CA1175723A - Method and prosthesis for prevention of gastro esophageal reflux - Google Patents
Method and prosthesis for prevention of gastro esophageal refluxInfo
- Publication number
- CA1175723A CA1175723A CA000374517A CA374517A CA1175723A CA 1175723 A CA1175723 A CA 1175723A CA 000374517 A CA000374517 A CA 000374517A CA 374517 A CA374517 A CA 374517A CA 1175723 A CA1175723 A CA 1175723A
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- prosthesis
- free ends
- cushion
- esophagus
- generally
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Abstract
ABSTRACT OF THE DISCLOSURE
An improved prosthesis is provided herein for maintaining the intra-abdominal reduction of a sliding esophageal hernia. The prosthesis comprises a generally C-shaped cushion which is positioned around the distal esophagus between the diaphragm and stomach. The overall size of the prosthesis is large enough to prevent extension of the gastric fundus into the thoracic cavity through an enlarged esophageal hiatus. The pros-thesis is of generally constant cross-sectional area along its entire length to prevent upward migration of the prosthesis through the enlarged esophageal hiatus and to maintain the accentuated curvature of the esophagus induced by emplacement of the prosthesis. Tie means are pro-vided to maintain the prosthesis in operative position. Radiopaque indicia are also preferably provided to facilitate radiographic determina-tion of the position of the prosthesis after emplacement thereof.
An improved prosthesis is provided herein for maintaining the intra-abdominal reduction of a sliding esophageal hernia. The prosthesis comprises a generally C-shaped cushion which is positioned around the distal esophagus between the diaphragm and stomach. The overall size of the prosthesis is large enough to prevent extension of the gastric fundus into the thoracic cavity through an enlarged esophageal hiatus. The pros-thesis is of generally constant cross-sectional area along its entire length to prevent upward migration of the prosthesis through the enlarged esophageal hiatus and to maintain the accentuated curvature of the esophagus induced by emplacement of the prosthesis. Tie means are pro-vided to maintain the prosthesis in operative position. Radiopaque indicia are also preferably provided to facilitate radiographic determina-tion of the position of the prosthesis after emplacement thereof.
Description
~75~23 This invention relates to a surgical prosthesis. More parti-cularly, the inventlon concerns an improved prosthesis for use in preven-ting gastro esophageal reflux.
When the esophageal hiatus of the diaphragm muscle becomes enlarged, a portion of the stomach immediately below the gastro esophageal junction (the gastric fundus) may actually slide upwardly through the esophageal hiatus into the chest or thoracic cavity. This anatomic con-dition, known as a "sliding esophageal hernia" frequently causes gastro esophageal reflux in which stomach acids and foods are regurgitated into the esophagus. The characteristic symptoms of gastro esophageal reflux consist of substernal burning, regurgitation and frequent eructations.
These symptoms are accentuacted by recumbency, tight garments and physical activity, particularly bending at the waist. Long-term gastro esophageal reflux leads to complications, namely dysphagia from an esophageal stric-ture.
Various procedures have been devised for the repair of sliding esophageal hernias and for the prevention of gastro regurgitation and eructations. Crural repair almost invariably fails since it is almost impossible effectively to suture the constantly moving diaphragm. There-fore, other procedures to prevent the stomach from sliding through theenlarged esophageal hiatus were devised. According to the "posterior gastropexy" procedure of Hill, the crura is closed behind the escphagus and the stomach is sutured to the arcuate ligament over the aorta to hold the stomach within the abdominal cavity. According to the "Niessen II"
procedure, the gastric fundus is formed into a ring around the distal esophagus. The added bulk of this ring around the esophagus forms a valve preventing regurgitation and,at the same time, preventing the stomach from sliding through the enlarged esophageal hiatus.
The Hill procedure described above is very difficult to perform , - 1 - '~
~7~7;~3 on obese patients and it appears that the sutures from the lesser rurva-ture of the stomach to the arcuate ligament are of a transient nature.
According to the Niessen II procedure, it is necessary to suture the stomach to itself and to the esophagus.
