Implantable device fastening system and methods of use

BACKGROUND OF THE INVENTION

1. FIELD OF THE INVENTION

The present invention relates to the field of implantable medical devices and surgical instruments and abutments. The present invention includes surgical abutments and instruments used in surgical procedures to attach devices or implants.

2. DESCRIPTION OF THE NEXT STATE OF TECHNOLOGY

Surgical abutments, such as clamps, clamps, forceps, bands, staplers or other devices for closing wounds or incisions are commonly used in surgical procedures, enabling the surgeon to attach, secure and / or repair body tissues. Examples of surgical abutments are shown in US Patent Nos. 4,994,073, 4,950,284, 4,934,364 and 4,932,960.

Surgical abutments are used in surgical procedures to eliminate the need for suturing, which is both time consuming and cumbersome. In these cases, the surgeon often uses an implant device with one or more surgical devices to do in a few seconds what would take many minutes when stapling. Reduction of working time reduces blood loss and shock for the patient.

Usually, such fastening systems are mainly used to close incisions or wounds, or to connect tissues together.

A surgical clamping system that can be used with many types of implantable devices would be beneficial for surgeons. Currently, surgical devices that include fastening systems often use extremely specialized systems that may be unnecessarily complicated and are unsuitable for adaptation to other applications. As a result, most implanted devices are attached by stapling. For example, when putting on the gastric band and its associated access port, the port is sewn with 4 to 5 stitches to the rectus sheath. This suture location is often at risk because the ports are placed under a few inches of fat and the port is often sewn as long as the band itself. The improved fastening system will allow easy, one-step fastening while maintaining the same security as for a sewn device.

The present invention overcomes the aforementioned problems of the current state of the art.

US 5,540,648 describes a stabilizer of a medical device with an anchoring system according to the preamble of claim 1, in which it is necessary to manually grip and screw each individual needle into the tissue of the anatomical wall.

DE 197 51 791 A1 discloses a surgical caliper device with a fluid port in which it is necessary, to attach fluid ports, to bend the clamp arms along the crossbars.

SUMMARY OF THE INVENTION

The present invention relates to an injection port as defined for the implantation system of claim 1.

BRIEF DESCRIPTION OF THE DRAWINGS

The above objectives and advantages of the present invention will be better understood upon reviewing the following description and attached drawings, in which:

Figure 1 is a perspective view of the latch with radial tilting with the clamps in a pre-extended position;

Figure 2 shows a perspective view of the hook with radial tilting of Figure 1 with the clamps in the extended position;

Figure 3 is a perspective view of a detail of the radial tilting latch of Figure 1 with the clamps in a pre-extended position;

Figure 4 is a perspective view of a detail

Fig. 2 with staples in perspective view of the hitch system with radial tilting of the extended position;

Figure 5 shows a view of the feeder;

Figure 6 shows a partial perspective cross-section of the delivery system shown in Figure 5 and the port hook;

Figure 7 is a partial perspective cross-section of the distal end of the delivery system of Figure 6 and the port latch in a pre-extended position;

Figure 8 is a partial perspective section view of the distal end of the delivery system of Figure 6 and the port latch in the extended position;

Figure 9 is a perspective view of the pencil holder handle configuration for the delivery system;

Figure 10 is a partial perspective cross-sectional view of the detail of the delivery system of Figure 9, shown in the initial position;

Figure 11 is a partial perspective cross-sectional view of the detail of the delivery system of Figure 9, shown in the released position;

Figure 12 is a perspective view of the pistol grip handle configuration for the delivery system;

Figure 13 is a perspective view of a detail of the handle of the delivery system of Figure 12, shown in the initial position;

Figure 14 is a perspective view of a detail of the handle of the delivery system of Figure 12, shown in the released position;

Figure 15 illustrates a perspective view of another pistol grip handle configuration for the delivery system;

Figure 16 shows a detail of the gear mechanism of the feeding system of Figure 15;

Figure 17 shows in detail a partial perspective section view of the delivery system of Figure 15, shown in its initial position;

Figure 18 is a detailed partial perspective view of the delivery system of Figure 15, shown in the fully retracted spring position;

Figure 19 shows in detail a partial perspective section view of the delivery system of Figure 15, shown in the released position;

Figure 20 illustrates a perspective view of the continuous NiTi wire in the pre-extended position;

Figure 21 illustrates a perspective view of the continuous NiTi wire of Figure 20 in the extended position;

Figure 22 is a bottom perspective view of the continuous wire hook with straight arms and blunt tips;

Figure 23 is a bottom perspective view of the continuous wire hook with bent arms and blunt ends;

Figure 24 is a perspective view from below of a hook in the form of a continuous wire with molded ends;

Figure 25 is a perspective view of the latch in the form of a continuous NiTi wire with filed ends in a position facing outward when extended;

Figure 26 is a perspective view of the latch in the form of a continuous NiTi wire with filed ends in an inward facing position when extended;

Figure 27 is a bottom perspective view of the latch in the form of a continuous NiTi wire with the filed ends of Figure 26 in an inward facing position when extended;

Figure 28 is a perspective view of the radial slide latch with straight arms and clamp guides;

Figure 29 is a perspective view of the latch with the radial slide of Figure 28;

