MXPA06008304A - Flexible endoscopic anastomotic ring applier device - Google Patents

Abstract

A surgical instrument for deploying an anastomotic ring device has a ring deployment mechanism, which is configured to receive and deploy an anastomotic ring. The instrument further comprises a flexible elongate shaft having one or more actuation cables extending therethrough. The shaft also has an imaging element, which is coupled to a camera with a lens located in the tip of the instrument. The instrument may be inserted through the esophagus of a patient to deploy an anastomotic ring device.

Description

APPLICATION DEVICE FOR A FLEXIBLE ENDOSCOPIC ANTI-OCCASION ANESTHETIC RING FIELD OF THE INVENTION The present invention relates, in general, to surgery, and more particularly, to a device for performing a surgical procedure in the digestive system.

BACKGROUND OF THE INVENTION The percentage of the world population that suffers from morbid obesity increases steadily. Severely obese people may be susceptible to an increased risk of heart disease, stroke, diabetes, lung disease and accidents. Due to the effects of morbid obesity on the patient's life, methods to treat morbid obesity have been the subject of intense investigation. A known method for treating morbid obesity includes the use of anastomotic rings. The devices for applying the anastomotic rings are known in the art. Devices of this nature are commonly adapted to insert an compressed anastomotic ring into an anastomotic opening formed between the walls of the proximal gastrointestinal tissue. These applicator devices may use a ring deployment mechanism comprising an expansion element that is actuated once the compressed ring is placed in the anastomotic opening, causing the anastomotic ring to expand from its cylinder-shaped, compressed position, to a position with hollow rivet shape, driven. It may be desirable for the surgeon to insert the applicator device through the patient's esophagus. In addition, it may be desirable for the surgeon to have a view of the site of the anastomosis. Although it is possible to insert an endoscope to observe the site of the anastomotic junction, this can disadvantageously add additional steps and costs to the surgery, require additional space and / or incisions, or introduce other unintended consequences.

BRIEF DESCRIPTION OF THE INVENTION Several embodiments of the present invention provide an anastomotic ring applicator device that allows the surgeon to insert the device transorally and observe the anastomotic junction site. In one embodiment, a surgical instrument is operable to deploy an anastomotic ring device at an anastomosis site. The instrument comprises a ring deployment mechanism. The ring deployment mechanism is configured to receive and deploy an anastomotic ring. The instrument further comprises an elongate body comprising a plurality of drive members. Each of the drive members is operable to communicate one or more driving forces to the ring deployment mechanism. The body is flexible. The instrument further comprises one or more actuators. Each of the one or more actuators is operable to communicate one or more drive forces to at least one of the drive members. In another embodiment, a surgical instrument is operable to deploy an anastomotic ring device at an anastomosis site. The instrument comprises a handle having one or more actuators. Each of the one or more actuators is configured to receive input from the user to provide one or more driving forces. The instrument further comprises an elongate body having a first end and a second end. The handle is connected to the first end of the elongate body. The elongate body comprises one or more drive members. The one or more drive members are in communication with one or more actuators. The body and the one or more drive members are flexible. The instrument further comprises a ring deployment mechanism positioned adjacent the second end of the body. The ring deployment mechanism is configured to receive a device from the anastomotic ring. The one or more drive members are configured to communicate one or more drive forces to the ring deployment mechanism. The ring deployment mechanism is operable to deploy the anastomotic ring device in response to at least one of one or more driving forces. In another modality, a method for deploying an anastomotic ring device at an anastomosis site, comprises providing an instrument for deploying the anastomotic ring device. The instrument comprises a ring deployment mechanism. The ring deployment mechanism is configured to receive and deploy the anastomotic ring device. The instrument further comprises an elongate body comprising a plurality of drive members. Each of the drive members is operable to communicate one or more driving forces to the ring deployment mechanism. The instrument further comprises one or more actuators. Each of the one or more actuators is operable to communicate one or more drive forces to at least one of the drive members. The method further comprises inserting at least a portion of the instrument through the esophagus of a patient to reach an anastomosis site. The method further comprises deploying the anastomotic ring device at the site of the anastomosis. The method further comprises extracting at least a portion of the instrument from the patient's esophagus.

