MXPA06007379A - Implantable medical device with reversible attachment mechanism and method. - Google Patents

Abstract

An attachment mechanism for a surgically implantable medical device includes one or more fasteners (10) which may be simultaneously moved from an undeployed position to a deployed position by operation of an integral actuator (12). 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 REVERSIBLE FIXING MECHANISM AND METHOD This application is a partial continuation and claims priority of U.S. patent application serial number 10/741, 875, filed on December 19, 2003, entitled Subcutaneous Self Attaching Injection Port With Integral Moveable Retention Members. This application incorporates as reference the following patent applications from the United States, which were filed on December 19, 2003: application serial No. 10/741, 127 entitled Subcutaneous Injection Port For Applied Fasteners; application Serial No. 10 / 10,741, 875 entitled Subcutaneous Self Attaching Injection Port With Integral Moveable Retention Members; and application Serial No. 10/741, 868 entitled Subcutaneous Self Attaching Injection Port With Integral Fasteners.

TECHNICAL FIELD The present invention relates generally to medical implants and apiicators therefor, and more particularly to a fixation mechanism for use with a variety of medical implants and applicators for securing said medical implants to body tissue. The invention will be described with respect to, but not limited to, surgically implantable injection ports and an applicator therefor.

BACKGROUND OF THE INVENTION 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 ports, injection ports (such as those used with gastric bands) and gastric pacemaker devices. Such implants need to be fixed, typically subcutaneously, in an appropriate place in order to function properly. It is advisable that the procedure to implement these devices is quick, easy and effective. In many cases it can be beneficial if the surgeon can remove or replace the device quickly, easily and efficiently. The present invention encompasses a fixing mechanism for rapidly and easily securing a medical implant device to body tissue. The fixation mechanism can be reversible, which allows the implantable medical device to be detached quickly and easily for repositioning or removal. Although they are standard, commercially available instruments can be used to drive the fixation mechanism, the present invention also encompasses an applicator for placing a implantable medical device in the desired location and quickly and easily activating the fixation mechanism to secure the medical device. implantable.

BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are incorporated and constitute a part of this specification, illustrate embodiments of the invention, and, together with the general description of the invention given above, and the detailed description of the embodiments presented below, serve to explain the principles of the present invention. Figure 1 is a perspective view of an injection port with a fixing mechanism constructed in accordance with the present invention; Figure 2 is a top view of the injection port of Figure 1; Figure 3 is a bottom view of the injection port of Figure 1; Figure 4 is a cross-sectional view of the injection port of Figure 1 taken along line 4-4 of Figure 3; Figure 5 is a schematic perspective view of the injection port of Figure 1; Figure 6 is a perspective view of the lower part of the injection port of Figure 1, showing the fixing mechanism in the retracted position; Figure 7 is a perspective view of the lower part of the injection port of Figure 1, similar to Figure 6, showing the fixing mechanism in the extended / fired position; Figure 8 is a side sectional view in partial cross section illustrating a fastener of the fixing mechanism in the retracted position; Figure 9 is a side sectional view in partial cross-section similar to Figure 8 illustrating a fastener of the fastening mechanism which is advanced by the drive ring to the extended / fired position; Figure 10 is a side sectional view in partial cross section similar to Figure 8 illustrating a fastener of the fixing mechanism in the extended / fired position; Fig. 11 is a side sectional view in partial cross section similar to Fig. 8 illustrating a fastener of the fastening mechanism which is advanced by the drive ring towards the retracted position; Figure 12 is a top view of the injection port of Figure 1, omitting the actuator ring to illustrate the positions of the links when the fasteners are in the retracted position; Figure 13 is a top view of the injection port of Figure 1, omitting the actuator ring to illustrate the positions of the links when the fasteners are in the extended / fired position; Figure 14 is a fragmentary, enlarged top view of the visual position indicator and detent system of the actuator ring of the fixing mechanism of Figure 1 in the retracted position; Fig. 15 is a fragmentary, enlarged top view of the visual position indicator and drive ring detent system of the locking mechanism of Fig. 1 in the extended / fired position; Figure 16 is a schematic, fragmented, enlarged perspective view of the connector and closure connector of the injection port of Figure 1; Figure 17 is a fragmentary, enlarged partial cross-sectional view of the closure connector assembled to the fit and the septum retainer but not locked in place; Figure 18 is a fragmentary, enlarged, partial cross-sectional view similar to Figure 17 showing the lock connector locked in place; Figure 9 is an enlarged perspective view of the safety cap; Figure 20 is a perspective view of an apudora constructed to implant the injection port of Figure 1; Figure 21 is a perspective, schematic view of the applicator of Figure 20; Fig. 22 is a side view of the applicator of Fig. 20 with one of the two body halves showing the internal components in the unactuated position, without applying; Figure 23 is a side view of the applicator of Figure 20 similar to Figure 22, showing the internal components in the applied, applied position; Figure 24 is a fragmentary, enlarged side view of the rotary linear cam mechanism of the applicator of Figure 20; Figure 25 is an enlarged, top perspective view of the applicator positioner of Figure 20; Figure 26 is an enlarged, bottom perspective view of the positioner and port driver of the applicator of Figure 20; Figure 27 is an end view partly in section of the applicator positioner of Figure 20; Figure 28 is an enlarged cross-sectional view of the injection port of Figure 1 retained by the positioner of the applicator of Figure 20; and Figure 29 is an enlarged cross-sectional view of the injection port of Figure 1 disposed in the positioner of the applicator of Figure 20 after the applicator has been operated to rotate the applicator driver to the deployed position. Detailed reference will now be made to the preferred embodiment of the present 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 all the views. Also, in the following description, it will be understood that terms such as frontal, posterior, interior, exterior, and the like are words of convenience and should not be construed as limiting terms. The terminology used in this patent is not intended to be limiting since the devices described herein, or portions thereof, may be fixed or used in other orientations. Referring more closely to the drawings, one embodiment of the invention will now be described. With reference to Figures 1-5, there is shown an implantable medical device, more specifically an injection port, generally indicated with the number 2, which has a fixing mechanism constructed in accordance with the present invention. Although the fixation mechanism is illustrated in the figures by presenting an injection port 2, the fixation mechanism can be used with any implantable medical device for which it is suitable, including by way of example only pacemakers, vascular access ports, ports of injection (such as those used in gastric bands) and gastric pacemaker devices. Injection port 2 includes a septum retainer 4, septum 6 and port body 8. The injection port 2, with the integrally constructed fixing mechanism, also includes one or more fasteners 10, actuator 12 and a plurality of link elements 14. As seen in figure 4, the septum 6, which may be made of any biocompatible material such as silicone, is partially disposed within the internal cavity 16 of the septum retainer 4, adjacent to the annular recess 18. The septum retainer 4, the body of the septum port 8, and actuator 12 may be made of any biocompatible material having sufficient stiffness and strength, such as polyetheretherketone (known as PEEK). The fasteners 10 and link elements 14 may be made of any suitable biocompatible material, such as stainless steel. The body of the port 8 includes an annular flange 20, which couples the upper surface of the septum 6 around an annular portion. The body of the port 8 is retained in the retainer of the septum 4 by a plurality of pins 22 which are disposed through respective holes 24 formed in the recesses 24a in the body of the port 8 and extending inwardly in the respective recesses. 