Figure 30 is a perspective view of the radial shift latch with bent arms;

Figure 31 is a perspective view of the two-part fastening system before installation;

Figure 32 is a perspective view of the two-part fastening system of Figure 31 after installation;

Figure 33 is a perspective view of another two-part fastening system before installation;

Figure 34 is a perspective view of the two-part fastening system of Figure 33 after installation;

Figure 35 is a perspective view of an independent catch built into the device;

Figure 36 is a perspective view of another independent hook embedded in the device;

Figure 37 is a perspective view of another independent hook embedded in the device;

Figure 38 is a perspective view of another independent hook embedded in the device;

Figure 39 is a perspective view of another independent latch built into the injection port in a pre-installation position;

Figure 40 is a perspective view of the independent latch of Figure 39 in a post-installation position;

Figure 41 is a perspective view of the coupling in the form of a helical spiral;

<td>Figure</td><td>42 presents</td><td>view</td><td colspan="3">perspective</td><td>different</td>

<td colspan="3">hook in the form of a helical spiral;</td><td></td><td></td><td></td><td></td>

<td>Figure</td><td>43 presents</td><td>view</td><td>from</td><td>mountains</td><td>base</td><td>the</td>

<td>mounting</td><td>with horizontal coil;</td><td></td><td></td><td></td><td></td><td></td>

<td>Figure</td><td>44 presents</td><td>view</td><td>from</td><td>side</td><td>base</td><td>the</td>

<td>mounting</td><td>with horizontal coil</td><td colspan="2">from Figure</td><td> 43;</td><td></td><td></td>

<td>Figure</td><td>45 presents</td><td>view</td><td>from</td><td>down</td><td>base</td><td>the</td>

<td>mounting</td><td>with horizontal coil</td><td colspan="2">from Figure</td><td> 43;</td><td></td><td></td>

Figure 46 is a perspective view of the drive tool of the fastening system for the fastening system with the horizontal coil of Figure 43;

Figure 47 is a detail view of the base of the fastening system with the horizontal coil of Figure 43;

Figure 48 shows a side view of a fastening system with a closed metal loop incorporated into the device;

Figure 49 shows a top view of the device with built-in fastening system with the closed metal loop of Figure 48;

Figure 50 is a side view of a two-part latch fastening system;

Figure 51 shows a perspective view of another closed metal loop system employing curved pins or hooks;

Figure 52 is a side view of the closed metal loop system using the curved pins or hooks of Figure 51 embedded in the device;

Figure 53 shows a top and bottom view of the fastening system in the form of a curved pin embedded in the device;

Figure 54 shows a top and bottom view of another fastening system in the form of a curved pin embedded in the device;

Figure 55 shows bottom and side views of the fastening system in the form of a helical spring;

Figure 56 shows a side view of the bending base plate with bent tabs in an open and closed position;

Figure 57 shows top and side views of the hooks with rotating hooks built into the device;

Figure 58 shows a perspective view of the mounting system in the form of a rotatable disc with the latches in a pre-extended position;

Figure 59 is a bottom view of the fastening system in the form of the rotary disk of Figure 58 with the latch in the extended position;

Figure 60 is a side view of the mounting system in the form of the rotary disk of Figure 58 with the latches in the extended position;

Figure 61 is a side view of the mounting system in the form of the rotary disk of Figure 58 with the tabs partially extended, and

Figure 62 is a perspective view of the curved latch of the fastening system in the form of the rotary disk of Figure 58, showing the axis of rotation.

Figure 63 is a partial perspective section view of the delivery system;

<td>Figure 64 is a perspective view</td><td>view from</td><td>side of the system</td>

<td>feed.</td><td></td><td></td>

<td>Figure 65 is a top view of the delivery system of Figures 63 and 64;</td><td>lever</td><td>activator</td>

<td>Figure 66 is a side view of the delivery system of Figures 63 and 64;</td><td>lever</td><td>activator</td>

<td>Figure 67 is a bottom view of the delivery system of Figures 63 and 64;</td><td>lever</td><td>activator</td>

Figure 68 is a perspective side view of the actuator lever of the delivery system of Figures 63 and 64.

Figure 69 is a partially exploded view and partly in perspective view of a cover of the port of the delivery system of Figures 63 and 64;

Figure 70 is a partial perspective view of the port cover of the delivery system of Figures 63 and 64;

Figure 71 is a rear view of the port cover of the delivery system of Figures 63 and 64;

Figure 72 is a perspective side view of the port cover of the delivery system of Figures 63 and 64;

Figure 73 is a perspective side view of the loading device;

Figure 74 is a bottom view of the loading device;

Figure 75 is a perspective view of the loading device;

Figure 76 is a perspective view of an assembly consisting of a disc latch, port and loading device;

Figure 77 is an exploded view of the assembly consisting of a disc catch and a loading device;

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The present invention includes surgical fastening systems in which the implantable device includes a plurality of tabs (e.g., clamps) in a pre-extended position, and furthermore there are tabs provided adapted for stapling the holes, wherein the implantable device may have a detachable housing mounted over the device, and the housing has a plurality of tabs in a pre-extended position.