More modalities will be described below. Other modalities will be apparent to those with ordinary skill in the art.

BRIEF DESCRIPTION OF THE FIGURES The accompanying drawings, which are incorporated and constitute a part of this specification, illustrate versions of the invention, and together with the general description of the invention given above, the detailed description of the versions given below, serve to explain the principles of the present invention. Figure 1 is a perspective view of an applicator device of the anastomotic ring, shown with a mechanism for deploying the ring in an unactuated position. Figure 2 is a partial perspective view of the distal portion of an anastomotic ring applicator device holding an anastomotic ring in an inactive position. Figure 3 is a partial perspective view of the distal portion of the device of Figure 2, holding an anastomotic ring in the actuated position. Figure 4 is a front view of a powered anastomotic ring.

Figure 5 is a perspective view of the device of Figure 1, shown with a distal portion of the ring deployment mechanism in a partially driven position. Figure 6 is a perspective view of the device of Figure 1, shown with the distal portion and a proximal portion of the ring deployment mechanism, each in a partially actuated position. Figure 7 is a perspective view of the device of Figure 1, shown with the distal portion and the proximal portion of the ring deployment mechanism, each in the fully actuated position. Figure 8 is an exploded view of a ring deployment mechanism and a display system of the device of Figure 1. Figure 9 is an exploded view of a drive mechanism of the device of Figure 1. Figure 10 is a partial cross-sectional view of the device of Figure 1, shown with the ring deployment mechanism in a non-powered position. . Figure 11 is a partial cross-sectional view of the device of Figure 1, taken along the Plane 11 of Figure 10, shown with the ring deployment mechanism in a non-driven position.

Figure 12 is a partial cross-sectional view of the device of Figure 1, shown with a distal portion of the ring deployment mechanism in a partially driven position. Figure 13 is a partial cross-sectional view of the device of Figure 1, shown with the distal portion and a proximal portion of the ring deployment mechanism, each in a partially driven position. Figure 14 is a partial cross-sectional view of the device of Figure 1, shown inserted through an anastomotic opening, with the distal portion and the proximal portion of the ring deployment mechanism, each in a fully actuated position. Figure 15 is a cross-sectional view taken on the plane 15 of the device of figure 10. Figure 16 is a cross-sectional view taken on the plane 16 of the device of figure 10. Figure 17 is a sectional view transverse taken on the Plane 17 of the device of Figure 10.

