from a half circle to a question mark to a relaxed curved shape, with several different sizes.
  • a stapler would fit through a small, 2cm, thoracoscopy incision, and would conform to the typical, spherical shape of a lung tumor. If the stapler is appropriately sized, up to one-half of the circumferences of the tumor could be encompassed with the first fire.
  • the curved shape would allow for more even and reliable margins when dealing with a spherical tumor.
  • a curved or question mark shaped design would, in theory, require just two application of the stapler to completely encompass and remove the lesion. Fewer applications of the stapler lessen the risk of poor lung healing and would likely lessen the incidence of prolonged air leak.
  • Different sized staplers would be available to accommodate different sized lung tumors. It is envisioned that, in one embodiment, the smallest tumor would be up to 2cm in diameter, such as the example shown in Figure 2. Studies have shown that localized "wedge" resection (as opposed to a formal lobectomy involving dissection and division of individual lobar blood vessels and bronchi) may be adequate therapy for such small, peripheral lesions. Ideal margins would be 2cm for such tumors. In one embodiment, a smaller sized stapler (such as in Figure 2) would be used which might accommodate tumors up to .5-4cm in diameter.
  • a larger sized stapler (such as in Figure 3) would be used which might accommodate tumors up to 4-5cm in diameter, though these staplers would likely not encompass 180 degrees around the tumor, but would rather be gentle curves which would allow for more reliable margins around a spherical lung tumor.
  • the stapler would accommodate staples that are in the thickness range of 4-5.5 mm in height, and may also contain a cutting knife.
  • the knife may cut between two separate rows of staplers, or, if designed specifically for lung resection, may cut on the specimen side only, allowing for increased ease of inking the cut edge of the specimen to allow for more accurate margin assessment by pathology.
  • each staple 12 comprises a single piece of a bio-compatible, resilient thermoplastic material having a base member 15 and two substantially parallel legs 16 extending perpendicular from the base member to sharp ends 17 for allowing the legs to pierce body tissue.
  • the staples 12 may be made from a bio-compatible, resilient thermoplastic material that is also bio-absorbable. As shown, the staples 12 extend longitudinally within the lower jaw 13 and are formed together with removable tangs 18 between each staple.
  • the lower jaw 13 includes an ejector system for ejecting the staples 12 from the lower jaw, through layers of body tissue 20 and against the upper jaw 14.
  • the one embodiment of the system includes a platform 21 for ejecting the staples 12 upon being moved towards the upper jaw 14, cams 22 for moving the platform towards the upper jaw upon being rotated, and an ejection bar 23 for rotating the cams upon being longitudinally moved within the lower jaw 13.
  • the ejection bar 23 has teeth 24 on a top surface thereof that engage teeth 25 on the rotatable cams 22, such that as the ejection bar is longitudinally moved towards a distal end of the lower jaw 13, the cams are rotated counter-clockwise to raise the staple ejection platform 21.
  • the ejection bar 23 is longitudinally moved by one of the triggers on the proximal end of the first handle portion of the stapler.
  • the upper jaw 14 includes longitudinal chambers 26, and the plurality of recesses 27 for receiving and forming the ends 17 of the ejected staples 12 communicate with the chambers.
  • the longitudinal chambers 26 receive elongated ultrasonic horns 28, while the recesses 27 receive ultrasonic anvils 29.
  • the anvils 29 and the walls of the recesses 27 receive and guide the ends 17 of the ejected staples 12, such that the ends overlap between the anvil 29 and the horn 28 after passing through the layers of body tissue 20, as shown in Figure 12.
  • the gently curved stapler is ideal for thoracoscopic or VATS surgery (Video-assisted thoracoscopic surgery).
  • said stapler is capable of fitting through a narrow (2 cm) opening and can be maneuvered through the rigid bony skeleton of the chest.
  • a shorter curved version would also be very useful for maneuvering around the branches of the pulmonary artery and veins in the chest, again through the bony skeleton.
  • Figure 9 shows one version of the curves stapler wherein the curve of the stapler is gentler. In this version, more passes may need to be made to provide the same margins about a tumor, however, the gentler curve may allow for increased flexibility within the chest cavity.
  • Figure 14 shows an illustration of one procedure, severing and stapling of the superior pulmonary vein, shown performed by a standard stapler that may preferentially be done with an embodiment of the current invention.
  • a shorter curved version of the instrument would also be very useful for maneuvering around the branches of the pulmonary artery and veins in the chest, through the bony skeleton.
  • a small curved circular stapler provides the advantage of positioning within small opening compared to linear staplers. Additional advantages include less chest wall bleeding, less pain, and faster recovery.
  • Bittner, J. R. et al. "Cutting blade for a surgical anastomosis stapling instrument," United States Patent 6,193,129, Application 09/490,855, filed 1/24/2000. (issued 2/27/2001).
  • Hur, Y.-s. “Circular surgical stapler with a detachable anvil,” United States Patent 7,401,722, Application 10/553,002, filed 4/9/2004. (issued 7/22/2008).

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  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

La présente invention concerne, d'une manière générale, des instruments d'agrafage chirurgicaux incurvés pour appliquer des agrafes chirurgicales à un tissu et une résection de tissu, et, plus particulièrement, un instrument d'agrafage chirurgical incliné circulaire ayant une conception prévue pour la résection de tumeurs sphériques.
PCT/US2014/013825 2013-02-07 2014-01-30 Agrafeuse chirurgicale incurvée WO2014123747A1 (fr)

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US201361762157P 2013-02-07 2013-02-07
US61/762,157 2013-02-07

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WO2014123747A1 true WO2014123747A1 (fr) 2014-08-14

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5569285A (en) * 1994-11-02 1996-10-29 Webb; Nicholas J. Scalpel with rotary depth guard
US5653373A (en) * 1990-09-17 1997-08-05 United States Surgical Corporation Arcuate apparatus for applying two-part surgical fasteners
US20020120266A1 (en) * 2001-02-24 2002-08-29 Csaba Truckai Electrosurgical working end for transecting and sealing tissue
US20040215188A1 (en) * 1997-07-29 2004-10-28 Medtronic, Inc. Tissue sealing electrosurgery device and methods of sealing tissue
US20080169330A1 (en) * 2007-01-11 2008-07-17 Shelton Frederick E Surgical stapling device with a curved end effector
US20100072258A1 (en) * 2008-09-23 2010-03-25 David Farascioni Surgical Instrument And Loading Unit For Use Therewith
US20110089221A1 (en) * 2009-10-21 2011-04-21 Masiakos Peter T Apparatus and Method For Preserving A Tissue Margin

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5653373A (en) * 1990-09-17 1997-08-05 United States Surgical Corporation Arcuate apparatus for applying two-part surgical fasteners
US5569285A (en) * 1994-11-02 1996-10-29 Webb; Nicholas J. Scalpel with rotary depth guard
US20040215188A1 (en) * 1997-07-29 2004-10-28 Medtronic, Inc. Tissue sealing electrosurgery device and methods of sealing tissue
US20020120266A1 (en) * 2001-02-24 2002-08-29 Csaba Truckai Electrosurgical working end for transecting and sealing tissue
US20080169330A1 (en) * 2007-01-11 2008-07-17 Shelton Frederick E Surgical stapling device with a curved end effector
US20100072258A1 (en) * 2008-09-23 2010-03-25 David Farascioni Surgical Instrument And Loading Unit For Use Therewith
US20110089221A1 (en) * 2009-10-21 2011-04-21 Masiakos Peter T Apparatus and Method For Preserving A Tissue Margin

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