MXPA06007381A - Implantable medical device with indicator. - Google Patents

Abstract

An attachment mechanism for a surgically implantable medical device includes one or more fasteners which may be simultaneously moved from an undeployed position to a deployed position by operation of an integral actuator. The attachment mechanism may be configured to be deactuated, and the fasteners simultaneously moved from a deployed position to an undeployed position, allowing removal or repositioning of the medical device. An applier includes a locator for detachably holding the implantable medical device, locating it at the desired position, and actuating the attachment mechanism. The applier is configured to undeploy the attachment mechanism the implantable medical device can be detached from the body tissue.

Description

IMPLANTABLE MEDICAL DEVICE WITH INDICATOR This application incorporates as a reference the following U.S. patent applications, all of which were filed on December 19, 2003: Application Serial No. 10/741, 127, entitled Opening for Subcutaneous Injection for Applied Bras; Application Serial No. 10 / 10,741, 875, entitled Opening for Subcutaneous Self-Injecting with Integral Mobile Retention Members; and Application Serial No. 10/741, 868, entitled Opening for Subcutaneous Injection Self-Coaxing with Integrated Fasteners.

TECHNICAL FIELD OF THE INVENTION The present invention relates generally to medical implants and applicators therefor, and more particularly, to a joining mechanism for use with a variety of medical implants and applicators for attaching such medical implants to body tissue. The invention will be described with respect to, non-exclusively, surgically implantable injection openings and an applicator thereof.

BACKGROUND OF THE INVENTION The implantable medical devices are typically implanted in a patient to perform a therapeutic function for that patient. Non-limiting examples of such devices include pacemakers, vascular access openings, injection openings (such as used with gastric bands), and forward gastric devices. Such implants need to be attached, typically subcutaneously, in an appropriate place in order for them to function properly. It is desirable that the method for implementing such devices be quick, easy and efficient. In many cases, it would be beneficial if the surgeon could remove or reposition the device quickly, easily and efficiently. The present invention encompasses a joining mechanism for securing a medical implant device to body tissue in a quick and easy manner. The binding mechanism can be reversible, allowing the implantable medical device to detach quickly, and be easily replaced or removed. Although standard, available commercial instruments can be used to drive the attachment mechanism, the present invention also encompasses an applicator for locating an implantable medical device in the desired location and quickly and easily activating the attachment mechanism to secure the implantable medical device. .

BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are incorporated in, and constitute a part of, this specification, illustrate the embodiments of the invention, and, together with the general description of the invention provided above, and the detailed description of the modalities provided below, serve to explain the principles of the present invention. Figure 1 is a perspective view of an opening for injection with a joint mechanism constructed in accordance with the present invention. Figure 2 is a top view of the opening for injection of Figure 1. Figure 3 is a bottom view of the opening for injection of Figure 1. Figure 4 is a cross-sectional view of the opening for the injection of Figure 1, taken along line 4-4 of Figure 3. Figure 5 is an exploded perspective view of the opening for injection of the Figure. Figure 6 is a perspective view of the bottom of the opening for injection of Figure 1, showing the joint mechanism in the retracted position.

Figure 7 is a perspective view of the bottom of the opening for injection of Figure 1, similar to Figure 6, showing the joint mechanism in the extended / fired position. Figure 8 is a cross-sectional side cross-sectional view illustrating a fastener of the joint mechanism in the retracted position. Figure 9 is a sectional side cross-sectional view similar to Figure 8, which shows a fastener of the joining mechanism that is advanced by the actuator ring to the extended / fired position. Figure 10 is a sectional side cross-sectional view similar to Figure 8, illustrating a fastener of the joint mechanism in the extended / fired position. Figure 11 is a sectional side cross-sectional view similar to Figure 8, illustrating a fastener of the attachment mechanism that is advanced by the actuator ring to the retracted position. Figure 12 is a top view of the injection opening of Figure 1, with the actuator ring omitted to illustrate the positions of the connections when the fasteners are in the retracted position. Figure 13 is a top view of the injection opening of Figure 1, with the actuator ring omitted to illustrate the positions of the connections when the fasteners are in the extended / fired position. Figure 14 is an enlarged, fragmented top view of the visual position indicator and the arrest system of the actuator ring of the joint mechanism of Figure 1, in the retracted position. Figure 15 is an enlarged, fragmented top view of the visual position indicator and the arrest system of the actuator ring of the joint mechanism of Figure 1, in the extended / fired position. Figure 16 is an exploded, fragmented, exploded perspective view of the installation and securing connector for the injection opening of Figure 1. Figure 7 is an enlarged, fragmented, partial cross-sectional view of the connector Assurance mounted to septum retainer attachment, but not secured in place. Figure 18 is an enlarged, fragmented view, in partial cross-section similar to Figure 17, showing the securing connector connected in place. Figure 19 is an enlarged perspective view of the security lid. Figure 20 is a perspective view of an applicator constructed to implant the opening for injection of Figure 1.