DETAILED DESCRIPTION OF THE MODALITIES OF THE INVENTION Returning to the Drawings, where similar numbers denote similar components throughout the various views, Figure 1 describes an applicator 10 that is operable to deploy and operate an anastomotic ring device 14 (not illustrated in Figure 1), of a generally cylindrical shape to one having properties of a hollow rivet or ring, capable of forming an anastomotic junction at an objective site of the anastomosis, such as in the bariatric gastric bypass of a patient with morbid obesity. Figure 2 describes another applier 12. It will be appreciated that the applicators 10, 12, can be used in a variety of ways, including, non-exclusively, laparoscopically or endoscopically. The applicator 12 is shown in Figure 2 with an anastomotic ring 14 in a deployment mechanism 16. In Figure 2, the anastomotic ring 14 is shown in the cylindrically compressed position. In Figure 3, the deployment mechanism 16 of the applicator 12 has moved the anastomotic ring 14 to a hollow rivet-driven position. Figure 4 is a close-up view of the anastomotic ring 14 in the actuated position. The anastomotic ring 14 may comprise a material with shape memory effect (SME), such as nitinol by way of example only, which further aids in the actuation to a hollow rivet shape that engages. Other suitable anastomotic ring materials 14 will be apparent to those of ordinary skill in the art. An exemplary anastomotic ring 14 is described in detail in the U.S. Patent Application Publication. No. US 2003/0032967, by Park et al. It will be appreciated that the terms "proximal" and "distal" are used herein with reference to a clinician holding a handle of the applicator 10. It will further be appreciated that for convenience and clarity, spatial terms such as "right", " "left", "vertical" and "horizontal" are used in the present with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not meant to be limiting and absolute. In addition, the aspects of the invention have application to surgical procedures performed endoscopically and laparoscopically, as well as an open procedure and other procedures. The use of one of these similar terms or terms herein is not to be construed as limiting the present invention for use in only one category of surgical procedure. Referring now to Figures 1 and 5-15, the applicator 10 of the present example has a body 15 comprising a tubular liner 24. A handle 19 is positioned at the proximal end of the body 15, while the ring deployment mechanism 26 is placed at the distal end of the body 15. A tip 13 is placed on the distal end of the ring deployment mechanism 26. The applicator 10 further comprises an element for imaging 11. The imaging element 11 it is coupled with a camera 90 having a lens 92. The camera 90 and the lens 92 are positioned at the tip 13. The camera 90 can be a CCD camera, a CMOS camera, or any other device for imaging. The imaging element 11, the camera 90 and the lens 92, are configured to provide visualization through the tip. Any device, examples of which will be apparent to those of ordinary skill in the art, can be coupled with the proximal end of the image forming element 11 to observe the images communicated through the image forming element 11. Other Suitable configurations to allow the imaging element 11 to capture a view will be apparent to those of ordinary skill in the art. In one embodiment, the image forming element 11 comprises one or more fibers for imaging. In one embodiment, the illumination is provided at the distal end of the imaging element 11, by illumination fibers (not shown), which run adjacent to the imaging element 11. It will be appreciated that such illumination can help to capture the images by the imaging element 11 during the use of the applicator 10. Suitable configurations of the illumination fibers will be apparent to those of ordinary skill in the art. Of course, the illumination may be provided by a variety of alternate means, devices, methods and / or configurations, or may be eliminated. In the present example, the ring deployment mechanism 26 comprises a plurality of proximal fingers 60 connected to a proximal ring 30; and a plurality of distal fingers 62 connected to a distal ring 32. A stationary middle ring 64 is positioned longitudinally between the proximal ring 30 and the distal ring 32. Both proximal fingers 60 and distal fingers 62 are in a double jointed relationship with the ring stationary means 64 of the ring deployment mechanism 26. The proximal ring 30 is configured to slide distally towards the middle ring 64, causing the proximal fingers 60 to be driven outwardly relative to the body 15. The middle ring 64 is held stationary by a portion of the stationary distal ground tube 65B, as will be described below. Similarly, the distal ring 32 is configured to slide proximally toward the middle ring 64, causing the distal fingers 62 to be driven outwardly relative to the body 15. The fingers 60, 62 are configured to hold an anastomotic ring 14 for coupling petals 52 before and during deployment of the anastomotic ring 14, and release petals 52, upon deployment of the anastomotic ring 14. The applicator 10 further comprises a pair of deployment actuators 34, 36. As described below with more detail, the first deployment actuator 34 is operable to drive the proximal fingers 60 of the ring deployment mechanism 26, advancing the proximal ring 30 distally; and the second deployment actuator 36 is operable to drive the distal fingers 62, pulling distal ring 32 proximally. In Figures 5 and 12, the distal fingers 62 are shown in a partially driven position to partially deploy a distal portion of an anastomotic ring 14. The arrow 42 describes the actuation movement of the second actuator 36. In Figures 6 and 13, the proximal fingers 60 are shown in a partially driven position to partially deploy a proximal portion of the anastomotic ring 14, to partially complete the anastomotic junction between the proximal tissue walls 46, 48. The arrow 50 describes the actuation movement of the first actuator 34. Figures 7 and 14 show the fingers 60, 62 in a fully actuated position, effecting the deployment of the anastomotic ring 14. It will be appreciated that any suitable alternative for the deployment mechanism of the ring 26 and / or the deployment actuators 34, 36 , it can be used. As indicated above, the first deployment actuator 34 of the present example is operable to control the proximal fingers 60; and the second deployment actuator 36 is operable to control the distal fingers 62. Referring to Figures 9 and 16-17, the first and second ring deployment actuators 34, 36 each have a pair of notches 67 that are configured to slide on a track 68 of the grip 19. The range of the first actuator 34 is limited by the width of a slot 70, while the range of the second actuator 36 is limited by the width of a slot 72. In the present example, the first actuator 34 is fixedly attached to a proximal portion 74 of the track 68. The track 68 slides inside the handle 19. A distal portion 76 of the track 68 is fixedly attached to a slider 78. The slider 78 is fixedly connected to a pair of thrust cables 80. The longitudinal movement of the first actuator 34 is operable, therefore, to cause the corresponding longitudinal