U.S. patent application number 12/857447 was filed with the patent office on 2012-02-16 for implantable access port system.
This patent application is currently assigned to ALLERGAN, INC.. Invention is credited to Matthew B. DeNardo, Kenneth A. Eliasen, Jordan Jacobs, Chris Maurer, Mark J. Orphanos.
Application Number | 20120041258 12/857447 |
Document ID | / |
Family ID | 45565317 |
Filed Date | 2012-02-16 |
United States Patent
Application |
20120041258 |
Kind Code |
A1 |
Jacobs; Jordan ; et
al. |
February 16, 2012 |
IMPLANTABLE ACCESS PORT SYSTEM
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.
Inventors: |
Jacobs; Jordan; (Randolph,
MA) ; Orphanos; Mark J.; (Stoughton, MA) ;
Maurer; Chris; (Wakefield, MA) ; Eliasen; Kenneth
A.; (Wrentham, MA) ; DeNardo; Matthew B.;
(West Roxbury, MA) |
Assignee: |
ALLERGAN, INC.
Irvine
CA
|
Family ID: |
45565317 |
Appl. No.: |
12/857447 |
Filed: |
August 16, 2010 |
Current U.S.
Class: |
600/37 |
Current CPC
Class: |
A61F 5/0056 20130101;
A61M 39/0208 20130101; A61M 2039/0223 20130101; A61F 2/04
20130101 |
Class at
Publication: |
600/37 |
International
Class: |
A61F 2/04 20060101
A61F002/04 |
Claims
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 of claim 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 of claim 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 of claim 1, wherein the anchor is
formed in the shape of a spiral and has a pointed end.
5. The implantable injection port of claim 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 of claim 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 of claim 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 of claim 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 of claim 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 of claim 9, wherein the flange
has a plurality of protrusions to lock the stem in place.
11. The implantable injection port of claim 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 of claim 12, wherein the
port comprises an implantable access port.
14. The implantable injection port system of claim 12, wherein the
gastric band and the port are placed subcutaneously inside a
patient.
15. The implantable injection port system of claim 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 of claim 16, wherein the applier comprises a
compression spring around the shaft.
18. The apparatus of claim 17, wherein the applier comprises a
sleeve surrounding the compression spring.
19. The apparatus of claim 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 of claim 16, wherein the anchor is formed in the
shape of a cork screw.
Description
BACKGROUND
[0001] 1. Field
[0002] 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.
[0003] 2. Description of the Related Art
[0004] 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.
[0005] 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.
[0006] 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.
[0007] 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.
[0008] 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.
[0009] 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.
[0010] The present invention overcomes at least some of the
drawbacks of these conventional medical devices and methods.
SUMMARY
[0011] 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.
[0012] 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
[0013] 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:
[0014] 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;
[0015] FIG. 2 is a perspective view of the port according to an
embodiment of the present invention;
[0016] FIG. 3 is a top view of the port of FIG. 2, illustrating a
circular fitting that connects to or meshes with the applier,
according to an embodiment of the present invention;
[0017] FIG. 4 is a perspective view of the port of FIG. 2 with a
top portion removed to show the reservoir according to an
embodiment of the present invention;
[0018] FIG. 5 is a disassembled perspective view showing the
different parts of the port of FIG. 2 according to an embodiment of
the present invention;
[0019] FIG. 6 is a perspective view of the inner ring of FIG. 5
according to an embodiment of the present invention;
[0020] FIG. 7 is a perspective view of the septum of FIG. 5
according to an embodiment of the present invention;
[0021] FIG. 8 is a perspective view of the housing of FIG. 5
according to an embodiment of the present invention;
[0022] FIG. 9 is a perspective view of the reservoir of FIG. 5
according to an embodiment of the present invention;
[0023] 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;
[0024] FIG. 11 is a perspective view of the radiopaque marker
according to an embodiment of the present invention;
[0025] 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;
[0026] FIG. 13 is a side view of the gear with the teeth according
to an embodiment of the present invention;
[0027] 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;
[0028] 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;
[0029] FIG. 16 is a side view of the anchor connected to the gear
according to an embodiment of the present invention;
[0030] FIG. 17 is a side view of the anchor connected to the gear
according to an embodiment of the present invention;
[0031] 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;
[0032] 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;
[0033] FIG. 20 is a side view of the top teeth engaged with the
bottom teeth according to an embodiment of the present
invention;
[0034] 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;
[0035] FIGS. 23 and 24 are perspective top and bottom views of a
port having cork screw anchors according to an embodiment of the
invention;
[0036] FIG. 25 is a perspective view of a flip top port according
to an embodiment of the present invention;
[0037] FIG. 26 is a side view of a flip top anchor according to an
embodiment of the present invention;
[0038] 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;
[0039] FIGS. 29 and 30 are assembled and disassembled perspective
views of the applier according to an embodiment of the present
invention;
[0040] FIGS. 31 and 32 are perspective views of different appliers
and according to various embodiments of the present invention;
and
[0041] FIG. 33 is an end view of the applier of FIG. 32 according
to an embodiment of the present invention.