Figure 21 is an exploded perspective view of the applicator of Figure 20. Figure 22 is a side view of the applicator of Figure 20, with one of the two halves of the body showing the internal components in the unstressed position. apply, not activated. Figure 23 is a side view of the applicator of Figure 20, similar to Figure 22, showing the internal components in the applied, actuated position. Figure 24 is an enlarged, fragmented view of the rotary linear cam mechanism of the applicator of Figure 20. Figure 25 is an enlarged, top perspective view of the applicator locator of Figure 20. Figure 26 is an amplified view in bottom perspective of the locator and the actuator of the applicator opening of Figure 20. Figure 27 is a partially cut away end view of the applicator locator of Figure 20. Figure 28 is an amplified view, in cross section of the opening for injection of Figure 1, maintained by the locator of the applicator of Figure 20. Figure 29 is an enlarged, cross-sectional view of the opening for injection of Figure 1, placed in the locator of the applicator of Figure 20, after the applicator has been operated to rotate the applicator driver to the deployed position.

Reference will now be made in detail to the present preferred embodiment of the invention, an example of which is illustrated in the accompanying drawings.

DETAILED DESCRIPTION OF THE INVENTION In the following description, similar reference characters designate similar or corresponding parts throughout the various views. Also, in the following description, it will be understood that terms such as front, back, inside, outside, and the like, are words of convenience and should not be considered as limiting terms. The terminology used in this patent is not intended to be limiting, insofar as the devices described herein, or portions thereof, may be joined or used in other orientations. Referring in more detail to the drawings, one embodiment of the invention will now be described. Referring to Figures 1-5, there is shown an implantable medical device, more specifically, an opening for injection, generally indicated at 2, incorporating a joining mechanism constructed in accordance with the present invention. Although the linking mechanism is illustrated in the figures as being incorporated with an opening for injection 2, the joining mechanism can be used with any implantable medical device for which only pacemaker, vascular access openings, for example, are suitable. openings for injection (such as those used in gastric bands) and gastric advance devices. The opening for injection 2 includes the seal of the septum 4, the septum 6 and the body of the opening 8. The opening for injection 2, with the integrally constructed joining mechanism, also includes one or more fasteners 10, the actuator 12 and a plurality of connecting members 14. As seen in Figure 4, the septum 6, which can be made of any biocompatible material such as silicone, is placed partially within the internal cavity 16 of the septum retainer 4, the annular recess adjacent 8. The seal of the septum 4, the body of the opening 8 and the actuator 12, can be made of any suitable biocompatible material having sufficient stiffness and strength, such as polyether ether ketone (known as PEEK). The fasteners 10 and the connecting members 14 may be made of any suitable biocompatible material, such as stainless steel. The body of the opening 8 includes an annular flange 20, which couples the upper surface of the septum 6 around an annular portion. The body of the opening 8 is held next to the seal of the septum 4, by a plurality of bolts 22, which are placed through respective holes 24, formed in recesses 24a in the body of the opening 8 and extending inwardly. in respective recesses 26, formed around the periphery of the septum retainer bottom 4. The bolts 22 can be made of any biocompatible material, such as stainless steel.

The uncompressed height of the septum 6 is about 5 mm around the outside diameter and the uncompressed diameter is about 18 mm. The exposed diameter for access to the tank 20 is approximately 14 mm. The distance between the lower surface of the annular flange 20 and the annular recess 18 is approximately 4 mm, so that the septum 6 is compressed by approximately 20% in order to self-couple adequately to maintain a fluid-tight system under pressure and allow Still a low profile. The plate 28 is placed in the recess 16a formed in the bottom of the seal of the septum 4, underlying the septum 6 and the chamber or reservoir of fluid 30. As seen in Figure 4, the plate 28 does not come into contact with the wall lateral 16b. In the described embodiment, plate 28 is metallic, such as stainless steel. When the needle is inserted through the septum 6 to introduce or withdraw the fluid from the fluid chamber 30, such as to adjust the size of an adjustable gastric band, the metal plate 28 will protect the septum retainer 4 from the perforation, and will provide tactile feedback to the surgeon through the needle indicating that the needle has touched the bottom in the reservoir 30. The plate 28 can be secured to the septum retainer 4 in any suitable manner. In the described embodiment, the plate 28 is held in place by a retaining lip 4a extending over the periphery of the plate 28 as best seen in Figures 4, 28 and 29. Initially, the retaining lip 4a, it extends upwards like an annular lip, they provide a space for the insertion of the plate 28 into the recess in the bottom of the septum retainer 4, and the retaining lip 4a is then rolled up or otherwise deformed to cover the less a portion of the periphery of the plate 28, thereby retaining the plate 28. In the described embodiment, the diameter of the recess 16a is smaller than the diameter of the side wall 16b, providing space to form the annular lip and to deform it in the retaining lip 4a. The plate 28 can be inserted molded, with the retaining lip 4a molded as illustrated. The seal of the septum 4 includes the passage 32, in fluid communication with the fluid chamber 30, which is defined by the fitting 34, which extends from the periphery adjacent the bottom of the retainer 4. The tube 36, which, in the described modality, leads to an adjustable gastric band (not shown), is connected to the accessory 34, which is pressed compressively against the annular edge 38 by the connector 40, which is placed around the 36 and secured to the body of the opening 8 as described below. The sleeve 42 is placed around the tube 36, is secured to the connector 40 by the annular edges 44. The sleeve 42 relieves the tension in the tube 36, preventing the tube 36 from twisting when it is laterally loaded. The actuator 12 is secured to the body of the opening 8. Although in the described embodiment, the actuator 12 is illustrated as an annular ring rotatably supported by the body of the opening 8, the actuator 12 can be of any suitable configuration and supported in any suitable manner to allow the actuator 12 to operate to move the fasteners 10 between and including the deployed and undeployed positions.