The detachable housing and abutments may be made of a variety of materials used in the field to manufacture surgical abutments and implants. Hooks can be made of metal, polymer, or other suitable materials. The detachable housing can be made of metal, polymer, ceramics or composites; for example, polysulfone, acetyl copolymers, titanium, elastomers and stainless steel are commonly used.

These materials must be bio-compatible, i.e. they must not adversely affect the surrounding environment of living beings and, on the other hand, their action cannot be adversely affected by the surrounding environment of living beings. Materials can be inert, non-absorbed or biodegradable. Inert materials can be quite durable and can maintain their form and function for a longer period of time.

Metals and metal alloys, in particular titanium and titanium alloys, are used to make various implantable components for medical applications. All implanted elements are characterized by a certain degree of biological incompatibility, which can be manifested by tissue inflammation, necrosis, hyperplasia, mutagenicity, toxicity and other reactions such as the attack of giant cells, leukocytes and macrophages. Although titanium and its alloys are generally considered inert during implantation, some biological and biochemical interactions may, however, occur and it has been found that for various reasons it is desirable to apply different coatings to the surfaces of implants of titanium and titanium alloys. The same applies to many other metals and metal alloys. Thus, the present invention includes the use of such coatings on the surfaces of hooks, a detachable housing or device.

Some coatings that can be used in implantable materials (made of titanium or other materials) include biological agents (such as genetic material or cellular material) or chemical agents (such as regulating reagents related to anti-cell growth), proliferation or factors to reduce problems with increasing the number of cells or inflammation. These agents can, after mixing with binders such as elastomers or bioresorbable polymers, be applied to the surface of a metal or polymeric object.

The fasteners contemplated herein, including clamps, are often made of wire and therefore have a relatively large surface area with respect to methods that allow biochemical agents to implant surfaces may be beneficial for minimizing the negative reaction of body tissues with the implant. This may include coatings applied to titanium alloys (e.g., NiTi alloys) for tissue purposes. Such coatings are based on their size. Accordingly, the addition of biological and stainless steel and the inhibition of the reaction of stable biocompatible polymers (such as isobutene styrene (SIBS)) and bioresorbable polymers such as polyglycolic acid. In prior art studies, the active chemical or biological agent is mixed with the polymeric coating material, and then the agent is flushed out of the coating after placing the implant in the body.

The present invention also provides that the latches may be shaped with memory (SMA). The reason for being made of alloy for metal shape memory deformation, in alloys with permanent alloys, medical devices with their high resistance compared to traditional ones used in these applications. The alloys used in various medical devices are based on stainless steel, high nickel alloys such as Elgiloy ™ and titanium based alloys, all of which can be given a fairly high yield strength by crushing. Normal metals, even with very high yield strength, cannot withstand stresses much greater than 0.2% without permanent deformation. If a device made of one of the above traditional alloys is subjected to bending or twisting, it cannot be removed in principle. The unusual trait of pseudo-elasticity, which characterizes shape memory alloys such as Au-Cd, Cu-Zn-Al, Ni-Ti and many others, allows complete, "elastic" restoration after stresses of up to 10%. Thanks to the high stress resistance and excellent corrosion resistance, the preferred shape memory alloy for medical components is an element of the Ni-Ti alloy family.

Shape memory alloys belong to a class that has a thermoplastic martensite phase. The term "martensite" refers to the crystalline phase that is produced in steel during rapid cooling from high temperatures. The phase that exists at elevated temperature is called austenite; these terms have been moved here to describe the transformation that occurs in shape memory alloys. When the steel is quickly cooled from the austenite to the martensite temperature, in order to re-produce the austenite, the structure needs to be heated to quite high temperatures, usually over 760 ⁰C (1400 ⁰F).

In contrast, thermoelastic shape memory alloys can go from the martensite phase to austenite and back again when heating and cooling in a very small temperature range, usually from -7.8 to 12.8 ⁰C (18 to 55 ⁰F). The shape memory alloy transformation is usually described by a hysteresis curve in which it is shown that upon cooling from the austenite phase, often called the parent phase, the martensite phase begins to appear at a temperature referred to as MS, and after reaching a lower temperature, MF, the alloy is completely in the martensite phase. When heated from MF, the martensite phase begins to turn into an austenite structure at AS and when the temperature, referred to as AF, is reached, the alloy is completely in the austenite phase.

These two phases or crystal structures have very different mechanical properties: Austenite Young's modulus is equal to ~ 82.7 x 10³ N / mm² (~ 12 x 10⁶ psi), whereas for martensite it is equal to ~ 27.6 x 10³ N / mm² (~ 4 x 10⁶ psi), and the yield strength, which depends on the amount of crumble to which the alloy has been subjected, is in the range from 193 to 689 N / mm² (28 to 100 books) for austenite and from 68.9 to 138 N / mm² (10 to 20 books) for martensite.

A unique feature of shape memory alloys is their ability to reproduce the shape after deformation. When a shape memory alloy sample undergoes stress in the martensite phase, deformation occurs through the growth and contraction of individual martensite varieties, rather than by stimulating the mechanisms that prevail in traditional alloys: slip, grain boundary dislocation and dislocations. When the deformed martensite is heated to the final temperature of the austenite phase AF, the sample returns to its original, undistorted shape. Thus, with respect to medical implants, it is possible to develop a structure in which the device is stored at a temperature below the body temperature in a deformed shape, and when placed in the body, the temperature of the device increases to body temperature, resulting in a return to the austenite structure. For applications with rapid shape changes, the latches can optionally be made of SMA such as NiTi.

