U.S. patent application number 13/554970 was filed with the patent office on 2012-11-15 for percutaneous ostomy implant.
This patent application is currently assigned to OSTOMYCURE A/S. Invention is credited to Robert Axelsson, Bjorn Edwin, Erik Fosse, Martin Johansson, Anette Johnsson.
Application Number | 20120289916 13/554970 |
Document ID | / |
Family ID | 35997205 |
Filed Date | 2012-11-15 |
United States Patent
Application |
20120289916 |
Kind Code |
A1 |
Johansson; Martin ; et
al. |
November 15, 2012 |
PERCUTANEOUS OSTOMY IMPLANT
Abstract
A method of providing a stoma with a removable connection for a
receptacle includes securing an implant onto the stoma of a
patient, wherein the implant has an axial interior section for
fixation inside the body and an axial exterior section extending
outwards from the body, a free end of the exterior section
accommodates mounting of a detachable device, and a distal portion
of the interior section includes an anchoring section, extending
radially from the distal portion of the interior section. The
anchoring section has an inner anchoring ring, an outer anchoring
ring and at least one connection member configured and dimensioned
for resiliently connecting the inner and outer anchoring rings in a
manner to provide axial resilience and anchorage to the anchoring
section such that the anchoring section is able to respond to
movements and absorb the shear of the implant in relation to
adjacent organs.
Inventors: |
Johansson; Martin;
(Kungsbacka, SE) ; Axelsson; Robert; (Granna,
SE) ; Johnsson; Anette; (Jonkoping, SE) ;
Edwin; Bjorn; (Saetre, NO) ; Fosse; Erik;
(Oslo, NO) |
Assignee: |
OSTOMYCURE A/S
Oslo
NO
|
Family ID: |
35997205 |
Appl. No.: |
13/554970 |
Filed: |
July 20, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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13088827 |
Apr 18, 2011 |
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13554970 |
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|
11218905 |
Sep 1, 2005 |
7935096 |
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13088827 |
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60615576 |
Oct 5, 2004 |
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Current U.S.
Class: |
604/337 ;
604/338; 604/343 |
Current CPC
Class: |
A61M 25/02 20130101;
A61M 2025/0286 20130101; A61M 2025/0293 20130101 |
Class at
Publication: |
604/337 ;
604/338; 604/343 |
International
Class: |
A61F 5/449 20060101
A61F005/449; A61F 5/445 20060101 A61F005/445; A61F 5/448 20060101
A61F005/448 |
Foreign Application Data
Date |
Code |
Application Number |
Sep 6, 2004 |
EP |
04077475.4 |
Claims
1. A method of providing a stoma with a connection for a detachable
device, which method comprises securing an implant onto the stoma
of a patient, wherein the implant comprises: an axial interior
section for fixation inside the body, an axial exterior section in
communication with the interior section and extending outwards from
the body with a free end, said free end of the exterior section
serving for mounting of a detachable device, and a distal portion
of the interior section opposite the exterior section is provided
with an anchoring section, extending radially from the distal
portion of the interior section; and wherein the anchoring section
comprises an inner anchoring ring extending from or integral with
the interior section, an outer anchoring ring, and at least one
connection member configured and dimensioned for resiliently
connecting the inner anchoring ring with the outer anchoring ring
in a manner to provide axial resilience and anchorage to the
anchoring section such that the anchoring section is able to
respond to movements and to absorb the shear of the implant in
relation to adjacent organs.
2. The method according to claim 1, wherein the outer anchoring
ring has an inner diameter that is greater than the outer diameter
of the inner anchoring ring and each connection member has a shape
that defines at least one gap or opening between the inner
anchoring ring and the outer anchoring ring.
3. The method according to claim 2, wherein at least two connection
members are provided, each extending from the inner ring to the
outer ring in a plane therebetween to provide said axial resilience
and anchorage to the anchoring section.
4. The method according to claim 3, wherein each connection member
defines a gap having first and second gap parts that are of
different lengths and which delimit and overall elongated
circumferential gap between the inner anchoring ring and the outer
anchoring ring.
5. The method according to claim 1, wherein the anchoring section
extends from the distal portion of the interior section at an angle
a of approximately 90-110.degree. and the anchoring section extends
from the distal portion of the interior section at an angle a of
approximately 90.degree..
6. The method according to claim 1, wherein at least one of the
inner anchoring ring, the outer anchoring ring or the at least one
connection member has a substantially circular cross-section.