As seen in Figure 5, the body of the opening 8 includes a plurality of tabs extending downwardly and outwardly 46. In the described embodiment, there are four equally spaced tabs 46. The actuator 12 includes an equal number of recesses. corresponding 48, each having an arched bottom 50. To mount the actuator 12 to the body of the opening 8, the recesses 48 align with the tabs 46, and are pushed down, temporarily flexing the tabs 46 inward, until the tongues 46 reach the recesses 48 and move outwards to place the lower sides 46a in the recesses 48, so that the actuator is retained by them. The lengths of the tabs 46 and the depth of the holes 48 allow some axial end play between the actuators 12 and the body of the opening 8, as will be described below. The actuator 12 can rotate generally about the central axis of the opening body 8. In the described embodiment, the actuator 12 can rotate through an angle of approximately 40 degrees, although any suitable angle can be used. In the described embodiment, when the actuator 12 is rotated in the deployment direction, causing the fasteners 10 to move to the deployed position, rotation of the actuator 12 beyond the fully deployed position is limited by the end 48c of the contact tongue 46. A stop system is formed by a pair of separate raised stop edges 48a, 48b, extending inward from the wall of each recess 48, and a corresponding raised edge 46b, extending outward from the tongue 46. The stop system helps prevent the actuator 12 from rotating and the fasteners 10 from moving completely retracted or fully extended, triggered under vibration or incidental charges, as described below. The actuator 12 includes a plurality of spaced openings or slots 54, which can be coupled by any suitable instrument for transmitting adequate torque to the actuator 12 to extend the fasteners 10 to the actuated position. The slots 54 are configured to be coupled by commercially available, rectangular instruments in the manner described, or by the dedicated applicator described below. The body of the opening 6 includes a plurality of recesses 56, positioned around its lower periphery, which are configured to cooperate with the dedicated applicator as described below. Referring also to Figures 6 and 7, the septum retainer 4 includes a plurality of location tabs 58, which extend outward from the periphery of the adjacent septum retainer bottom 4. The location tabs 58a may be integral with the septum. accessory 34. The tongues 58 and 58a, are located in recesses with respective complementary shapes 60, formed on the inner surface of the body of the opening 8, aligning the seal of the septum 4 appropriately with the body of the opening 8.

Figure 6 illustrates the fasteners 10 in the retracted position. As can be seen, the fasteners 10 are placed in respective recesses or grooves 60, formed in the body of the opening 8. Figure 7 illustrates the fasteners 10 in the extended or fired position, which extend from the grooves 60. The rotation of the actuator 12 moves the fasteners 10 from the retracted position to the extended position. Figures 8-11 are a series of figures illustrating the operation of the actuator 12 and one of the plurality of fasteners 10, it is understood that the operation in one of the fasteners 10 can be the same for all the fasteners 10, which can , in one embodiment, move from a deployed position to a non-deployed position simultaneously. Figure 8 illustrates the fastener 10 in a fully retracted state, the undeployed position, positioned completely within the groove 62, so that the sharp tip 64 is not exposed. This prevents tip 64 from accidentally being keyed into the surgeon or penetrating any object. The actuator 12 is shown rotated counterclockwise, as allowed by the recesses 48 and the tabs 46. In this position, the edges 46b are positioned clockwise from the edges 48b , as seen in Figure 14. The first ends 14a of the connecting members 14 are rotatably carried by the actuator 12, separated in positions corresponding to the positions of the fasteners 10. The second ends 14b are placed within the openings 66 of the fasteners 10.