movement of the track 68, the slider 78, and the power cables. push 80. Other suitable relationships between these components, as well as the alternate components and configurations, will be apparent to those of ordinary skill in the art. Referring to Figure 15, the push ropes 80 are each placed within a liner of the respective cable 79. Each liner of the cable 79 extends longitudinally through a conduit of the respective cable 27 in the body 15. In the present example, the cable ducts 27 are formed in the liner 24. Referring to Figures 8 and 10-15, the distal end of each push cable 80 is fixedly secured to the proximal end of a push tube 85. The distal end of the thrust tube 85 has a pair of flanges 81, which are configured to engage with the proximal ring 30 of the ring deployment mechanism 26. Accordingly, the thrust tube 85 is operable to communicate longitudinal movement to the proximal ring 30, thus actuating or deacting the proximal fingers 60. Due to the coupling between the thrust cables 80 and the thrust tube 85, such longitudinal movement can be provided by the actuation of the first actuator 34. Of course, any other components or configurations can be used. adequate. The body 15 further comprises a portion of the proximal ground tube 65A, which extends longitudinally through. The proximal end of the portion of the proximal ground tube 65A is fixedly attached to an anchoring member 84. The anchoring member 84 is configured to engage with lugs 86, which are integral with the handle 19. Consequently, in the present example, the anchor member 84 and the lugs 86 are configured to prevent relative movement between the proximal ground tube portion 65A and the handle 19. The portion of the proximal ground tube 65A extends longitudinally through the conduits of the grounded tube 25, which are formed in the liner 24 adjacent to and between the conduits of the cable 27. A portion of the distal grounded tube 65B is fixedly secured to a portion of the proximal grounded tube 65A. The distal end of the distal ground tube portion 65B has a rim 66, which is configured to engage the middle ring 64 of the ring deployment mechanism 26. The portions of the grounded tube 65A, 65B thus prevent longitudinal movement of the middle ring 64 relative to the handle 19. It will be appreciated that any other suitable components or configurations may be used. The second actuator 36 is fixedly secured to a portion of the proximal inner tube 82A, which extends longitudinally through the proximal ground tube portion 65A. A portion of the distal inner tube 82B is fixedly secured to a portion of the proximal inner tube 82A. The portion of the distal inner tube 82B extends longitudinally through the distal ground tube portion 65B. The distal end of the distal inner tube portion 82B has a pair of ridges 83, which are configured to engage the distal ring 32 of the ring deployment mechanism. Accordingly, the portion of the distal inner tube 82B is operable to communicate longitudinal movement to the distal ring 32, thereby driving or disengaging the distal fingers 62. Due to the coupling between the distal inner tube portion 82B and the inner tube portion 82A, such longitudinal movement can be provided by actuating the second actuator 36. Of course, any other suitable components or configurations can be used. It should be noted that although the second actuator 36 is configured to slide on the track 68 in the present example, the second actuator 36 is not statically attached to the track 68. Therefore, the longitudinal movement of the track 68 caused by the movement of the first actuator 34, does not cause the longitudinal movement of the second actuator 36. Of course, the handle 19 and the components thereof can be configured in any other suitable manner. By way of example only, the first actuator 34 can be configured to control the actuation of the distal fingers 62, and the second actuator 36 can be configured to control the actuation of the proximal fingers 60. Still other suitable alternate configurations will be apparent to those with experience ordinary in the art. It will be appreciated that the applicator 10 of the present example can be used to deploy an anastomotic ring 14 without the involvement of a non-functional enterotomy. For example, the applicator 10 can be configured so that the tip 13, the deployment mechanism of the ring 26, and the body15 can be inserted down a patient's esophagus. The consequence, the body 15 can be dimensioned (for example, for diameter and length), to reach an anastomosis site transorally, via the esophagus. Particularly when the imaging element 11, the chamber 90, and the lenses 92 are included in the applicator 10, such use can eliminate the need for at least one opening of the trocar in the abdomen or in some other place in the patient . Of course, the applicator 10 can be used in any other suitable manner, including non-exclusively, use through a non-functional enterotomy or use in an open procedure. In the present example, the body 15 is flexible. However, it will be appreciated that the body 15, including the components thereof, may have any other properties including, but not limited to, malleability, rigidity, elasticity, other properties or combinations thereof. It will also be appreciated that the components of the applicator 10 may have any suitable dimensions. By way of example only, the tip 13, the deployment mechanism of the ring 26, and / or the body can have a maximum external diameter between about 12 and 18 mm. Of course, any other dimensions can be used. In another embodiment, one or more tubes 82A, 82B, 65A, 65B and / or 85 is eliminated, and the cables are replaced by the same. For example, a pull wire can be replaced by a portion of the proximal inner tube 82A. The cables can be individually wrapped and / or put together in bundles, or have any other components or configurations. It will be appreciated that by providing linings around the cables, deformation of the cables can be prevented. Of course, the liners may provide other advantages over unlined cables, or may not provide advantages. As with several other components, the liners, including but not limited to the linings of the cables 79, are optional. For example, the conduits of the cable sheath 27 can be configured to provide shells for the thrust cables 80. In yet another embodiment, the body 15 comprises one or more working channels. By way of example only, such channels can be used to introduce microforms or any other device. Where the microforceps are included, they can be used to hold the tissue to be cut or anastomotized. Other variations will be apparent to those with ordinary experience in the art. In yet another embodiment, the portion of the proximal ground tube 65A is removed, and the conduit of the ground tube 25 provides grounding for the middle ring 64. In a version of this mode, the proximal end of the pipeline to ground 25 extends in the handle 19 more than the other portions of the liner 24, and is fixedly secured to an anchoring member 84. In this alternate version, the distal end of the tube to ground conduit 25 is fixedly secured to the distal ground tube portion 65B. Any other variation of, substitute for, or supplement to the grounded tube 65A, 65B can be used.