7. The method according to claim 1, wherein a lower face of the
anchoring section is covered with a polypropylene or tissue
mesh.
8. The method according to claim 7, wherein the mesh is adhered to
the inner anchoring ring and the elongated connection members by
means of a biological acceptable glue.
9. The method according to claim 8, wherein the mesh has a central
portion which is either of a different pore structure or a
different thickness than the rest of the mesh or is saturated with
glue.
10. The method according to claim 8, wherein the central portion
has a guiding hole.
11. The method according to claim 1, wherein at least one surface
on the anchoring section is coated with a biologically acceptable
tissue glue and the anchoring section and glue are covered by a
peelable foil.
12. The method according to claim 1, wherein the anchoring section
comprises an axially resilient circumferential spring means.
13. The method according to claim 1, wherein the at least one
connection member is configured and dimensioned for resiliently
connecting the inner anchoring ring with the outer anchoring ring
with a spring force that provides axial resilience and anchorage to
the anchoring section.
14. The method of claim 1, further comprising mounting a detachable
device on the free end of the exterior section.
15. The method of claim 14, wherein the detachable device is a cap
or pouch.
16. The method of claim 1, comprising fixing the axial interior
section inside the body.
17. The method of claim 16, wherein the axial interior section is
fixed inside the body with tissue glue or sutures.
18. The method of claim 1, comprising anchoring the implant with
the anchoring section.
19. The method of claim 18, wherein the anchoring section is
secured in situ with sutures, tissue glue and/or staples.
20. The method of claim 18, wherein the implant is anchored with
the anchoring section subcutaneously.
21. The method of claim 1, wherein the anchoring section is located
on top of a vessel wall or fascia.
22. The method of claim 21, the vessel wall being a vessel wall of
the intestines or bladder.
23. The method of claim 1, wherein the stoma is an opening in an
abdominal wall.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of U.S. application Ser.
No. 13/088,827 filed Apr. 18, 2011, which is a continuation of U.S.
application Ser. No. 11/218,905 filed Sep. 1, 2005, now U.S. Pat.
No. 7,935,096, which in turn claims the benefit of U.S. application
Ser. No. 60/615,576 filed Oct. 5, 2004.
BACKGROUND
[0002] The invention relates to a percutaneous implant for
implantation into an animal or a human body.
[0003] A method for implantation of the implant according to the
present invention into an animal or a human body is also described
together with preferred uses.
[0004] The implant is of the kind comprising an axial interior
section for fixation inside the body, an axial exterior section in
communication with the interior section, the axial exterior section
extending outwards from the body with a free end, which serves for
mounting of a detachable device, the distal end of the interior
section opposite the exterior section being provided with an
subcutaneous anchoring section, extending radially from the distal
end of the interior section.
[0005] Many diseases such as e.g., Crohn's disease, ulcerative
colitis, intestinal cancer and adenomatous polyposis or bladder
cancer require removal of all or part of the intestines or bladder.
When the intestines or the bladder are removed, the bodily wastes
are expelled through a new surgical opening in the abdominal wall.
The surgery to create the new opening, the stoma, is called ostomy.
The main steps in the surgery are to create an abdominal opening,
to externalize an intestine through the abdominal wall and skin,
and suture the intestine to the skin so as to complete the
stoma.
[0006] The prior art types of intestinal ostomies are performed
depending on how much and what parts of the intestines are removed.
The surgery is called an ileostomy if the colon and rectum are
removed, in which case an ileostomy is performed by attaching the
ileum to the stoma. If the rectum is removed, the colon is attached
to the stoma to perform a colostomy. Most persons with ostomies
must wear special appliances over the stoma and use ostomy pouches
to collect and eliminate waste.
[0007] A continent ileostomy is the most preferred alternative to
using an outside collecting bag. An internal reservoir pouch is
created from part of the small intestine. A valve is constructed
and a stoma is placed through the abdominal wall. A tube must be
inserted through the stoma and the valve in order to drain the
pouch from time to time. The most common kind of continent ileoanal
reservoir has a capacity of 500 to 1000 mL and a valve made by
intussusception of the terminal ileum.
[0008] Only for very few patients, ileoanal reservoir surgery is a
possible alternative to a permanent ileostomy. Ileoanal reservoir
surgery is completed in two surgeries. In the first surgery, the
colon and rectum are removed and a pouch or reservoir is
constructed from the last part of the small intestine. This pouch
is attached to the anus. In the second surgery, the ileostomy is
closed. The muscles surrounding the anus and anal canal are left in
place, so the stool in the pouch does not leak out of the anus.
