MXPA06007428A - Applier for implantable medical device - 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

APPLICATOR FOR IMPLANTABLE MEDICAL DEVICE This application incorporates by reference the following United States patent applications, all of 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 applicators 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 in relation 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 desirable that the method for implementing such devices be quick, easy and effective. In many cases it can be beneficial if the surgeon can remove or reposition the device quickly, easily and effectively. The present invention encompasses a fixation mechanism for securing a medical implant device to the body tissue quickly and easily. The fixation mechanism can be reversible, allowing the implantable medical device to detach quickly and easily for repositioning or removal. Although they are standard, commercially available instruments can be used to operate the fixation mechanism, the present invention also encompasses an applicator for placing an implantable medical device in the desired location and quickly and easily activating the fixation 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 embodiments of the invention, and, together with the general description of the invention given above, and the detailed description of the embodiments given 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 which is 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.

Fig. 9 is a side sectional view in partial cross section similar to Fig. 8 illustrating a fastener of the fastening mechanism that is advanced by the drive ring towards the extended / fired position. Fig. 10 is a side sectional view in partial cross section similar to Fig. 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, with the actuator ring omitted 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, with the actuator ring omitted to illustrate the positions of the links when the fasteners are in the extended / fired position. Figure 14 is a fragmentary, elongated top view of the visual position indicator and the detent system of the actuator ring of the fixing mechanism of Figure 1 in the retracted position. Figure 15 is a fragmentary, elongated top view of the visual position indicator and the drive ring retainer system of the locking mechanism of Figure 1 in the extended / fired position.

Figure 16 is a schematic, fragmented, elongated perspective view of the splice connector and closure of the injection port of Figure 1. Figure 17 is a fragmentary, fragmentary, cross-sectional view of the closure connector assembled to the adjustment of the retainer and the septum but it does not lock in place. Figure 18 is a fragmentary, elongated, partial cross-sectional view similar to Figure 17 showing the lock connector locked 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 injection port of Figure 1. Figure 21 is a schematic, perspective view of the applicator of Figure 20. Figure 22 is a side view of the applicator of Figure 20. Figure 20 with one of the two halves of the body 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 side view in elongated fragmentation of the linear to rotary 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 actuator of the port of the applicator of Figure 20. Figure 27 is a view of partially cut end of the applicator positioner of figure 20. Figure 28 is an elongated cross-sectional view of the injection port of figure 1 retained by the positioner of the applicator of figure 20. Figure 29 is a view in elongated cross section of the injection port of Figure 1, placed in the positioner of the applicator of Figure 20 after the applicator has been operated to rotate the applicator driver to the deployed position. Reference is now made in detail to the preferred embodiment of the present invention, the 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 should 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 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. With reference to more detail 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 as presented with an injection port 2, the fixation mechanism can be used with any implantable medical device for which it is convenient, including by way of example only pacemakers, vascular access ports, injection ports (such as those used in gastric bands) and gastric pacemaker devices. The injection port 2 includes a septum retainer 4, septum 6 and port body 8. The injection port 2, with the integrally constructed locking mechanism, also includes one or more fasteners 10, actuator 12 and a plurality of seal elements. link 14. As seen in Figure 4, the septum 6, which can be made from any biocompatible material such as silicone, is partially placed within the internal cavity 16 of the septum retainer 4, adjacent to the annular recess 18. The retainer of the septum Septum 4, the body of port 8, and actuator 12 can be made of any biocompatible material that have sufficient stiffness and strength, such as polyetheretherketone (known as PEEK). The fasteners 10 and link elements 14 can be made from 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 septum retainer 4 by a plurality of pins 22 which are placed through the 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 from 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 flange 20 and the annular recess 18 is approximately 4 mm, so that the septum 6 is compressed