United States Patent No. 3,875,928, issued April, 1975 to J.P. Angelchik, discloses a further method for maintaining the reduc-tion of a sliding esophageal hiatal hernia. The method comprises emplac-ing a C-shaped prosthesis about the distal esophagus between the gastric fundus and the diaphragm. The prosthesis has a tape secured about the periphery thereof. The free ends of the tape, which extend well beyond the tapered ends of the C-shaped cushion, are tied together, then sutured to the stomach to maintain the prosthesis in proper operative position.
Both the Hill and Niessen II procedures described above and the method described in United States Patent No. 3,875,928 above, attempt to maintain the stomach in its natural position below the diaphragm in order to prevent gastro esophageal reflux.
As illustrated in Figure 6 of ~nited States Patent No. 3,075,928, when the prosthesis is in the proper operative position, the larger dia-meter central portion of the C-shaped cushion bears against the hind side of t'ne esophagus and accentuates the curvature which exists in the por-tion of the esophagus between the stomach and diaphgram. This increased --curvature in the esophagus apparently minimizes the probability of recurrence of gastro esophageal reflux and also makes upward migration of the prosthesis and upper portion of the stomach through the hiatal hernia more difficult.
Observation has confirmed that the repetitive contracting move-ments of the stomach cause the sutures attaching the free ends to the stomach to be of transient nature. When the sutures free themselves from the wall of the stomach, the prothesis tends to rotate about the esophagus ~7S723 and the tapered ends move behind the distal esophagus and above the upper part of the stomach. When the tapered ends have rotated to a position behind the esophagus, outward pressure on the esophagus is largely diminished. As a result, the additional curvature originally imparted to the esophagus by the greater sized center portion of the prosthesis is lost, and the recurrence of gastro esophageal reflux i5 more probable.
In addition, after rotating to a position above the upper part of the stomach, the tapered ends typically move upwardly into and through the enlarged esophageal hiatus such that the prosthesis migrates from the desired operative position to a position above the diaphragm.
Alternatively, when the sutures disengage from the stomach, the prosthesis may, without rotating, simply travel essentially vertically up the esophagus allowing the tapered ends to move into the enlarged esopha-geal hiatus and promote migration of the prosthesis from the proper operative position to a posltion above the diaphragm.
Accordingly, it is an object of a principal aspect of the present invention to provide an improved prosthesis for preventing gastro esophageal reflux.
An object of another aspect of the invention is to provide an improved prosthesis for maintaining the intra-abdominal reduction of a sliding esophageal distal hernia.
~ n object of still another aspect of the invention is to provide an improved surgical prosthesis which would, when positioned about the distal esophagus, maintain the desired position between the diaphragm and stomach.
An object of yet another aspect of the invention is to provide an improved prosthesis which would, when emplaced about the distal esophagus, maintain the accentuated curvature of the portion of esophagus between the stomach and diaphragm and which would not necessitate suturing the prosthesis to the stomach or to other anatomical structures.
- By a broad aspect of this invention, a prosthesis is provided comprising a generally C-shaped cushion prosthesis, the inside diameter of the prosthesis generally corresponding to the normal outside diameter of the distal esophagus, the C-shaped prosthesis being deformable to permit adjustment of the spacing of the free ends thereof at a selected distance; and means for fixing the free ends of the cushi.on prosthesis in the deforrnable position around the distal esophagus and for maintaining the spacing of the free ends, the prosthesis being maintained in the deformable pOSition free of any sutures interconnecting the prosthesis with the human body.
In one embodiment and aspect thereof, the prosthesis which is provided is for use in maintaining the intra-abdominal reduction of a sliding esophageal hiatal hernia by preventing extension of the gastric fundus into the thoracic cavity through an enlarged esophageal hiatus, and the prosthesis comprisi.~g: (a) generally C-shaped cushion prosthesis, the inside diameter of the prosthesis generally corresponding to the normal outside diameter of the distal esophagus and the outside diameter thereof being larger than the enlarged esophageal hiatus, the C-shaped prosthesis being deformable to permit adjustment of the spacing of the free ends thereof at a selected distance and having a generally constant cross-sectional area along the length thereof; and (b) means for fixing the free ends of the cushion prosthesis in operative position around the distal esophagus between the gastric fundus and the diaphragm and for maintaining the selected spacing of ~he free ends, the prosthesis being maintained int he operative position free of any sutures interconnecting the prosthesis with an organ of the human body.