To actuate the joint mechanism, the integral actuator 12 is rotated in a deployment direction, which, in a manner as described, is clockwise (any suitable direction configured to drive the joint mechanism may used), and edge 46b passes edge 48b, which can produce an audible signal in addition to a tactile signal to the surgeon. The second end 14b of the connecting member 14 is free to move within the slot 66 during actuation, as the force rotating the fastener 10 towards the extended position is transmitted to the fastener 10 through the interaction between the cam surface 68 of the holder 10 and the actuating cam surface 70 of the actuator 12. As the actuator 2 rotates clockwise, the actuating cam surface 70 engages and pushes against the cam surface 68, rotating the fastener 10 around the pivot pin 22. The majority of the force of the drive cam surface 70 acts tangentially on the cam surface 68, off-center relative to the pivot pin 22, causing the fastener 10 to rotate. During actuation, the end 14b of the connecting member 14 remains free to move within the slot 66, without applying any driving force to rotate the fastener 10. In Figure 9, the fastener 10 is rotated approximately half of its range of rotation, approximately 90 degrees as a result of the clockwise rotation of the actuator 12. As the actuator 12 rotates clockwise, the force between the cam surface of the actuator 70 and the surface of cams 68 causes the actuator 12 to move up slightly, as allowed by the tolerances of the components. As the actuator 12 further rotates clockwise from the position shown in Figure 9, the cam surface of the actuator 70 continues to engage and push against the cam surface 68, rotating the fastener 10 further in the direction counterclockwise. In Figure 10, the actuator 12 rotates clockwise to its full extent, with the edge 46b that has been propelled beyond the stopping edge 48a (see Figure 15). In this position, the fastener 10 has rotated to its full extent, almost 180 degrees in the illustrated embodiment, with the tip 64 positioned within the gap 62. In this position the cam surface of the actuator 70 is on the center, and the actuator 12 is resistant to return driven by an unfolding force imparted to the fastener 10, as the cam surface 68 acts against the cam surface of the actuator 70, in a direction that tends to push the actuator 12 upward, instead of rotating the actuator 12. The distal end portion of the fastener 10 is essentially configured as a beam, described as having a generally rectangular cross section over its entire length, tapering towards the sharp tip 64. With the fastener 10 extending approximately 180 degrees in the fully extended, the position deployed, the forces that can act on the fasteners 10, tend to act through the pivot axis defined the pivot pin 22, instead of rotating the fasteners 10. Note that although the bolt 22 is illustrated as a separate part of the fastener 10, the two can be integral or even of unitary construction. If it is desirable to retract the fasteners 10, such as to remove or replace the implanted device, the actuator 12 may be rotated in an undeployed direction, counterclockwise in a described manner. Starting with the position of the actuator 12 shown in Figure 10, the actuator 12 can be rotated counterclockwise, with the cam surface of the actuator 70 sliding against the cam surface 68, without rotating the fastener 10. In the described embodiment, the rotation continues in the counterclockwise direction of the actuator 12, moves the cam surface 70 out of contact with the cam surface 68, without any substantial rotational force, which is exerted on the fastener 10, until the second end 14b of the connecting member reaches a location in the slot 66, such as at one end of the slot 66, in which the connecting member 14 begins to pull against the slot 66, causing the fastener 10 turn and start to retract. As seen in Figure 11, the actuator 12 has been advanced in the counterclockwise direction, as compared to the position shown in Figure 10, and the fastener 10 is rotated approximately half through its range. . As can be seen by comparing Figure 9 with Figure 11, the actuator 12 is in different positions with the fastener 10 in the same position, depending on whether the joint mechanism is being actuated or not actuated (retracted). This results from the loss of movement that results when the connecting member 14 is pulling in the groove 66, as compared to the cam surface of the actuator 70, which pushes directly on the cam surface 68. To retract the fasteners 10 completely, the actuator 12 rotates until the stop edge 46b presses past the stop edge 48b. Referring to Figure 8, when the fasteners 10 reach the fully undeployed position, the tip 64 can be completely placed in the groove or recess 62. The further undeployed rotation of the actuator 12 is prevented by the connecting member 14, which is prevented to move further by the fastener 10. Referring to Figures 2 and 3, the actuator 12 includes openings 52a formed therethrough, which align with the corresponding openings 52b formed in the body of the opening 8 when the actuator is in the position not deployed. The openings 52a and 52b can be slid by the surgeon to suture the opening for injection 2 if the integral joint mechanism is not used. Referring to Figures 12 and 13, the joining mechanism is shown without the actuator 12. The connecting members 14, they are shown in their real positions when the first ends 14a are supported by the actuator 12, in the deployed and undeployed states. Referring to Figures 14 and 15, a top view of the visual position indicator and a portion of the stop system of the actuator ring of the joint mechanism as incorporated in the opening for injection 2 is illustrated. In Figure 14, the Union mechanism is in the state or position retracted, not deployed. In this position, the stop edge 46b is clockwise of the stop edge 48b, and therefore, is in the undeployed stop position. In Figure 5, the joint mechanism is in the actuated or unfolded position. In this position, the stop edge 46b is counterclockwise of the stop edge 48b, and therefore, in the deployed stop position. Figures 14 and 15 illustrate a visual indicator of the state of the joining mechanism. As shown in Figure 14, indications may be used, such as an open lock icon 72 and a closed padlock icon 74 integrally molded with the driver ring 12. Any suitable graphic indicator may be used, and may be printed or printed. applied differently in a suitable way. The body of the opening 6 may include an indicator 76 to provide a reference point for the mobile indications. The arrow 78 can be included to indicate bidirectional movement of the actuator 12.