by approximately 20% to adequately self-regenerate to maintain a fluid tight system under pressure and even allow a low profile. The plate 28 is placed 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 with 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, in order to adjust the size of an adjustable gastric band, the metal plate 28 will protect the retainer of the septum 4 from perforation and provide feedback Touching 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 a suitable manner. In the embodiment shown, 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 is extends upwards 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 rolled or otherwise deformed to cover at least a portion from the periphery of the plate 28 thus retaining the plate 28. In the embodiment shown, the diameter of the recess 16a is smaller than the diameter of the side wall 16b, providing space to form the annular edge and to deform it in the retaining edge 4a. The plate 28 can be molded by insertion, 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 the bottom of the retainer 4. The tube 36, which in the modality shown, leads to a gastric band adjustable (not shown), is connected to the splice 34, which is pushed by compression against the annular rim 38 by the connector 40, which is placed around the tube 36 and secured to the body of the port 8 as described below. The sleeve 42 is placed 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 loaded laterally. 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 port body 8, the actuator 12 may have any suitable configuration and be supported in any way suitable for allowing 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 shown, there are four equally spaced tabs 46. The actuator 12 includes an equal number of corresponding recesses 48, each having a portion lower arched 50. To assemble the actuator 12 to the port body 8, the recesses 48 align with the tabs 46, and push downward, temporarily deviating the tabs 46 inwardly until the tabs 46 reach the recesses 48 and move outwardly to color the lower edges 46a in the recesses 48 so that the actuator is held like this. The lengths of the tabs 46 and depth of the holes 48 allow an axial end play between actuator 12 and the body of port 8, as will be described later. The actuator 12 can generally rotate about the central axis of the port body 8. In the embodiment shown, the actuator 12 can rotate through an angle of about 40 degrees, although any suitable angle can be used. In the embodiment shown, when the actuator 12 is rotated in the deployment direction, causing the fasteners 10 to move to the deployed position, the rotation of the actuator 12 beyond the fully deployed position is limited by the end 48c that makes contact with tab 46. A retainer system is formed by a pair of spaced-apart raised retainer flanges 48a, 48b extending inward from the wall of each recess 48, and by a corresponding raised rim 46b extending outward from the tongue 46. The retainer system helps prevent the actuator 12 from rotating and the fasteners 10 from moving out of the fully extended or fully contracted fired states under vibration or incidental loads, 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 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 applicator specialized described below. The port body 6 includes a plurality of recesses 56 positioned around its lower periphery which are configured to cooperate with the specialized applicator as shown below. Referring now to Figures 6, and 7, the septum retainer 4 includes a plurality of positioning tabs 56 that extend outward from the adjacent portion of 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 complementary formed holes 60 formed in the inner surface of the port body 8 by aligning the septum retainer 4 appropriately with the body of the port 8. Figure 6 illustrates fasteners 10 in the retracted position. As noted, the fasteners 10 are placed in respective recesses or slots 60 formed in the port body 8. Figure 7 illustrates fasteners in the extended or fired position extending from the slots 60. Rotating 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 should be understood that the operation in one of the fasteners 10 may be the same for all the fasteners 10, which, in one embodiment, they can move from a deployed position to a non-deployed position simultaneously. Figure 8 illustrates the fastener 10 in a fully retracted state, the position not deployed, fully disposed within the slot 62 so that the sharp point 64 is not exposed. This prevents tip 64 from accidentally adhering to the surgeon or penetrating any object. The actuator 12 is shown rotated counterclockwise until allowed by the recesses 48 and the tabs 46. In this position, the ribs 46b are placed clockwise on the flanges 48b. , as seen in Figure 14. The first ends 14a of the link elements 14 are rotatably carried by the actuator 12, separated in the positions corresponding to the positions of the fasteners 10. The second ends 14b are placed inside. of the openings 66 of the fasteners 10. To activate the fixing mechanism, the integral actuator 12 is rotated in a deployment direction, which in a manner as shown is clockwise (any suitable direction configured to drive the fixing mechanism can be used), and the flange 46b passes the flange 48b, which can produce an auditory signal in addition to a tactile signal for the surgeon. The second end 14b of the link member 14 is free to move within the slot 66 during actuation, as the force that rotates the clip 10 in the extended position is transmitted to the clip 10 through the interaction between the surface of the cam 68 of the fastener 10 and driving the cam surface 70 of the actuator 12. As the actuator 12 rotates in a clockwise direction, the cam surface of the actuator 70 engages and is pushed against the cam surface 68, by rotating the fastener 10 around the pivot pin 22. Most of the force from the drive cam surface 70 acts tangentially on the cam surface 68 offset relative to the cam surface 68. 