MXPA06004951A - Anastomotic ring applier device providing forward and retrograde visualization - Google Patents

Abstract

A surgical instrument for deploying an anastomotic ring device comprises a ring deployment mechanism, which is configured to receive and deploy an anastomotic ring. The instrument further comprises an imaging element that is operable to capture an image of the anastomosis site. In one version, the instrument is operable to capture both a forward view and a retrograde view of the anastomosis site.

Description

ANASTOMOTIC RING APPLICATOR DEVICE THAT PROVIDES FRONT AND RETROGRADE DISPLAY FIELD OF THE INVENTION In general, the present invention relates 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 is constantly growing. Severely obese people may be at increased risk of heart disease, stroke, diabetes, lung disease, and accidents. Due to the effects of morbid obesity on the patient's life, methods of treating morbid obesity have been the subject of intense research. A known method for treating morbid obesity includes the use of anastomotic rings. The devices for applying the anastomotic rings are known. Devices of this nature are commonly adapted to insert an anastomotic ring compressed into an anastomotic opening, formed between proximal walls of gastrointestinal tissue. These applicator devices may utilize 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 cylindrically compressed position to a hollow rivet driven position. During the use of such applicator devices, it may be desirable for the surgeon to accurately position the applicator device in the anastomotic opening to deploy the ring. In addition, it may be desirable for the surgeon to ensure that the anastomotic ring has been properly deployed, since an improperly deployed ring can cause complications or device failure. Although it is possible to insert an endoscope to see the site of the anastomotic junction, this can disadvantageously add steps and extra cost to the surgery. Accordingly, it may be desirable to have a device for inserting and deploying an anastomotic ring in the anastomotic opening, which allows the surgeon to visually confirm whether the applicator is properly located and whether the anastomotic ring has been properly positioned. It may also be desirable to have a visualization method that can be implemented with the existing anastomotic ring applicator technology, with a relatively low added cost.

BRIEF DESCRIPTION OF THE INVENTION Several embodiments of the present invention provide an anastomotic ring applicator device that allows the surgeon to view the anastomotic attachment site and confirm the proper deployment of the anastomotic ring. In one embodiment, a surgical instrument comprises a handle attached by an elongated arrow to a ring deployment mechanism. In addition, the instrument comprises an image element adapted to capture an image of the site of the anastomosis. This may allow the surgeon to see the site of the anastomosis without introducing other instruments into the surgical site. In another embodiment, a surgical instrument comprises a handle attached by an elongated arrow to a ring deployment mechanism. The instrument also comprises an image element, adapted to capture an image of a front view and an image of a retrograde view of the site of the anastomosis. This modality may allow the surgeon to see both sides of the anastomotic junction before and after the deployment of the anastomotic ring. In another embodiment, an instrument comprises an actuator member configured to receive an anastomotic ring and move it from a cylindrical position compressed to a position forming a hollow rivet, actuated, in response to a compressive driving force. The instrument also comprises a handle and a drive mechanism to produce the driving force, together with an elongated arrow joining the handle to the drive member. The instrument also includes an operable image element to capture an image of the site of the anastomosis. In this modality, the surgeon can see the site of the anastomosis before the anastomotic ring is deployed from an inactive position, and can also see the site of the anastomosis after the ring has moved to an activated position, to make sure that the ring has been properly deployed in a hollow rivet forming position.

BRIEF DESCRIPTION OF THE FIGURES The accompanying drawings that 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 and 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 anastomotic ring applicator device, shown with a retracted tip. Figure 2 is a partial perspective view of the distal portion of an anastomotic ring applicator device, retaining an anastomotic ring in an unactuated position.

