US20120041258A1 - Implantable access port system - Google Patents

Abstract

An implantable injection port for use with a gastric band for treating obesity and for attaching to a tissue of a patient is disclosed. The implantable injection port includes a base having an anchor opening, a gear coupled to the base and rotatable about a central axis, the gear having a plurality of gear teeth, an anchor coupled to the gear, and a top portion spaced apart from the base and having a plurality of top teeth that engage with the plurality of gear teeth. The top portion is rotatable causing rotation of the gear such that the rotation of the gear causes movement of the anchor through the anchor opening of the base and into the tissue of the patient.

Description

BACKGROUND
• 1. Field
• The present invention relates generally to implantable access ports and attachment mechanisms or systems for attaching the implantable access ports to a patient. More specifically, the present invention relates to implantable access ports with independent moving and locking gears for the anchors and related actuation devices. The implantable access ports may be connected to an inflatable portion of a gastric band and may be used to fill and remove fluid from the inflatable portion of the gastric band.
• 2. Description of the Related Art
• Implantable medical devices for performing therapeutic functions for a patient are well known. Such devices include pace makers, vascular access ports, injection ports (such as those used with gastric banding devices) and gastric pacing devices. Such devices are attached to a human, typically subcutaneously, in an appropriate place in order to function properly. It is desirable that the procedure to implant such devices be quick, easy, efficient, and require as small of an incision as possible.
• A suture (also known as stitches) is typically used by doctors to hold skin, internal organs, blood vessels and all other tissues of the human body together after they have been severed by injury, incision or surgery. Suturing is both time consuming and inconvenient. Surgical fasteners, such as staples, clips, clamps, bands, tacks, or other wound or incision closure devices, have been used in surgical procedures to eliminate the need for suturing. Surgical fasteners are commonly used in surgical procedures to allow a surgeon to fasten, secure, and/or repair bodily tissue. In these applications, the surgeon often uses a fastener implanting device loaded with one or more surgical fasteners to accomplish in a few seconds what would have taken many minutes to perform by suturing. This reduction in operating time reduces blood loss and trauma to the patient.
• Typically, such surgical fasteners have been used mainly for the closure of incisions or wounds, or to fasten tissues together. A surgical fastener that can be used with a number of different types of implantable medical devices would be beneficial for surgeons. Currently, surgical systems that incorporate surgical fasteners often use extremely specialized devices that may be unnecessarily complicated and are unsuitable for adaptation to other applications.
• As a result, the majority of implantable medical devices are secured with sutures. For example, when inserting a gastric band and an associated access port, the associated access port may be sutured into place with 3 to 5 sutures against the rectus muscle sheath. Such placement of the sutures is often challenging because the associated access port is placed below several inches of bodily tissue (e.g., fat), and suturing the associated access port often takes as long as placing the gastric band itself. An improved fastening device would allow easy, one-step attachment with security equivalent to the sutured medical device.
• One conventional method for fastening an implantable access port to the patient includes an external pistol-like applying means. The external pistol may include a trigger having geared teeth, a gear which meshes with the geared teeth, and a spring. The external pistol attaches to the implantable access port and tightens a fastener into the tissue of the patient upon pressing of the trigger. After attachment, the external pistol is removed from the implantable access port.
• Another conventional method for fastening an implantable access port includes fasteners extending from the housing of the implantable access port. In a self-attaching method, the implantable access port may be self attached upon the surgeon applying a distal force to the access port housing, causing the fasteners to penetrate the tissue, engaging the tissue to hold the access port in place. In an electronic method, the fasteners may be electronically switched between a deployed position and an un-deployed position using an actuator.
• The present invention overcomes at least some of the drawbacks of these conventional medical devices and methods.
SUMMARY
• Generally described herein are implantable access ports and related actuation devices. The apparatus, systems and methods described herein provide relatively easy attachment and locking capabilities of the implantable access ports to bodily tissue.
