U.S. patent application number 09/752771 was filed with the patent office on 2001-12-06 for hiatal hernia repair patch and method for using the same.
Invention is credited to Rehil, Om P..
Application Number | 20010049539 09/752771 |
Document ID | / |
Family ID | 22655423 |
Filed Date | 2001-12-06 |
United States Patent
Application |
20010049539 |
Kind Code |
A1 |
Rehil, Om P. |
December 6, 2001 |
Hiatal hernia repair patch and method for using the same
Abstract
This invention relates to a surgical prosthesis and method of
use. The hiatal hernia repair patch is a ring with an integral mesh
attached to and surrounding the ring. The ring and the mesh have a
slit therein extending radially so that the ring may be placed
about the esophagus. The ring may be hollow or solid and is
flexible so that it may be inserted through a small incision or a
laparoscopic port into the abdominal cavity. The patch, including
the ring and mesh, is made as a one-piece unit and is made from
polypropylene or other biocompatible material. In use, the ring is
placed around the esophagus, between the stomach and the diaphragm.
Next, the mesh is stapled or sutured to the undersurface of the
diaphragm, bridging the hiatal hernia defect.
Inventors: |
Rehil, Om P.; (Marion,
IN) |
Correspondence
Address: |
Richard C. Litman
LITMAN LAW OFFICES, LTD.
P.O. Box 15035
Arlington
VA
22215
US
|
Family ID: |
22655423 |
Appl. No.: |
09/752771 |
Filed: |
January 3, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60179149 |
Jan 31, 2000 |
|
|
|
Current U.S.
Class: |
606/151 ; 606/1;
606/213 |
Current CPC
Class: |
Y10S 623/902 20130101;
A61B 17/0057 20130101; A61F 2/0063 20130101; A61B 17/00234
20130101 |
Class at
Publication: |
606/151 ; 606/1;
606/213 |
International
Class: |
A61B 017/00; A61F
002/00; A61F 013/00; A61B 017/08; A61D 001/00 |
Claims
I claim:
1. A hiatal hernia repair patch, comprising: a ring defining an
opening, the opening being sized and dimensioned for encircling a
patient's distal esophagus, the ring having a slit extending
radially through the ring; and at least one section of
biocompatible mesh, said mesh extending radially from said
ring.
2. The hiatal hernia repair patch according to claim 1, wherein
said at least one section of biocompatible mesh is a single section
of mesh extending radially from said ring substantially 360.degree.
about the circumference of said ring, said mesh having a slit
extending radially through said mesh in registry with the slit
extending through said ring.
3. The hiatal hernia repair patch according to claim 1, wherein
said ring has the shape of a torus, said ring having a superior
side and an inferior side.
4. The hiatal hernia repair patch according to claim 3, wherein
said mesh extends from the superior side of said ring tangential to
the ring.
5. The hiatal hernia repair patch according to claim 3, wherein
said ring is solid.
6. The hiatal hernia repair patch according to claim 3, wherein
said ring is hollow.
7. The hiatal hernia repair patch according to claim 1, further
comprising a radiopaque marker incorporated into said ring and
disposed about the circumference of said ring.
8. The hiatal hernia repair patch according to claim 1, wherein
said patch is made from a flexible biocompatible material.
9. The hiatal hernia repair patch according to claim 1, wherein
said patch is made from polypropylene.
10. A method for implanting the hiatal hernia repair patch of claim
1, comprising the steps of: (a) dissecting a hiatal hernia,
including mobilizing a patient's stomach and lower esophagus out of
the hiatal hernia sac using blunt and sharp dissection; (b)
dissecting the patient's esophago-gastric junction
circumferentially; (c) placing the patch around the patient's
esophagus; and (d) attaching the mesh to an edge of the hiatal
hernia defect and to an undersurface of the patient's diaphragm,
bridging the hiatal hernia defect.
11. The method of implanting a hiatal hernia repair patch according
to claim 10, further comprising the step of verifying that the ring
is generally larger than the diameter of a specific patient's
distal esophagus before placing the patch around the patient's
esophagus.
12. The method of implanting a hiatal hernia repair patch according
to claim 10, further comprising the step of inserting an esophageal
bougie through the patient's mouth into the esophageal lumen after
mobilization of the distal esophagus and the stomach out of the
hiatal hernia sac in order to ensure that the ring fits snugly
outside the esophagus.