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, not applying driving force to rotate the fastener 10. In FIG. 9 , the fastener 10 being rotated approximately half through its rotation scale, approximately 90 degrees as a result of the clockwise rotation of the actuator 12. As the actuator 12 rotates in the direction of the 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 actuator. to tolerance of the components. As the actuator 12 is further rotated 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, rotating the 10 fastener also in the counterclockwise direction. In Figure 10, the actuator 12 rotates clockwise to its full extent, with the flange 46b driven beyond the detent flange 48a (see Figure 15). In this position, the bra 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 over centered and the actuator 12 is resistant to propelling toward back by an undeployed force imparted to the holder 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 portion The distal end of the fastener 10 is essentially shown as a beam, shown with a generally rectangular cross-section along its length, tapering to the sharp point 64. With the fastener 10 extending approximately 180 degrees in the fully extended state, the position unfolded, the forces, which can act on the fasteners 10 tend to act through the pivot axis defined by the pivot pin 22, in place r of rotating the fasteners 10. It is noted that although the pin 22 is illustrated as a separate piece from the fastener 10, the two can be integral or even of unitary construction. If it is desired to retract the fasteners 10, to remove or reposition the implanted device, the actuator 12 can be rotated in an undeployed direction, counterclockwise in a shown 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 fastener 10 In the embodiment shown, rotation in the counterclockwise direction of the actuator 12 moves the cam surface 70 out of contact with the cam surface 68, without substantial rotational force exerted on the fastener 10 until the second end 14b of the link element reaches a location in the slot 66, as at one end of the slot 66, where the link member 14 starts to pull against the slot 66 causing the clip 10 to rotate and begin to retract. As seen in Figure 11, the actuator 12 has advanced counterclockwise compared to the position shown in Figure 10 and the holder 10 is rotated approximately half through its scale. As seen when comparing figure 9 with figure 11, the actuator 12 is in different positions with the holder 10 in the same position, depending on whether the fixing mechanism is activated or deactivated (retracts). This results from the lost movement that results when the link member 14 is pulled into the slot 66 as compared to the cam surface of the actuator 70 that is pushed directly into the cam surface 68. To retract the clips 10 completely, the driver 12 it is rotated until the detent flange 46b fits beyond the detent flange 48b. Referring to Figure 8, when the fasteners 10 reach the fully undeployed position tip 64 it can be fully disposed in the slot or recess 62. An additional non-deployment rotation of the actuator 12 by means of the linking element 14 which is prevented from moving further by means of the fastener 10. With reference to figures 2 and 3, the actuator 12 includes openings 52a formed therethrough, which align with the openings corresponding 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 is shown without the actuator 12. The linking elements 14 are shown in their real positions when the first ends 14a are supported by the actuator 12, in the deployed states and in the states not deployed. Referring to Figures 14 and 15, there is illustrated a top view of the visual position indicator and a portion of the retainer system of the actuator ring of the attachment mechanism as presented in the injection port 2. In Figure 14, the mechanism Fixation is in a state or retracted position, not deployed. In this position, the detent flange 46b rotates clockwise of the detent flange 48b, and thus in the undeployed detent position. In Figure 5, the fixing mechanism is in the activated or unfolded position. In this position, the detent flange 46b rotates counterclockwise in the detent flange 48b and thus in the unfolded 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 on or from another way to be applied in a proper way. Port body 6 may include an indicator 76 to provide a reference point for the mobile indication. The arrow 78 can be included to indicate bidirectional movement of the actuator 12. Figures 16-18 illustrate the closing connection between the connector 40 and a port body 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 positioned around the splice 34. and the tube 36 aligned in the circumferential groove 78c of the extension 78. The connector 40 includes a pair of tongues 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 safety