26 formed around the lower periphery of the septum retainer 4. The pins 22 can be made of any suitable 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 rim 20 and the annular recess 18 is approximately 4 mm, so that the septum 6 is compressed approximately 20% to adequately self-regenerate and maintain a fluid-tight system under pressure and still allow a low profile The plate 28 is disposed in the recess 16a formed in the lower part of the septum retainer 4, underlying the septum 6 and the fluid chamber or reservoir 30. As seen in FIG. 4, the plate 28 does not contact the side wall 16b. In the embodiment shown, plate 28 is metallic, such as stainless steel. When a needle is inserted through the septum 6 to introduce or withdraw fluid from the fluid chamber 30, for example to adjust the size of an adjustable gastric band, the metal plate 28 will protect the septum retainer 4 against perforation and provide tactile feedback to the surgeon through the needle indicating that the needle has reached the bottom of the reservoir 30. The plate 28 can be secured to the septum retainer 4 in any suitable manner. In the illustrated embodiment, the plate 28 is held in place by the retaining edge 4a extending over the periphery of the plate 28 as best seen in Figures 4, 28 and 29. Initially, the retaining edge 4a extends upwardly as an annular edge, providing space for insertion of the plate 28 into the recess in the lower part of the septum retainer 4, and the retaining edge 4a is then wound or otherwise deformed to cover at least a portion of the periphery of the plate 28, thus retaining the plate 28. In the illustrated embodiment, the diameter of the recess 16a is smaller than the diameter of the side wall 16b, providing space for forming the annular edge and for deforming it on the retaining edge 4a. The plate 28 can be molded by insert, with the retaining edge 4a molded as illustrated. The septum retainer 4 includes a passage 32, in fluid communication with the fluid chamber 30, which is defined by the splice 34 extending from the periphery adjacent to the bottom of the retainer 4. The tube 36, which in the illustrated embodiment, leads to an adjustable gastric band (not shown), is connected to the splice 34, which is pushed by compression against the annular rim 38 by the connector 40, which is arranged around the tube 36 and secured to the body of the port 8 as described below. The sleeve 42 is arranged around the tube 36, secured to the connector 40 by annular flanges 44. The sleeve 42 releases the tension in the tube 36, preventing the tube 36 from twisting when it is laterally loaded. The actuator 12 is secured to the port body 8. Although in the embodiment shown the actuator 12 is illustrated as an annular ring rotatably supported by the body of the port 8, the actuator 12 can have any suitable configuration and can be supported from any convenient way to allow the actuator 12 to operate to move the fasteners 10 between and including deployed and undeployed positions. As seen in Figure 5, the port body 8 includes a plurality of tabs extending downwardly and outwardly 46. In the embodiment illustrated, four equally spaced tabs 46 are provided. The actuator 12 includes an equal number of recesses. corresponding 48, each having a lower arched portion 50. To assemble the actuator 12 to the port body 8, the recesses 48 align with the tabs 46, and are pushed downward, temporarily deflecting the tabs 46 inwardly until the tabs 46 reach the recesses 48 and move outwards to color the lower edges 46a in the recesses 48 so that the actuator is retained by means of this. The lengths of the tabs 46 and depth of the holes 48 allow an axial end play between the actuator 12 and the body of the port 8, as will be described later. The actuator 12 can rotate generally about the central axis of the port body 8. In the embodiment shown, the actuator 12 can rotate through an angle of approximately 40 degrees, although any suitable angle can be used. In the illustrated 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 that makes contact with tongue 46. A retainer system is formed by a pair of spaced-apart raised retaining flanges 48a, 48b extending inwardly from the wall of each recess 48, and by a corresponding raised rim 46b extending outward from the tongue 46. The retainer system helps to prevent the actuator 12 from rotating and the fasteners 10 from moving fully extended or fully retracted states under vibration or incidental loads, as described below. The actuator 12 includes a plurality of separate openings or slots 54, which can be coupled through any suitable instrument to transmit the necessary torque to the actuator 12 to extend the fasteners 10 to the activated position. The slots 54 are configured to be coupled by commercially available, rectangular instruments in the embodiment shown, or by the specialized applicator described below. The body of port 6 includes a plurality of recesses 56 disposed around its lower periphery, which are configured to cooperate with the specialized applicator as described below. Referring further to Figures 6 and 7, the septum retainer 4 includes a plurality of positioning tabs 56 extending outwardly from the portion adjacent to the lower periphery of the septum retainer 4. The positioning tab 58a may be integral with the splice 34. The tabs 58 and 58a are located in respective recesses configured in a complementary fashion 60 formed on the inner surface of the port body 8, aligning the septum retainer 4 appropriately with the body of port 8. Figure 6 illustrates fasteners 10 in the retracted position. As you can see, the fasteners 10 are disposed in respective recesses or grooves 60 formed in the port body 8. Figure 7 illustrates fasteners in the extended or fired position, which extend from the slots 60. The rotation of the actuator 12 moves the fasteners 10 of 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 being understood that the operation in one of the fasteners 10 may be the same for all the fasteners 0, which, in one embodiment , they can be moved simultaneously from a deployed position to an undeployed position. Figure 8 illustrates the fastener 10 in a fully retracted state, the undeployed position, fully disposed within the groove 62 so that the sharp tip 64 is not exposed. This prevents tip 64 from accidentally adhering to the surgeon or penetrating any object. The actuator 12 is shown rotated in the counterclockwise direction until allowed by the recesses 48 and the tabs 46. In this position, the rims 46b are arranged clockwise of the rims 48b, as seen in Figure 14. The first ends 14a of the linking elements 14 are rotatably carried by the actuator 12, separated in positions corresponding to the positions of the fasteners 10. The second ends 14b are disposed within the apertures 66 of the fasteners 10. To activate the fastening mechanism, the integral actuator 12 is rotated in a deployment direction, which in a shown embodiment, goes clockwise (any suitable direction configured for actuate the locking mechanism), and the flange 46b passes the flange 48b, which can produce an auditory signal in addition to a tactile signal for the surgeon. year. The second end 14b of the link member 4 is free to move within the slot 66 during actuation, since the force which rotates the holder 10 towards the extended position is transmitted to the holder 10 through the interaction between the surface cam 68 of the fastener 10 and the actuating cam surface 70 of the actuator 12. As the actuator 12 rotates clockwise, the actuating cam surface 70 engages and pushes against the cam surface 68, by rotating the fastener 10 about the pivot pin 22. Most of the force of the drive cam surface 70 acts tangentially on the cam surface 68 offset relative to the pivot pin 22, causing the fastener 10 to rotate. During actuation, the end 14b of the link element 14 remains free to move within the slot 66, without applying driving force to rotate the clip 10. In Figure 9, the fastener 10 is rotated approximately halfway through its rotation scale, approximately 90 degrees, as a result of the clockwise rotation of the actuator 12. As the actuator 12 rotating clockwise, the force between the cam surface of the actuator 70 and the cam surface 68 causes the actuator 12 to move up slightly as allowed by the tolerance of the components. As