75~Z3 `~" ` .
In another embodiment and aspect of this invention, the pros-thesis which is provided is for use in preventing gastro esophageal reflux when the gastro esophageal ~unction is positioned above the diaphragm, and the prosthesis comprises: (a) a generally C-shaped cushion prosthesis, the inside diameter of the prosthesis generally corresponding to the normal outside diameter of the distal esophagus, the C-shaped member being deformable to permit adjustment of the spacing of the free ends thereof at a selected distance; and (b) means for fixing the free ends of the prosthesis in the adjusted position to maintain the C-shaped cushion prosthesis in operative position around the distal esophagus gen-B
_ 4a -757~3 erally adjacent to the gastric fundus when the gastro esophageal junction is positioned above the diaphragm and to maintain the adjusted spacing of the free ends, the prosthesis being positioned a~ove the diaphragm free of any sutures interconnecting the prosthesis with the human body.
By one variant of these aspects, the cushion prosthesis is formed from a silicon èlastomer.
By another variant of these aspects, the C-shaped cushion prosthesis is filled with a gel liquid.
By a variation thereof, the gel liquid is a highly cross-linked silicone gel.
By another variant of these aspects, the means (b) comprises an elongate tape secured around the periphery of the cushion member, the free ends of the tape extending substantially beyond the free ends of the cushion member.
By a variation thereof, the tape is formed of a silicone-coated synthetic polymer.
By yet another variant of these aspects, the prosthesis includes a radiopaque determlnation of the position of the prosthesis after em-placement thereof.
By a variation thereof, the radiopaque indicia comprises a tantalum-filled silicone strip.
-~ - 5 -:
~5723 The means for fixing the free ends of the prosthesis in its operative position preferably comprises an elongate tape member secured around the periphery of the cushion member. ~he free ends of the tape extend substantially bevond the free ends of the C-shaped cushion member, i.e., a distance sufficient to allow the ends of the tape member to be tied together.
In the accompanying drawings, Figure 1 is a perspective view of the preferred embodiment of the prosthesis of an aspect of this invention for repairing a sliding esophageal distal hernia;
~ Figure 2 is a sectional side view of the prosthesis of Figure .. . . .
1 taken along sectlon llne 2-2 thereof;
Figure 3 is a top view of the prosthesis of Figure l;
Figure 4 is a perspective anatomical drawing illustrating the - 5a -initial steps according to the procedure of reduction of the hiatal hernia using the prosthesis of an aspect of this invention;
Figure 5 is a perspective anatomical drawing illustrating the prosthesis of Figures 1 - 3 located in a proper operative position to prevent recurrence of the hiatal hernia;
Figure 6 is a cross-sectional view of the stomach, diaphragm and esophagus illustrating a typical sliding esophageal hernia;
Figure 7 is a perspective view of a preferred embodiment of the prosthesis for use in a procedure for preventing gastro esophageal reflux;
Figure 8 is a sectional perspective view of the prosthesis of Figure 7 taken at section line 7-7 thereof;
Figure 9 is a perspective anatomical drawing illustrating the initial steps in the implantation of the prosthesis of Figures 7 - 8; and Figure 10 is a perspective anatomical drawing illustrating the prosthesis of Figures 7 - 8 located in its proper operative position to prevent gastro esophageal reflux.
Turning now to the drawings, Figure 1 depicts the preferred embodiment of the surgical prosthesis which is utilized to maintain the reduction of an esophageal hiatal hernia. The prosthesis consists of a generally C-shaped cushion member Zl, the inside dimensions of which generally correspond to ~he normal outside dimensions of the distal esophagus (reference character 17, Figure 5). In a typical prosthesis, the inside dimensions will equal 3.1 by 2.5 centimeters, although pros-thetic devices having somewhat larger and somewhat sm~ller inside dimen-sions should be provided to the surgeon for use where the patient may have an esophagus somewhat larger or somewhat smaller than normal.
The outside dimensions of the prothesis are sized to be sub-stantially larger than the enlarged esophageal hiatus (reference character 12, Figure 5~, and in a tyFical prosthesis, the outsi-lc dimensions will .
~ 5723 equal 6.0 by 7.0 centimeters. Obviously, these outside dimensions are also variable in accordance with the size of the enlarged esophageal hiatus of a particular patient.