Figure 3 is a partial perspective view of the distal portion of the device of Figure 2, retaining an anastomotic ring in an actuated position. Figure 4 is a front view of an operated anastomotic ring. Figure 5 is a perspective view of the device of Figure 1, shown with the tip extended. Figure 6 is a perspective view of the device of Figure 1, shown with the case retracted. Figure 7 is a perspective view of the device of the figure 1, shown with a distal portion of the driven ring deployment mechanism. Figure 8 is a perspective view of the device of Figure 1, shown with a distal portion and a proximal portion of the actuated ring deployment mechanism. Fig. 9 is a view of separate parts of a ring deployment mechanism and a display system of the device of Fig. 1; Fig. 10 is a view of separate parts of a drive mechanism of the device of Fig. 1; Figure 11 is a cross-sectional view of a distal portion of the device of Figure 1. Figure 12 is a cross-sectional view of a proximal portion of the device of Figure 1. Figure 13 is a cross-sectional view of a Distant portion of the device of Figure 1 inserted through an anastomotic opening, with a distal portion of a driven ring deployment mechanism. Fig. 14 is a cross-sectional view of a distal portion of the device of Fig. 1 inserted through an anastomotic opening, with a proximal portion and a distal portion of a driven ring deployment mechanism. Figure 15 is a cross-sectional view of a proximal portion of the device of Figure 1, shown with ring deployment actuators in the actuated position, a sheath actuator in the retracted position and a locking member in the unlocked position. Figure 16 is a cross-sectional view taken in the plane 16 of the device of Figure 11. Figure 17 is a cross-sectional view taken in the plane 17 of the device of Figure 12. Figure 18 is a sectional view. transverse taken in the plane 18 of the device of figure 12. Figure 19 is a cross-sectional view taken in the plane 19 of the device of figure 12.

DETAILED DESCRIPTION OF THE MODALITIES OF THE INVENTION Turning to the drawings, in which similar numbers denote similar components in all the various views, Figure 1 depicts an applicator, 10, which is operable to deploy and actuate an anastomotic ring device (not shown in Figure 1), a generally cylindrical shape to a shape having properties of a hollow rivet, or ring, capable of forming an anastomotic junction at a target anastomosis site, for example in a gastric bariatric bypass of a morbidly obese patient. Figure 2 depicts another applicator, 12. It will be appreciated that the applicators, 10, 12, can be used in a variety of ways including, without limitation, 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 cylindrical, compressed position. In Figure 3, the deployment mechanism 16 of the applicator 12 has moved the anastomotic ring 14 to the hollow rivet-shaped position, actuated. Figure 4 is a close-up view of the anastomotic ring 14 in the actuated position. The anastomotic ring 14 may comprise a shape memory effect material (SME), such as nitinol by way of example only, which further aids the actuation to a hollow rivet coupling shape. 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 publication of the US patent application. 2003/0032967, by Park and others. It will be appreciated that the terms "near" and "distant" are used herein to refer to a clinician holding a handle of the applicator 10. It will also be appreciated that for convenience and clarity, spatial terms such as "right" and "left" , "vertical" and "horizontal", are used here with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting or absolute. In addition, the aspects of the invention have application to surgical procedures performed endoscopically and laparoscopically, as well as an open procedure or other procedures. The use of these similar terms or terms should not be considered to limit the present invention to only one category of surgical procedure. In the present example, the applicator 10 is configured to allow forward and retrograde visualization of the anastomotic site and an unfolded anastomotic ring. The applicator 10 comprises an image element (Figure 11). The image element 11 is configured to provide front display and retrograde display. As shown in Figure 1, the image element 11 is configured to provide front viewing through a tip 13, located at the distal end of an elongated arrow 15, as represented by the arrows 6. To allow the element 11 image capture a front view, the tip 13 comprises a transparent tip point, 17. Other configurations suitable for allowing the image element 11 to capture a front view, will be apparent to those of average skill in the art. In one embodiment, the image element 11 comprises one or more image fibers. As shown in Figure 5, the applicator 10 is also operable to provide retrograde visualization by moving the tip 13 distantly, from a retracted position to an extended position. The applicator 10 includes a tip actuator, 18, located on a handle, 19. The tip actuator 18 is operable to move the tip 13 from a retracted position to an extended position. The tip 13 includes a proximal edge, 20, which comprises a mirror surface. When the tip 13 is in the extended position, the image element 11 is configured to capture a reflected image of the near mirror edge 20 of the tip 13, thus giving a retrograde view, as represented by the arrows 22. Alternatively, the Applicator 10 may include one or more additional image elements positioned or operable to provide a retrograde view. Those of ordinary skill in the art will also appreciate that the applicator 10 may include one or more components other than the mirror tip 13, to provide a retrograde view through the image element 11, including without limitation an operable mechanism for relocating or reconfigure the image element in another way 11. Other methods and configurations to provide a retrograde view will be evident to those with average knowledge in the matter. In one embodiment, illumination is provided at the far end of the image element 11 with illumination fibers (not shown), which run adjacent to! Image Element 11. It will be appreciated that such illumination may assist the imaging element 11 in capturing images 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, lighting can be provided by a variety of means, devices, methods or alternative configurations. Referring now to Figure 1 and Figures 5-15, the applicator 10 of the present example has an arrow, 15, which comprises a tubular sheath, 24. The tubular sheath 24 is movable from a first position to a second position. In the first position, the sheath 24 is configured to cover a ring deployment mechanism, 26 (figures 1 and 11), to prevent tissue from being caught in the deployment mechanism 26 during insertion and removal of the applicator 10. sheath 24 is configured in such a way that the deployment mechanism 26 is exposed and free to actuate when the sheath 24 is in the second position. In addition, the applicator 10 comprises a sheath actuator, 28, operable to move the sheath 24 between the first and the second position. Suitable alternatives of the sheath 24 or sheath actuator 28 will be apparent to those of ordinary skill in the art. Referring now to Figures 6-9 and 11-14, the ring deployment mechanism 26 of the present example comprises a proximal portion, 30, and a distal portion, 32. The applicator 10 also comprises a pair of deployment actuators 34. , 36. As described in detail below, the first deployment actuator 34 is operable to drive the proximal portion 30 of the ring deployment mechanism 26.; and a second deployment actuator 36 is operable to drive the distal portion 32. In Figures 7 and 13, the distal portion 32 is shown in the actuated position to deploy a distal portion of an anastomotic ring 14. The arrow 42 represents the movement of actuation of the second actuator 36. Figures 8 and 14 show the proximal portion 30 in the actuated position to deploy a proximal portion of the anastomotic ring 14, to complete an anastomotic junction between the proximal tissue walls 46, 48. The arrow 50 represents the actuation movement of the first actuator 34. The fingers 60, 62, are configured to retain an anastomotic ring 14 by engaging the petals 51 before and during the deployment of the anastomotic ring 14, and to release the petals 51 after deployment of the ring Anastomotic 14. It will be appreciated that any suitable alternative to the ring deployment mechanism 26 or the ac Deployment tilers 34, 36. To prevent inadvertent deployment of the ring deployment mechanism 26, the applicator 10 of the present example is provided with a locking element 52. In the present example, the locking element 52 is operable to move from a locked position to an unlocked position.