Figures 16-8 illustrate the securing connection between the connector 40 and the body of the opening 6. Figure 16 is an exploded perspective view showing the accessory 34 partially surrounded by the extension 78. Figure 17 shows the extension 78 in cross section, with the connector 40 generally positioned around the fitting 34 and the tube 36 aligned in the circumferential groove 78c of the extension 78. The connector 40 includes a pair of tabs 40a, 40b, extending outwardly therefrom. For mounting, the connector 40 is guided along the tube 36 and the fitting 34, with the tabs 40a and 40b aligned with the openings 78a and 78b of the extension 78. With the tabs 40a and 40b aligned with the circumferential groove 78c, the connector 40 is rotated to secure it in place. During rotation, the side 78d creates interference against the rotation of the tongue 40a, but is dimensioned to allow the tongue 40a to rotate further, to the secured position observed in Figure 18. Figure 19 illustrates the safety cap 80, which can be removably secured to the bottom of the injection opening 2 to cover the fasteners 10, to protect users from accidental exposure to the sharpened tips 64 while handling the opening for injection 2. The safety cap 80 includes a body 82 with an annular flange 84 and an elevated center 86, defining an annular recess 88. The safety cap 80 can be oriented and maintained with the opening for injection through any suitable configuration. As described, the body 82 includes a plurality of arcuate retention tabs 90, which extend upwardly from the raised center 86. The arcuate retention tabs 90 are formed in a complementary manner with the corresponding arcuate slots 92, best observed in the Figures 3, 6 and 7, and may have edges as shown. The safety cap 80 is secured to the opening for injection 2 by inserting the arcuate retention tabs 90 into the arcuate grooves 92, which are dimensioned to retain the tabs 90. The fasteners 10 thus align with the annular recess 88, the which is dimensioned to allow the fasteners 10 to extend without coming into contact with the safety cap 80. As described, since the arcuate retention tabs 90 and the arcuate grooves 92 are respectively of the same size and equally spaced, the cap of security 80, is not indexed to a particular position, and can be secured to the opening for injection 2 in four different positions. The security cover 80 includes the pull tab 94 with a plurality of raised edges 96 to provide a better holding surface. Although the pull tab 94 can be oriented in any suitable orientation, in the embodiment, the relative position between the pull tab 94 and the arcuate retention tabs 90 locates the pull tab at 45 degrees towards the direction of the connector 40. The tabs 90 and the slots 92 may be of any suitable form.

As previously mentioned, the joining mechanism can be actuated by engaging the slots 54 with commercially available instruments or by a dedicated applicator. Figure 20 illustrates an applicator, generally indicated at 100, which is configured to position, actuate, actuate, remove or replace the opening for injection 2. Note that the practice of the aspects of the present invention for an applicator, it is not limited to the specific applicator modality described herein. As shown in Figure 20, the applicator 100 includes a body 102, a locator 104, an actuator 106 and a safety switch 108. As will be described below, the opening for the injection 2 can be mounted in the locator 104, with the extension 78 and the tabs 96 placed in the alignment slots 110 and 112. The locator 104 is angled relative to the body 102, allowing easier and better visualization of the opening for injon 2 during implantation. In the described embodiment, the angle is 20 degrees and the axis portion of the body 102 is 10 cm. Referring to Figure 21, the body 102 includes first and second halves 102a and 102b, mounted with one another to contain the internal components. Except for locating pins 202, pivot bolts 114 and shipping wrap, body halves 102a and 102b are substantially similar to one another. The locating pins 202, illustrated as extending from the middle of the body 102a, fit into the respve complementary shaped openings (not shown) in the body half 102b. The coupling of the plurality of locating pins 202 in the openings is sufficient to maintain the body halves 102a and 102b together. The bolts 202 can extend alternately of the body half 102b with the openings carried by the body half 102a. Any suitable configuration can be used to assemble and secure the body halves 102a and 102b together. The actuator 106 includes first and second halves 106a and 106b. The locating bolts 204, illustrated as extending from the middle of the actuator 106a, fit into the respve complementary shaped openings (not shown) in the middle of the actuator 106b. The bolts 204 may extend alternately of the half of the actuator 106b with the openings carried by the half of the actuator 106a. Any suitable configuration can be used to assemble and secure the halves of the actuator 106a and 106b together. The body half 102b includes a pivot pin 114b, which rotatably supports the actuator 106 at one end, extending through the holes for the pivots 116a and 16b in the opening 114a. The body half 102a includes a pivot pin 18b (see Figure 22), which rotatably supports the safety switch 108. The body halves 102a and 102b, the locator 104, the halves of the actuator 106a and 106b, and the Safety switch 108, can be made of any biocompatible material, such as polycarbonate.