DETAILED DESCRIPTION
[0042] 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.
[0043] 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.
[0044] FIG. 1 is a simplified partial front view of a human body
105 with a food intake restriction system 100 having a band 110, a
port 130 and an applier 135 according to an embodiment of the
present invention. The food intake restriction system 100 is used
to treat obesity and to attach to a tissue of a patient. The band
110 may be a gastric band, such as the Lap-Band.RTM., and may be
adjustable, implantable, inflatable and positioned around or near
the upper portion of a stomach 120 of a human 105. Generally, the
band 110 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. The band 110 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 a catheter 125. Alternatively, a
mechanical device or a combination hydraulic/mechanical device may
be coupled to the band 110 to constrict the stoma. When the stoma
is of an appropriate size that is restricted by the band 110, food
held in the upper portion of the stomach may provide a feeling of
satiety or fullness that discourages overeating.
[0045] The port 130 may be implanted in a body region accessible
for needle injections from a syringe 140 and/or for receiving
telemetry communication signals. The port 130 is a medical device
that may be referred to as an access port, an injection port, an
implantable access device or a housing. The port 130 fluidly
communicates with the inflatable portion of the band 110 via the
catheter 125.
[0046] A medical professional (e.g., doctor, health care provider,
nurse, surgeon, technician, etc.) may position and temporarily or
permanently implant the port 130 inside the body of the human 105
in order to perform adjustments of the food intake restriction or
stoma created by the band 110. The medical professional, for
example, may implant the port 130 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 human 105. Also, any other
suitable attachment areas or port sites may be used.
[0047] The applier 135 may be used to secure the port 130 to the
human 105, as rotation of an applier handle rotates a portion of
the port 130 and secures anchors of the port 130 into bodily tissue
of the human 105. In particular, the anchors may be moved from an
undeployed position to a deployed position. The applier 135 may be
a tool such as a delivery tool.
[0048] FIG. 2 is a perspective view of the port 130 according to an
embodiment of the present invention. FIG. 3 is a top view of the
port 130 of FIG. 2, illustrating a circular fitting 207 that
connects to or meshes with the applier 135, according to an
embodiment of the present invention. FIG. 4 is a perspective view
of the port 130 of FIG. 2 with a top portion 205 removed to show
the reservoir 210 according to an embodiment of the present
invention. FIG. 5 is a disassembled perspective view showing the
different parts of the port 130 of FIG. 2 according to an
embodiment of the present invention.
[0049] Referring to FIGS. 1-5, the port 130 is configured to
receive fluid from the syringe 140 for movement into the inflatable
portion of the band 110. The port 130 includes the top portion 205
and the reservoir 210. The reservoir 210 contains an interior space
for holding the fluid. The reservoir 210 may be an internal
titanium port reservoir or a port without the top portion 205. As
shown in FIG. 4, the reservoir 210 is formed in the shape of a
cylinder.
[0050] The top portion 205 may be a drive cap, a port cap, a
rotating cap, a top cap or a top outer ring. The top portion 205
may be attached to or be integrally formed with an inner ring 206.
The inner ring 206 may also be referred to as a flange.
Alternatively, the top portion 205 may include the inner ring
206.
[0051] The top portion 205 may have a center opening 207. The
center opening 207 allows the inner ring 206 to fit therein. In
addition, a septum 215 (e.g., a needle penetrable septum) may be
located or positioned within the inner ring 206 and/or the center
opening 207 of the top portion 205. The inner ring 206 and/or the
septum 215 may be attached to the reservoir 210. The top portion
205 can rotate without rotating the inner ring 206 and/or the
septum 215. That is, the inner ring 206 and/or the septum 215 may
be permanently attached or fixedly attached to the reservoir 210.