the actuator 12 further rotates clockwise from the position shown in FIG. 9, the cam surface of the actuator 70 continues to engage and push against the cam surface 68, further rotating the cam. bra 10 counterclockwise. In Figure 10, the actuator 12 is rotated clockwise to its full extent, with the flange 46b having been pushed past the detent flange 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 disposed within the gap 62. In this position, the cam surface of the actuator 70 is over centered and the actuator 12 resists being urged backward by a non-deployment 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, shown with a generally rectangular cross section along its 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 by the pivot pin 22, instead of rotating the fasteners 0. It should be noted that although the pin 22 is illustrated as a separate part of the fastener 10, the two can be integral or even of unitary construction. If it is desired to retract the fasteners 10, for example to remove or reposition the implanted device, the actuator 12 may be rotated in a non-deployment direction, counterclockwise in an illustrated embodiment. 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 actuator. 10. In the embodiment illustrated, the continuous rotation of the actuator 12 in the counterclockwise direction moves the cam surface 70 out of contact with the cam surface 68, without exerting a substantial rotational force on the cam. the fastener 10 until the second end 14b of the link element reaches a location in the slot 66, such as at one end of the slot 66, where the link element 14 begins to pull against the slot 66 causing the fastener 10 turn and start to retract. As seen in Fig. 11, the actuator 12 has advanced counterclockwise as compared to the position shown in Fig. 10, and the fastener 10 is rotated approximately half through its scale. As seen when comparing figure 9 to figure 11, the actuator 12 is in different positions with the holder 10 in the same position, depending on whether the fixing mechanism is being activated or deactivated (retracted). This results from the lost movement that occurs when the linking element 14 pulls on the groove 66 in comparison with the cam surface of the actuator 70 which pushes directly on the cam surface 68. To completely retract the fasteners 0, the actuator 2 is rotates until the detent flange 46b fits beyond the detent flange 48b. Referring to Figure 8, when the fasteners 10 reach the fully undeployed position, the tip 64 may be fully disposed in the slot or recess 62. The additional non-deployment rotation of the actuator 12 is prevented by the link member 14 on the which is prevented from moving further through the fastener 0. Referring to Figures 2 and 3, the actuator 12 includes openings 52a formed therethrough, which align with the corresponding openings 52b formed in the port body 8 when the actuator is in the undeployed position. The openings 52a and 52b can be used by the surgeon to suture the injection port 2 if the integral fixation mechanism is not used. With reference to Figures 12 and 13, the fixing mechanism without the actuator 12 is shown. The link elements 14 are shown in their real positions when the first ends 14a are supported by the actuator 12., in the states deployed and not deployed. Referring to FIGS. 14 and 15, a top view of the visual position indicator and a portion of the detent system of the actuator ring of the fixation mechanism as shown in the injection port 2 are illustrated. In FIG. 14, the mechanism Fixation is in the state or position retracted, not deployed. In this position, the detent flange 46b is clockwise of the detent flange 48b, and therefore, in the undeployed detent position. In Figure 15, the fixing mechanism is in the activated or unfolded position. In this position, the detent flange 46b is counterclockwise in the detent flange 48b and therefore in the extended detent position. Figures 14 and 15 illustrate a visual indicator of the state of the fixing mechanism. As seen in Figure 14, indications may be used, such as an unlocked lock icon 73 and a lock icon 74 integral molded with the actuator ring 12. Any suitable graphic indicator may be used, and may be printed or printed. another way to apply in a proper way. Port body 6 may include an indicator 76 to provide a reference point for mobile indications. The arrow 78 can be included to indicate bidirectional movement of the actuator 12. Figures 16-18 illustrate the closure connection between the connector 40 and the body of the port 6. Figure 16 is a schematic perspective view showing the splice 74 partially surrounded by the extension 78. Figure 17 shows the extension 78 in cross section, with the connector 40 generally disposed about the splice 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 assembly, the connector 40 is guided along the tube 36 and the splice 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 lock it in place. During rotation, the detent edge 78d creates interference opposite to the rotation of the tongue 40a, but is dimensioned to allow the tongue 40a to rotate further, to the closed position observed in Figure 18. Figure 19 illustrates the cover safety 80 that can be releasably secured to the underside of the injection port 2 to cover the fasteners 10 to protect users from accidental exposure to the sharp tips 64 when operating the injection port 2. The safety cap 80 it includes a body 82 with an annular rim 84 and an elevated center 86 defining the annular recess 88. The safety cap 80 can be oriented and retained in the injection port through any suitable configuration. As illustrated, the body 82 includes a plurality of arcuate retention tabs 90 extending upwardly from the raised center 86. The arcuate retention tabs 90 are configured in a complementary manner to the corresponding arcuate grooves 92, best appreciated in the figures. 3, 6 and 7, and may have rims as shown. The safety cap 80 is secured in the injection port 2 by inserting the arcuate retention tabs 90 into the arcuate grooves 92, which are dimensioned to retain the tabs 90. In this manner, the fasteners 10 align with the annular recess 88. , which is dimensioned to allow the fasteners 10 to extend without contacting the safety cap 80. As shown, because the arcuate retention tabs 90 and the arcuate grooves 92 are respectively the same size and equally spaced, the safety cap 80 is not graduated to a particular position, and can be secured to the injection port 2 in four different positions. The safety cap 80 includes a pull tab 94 that raises a plurality of flanges 96 to provide a better holding surface. Although you can orient the pull tab 94 in any suitable orientation, in the embodiment, the relative position between the pull tab 94 and the arcuate retention tabs 90 places the pull tab at 45 degrees toward the direction of the connector 40. The tabs 90 and slots 92 may have any suitable shape. As previously mentioned, the fixing mechanism can be driven by coupling slots 54 with commercially available instruments or by a specialized applicator. Figure 20 illustrates an applicator, generally indicated with the numeral 100, which is configured to position, actuate, deactivate, remove or reposition the injection port 2. It should be noted that the practice of aspects of the present invention such as is used for an applicator, is not limited to the specific applicator modality shown herein.