Referring to Figures 21-24, the applicator 100 includes a cam 120, a drive shaft 122 with a flexible shaft 124, a drive shaft bolt 126, a cam return spring 128, a safety bypass spring 130, and an actuator 132. The actuator 132 is configured to effect the deployment or non-deployment of the attachment mechanism of the medical implant. The cam 120 includes the shaft 134 and the collar of the cam 136. The upper end of the shaft 34 has a "T" configuration, which terminates in a transverse member 138. The collar of the cam 136 defines a hollow interior and a pair of cam tracks, formed in a complementary manner, spaced 140a and 140b, formed on opposite sides of the cam collar 136. The upper end 122a of the drive shaft 122 is positioned partially within the hollow interior defined by the cam collar 136, captured therein by the drive shaft bolt 126. The drive shaft bolt 126 is dimensioned so that each end is located within the track of the respective cam 140a, 140b. The length of the hollow interior allows the end 122a to oscillate therein, with the cam tracks 140a and 140b imparting rotation to the actuating arm 122 through the bolt of the drive shaft 126 during oscillation. The cam 120, the drive shaft 122 and the actuator 132 can be made of any suitable material having sufficient stiffness and strength. In the described embodiment, the cam 120 and the actuator 132 are made of a liquid crystal polymer, such as Vectra ™ LCP, and the drive shaft 122 is made of a PPE + PS, such as Noryl ™. The pin of the drive shaft 126 and the spring returning the cam 128 can be made of any suitable material, such as stainless steel. The cam 120 is retained between the portions of the body 102a and 102b, and in one embodiment, such as the one described, may oscillate. The collar of the cam 136 has generally planar external surfaces 142a and 142b through which the tracks 140a and 140b are formed. These surfaces 140a and 140b are positioned between the guide walls 144a and 144b formed in the body portions 102a and 102b. The collar of the cam 136 also includes opposite oriented channels 146a and 146b (see Figure 23), which are guided for axial oscillation by the guides 148a and 148b (not shown), formed in the portions of the body 102a and 102b , respectively. The upper end of the shaft 134 and the transverse member 138 are placed interspersed between the halves of the actuator 106a and 106b. Each half of the actuator 106a, 106b includes a track for the cam 150, defined by a pair of spaced-apart walls 150a and 150b, which extend from the inner surfaces of the actuator halves 06a and 106b. The track for the cam 150 is configured to receive and guide a transverse member 138 as the actuator 106 rotates about the bolt 114, forcing the cam 120 to advance linearly downward toward the body 102. The drive shaft 122 includes an annular collar 152 received in slots 154a and 154b (not illustrated), formed in the body halves 102a and 102b, respectively. The grooves 154a and 154b rotatably support the drive shaft 122. The drive shaft 22 and the cam 120 are generally aligned collinearly with one another, defining the axis of the axis portion of the body 102. According to FIG. When the cam 120 is advanced downwardly, the drive shaft bolt 126 follows the tracks for the cam 140a and 140b, causing the drive shaft 122 to rotate, thereby converting the linear movement to rotary movement. The spring returning the cam 128 provides a nominal return force against the cam collar 136. The flexible shaft 124 is supported by a plurality of edges 156, formed in each body half 102a, 102b, which support bending in the body. flexible body 124 which allows the rotary movement to be transferred to the actuator 132, which is positioned at an angle relative to the axis of the body 102. The flexible shaft 124 can be made of any suitable biocompatible material, such as stainless steel. In a described embodiment, the flexible shaft 124 has a braided construction, with a central core having multiple layers of wire wrapped around it. The ends 124a and 124b of the flexible shaft 124 can be attached to the end 122b and the actuator 132, respectively, in any suitable manner, which sufficiently limits the rotational end play to avoid or minimize the loss of rotational movement. In a described embodiment, the end 124a is overmold at the end 122b, and the end 124b is pressed on the actuator 132. Alternatively, the end 124a may be pressed at the end 122b, and the end 124b overmoulded at the actuator 132, both can be pressed or both can be overmoulded (with a corresponding change in locator configuration 104 to allow assembly). Referring to Figures 21-25, the actuator 132 includes a disc-shaped member 158 and an axis 160 extending upward therefrom. The upper end of the shaft 160 includes a pair of outwardly extending tabs 162a and 162b. Locator 104 includes a hub 64 defining a bore 166 through. The perforation 166 is formed to rotatably receive and support the shaft 160, and includes two outwardly extending arcuate recesses 168a and 168b configured to provide a space for mounting for the tabs 162a and 162b, allowing the hub 164 to be insert into the perforation 166. The lengths of the shaft 160 and the hub 164, are dimensioned so that the tabs 162a and 162b are located above the upper surface 164a of the hub 164, allowing the rotation of the actuator 132, while retaining it axially relative to the hub 164. The stops 170 and 70b extend upwardly from the upper surface 164a, limiting the rotation of the actuator 132. The bore 166 defines a central axis of the locator 104 about which the actuator 132 rotates. The central axis of the locator 104 is positioned at an angle to the axis of the body axis portion 102, as previously mentioned. The hub 164 includes a pair of opposingly extending tabs 172a and 172b, which retain the actuator of the opening 104 with the body 102 and prevent rotation. The body halves 102a and 102b include respective recesses 174a (see Figure 21) and 174b (not shown), formed in a complementary manner with the tabs 172a and 172b. Referring also to Figures 26 and 27, the disc-shaped member 158 of the actuator 132 is observed to be located within the locator 104. The actuator 132 includes a pair of spaced apart posts 176a and 76b, extending from the adjacent periphery 158a of the member 158. Posts 176a and 176b are formed in a complementary fashion with openings 54. In the described embodiment, the distal ends of posts 176a and 167b are tapering to assist guide posts 176a and 176b toward openings 54. any suitable configuration being used to create a releasable contact between the actuator 132 and the actuator 12, capable of actuating the actuator 12. The disc-shaped member 158 also includes a pair of spaced-apart cams 178a and 178b, which extend outwards and up from the periphery 158a of the member 158. Figure 27 illustrates the cam 178a in a cross section taken near the bottom surface of the member 158. The cams 178a and 1 78b include ramps 180a and 180b that start at the periphery 158a and lead to the surfaces 82a and 182b, respectively. Each surface 182a, 182b is arcuate, shown in the manner described as having generally a constant radius. In the described embodiment, the locator 104 includes a pair of separate cantilevered arms 184a and 184b, each having an edge 186a and 186b, respectively. For clarity, Figure 27 illustrates arm 184a in cross section taken through edge 186a, at the same level as for cam 178a. At their distal ends, arms 184a and 184b include respective inwardly extending flanges 188a and 188b. The flanges 188a and 188b are formed in a complementary manner with the recesses 56 in the opening portion 6, configured to engage the projections 56a when the opening for injection 2 is retained by the locator 104. In the embodiment described, in the condition not actuated, the posts 176a and 176b are generally aligned with the arms 184a and 184b, respectively, although the posts 176a and 176b may be in any position corresponding to the position of the actuation characteristic of the actuator 12, which in the described embodiment are the openings 54. As the actuator 106 is depressed, the actuator 132 rotates (counterclockwise in the described mode, when viewed from the bottom), advances the cams 178a and 178b so that the ramps 180a and 180b come into contact with edges 186a and 186b, respectively, by flexing arms 184a and 184b outwardly. When the surfaces 182a and 182b engage the edges 186a and 186b, the arms 184a and 184b flex a sufficient distance to move the flanges 188a and 188b to a position where they do not extend further into the recesses 56 or come into contact with the projections 56a, thereby releasing the opening for injection 2 of locator 104.