In one embodiment, the top portion 205 is moveably or rotatably
attached to the inner ring 206.
[0052] As an example, the syringe 140 may be used to pierce the
septum 215, thus allowing the fluid in the syringe 140 to pass into
the reservoir 210 and then ultimately through the catheter 125 and
into the inflatable portion of the band 110. Also, the syringe 140
may be used to remove fluid from the reservoir 210, which causes
the fluid in the inflatable portion of the band 110 to be removed
therefrom. The septum 215 may be made of any suitable needle
penetrable material, for example, a self sealing needle penetrable
material.
[0053] The top portion 205 may also have one or more fittings 207
(e.g., cavities, holes or notches) located on a top surface of the
top portion 205 to allow the applier 135 to attach to or mate with
the top portion 205. The fittings 207 may be referred to as snap
fittings because the applier 135 can snap into and out of the
fittings 207. Located in or near the fittings 207, can be a lock
indicator 225, illustrating when the port 130 is securely attached
to the bodily tissue of the human 105. For example, the lock
indicator 225 can be a color-coded indicator on a bottom surface of
the fittings 207 where a green color indicates a locked position
and a red color indicates an unlocked position. The applier 135 can
mate with the top portion 205 to rotate the top portion 205. In one
embodiment, the top portion 205 rotates in a circular direction
guided by the applier 135.
[0054] The top portion 205 may also have teeth 230 protruding from
a bottom surface of the top portion 205. In an example embodiment,
the teeth 230 are positioned along an axis that is substantially
perpendicular to a plane defined by the top portion 205. The teeth
230 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., the gear 275 and the anchor 255) of the port 130.
The teeth 230 may be positioned along an outer edge of the entire
top portion 205 forming a circle.
[0055] The port 130 has a base 245, one or more axles 250, one or
more axle holders 251, one or more gears 275 and one or more
anchors 255. The base 245 may also be referred to as a port base, a
bottom base, a bottom cap, a bottom ring or a bottom portion. The
base 245 may lie along a plane that is substantially parallel to
the plane defined by the top portion 205. The reservoir 210 is
fixedly attached to the base 245 and does not move with the
rotation of the top portion 205. The base 245 includes one or more
anchor openings 265 and one or more tip openings 270. As an
example, the one or more anchor openings 265 may be formed in the
shape of a rectangle and the one or more tip openings 270 may be
formed in the shape of a circle.
[0056] The axle holder 251 is attached to or integrated with the
base 245. The axle holder 251 may include two pylons 251a and 251b
each having a hole for the axle 250 to pass therethrough (see FIG.
5). The two pylons 251a and 251b are positioned adjacent to and on
opposite sides of the anchor opening 265. The anchor 255 and the
gear 275 also have openings that allow for the axle 250 to pass
therethrough. As shown in FIG. 5, the gear 275 may have a side
groove 277 for holding the anchor 255 in place and allowing for
simultaneous rotation. In an assembled state, a base portion 257 of
the anchor 255 tightly fits into the side groove 277 of the gear
275 and the combined anchor 255 and gear 275 fit between the two
pylons 251a and 251b. The axle 250 passes through the holes of the
pylori 251a, the anchor 255, the gear 275, and the pylori 251b and
is positioned therein. The movement of the gear 275 causes a
similar circular or rotational movement of the anchor 255.
[0057] The axle 250 may rotate circularly when force is applied
thereon. The axle 250 may also be referred to as a center pin. The
gear 275, attached to the axle 250, may rotate in unison with the
axle 250.
[0058] The gear 275 may also be referred to as a pinion gear. The
gear includes teeth 280 which mate with the teeth 230 of the top
portion 205 to rotate the anchor 255. The teeth 280 may include
ridges, bumpy surfaces, flat surfaces with friction, and any other
surface with sufficient friction to interact with and to move
components of the port 130.
[0059] To deploy the anchor 255, the top portion 205 is rotated in
a clockwise direction and the teeth 230 are engaged with the teeth
280 to rotate the gear 275 and the anchor 255 in a
counter-clockwise direction causing the anchor 255 to move through
the anchor opening 265 and into the tissue of a patient. An anchor
tip 260 may also move into the tip opening 270 when the anchor 255
is fully deployed.