As shown in Figure 20, applicator 100 includes body 102, positioner 104, actuator 106 and safety switch 108. As will be described later, injection port 2 can be assembled in positioner 104, with extension 78. and the tongue 96 disposed in the alignment slots 1 10 and 1 12. The positioner 104 is biased relative to the body 102, allowing better and easier viewing of the injection port 2 during the implant. In the illustrated embodiment, the angle is 20 degrees and the axis portion of the body 102 is 10 centimeters. Referring to Figure 21, the body 102 includes first and second halves 102a and 102b assembled together to contain the internal components. Except for the positioning pins 202, the pivot pins 1 14 and tongue and groove, the body halves 102a and 102b are substantially similar to each other. The positioning pins 202, illustrated extending from the body half 102a, fit into respective openings configured complementarily (not shown) in the body half 102b. The coupling of the plurality of positioning pins 202 in the openings is sufficient to hold the body halves 102a and 102b together. The pins 202 may extend alternatively from the body half 102b with the openings carried by the body half 102a. Any suitable configuration can be used to assemble and secure together the body halves 102a and 102b.

The actuator 106 includes first and second halves 106a and 106b. The positioning pins 204, illustrated extending from the middle of the actuator 106a, fit into respective openings configured in a complementary manner (not illustrated) in the middle of the actuator 106b. The pins 204 can extend alternatively from the middle 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 together the halves of the actuator 106a and 106b. The body half 102b includes a pivot pin 114b that rotatably supports the actuator 106 at one end, which extends through pivot holes 16a and 116b in the opening 114a. The body half 102a includes the pivot pin 118b (see figure 22) which rotatably supports the safety switch 108. The body halves 102a and 102b, the positioner 104, the actuator halves 106a and 06b, and the Security switch 108 may be made of any biocompatible material such as polycarbonate. Referring to Figures 21-24, the applicator 00 includes a cam 120, a drive shaft 122 with flexible shaft 124, a drive shaft pin 126, a cam return spring 128, a safety bypass spring 130. , and the actuator 132. The actuator 132 is configured to effect the deployment or non-deployment of the fixation mechanism of the medical implant. The cam 120 includes an axle 134 and a cam collar 136. The upper end of the axle 134 has a "T" configuration that terminates in a transverse member 138. The cam collar 136 defines a hollow interior and a pair of cam formed in a complementary manner, spaced apart 140a and 140b formed on opposite sides of the cam collar 136. The upper end 122a of the drive shaft 122 is arranged partially within the hollow interior defined by the cam collar 136, captured therein by a driving shaft pin 126. The driving shaft pin 126 is dimensioned so that each end is placed within a respective cam rail 140a, 140b. The length of the hollow interior allows the upper end 122a to alternate therein, with the cam rails 140a and 140b imparting rotation to the drive shaft 122 through the pin of the drive shaft 126 during the alternation. 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 illustrated embodiment, the cam 120 and the actuator 132 are made of a liquid crystal polymer such as Vectra * "1 LCP, and the drive shaft 122 is made of PPE + PS such as Noryltm. drive 126 and cam return spring 128 may be made of any suitable material, such as stainless steel, cam 120 is retained between body portions 102a and 102b, and in one embodiment, such as shown, may also alternate The cam collar 136 has separate generally flat outer surfaces 142a and 142b through which the rails 140a and 140b are formed.These surfaces 140a and 140b are disposed between the guide walls 144a and 144b formed in the portions of the body 102a and 102b The cam collar 136 also includes opposite facing channels 146a and 146b (see figure 23), which are guided for axial permutation by means of guides 148a and 148b (not shown) formed in body portions 102a and 102b, respectively. The upper end of the shaft 134 and the transverse member 138 are disposed interleaved between the halves of the actuator 106a and 106b. Each half of the actuator 106a, 106b includes a cam track defined by a pair of spaced apart walls 150a, and 150b extending from the interior surfaces of the actuator halves 106a and 106b. The cam track 150 is configured to receive and guide the transverse member 138 as the actuator 106 is rotated about the pin 114, forcing the cam 120 to advance linearly downwardly toward the body 102. The drive shaft 122 includes a annular collar 152 which is received in slots 154a and 154b (not shown) formed in the body halves 102a and 102b, respectively. The slots 154a and 154b rotatably support the drive shaft 122. The drive shaft 122 and the cam 120 are generally aligned and collinear with each other, defining the axis of the axis portion of the body 102. As the cam 120 is advanced downwardly, the pin of the drive shaft 126 follows the cam tracks 140a and 140b, causing the drive shaft 122 to rotate, thereby converting the linear motion into rotational movement. The cam return spring 128 provides a nominal return force against the cam collar 36.