13. The method of implanting a hiatal hernia repair patch according
to claim 10, further comprising the step of trimming the mesh so
that said mesh conforms generally to the shape and size of the
patient's diaphragm.
14. The method of implanting a hiatal hernia repair patch according
to claim 13, wherein the step of trimming the mesh is performed
during the manufacturing of the prosthesis, and wherein said method
further comprises the step of selecting the prosthesis of a proper
size from a plurality of prostheses with variously sized mesh.
15. The method of implanting a hiatal hernia repair patch according
to claim 10, wherein the steps of dissecting the hiatal hernia and
placing the patch about the patient's esophagus are performed using
an open technique.
16. The method of implanting a hiatal hernia repair patch according
to claim 10, wherein the steps of dissecting the hiatal hernia and
placing the patch about the patient's esophagus are performed using
a laparoscopic technique.
17. The method of implanting a hiatal hernia repair patch according
to claim 16, further comprising the steps of: (a) inserting a
laparoscopic port through the patient's abdomen; (b) folding the
patch into an elongated tubular shape; (c) inserting the folded
patch through the laparoscopic port; and d) unfolding the patch in
order to place the patch about the patient's distal esophagus.
18. The method of implanting a hiatal hernia repair patch according
to claim 10, further comprising the step of verifying proper
placement of the patch about the patient's distal esophagus by
radiographic imaging.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims the benefit of U.S. Provisional
Patent Application Ser. No. 60/179,149, filed Jan. 31, 2000.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to a method, and a prothesis,
for use in maintaining the intra-abdominal reduction of a sliding
esophageal hiatal hernia.
[0004] 2. Background of Invention and Discussion of Related Art
[0005] In humans, there is no anatomical valve, or discrete
sphincter at the esophago-gastric (EG) junction. When anatomy in
the area is normal, esophageal peristalsis pushes food through the
EG junction. The stomach fills, like a sack, pulling the EG
junction tighter. Normal, intact esophageal hiatal muscles prevent
reflux. However, a gaping hiatal muscle sling creates a large
defect around the esophagus, thereby interfering with the EG
junction mechanism. This may lead to a hiatal hernia.
[0006] Anatomically, hiatal hernia is a muscular defect in the
diaphragm. The upper part of the stomach migrates through the
defect, into the chest, or lower mediastinum. Here, negative
pressure leads to free reflux of the stomach's acid into the
esophagus. This reflux leads to an array of related symptoms and
complications.
[0007] Patients afflicted with hiatal hernia suffer immensely.
Immediate problems include: severe heartburn, retrosternal pain and
burning, and difficulty swallowing. At some point, esophageal
ulceration and stricture commonly occur.
[0008] Methods and prostheses aimed at repairing hiatal hernias
have been the subject of earlier patents. The prior art, discussed
below, illustrates previous developments.
[0009] Several patents teach the placement of a prosthesis around
the esophagus to prevent the stomach from entering the esophagus,
or as an anti-reflux measure to prevent reflux of the stomach
contents into the esophagus. The placement of a collar or other
prosthetic device around the esophagus is sometimes used as an
adjunct to hiatal hernia repair procedures in lieu of
fundoplication procedures, such as the Nissen fundoplication.
[0010] U.S. Pat. No. 3,875,928, issued on Apr. 8, 1975, to Pierre
Angelchik, discloses the placement of a C-shaped cushion around the
distal esophagus, the cushion having flexible tape at the ends
which is tied and then sutured to the gastric fundus. The cushion
is filled with a deformable liquid gel and is positioned between
the gastric fundus and the diaphragm. The cushion is coated with a
radiopaque dye for visualizing the position of the cushion after
emplacement on the distal esophagus. The patent fails to mention a
means of attachment of the cushion to the diaphragm.
[0011] U.S. Patent, No. 4,271,827, issued on Jun. 9, 1981 to
Angelchik, discloses a similar prosthesis. This second patent
differs only in that it teaches placement above the diaphragm, and
in that it teaches securing the patent only by tying the ends of
the tape without suturing the cushion to surrounding tissue.
Otherwise, the second Angelchik patent has all the limitations of
his first. Both of these devices require opening the abdominal or
thoracic cavity for placement of the cushion, being unsuited to
laparoscopic techniques due to the incompressible liquid or gel
filling the cushion.