[0060] The anchor 255 secures the port 130 to the human 105, by the
anchor tip 260 penetrating the human's skin or muscle (e.g.,
abdominal muscle fascia). The anchor tip 260 may also be referred
to as a hook or pointed end. The anchor tip 260 is structured to
penetrate and enter the bodily tissue as the anchor 255 rotates
into the deployed position. In some embodiments, the anchor tip 260
includes one or more flat faces. For example, the anchor tip 260
may have a single facet, or may have two or more facets. The anchor
255 may also be referred to as an attachment mechanism, a hook, a
needle anchor, a needle device, or a cork screw. Also, the anchor
255 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 (see FIGS. 24 and 25)). In one embodiment, each
anchor 255 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. The port 130 may include two, three, four, five or more
anchors 255 and related components that are attached and positioned
an equi-distance around the base 245.
[0061] In one embodiment, a plurality of anchors 255 are
simultaneously deployed or moved from an un-deployed position (FIG.
20) to a deployed position (FIG. 21). Each anchor 255 is rotated
from an un-deployed position where the anchor 255 is above the base
245 to a deployed position where the anchor 255 travels through the
anchor opening 265 and the base portion 257 of the needle 255 is in
direct contact with the base 245. When in the deployed position,
the anchors 255 fix the port 130 to the bodily tissue. In the case
where the port 130 is used in conjunction with a gastric band, the
port 130 may be secured, by means of the anchors 255, to the rectus
muscle fascia. The anchor 255 may protrude through the anchor
opening 265 in the base 245, and may also protrude through the tip
opening 270 in the base 245 as the anchor 255 is rotated around the
axle 250. The tip opening 270 provides a safe storage position for
the anchor tip 260 so the anchor tip 260 does not get dulled or
damaged. The positioning of the anchor tip 260 can be adjusted by
having an anchor 255 with different base portion 257 thicknesses,
as the anchor 255 can rotate until the base portion 257 of the
anchor 255 contacts the base 245.
[0062] The base 245 may also have one or more suture holes 285 for
suturing the port 130 to the human 105, in the event that the use
of the applier 135 to attach the port 130 is not desired or
allowable. A drawback of suturing is the additional time and effort
required by the medical professional to secure the port 130 during
surgery.
[0063] In some embodiments, the anchors 255 are simultaneously
removable or reversible, allowing the anchors 255 to be detached
from the bodily tissue. For example, the top portion 205 can be
rotated in a counter-clockwise direction to remove the anchors 255
from the tissue. Specifically, to un-deploy the anchors 255, the
cap 205 is rotated in a counter-clockwise direction and the teeth
230 are engaged with the teeth 280 to rotate the gear 275 and the
anchor 255 in a clockwise direction causing the anchors 255 to move
through the anchor opening 265 and out of the tissue. The anchor
tip 260 may also move into the anchor opening 265.
[0064] In one embodiment, a plurality of anchors 255 includes four
anchors that are evenly spaced apart around the base 245. Each
anchor 255 may be referred to as being independent, which includes
being a separate component or having separate operation from
another anchor 255. Each anchor 255 includes a curved distal
portion or anchor tip 260 which engages the bodily tissue and a
pivotal proximal portion or body portion 257, which is rotatably
connected to the base 245 of the port 130. 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, each anchor 255 may include a generally spiral
distal portion and a straight proximal portion substantially
perpendicular with the spiral distal portion.
[0065] The port 130 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
the port 130 by a press-on fit. The color of the safety cap may be
easily distinguishable from the color of the port 130.
[0066] The base 245 may be moveably attached to the top portion 205
by the reservoir 210. A stem 240 is attached to the reservoir 210
for injecting the fluid from the port 130 to the band 110. The stem
240 may include a strain relief element which locks into the
housing 500 and protects the catheter 125 from folding, kinking,
rotating, or torquing when the catheter 125 is connected to the
reservoir 210. 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 the catheter 125.
[0067] Referring to FIG. 5, the disassembled perspective view
showing the different parts of the port 130 of FIG. 2 discloses the
inner ring 206, the septum 215, the top portion 205, the housing
500, the reservoir 210 and the stem 240, the base 245 and the
related components and a radiopaque marker 520. The inner ring 206
may also include a titanium palpation ring. The housing 500 may
also be referred to as a port housing. The housing 500 surrounds
the port 130 and covers the components therein.