In figures 1, 5, 6 and 12, the locking element 52 is shown in a locked position, which prevents the actuating movement of the first actuator 34 and the second actuator 36. In figures 7, 8 and 15, the element 52 is shown in the unlocked position, which allows the actuators 34, 36, to move to the actuated position. Referring now to Figures 9, 11, 13 and 14, tip 13 is shown, comprising a channel 54 that allows image element 11 to pass to tip 13 when tip 13 is in the retracted position. The image element 11 is passable through a guide tube, 56. The guide tube 56 is slidable within the arrow 15 and is in communication with the tip actuator 18. The distal end of the guide tube 56 comprises a plurality of connectors 58 which are attached to the tip 13. In this manner, the tip actuator 18 is operable to communicate movement to the tip 13 by means of the guide tube 56, to move the tip 13 between the retracted position and the extended position. The guide tube 56 also comprises a bushing, 59, which is configured to keep the image element 11 centered. Suitable alternative configurations of the guide tube 56 will be apparent to those of ordinary skill in the art. In the present example, the proximal portion 30 of the ring deployment mechanism 26 comprises a plurality of fingers, 60; and a distal portion 32 also comprises a plurality of fingers 62. Both the proximal fingers 60 and the distal fingers 62 are in a doubly hinged relationship with a stationary ring means, 64, of the ring deployment mechanism 26. The proximal fingers 60 are configured to slide towards the ring means 64 in response to the engagement of the first actuator 34, causing the proximal fingers 60 to act externally of the arrow 15. The ring means 64 is held stationary by a fixed stationary tube, 65. Similarly, the fingers 62 are configured to slide towards the ring means 64 in response to the actuation of the second actuator 36, causing the distal fingers 62 to be actuated externally of the arrow 15. As shown in FIGS. 9, 11, 13 and 14, the components previously described actuators of the ring deployment mechanism comprise a series of concentric tubes, 82, 65, 80, within the arrow 15. A bushing 66 (figures 8, 9, 11, 13 and 14) is included within the arrow 15 to keep the concentric tubes centered. However, it will be appreciated that the components described above do not need to be concentrically aligned and any suitable alternative of the bushing 66 can be used. As indicated above, the first deployment actuator, 34, of the present example, is operable to control the next fingers 60, and the second deployment actuator, 36, is operable to control the distal fingers 62. The first and second ring deployment actuators 34, 36, comprise a pair of notches, 67, which are adapted to run on a rail 68. (figure 10) of the handle 19. The path of the first actuator 34 is limited by the width of a groove, 70, while the path of the second actuator 26 is limited by the width of a groove, 72. As mentioned before, the The locking element 52 can be used to prevent inadvertent movement of the first or second actuator 34, 36, within the slots 70, 72, respectively. In the present example, the first actuator 34 is fixedly attached to a proximal portion, 74, of the rail 68. The rail 68 is slidable within the handle 19. A distal portion 76 of the rail 68 is fixedly attached to a slider 78, which is slidably coupled with the handle 19. The slider 78 is fixedly attached to the outer tube 80. The longitudinal movement of the first actuator 34 is thus operable to cause the corresponding longitudinal movement of the rail 68, the slider 78 and the outer tube 80. Other suitable relationships between these components, as well as alternative components, will be evident to those with average knowledge in the field. The proximal end of the fixed tube 65 is fixedly attached to the anchor member 84. The anchor member 84 is configured to engage protuberances, 86, which are integral with the handle 19. Accordingly, in the present example, the anchor 84 and the protuberances 86 are configured to prevent relative movement between the fixed tube 65 and the handle 19. Of course, other configurations may be used. The second actuator 36 is attached to an inner tube, 82. The inner tube 82 extends longitudinally through the fixed tube 65. The inner tube 82 is operable to communicate movement to the distal fingers 62.