In use, the applicator 10 can be inserted adjacent to the anastomotic opening in the proximal tissue walls 46, 48. The imaging element 11, the chamber 90, and the lens 92, can be used to capture a view of the site of the anastomosis, such as to properly position the applicator 10. As shown in Figures 5 and 12, the second actuator slider 36 may be partially driven to partially drive the distal fingers 62, thereby partially deploying a distal portion. of the anastomotic ring 14. As shown in Figures 6 and 13, the first slider of the actuator 34 can be partially driven to partially drive the proximal fingers 60, thereby partially deploying a proximal portion of the anastomotic ring 14. The surgeon can then confirm the proper placement of the applicator 10, such as through tactile feedback or through any other technique. As shown in Figures 7 and 14, the first and second actuator sliders 34, 36 can slide completely to fully engage the deployment mechanism of the annulus 26, thereby completing the deployment of the anastomotic ring 14 to perform an anastomosis. After the anastomotic ring 14 has been deployed, the above steps can be reversed, and the applicator 10 can be removed. Other variations of use of the applicator 10 will be apparent to those of ordinary skill in the art. Although the applicator 10 has been described as being operable to deploy an anastomotic ring 14, it will be appreciated that the applicator 10 may have a variety of other uses. By way of example only, wherein an anastomotic ring 14 has already been deployed, the applicator 10 can be used to compress or otherwise modify or manipulate the deployed anastomotic ring 14. Still other uses will be apparent to those of ordinary skill in the art. . Having shown and described various embodiments and concepts of the invention, further adaptations of the methods and systems described herein can be achieved, by appropriate modifications, by one of ordinary skill in the art, without departing from the scope of the invention. Several such alternatives, modifications and potential variations have been mentioned, and others will be apparent to those with experience in the art, in light of the above teachings. Accordingly, the invention is intended to encompass all such alternatives, modifications and variations, which may fall within the spirit and scope of the appended claims, and is meant to be not limited to the details of the structure and operation shown and described in the specification. and the drawings. Additional advantages can easily appear for those skilled in the art.