[0012] U.S. Pat. No. 5,006,106, issued Apr. 9, 1991 to Angelchik,
discloses a C-shaped cushion with an outer integument of silicone
elastomer filled with normal saline solution or hydrogel. A spring
is enclosed within and secured to the outer wall of the cushion,
the spring having shoulders at its ends so that the spring may be
engaged by the tines of laparoscopic forceps. The spring may be
made of titanium for radiographic visualization of cushion
placement, or made of plastic incorporating a barium compound. The
fluid may not be inserted into the cushion until after placement of
the integument and spring about the esophagus. The cushion is not
sutured or secured to the surrounding tissue.
[0013] Other patents directed to preventing the occurrence or
recurrence of hiatal hernia include: U.S. Pat. No. 4,796,603,
issued on Jan. 10, 1989, to Dahlke et al. (pad made of resorbable
material wrapped around the esophagus); U.S. Pat. No. 5,861,036,
issued Jan. 19, 1999 to N. Godin (tube extending from
esophago-gastric opening into stomach to extend the length of the
esophagus and act as a valve, the tube having an annular flange
sutured to the basis of a hiatal hernia or the esophagus); U.S.
Pat. No. 5,919,233, issued on Jul. 6, 1999, to Knopf et al.
(flexible, elongated cylinder having a flattened end with a hole in
it, the cylinder being wrapped around the esophagus with the free
end of the cylinder being inserted through the hole to secure the
device to the esophagus); and International Patent No. WO 91/01117,
published Feb. 7, 1991 (tubular anti-reflux valve inserted in the
esophagus at the level of the hiatal hernia). All teach prostheses
that are allowed to move freely around the distal esophagus, or
tubes or valves inserted into the esophagus or stomach. All fail to
mention a means for attaching the protheses to the diaphragm.
[0014] U.S. Pat. No. 4,403,604, issued Sep. 13, 1983 to Wilkinson
et al., shows a gastric pouch having mesh panels made of Teflon,
Dacron or polypropylene, including a mesh panel wrapped around the
junction of the esophagus with the stomach, the pouch being wrapped
around the stomach to prevent distention of the stomach and limit
the stomach's capacity in order to treat obesity. U.S. Pat. No.
5,246,456, issued Sep. 21, 1993 to L. H. Wilkinson, describes a
modification to the pouch due to inability to remove the pouch of
the '604 patent because of tissue growth through the mesh. The
pouch of the '456 patent is a sheet having holes punched through
it, the pouch having a collar made of silicone elastomer with a
slit in it for fitting around the esophagus to prevent herniation
of the stomach through the hiatal opening in the diaphragm. It will
be noted that the curvature of, the stomach is inverted by a Nissen
fundoplication before wrapping the pouch of both the '604 and '456
patents around the stomach, a procedure which the present invention
is designed to avoid.
[0015] Hernia mesh patches made from polypropylene, Prolene, or
Marlex (made by Phillips Petroleum) have been used for the repair
of inguinal hernias and other hernias of the abdominal wall.
Representative devices are shown in U.S. Pat. No. 5,634,931, issued
Jun. 3, 1997 to R. D. Kugel, and U.S. Pat. No. 5,824,082, issued
Oct. 20, 1998 to R. B. Brown. No device using a hernia mesh patch
made from polypropylene for the repair of a hiatal hernia is known
to applicant.
[0016] None of the above inventions and patents, taken either
singly or in combination, is seen to describe the instant invention
as claimed.
SUMMARY OF THE INVENTION
[0017] This invention relates to a surgical prosthesis and method
of use. The hiatal hernia repair patch is a ring with an integral
mesh attached to and surrounding the ring. The ring and the mesh
have a slit therein extending radially so that the ring may be
placed about the esophagus. The ring may be hollow or solid and is
flexible so that it may be inserted through a small incision or a
laparoscopic port into the abdominal cavity. The patch, including
the ring and mesh, is made as a one-piece unit and is made from
polypropylene or other biocompatible material. In use, the ring is
placed around the esophagus, between the stomach and the diaphragm.
Next, the mesh is stapled or sutured to the undersurface of the
diaphragm, bridging the hiatal hernia defect.
[0018] The invention concerns the reconstruction, and reinforcement
of the esophago-gastric (EG) junction. Helping the EG junction
perform properly controls gastro-esophageal reflux. It also
prevents the stomach from migrating into the lower mediastinum,
thereby eliminating hiatal hernia.
