WO2014123747A1

WO2014123747A1 - Curved surgical stapler

Info

Publication number: WO2014123747A1
Application number: PCT/US2014/013825
Authority: WO
Inventors: Philip A. LINDEN
Original assignee: University Hospitals Cleveland Medical Center
Priority date: 2013-02-07
Filing date: 2014-01-30
Publication date: 2014-08-14

Abstract

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.

Description

CURVED SURGICAL STAPLER

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit of U.S. Provisional Patent Application No. 611162, 157, filed on. February 7, 2013, which is incorporated herein by reference.

FIELD OF THE INVENTION

BACKGROUND OF THE INVENTION

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. In some instruments, 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. Typically, 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. Where two part fasteners are used, this member carries the mating part, e.g. the receiver, to the fasteners driven from the cartridge. Generally, 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].

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]. In patients with poor lung function, often a limited, "wedge" resection of tumor and a small amount of adjacent lung is possible; removal of a full lobe of lung would leave the patient short of breath. In this instance, a wide margin is paramount. Using current techniques of minimally invasive, thoracoscopic surgery the tumor sometimes cannot be seen and can be difficult to palpate through small incisions. The current technology of linear staplers is suboptimal for resection of spherical lung tumors. Repeat applications of a linear stapler can lead to inadequate (or even positive) margins. What is needed is a stapler that is curved such that it fits through a small (for example two centimeters) thoracoscopy incision, and conforms to the typical spherical shape of a lung tumor.

SUMMARY OF THE INVENTION

This invention is described in preferred embodiments in the following description with reference to the Figures, in which like numbers represent the same or similar elements. Reference throughout this specification to "one embodiment," "an embodiment," or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrases "in one embodiment," "in an embodiment," and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment. In one embodiment, 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. In one embodiment, the invention further comprises a firing trigger connected to said curved first handle portion. In one embodiment, the invention further comprises a sliding trigger connected to said curved first handle portion. In one embodiment, said stapling head array further comprises a plurality of staple slots. In one embodiment, said blade is operably coupled to said sliding trigger. In one embodiment, the invention further comprises gently curved tips. In one embodiment, said curved first handle portion is question mark shaped. In one embodiment, said blade is circular. In one embodiment, said blade is linear. In one embodiment, said instrument comprises a diameter of less than 2 centimeters. In one embodiment, said instrument conforms to a spherical shape.

In one embodiment, 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. In one embodiment, the invention further comprises a firing trigger connected to said curved first handle portion. In one embodiment, the invention further comprises a sliding trigger connected to said curved first handle portion. In one embodiment, said stapling head array further comprises two rows of a plurality of staple slots. In one embodiment, said blade is operably coupled to said sliding trigger. In one embodiment, the invention further comprises gently curved tips. In one embodiment, said curved first handle portion is question mark shaped. In one embodiment, said blade is circular. In one embodiment, said blade is linear. In one embodiment, said instrument comprises a diameter of less than 2 centimeters. In one embodiment, said instrument conforms to a spherical shape.

In one embodiment, 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. In a preferred embodiment, said instrument has gently curved or soft tips. In one embodiment, the instrument further comprises a firing trigger connected to said curved first handle portion. In one embodiment, the instrument further comprises a sliding trigger comiected to said curved first handle portion. In one embodiment, said stapling head array further comprises a plurality of staple slots. In one embodiment, said blade is operably coupled to said sliding trigger. In one embodiment, the instrument further comprises gently curved tips. In one embodiment, said curved first handle portion is question mark shaped. In one embodiment, said instrument comprises a diameter of less than 2 centimeters. In one embodiment, said instrument confomis to a spherical shape. In one embodiment, said blade is circular, hi one embodiment, said blade is linear. In one embodiment, said tissue is a lung tumor. In one embodiment, said tissue is a peripheral lung tumor.

In one embodiment, the gently curved stapler is ideal for thoracoscopic or VATS surgery. In one embodiment, 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. In one embodiment, 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. In a preferred embodiment, said stapler has a soft curved tip. In one embodiment, 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. In one 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. In one embodiment, additional advantages of using small curved circular stapler compared to a linear stapler include less chest wall bleeding, less pain, and faster recovery.

In 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 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. In one embodiment, 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. In one embodiment, the curved first handle portion 2 is question mark shaped. In one embodiment, the instrument conforms to a spherical shape. In one embodiment, 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. In one embodiment, 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. In one embodiment, 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. In one embodiment, 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.

In one embodiment, the stapling action of the current invention is similar to the stapling mechanism as described in U.S. Patent 6,722,552 [8], herein incorporated by reference. As shown in Figure 11 and Figure 12, aplurality of surgical staples 12 are received in the lower jaw 13 of the stapler for ejection through the slots 19 of the lower jaw 13. In one embodiment, 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. In some cases, 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. In particular, 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. In one embodiment, as shown in Figure 11 and Figure 12, 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.