• In one example embodiment, an implantable injection port for use with a gastric band for treating obesity and for attaching to a tissue of a patient is disclosed. The implantable injection port includes a base having an anchor opening, a gear coupled to the base and rotatable about a central axis, the gear having a plurality of gear teeth, an anchor coupled to the gear, and a top portion spaced apart from the base and having a plurality of top teeth that engage with the plurality of gear teeth. The top portion is rotatable causing rotation of the gear such that the rotation of the gear causes movement of the anchor through the anchor opening of the base and into the tissue of the patient.
BRIEF DESCRIPTION OF THE DRAWINGS
• The features, objects, and advantages of the invention will become more apparent from the detailed description set forth below when taken in conjunction with the drawings, wherein:
• FIG. 1 is a simplified partial front view of a human body with a food intake restriction system having a band, a port and an applier tool according to an embodiment of the present invention;
• FIG. 2 is a perspective view of the port according to an embodiment of the present invention;
• FIG. 3 is a top view of the port ofFIG. 2, illustrating a circular fitting that connects to or meshes with the applier, according to an embodiment of the present invention;
• FIG. 4 is a perspective view of the port ofFIG. 2 with a top portion removed to show the reservoir according to an embodiment of the present invention;
• FIG. 5 is a disassembled perspective view showing the different parts of the port ofFIG. 2 according to an embodiment of the present invention;
• FIG. 6 is a perspective view of the inner ring ofFIG. 5 according to an embodiment of the present invention;
• FIG. 7 is a perspective view of the septum ofFIG. 5 according to an embodiment of the present invention;
• FIG. 8 is a perspective view of the housing ofFIG. 5 according to an embodiment of the present invention;
• FIG. 9 is a perspective view of the reservoir ofFIG. 5 according to an embodiment of the present invention;
• FIG. 10 is a bottom view of the base showing the anchor opening, the tip opening and the one or more suture holes according to an embodiment of the present invention;
• FIG. 11 is a perspective view of the radiopaque marker according to an embodiment of the present invention;
• FIG. 12 is a partial perspective view of the housing showing the radiopaque marker embedded into an inner cutout of the housing according to an embodiment of the present invention;
• FIG. 13 is a side view of the gear with the teeth according to an embodiment of the present invention;
• FIG. 14 is a side view of the anchor having a first hole, the base portion and the anchor tip according to an embodiment of the present invention;
• FIG. 15 is a side view of the anchor having a first hole and a second hole according to an embodiment of the present invention;
• FIG. 16 is a side view of the anchor connected to the gear according to an embodiment of the present invention;
• FIG. 17 is a side view of the anchor connected to the gear according to an embodiment of the present invention;
• FIG. 18 is an exploded side view of the gear and the anchor in a deployed position according to an embodiment of the present invention;
• FIG. 19 is an exploded side view of the gear and the anchor in an un-deployed position where the anchor is positioned between the top portion and the base according to an embodiment of the present invention;
• FIG. 20 is a side view of the top teeth engaged with the bottom teeth according to an embodiment of the present invention;
• FIGS. 21 and 22 are perspective top and side views of the housing with the top portion, the base and the anchors according to an embodiment of the present invention;
• FIGS. 23 and 24 are perspective top and bottom views of a port having cork screw anchors according to an embodiment of the invention;
• FIG. 25 is a perspective view of a flip top port according to an embodiment of the present invention;
• FIG. 26 is a side view of a flip top anchor according to an embodiment of the present invention;
• FIGS. 27 and 28 are partial perspective views of a locking rod capable of being locked onto a base of a port according to an embodiment of the present invention;
• FIGS. 29 and 30 are assembled and disassembled perspective views of the applier according to an embodiment of the present invention;
• FIGS. 31 and 32 are perspective views of different appliers and according to various embodiments of the present invention; and
• FIG. 33 is an end view of the applier ofFIG. 32 according to an embodiment of the present invention.
DETAILED DESCRIPTION
• Apparatus, systems and methods that implement the embodiments of the various features of the present invention will now be described with reference to the drawings. The drawings and the associated descriptions are provided to illustrate some embodiments of the present invention and not to limit the scope of the present invention. Throughout the drawings, reference numbers are re-used to indicate correspondence between referenced elements.