In this way, the first actuator 34 controls the actuation of the proximal fingers 60, and the second actuator 36 controls the actuation of the distal fingers 62. It should be noted that although the second actuator 36 is configured to slide on the rail 68 in the present example, the second actuator 36 is not statically connected to the rail 68. Therefore, the longitudinal movement of the rail 68 caused by the movement of the first actuator 34, does not cause longitudinal movement of the second actuator 36. Of course, the handle 19 and its components can be configured in any other suitable way. 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. Other suitable alternative configurations will be apparent to people with average knowledge in the matter. Referring to Figures 10, 12 and 15, the proximal end of the image element 11 terminates in the bracket, 88, and is fixed thereon. The bracket 88 is configured to be coupled with an endoscope or other imaging device, which can be used to amplify or view the image captured by the image element 11. A locking slide collar, 90, is disposed on the imaging element 11. , and can run over the bracket 88 to secure the bracket 88 to an endoscope or other device. In the present example, the image element 11 is not fixed securely inside the applicator 10. In this way, the image element 11 can be pushed or pulled with respect to the applicator 10 to longitudinally position the image element 11. As a result of example only, the image element 11 itself or the collar 90 can be clamped to perform said movement. Other ways to position the image element 11 will be apparent to those of average skill in the art. It will also be appreciated that the image element 11 can be securely secured within the applicator 10. Of course, as with other components described above, the above components are optional and a variety of other configurations can be used to facilitate observation of images captured by the image element 11, as well as alternative configurations for coupling the image element 11 or other parts of the applicator 10 with other devices. During use, the applicator 10 can be inserted adjacent to an anastomotic opening in adjacent tissue walls 46, 48. The tip 13 can be located in the retracted position allowing the image element 11 to capture a front view through the point of transparent tip 17. Once the tip 13 is inserted through the anastomotic opening, the tip 13 can be extended using the tip actuator 18. With the tip 13 in the extended position, the image element 11 can capture a view retrograde reflected from the proximal mirror edge 20 of the tip 13. The sheath actuator 28 can be used to retract the sheath 24 and expose the ring deployment mechanism 26. After an anastomotic ring 14 has been deployed, the tip 13 it can be withdrawn through the anastomotic opening, and the tip 13 can be moved to the retracted position using the tip actuator 18, such that the anastomotic junction can be seen from above. front to confirm the appropriate deployment. Other variations of the use of the applicator 10 will be evident for people with average knowledge in the field. Having shown and described various embodiments and concepts of the invention, a person with ordinary skill in the art can make further adaptations of the methods and systems described herein by appropriate modifications, without departing from the scope of the invention. Several of these alternatives, modifications and potential variations have been mentioned, and others will be evident to the expert in light of the previous teachings. Accordingly, it is considered that the invention encompasses all of these alternatives, modifications and variations that may be within the spirit and scope of the appended claims, and is understood to be not limited to the details of the structure and operation shown and described in specification and drawings. Additional advantages may easily appear for those skilled in the art.