DEFINITIONS

To facilitate the understanding of this invention, a number of terms are defined below. Terms defined herein have meanings as commonly understood by a person of ordinary skill in the areas relevant to the present invention. Terms such as "a", "an" and "the" are not intended to refer to only a singular entity, but include the general class of which a specific example may be used for illustration. The terminology herein is used to describe specific embodiments of the invention, but their usage does not delimit the invention, except as outlined in the claims.

As used herein, the term "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 hyperplasia, Carcinoma, Carcinoma-general, Acinic cell tumor, Adenocarcinoma- general, Subtypes:, Bronchial surface cell type with little/no mucin, Goblet cell type, Bronchial gland cell type, Clara cell type, Hepatoid, Adenocarcinoma of fetal lung type, Adenocarcinoma - well differentiated fetal type, Adenocarcinoma vs. 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, Burkitt's lymphoma, Diffuse large B cell lymphoma, Follicular bronchitis / bronchiolitis, Hodgkin's lymphoma, Lymphomatoid granulomatosis, MALT lymphoma, Nasal type NK-T cell lymphoma, Plasmacytoma, SLL/CLL, and Waldenstrom macro globulinemia; and other malignancies: Angiosarcoma, Desmoplastic small round cell tumor, Epithelioid hemangioendothelioma, Hemangiopericytoma, Histiocytic-dendritic neoplasm, HIV associated polymorphic lymphoproliferative disorders, Kaposi's sarcoma, Leiomyosarcoma, Melanoma, Rhabdomyosarcoma, Synovial sarcoma, and Grossing lung tumors.

As used herein, the term "peripheral lung tumor" is used throughout the specification to describe

As used herein, the term "" is used throughout the specification to describe

As used herein, the term "lung resection" is used throughout the specification to describe the removal of part of a lung tissue.

As used herein, the term "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.

As used herein, the term "Lobectomy" is used throughout the specification to describe the surgical removal of a lobe of the lungs.

As used herein, the term "Pneumonectomy" is used throughout the specification to describe removal of an entire lung.

As used herein, the term "video-assisted thoracoscopic surgery" or "VATS" is used throughout the specification to describe a type of thoracic surgery performed using a small video camera that is introduced into the patient's chest via a scope. 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". In one embodiment, 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. In one embodiment, these small ports may be advantageous in reducing chest wall bleeding, reducing pain, and consequently lead to a faster recovery.

As used herein, the term "Video-assisted (VATS) lobectomy" is used throughout the specification to describe a lobectomy using video-assisted thoracic surgery. Depending on the size and location of the tumor or cancer, it may be possible to use a minimally invasive approach called VATS (video-assisted thoracic surgery). With VATS, 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.

As used herein, 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" or "preventing" 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.

As used herein, 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

The accompanying figures, which are incorporated into and form a part of the specification, illustrate several embodiments of the present invention and, together with the description, serve to explain the principles of the invention. The figures are only for the purpose of illustrating a preferred embodiment of the invention and are not to be construed as limiting the invention.

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. In one embodiment, the stapling head array 9 further comprises a cutting blade within said stapling head array. In one embodiment, the invention further comprises a firing trigger connected to said curved first handle portion 2. In one embodiment, the curved first handle portion 2 is question mark shaped. In one embodiment, the instrument conforms to a spherical shape. In one embodiment, 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. In a preferred embodiment, 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. In this embodiment of the device, 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. In one 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 for example in Figure 14B.

DETAILED DESCRIPTON OF THE INVENTION

1. OTHER SURGICAL STAPLERS

Various surgical staplers are known in the art. For example, U.S. Patent 6,193,129 [9]. This patent describes a surgical cutting and stapling instrument that has a handle with a moveable firing trigger, a shaft extending from the handle, and a stapling head at the end of the shaft. An array of staples is located within the stapling head. A blade located within the distal face of the stapling head has a distal cutting edge and at least one wedge spike facing the annular thin web of the breakaway washer. When the anvil is moved adjacent to the stapling head and the firing trigger is closed, the staples are formed and the blade is moved to sever the breakaway washer in a two-step process. While the device described is a surgical stapler with a blade, the orientation and design of the device are markedly different from the device of the present invention. The reference does not describe the curved or question mark shape design of the present invention.

Another example of a surgical stapler is described in US Patent 7,401,722 [10]. This patent describes a circular stapler for cutting off and suturing a jejunum. This stapler is designed to considerably reduce the potential for constricting the small intestine, to reduce the bleeding due to stapling in a state where the tension is applied, and to reduce a risk of the small intestine being caught by the head section during suturing. While the device described is a surgical stapler with a blade, the orientation of, specific purpose for, and design of the device are markedly different from the device of the present invention. The reference does not describe the curved shape design of the present invention.