[0009] Different kinds of urostomy surgery are used dependent on
the disease causing the surgery. Usually the ureters are detached
from the bladder and joined to a section of the ileum to create an
ileal conduit for the urine. One end of this section of ileum is
sealed off and the other end is brought to the surface of the
abdomen to the stoma to allow urine to be collected in a urine
pouch attached around the stoma.
[0010] Alternatively, an uretero-cutaneostomy is possible in which
the ureters are detached from the bladder and brought to the
surface of the abdomen. A uretero-cutaneostomy can be made as a
"single" uretero-cutaneostomy in which only one ureter is brought
to the surface, a "bilateral" uretero-cutaneostomy with one ureter
in each side of the abdomen, a "double-barrel" uretero-cutaneostomy
in which both ureters are brought to the same side of the abdomen
but externalized using two holes, or a "transuretero"
uretero-cutaneostomy in which both ureters are brought to the same
side of the abdomen and externalized via one common hole.
[0011] The above-mentioned methods are drastic surgical procedures
of great discomfort to the patient both before and after surgery is
completed.
[0012] In summary there are several drawbacks with the above
conventional methods including ulceration, incisional hernia, or
bulging of the bowel through the incision, narrowing of the stoma,
scar tissue and bowel obstruction, marsupialization, avulsion, skin
irritation from stool that leaks under the drainage bag and
necrosis.
[0013] In addition, use of a stoma pouch for collection of the
bodily wastes must be used for most ostomies. The stoma pouch is
conventionally adhered to the skin by means of an adhesive contact
surface on the pouch so as to allow the pouch to surround the stoma
for sealingly collecting stool or urine. If liquid secretion
penetrates the adhesive surface, this surface will loosen to a
certain extent, resulting in leakage from the pouch and the release
of an unpleasant smell.
[0014] Another problem with ostomies is that the site where the
intestine passes the abdominal wall is weak and susceptible to
herniation. Hernias result in blockage of the stoma and relief
surgery is urgently required.
[0015] A number of implants have been provided in order to remedy
the above-named disadvantages of the above mentioned prior art
systems available today for patients having a stoma.
[0016] U.S. Pat. No. 4,183,357 discloses a transcutaneous implant
for use with enterostomies. The implant consists of a hollow barrel
with a protruding flange, which is permanently positioned under the
skin between the dermis and the fascia. The intestine is
externalized by drawing the intestine up through the barrel. The
barrel surrounds and supports the stoma, however the rigid wall of
the implant critically restricts the peristaltic movements.
[0017] Similar implant devices for surrounding an enterostomy are
disclosed in U.S. Pat. No. 4,217,664 and GB patent No. 2 019
219.
[0018] International patent application WO 98/58691 discloses an
implant to be used in an intraluminal procedure. A hole is prepared
with a purse string suture in the terminated proximal sigmoideum.
The plane contact face of the implant is introduced via a colostomy
aperture in the abdominal wall and fitted into the prepared
aperture in the sigmoideum. The purse string suture is secured and
the sigmoideum wall is brought into contact and attached to the
parienteral peritoneum surrounding the exterior surface of the
implant, the flange part of which is left inside the sigmoideum.
The extent of the anchoring zone between the sigmoideum, the
peritoneum and the flange is minimal so that fluctuating tensile
forces and compressions resulting from peristaltic movements are
not restricted. Use of this device involves a high risk of total or
partial rupture between tissue and implant, e.g. in case of high
back pressure resulting from constipation. Urine or stool may leak
and cause inflammation and peritonitis. Thus, improvements in these
type devices are desired.
SUMMARY OF THE INVENTION
[0019] In a first aspect according to the present invention, a
percutaneous implant of the kind mentioned in the opening paragraph
is provided, which can be used in ostomy without externalization of
a vessel, such as an intestine or a ureter, through the abdominal
wall.
[0020] In a second aspect according to the invention, an implant is
provided, which provides a stable, effective and well vascularized
skin-implant junction.
[0021] In a third aspect according to the invention, an implant is
provided, which is able to conform to and keep pace with any
peristaltic movements or mechanical stress.
[0022] In a fourth aspect according to the invention, an implant is
provided which is not sensed by the patient after implantation, and
which can be detachably attached to and disconnected from devices,
such as e.g. caps or pouches, thereby giving the surgically treated
patient an unprecedented comfort.
[0023] In a fifth aspect according to the invention an implant is
provided which causes an unprecedented minimum of allergic and
inflammatory reaction.