Claims (20)

NOVELTY OF THE INVENTION CLAIMS

1. - A surgical instrument for implanting an anastomotic ring device at an anastomosis site, comprising: (i) a handle; (ii) an elongated arrow comprising a proximal portion and a distal portion, the proximal portion being attached to the handle; (iii) a ring deployment mechanism in the distal portion of the arrow, the ring deployment mechanism being configured to receive and deploy an anastomotic ring; and (iv) one or more image elements placed in or on the elongated arrow, wherein at least one of the image elements is operable to capture an image of an anastomosis site.

2. The surgical instrument according to claim 1, further characterized in that at least one of the image elements comprises one or more image fibers.

3. The surgical instrument according to claim 1, further characterized in that it comprises one or more illumination fibers operatively configured to transmit light to the distant portion of the elongated arrow to assist the image element in capturing an image.

4.- The surgical instrument in accordance with the claim 1, further characterized in that it comprises a tip in the distal portion of the elongated arrow.

5. The surgical instrument according to claim 4, further characterized in that the tip comprises a substantially optically transparent tip point.

6.- The surgical instrument in accordance with the claim 5, further characterized in that the tip comprises a proximal mirror edge.

7.- The surgical instrument in accordance with the claim 6, further characterized in that the tip is movable from a retracted position to an extended position.

8. The surgical instrument according to claim 7, further characterized in that at least one of the image elements is operable to capture a front image when the tip is in the retracted position.

9.- The surgical instrument in accordance with the claim 7, further characterized in that at least one of the image elements is operable to capture a retrograde image of the proximal mirror edge of the tip, when the tip is in the extended position.

10. The surgical instrument according to claim 7, further characterized in that it comprises a tip actuator operable to move the tip between the retracted position and the extended position.

11. The surgical instrument according to claim 10, further characterized in that it comprises a guide tube attached to the tip actuator.

12. - The surgical instrument according to claim 11, further characterized in that it comprises a plurality of connectors connecting the guide tube with the tip.

13. The surgical instrument according to claim 1, further characterized in that it comprises a clamping mechanism configured to couple at least one of the image elements with an image amplification device.

14. The surgical instrument according to claim 13, further characterized in that the arrow also comprises a retractable sheath.

15. A surgical instrument for implanting an anastomotic ring device at an anastomosis site, comprising: (i) a handle; (I) an elongated arrow comprising a proximal portion and a distal portion, the proximal portion being attached to the handle; (iii) a ring deployment mechanism in the distal portion of the arrow, the ring deployment mechanism being configured to receive and deploy an anastomotic ring; (iv) one or more image elements placed on the distant portion of the elongated arrow, said image elements (one or more) being operatively configured to capture an image of a front view and a retrograde view of the site of the anastomosis.

16. A surgical instrument for implanting an anastomotic ring device at an anastomosis site, comprising: (i) a drive member, configured to receive an anastomotic ring and movable between an undriven cylindrical position and a rivet forming position hollow in response to a compressive driving force; (ii) a handle, which includes a drive mechanism operable to produce the compressive driving force; and (iii) an elongated arrow, which joins the handle to the drive member and is operatively configured to transfer the compressive driving force of the handle to the drive member; (iv) one or more image elements placed in or on the elongated arrow, wherein the image elements (one or more) are operable to capture a view of an anastomosis site.

17. The surgical instrument according to claim 16, further characterized in that it comprises a pair of input members configured to receive user input to generate the compressive driving force.

18. The surgical instrument according to claim 17, further characterized in that it comprises a locking element configured to prevent inadvertent coupling of the entry members.

19. The surgical instrument according to claim 18, further characterized in that the entry members are each slidable from a first non-actuated position to a second actuated position. 20.- The instrument. according to claim 19, further characterized in that the locking element is movable from a locked position to an unlocked position, wherein the locking element is configured to prevent the entry members from slipping into the second actuated position when the Locking element is in the locked position.