cap 80 that can be releasably secured to the bottom of the injection port 2 to cover the fasteners 10 to protect users from accidental exposure to the sharp tips 64 while operating the injection port 2. The safety cap 80 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 maintained toward the port in the direction through any suitable configuration. As shown, the body 82 includes a plurality of arcuate retention tabs 90 extending upwardly from the raised center 86. The arcuate retention tabs 90 are formed complementary to the corresponding arcuate grooves 92., which is best observed in figures 3, 6 and 7, and may have rims as shown. The safety cap 80 is secured to the injection port 2 by inserting the arcuate retention tabs 90 into the arcuate grooves 92, which are dimensioned to retain the tabs 90. The fasteners 10 in this manner are aligned with the annular recess 88, which it is dimensioned to allow the fasteners 10 to extend without contacting the safety cap 80. As shown, since the arcuate detent tabs 90 and the arcuate grooves 92 are respectively the same size and are equally spaced apart, the cap Safety 80 does not graduate to a particular position, and can be secured to injection port 2 in four different positions. The safety cap 80 includes a pull tab 94 which is raised to a plurality of flanges 96 to provide a better surface of subject 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 locate the pull tab 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 operated 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 the aspects of the present invention as applied to a 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 below, injection port 2 can be assembled to positioner 104, with extension 78 and tab 96 positioned in the alignment slots 110 and 112. The positioner 104 is formed at an angle relative to the body 102, allowing better and easier viewing of the injection port 2 during implantation. In the embodiment shown, the angle is 20 degrees and the axis portion of the body 102 is 10 centimeters. With reference 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 114 and tongue and groove, the body halves 102a and 102b are substantially similar to each other. The positioning pins 202, illustrated as extending from the body half 102a, fit into respective complementary formed openings (not shown) in the body half 102b. The engagement of the plurality of positioning pins 202 in the openings is sufficient to maintain 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 the body halves 102a and 102b together. The actuator 106 includes first and second halves 106a and 106b. The positioning pins 204, illustrated as extending from the middle of the actuator 106a, fit into respective complementary formed openings (not shown) in the middle of the actuator 106b. The pins 204 may alternatively extend 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 the halves of the actuator 106a and 106b together. The body half 102b includes a pivot pin 114b that rotatably supports the actuator 106 at one end, which extends through the pivot holes 116a and 116b in the aperture 114a. Half of the body 102a it 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 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 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 axis 134 and a cam collar 136. The upper end of the shaft 134 has a "T" configuration that terminates in a transverse member 138. The cam collar 136 defines a hollow interior and a pair of Completely formed cam, spaced 140a and 140b formed on opposite sides of the cam collar 136. The upper end 122a of the drive shaft 122 is partially positioned within the hollow interior defined by the cam collar 136, captured therein by a drive shaft pin 126. The pin of the drive shaft 126 is dimensioned so that each end is located within a respective cam rail 140a, 140b. The length of the hollow interior allows the upper end 122a to permute 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 permutation. 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 embodiment shown, the cam 120 and the actuator 132 are made of a liquid crystal polymer such as Vectratm LCP, and the drive shaft 122 is made of PPE + PS such as Noryltm. The drive shaft pin 126 and the cam return spring 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, as shown also can be swapped. The cam collar 136 has separate generally flat outer surfaces 142a and 142b through which the paths 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 cam collar 136 also includes opposing facing channels 146a and 146b (see FIG. 23), which are guided for axial permutation by means of the guides 148a and 148b (not shown) formed in the body portions 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 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 to as the actuator 106 is rotated about the pin 114, forcing the cam 120 to advance linearly downwardly in the body 102. The drive shaft 122 includes an annular collar 152 which is received in the slots 154a and 154b (not shown) formed in the body halves 102a and 102b, respectively. The grooves 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 shaft portion of the body 102. As the cam 120 is advanced downward, the pin of the drive shaft 126 follows the cam track 140a and 140b causing the drive shaft 122 to rotate, thereby converting the linear movement into rotational movement. The cam return spring 128 provides a nominal return force against the