• A system is disclosed having a port (e.g., an implantable access port or an implantable injection port) that is securely fastened to bodily tissue of a human or a patient. The port is used to fill and remove fluid from an inflatable portion of a band (e.g., a gastric band) via a catheter attached between the port and the inflatable portion of the band. One or more anchors (e.g., four anchors) of the port may be subcutaneously and securely attached to the bodily tissue of the human by rotating one or more mating components (e.g., an applier, an axle, a cap, a gear, etc.). The one or more mating components provide a continually secure attachment of the one or more anchors to the bodily tissue of the patient after surgery.
• FIG. 1 is a simplified partial front view of ahuman body105 with a foodintake restriction system100 having aband110, aport130 and anapplier135 according to an embodiment of the present invention. The foodintake restriction system100 is used to treat obesity and to attach to a tissue of a patient. Theband110 may be a gastric band, such as the Lap-Band®, and may be adjustable, implantable, inflatable and positioned around or near the upper portion of astomach120 of a human105. Generally, theband110 is placed about the fundus, or esophageal junction, of a patient's upper stomach forming a stoma that restricts the food's passage into a lower portion of the stomach. Theband110 may include an inflatable portion (e.g., a cavity) made of silicone rubber, or another type of biocompatible material, that inflates or expands inward to constrict the stoma (stomach inlet) when filled with a fluid (e.g., saline) from acatheter125. Alternatively, a mechanical device or a combination hydraulic/mechanical device may be coupled to theband110 to constrict the stoma. When the stoma is of an appropriate size that is restricted by theband110, food held in the upper portion of the stomach may provide a feeling of satiety or fullness that discourages overeating.
• Theport130 may be implanted in a body region accessible for needle injections from asyringe140 and/or for receiving telemetry communication signals. Theport130 is a medical device that may be referred to as an access port, an injection port, an implantable access device or a housing. Theport130 fluidly communicates with the inflatable portion of theband110 via thecatheter125.
• A medical professional (e.g., doctor, health care provider, nurse, surgeon, technician, etc.) may position and temporarily or permanently implant theport130 inside the body of the human105 in order to perform adjustments of the food intake restriction or stoma created by theband110. The medical professional, for example, may implant theport130 in the lateral, subcostal region of the human's abdomen under the skin and layers of fatty tissue, or on or near the sternum of the human105. Also, any other suitable attachment areas or port sites may be used.
• Theapplier135 may be used to secure theport130 to the human105, as rotation of an applier handle rotates a portion of theport130 and secures anchors of theport130 into bodily tissue of the human105. In particular, the anchors may be moved from an undeployed position to a deployed position. Theapplier135 may be a tool such as a delivery tool.
• FIG. 2 is a perspective view of theport130 according to an embodiment of the present invention.FIG. 3 is a top view of theport130 ofFIG. 2, illustrating acircular fitting207 that connects to or meshes with theapplier135, according to an embodiment of the present invention.FIG. 4 is a perspective view of theport130 ofFIG. 2 with atop portion205 removed to show thereservoir210 according to an embodiment of the present invention.FIG. 5 is a disassembled perspective view showing the different parts of theport130 ofFIG. 2 according to an embodiment of the present invention.
• Referring toFIGS. 1-5, theport130 is configured to receive fluid from thesyringe140 for movement into the inflatable portion of theband110. Theport130 includes thetop portion205 and thereservoir210. Thereservoir210 contains an interior space for holding the fluid. Thereservoir210 may be an internal titanium port reservoir or a port without thetop portion205. As shown inFIG. 4, thereservoir210 is formed in the shape of a cylinder.
• Thetop portion205 may be a drive cap, a port cap, a rotating cap, a top cap or a top outer ring. Thetop portion205 may be attached to or be integrally formed with aninner ring206. Theinner ring206 may also be referred to as a flange. Alternatively, thetop portion205 may include theinner ring206.
• Thetop portion205 may have acenter opening207. Thecenter opening207 allows theinner ring206 to fit therein. In addition, a septum215 (e.g., a needle penetrable septum) may be located or positioned within theinner ring206 and/or the center opening207 of thetop portion205. Theinner ring206 and/or theseptum215 may be attached to thereservoir210. Thetop portion205 can rotate without rotating theinner ring206 and/or theseptum215. That is, theinner ring206 and/or theseptum215 may be permanently attached or fixedly attached to thereservoir210. In one embodiment, thetop portion205 is moveably or rotatably attached to theinner ring206.
• As an example, thesyringe140 may be used to pierce theseptum215, thus allowing the fluid in thesyringe140 to pass into thereservoir210 and then ultimately through thecatheter125 and into the inflatable portion of theband110. Also, thesyringe140 may be used to remove fluid from thereservoir210, which causes the fluid in the inflatable portion of theband110 to be removed therefrom. Theseptum215 may be made of any suitable needle penetrable material, for example, a self sealing needle penetrable material.