[0024] The novel and unique features, whereby this is achieved
according to the present invention, is the fact that the anchoring
section comprises an inner anchoring ring extending from or
integral with the interior section, an outer anchoring ring, and at
least one connection member for connecting the inner anchoring ring
with the outer anchoring ring.
[0025] The problem of establishing a leak proof zone between the
implant and the enterostomy is solved according to known prior art
implants by either entirely enclosing the externalized vessel or by
placing at least a part of the implant inside the lumen of the
vessel. In contrast, the implant according to the present invention
is situated on top of the vessel wall. For example, if the vessel
to be brought in fluid communication with the exterior is the small
intestine, the lower face of the anchoring section can be placed
directly on the selected spot on the fascia above the intestinal
serosa and secured in situ, e.g. by means of sutures, tissue glue
or staples. The exterior section of the implant is externalized
through an access hole in the abdominal wall and the upper face of
the anchoring ring is brought into contact with the epithelium of
the peritoneum and secured in a similar manner as the lower face of
the anchoring section. Finally the contact zone is left to heal up.
In this simple manner the vessel and peritoneum covering the fascia
is fused together in the area adjacent the anchoring section.
Gradually, a natural, strong adherence is spontaneously generated
between the implant, vessel, and peritoneum.
[0026] The anchoring section ends up infiltrated with vascularized
connective tissue, which ensures that a strong, and reliable
attachment level between the wall of the vessel, the
peritoneum/fascia, Mm. abdominis and the implant can be obtained.
The access opening in the vessel may be created at any time during
the procedure to finally allow the stool to escape. Scar formation
can be kept to a minimum and only the intestinal mucosa will, as
usual, be in direct contact with stool. Accordingly the risk of
inflammation and/or infection is also minimal.
[0027] When a first connection point between a first end of the at
least one connection member and the inner anchoring ring is
angularly offset from a second connection point between a second
end of the connection member and the outer anchoring ring, the
rings together with the connection members act as an axially
resilient, circumferential spring means, which is able to respond
to any movements and/or to absorb shear of the implant in relation
to the adjacent organs, without damaging the established,
biological connective tissue adherences.
[0028] In a preferred embodiment the inner diameter of the outer
anchoring ring is greater than the outer diameter of the inner
anchoring ring. The radial distance between the rings contributes
to the flexibility and resiliency of the anchoring section, but
also the chosen material and the material thickness are of
significant importance to flexibility.
[0029] Preferably, the at least one connection member is S-shaped.
Said S-shape has shown to provide the anchoring section with a high
level of requisite resiliency. A main part of the connective tissue
is created and integrated in the gaps between the components of the
anchoring section and this connective tissue fusion constitutes in
co-operation with the rings an elastic coupling of the implant to
the body when the patient and/or the organs or implant move beyond
control of the patient.
[0030] In one advantageous embodiment according to the present
invention the anchoring section extends at an angle of
approximately 90-110[deg.], preferably 90[deg.] from the interior
section, so as to substantially follow the curvature of the
internal abdominal wall at the area of the access site in the
abdominal wall.
[0031] A seal and connection of the anchoring section between the
intestinal serosa and the epithelium of the peritoneum can be
easily obtained if at least one of the inner anchoring ring, the
outer anchoring ring and the at least one connection member is
provided with through-going transverse openings. Such openings may
have different sizes and allow for ingrowths of connective tissue
and subsequent vascularization of the created connective
tissue.
[0032] It is further preferred that at least one of the inner
anchoring ring, the outer anchoring ring or the at least one
connection member has a cross-section with rounded edges,
preferably a substantially circular cross-section, to form a smooth
tissue junction between the connective tissue which traverses and
surrounds the respective components of the implant.
[0033] Rounded edges have the important advantage that no cutting
action occurs when the implant moves slightly in response to organ
movements and physical action of the person wearing the implant.
The risk of avulsion is further prevented by means of this
design.
[0034] Yet a further and very important advantage of rounded edges
over edged edges is the fact that the new tissue, which is
gradually created around parts of the anchoring section and through
the through-openings, is enabled to create a solid, fluid-proof
seal between implant parts and surrounding tissue, especially the
accessed intestine.
[0035] For this reason it is most preferred that all of at least
one of the inner anchoring ring, the outer anchoring ring or the at
least one connection member has a cross-section with rounded edges.