The flexible shaft 124 is supported by a plurality of flanges 156, formed in each body half 102a, 102b, which support flexure in the flexible shaft 124 that allows the rotational movement to be transferred to the actuator 132 which is disposed in a angle relative to the axis of the body 102. The flexible shaft 124 may be made of any suitable biocompatible material, such as stainless steel. In an illustrated 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 fixed to the end 122b and the actuator 132, respectively, in any suitable manner that sufficiently limits the rotational end play to avoid or minimize the lost rotational movement. In an illustrated embodiment, end 124a was overmolded at end 122b, and end 124b was press fit into actuator 132. Alternatively, end 124a may be press fit at end 122b, and end 124b may be overmolded in the actuator 132, both can be snapped, or both can be overmolded (with a corresponding change in the configuration of the positioner 104 to allow assembly). Referring to Figures 21-25, the actuator 132 includes a disc-shaped element 58 and an axis 160 extending upward therefrom. The upper end of the shaft 160 includes a pair of outwardly extending tabs 162a and 162b. The positioner 104 includes a hub 164 that defines the orifice 166 therethrough. The orifice 66 is configured to rotatably receive and support the shaft 160, and includes two outwardly extending arcuate recesses 168a and 168b configured to provide assembly clearance for the tabs 162a and 162b, allowing the hub 164 to be inserted. in the hole 166. The lengths of the shaft 160 and the hub 164 are dimensioned so that the tabs 162a and 162b are placed on the upper surface 164a of the hub 164, allowing the rotation of the actuator 132 while maintaining axially relative to the hub 164. The stops 170 and 170b extend upwards from the upper surface 164a, limiting the rotation of the actuator 132. The orifice 166 defines a central axis of the positioner 104 around which the actuator 132 is rotated. The central axis of the positioner 104 is arranged at an angle to the axis of the axis portion of the body 102, as mentioned above. The hub 164 includes a pair of opposingly extending tabs 172a and 172b which retain the actuator of the port 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) configured in a complementary manner with the tabs 172a and 172b. Referring further to Figures 26 and 27, the disc-shaped element 158 of the actuator 1325 is observed to be disposed within the positioner 104. The actuator 132 includes a pair of spaced posts 176a and 176b, extending from the adjacent periphery 158a of the item 158.