cam collar 136. The flexible shaft 124 is supported by a plurality of flanges 156, formed in each half of the body 102a, 102b that support flexure in the flexible shaft 124 which allows the rotary movement to be transferred to the actuator 132 which is positioned at an angle relative to the body axis 102. The flexible shaft 124 can be made from any suitable biocompatible material, such as stainless steel. In one embodiment shown, 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 a suitable manner that limits the rotating end set sufficiently to avoid or minimize the lost rotational movement. In one embodiment shown, the end 124a is overmolded at the end 122b, and the end 124b has press fit on the actuator 132. Alternatively, the end 124a can be press fit on the end 122b, and the end 124b overmoulded on the actuator 132, both can be pressurized, or both can overmold (with a corresponding change to the configuration of the positioner 104 to allow assembly). Referring to Figures 21-25, the actuator 132 includes a disc-shaped element 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. The positioner 104 includes a hub 164 that defines the orifice 166 therethrough. The orifice 166 shaped to receive and rotatably support the shaft 160, and includes two outwardly extending arcuate recesses 168a and 168b configured to provide assembly space for the tabs 162a and 162b, allowing the hub 164 to be inserted into the orifice 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 rotation of the actuator 132 while maintaining axially relative to the hub 164. The stops 170 and 170b extend upwardly from the top surface 164a, limiting the rotation of the actuator 132. The orifice 166 defines a central axis of the positioner 104 around which rotates the actuator 132. The central axis of the positioner 104 is positioned at an angle to the axis of the axis portion of the body 102, as previously mentioned. The hub 164 includes a pair of opposingly extending tabs 172a and 172b that hold the port driver 104 to 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 complementarity with the tabs 172a and 172b. Referring also to Figures 26 and 27, the disc-shaped element 158 of the actuator 1325 is observed positioned within the positioner 104. The actuator 132 includes a pair of spaced posts 176a and 176b, extending from the adjacent periphery 158a of the element 158. Posts 176a and 176b are formed complementary to openings 54. In the embodiment shown, the distal ends of posts 176a and 167b are tapered to assist in guiding posts 176a and 176b in openings 54. Any suitable configuration may used to create releasable contact between the actuator 132 and the actuator 12 capable of actuating the actuator 12. The disk-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 in the periphery 158a and leading to surfaces 182a and 182b, respectively. Each surface 182a and 182b arches, which is shown in the generally shown embodiment with a constant radius. In the embodiment shown, the positioner 104 includes a pair of spaced apart cantilevers 184a and 184b, each having a flange 186a and 186b respectively. For clarity, Figure 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, the arms 184a and 184b include respective inwardly extending flanges 188a and 188b. The flanges 188a and 188b are formed complementary to the recesses 56 in the body of the port 6, configured to engage the projections 56a when the injection port 2 is held by the positioner 104. In the embodiment shown, in the non-activated state, the posts 176a and 176b are generally aligned with arms 184a and 184b, respectively, although posts 176a and 176b may be in any position corresponding to the position of the actuation feature of actuator 12, which in the embodiment shown are openings 54 As the actuator 106 is depressed, the actuator 132 rotates (counterclockwise in the mode shown when viewed from the bottom), advancing the cams 178a and 178b so that the ramps 180a and 180b contact the flanges 186a and 186b, respectively, by deflecting the arms 184a and 184b outwardly. When the surfaces 182a and 182b couple the flanges 186a and 186b, the arms 184a and 184b deviate a sufficient distance to move the flanges 188a and 188b to a position where they do not extend further into the recesses 56 or make contact with the projections 56a, thereby releasing the injection port 2 of the positioner 104. The figure 28 illustrates an injection port 2 placed on and held by the positioner 104, with the extension housing 78 and tab 96 positioned in the slots 110 and 112, respectively (see figure 20, not shown in figure 28). As shown, the posts 176a and 176b extend into the openings 54 of the actuator 12, and the flanges 188a and 188b extend into the recesses 56 of the proximal 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). With reference 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 placed in the slots 110 and 112, respectively. The actuator 106 may, as illustrated in FIG. 20, 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 for indicating whether the actuator 106 is in the unfolded state, such as a locked closure icon 192. Said visual indication may be included in any manner, such as by integral mol with the actuator 106 applying an adhesive film, or printing directly in the actuator 106. With the indicator illustrated, the non-locked closure cone 190 is visible adjacent the upper edge of the body 102, although other indication configurations may be used, such as a window