• Thetop portion205 may also have one or more fittings207 (e.g., cavities, holes or notches) located on a top surface of thetop portion205 to allow theapplier135 to attach to or mate with thetop portion205. Thefittings207 may be referred to as snap fittings because theapplier135 can snap into and out of thefittings207. Located in or near thefittings207, can be alock indicator225, illustrating when theport130 is securely attached to the bodily tissue of the human105. For example, thelock indicator225 can be a color-coded indicator on a bottom surface of thefittings207 where a green color indicates a locked position and a red color indicates an unlocked position. Theapplier135 can mate with thetop portion205 to rotate thetop portion205. In one embodiment, thetop portion205 rotates in a circular direction guided by theapplier135.
• Thetop portion205 may also haveteeth230 protruding from a bottom surface of thetop portion205. In an example embodiment, theteeth230 are positioned along an axis that is substantially perpendicular to a plane defined by thetop portion205. Theteeth230 include ridges, alternating cut-outs and protrusions, bumpy or uneven surfaces, a flat surface with friction and/or any other surface(s) with sufficient friction to interact with and move components (e.g., thegear275 and the anchor255) of theport130. Theteeth230 may be positioned along an outer edge of the entiretop portion205 forming a circle.
• Theport130 has abase245, one ormore axles250, one ormore axle holders251, one ormore gears275 and one or more anchors255. The base245 may also be referred to as a port base, a bottom base, a bottom cap, a bottom ring or a bottom portion. The base245 may lie along a plane that is substantially parallel to the plane defined by thetop portion205. Thereservoir210 is fixedly attached to thebase245 and does not move with the rotation of thetop portion205. Thebase245 includes one ormore anchor openings265 and one ormore tip openings270. As an example, the one ormore anchor openings265 may be formed in the shape of a rectangle and the one ormore tip openings270 may be formed in the shape of a circle.
• Theaxle holder251 is attached to or integrated with thebase245. Theaxle holder251 may include twopylons251aand251beach having a hole for theaxle250 to pass therethrough (seeFIG. 5). The twopylons251aand251bare positioned adjacent to and on opposite sides of theanchor opening265. Theanchor255 and thegear275 also have openings that allow for theaxle250 to pass therethrough. As shown inFIG. 5, thegear275 may have aside groove277 for holding theanchor255 in place and allowing for simultaneous rotation. In an assembled state, abase portion257 of theanchor255 tightly fits into theside groove277 of thegear275 and the combinedanchor255 andgear275 fit between the twopylons251aand251b. Theaxle250 passes through the holes of thepylori251a, theanchor255, thegear275, and thepylori251band is positioned therein. The movement of thegear275 causes a similar circular or rotational movement of theanchor255.
• Theaxle250 may rotate circularly when force is applied thereon. Theaxle250 may also be referred to as a center pin. Thegear275, attached to theaxle250, may rotate in unison with theaxle250.
• Thegear275 may also be referred to as a pinion gear. The gear includesteeth280 which mate with theteeth230 of thetop portion205 to rotate theanchor255. Theteeth280 may include ridges, bumpy surfaces, flat surfaces with friction, and any other surface with sufficient friction to interact with and to move components of theport130.
• To deploy theanchor255, thetop portion205 is rotated in a clockwise direction and theteeth230 are engaged with theteeth280 to rotate thegear275 and theanchor255 in a counter-clockwise direction causing theanchor255 to move through theanchor opening265 and into the tissue of a patient. Ananchor tip260 may also move into thetip opening270 when theanchor255 is fully deployed.
• Theanchor255 secures theport130 to the human105, by theanchor tip260 penetrating the human's skin or muscle (e.g., abdominal muscle fascia). Theanchor tip260 may also be referred to as a hook or pointed end. Theanchor tip260 is structured to penetrate and enter the bodily tissue as theanchor255 rotates into the deployed position. In some embodiments, theanchor tip260 includes one or more flat faces. For example, theanchor tip260 may have a single facet, or may have two or more facets. Theanchor255 may also be referred to as an attachment mechanism, a hook, a needle anchor, a needle device, or a cork screw. Also, theanchor255 may be formed in the shape of a hook, a needle or a cork screw (e.g., a series of spirals with a sharp point at the end of the series of spirals (seeFIGS. 24 and 25)). In one embodiment, eachanchor255 may be made of a wire, for example, a bent stainless steel wire having a round cross section and a multi-faceted sharp distal tip. Theport130 may include two, three, four, five ormore anchors255 and related components that are attached and positioned an equi-distance around thebase245.