Another example of a surgical stapler is described by Covidient "Duet TRS™ Reload with Tissue Reinforcement." This device is described as an endoscopic surgical stapler with an articulating neck shown without the hand-operated section. The Duet TRS™ Reload with Tissue Reinforcement, stapler uses of buttressed staples as well as an improved "knife" for firing of the stapler. The stapler touts reduced acute air leaks and strong tensile strength for critical wound healing. While there is a hinge between the neck and the extension to the handle, there is no description of isolating peripheral lung tumors. Additionally, the reference does not describe the same curved shape design of the present invention.

Another example of a surgical stapler is described in US Patent 4,684,051 [11]. This reference describes surgical instrument with a closed rectangular frame for placing linear staple sutures. Each lateral side of the frame is provided with a slot located on an inner surface close to the adjacent side of the frame. The design of this device is also markedly different from the device of the current invention in the directional application of the staples, the device's basic shape, and the lack of a cutting surface. The reference does not describe the curved shape design of the present invention.

Another example of a surgical stapler is described by Watanabe et al. (2009) [12]. This reference describes the use of two different linear surgical staplers, the Endo-GIA and Ethicon ETS-45, for the removal of peripheral lung tumors. The design of this device is also markedly different in shape and lack of a cutting edge from the device of the current invention. The reference does not describe the curved shape design of the present invention.

Another example of a surgical stapler is described by Koizumi, et al. (1997) [13]. This reference describes a segmental resection of the lung by thoracoscopy using the ELC35 (Ethicon) endoscopic stapler. This stapler has the same style as those described by Watanabe et al. [12]. This reference does not describe any cutting action of the surgical stapler. This reference also does not describe the curved shape stapler design of the present invention.

Another example of a surgical stapler is described by Yoshida, et al. (1993) [14]. This reference describes a comparative case of lung resection using various methods, including the 12-mm Endo-GIA stapling device. The stapler is of the same style as those in Watanabe et al.

[12], 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.

2. GENERAL DESCRIPTION OF THE CURRENT INVENTION

In one embodiment, 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. Moreover, depending upon the size of the stapler, 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. In one embodiment, thesurgical 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. In addition to staples (4.0 - 5.5 mm in height), 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. Moreover, 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. Additionally, using such a stapler in a thoracoscopic surgery may reduce chest wall bleeding, reduce pain, and result in a shorter recovery from surgery. While not limiting the current invention, it is belived that such a surgical stapler may also be useful in other endoscopic surgical situations or procedures wherein the curved shape and gently curved tips may reduce endoscopic surgical trauma and conform more easily with anatomical restrictions and challenges. 3. EMBODIMENTS OF THE CURRENT INVENTION

Currently available surgical staplers are either linear or round, as in the EEA design.

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. Such 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.

Moreover, depending upon the size of the stapler, 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.

It is not intended that present invention be limited to one particular stapler size or shape.

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. In one embodiment, 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.

In one embodiment, 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.

In one embodiment, the stapling action of the current invention is similar to the stapling mechanism as described in U.S. Patent 6,722,552 [8], herein incorporated by reference. As shown in Figure 11 and Figure 12, a plurality of surgical staples 12 are received in the lower jaw 13 of the stapler for ejection through the slots 19 of the lower jaw 13. In one embodiment, 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. In some cases, 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. In particular, 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. In one embodiment, as shown in Figure 11 and Figure 12, 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.

In one embodiment, the gently curved stapler is ideal for thoracoscopic or VATS surgery (Video-assisted thoracoscopic surgery). In one embodiment, said stapler is capable of fitting through a narrow (2 cm) opening and can be maneuvered through the rigid bony skeleton of the chest. In one embodiment, 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. In one 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.

Thus, specific device parameters and methods of the curved surgical stapler have been disclosed. It should be apparent, however, to those skilled in the art that many more modifications besides those already described are possible without departing from the inventive concepts herein. The inventive subject matter, therefore, is not to be restricted except in the spirit of the disclosure. Moreover, in interpreting the disclosure, all terms should be interpreted in the broadest possible manner consistent with the context. In particular, the terms "comprises" and "comprising" should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced.

All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited. The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates, which may need to be independently confirmed.

Although the invention has been described with reference to these preferred embodiments, other embodiments can achieve the same results. Variations and modifications of the present invention will be obvious to those skilled in the art and it is intended to cover in the appended claims all such modifications and equivalents. The entire disclosures of all applications, patents, and publications cited above, and of the corresponding application are hereby incorporated by reference.

EXAMPLES

The following examples are provided in order to demonstrate and further illustrate certain preferred embodiments and aspects of the present invention and are not to be construed as limiting the scope thereof.