Figure 28 illustrates the opening for injection 2 placed in, and retained by locator 104, with extension housing 78 and tab 96 positioned in slots 110 and 112, respectively (see Figure 20, not noted in Figure 28). As described, the posts 176a and 176b extend towards the openings 54 of the actuator 12, and the flanges 188a and 188b extend toward the recesses 56 proximal to the projections 56a. The safety cap 80 is connected to the opening for injection 12 when the opening for injection 12 is inserted into the locator 104, covering the fasteners 10 (not shown in Figure 28). Referring also to Figures 20 and 22, to insert the opening for injection 2 into the locator 104, the actuator 106 is oriented in the undeployed position, so that the actuator 132 is in the undeployed position. The actuator 12 is oriented in the undeployed position, and inserted into the locator 104, with the extension housing 78 and the tongue 96 placed in the slots 110 and 112, respectively. The actuator 106 may, as illustrated in Figure 20, include a visual indicator to indicate when the actuator 106 is in the fully undeployed state, such as an icon of an open padlock 190, and indications to indicate when the actuator 106 is in the unfolded state, such as an icon with a closed padlock 192. Such a visual indication may be included by any suitable means, such as integral molding with the actuator 106, applying as an adhesive film or the like, or by printing directly on the actuator 106 With the indicator illustrated, the open lock icon 190 is visible adjacent the upper side of the body 102, although other indication configurations may be used, such as a window or the like formed in the body 102 to reveal the indications. To use it, the locator 104 and a portion of (sic) 102, if necessary, are inserted through an incision by the surgeon and located in the desired position adjacent to the body tissue to which the medical implant is to be attached ( which in the embodiment described is an opening for injection 2). The angle between locator 104 and body 102 allows the surgeon to visualize the site directly. With the opening for injection 2 in position, one or more fasteners 10 move from the undeployed position to the deployed position in an annular path for coupling the tissue. The fasteners 10 allow the opening for injection 2 to be secured to the tissue with a holding strength equal to or greater than when secured with sutures. The safety switch 108 is rotated about the pivot pin 118, removing the securing tab 194 from the lower opening 196, allowing the actuator 106 to be rotated about the pivot pin 114. This action causes the track for the cam 150 to move the transverse member 138 downwards, causing the collar of the cam 136 to rotate the drive shaft 122, thereby rotating the actuator 132 relative to the locator 104.