In case the surgeon prefers to use tissue glue for attachment of
the anchoring section to the vessel, the tissue glue may be
advantageously applied in advance to at least one surface on the
anchoring section. For example the surface may be coated with a
biologically acceptable tissue glue, optionally covered by a
peelable foil, so that the implant is easy to maneuver inside the
body without sticking to unintended sites during attempt to place
the implant correct in situ.
[0036] Commercially available tissue glues are known to the person
skilled in the art of surgery and may e.g. be selected from the
group consisting of cyanoacrylates, fibrin sealants or combinations
of these. Fibrin sealant is a non-toxic, biological product that
can stimulate wound healing and reduce hospital stay.
[0037] A sheet of mesh, such as e.g., monofilament polypropylene
mesh, having approximately the same size as the area of the lower
anchoring face defined by outer periphery of the anchoring section,
can advantageously be provided on and cover the lower face of the
anchoring section. The mesh can be glued to any part of the lower
face of the anchoring section not provided with through-going
transverse openings and serves as a sealing material between fascia
and anchoring section.
[0038] In a preferred embodiment according to the present invention
the mesh is firmly adhered by means of biological acceptable glue
to both the elongated connection members and the part of the axial
interior section defined by the distal wall thickness.
[0039] A central portion of the mesh has a radius, which
corresponds approximately to the radius of the inner anchoring ring
of the implant. This central portion is saturated with the
biological acceptable glue, which in solidified condition provides
a fluid barrier across the total thickness of the mesh at the
entire radial distance of the central portion. This barrier is
effective as a seal in the area of contact between implant, mesh
and fascia. None of the through-going transverse openings in the
implant are covered or filled with glue. Accordingly, tissue
in-growth and vascularization conditions are excellent.
[0040] The central portion can preferably have a central guiding
hole for guidance of the trocar of a surgical cutting and stapling
device, thus ensuring correct position of the surgical cutting and
stapling device. A suitable device is designed for in a first step
carefully penetrating the respective layers to be anastomosed. In
the second step a circular section is cut out in one single
operation of the pressed together layers of overlaying layers of
glue saturated mesh, fascia, peritoneum and intestinal wall to
provide an outlet opening which allow the content of the vessel to
escape freely into the bore of the implant for disposal when
required. Simultaneously the surgical cutting and stapling device
staples the created circumferential walls of the holes of the glue
saturated mesh, fascia, peritoneum and intestinal wall sealingly
together with the inner anchoring ring and the mesh. The healing
process including tissue in-growth and vascularization, is
initiated by the natural mechanism. Surgical cutting and stapling
device devices are commercially available and will not be described
in greater detail here. Various suitable surgical cutting and
stapling devices for use in the surgical procedure according to the
present invention is obtainable from e.g. Ethicon Endo-Surgery,
Inc., 4545 Creek Road, Cincinnati, Ohio 45242, USA.
[0041] A suitable device is selected according to the required
diameter of the stoma. As an example of suitable devices can be
mentioned various sizes of Proximate ILS, straight Intraluminal
Stapler, from Ethicon Endo-Surgery Inc.
[0042] The solidified and integrated glue structure of the central
portion of the mesh has the further advantage of stiffening the
central portion thereby promoting proper and fast identification of
the guiding hole by the trocar of the surgical cutting and stapling
device for further penetration through fascia, peritoneum and
intestinal wall.
[0043] The presence of the sealing material effectively prevents
fluid, which flows in the accessed vessel, e.g. an intestine, from
leaking in between the joined layers of various tissues and
implant. The mesh further promotes strong tissue in-growth and body
acceptability of the implant and reduces time of healing.
[0044] The central portion can in an alternative embodiment be made
of another type of mesh having a closed pore structure and is
thicker than the rest of the central portion.
[0045] Also a tissue mesh is foreseen within the scope of the
present invention. A preferred tissue mesh is an autograft.
[0046] The implant according to the present invention is made of at
least one biologically acceptable material. Preferably the implant
is made of titanium, due to the strength, workability and
biological acceptability, but other materials or combinations of
materials recognized within the art are also within the scope of
the present invention. Other biologically acceptable material
materials or combinations of materials are foreseen within the
scope of the present invention. E.g. the implant can be made of a
polymeric material solely or of two materials of different
hardness, e.g., polymeric material-metal. The polymeric material
can e.g. be a thermosetting and the metal e.g. NITINOL.RTM. or the
above mentioned titanium.