Claims (20)

NOVELTY OF THE INVENTION CLAIMS

1. - A surgical instrument for deploying an anastomotic ring device at an anastomosis site, comprising: (a) a ring deployment mechanism, wherein the ring deployment mechanism is config to receive and deploy an anastomotic ring; (b) an elongated body comprising a plurality of drive members, wherein each of the drive members is operable to communicate one or more driving forces to the ring deployment mechanism, wherein the body is flexible; and (c) one or more actuators, wherein each of the one or more actuators is operable to communicate one or more drive forces to at least one of the drive members.

2. The surgical instrument according to claim 1, further characterized in that the body further comprises an element for the formation of images.

3. The surgical instrument according to claim 2, further characterized in that it comprises a tip positioned distally in relation to the deployment mechanism of the ring, wherein the tip comprises a lens in communication with the element for imaging.

4. - The surgical instrument according to claim 1, further characterized in that at least one of one or more drive members comprises a slider.

5. The surgical instrument according to claim 1, further characterized in that it comprises a handle, wherein at least one of one or more drive members are placed in the handle.

6. The surgical instrument according to claim 1, further characterized in that at least a portion of the driving members comprises one or more tubes.

7. The surgical instrument according to claim 1, further characterized in that at least a portion of the driving members comprises one or more cables.

8. The surgical instrument according to claim 1, further characterized in that at least a portion of the driving members comprises a combination of tubes and cables.

9. The surgical instrument according to claim 1, further characterized in that the ring deployment mechanism comprises a plurality of fingers.

10. The surgical instrument according to claim 9, further characterized in that the plurality of fingers comprises a set of distal fingers and a set of proximal fingers.

11. - The surgical instrument according to claim 9, further characterized in that the fingers are operable to be driven outward in response to at least one of one or more driving forces.

12. The surgical instrument according to claim 1, further characterized in that the body comprises an external liner.

13. The surgical instrument according to claim 12, further characterized in that the liner comprises one or more conduits, wherein each of the one or more conduits is config to receive at least one of the actuating members.

14. The surgical instrument according to claim 1, further characterized in that the body has a sufficient length to advance the deployment mechanism of the ring to an anastomosis site via the esophagus.

15. The surgical instrument according to claim 1, further characterized in that the body and the deployment mechanism of the ring each have a diameter sized to adjust the body and the mechanism of deployment of the ring in the esophagus.

16. A surgical instrument for deploying an anastomotic ring device at an anastomosis site, the instrument comprising: (a) a grip having one or more actuators, wherein each of one or more actuators is config to receive the user input to provide one or more driving forces; (b) an elongated body having a first end and a second end, wherein the handle is connected to the first end of the elongated body, wherein the elongate body comprises one or more actuating members, wherein one or more actuating members they are in communication with one or more actuators, wherein the body and one or more actuating members are flexible; (c) and a ring deployment mechanism positioned adjacent the second end of the body, wherein the ring deployment mechanism is configured to receive an anastomotic ring device, wherein one or more drive members are configured to communicate one or further driving forces to the ring deployment mechanism, wherein the ring deployment mechanism is operable to deploy the anastomotic ring device in response to at least one or more driving forces.

17. The surgical instrument according to claim 16, further characterized in that the instrument is configured to fit through the mouth and esophagus of a patient to reach an anastomosis site.

18. The surgical instrument according to claim 16, further characterized in that the ring deployment mechanism comprises a set of distal fingers and a set of proximal fingers.

19. - A method for deploying an anastomotic ring device at an anastomosis site, the method comprising: (a) providing an operable instrument for deploying an anastomotic ring device, wherein the instrument comprises: (i) a mechanism for deploying the anastomotic ring; ring, wherein the ring deployment mechanism is configured to receive and deploy the anastomotic ring device, (ii) an elongate body comprising a plurality of drive members, wherein each of the drive members is operable to communicate one or more driving forces to the ring deployment mechanism, and (iii) one or more actuators, wherein each of the one or more actuators is operable to communicate one or more driving forces to at least one of the driving members; (b) inserting at least a portion of the instrument through a patient's esophagus to reach an anastomosis site; (c) deploying the anastomotic ring device at the site of the anastomosis; and (d) extracting at least a portion of the instrument from the patient's esophagus.

20. The method according to claim 19, further characterized in that the act of inserting at least a portion of the instrument comprises inserting at least a portion of the instrument through the mouth of the patient into the esophagus.