• In one embodiment, a plurality ofanchors255 are simultaneously deployed or moved from an un-deployed position (FIG. 20) to a deployed position (FIG. 21). Eachanchor255 is rotated from an un-deployed position where theanchor255 is above the base245 to a deployed position where theanchor255 travels through theanchor opening265 and thebase portion257 of theneedle255 is in direct contact with thebase245. When in the deployed position, theanchors255 fix theport130 to the bodily tissue. In the case where theport130 is used in conjunction with a gastric band, theport130 may be secured, by means of theanchors255, to the rectus muscle fascia. Theanchor255 may protrude through the anchor opening265 in thebase245, and may also protrude through thetip opening270 in the base245 as theanchor255 is rotated around theaxle250. Thetip opening270 provides a safe storage position for theanchor tip260 so theanchor tip260 does not get dulled or damaged. The positioning of theanchor tip260 can be adjusted by having ananchor255 withdifferent base portion257 thicknesses, as theanchor255 can rotate until thebase portion257 of theanchor255 contacts thebase245.
• The base245 may also have one ormore suture holes285 for suturing theport130 to the human105, in the event that the use of theapplier135 to attach theport130 is not desired or allowable. A drawback of suturing is the additional time and effort required by the medical professional to secure theport130 during surgery.
• In some embodiments, theanchors255 are simultaneously removable or reversible, allowing theanchors255 to be detached from the bodily tissue. For example, thetop portion205 can be rotated in a counter-clockwise direction to remove theanchors255 from the tissue. Specifically, to un-deploy theanchors255, thecap205 is rotated in a counter-clockwise direction and theteeth230 are engaged with theteeth280 to rotate thegear275 and theanchor255 in a clockwise direction causing theanchors255 to move through theanchor opening265 and out of the tissue. Theanchor tip260 may also move into theanchor opening265.
• In one embodiment, a plurality ofanchors255 includes four anchors that are evenly spaced apart around thebase245. Eachanchor255 may be referred to as being independent, which includes being a separate component or having separate operation from anotheranchor255. Eachanchor255 includes a curved distal portion oranchor tip260 which engages the bodily tissue and a pivotal proximal portion orbody portion257, which is rotatably connected to thebase245 of theport130. In some embodiments, the pivotal proximal portion is substantially perpendicular with the curved distal portion, or more specifically, substantially perpendicular with a plane in which the curved distal portion rotates when the anchors are moved into the deployed position. In some embodiments, eachanchor255 may include a generally spiral distal portion and a straight proximal portion substantially perpendicular with the spiral distal portion.
• Theport130 may further include a removable safety cap (not shown) to protect the medical professional's hands and fingers from accidental anchor sticks. The safety cap may mount to the bottom of theport130 by a press-on fit. The color of the safety cap may be easily distinguishable from the color of theport130.
• The base245 may be moveably attached to thetop portion205 by thereservoir210. Astem240 is attached to thereservoir210 for injecting the fluid from theport130 to theband110. Thestem240 may include a strain relief element which locks into thehousing500 and protects thecatheter125 from folding, kinking, rotating, or torquing when thecatheter125 is connected to thereservoir210. Further strain relief may be provided by a flexible sleeve made of a puncture resistance material. The flexible sleeve and the strain relief element provide protection against accidental needle punctures to thecatheter125.
• Referring toFIG. 5, the disassembled perspective view showing the different parts of theport130 ofFIG. 2 discloses theinner ring206, theseptum215, thetop portion205, thehousing500, thereservoir210 and thestem240, thebase245 and the related components and aradiopaque marker520. Theinner ring206 may also include a titanium palpation ring. Thehousing500 may also be referred to as a port housing. Thehousing500 surrounds theport130 and covers the components therein.
• Theradiopaque marker520 is a type of locator element on theport130 that is clearly visible under an x-ray. Theradiopaque marker520 may be secured in thehousing500 so as not to hide theradiopaque marker520. Theradiopaque markers520 can be used to facilitate identification of the type of gastric band or other useful information to be identified by the x-ray image of theport130, for example, by using varied configurations, sizes or shapes of theradiopaque marker520.
• FIG. 6 is a perspective view of theinner ring206 ofFIG. 5 according to an embodiment of the present invention.FIG. 7 is a perspective view of theseptum215 ofFIG. 5 according to an embodiment of the present invention.
• FIG. 8 is a perspective view of thehousing500 ofFIG. 5 according to an embodiment of the present invention. Acoupler501 is attached to an exterior surface of thehousing500 for attachment to theapplier135. Thestem240 extends through anopening505 in thehousing500. A plurality of slits oropenings502,503 and504 in thehousing500 are used for attachment to theapplier135. In one embodiment, the center slit oropening503 is a suture cutout that are aligned with the suture holes285 on thebase245.FIG. 9 is a perspective view of thereservoir210 ofFIG. 5 according to an embodiment of the present invention. Thereservoir210 has an opening2100 for thestem240 for connection to thereservoir210.