BRIEF DESCRIPTION OF THE DRAWINGS
[0047] The invention is described in more detail below, exclusively
describing examples of embodiments with reference to the drawing,
in which
[0048] FIG. 1 shows, in perspective, an implant according to the
present invention and a closure plug for insertion into the bore of
the implant,
[0049] FIG. 2 shows a top view of the implant according to the
present invention,
[0050] FIG. 3 shows a section of the implant of FIG. 1 taken along
the line The implant is seen schematically in a first implantation
step immediately after implantation according to a first embodiment
of a surgical procedure,
[0051] FIG. 4 shows the same but the implant is implanted according
to a second embodiment of a surgical procedure,
[0052] FIG. 5 shows on an enlarged scale a perspective view of a
detail of a modification of the anchoring section seen in FIG.
1,
[0053] FIG. 6 shows in an exploded view the lower face of the
implant of FIG. 1 provided with a sealing mesh; the locations of
the glue applications are indicated separately,
[0054] FIG. 7 shows the embodiment shown in FIG. 6 in a position
ready for implantation,
[0055] FIG. 8 shows a section of the implant of FIG. 7 taken along
the line VII-VII. The implant is seen schematically after
implantation on top of an intestinal vessel in a first step of a
surgical implantation procedure using a conventional cutting and
stapling device, and
[0056] FIG. 9 shows the same in a third step of the surgical
implantation procedure.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0057] The implant shown in FIGS. 1 and 2 is in its entirety
designated with reference number 1. The implant 1 is only by way of
an example shown in the drawing implanted in relation to the ileum,
however the use with any other vessel is intended within the scope
of the present invention.
[0058] FIG. 1 shows an implant 1 with an axial exterior section 2,
an axial interior section 3, from which an anchoring section 4
extends radially in an angle a of approximately 90[deg.]. The
anchoring section 4 consists of an inner anchoring ring 5, an outer
anchoring ring 6 concentric with the inner anchoring ring 5 and
three elongated connection members 7a,7b,7c for connecting the
inner anchoring ring 5 with the outer anchoring ring 6. As seen
best in FIG. 2 the connection member 7b is connected at a
substantially right angle to the inner anchoring ring 5 at a first
connection point 8b, and at a substantially right angle to the
outer connection ring 6 at a second connection point 9b. In a
similar manner the connection members 7a,7c are connected to the
rings 5,6.
[0059] The connection points 8a,8b,8c between the connection
members 7a,7b,7c and the inner anchoring ring 5 are
circumferentially, angularly offset from the connection points
9a,9b,9c between the connection members 7a,7b,7c and the outer
anchoring ring 6 at an angle [beta]. The substantially right
connection angle and the angular offset [beta] give the connection
members substantially an S-shape. However, within the scope of the
present invention the connection members can be connected to the
rings at different angles a, such as e.g. an acute angle of
45.degree..
[0060] The outer anchoring ring 6 has a greater diameter than the
inner anchoring ring 5. The circumferentially, angularly offset
joining of the rings 5,6 obtained by means of the connection
members 7 delimit elongated circumferential gaps 10a,10b,10c
between the rings 5,6. The combination of gaps 10 and connection
members 7 provide the desired resiliency of the anchoring section 4
in order for this section to absorb external stresses acting on the
skin and the implant keeping the internal region free of
stress.
[0061] The inner 5 and outer anchoring ring 6 have a plurality of
through-going transverse openings 11a,11b,11c with identical or
different diameters. The openings 11 serve for in-growth of
connective tissue and vascularization.
[0062] In addition, in a preferred embodiment some of the openings
11 are used as suturing holes when the ileum, fascia and peritoneum
are to joined, e.g. by means of sutures, to allow healing and
formation of connective tissue.
[0063] The axial exterior section 2 extends outwards from the body
with a free end 12, which is adapted for mounting a detachable
device, such as a closure plug 13, a cap or an ostomy pouch (not
shown).
[0064] When the closure plug 13 is inserted in the tubular bore 14
of the implant 1, stool is prevented from being expelled. The lumen
of the externalized intestine serves as a temporary reservoir and
must be emptied from time to time. The peristaltic movements
promote emptying. Alternatively conventional irrigation means can
be used to assist emptying of stool accumulated in the intestinal
reservoir.
[0065] The axial exterior section 2 is furthermore provided with a
plurality of circumferential ribs 15, intended for promoting firm
mechanical securing of the exterior section to the surrounding
tissue. Furthermore the ribs impede downgrowth of epithelium.
[0066] The exterior section may furthermore be equipped with
various coupling means for the properly sealed attachment of caps
and pouches. Such means include but are not limited to recesses or
indentations, O-rings, snap-fitting means, bayonet coupling means,
locking rings etc.
