Surgigal instrument for establishing compression anastomosis

description

The present invention generally relates to tissue anastomosis. More particularly, νρ_ΐΛο-Ξ refers to a surgical instrument particularly suited for use in the installation of a set of interconnected coupling elements for performing anastomosis by compression of tubular structures. The instrument, designed to facilitate placement of the coupling assembly on a patient and to aid removal of the instrument after placement, includes a new cutting element that incorporates a rotary movement as the cutting blade advances along the tissue and of the coupling assembly. Additionally, the instrument may include a unique coupling feature to improve operational safety, an alignment feature of a single coupling member to improve positioning of the coupling elements and the application of compressive force to the elements, and a unique flexible portion to accommodate various surgical conditions.

A compression anastomosis coupling assembly is used specifically when cutting a 1-ANA segment.

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of the colon or a similar tubular organ. After a section of the pollen is removed, leaving the opposite near and distal ends free, the coaxially oriented coupling elements are introduced, aligned and engaged. The coupled elements capture and compress the free ends of the colon together to perform an anastomosis keeping the tissue in compression until healing occurs. The blood supply to the captured tissue is interrupted. Necrosis occurs in the area of ​​the captured colon within the joint without causing excessive inflammation and trauma. Then, the coupled assembly detaches from the anastomotic site and is spontaneously expelled from the rectum. After expulsion of the joint, the colon provides an open passageway at the anastomosis site substantially identical to that before cutting.

A presentation of a known type surgical instrument used to install a circular anastomosis assembly of tubular organs can be found in US Patent NP. No. 4,681,188. This device has advanced and developed the technique until known by introducing a circular mechanical anastomotic gun suitable for performing circular anastomosis in tubular organs using a compression device. Previously, in most cases, a mechanical gun was used in systems incorporating various metal staples that were actuated at the ends of the tissue to perform the anastomosis. Specifically, the device disclosed in the aforementioned patent includes three coaxial tubular elements conveying systems and means for positioning the elements of a coupling assembly, a circular cutting blade, and motor systems for first advancing the coupling elements for coupling and then advance the circular blade to make the cut. The new surgical instrument presented here further develops the technique in this field by introducing a cutting element that rotates as it advances. Rotational movement of the cutting element has the advantage of reducing the cutting force required to cut both the excess organ tissue captured and the coupling coupling cutting element 2.

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together to provide an open passage for the passage of material through it. The existing patented instrument includes a round rod that is rotated for positioning the outer coupling element and for exerting a compressive force between the outer and intermediate coupling elements prior to full engagement of the coupling element assembly.

The present device improves the positioning of the coupling elements by providing a sliding approach system for easier and faster operation. Furthermore, the present device may incorporate an automatic coupling system for securing one of the coupling elements in various positions relative to the other coupling elements as an additional refining of the sliding approach system. In addition, the sliding approach system is designed and configured to provide a superior mechanical advantage thereby reducing the required force applied by the user to achieve compression between the coupling elements of the assembly. An additional feature of the new instrument which is an improvement over known devices relates to an improved safety coupling system which provides for alternative engagement of the instrument and alignment systems and motors. Specifically, the coupling system allows alignment or movement at a given time but not simultaneously, namely when the alignment system is operational the motor system is inoperative and alternatively when the motor system is operational the alignment system is inoperative. In addition, the new instrument can be either disposable or reusable. In addition, the instrument may include an anatomically curved segment for ease of device introduction into the patient. Finally, an improvement not known in the art is that the instrument may be flexible enough to accommodate various anatomical orientations and operating conditions.

The primary object of the present invention is to develop the technique thus providing a surgical instrument which is used to perform compression anastomosis in tubular organs and which is an improvement over the devices.

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existing. Accordingly, this patent discloses a surgical instrument which is specially designed and designed for ease of installation of a compression anastomosis coupling assembly and incorporating a rotary cutting device. In addition, the instrument can incorporate unique coupling, alignment and guidance systems for added safety and ease of operation.