It is within the scope of the present invention that such attachment systems as described herein can be attached to body tissue in less time than is required to attach the device. In the case described here (placement of the gastric band access port), the placement and fixation of the fastening system should not take longer than five minutes. In addition, the fastening system can be completely detached and removed from the tissue to facilitate displacement of the device, or to completely remove the implanted device. Such implantation and removal will not cause increased shock to the patient, and the fastening system does not produce more adhesion than traditional stapling. The average surgeon or other physician can reliably and systematically perform attachment and removal of the attachment system.

In addition, during the manufacture of the fastening systems described herein, the size of the abutments determines the depth in the body tissue at which the abutments are extended. In this case, the access port should be attached to a depth below the device not exceeding 3 mm. Also, in this application, the body tissue into which the abutments are inserted is the fascia. However, it is within the scope of the invention that the body tissue to which the device is attached varies depending on the particular device. Furthermore, attaching the attachment system to the tissue does not cause tissue damage during attachment or during body movement; for example, the access port for the gastric band is often attached directly above the abdominal rectus muscle. In addition, the attachment of the device has equivalent or greater strength compared to stapling and resists displacement or detachment, supporting a long-lasting implant.

The invention described herein can be used with any type of implantable device. Examples of such devices include internal monitors, ports, pacemakers, therapeutic agents, drug delivery systems, nerve stimulators, orthopedic devices, tendon reconstruction agents, etc. For ease of explanation, the invention will now be described with reference to Figures 1-40, with as the invention is shown with respect to the access port. One skilled in the art will recognize that the present invention may be used with other types of implantable devices and that the invention may take other forms analogous to those set forth herein.

Furthermore, in the accompanying figures, the housing is ring-shaped and can be suitably described as such. However, one of ordinary skill in the art will recognize that the shape of the housing depends on the shape of the device, such that the present invention is not limited to devices in which the housing is round.

Fig. 1 shows an access port fastening system according to one embodiment of the present invention. The access port 10 includes a septum 11 which in practice is pierced through a needle to introduce fluid, e.g. brine, into the access port for use with, e.g., a hydraulically operated gastric band.

The access port 10 includes a detachable housing 12 that surrounds the outer edge of the access port. The housing 12 includes cutouts or holes 15. The cutouts accommodate the latches 14. The holes 15 can have various forms to accommodate the latches 14 while allowing the latches 14 to move. It is within the scope of the invention that there are at least three latches 14 to minimize movement or device displacement. As shown in Fig. 1 - 4, the catches 14 are attached to the ring 12 by perpendicular segments, hooked behind the holes, and therefore are pivotably connected to the catches 14 have a first position as well as a third and a second or fixed position as shown in Figs. 2 and 4. To move from the first to the second position, the hook is rotated about the axis of the hook.

The cutout 15 allows this rotation, and the small locking tongue

The cutout or corresponding ring 12 shown in Fig keeps the latch in the rotated position. In one embodiment, the latches 14 may be two-armed staples. In another embodiment, the staples are rigid so that they do not deform when rotated into the patient's fascia. Traditional metals are suitable for such applications. In addition, the clamps may be in the shape of the letter "U" or variants thereof, including the following shape:

In the second position, the latch 14 is rigidly locked by the locking tongue 16 and the latch 14 can flex, allowing the latch to move to the locked position. The locking tab 16 can be formed in such a way that when the hook 14 is moved from the first to the second position, the surgeon clicks to indicate that the hook 14 is fully locked by the locking tab 16. The click can also be felt, allowing the surgeon to feel when the latch is fully locked by the locking tab 16. In a second position, the access port 10 is secured, inside the housing 12, in the patient by means of latches 14 that connect it to the patient's fascia. In principle, fascia or other body tissue is immobilized between the catches 14 and the housing 12 or device 10. In addition, the housing 12 may include pins (not shown) that are hooked to seam holes (not shown) that surround the edge of the device 10.

Figs. 5-8 show the access port of Fig. 1 and its interaction with the access port delivery system 20. As shown in Fig. 5, the access port delivery system may have a finger recess 25 that is used by the operator to hold the access port and the delivery system in place and position.

Feed system 20 includes a port cover 21. The port cover 21 houses a piston 22, a slider pusher 24, and a slider assembly 26.

The port cover may be formed into any shape that is generally needed to cover the access port 10.

The piston 22 provides operating means for the delivery system 20 and is connected to the firing means, which will be described below. After activation of the triggering means, the piston 22 is moved towards the access port 10. This movement activates the slider pusher 24. The slider pusher 24 transfers the energy of the moving piston 22 to the slider assembly 26. The slider assembly 26 is generally circular in shape and surrounds access port 10. In other applications, the slider assembly may take a form suitable for the implanted device and its housing. When activated, the slider assembly 26 is moved toward the access port 10. The positioning brackets 30 are attached to the port cover 21 and act on the access port 10 to ensure its proper positioning. The movement of the slider assembly 26 causes the beams 28 attached to the slider assembly 26 to act on the latches 14. Exerting force on the latches 14 causes them to rotate in the ring holes (not shown) and describes the arc essentially limited by the notch 15. This rotation coincides with the movement from the first to the second position described above. When the beams 28 continue to move towards the access port 10, the catches 14 reach a second position and are locked by the locking tabs 16. In this position, the access port 10 is rigidly locked by the catches 14 and their interaction with the fascia or other patient tissue.