The rotation of the actuator 132 drives the actuator 12 by turning it. The coupling between the extension 78 and the tongue 96 and the grooves 110 and 112, respectively, prevent the body of the opening 8 from rotating, allowing relative movement between the actuator 12 and the opening of the body 8. Once the actuator 106 reaches the unfolded position, the securing tab 194 is urged towards the upper opening 198, keeping the actuator 106 in the unfolded position. In the described embodiment, the spring 130 biases the securing tab 194, sufficiently to produce a sound as the securing tab 94 snaps into the upper opening 198, providing an audible signal that the actuator 106, and thus the actuator 12, and the fasteners 10 are fully deployed. As illustrated in Figure 29, with the actuator 106 in the deployed position, the actuator 12 has been rotated and the fasteners 10 are in the deployed position, having penetrated the body tissue, such as the conjunctiva envelope of the rectum. The cams 178a and 178b have been rotated to a position where the surfaces 182a and 182b are adjacent the edges 186a and 186b, with the arms 184a and 84b bent outwardly, so that the flanges 188a and 188b are not placed in the legs. holes 56 and do not engage projections 56a. With the opening for injection 2 secured to the body tissue, and released from the locator 104, the surgeon can remove the locator 104, leaving the opening for injection 2 in place. If a visual indicator of the state of the attachment mechanism with the implant is included, the surgeon can tell whether the attachment mechanism is fully deployed. The connecting mechanism incorporated in the opening for injection 2 is configured to be reversible, so that the medical implant, the opening for injection 2, can be moved, such as to reattach or withdraw it from the patient. To do so, with the actuator 106 in the deployed position, the locator 104 is placed over the injection opening 2, locating the extension 78 and the tongue 96 in the slots 110 and 112, so that the posts 176a and 176b are coupled with the recess 54. The safety switch 108 is rotated to remove the securing tab 194 from the upper opening 198, while the surgeon pulls the extension 200 from the actuator 106. Although the return spring of the cam 128 drives the collar from cam 136 upwards, extension 200 allows an additional return force to be applied. As the transverse member 138 is pulled up the track for the cam 150, the actuator 132 rotates the actuator 12, moving the fasteners 10 from the deployed position to the non-deployed position simultaneously, while the cams 178a and 178b are rotated. uncouple from the edges 186a and 186b, allowing the flanges 188a and 188b to engage the recess 56 and the spring 56a to retain the opening for injection 2 in the locator 104. When the actuator 106 has moved to the undeployed position, the securing tab 194 snaps into lower opening 196, generating an audible signal that actuator 106 is completely undeployed, and opening for injection 2 separates from body tissue and can be repositioned or removed. In summary, numerous benefits resulting from employing the concepts of the invention have been described. The above description of one or more embodiments of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form described. Modifications or variations are possible in light of the above teachings. The one or more modalities were chosen and described for the purpose of illustrating the principles of the invention and their practical application to thereby enable someone skilled in the art to use the invention in various modalities, and with various modifications that they are suitable for the particular use contemplated. It is intended that the scope of the invention be defined by the claims presented herein.

Claims (18)

NOVELTY OF THE INVENTION CLAIMS

1. - A surgically implantable device: (a) a medical implant for performing a therapeutic function, the implant has at least one fastener for attaching the implant to the body, the at least one fastener has a deployed position and an undeployed position, and moves between them; and (b) a visual indicator to indicate that at least one fastener has moved to its deployed position.

2. - The device according to claim 1, further characterized in that the visual indicator is on the implant.

3. The device according to claim 1, further characterized in that the visual indicator comprises indications.

4. - The device according to claim 1, further characterized in that the visual indicator comprises a graphic indicator.

5. - The device according to claim 1, further characterized in that it comprises a visual indicator to indicate that at least one fastener has moved to its undeployed position.

6. - The device according to claim 1, further characterized in that at least one fastener comprises a plurality of fasteners, and the visual indicator provides a single indication indicating that all fasteners have moved to their deployed position.

7. - The device according to claim 6, further characterized in that it comprises a visual indicator to indicate that the plurality of indicators has been moved to its undeployed state.

8. - A surgical device: (a) a medical implant for performing a therapeutic function, the implant has at least one fastener for attaching the implant to the body, each of the at least one fastener has a deployed position and an undeployed position, and moves between them; (b) an applicator for moving the fastener from the deployed position to the undeployed position; and (c) a visual indicator to indicate that at least one fastener has moved to its undeployed position.

9. - The device according to claim 8, further characterized in that the visual indicator is on the implant.

10. - The device according to claim 5, further characterized in that the visual indicator is on the applicator.

11. - The device according to claim 10, further characterized in that the visual indicator comprises indications.

12. - The device according to claim 10, further characterized in that the visual indicator comprises a graphic indicator.

13. - The device according to claim 10, further characterized in that it comprises a visual indicator to indicate that at least one fastener has been moved to its undeployed position.

14. - The device according to claim 10, further characterized in that at least one fastener comprises a plurality of fasteners, and the visual indicator provides a single indication indicating that all fasteners have been moved to their deployed position.

15. - The device according to claim 4, further characterized in that it comprises a visual indicator to indicate that the plurality of indicators has been moved to its undeployed state.

16. - A surgical device: (a) a medical implant to perform a therapeutic function, the implant has at least one fastener for attaching the implant to the body, each of the at least one fastener has a deployed position and an undeployed position, and moves between them; (b) an apiicator for moving the fastener from the deployed position to the undeployed position; and (c) the apiicator is configured to generate an audible signal to indicate that at least one fastener has moved to its deployed position.

17. - The device according to claim 16, further characterized in that the apiicator is configured to generate an audible signal to indicate that at least one fastener has been moved to its undeployed position.

18. - The device according to claim 16, further characterized in that at least one fastener comprises a plurality of fasteners, and the applicator is configured to generate a single signal indicating that all fasteners have moved to their deployed position.