[0067] A surgical procedure is now described by way of example with
reference to FIG. 3. The first step in the surgical procedure is to
make a first vertical incision through the abdominal wall down to
the fascia 17. This incision is made approximately 5-10 cm from the
site where the implant 1 is to be located. Next the fascia 17 is
separated from the Mm. abdominis 18 by dilatation to create a gap
for the later introduction of the implant 1 and permanent location
of the anchoring section 4 between fascia 17 and Mm. abdominis
18.
[0068] An access hole 20 for the implant 1 is surgically created
through the skin 19 and further through the detached tissue layers
18 of the abdominal wall by means of punching, cutting and blunt
dissection, taking precautions not to penetrate the intestine 21 at
this early surgical step.
[0069] The required surgical procedure, e.g. removal of a
malfunctioning or diseased section of the intestine, optional
refashioning of the intestine to create a reservoir such as e.g. a
Koch's reservoir, and closure of any intestinal residues left in
situ, is then performed.
[0070] Now the implant 1 is introduced via the first incision into
the created gap between the fascia 17 and the Mm. abdominis 18. The
axial exterior section 2 is passed through the access hole 20 such
that the free end 12 protrudes a small distance from the body. The
anchoring section 4 is placed directly on the fascia 17 above the
spot on the intestine 21, which is to be brought into communication
with the exterior via the bore 14 of the implant 1. To avoid
displacement of the implant 1 in relation to the intestine 20 and
abdominal tissue, including the fascia 17 and the peritoneum 22,
different kinds of attachment means and systems can be used.
[0071] Optionally, the outer wall of the axial exterior section 2
including the ribs 15 may be further secured to the wall of the
access hole 20 by means of tissue glue or sutures (not shown) if
necessary.
[0072] An important aspect is to create a superior tight connection
between tissues and implant. By creating a superficial lesion on
the exterior outside of the intestinal wall and optionally a
corresponding superficial lesion on the epithelium of the
peritoneum, so as to enhance inclination to produce natural
adherences, the natural tendency to create adherences is
advantageously utilized. Since the fascia in an early surgical step
is separated from Mm. abdominis, both fascia and Mm. abdominis are
lesional and strongly inclined to grow together again.
Consequently, a natural strong connective tissue adherence, which
keeps the implant in situ, and which connects the intestine with
the implant and the adjacent tissue can be established by natural
healing procedure in a very simple manner.
[0073] In one embodiment, as seen in FIG. 3, the implant 1 is
initially combined with the relevant section of the intestine 21
and the fascia/peritoneum 17;22 by means of a number of sutures 23
through at least some of the plurality of holes 11a,11c of the
inner anchoring ring 5 and the outer anchoring ring 5,
respectively. Optionally, any tissue overlaying the upper face of
the anchoring section 4 can also be secured to the implant by means
of said sutures 23 (or other sutures) if appropriate to avoid
preliminary dislocation of the implant 1. Eventually the sutures 23
will dissolve or be digested by the body.
[0074] In a second embodiment, as seen in FIG. 4, the sutures 23
are substituted by tissue glue layers 24a, which attach the
lesional serosa of the intestine to the epithelium of the
peritoneum 22, and tissue glue layer 24b, which attaches the lower
face of the anchoring section 4 to the fascia 17. Optionally, the
upper face of the anchoring section 4 can also be glued to adjacent
tissue. Such tissue glue is very suitable for performing a highly
strong joining of biologically acceptable components, and will be
absorbed eventually leaving a tight pressure resistant vascularized
skin-implant junction. The glue may be applied either on the tissue
or on a surface of the implant. In a very simple embodiment the
glue may also be pre-coated on the implant.
[0075] The outlet opening in the ileum 21 is made whenever
appropriate via the access opening 14 of the implant 1 using e.g. a
scalpel or another other appropriate surgical cutting tool.