Fig. 9 shows the delivery system of the access port complete with the firing means 40. Fig. 10 shows the cross-section of the firing means 40 in the initial or tensioned position. In this position, the spring 42 is compressed and the hook 44, which is connected to the rod 46, is attached to the projection 48 to prevent the compressed spring 42 from expanding. The trigger means include a trigger 50 connected to the lever 52. As shown in Fig. 10 , spring 42 and rod 46 are in housing 54.

As shown in Fig. 11, when a certain force is applied to the trigger 50, the lever 52 acts on the housing 54. The housing 54 tilts on the support (this tilt is not shown, the hook 44 lifts over the end of the spring compression spring)

48. When lifted, the force 42 pushes the piston 22 towards the access port and actuates the associated mechanism as described above. In this configuration, the travel path, speed and impact strength can be set to meet the needs of the application. As tested, the piston travel distance is between 0.6 and 1.9 cm (0.25 and 0.75 inches) and can generate up to 222.4 N (50 pounds) of force per piston, depending on the spring used in the particular case.

An alternative to the spring-loaded drive mechanism is shown in Fig. 12. Fig. 12 shows a manual handle actuating the firing mechanism 60. The manual handle is a very simple design, requiring only one moving part to move the piston 22. In a first position, as shown in Fig. 13, here there is a movable handle 61, a fixed handle 62, pivot point 64 and activation tip 66.

In action, the user squeezes the movable handle 61, pushing it toward the fixed handle 62. This movement pushes the activation tip 66, which is connected to the movable handle 61 and pivot point 64 in the opposite direction of the movable handle 61. By using a simple lever, the relatively small force applied to the movable handle 61 is reinforced by the pivot point 64 and applied by the activation tip 66 to the piston 22. The piston 22 is moved through the activation tip 66 towards access port 10 and activates the associated mechanism as described above. The force generated by the hand squeeze device is limited only by the force of the user, during testing the device could generate a force exceeding 222.4 N (50 pounds) with a piston path length of 0.6 cm (0.25 inch). Alternatively, a gear mechanism may be used that can produce similar or greater force, although it requires a longer path of the movable handle 61. The force generated by the device shown in Figs. 12-14 can also be changed, if necessary, by moving the pivot point closer to the piston 22 to produce more force, or further away from the piston to produce less force.

Still other alternative triggering means are shown in Figs. 15-19. Pistol grip triggering means 70 include a trigger 72 having gear teeth 73 located at one end, a gear 74 that engages with gear teeth 73, a rack 75, driven by gear 74 and spring 76. The rack may also include means 78 for gripping the piston 22.

The operating movement is shown in Figs. 17-19. In Fig. 17, the trigger is extended and the spring is slightly tensioned or not at all tensioned. The gear teeth 73 are meshed with the respective teeth of the gear 74 and with the teeth of the rack 75. The piston 22 is in the extended position. When the trigger 72 is pressed, the gear teeth 73 actuate the gear 74, and which in turn cause the spring 76 to compress the rack 75, as shown in Fig. 18. At a certain distance, the gear teeth 73 stop meshing with the gear 74. At this point, the gear 74 can rotate freely. The stored energy of spring 76 pushes the rack 75 towards the piston 22. The freely rotating gear 74 allows the rack 75 to move, which, in turn, pushes the piston towards the access port 10 and activates the associated mechanism as described above.

Another component that can be placed in the trigger means 70 of the pistol grip is a lock (not shown) which, when the spring 76 is compressed, prevents the gear 74 from rotating. Then, if desired, the operator can release the lock, allowing the spring 76 to expand. as described above.

As proven, the firing means 70 in the form of a pistol grip allow the piston to travel about 1.0 cm (0.4 inch) and can generate a force of over 222.4 N (50 pounds). A distinct advantage of this embodiment, in relation, for example, to the above-described device with movable handle, is its immediate extension, characterized by a very high impact force.

In Fig. 20 another embodiment of the present invention is shown. The use of NiTi materials or SMA alloy is well known in medicine as described above. As shown in Fig. 20, NiTi latches are shown in a pre-extended condition. The catches 14 are continuous and are attached to the access port 10 by means of the holes made in it. In operation, the catches 14 are pressed to the patient's fascia to attach an access port. The NiTi hooks 14 have the unique ability to change their shape when heated, e.g. to body temperature. As shown in Fig. 21, when the tabs are extended, they can change shape by bending under and securing access port 10.

In Fig. 22 the catches 14 are shown with straight arms 80 in this extended condition. Alternative configurations include curved arms 81 as shown in Fig. 23. Using curved arms 81, the fascia can be clamped between the clip and the bottom of the access port. Another alternative is shown in Fig. 24, where the tips of the abutment arms 81 are surrounded by molded tips 82. The molded tip may be formed into a shape that helps to pierce the patient's fascia. This eliminates the need to form the hook 14 in a shape suitable for piercing. In addition, tips 82 may be formed from bio-absorbed material.