The device of the present invention is a novel surgical instrument designed and designed to install a coupling assembly, with multiple coupling elements, to perform compression anastomosis on a tubular organ. The instrument comprises a body with a central bore and includes a motor system, cutting system and a system for supporting the coupling elements of the assembly. 0 The instrument further includes a system for communicating the rotary movement of the cutting element, a system for aligning the cutting elements, and a system for actuating the motor system to bring the coupling elements to an engagement position and to advance and rotate the cutting element. . 0 The motor system may include a centrally placed conduit sliding into the center bore with the first end of the conduit adapted to engage a lever and a second end of the conduit adapted to engage the motor system. The instrument preferably comprises a handling part, an intermediate part and a head having the head a recess that intercepts the central bore and the recess including the motor and cutting system. 0 The recess is dimensioned and designed to guide the movement of the motor system and a system for rotating the cutting element. Rotational movement of the cutting element may be achieved through an inclined surface that engages a complementary projection wherein the projection in the motor system or recess slides along a coacting inclined surface. The intermediate part of the instrument may be either flat or curved, with a curvature ranging from about 102 to about 252 with a preferred curvature of about 152

In one form of the invention, contemplated within the scope of the disclosure, the surgical instrument includes one or more delivery systems.

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clamping to alternately clamp the motor system and the alignment system and prevent their movement. A clamping device is adapted for movement between the two clamping positions. In a first location, the motor system is fixed and the alignment system is operational while, in a second location, the alignment system is fixed and the motor system is operational. Both the motor system and the alignment system are not simultaneously operational.

In another form contemplated for the invention, the surgical instrument includes an alignment system comprising a central bore with a first end connected to one of the coupling members of the assembly and a second end connected to a cabinet, a head attached to the element, and systems placed on the handling part to guide the movement of the element and the head. In addition, the guide system may include at least one elongate slot which cooperates with one or more pins to engage the element and the kneecap. The groove may further be configured to provide a means for applying a compressive force between at least two of the coupling struts and a bend at one end of the groove. Additionally, the groove may further include one or more creases along the length of the groove to temporarily fix one of the coupling elements at various positions relative to the other coupling elements.

center hole may be slidably placed in a conduit located in the center hole. Alternatively, the conduit may be slidably placed in the core located in the central bore.

In yet another contemplated form of the invention, the surgical instrument comprises an intermediate portion with a tubular member including a flexible conduit and a flexible core located within a tubular member. The tubular member may further be a flexible position retaining member capable of multiple planar orientation and furthermore manipulable to undergo a 360 ° spherical rotation.

The various features of the novelty which characterize the invention are particularly emphasized in the appended claims which form part of this disclosure. For a better understanding of the invention, its advantages of operation and the specific results obtained by its use, reference should be made to the corresponding drawings and corresponding descriptive material illustrating and describing the typical practical embodiments of the invention.

Fig. 1 is a schematic representation of a surgical instrument used to establish pressure anastomosis in accordance with the principles of the present invention, illustrating an overall view of the device.

Fig. 2 is an enlarged partial perspective view of the handling part of the instrument shown in Fig. 1 showing the device alignment part fixed in place making the motor system operational.

Fig. 3 is a partial schematic representation of a surgical instrument such as that of Fig. 1 showing the head portion of the device and a modified intermediate portion.

Fig. 3A is a view very similar to that shown in Fig. 3a showing yet another modified intermediate part.

Fig. 4 is an enlarged fragmentary sectional view taken along the length of the instrument shown in Fig. 1, further including an unbound assembly, showing the instrument and assembly placed in a colon but prior to coupling of the assembly and before The instrument should be removed from the patient leaving the device in position until the anastomosis has healed.

Fig. 5 is an enlarged partially sectional view of the handling part of the instrument shown in Fig.

and showing the coupling element alignment system in an operative mode while the motor system is locked preventing movement by positioning the coupling elements in an orientation similar to that shown in Fig. 12.

Fig. 6 is a view similar to that shown in Fig.

but with the alignment system in another position, with the motor system still locked.

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Fig. 7 is a view similar to that shown in Fig. 6 but with the locked alignment system preventing movement and with the motor system in an operative mode prior to activation, the coupling elements of the assembly being in a position similar to that shown in Fig. 13

Fig. 8 is a view essentially as shown in Fig. 7 but with the motor system fully activated, the coupling elements of the assembly being in a position similar to that shown in Fig. 15.