Tumor Sizes in very general samples:

- 1CM Spherical Diameter Tumor would require a 5 CM Diameter resection sample

- 2CM Spherical Diameter Tumor would require a 6CM Diameter resection sample

- 3 CM Spherical Diameter Tumor would require a 7CM Diameter resection sample

- 4CM Spherical Diameter Tumor would require a 8CM Diameter resection sample

- 5CM Spherical Diameter Tumor would require a 9CM Diameter resection sample

- Most surgeons will not attempt to try to resection anything larger than 5 CM

Envisioned Stapler Sizing Options:

-Small Diameter (40mm inside curve) with 150° blade; Dual Staples

- Small Diameter (40mm inside curve) with 150° blade; Single Staples

- Small Diameter (40mm inside curve) with 180° blade; Dual Staples

- Small Diameter (40mm inside curve) with 180° blade; Single Staples

- Small Diameter (40mm inside curve) with 220° blade; Single Staples - Large Diameter (60mm inside curve) with 180° blade; Dual Staples

- Large Diameter (60mm inside curve) with 180° blade; Single Staples

- Large Diameter (60mm inside curve) with 220° blade; Single Staples

Sergeevich, B. B. and Jakovlevich, G. J. "Instalment for placing lateral gastrointestinal anastomoses," United States Patent 3,079,606, Application 7961, filed 1/4/1960. (issued 3/5/1963).

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anastomoses," United States Patent 3,490,675, Application 585672, filed 10/10/1966. (issued 1/20/1970).

Green, D. T. "Instrument for placing lateral gastro -intestinal anastomoses," United States Patent 3,499,591, Application 648276, filed 6/23/1967. (issued 3/10/1970).

Green, D. T. "Surgical instruments," United States Patent 4,429,695, Application 06/394,132, filed 7/1/1982. (issued 2/7/1984).

Schulze, D. R. et al. "Surgical stapler with locking means," United States Patent

5,065,929, Application 07/678,919, filed 4/1/1991. (issued 11/19/1991).

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(Hong, W. K., et al, Eds.), People's Medical Publishing House.

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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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Claims

CLAIMS: We claim:

1. 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.

2. The instrument of claim 1, further comprising a firing trigger connected to said curved first handle portion.

3. The instrument of claim 1, further comprising a sliding trigger connected to said curved first handle portion.

4. The instrument of claim 1, wherein said stapling head array further comprises a plurality of staple slots.

5. The instrument of claim 3, wherein said blade is operably coupled to said sliding trigger.

6. The instrument of claim 1 , further comprising gently curved tips.

7. The instrument of claim 1, wherein said curved first handle portion is question mark shaped.

8. The mstrument of claim 1 wherein said blade is circular.

9. The instrument of claim 1 wherein said blade is linear.

10. The instrument of claim 1 wherein said instrument comprises a diameter of less than 2 centimeters.

11. The instrument of claim 1 wherein said instrument conforms to a spherical shape.

12. 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.

13. The instrument of claim 12, further comprising a firing trigger connected to said curved first handle portion.

14. The instrument of claim 12, further comprising a sliding trigger connected to said curved first handle portion.

15. The instrument of claim 12, wherein said stapling head array further comprises two rows of a plurality of staple slots.

16. The instrument of claim 14, wherein said blade is operably coupled to said sliding trigger.

17. The instrument of claim 12, further comprising gently curved tips.

18. The instrument of claim 12, wherein said curved first handle portion is question mark shaped.

19. The instrument of claim 12 wherein said blade is circular.

20. The instrument of claim 12 wherein said blade is linear.

21. The instrument of claim 12 wherein said instrument comprises a diameter of less than 2 centimeters.

22. The instrument of claim 12 wherein said instrument conforms to a spherical shape.

23. A method for stapling and cutting tissue comprising the steps: 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.

24. The method of claim 23 the instrument further comprising a firing trigger connected to said curved first handle portion.

25. The method of claim 23 the instrument further comprising a sliding trigger connected to said curved first handle portion.

26. The method of claim 23 the instrument wherein said stapling head array further comprises a plurality of staple slots.

27. The method of claim 25 the instrument wherein said blade is operably coupled to said sliding trigger.

28. The method of claim 23 the instrument further comprising a gently curved tips.

29. The method of claim 23 the instrument wherein said curved first handle portion is question mark shaped.

30. The method of claim 23 the instrument wherein said instrument comprises a diameter of less than 2 centimeters.

31. The method of claim 23 the instrument wherein said instrument conforms to a spherical shape.

32. The method of claim 23 wherein said blade is circular.

33. The method of claim 23 wherein said blade is linear.

34. The method of claim 23 wherein said tissue is a lung tumor.

35. The method of claim 34 wherein said tissue is a peripheral lung tumor.