In another embodiment of the present invention, the NiTi fastener may be formed in the form of a continuous ring 84. Using the ring 84 allows forming the fasteners 14 of continuous design. After forming the ring 84 with the tabs, the ends of the arms 80 can be ground to produce individual tabs 14 substantially U-shaped. The ring 84 ensures that the catches 14 can be inserted as one unit as described above, and the grinding of the arms provides a sufficiently sharp blade to pierce the fascia. As shown in Figs. 25 and 27, the arms may be formed and positioned in the ring 84 so that when bent by heating, the arms 80 will be directed inward to the access port 10 or out from the access port

10.

Yet another embodiment of the present invention is a two-part fastening system as shown in Figs. 23-34. Fig. 28 shows guides 90 formed with a plurality of individual tabs 14. The tabs 14 can be moved in the guide 90 from the first to the second position. In operation, the guide 90 is placed over the access port 10 and aligned with the cutouts 15. The catches 14 are formed of a resilient material and have a shape suitable for attachment to the access port 10. The catches 14 are moved from the first position, as shown in Fig. 28, to the second position, as shown in Fig. 29. The catches 14 pierce the fascia and securely attach the access port 14. As previously described, the catches may have straight or curved arms . After all the tabs are moved from the guide 90 to the access port 10, the guide can be removed if it is not part of the final implantable device. Alternatively, guide 90 may also be a solid part of the implantable device.

Another two-part fastening device includes a pre-formed ring 100 (Fig. 31 and Fig. 32). The ring includes first attachment means 104 for attaching the ring 100 to the fascia. The ring also includes a second attachment means 102 for attaching the access port 10 to the attachment ring 100. In operation, the ring 100 is placed on the fascia and then rotated to hook the fascia through the first attachment means 104. The access port 10 is then positioned over the ring 100 and engages the second attachment means 102 through the holes 106 in the access port. This design ensures repeatability of proper fastening and reinstallation without disconnecting the pre-formed ring.

Fig. 33 and Fig. 34 show yet another two-part attachment device comprising an applicator 112 and a ring 110 having NiTi tabs 114. In practice, the ring 110 is inserted into the applicator 112. The applicator 112 is placed over the access port 10 with the tabs 114 opposite the cutouts 115 and the holes 106. The tabs 114 are pushed through the holes 106 and hook behind the patient's fascia on which the access port 10 rests. . As a result of heating, the latches 114 change shape and secure the fascia access port. After a specified time, the applicator can be removed.

Another embodiment of the present invention relates to independent latches. As shown in Figs. 35-38, various designs can be used to attach the access port 10 to the patient's fascia. The hooks can contain NiTi so that the hooks change shape when they get enough heat. The tabs 14 may be inserted singly or as part of a pre-formed ring as described above. When they are inserted one at a time, the latches 14 may be straight rods or may have some preformed shape that can be enlarged in the heating process. In Fig. 35, the latch assumes a substantially C-shape. Figures 37 and 38 show U-shaped latches 14, their ends being curved linearly to form an omega, as shown in Fig. 37, or perpendicular to form shape as shown in Fig. 38. These shapes can be selected depending on the needs of the application.

Still another embodiment of the present invention is shown in Fig. 39. In Fig. 39, the catches 14 are slidably installed in the access port 10. This can be accomplished by cold forming the NiTi fastening system in the device and ensures proper attachment and repeatable alignment. By using the installation tool 120, the catches are pushed through the holes in the bottom of the access port 10 and hook into the fascia. By installing the tabs as an integral part of the access port 10, no ring or housing as described above housing the tabs is needed. Installation tool 120 may be part of a drain device as described herein. Fig. 40 shows the latch 14 in the extended position.

As described above and shown in Figures 1-8, radial tilting tabs are a simple feeding system with direct drive. The associated feeding system activates the tilt to radially extend the catches.

Buckles can be made of stainless steel, titanium, Nitinol or Elgiloy^™-u, or other appropriate materials, including other metals or plastics. The molded tilting / locking system may be designed to fit into existing stapling holes in implantable devices. In addition, the simple shape of the clamp allows easy manufacture. Such a system is self-piercing, i.e. it is not necessary to pre-pierce body tissue, e.g. fascia. The curved shape of the buckles allows predictable penetration into body tissue when the buckle is extended, and tilting the curved buckle ensures easy passage through the tissue. Removal of the fastening system requires the use of a removal tool and the clamps are unscrewed from the original insertion path only with little resistance from the surrounding surrounding tissue. However, the force needed to remove the system is adequate to allow the clamps to remain in position outside the removal procedure.