Fig. 9 is an enlarged sectional view taken along line 9-9 through the head portion of the instrument shown in Fig. 1.

Fig. 10 is an exploded cross-sectional view of the head portion of the instrument having the outer body removed and incorporating the coupling elements of the assembly.

Fig. 11 is an elongated cross-sectional view of the body forming a recess at the location of the head portion of the instrument.

Fig. 12 is a schematic sectional representation of the instrument incorporating elements of the coupling assembly, being located at the free ends of a sectioned colon but before the coupling elements are moved into engagement by engagement.

Fig. 13 is a schematic sectional representation similar to that shown in Fig. 12 showing the assembly elements approximate but prior to attachment and before the cutting element advances to cut the captured colon tissue and cut along the coupling member of the set.

Fig. 14 is similar to Fig. 13 but shows the fully attached coupling elements and the initial rotational movement of the motor and the cutter as the cutter begins its passage through the fabric.

Fig. 15 is similar to Fig. 14 and shows an additional rotational motion of the motor system and particularly illustrates the rotational motion communicated to the custom cutter.

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the cutter passes through the fabric and the coupling element.

Fig. 16 is similar to Fig. 15 and shows the removal of the instrument from the colon in the indicated direction.

Fig. 17 is similar to Fig. 16 and illustrates that upon removal of the instrument the coupled assembly remains in the colon, which holds the captured colon tissue in position until the anastomosis heals and is then naturally expelled intact. by the patient.

The description given herein refers to the accompanying drawings in which reference numerals correspond to the same parts in all views. Referring first to Fig.

1 illustrates a schematic representation of the surgical instrument 10 of the present invention showing an overview of the device. The instrument includes a handling part 12, an intermediate part 14, and a head 16. Also shown in Fig. 1, and further explained in further detail with respect to other figures in the drawing are the knob 18, one of the pair of eye pleats. guide 20, safety fastener 22, a lever 24, a pivot pin 26, and a core 28. Turning now to Figs. 2, 3, and 3A, first illustrated in Fig. 2 is an enlarged partial perspective view of the handling portion 12 and Figs. 3 and 3A is a partial schematic view showing the head part 16 and modified intermediate parts 14 'and 14. Part 14' is curved at an angle to the center line of the handling part.

The portion 14 is a flexible position retaining element, for example goose neck, which may take various orientations.

Part 14 is susceptible of multiple planar orientation and can be manipulated to undergo a 360 ° spherical rotation.

The intermediate part 14 of Fig. 1 is substantially flat and horizontal while the intermediate part 14 'of Fig. 3 the angle θ may range from about 10 ° to about 25 °, with the preferred angle ≤ about 15th. Fig. 4 shows a fragmentary sectional view of the instrument 10 taken along the length of the instrument without an intermediate segment 14, 10.

showing the instrument located in colon 30 with wall parts 32, 34 used together with coupled assembly 40 including coupling elements 42, 44 and 46 (not being 46 shown in this view). Coupling member 42 is dragged by core 28 and held in position by end bearing 48 coupled to core 28.

Turning now to Figs. 5-8, the alignment, clamping and movement operation associated with the operation of the instrument 10 are better noted, systems which are located in the handling part 12. Specifically, Fig. 5 describes the instrument alignment system 10 in a first operative location by positioning coupling member 42 of assembly 40 as shown in Fig. 12. The alignment system comprises a movable element 50 (located in the handling part 12) with a recess 52 disposed therein and coupled to one end of the core 28 and at the other end to the kneecap 18 via pin 54. Movement of the element 50 is guided by means of a handle by means of the pin 54 which travels along the grooves 20 having a curved part 56 at one end of the bend. Each slot 20 may further include creases 21 for positioning member 50 in the areas chosen along the slot by locating pin 54 in the desired crease. The overall operation of the alignment system will be discussed with reference to Figs. 6 and 7. Fig. 5 further shows the motor system 58 engaging the head 60 of the conduit 62. The head and the conduit are slidably positioned in the central bore 63 running along intermediate 14 and intersecting a recess (Fig. 11) on the head portion 16. The core 28, which may be flexible or rigid, is slidably placed in the conduit 62, which may also be flexible or rigid. A flexible conduit and flexible core are preferred, particularly when the intermediate part 14 assumes a different configuration than the flat one. In an alternative construction, not shown, the conduit may be slidably disposed in the core. Fig. 5th shows a fastener 22, in one position, the motor fastening system 58 against movement wherein at location 64 of a lever part 24 remains against the upper part