In accordance with the prosthesis as shown in Figures 1 - 3, the cushion member has a generally circular cross-section and is of generally constant cross-sectional area along the length thereof. The pro-thesis is preferably constn~cted by filling outer flexible integement 24 with a gel liquid 25 such that the entire cushion mernber 21 is deformable to permit adjustment of the spacing of the free ends 23 at a selected distance which will permit the normal expansion of the esophagus during swallowing. The precise materlals of construction of the integement 24 and the filler 25 of the C-shaped cushion member 21 are not highly critical so long as they are compatible with body tissues, i.e., do not induce rejection or cause other body reaction. In the presently preferred embo-diment of the present invention, a silicone elastomer shell filled with a highly cross-linked silicone gel manufactured by Dow Chemical Company and sold under the trade mark SILASTIC is used. A tape 26, preferably a silicone-coated synthetic material known by the trade mark DACRON is secured to the C-shaped cushion member 21 around the outer periphery thereof and the free ends 27 of the tape extend substantially beyond the free ends 23 of the C-shaped cushion member 21 to a distance sufficient to allow the free ends 27 of the tape 26 to be tied together.
Preferably, the prosthesis is provided with a tantalum filled silicone strip 28 on tape 26 such that after implantation of the prosthe-sis, radiographic examination will reveal whether the prosthesis is in its proper operative position.
The method of use of the prosthesis of Figures 1 - 3 is illus-trated in Figures 4 and 5. That procedure consists of opening the abdominal cavity with an upper midline incislon and exposing the area of ~7~ 23 the diaphragmatic hiatus by medially retracting the left lobe of the liver.
The peritoneum and sac of the hiatal hernia 12 are then incised and the hernia 12 is reduced by retracting the stomach 43 intra-abdominally. As shown in Figure 4, the prosthesis 20 of Figures 1 - 3 is then placed around the distal esophagus 17 in~ediately above the gastric fundus 45.
Figure 5 illustrates the prosthesis 20 in position after the free ends 27 of the tape 26 are anteriorly tied at 46 to locate the free ends 23 of the prosthesis 20 at the proper spacing and the tape end remnants are cut leaving an inch of length. Suturing of the free ends to the stomach or to other anatomical structures is not required to maintain the prosthesis 20 in its proper operative position around the distal esophagus 17 bet~een the gastric fundus 45 and the diaphragm 13.
The prosthesis shown in United States Patent No. 3,875,928 has tapered ends and a larger sized center portion. In the proper operational position, the center portion of the tapered prosthesis is situated behind the distal esophagus 17 to increase the curvature of the esophagus.
Increased curvature of the esophagus apparently tends to reduce gastro esophageal reflux. When the sutures binding the free ends of the DACRON
tape to the stomach free themselves, the tapered ends of the C-shaped cushion prosthesis tend to rotate to a position behind the esophagus 17 and above the gastric fundus 45. Since the size of the tapered ends of the prosthesis is insufficient to accentuate the curvature of the esopha-gus, the lessening of gastro esophageal reflux achieved when the tapered prosthesis also initially placed in the proper operative position is lost.
In addition, after rotating to a position above the gastric fundus, the tapered ends tend to enter the hiatal hernia 12 and promote upward migra-tion of the prosthesis through the diaphragmatic hiatus 12.
In contrast to the tapered prosthesis described in the above-identified United States Patent No. 3,875,928, the prosthesis herein ~ ~75723 illustrated in Figures l - 3 is of generally constant cross-sectional --- area-along its entire length, î.e., the ends of the prosthesis are not substantially tapered. Consequently, even if the prosthesis rotates about the distal esophagus, the accentuation of the curvature of the esophagus 17 is maintained. Further, in the great majority of hiatal hernias, the consistent size of the prosthesi~ of an aspect of the present invention along the length thereof eliminates upward migration of the prosthesis into and through the diaphragmatic hiatus. The prosthesis generally maintains the proper operative position between diaphragm 13 and stomach 43.
In sum, in the presently preferred embodiment of the present invention, the prosthesis need not be sutured in position effectively to maintain the reduction of a sliding esophageal hiatal hernia.