• FIG. 10 is a bottom view of the base245 showing the anchor opening265, thetip opening270, and the one ormore suture holes285 according to an embodiment of the present invention.
• FIG. 11 is a perspective view of theradiopaque marker520 according to an embodiment of the present invention. As an example, theradiopaque marker520 is formed in the shape of a cylinder.
• FIG. 12 is a partial perspective view of thehousing500 showing theradiopaque marker520 embedded into aninner cutout506 of thehousing500 according to an embodiment of the present invention. As shown, theradiopaque marker520 fits snugly into theinner cutout506.
• FIG. 13 is a side view of thegear275 with thegear teeth280 according to an embodiment of the present invention.
• FIG. 14 is a side view of theanchor255 having afirst hole256, thebase portion257 and theanchor tip260 according to an embodiment of the present invention. The axle250 (not shown) is positioned through thefirst hole256.
• FIG. 15 is a side view of theanchor255 having afirst hole256 and asecond hole258 according to an embodiment of the present invention. The axle250 (not shown) is positioned through thefirst hole256. Thesecond hole258 is formed in the shape of a circle.
• FIG. 16 is a side view of theanchor255 connected to thegear275 according to an embodiment of the present invention. Thegear275 is secured to a middle portion of theanchor255. Thegear275 and theanchor255 rotate together.
• FIG. 17 is a side view of theanchor255 connected to thegear275 according to an embodiment of the present invention. Thegear275 is secured to a side portion of theanchor255. Thegear275 and theanchor255 rotate together.
• FIG. 18 is an exploded side view of thegear275 and theanchor255 in a deployed position where theanchor255 is positioned through the anchor opening265 in thebase245 and theanchor tip260 is positioned within thetip opening270 in the base245 according to an embodiment of the present invention.
• FIG. 19 is an exploded side view of thegear275 and theanchor255 in an un-deployed position where theanchor255 is positioned between thetop portion205 and the base245 according to an embodiment of the present invention. Thetop teeth230 are in movable engagement with thebottom teeth280. As thetop portion205 is rotated, thetop teeth230 move, which in turn moves thebottom teeth280, which rotate theanchor255.
• FIG. 20 is a side view of thetop teeth230 engaged with thebottom teeth280 according to an embodiment of the present invention. When theanchor255 is in the fully deployed position, thestem240 is locked in place by a lockingmember299, which is attached to thebase245. The lockingmember299 has a concave top surface that mates with a convex top surface of the lockingmember299.
• FIGS. 21 and 22 are perspective top and side views of thehousing500 with thetop portion205 and the base245 according to an embodiment of the present invention. As shown, theanchors255 protrude from thebase245 and form a curve when theanchors255 are in a deployed position.
• FIGS. 23 and 24 are perspective top and bottom views of aport2300 having cork screw anchors2305 according to an embodiment of the invention. The cork screw port2400 has cork screw anchors2405 protruding through thebase245 and capable of being screwed into the bodily tissue. Thetop portion205 can be rotated causing arotating device2310 to rotate with thetop portion205 and move the cork screw anchors2405 into and out of the housing500 (i.e., from an un-deployed position to a deployed position and vice versa).
• FIG. 25 is a perspective view of a fliptop port2500 according to an embodiment of the present invention.FIG. 26 is a side view of a fliptop anchor2505 according to an embodiment of the present invention. The fliptop anchors2505 attach to bodily tissue as the flip top2510 is moved downwards. When the flip top2510 is pulled up, theanchors2505 are in an undeployed position and when the flip top2510 is pushed down and comes into contact with thehousing2501, theanchors2505 in a deployed position.
• FIGS. 27 and 28 are bottom side views of thestem240 in a right side position indicating an undeployed position for the anchors according to an embodiment of the present invention. InFIG. 27, thestem240 is locked in place between aflange2705 or2708 and a bump orprotrusion2706 or2707 on theflange2705 or2708. Theflanges2705 and2708 may be formed in the shape of a “L” and may be attached to the base245 as shown inFIG. 20. Thestem240 may move between a left side position indicating a deployed position for the anchors and a right side position indicating an undeployed position for the anchors. Eachflange2705 or2708 may have acutout2809 for securing or locking thestem240 in place. When thestem240 is in thecutout2809, the anchors are in a locked position. InFIG. 28, thestem240 is locked in place between aflange2805 or2808 and a bump orprotrusion2806 or2807 on theflange2805 or2808. Theflanges2805 and2808 may be formed in the shape of a “L” and may be attached to the base245 as shown inFIG. 20. Thestem240 may move between a left side position indicating a deployed position for the anchors and a right side position indicating an undeployed position for the anchors. Eachflange2805 or2808 may have acutout2809 for securing or locking thestem240 in place. When thestem240 is in thecutout2809, the anchors are in a locked position.