[0019] Accordingly, it is a principal object of the invention to
repair a hiatal hernia by implanting a hiatal hernia repair patch
which reinforces the esophago-gastric junction, reconstructing the
anatomy and stabilizing the esophago-gastric junction, thereby
helping it to perform properly.
[0020] It is another object of the invention to attach a
lightweight prosthesis to the diaphragm which reinforces the
junction between the esophagus and the gastric region.
[0021] It is a further object of the invention to produce a
prosthesis for the repair of a hiatal hernia that allows
surrounding tissue to grow into its supporting framework.
[0022] It is an object of the invention to provide improved
elements and arrangements thereof in a prosthesis for the purposes
described which is inexpensive, dependable and fully effective in
accomplishing its intended purposes.
[0023] These and other objects of the present invention will become
readily apparent upon further review of the following specification
and drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] FIG. 1 is a top plan view of a hiatal hernia repair patch
according to the present invention.
[0025] FIG. 2 is an diagrammatic cross-sectional view of a hiatal
hernia repair patch according to the present invention showing
positioning of the patch.
[0026] FIG. 3 is a section view along the lines 3-3 of FIG. 1.
[0027] FIG. 4 is a section view of an alternative embodiment of a
hiatal hernia repair patch according to the present invention.
[0028] FIG. 5 is an environmental, perspective view of a third
embodiment of a hiatal hernia repair patch according to the present
invention.
[0029] FIG. 6 is an end view of a hiatal hernia repair patch
according to the present invention folded for insertion through a
laparoscopic port.
[0030] Similar reference characters denote corresponding features
consistently throughout the attached drawings.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0031] The present invention is directed to a surgical prosthesis,
and method for its use, and more specifically to a hiatal hernia
repair patch, and the surgical procedure for implanting the patch.
The hiatal hernia repair patch will first be discussed with
reference to FIG. 1.
[0032] The patch, designated generally as 9 in FIG. 1, comprises a
ring 10, surrounded by a piece of biocompatible mesh 12. The
diameter of the ring 10, measured from the inside, is generally
sized and dimensioned for encircling a patient's distal esophagus.
Preferably the mesh 12 extends substantially 360.degree. about the
ring 10; however, it will be understood that the scope of the
present invention extends to any hernia patch having a ring 10 with
a mesh 12 extending radially therefrom, regardless of the pattern
of the mesh 12, e.g., the mesh 12 may extend radially from the ring
10 at angular intervals. A single slit 14 in the ring 10 extends
radially to and through the surrounding mesh 12. The slit 14 allows
placement of the patch 9 around the esophagus 30, as shown in FIG.
5. The mesh 12 may be stapled or sutured to the undersurface of the
diaphragm 24 to secure the patch 9. The patch 9 is made from a
synthetic biocompatible material, preferably polypropylene,
although the patch 9 may be made from other biocompatible material,
such as polytetrafluoroethylene (PFTE) Preferably the mesh 12 is
attached to the ring 10 by ultrasonic welding, adhesive, molding,
or other joining or plastic forming techniques so that the mesh 12
is integral with the ring 10.
[0033] FIG. 2 depicts a diagrammatic, close-up, cross-sectional
view of the patch 9, illustrating positioning of the patch 9. As
shown in FIGS. 2 and 3, the ring 10 is preferably circular in
cross-section, with the mesh 12 extending tangentially from one
side of the ring 10 rather than extending medially. The patch 9 is
implanted with the mesh 12 oriented superiorly and the body of the
ring 10 depending inferiorly. Thus, the patch 9 may be referred to
as having a superior side 18 and an inferior side 20.
[0034] After implantation, surrounding tissue may grow into the
mesh 12. As a desirable consequence, this ingrowth further secures
the ring 10 to the diaphragm 24. As previously noted, the internal
diameter of the ring 10 is selected to closely approximate the
diameter of the patient's esophagus at the esophago-gastric (EG)
junction. The flexibility of the polypropylene ring 10, as well as
the slit 14, permits the ring 10 to expand and contract during
normal swallowing, while the mesh 12 restricts movement of the ring
10 up and down the esophagus 30. By strengthening the EG junction
26, the ring 10 prevents the stomach 28 from migrating through the
hiatal opening in the diaphragm 24, as occurs in a sliding hiatal
hernia. The ring 10 fits snugly around the esophagus 30 in order to
prevent such migration.