Continuous wire fastening systems contemplated herein include blunt tips, molded tips, and ground or cut ends. Continuous wire systems with blunt ends, shown in Figures 20-23, may require tissue pre-piercing to allow insertion of blunt ended wire. The latch assembly may be manufactured to include a locking element retaining either the wire structure or the embossed ring. Simple wire construction can be made of stainless steel, titanium, Elgiloy^™-u, NiTi or other suitable materials. Removing the abutment assembly can be easy with blunt tips that cause minimal tissue damage and shock. In addition, blunt tips reduce the force needed to remove the assembly. The continuous wire construction with molded tips, shown in figures 20 and 24, does not require pre-piercing body tissue and these tips allow easy insertion into body tissue. In addition, continuous wire constructions with ground or filed blunt ends, Figures 25-27, also do not require prior piercing of body tissue, which allows easy insertion into tissue.

The radial displacement mounting assembly shown here with the flat tabs (Figures 28 and 29) and the curved tabs (Figure 30) requires a larger insertion surface than other tab sets. Hooks create pathways through body tissue that are simple and safe, with additional hold in systems that use curved hooks. System removal is carried out using a suitable removal tool that retracts each hook from its position. Alternatively, the catches can be made so that they can be removed by lifting the assembly up, as a result of which the catches bend to an upright position, allowing easy removal.

Fig. 41 shows a hook 201 with a helical spiral that can optionally be used with a port that includes a pipe fitting extending from the center of the base. The corkscrew construction is mounted on a separate disk 203, which is latched on the port with hooks 202, or can be mounted on the port itself, centered on the base plate. The disk or port is manually attached to the tissue by rotating the disk or port, which causes the helix to travel through the helical path through the tissue. In one embodiment, the spiral may have a pointed tip.

A variation of the helical-spiral abutment is shown in Fig. 42. Fig. 42 shows a flat, spiral spring 204 that is deflected down for insertion into tissue. The biasing tool 205 can be retracted after implantation, allowing the spring to clamp during treatment. Compressing the spring reduces the profile of the implanted spiral clip and can reduce the likelihood of causing pain. Hooks 202 are used to lock the port or other device on the hook.

Figures 43-47 and Figure 55 show the horizontal coil implantation system. In a horizontal coil arrangement, a metal coil is used horizontally to suture the tissue port. That such ganglia can puncture and persist in tissues is known for their use as mesh attachment in minimally invasive hernia treatment procedures. In this case, the coil travels parallel to the tissue surface, and not perpendicularly, as in the helical spiral abutments described above. A small installation tool 206 is provided to assist the guiding of the coil 208 through the tissue and the correspondingly matching holes 207 in the coil holder 209 in the base (see Figures 46 and 47). Such holes may be straight holes passing through the slat at the bottom of the base (see Figs. 44, 45 and 47), or curved holes stamped in the base with a flat surface. A top view of the base is shown in Fig. 43. It is foreseen that the last hole is blind and that the end of the coil has the shape of a crossbar that can be moved along the slope and can be locked in place, for example in a gap. The variation may include a path for the coil that surrounds the port or base edge, facilitating access to the coil using a tool. This can also be done by changing the flexibility of the coil. You can add a pipe to the tool as a cover so that the rotated coil does not pull the tissue fibers through the holes.

Figs. 48 to 62 show various embodiments of a metal suturing system. This method of securing the port involves making one or more closed metal loops below the port base, using the base itself as a means to close the loop formed by the curved metal elements (see, e.g., Figures 48 and 52). Fig. 48 illustrates one closed loop, with a single bent metal element shown in its extended position. FIG. 49 is a top view of a slice of one embodiment of the invention showing the curved metal elements 211 in their position before sliding out. Fig. 57 illustrates bottom and side views of one embodiment of the invention showing curved metal elements forming a loop with the bottom of the base. Fig. 51 shows curved metal elements, the arrows showing the direction of rotation during extension. The attachment of the port in the manner described above can be performed with both one-part and two-part systems, the two-part system may include a ring 210 which is attached to the port or other device by snapping the hooks 202, as shown in Fig. 50 deflector, metal element from

One embodiment includes the separating blade of the base, allowing the tip of the element to pass down into the tissue. It can be a circular disk or the port itself. After the blade has traveled a certain distance, the tool is retracted, so that the bent element can continue its path crossing the base. Similarly, another embodiment includes a plurality of elements curved in two planes such that rotation of the base affects the formation of multiple loops.

An alternative method of obtaining such a loop is performed by means of a curved pin 212, which is inserted through a base positioned in a predetermined position on the tissue, as can be seen in Figs. 53 and 54. Such a pin inherently forms an arch through the tissue and can easily be directed back to the base of the port. The pin can be immobilized after traveling the entire path by adding a right angle bend 213 that is latched into the base slot 214, or by other well-known means. A variation of this theme includes an additional straight section at the end of the pin, parallel to the curved section. Lever arm 215 is used to move the curved section through the base and to cover the entire foreseen path.

In yet another embodiment, a two-part system may be used, the port being attached to a bent base 218 with sharp, curved projections 217 (see Fig. 56). The bent plate is placed on the tissue with the projections facing the tissue. When the base plate is bent (flattened), the tabs are pushed along the circular path by 90 degrees (see Fig. 56). The port is then snapped into the base plate, locking the tabs. In one embodiment, the tongue blades cover the blades of the other half, protecting the blades.