The posts 176a and 176b are configured in a complementary manner with the openings 54. In the illustrated embodiment, the distal ends of the posts 176a and 167b are tapered to assist in guiding the posts 176a and 176b toward the openings 54. Any configuration can be used. suitable to create 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 extending outwardly and upwardly from the periphery 158a of the element 158. Figure 27 illustrates the cam 178a in a cross section taken near the bottom surface of the element 158. The cams 178a and 178b include ramps 180a and 180b that start at the periphery 158a and lead to the surfaces 182a and 182b, respectively. Each surface 182a and 182b is arcuate, shown in the illustrated embodiment having generally a constant radius. In the illustrated embodiment, the positioner 104 includes a pair of spaced apart cantilevers 184a and 184b, each having a flange 186a and 186b respectively. For purposes of clarity, FIG. 27 illustrates the arm 184a in cross section taken through the ridge 186a, at the same level as the cam 178a. At their distal ends, arms 184a and 184b include respective inwardly extending flanges 188a and 188b. The flanges 188a and 188b are configured in a complementary manner to the recesses 56 in the body of the port 6, configured to engage the projections 56a when the injection port 2 is retained by the positioner 104. In the illustrated embodiment, in the state not activated, the posts 76a 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 activation feature of the actuator 12, which in the embodiment shown are the openings 54. As the actuator 106 is depressed, the actuator 132 rotates (counter-clockwise in the illustrated mode when seen from the bottom), advancing the cams 178a and 178b so that the ramps 180a and 180b contact the flanges 186a and 186b, respectively, by diverting arms 184a and 184b outwardly. When the surfaces 182a and 182b engage the ridges 186a and 186b, the arms 184a and 184b deviate a distance sufficient to move the flanges 188a and 188b to a position where they no longer extend into the recesses 56 or contact the recesses 56a and 184b. projections 56a, thereby releasing the injection port 2 of the positioner 104. Figure 28 illustrates an injection port 2 disposed and retained by the positioner 104, with the extension housing 78 and tab 96 disposed in the slots 110 and 112, respectively ( see figure 20, not shown in figure 28). As illustrated, the posts 176a and 176b extend toward 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 injection port 12 when the injection port 12 is inserted in the positioner 104, covering the fasteners 10 (not observed in figure 28). Referring also to Figures 20 and 22, to insert the injection port 2 into the positioner 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 positioner 104, with the extension housing 78 and the tongue 96 disposed in the slots 110 and 112, respectively. The actuator 106, as illustrated in FIG. 20, may include a visual indicator to indicate whether the actuator 106 is fully in the undeployed state, such as an unlocked closure icon 190, and indications to indicate whether the actuator 106 it is in the deployed state, such as a locked closure icon 192. Said visual indication can be included in any way, such as by integral molding with the actuator 106, application as an adhesive film, or direct printing on the actuator 106 With the indicator illustrated, the unlocked closure icon 190 is visible adjacent the upper edge of the body 102, although other indication configurations, such as a window, may be used or formed in the body 102 to reveal the indications. For use, the positioner 104 and a portion 102, if necessary, are inserted through an incision by the surgeon and placed in the desired position adjacent to the body tissue to which the medical implant will be attached (which in the embodiment illustrated it is an injection port 2). The angle between the positioner 104 and the body 102 allows the surgeon to visualize the site directly. With injection port 2 in position, the fastener (s) 10 are moved from the undeployed position to the deployed position in an annular path to engage the tissue. The fasteners 10 allow the injection port 2 to be secured to the tissue with a holding force equal to or greater than when secured with sutures. The safety switch 108 is rotated about the pivot pin 118, removing the locking tab 194 from the lower opening 196, allowing the actuator 106 to rotate about the pivot pin 14. This action causes the cam track 150 to move the transverse member 138 downward, causing the cam collar 136 to rotate the drive shaft 122, thereby rotating the actuator 132 relative to the positioner 104. Rotating the actuator 132 activates the actuator 12 by rotating it. The coupling between the extension 78 and the tongue 96 and the slots 110 and 112, respectively, prevent the body of the port 8 from rotating, allowing relative movement between the actuator 12 and the body of the port 8. Once the actuator 106 reaches the unfolded position, the locking tab 194 is pushed towards the upper opening 198, retaining the actuator 106, in the deployed position. In the illustrated embodiment, the spring 130 biases the locking tab 194 far enough to produce sound as the locking tab 94 is fixed in the upper opening 198, providing an audible signal that the actuator 106, and therefore the actuator 12 and 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 rectal envelope. The cams 178a and 178b have been rotated to a position where the surfaces 182a and 182b are adjacent flanges 186a and 186b with the arms 184a and 184b biased outward so that the flanges 188a and 188b are not disposed in the recesses 56 and are not fit with the projections 56a. With the injection port 2 secured to the body tissue, and released from the positioner 04, the surgeon can remove the positioner 104, leaving the injection port 2 in place. If a visual indicator of the state of the fixation mechanism is included with the implant, the surgeon can tell whether the fixation mechanism is fully deployed. The modalized fixation mechanism in the injection port 12 is configured to be reversible so that the medical implant, the injection port 2, can be moved, to be repositioned or removed from the patient. To do this, with the actuator 106 in the deployed position, the positioner 104 is placed over the injection port 2 by placing the extension 78 and the tongue 96 in the slots 110 and 112 so that the posts 176a and 176b engage the holes 54. The safety switch 108 is rotated to remove the locking tab 194 from the upper opening 198, while the surgeon lifts the extension 200 of the actuator 106. Although the cam return spring 128 pushes the cam collar 136 toward As it was lowering, the extension 200 allows an additional return force to be applied. As the transverse member 138 is lifted by means of the cam track 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 flanges 186a and 186b, allowing flanges 188a and 188b to engage hollow 56 and protrusion 56a to retain injection port 2 in positioner 104. When actuator 106 has moved to the undeployed position, the locking tab 194 fits into the lower opening 196, generating an auditory signal that the actuator 106 is fully undeployed, and an injection port 2 is detached from the body tissue and can be repositioned or removed. In summary, numerous benefits have been described which result from the use of the concepts of the invention. 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. By virtue of the above teachings, modifications or variations are possible. The modality or modalities were chosen and described in order to illustrate the principles of the invention and their practical application to enable one skilled in the art to use the invention in various modalities and with various modifications that are convenient for the particular use contemplated. It is intended that the scope of invention is defined by the claims presented herein.