Figure 6 depicts a typical sliding esophageal hiatal hernia and shows the gastric fundus 10 extending into the thoracic cavity 11 through the enlarged esophageal hiatus 12 of the diaphragm 13. In this position, the lesser sphincter 14 of the esophagus 15, being transposed into the chest from its normal position just below the esophageal hiatus 12 operates less effectively. This permits gastro esophageal reflux of stomach acids and foods which are not evacuated by esophageal peristalsis and which remain in the lower esophagus for prolonged periods causing irritation and damage to the lower esophagus mucosa 16.
Figures 7 and 8 depict the prosthesis device which is utilized in the preferred embodiment of the present invention for preventing gastro esophageal reflux. The prosthesis consists of a generally C-shaped cushion member 21, the inside dimensions of which generally correspond to the normal outside dimensions of the distal esophagus (reference character 17, Figure 6) In a typical prosthesis, the inside dimensions will equal 6.25 by 5.25 centimeters, although prosthetic devices having _ g _ ( ~757Z3 ( ., '~ . .
somewhat larger a~d somewhat smaller inner and outer dimensions should be . .
-~~ pFovided~to the surgeon for use where the patient may have an esophagus somewhat larger or somewhat smaller than normal.
In accordance with the prosthesis shown in ~igures 7 and 8, the cushion member has a generally circular cross-section and is tapered from the central portion 22 toward the free ends 23 thereof. The prothesis is preferably constructed by filling outer flexible integement 24 with a gel liquid 25 such that the entire cushion member 21 is deformable to permit adjust~ent of the spacing of the free ends 23 at a selected distance which will permit the normal expansion of the esophagus during swallowing.
The precise materials of construction of the integement 24 and the filler 25 of the C-shaped cushion member 21 are not highly critical so long as they are compatible with body tissues, i.e., do not induce rejection or cause other body reaction. In the presently preferred prothesis, a silicone elastomer shell filled with a highly cross-linked silicone gel~
is used. A tape 26, preferably a silicone-coated synthetic material known by the Trade Mark D~CRON, is secured to the C-shaped cushion member 21 around the outer periphery thereof and the free ends 27 of the tape extend substantially beyond the free ends 23 of the C-shaped cushion member 21 to a distance sufficient to allow the free ends 27 of the tape 26 to be tied together.
Preferably, the prosthesis is provided with a tantalum-filled silicone strip 28 on tape 26 such that after implantation of the prosthe-sis, radiographic examination will reveal whether the prosthesis is in its proper operative position.
The prosthesis shown in Figures 1 and 2 also may be employed in the method disclosed hereinabove. Obviously, a variety of variously sizes and shaped prosthetic devices could be employed in this improved method for preventing gastro esophageal reflux.
~ le method of use of the prosthesis of Figures 7 and 8 is ' ~3 .
illustrated in Figures 9 and 10. That procedure consists of opening the abdominal cavity with an upper midline incision and exposing the area of the diaphragmatic hiatus. As shown in Figure 9, the prosthesis 20 is then placed around the distal esophagus 17 immediately above the gastric fundus 45. Figure lO illustrates the prosthesis 20 in position after the free ends 27 of the tape 26 are anteriorly tied at 46 to locate the free ends 23 of the prosthesis 20 at the proper spacing and after the tape end remnants are cut leaving about an inch of length. The prosthesis 20, when emplaced around the distal esophagus immediately above the stomach, acts as a mechanical valve and generally precludes regurgitation while permitting the regular downward flow of food from the esophagus to the stomach.
Intra-abdominal retraction of the stomach 43 through the esophageal hiatus 12 prior to emplacement of the prosthesis 20 is not required. Similarly, reduction of or suturing of the diaphragmatic hiatus 12 is not necessary before or after the prosthesis 20 is in opera-tive position.
In order to prevent gastro esophageal reflux; the method des-cribed in Uni.:ed States Patent No. 3,875,928 attempted to preclude upward migration of the stomach through the esophageal hiatus by suturing a pros-thesis emplaced around the esophagus to the stomach. As described herein, the method described herein, without any suturing whatsoever and without reduction of the hiatal hernia, prevents gastro esophageal reflux by placing a prosthesis around ~-e esophagus when the gastro esophageal junction is located above the diaphragmatic hiatus.