Figs. 58-62 illustrate a preferred securing system with a rotating disc. Once placed in the desired location, the implanted device is attached to the tissue using a plurality of curved pins or hooks 501 (Fig. 62), whose tips are rotated along the arch and end their path back on or near the base plate 510. The disk 520 inside the base plate 510 is rotated, thereby causing the lever arms 525 to push the curved hooks 501, which, in turn, rotate about their solid axis in the base plate along the arc until the rotation of the disk is stopped. In the fully extended position (Figs. 59 and 60), the ends of the hooks 501 are preferably again in base plate 510, forming closed loops. Alternatively, the tips may form closed loops. In any case, it is preferred that the rotatable disk 520 be fixed at the end of its path, locking the hooks. Unidirectional, flexible locking tabs 527 that hook the stops 515, or other locking means, can be used to lock the hooks by preventing the disk from retracting. The ejection tool or delivery system as described above with reference to Figures 5-19 can be used to immobilize the device. The linear movement of the piston 22 and the slider pusher 24 is converted into rotary motion by means of a gear gear or other well-known means.

Figs. 63-72 illustrate the access port delivery system. According to Figure 63, which shows the port feeding system in the pre-delivery position, wherein the lever 605 is attached to the handle 607 in the hinge 621. The cable sheath 619 is attached to the handle 607 by the fastening pin 623. The cable sheath 619 surrounds the cable 617 which it is attached to the lever 605 at the end of the handle of the device in the cable stop 615. The cable cover 619 allows the cable to move linearly 617. At the end of delivery, the cable 617 is attached to the actuator lever 701, which is latched onto port cover 631. As can be seen in Figures 66 and 70, the activator lever 701 and port cover 631 have curved edges 721 for gripping the disc hitch base plate. In addition, the activator lever 701 has a groove 723 enabling the activator lever to rotate around the base plate with minimal contact, the only contact being provided by the curved edge 721. Figure 66 shows the edge 713 of the activator lever, which is latched into a matching groove of the port cover 631 and fixes the activator lever, but allows its rotational movement. Figure 65 shows a top view of the activator lever and shows a cable stop 705 to which the feed end of the cable 617 is attached. The cable 617 runs through the slot 707 and out through the cutout 709 and along the groove 711. When the user of the feeding tool pulls the lever 605 toward handle 607, the cable 617 is pulled through the sheath towards the handle 607. When the cable is pulled through the sheath, pulls the activator lever on the cable stop 705, causing the activator lever to rotate along the path described by edge 713 and its corresponding groove in port 631 cover. FIG. 69 and 70 show a partially dismantled assembly and a perspective cross-section of the details of the various parts of the activator lever, port cover, and cable assembly. Thus, the linear movement of the cable 607 is converted into the rotational movement needed to provide the fastening system.

Figures 71 and 72 show in more detail an embodiment of the port cover 631. The mounting position 735 is where the cable cover can be attached to the port cover. In addition, both Figure 71 and 72 show channel 737 of the device. Device channel 737 allows the port cover to be attached to a port or other device without contacting any pipes or other devices that may protrude from the port or device. In this embodiment, the channel has a rectangular shape, however, the channel may take different shapes to accommodate different devices.

Figs. 73-77 show a loading device for holding the port assembly and disc catch. The port and disc hitch system is latched onto a device that covers the assembly, protects the user from accidental contact with hooks, sharp tips, etc. used to attach the assembly to tissue, protects against premature triggering of the assembly, and allows the user to load the port and disc attachment into the tool giving, basically without touching the band. The delivery tool is latched onto the assembly while it is still in the loading device. Like the device channel in the port cover, the loading device has a device channel 739 allowing any wires to hang freely from the device to be attached without contact with the loading device. Figure 75 shows how the device can be immobilized by locking hooks 743 and / or pins 741. Figure 76 shows the port and disc hitch assembly held firmly by the loading device. Figure 77 is an exploded view of the disc mount / loading device assembly without the port device attached.

A brief description of the combined use of the preferred embodiment of the disc hitch system shown in Figs. 58-62, of the preferred embodiment of the feeding tool of Figs. 63-68 and the loading element of Figs. 73-77 will be helpful in understanding the invention. The user grips the port feeding system by the handle 607. The port and disc hitch assembly is held in the loading device as shown in Figure 76. The user maneuvers the port cover 631 over the port and disc hitch assembly, and the bent edges 721 of the actuator lever and port cover snap onto base plate 510 so that an audible and perceptible click is heard and sensed by the user. The user then pulls out the feeding tool from the loading unit with the port and hitch assembly attached and ready for delivery. The user then sets the port and disc hitch assembly so that the disc hitch is positioned at the point of delivery. After placing it in the right place, the user pulls the lever, moving the activator lever. The activation edge 725 hooks behind one lever arm 525, rotating the lever arms until the latches are fully extended. When fully ejected, an audible and perceptible click is both heard and sensed by the user when the port is ejected from the port delivery system and delivery is complete.

Although the invention has been specifically shown and described with respect to certain preferred embodiments, and in particular with respect to the access or injection port, those skilled in the art will readily recognize that any number of implantable medical devices can be used with the fastening system of the present invention and that various changes and modifications may be made thereto without departing from the scope of the invention as defined by the appended claims.

ALLERGAN, INC.

Proxy:

79P27301PL00

EP 1 670 362 B1