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of the fastener 22 thus preventing the lever 24 from rotating around the pin 26 by moving the conduit 62 towards the head portion 16. As can be seen from the perspective representation of Fig. 2, if the element 22 moves towards the From the head 16, the lower projection 23 will strike the surface of the element 22 preventing downward movement of the lever 24.

Fig. 6 is a view very similar to Fig. 5 but now shows the alignment system in a second characteristic location. The kneecap 18, the element 50 and the core 28 have moved to the left, advancing the coupling element 42 bringing the coupling element 44 very close to that shown in Fig. 13. The lever 24 and the motor system 58 remain fixed and do not move. Rotation of the ball bearing 18 and member 50 from the securing part (the leftmost part along the handle 12) to any of several operating locations along the groove 20 rotates the core 28 and establishes torsional forces. in the core. The torsional or rotational forces introduced into the core serve to cause pin 54 to enter a fixed position when the pin is recessed in slot 21. Fig. 7 is a view very similar to that of Fig. 6th but now shows the alignment system in another position. The kneecap 18, element 50 and core 28 have been moved to their leftmost operating situation where the kneecap 18, pin 54 and element 50 have been rotated to the position shown. The pin 54 ran through the curved portions 56 of the slots 20 completing the approach of the coupling elements 42, 44 establishing a compression between the members 42, 44 as shown in Fig. 13. The arrows indicate the direction of movement of the fastener 22 in which the downward force P e and the backward force P são are applied at 22 by placing one end of 22 in the recess 52 of the element 50 thereby securing the ball 18. element 50 and core 28 preventing its movement. The element 50 is generally circular in shape and fits well into the circular handling part 12 so that with the introduction of one end of the securing element 22 into the recess 52, the element 50 cannot be rotated, thereby securing the kneecap. 18, pin 54 and core 28 preventing the

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your movement. Although not shown, two fasteners which independently perform the dual fastening functions of the fastener 22 are included within the scope of the invention.

In the position shown, the locking element 22 has been moved to enable activation of lever 24 and the motor system 58 as lever 24 is now free to rotate around pivot pin 26. However, in this view the lever and motor system has not been activated. Fig. 8 as Fig. 7 represents the fastener 22 at its left-most part completely supporting the kneecap 18, core 28, and element 50 and element 54 preventing its movement. With the element 22 in this position, an unobstructed path is left for rotation of lever 24 around pin 26 and downward movement of projection 23 so that upon application of force F to lever 24 the lever rotates around pivot 26 causing motor system 58 to move head 60 and conduit 62 to the right. Fig. 8 shows the motor system at rest after full activation. It is to be understood that included within the scope of the invention are comparable but particularly motor systems. not limited to such devices as energy storage devices, threaded devices, slide rims or rotatable slide rims.

Turning now to Figs. 9 to 11, details of the head of the instrument are presented. Fig. 9 is specifically an enlarged cross-sectional view of head 16 including an outer housing 66 with a recess 68, with a motor system 70 and a core 28 located in the recess or cavity 68. Also shown in Fig. 9 that the motor system 70 includes a handle 72 with the projecting rim 74 and that handle 72 is positioned in the guide channel 76 which is disposed in recess 68. In Fig. 10, an exploded perspective sectional view of the head 10 without the outer housing 66 is shown. Fig. 10 specifically shows the motor system bracket 69, motor system 70 with handle 72, rim 74 and protrusion 75 and further including an inclined projection 78 near the base of the motor system. In addition, the cutting element 80 and coupling elements 42, 44 and 46 are further shown wherein the element 42 further includes the recess 43. In Fig. 11