• FIGS. 29 and 30 are assembled and disassembled perspective views of theapplier135 according to an embodiment of the present invention. Theapplier135 may be used to secure theport130 to the human105, as rotation of theapplier handle3005 rotates thetop portion205 of theport130 and secures theanchors255 of theport130 into the human105. As illustrated, theapplier135 includes ahandle3005, ashaft3010, a driver or aspring3015, asleeve3020 that holds theshaft3010 and thedriver3015, and aconnector3025. Thehandle3005 is used to place and rotate theapplier135. Theshaft3010 can provide leverage through its length or through internal components. Theconnector3025 attaches to thefittings207 on the top of thetop portion205. Thespring3015 can apply pressure to thedriver3015. Thesleeve3020 covers and protects theshaft3010 and thespring3015. The applier135 mates with theport130 to turn thegears275 by turning thetop portion205. A medical professional turns theapplier handle3005 in a large circular direction to turn thetop portion205 of theport130. Theapplier135 may be disposable. Also, theport130 can be attached to bodily tissue by suturing.
• FIGS. 31 and 32 are perspective views ofdifferent appliers3100 and3200 according to various embodiments of the present invention.FIG. 33 is an end view of theapplier3200 ofFIG. 32 according to an embodiment of the present invention. Theend portion3300 has acutout3316 that can attach to or fit around thecoupler501 shown inFIG. 8. Additionally, an inside surface of theend portion3300 can include protrusions that mate with and attach to theslits502 and504 of thehousing500 to allow better attachment and grip to rotate thetop portion205. In one embodiment, thetop portion205 is fixedly attached to thehousing500 so both components rotate together. Theend portion3300 may have aconnector3305 withprotrusions3320 that attach to thefittings207. Therim3325 is sized to be larger than thehousing500 so therim3325 can fit over thehousing500.
• The terms “a,” “an,” “the,” and similar referents used in the context of describing the present invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. Recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein is intended merely to better illuminate the present invention and does not pose a limitation on the scope of the present invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the present invention.
• Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member may be referred to and claimed individually or in any combination with other members of the group or other elements found herein. It is anticipated that one or more members of a group may be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is deemed to contain the group as modified thus fulfilling the written description of all Markush groups used in the appended claims.
• Certain embodiments of this invention are described herein, including the best mode known to the inventors for carrying out the invention. Of course, variations on these described embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventor expects skilled artisans to employ such variations as appropriate, and the inventors intend for the invention to be practiced otherwise than specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context.
• Furthermore, certain references have been made to patents and printed publications throughout this specification. Each of the above-cited references and printed publications are individually incorporated herein by reference in their entirety.
• Specific embodiments disclosed herein may be further limited in the claims using consisting of or consisting essentially of language. When used in the claims, whether as filed or added per amendment, the transition term “consisting of” excludes any element, step, or ingredient not specified in the claims. The transition term “consisting essentially of” limits the scope of a claim to the specified materials or steps and those that do not materially affect the basic and novel characteristic(s). Embodiments of the invention so claimed are inherently or expressly described and enabled herein.
• In closing, it is to be understood that the embodiments of the present invention disclosed herein are illustrative of the principles of the present invention. Other modifications that may be employed are within the scope of the present invention. Thus, by way of example, but not of limitation, alternative configurations of the present invention may be utilized in accordance with the teachings herein. Accordingly, the present invention is not limited to that precisely as shown and described herein.
• The previous description of the disclosed examples is provided to enable any person of ordinary skill in the art to make or use the disclosed methods and apparatus. Various modifications to these examples will be readily apparent to those skilled in the art, and the principles defined herein may be applied to other examples without departing from the spirit or scope of the disclosed method and apparatus. The described embodiments are to be considered in all respects only as illustrative and not restrictive and the scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims (20)