[0068] The radiopaque marker 520 is a type of locator element on
the port 130 that is clearly visible under an x-ray. The radiopaque
marker 520 may be secured in the housing 500 so as not to hide the
radiopaque marker 520. The radiopaque markers 520 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 the port
130, for example, by using varied configurations, sizes or shapes
of the radiopaque marker 520.
[0069] FIG. 6 is a perspective view of the inner ring 206 of FIG. 5
according to an embodiment of the present invention. FIG. 7 is a
perspective view of the septum 215 of FIG. 5 according to an
embodiment of the present invention.
[0070] FIG. 8 is a perspective view of the housing 500 of FIG. 5
according to an embodiment of the present invention. A coupler 501
is attached to an exterior surface of the housing 500 for
attachment to the applier 135. The stem 240 extends through an
opening 505 in the housing 500. A plurality of slits or openings
502, 503 and 504 in the housing 500 are used for attachment to the
applier 135. In one embodiment, the center slit or opening 503 is a
suture cutout that are aligned with the suture holes 285 on the
base 245. FIG. 9 is a perspective view of the reservoir 210 of FIG.
5 according to an embodiment of the present invention. The
reservoir 210 has an opening 2100 for the stem 240 for connection
to the reservoir 210.
[0071] FIG. 10 is a bottom view of the base 245 showing the anchor
opening 265, the tip opening 270, and the one or more suture holes
285 according to an embodiment of the present invention.
[0072] FIG. 11 is a perspective view of the radiopaque marker 520
according to an embodiment of the present invention. As an example,
the radiopaque marker 520 is formed in the shape of a cylinder.
[0073] FIG. 12 is a partial perspective view of the housing 500
showing the radiopaque marker 520 embedded into an inner cutout 506
of the housing 500 according to an embodiment of the present
invention. As shown, the radiopaque marker 520 fits snugly into the
inner cutout 506.
[0074] FIG. 13 is a side view of the gear 275 with the gear teeth
280 according to an embodiment of the present invention.
[0075] FIG. 14 is a side view of the anchor 255 having a first hole
256, the base portion 257 and the anchor tip 260 according to an
embodiment of the present invention. The axle 250 (not shown) is
positioned through the first hole 256.
[0076] FIG. 15 is a side view of the anchor 255 having a first hole
256 and a second hole 258 according to an embodiment of the present
invention. The axle 250 (not shown) is positioned through the first
hole 256. The second hole 258 is formed in the shape of a
circle.
[0077] FIG. 16 is a side view of the anchor 255 connected to the
gear 275 according to an embodiment of the present invention. The
gear 275 is secured to a middle portion of the anchor 255. The gear
275 and the anchor 255 rotate together.
[0078] FIG. 17 is a side view of the anchor 255 connected to the
gear 275 according to an embodiment of the present invention. The
gear 275 is secured to a side portion of the anchor 255. The gear
275 and the anchor 255 rotate together.
[0079] FIG. 18 is an exploded side view of the gear 275 and the
anchor 255 in a deployed position where the anchor 255 is
positioned through the anchor opening 265 in the base 245 and the
anchor tip 260 is positioned within the tip opening 270 in the base
245 according to an embodiment of the present invention.
[0080] FIG. 19 is an exploded side view of the gear 275 and the
anchor 255 in an un-deployed position where the anchor 255 is
positioned between the top portion 205 and the base 245 according
to an embodiment of the present invention. The top teeth 230 are in
movable engagement with the bottom teeth 280. As the top portion
205 is rotated, the top teeth 230 move, which in turn moves the
bottom teeth 280, which rotate the anchor 255.
[0081] FIG. 20 is a side view of the top teeth 230 engaged with the
bottom teeth 280 according to an embodiment of the present
invention. When the anchor 255 is in the fully deployed position,
the stem 240 is locked in place by a locking member 299, which is
attached to the base 245. The locking member 299 has a concave top
surface that mates with a convex top surface of the locking member
299.
[0082] FIGS. 21 and 22 are perspective top and side views of the
housing 500 with the top portion 205 and the base 245 according to
an embodiment of the present invention. As shown, the anchors 255
protrude from the base 245 and form a curve when the anchors 255
are in a deployed position.