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A sectional view of housing 66 is shown including channel 76 with an inclined end portion 82, an inclined surface 84 and a groove 86. When mounting for operation, coupling member 44 is dragged by the housing 66 as the tip of member 44 enters the housing at the location of annular groove 86; coupling member 46 remains at the end portion of the handles 72; and the cutting element 80 rests on the motor projection 75. The linear movement of the motor element 70 in recess 68 is guided by the position of the handles 72 in the channels 76 and the rotational movement of the motor element and the cutting element 80 is caused by the sliding coercion of the angled projection 78 into their grooves along the surface. inclined 84.

Turning now to Figs. 12 to 17, a series of schematic views are shown depicting the operation of the surgical instrument. Fig. 12 shows instrument 10 and coupling elements 42, 44, 46 placed on colon 30. Although illustrated here and described the use of the instrument and coupling elements in connection with a colon intervention, it is understood that their use is equally applicable to the repair of other tubular organs such as the large and small intestine. and the esophagus just to mention a few organs. Here, the colon 30 with its walls 32, 34 and free ends 36, 38 is shown with the free ends pressed against the core 28. The coupling member 42 supported by the core 28 and the end cap 48 is located at one end of the colon 30 while the head portion 16 is placed at the other end of the colon. Coupling element 42 is ready to move toward approaching element 44. Fig. 13 shows the coupling elements already approached, with the core 28 being moved to the left to bring the ends 36, 38 into contact, but before securing the members and before cutting the fabric and coupling elements. Tissue compression between the elements 42, 44 is achieved by moving the kneecap 18 and pin 54 through the curved portion 56 of the handling end of the instrument and the element 42 is prevented from moving by securing the

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alignment system as previously specified. The coupling elements are thus ready for clamping and cutting by operating the motor system 58 and motor element 70 wherein the motor system moves forward. Figs. 14 and 15 represent an additional operation of the instrument. Motor element 70 remains in channels 76 of housing 66 and the coercion configuration of the inner chamber and motor element slides with the movement of the motor element when the motor system is activated. Specifically, the motor system 70 has handles 72 and angled projections 78 with the handles positioned in channels 76 and the angled projections 78 in contact with the inclined surface 84.

The motor system is adapted to first move linearly forward as the handles 72 advance in the channels 76 and then rotate as the angled projections 78 slide along the ramp surface 84. handles 72 push coupling member 46 forward until it enters coupling member 44, thereby securing coupling members 42, 44 and 46 together. Next, the handles 72, which are flexible, fold inward as the rim. 74 — each handle slides along the inclined surface 82 at the end of the channel 76, gradually decreasing the inside diameter of the channel into which the handle slides, and the handles move within the coupling member 46. Attached to the motor system 70 is the cutting member 80 which cuts excess tissue, namely the free ends of colon 36, 38, and cuts a ring or recess 43 located in the cutting member 42. When the handles 72 fold inwardly , the motor element 70 is free to move further forward without moving the coupling elements of the assembly. The motor element advances, rotates as it advances, and communicates a rotary movement to the cutting element 80 which cuts the fabric and the coupling element. Rotation of the cutting member 80 facilitates the moderate cutting action required to cut the fabric and the coupling member by releasing the lumen and allowing the instrument to separate from the assembly. The ring 40 connects to the end of the element 46 by pushing the element 46 and the coupling element 44 freeing the element 44 from its connection to the housing 66 in the slot 86 and releasing the coupled assembly of the instrument.

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10 Fig. 16 shows removal of the instrument 10 from the colon leaving the attached set at the anastomotic site as shown in Fig. 17. The anastomosis will heal in and around the region designated 88, and then the set will naturally expelled intact by the patient leaving the colon 30 at the anastomotic site with an open, unobstructed passage substantially similar to that existing prior to resection.

While the foregoing will describe specific practical embodiments of the invention, those skilled in the art will appreciate that changes in the form of the invention covered by the appended claims may be made without departing from the scope and spirit, and that certain features of the invention may sometimes be construed. advantageously without corresponding use of the other features.