[0035] As shown in FIGS. 2 and 3, the ring 10 incorporates a
radiopaque marker 40 about its inner circumference. The radiopaque
marker 40 permits visualization of the ring 10 intraoperatively and
postoperatively to ensure that the patch 9 is properly positioned
during surgery, and that the patch 9, and particularly the ring 10,
maintains its position postoperatively in order to properly
strengthen and reinforce the EG junction. The radiopaque marker 40
may be any conventional marker known in the art for allowing
radiographic visualization of a prosthesis, and may comprise a
radiopaque dye; a metal wire molded into the ring 10 made from a
biocompatible material, such as titanium, tantalum, stainless
steel, or nitinol; or metallic salts (such a barium compounds)
embedded in the synthetic biocompatible material from which the
patch 9 is formed.
[0036] As shown in FIGS. 2 and 3, in a first embodiment the ring 10
has the shape of a torus in which the toroidal body is solid. FIG.
4 shows a second embodiment of the patch, referred to generally as
109, in which the toroidal body of the ring 110 is hollow. The mesh
112 extends from the superior side 118 of the ring 112 and the ring
112 has an inferior side 120 and a radiopaque marker 140 about its
inner circumference, as described above in connection with the
first embodiment of the patch 9. Although the shape of a torus, and
therefore a substantially circular cross-section, is preferred, it
will be understood that the scope of the invention extends to a
patch having a ring, regardless of the sectional shape of the ring,
which may be flat, as shown by the ring 210 shown in FIG. 5 so that
its cross-sectional shape is rectangular or C-shaped in vertical
section, or any other shape. Further, it will be understood that
while it is preferred that the mesh 12, 112, or 212, extend from
the superior side 18 or 118 of the ring 10, 110 or 210, since this
orientation places the mesh 12, 112 or 212 closer to the diaphragm
24 and provides better support for the EG junction 26, it will be
understood that the mesh 12, 112, or 212 may alternatively extend
from the ring 10, 110, 210 medially or from the inferior side 20 or
120. Other than the cross-sectional shape of the ring, the
embodiments shown in FIGS. 4 and 5 are otherwise substantially
identical to the embodiment shown in FIGS. 1-3.
[0037] Implanting the hiatal hernia patch involves several steps.
The hiatal hernia is dissected laparoscopically or by open
technique, mobilizing the stomach and lower esophagus out of the
hiatal hernia using blunt and sharp dissection. The esophagogastric
junction is dissected circumferentially. The hiatal hernia patch 9,
109 or 209 is placed around the esophago-gastric junction 26. Prior
to implantation the ring 10, 110 or 210 must be checked to verify
that it is generally larger than the patient's distal esophagus 30.
A 60 French blunt tip esophageal bougie should be inserted through
the patient's mouth into the esophageal lumen after mobilization of
the distal esophagus and the stomach out of the hiatal hernia sac
to ensure the ring fits snugly outside the esophagus. The ring must
fit snugly. If the ring's aperture is too large, the ring will be
ineffective at preventing the stomach's migration; if the ring's
aperture is too small the esophagus will become partially
obstructed.
[0038] The next step requires trimming the patch's biocompatible
mesh 12 so that the mesh generally conforms to the shape and size
of the patient's diaphragm. In the alternative, the manufacturer
can produce the patch in a variety of shapes and sizes. The
physician can select one, from an assortment, that conforms to the
shape and size of the patient's diaphragm.
[0039] The prothesis is then placed around the patient's esophagus.
The slit 14 in the prothesis allows for its placement. The ring and
mesh may be made of flexible polypropylene, which also aids in
placement through small, laparoscopic incisions, or through
laparoscopic ports. The patch 9 may be folded, as shown in FIG. 6,
for insertion through a laparoscopic port. The patch 9, however, is
resilient enough that it regains its shape after insertion through
the incision.
[0040] Finally, the physician secures the patch 9 to the edges of
the hernia defect and the undersurface of the diaphragm using a
stapling device or sutures of nonabsorbable material, bridging the
hiatal hernia defect. FIG. 5 illustrates an environmental view of
the prothesis once it has been put in place, and prior to its
attachment to the diaphragm. The procedure of implanting the patch
may be performed using laparoscopic techniques. The patch may be
viewed radiographically either intraoperatively or postoperatively
to ensure proper placement of the ring about the distal
esophagus.
[0041] It is to be understood that the present invention is not
limited to the sole embodiments described above, but encompasses
any and all embodiments within the scope of the following
claims.
* * * * *