[0083] FIGS. 23 and 24 are perspective top and bottom views of a
port 2300 having cork screw anchors 2305 according to an embodiment
of the invention. The cork screw port 2400 has cork screw anchors
2405 protruding through the base 245 and capable of being screwed
into the bodily tissue. The top portion 205 can be rotated causing
a rotating device 2310 to rotate with the top portion 205 and move
the cork screw anchors 2405 into and out of the housing 500 (i.e.,
from an un-deployed position to a deployed position and vice
versa).
[0084] FIG. 25 is a perspective view of a flip top port 2500
according to an embodiment of the present invention. FIG. 26 is a
side view of a flip top anchor 2505 according to an embodiment of
the present invention. The flip top anchors 2505 attach to bodily
tissue as the flip top 2510 is moved downwards. When the flip top
2510 is pulled up, the anchors 2505 are in an undeployed position
and when the flip top 2510 is pushed down and comes into contact
with the housing 2501, the anchors 2505 in a deployed position.
[0085] FIGS. 27 and 28 are bottom side views of the stem 240 in a
right side position indicating an undeployed position for the
anchors according to an embodiment of the present invention. In
FIG. 27, the stem 240 is locked in place between a flange 2705 or
2708 and a bump or protrusion 2706 or 2707 on the flange 2705 or
2708. The flanges 2705 and 2708 may be formed in the shape of a "L"
and may be attached to the base 245 as shown in FIG. 20. The stem
240 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. Each flange 2705 or 2708 may
have a cutout 2809 for securing or locking the stem 240 in place.
When the stem 240 is in the cutout 2809, the anchors are in a
locked position. In FIG. 28, the stem 240 is locked in place
between a flange 2805 or 2808 and a bump or protrusion 2806 or 2807
on the flange 2805 or 2808. The flanges 2805 and 2808 may be formed
in the shape of a "L" and may be attached to the base 245 as shown
in FIG. 20. The stem 240 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. Each
flange 2805 or 2808 may have a cutout 2809 for securing or locking
the stem 240 in place. When the stem 240 is in the cutout 2809, the
anchors are in a locked position.
[0086] FIGS. 29 and 30 are assembled and disassembled perspective
views of the applier 135 according to an embodiment of the present
invention. The applier 135 may be used to secure the port 130 to
the human 105, as rotation of the applier handle 3005 rotates the
top portion 205 of the port 130 and secures the anchors 255 of the
port 130 into the human 105. As illustrated, the applier 135
includes a handle 3005, a shaft 3010, a driver or a spring 3015, a
sleeve 3020 that holds the shaft 3010 and the driver 3015, and a
connector 3025. The handle 3005 is used to place and rotate the
applier 135. The shaft 3010 can provide leverage through its length
or through internal components. The connector 3025 attaches to the
fittings 207 on the top of the top portion 205. The spring 3015 can
apply pressure to the driver 3015. The sleeve 3020 covers and
protects the shaft 3010 and the spring 3015. The applier 135 mates
with the port 130 to turn the gears 275 by turning the top portion
205. A medical professional turns the applier handle 3005 in a
large circular direction to turn the top portion 205 of the port
130. The applier 135 may be disposable. Also, the port 130 can be
attached to bodily tissue by suturing.
[0087] FIGS. 31 and 32 are perspective views of different appliers
3100 and 3200 according to various embodiments of the present
invention. FIG. 33 is an end view of the applier 3200 of FIG. 32
according to an embodiment of the present invention. The end
portion 3300 has a cutout 3316 that can attach to or fit around the
coupler 501 shown in FIG. 8. Additionally, an inside surface of the
end portion 3300 can include protrusions that mate with and attach
to the slits 502 and 504 of the housing 500 to allow better
attachment and grip to rotate the top portion 205. In one
embodiment, the top portion 205 is fixedly attached to the housing
500 so both components rotate together. The end portion 3300 may
have a connector 3305 with protrusions 3320 that attach to the
fittings 207. The rim 3325 is sized to be larger than the housing
500 so the rim 3325 can fit over the housing 500.
[0088] 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.
[0089] 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.
[0090] 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.
[0091] 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.
[0092] 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.
[0093] 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.
[0094] 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.
* * * * *