or formed in the body 102 to reveal the indications . To 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 is to be fixed (which in the embodiment shown 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 the injection port 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 injection port 2 to be secured to the tissue with a retention strength 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 114. This action causes the cam track 150 to move. the transverse member 138 downwards, causing the cam collar 136 to rotate the axis of drive 122, thus 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 In the unfolded position, the locking tab 194 is pushed into the upper opening 198, keeping the actuator 106 in the unfolded position. In the embodiment shown, the spring 130 biases the locking tab 194 sufficiently to produce sound as the locking tab 194 is fixed in the upper opening 198, provi an audible signal that the actuator 106, and therefore the actuator 12 and the fasteners 10 are fully deployed. As illustrated in Fig. 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 rectus sheath. 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 outwardly so that the flanges 188a and 188b are not placed in the recesses 56 and not fit the projections 56a. With the injection port 2 secured to the body tissue, and released from the positioner 104, 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 if the fixation mechanism is fully deployed. The fixing mechanism presented in the injection port 12 is configured to be reversible so that the medical implant, the injection port 2, can be moved, to reposition it or remove it from the patient. To do so in this manner, with the actuator 106 in the unfolded position, the positioner 104 is placed over the injection port 2 locating the extension 78 and the tongue 96 in the slots 110 and 112 so that the posts 176a and 176b are engage with the gaps 54. The safety switch 108 is rotated to remove the tongue of the lock 194 from the upper opening 198 while the surgeon lifts the extension 200 of the actuator 106. Although the cam return spring 128 drives the cam collar 136 toward arriaba, the extension 200 allows an additional return force to be applied. Since 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 disengaged from the flanges 186a and 186b, allowing flanges 188a and 188b to engage hollow 56 and protrusion 56a to maintain injection port 2 in positioner 104. When actuator 106 has moved to the undeployed position, latch tab 194 it is adjusted in the lower opening 196, generating an auditory signal that the actuator 106 is fully unfolded, and an injection port 2 is detached from the body tissue and can be relocated 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. Modifications or variations are possible in light of the previous teachings. One or more 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 adapted to the particular use contemplated. It is intended that the scope of the invention be defined by the claims presented herein.

Claims (3)

NOVELTY OF THE INVENTION CLAIMS

1. - An applicator for fixing a medical implant to the tissue of the body, said medical implant has an unfolded and an undeployed state, said applicator comprising: a) a body having a distal end; b) an actuator carried by said body to change the state of said implant from deployed to undeployed; c) a locator fixed to and extending from said distal end of said body, said locator configured to have said medical implant detachably attached thereto.

2. The applicator according to claim 1, further characterized in that said body rotatably supports a flexible shaft.

3. The applicator according to claim 1, further characterized in that said body supports a cam of linear movement to rotary and a combination of drive shaft, and a flexible shaft, a first end of said flexible shaft connected to a tip of said drive shaft, a second end of said flexible shaft connected to a deployment actuator. 4 - An applicator for attaching a medical implant to a tissue of the body, said medical implant has an unfolded and an undeployed state, said applicator comprising: a) a body having an end distal b) an actuator carried by said body to change the state of said implant from deployed to undeployed; c) a flexible shaft rotatably supported by said housing, said flexible shaft having first and second ends; and d) a locator fixed to and extending from said distal end of said body, said locator configured to have said medical implant removably attached thereto. 5. The applicator according to claim 4, further characterized in that said flexible shaft is placed in an arcuate configuration so that said first and second ends are not collinear. 6. An applicator for fixing a medical implant to the tissue of the body, said medical implant has an unfolded and an undeployed state, said applicator comprising: a) a body having a sleeve portion; b) an actuator carried by said body to change the state of said implant from deployed to undeployed; c) said body comprises a shaft portion, said shaft portion having a proximal end fixed to said sleeve and a distal end extending therefrom; d) a fixed housing a and extending from said distal end of said shaft to an angle thereof, said locator configured to have said medical implant releasably attached thereto. 7. The applicator according to claim 6, further characterized in that said body rotatably supports a flexible shaft, said flexible shaft extends through said angle.