[0076] A detail of a preferred embodiment of the implant according
to the present invention is shown in FIGS. 1 and 2 and in enlarged
scale in FIG. 5. A detail of a preferred embodiment of the implant
according to the present invention is shown in FIGS. 1 and 2 and in
enlarged scale in FIG. 5. A plurality of S-shaped connection
members extend from the inner ring 5 to the outer ring 6 and
delimits elongated circumferential gaps 10a, 10b, 10c between the
inner anchoring ring and the outer anchoring ring wherein each gap
circumferentially extends from one S-shaped connection member's
second connection point 9a, 9b, 9c on the outer anchoring ring 6 to
define a first gap part 10a', 10b', 10c' each having a first
radius. The gaps 10a, 10b, 10c extend to a second gap part 10a'',
10b'', 10c'' of a subsequent circumferential S-shaped connection
member's first connection point 8a, 8b, 8c on the inner anchoring
ring 5. The first and second gap parts are connected by way of a
transition 10a''', 10b''', 10c'''. As shown, the second gap parts
10a', 10b', 10c' have a second radius that is smaller than the
first radius of the first gap part 10a', 10b', 10c'. The rounded
edges of the components of the anchoring section 4 ensure that the
cutting action from the edges of the components of the implant is
eliminated. In addition a strong seal of connective tissue can form
around and conform to said components. Especially preferred is a
circular cross-section of the connection members 7.
[0077] An especially preferred modification of the embodiment of
the implant according to the present invention shown in FIG. 1 is
shown in FIGS. 6 and 7.
[0078] In the exploded view of FIG. 6 a circular mesh 25 with a
guiding hole 26 are provided on the entire anchoring section 4, as
seen best in FIG. 7. The mesh 25 has an open pore structure.
[0079] By means of a biological acceptable glue 27d,27a,27b,27c,
the circular mesh 25 is adhered to only the inner anchoring ring 5
and the elongated connection members 7a,7b,7c, respectively.
[0080] The glue cake 27d fills the pore structure of the central
portion 28 of the mesh 25 as seen best in FIG. 7.
[0081] The initial step of implantation of this embodiment
corresponds to the embodiment shown in FIG. 3. The subsequent
procedure is described above and illustrated in the sectional views
of FIGS. 8 and 9 demonstrating securing the implant to the
subjacent layers by means of staples. The same numerals are reused
for like components.
[0082] The staples 29 have the advantage that conventional
available surgical instruments can be used as described above. They
are known to the surgeon, easy to use and the entire securing of
the implant is done within minutes. Furthermore, the staples 29
squeezes and holds the mesh 25, the fascia 17, the peritoneum 22
and the wall of the intestine 21 firmly and sealingly tight
together during the healing, preventing fluid from penetrating in
between these components and layers. The risk of irritation and
inflammation is thereby considerably reduced.
[0083] As can be seen from FIG. 9 the circumferential wall of the
cut-out extend a small distance into the bore of the implant to
establish a small protrusion for the staples. In case the
circumferential protrusion is of inconvenience to the patient the
protrusion and the staples can easily be removed as soon as a
sealingly tight and firm attachment is ensured.
[0084] Securing of the anchoring section 4 on top of the fascia 17
can be made using any of the means sutures, glue, staples and any
appropriate combinations of these means.
[0085] The first incision is closed and precautions may be taken
not to put extensive load on the surgical structure for the first
few days after surgery. In order not to stress the healing
procedure and put pressure on the connection between any tissue and
the implant, stool must be allowed to escape freely during an
initial period during which the patient may be equipped with a
conventional ostomy pouch. In addition a diet can be prescribed,
e.g., an astronautic diet for reducing stool formation.
[0086] Eventually, when the adherence between organs, tissue and
implant has been proved strong enough, the plug 13 can be placed in
the bore 14 of the implant 1. Whenever appropriate, the plug 13 is
removed in order to drain the reservoir of the externalized
intestine 21. Disposable plugs 13 may be preferred by some
patients. An O-ring 13' can be provided around the plug 13 to
further ensure air and liquid sealing capability.
[0087] In most cases there is no need to create an intestinal
reservoir since the intestinal wall will itself adapt to the new
conditions and develop a pressure resistant thickened wall.
[0088] The surface characteristics of the implant are important to
facilitate and improve healing with connective tissue. In order to
give a surface roughness that promotes interaction and healing with
tissue the proximal exterior section is in a preferred embodiment
brightly polished and the distal exterior section, the interior
section and the anchoring section are blasted, preferably with
aluminum oxide, or coated with surface coating.
[0089] It is further preferred to provide each implant with a
unique identifier to be able to trace the implant and problems that
might relate to production, e.g. choice of material and design, and
to collect and record relevant data in an anonymous manner. The
implant can be made very small and since various collecting and
closure devices can be detachably attached to the free end of the
exterior section of the implant, bodily waste can be expelled when
and where it is appropriate. The patient is offered a hitherto
unknown degree of freedom to behave and live an almost normal
life.
* * * * *