What is claimed is:

1. An implantable injection port for use with a gastric band for treating obesity and for attaching to a tissue of a patient, the implantable injection port comprising:

a base having an anchor opening;

a gear coupled to the base and rotatable about a central axis, the gear having a plurality of gear teeth;

an anchor coupled to the gear; and

a top portion spaced apart from the base and having a plurality of top teeth that engage with the plurality of gear teeth, the top portion being rotatable causing rotation of the gear such that the rotation of the gear causes movement of the anchor through the anchor opening of the base and into the tissue of the patient.

2. The implantable injection port ofclaim 1, wherein the anchor has an attachment end coupled to the gear and a free end configured in the shape of a hook.

3. The implantable injection port ofclaim 2, wherein the anchor has a flat surface adjacent to the attachment end that is used to stop the anchor from rotating beyond a predetermined position.

4. The implantable injection port ofclaim 1, wherein the anchor is formed in the shape of a spiral and has a pointed end.

5. The implantable injection port ofclaim 1, wherein the top portion has a center opening and an outer portion surrounding the center opening, the outer portion having one or more fittings.

6. The implantable injection port ofclaim 5, further comprising a septum positioned within the center opening of the top portion and made of a self sealing needle penetrable material.

7. The implantable injection port ofclaim 6, further comprising a reservoir positioned underneath the septum and between the top portion and the base for holding fluid.

8. The implantable injection port ofclaim 7, further comprising a stem extending outward from the reservoir and a flange connected to the base and having a first end and a second end, the stem being movable along the flange from the first end to the second end.

9. The implantable injection port ofclaim 8, wherein the anchor is in a deployed position when the stem is positioned at the first end of the flange and the anchor is in an undeployed position when the stem is positioned at the second end of the flange.

10. The implantable injection port ofclaim 9, wherein the flange has a plurality of protrusions to lock the stem in place.

11. The implantable injection port ofclaim 5, further comprising an actuation device having a handle and a port interface that attaches to and detaches from the one or more fittings to rotate the top portion.

12. An implantable injection port system for use with a gastric band for treating obesity and for attaching to a tissue of a patient, the implantable injection port system comprising:

a catheter having a first end and a second end;

a gastric band attached to the first end of the catheter; and

a port attached to the second end of the catheter, the port comprising:

a top portion having top and bottom surfaces and top teeth protruding from the bottom surface, a septum, and one or more fittings on the top surface,

a base spaced apart from the top portion,

a gear attached to the base, the gear having a plurality of bottom teeth that interact with the top teeth so that rotation of the top portion causes rotation of the gear, and

an anchor attached to the gear, wherein rotation of the top portion causes rotation of the gear causing the anchor to move into and out of bodily tissue.

13. The implantable injection port system ofclaim 12, wherein the port comprises an implantable access port.

14. The implantable injection port system ofclaim 12, wherein the gastric band and the port are placed subcutaneously inside a patient.

15. The implantable injection port system ofclaim 12, further comprising an applier configured to rotate the top portion.

16. An applier apparatus comprising:

a proximal end having a handle to be held by a medical professional or attached to a gripping device for rotating the handle;

a shaft attached to the handle, wherein rotation of the handle rotates the shaft; and

a distal end having a driver configured to mate with a fitting on a port to secure the port to a patient.

17. The apparatus ofclaim 16, wherein the applier comprises a compression spring around the shaft.

18. The apparatus ofclaim 17, wherein the applier comprises a sleeve surrounding the compression spring.

19. The apparatus ofclaim 16, wherein the port further comprises:

a top portion having an open center portion and a plurality of ridges;

a base having an anchor opening;

a cylindrical port positioned between the top portion and the base;

a gear coupled to the base and having teeth that interact with the plurality of ridges; and

an anchor attached to the gear and configured to pass through the anchor opening, the rotation of the gear causing rotation of the anchor into and out of bodily tissue.

20. The apparatus ofclaim 16, wherein the anchor is formed in the shape of a cork screw.

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