Claims (17)

NOVELTY OF THE INVENTION CLAIMS

1. - A surgically implantable device comprising: (a) a medical implant to perform a therapeutic function; (b) a fastening mechanism comprising at least one integral fastener to said implant for securing said implant to a body, said fastener having a deployed position and an undeployed position; and (c) means for moving said fastener from said undeployed position to said deployed position and back to said undeployed position.

2. - A surgically implantable device comprising: (a) a medical implant to perform a therapeutic function; (b) a fastening mechanism comprising at least one integral fastener to said implant for securing said implant to a body, said fastener having a deployed position and an undeployed position; and (c) an actuator capable of moving said at least one fastener from said undeployed position to said deployed position and back to said undeployed position.

3. The device according to claim 2, further characterized in that said actuator is configured to withstand a non-deployment force applied to said at least one integral fastener when said at least one fastener is disposed in said deployed position.

4. - The device according to claim 3, further characterized in that said non-deployment force is a rotational force.

5. - The device according to claim 2, further characterized in that each of said at least one fastener is configured to rotate about a respective axis as said at least one fastener moves from said undeployed position to said position unfolded

6. - The device according to claim 5, further characterized in that said actuator is configured to rotate about a respective axis, and comprises an associated surface for each of said at least one fastener, each said surface is configured to exert a rotational force on each associated fastener when said actuator is rotated in a deployment direction, thus moving each of said at least one fastener from said unexpanded position to said deployed position.

7. - The device according to claim 5, further characterized in that said actuator is configured to resist being rotated by a non-deployment rotational force applied to said at least one fastener when said at least one fastener is arranged in said unfolded position .

8. - The device according to claim 7, further characterized in that said fixing mechanism comprises a retainer system configured to withstand the unintentional rotation of said actuator.

9. - The device according to claim 5, further characterized in that said actuator is configured to rotate about a respective axis, and said fixing mechanism comprises an associated element for each of said at least one fastener, each said element is carried by said actuator, each of said at least one fastener and its associated element are configured in such a way that said element exerts a rotational force on each associated fastener when said actuator rotates in a non-deployment direction, thus moving each of said at least one fastener of said position deployed to said undeployed position.

10. - The device according to claim 9, further characterized in that each of said at least one fastener and its associated element are configured such that said element does not exert a deployment force when said actuator is rotated in a deployment direction .

11. - The device according to claim 2, further characterized in that said actuator is rotatable.

12. - The device according to claim 11, further characterized in that said actuator comprises a generally annular ring which is rotatably carried by said implant.

13. - The device according to claim 2, further characterized in that said actuator is configured to be manipulated to move said at least one fastener through any of one or more standard surgical instruments.

14. - The device according to claim 2, further characterized in that each of said at least one fastener comprises a distal tip configured to pierce body tissue, each of said at least one fastener is arranged in an associated recess of said implant each said distal tip is disposed in said associated gap when said at least one fastener is disposed in said undeployed position.

15. - The device according to claim 14, further characterized in that said at least one fastener is arranged completely within said associated gap when said at least one fastener is arranged in said undeployed position.

16. - The device according to claim 14, further characterized in that each said distal tip is arranged in an associated gap, each said distal tip is arranged in said associated gap when said at least one fastener is arranged in said deployed position.

17. - The device according to claim 2, further characterized in that each of said at least one fastener comprises a distal tip configured to pierce body tissue, each of said at least one fastener is arranged in an associated gap, each said distal tip it is arranged in said associated gap when said at least one fastener is disposed in said deployed position.