When the esophageal hiatus of the diaphragm muscle becomes enlarged, a portion of the stomach immediately below the gastro esophageal junction (the gastric fundus) may actually slide upwardly through the esophageal hiatus into the chest or thoracic cavity. This anatomic con-dition, known as a "sliding esophageal hernia" frequently causes gastro esophageal reflux in which stomach acids and foods are regurgitated into the esophagus. The characteristic symptoms of gastro esophageal reflux consist of substernal burning, regurgitation and frequent eructations.
These symptoms are accentuacted by recumbency, tight garments and physical activity, particularly bending at the waist. Long-term gastro esophageal reflux leads to complications, namely dysphagia from an esophageal stric-ture.
Various procedures have been devised for the repair of sliding esophageal hernias and for the prevention of gastro regurgitation and eructations. Crural repair almost invariably fails since it is almost impossible effectively to suture the constantly moving diaphragm. There-fore, other procedures to prevent the stomach from sliding through theenlarged esophageal hiatus were devised. According to the "posterior gastropexy" procedure of Hill, the crura is closed behind the escphagus and the stomach is sutured to the arcuate ligament over the aorta to hold the stomach within the abdominal cavity. According to the "Niessen II"
procedure, the gastric fundus is formed into a ring around the distal esophagus. The added bulk of this ring around the esophagus forms a valve preventing regurgitation and,at the same time, preventing the stomach from sliding through the enlarged esophageal hiatus.
The Hill procedure described above is very difficult to perform , - 1 - '~
~7~7;~3 on obese patients and it appears that the sutures from the lesser rurva-ture of the stomach to the arcuate ligament are of a transient nature.
According to the Niessen II procedure, it is necessary to suture the stomach to itself and to the esophagus.
United States Patent No. 3,875,928, issued April, 1975 to J.P. Angelchik, discloses a further method for maintaining the reduc-tion of a sliding esophageal hiatal hernia. The method comprises emplac-ing a C-shaped prosthesis about the distal esophagus between the gastric fundus and the diaphragm. The prosthesis has a tape secured about the periphery thereof. The free ends of the tape, which extend well beyond the tapered ends of the C-shaped cushion, are tied together, then sutured to the stomach to maintain the prosthesis in proper operative position.
Both the Hill and Niessen II procedures described above and the method described in United States Patent No. 3,875,928 above, attempt to maintain the stomach in its natural position below the diaphragm in order to prevent gastro esophageal reflux.
As illustrated in Figure 6 of ~nited States Patent No. 3,075,928, when the prosthesis is in the proper operative position, the larger dia-meter central portion of the C-shaped cushion bears against the hind side of t'ne esophagus and accentuates the curvature which exists in the por-tion of the esophagus between the stomach and diaphgram. This increased --curvature in the esophagus apparently minimizes the probability of recurrence of gastro esophageal reflux and also makes upward migration of the prosthesis and upper portion of the stomach through the hiatal hernia more difficult.
Observation has confirmed that the repetitive contracting move-ments of the stomach cause the sutures attaching the free ends to the stomach to be of transient nature. When the sutures free themselves from the wall of the stomach, the prothesis tends to rotate about the esophagus ~7S723 and the tapered ends move behind the distal esophagus and above the upper part of the stomach. When the tapered ends have rotated to a position behind the esophagus, outward pressure on the esophagus is largely diminished. As a result, the additional curvature originally imparted to the esophagus by the greater sized center portion of the prosthesis is lost, and the recurrence of gastro esophageal reflux i5 more probable.
In addition, after rotating to a position above the upper part of the stomach, the tapered ends typically move upwardly into and through the enlarged esophageal hiatus such that the prosthesis migrates from the desired operative position to a position above the diaphragm.
Alternatively, when the sutures disengage from the stomach, the prosthesis may, without rotating, simply travel essentially vertically up the esophagus allowing the tapered ends to move into the enlarged esopha-geal hiatus and promote migration of the prosthesis from the proper operative position to a posltion above the diaphragm.
Accordingly, it is an object of a principal aspect of the present invention to provide an improved prosthesis for preventing gastro esophageal reflux.
An object of another aspect of the invention is to provide an improved prosthesis for maintaining the intra-abdominal reduction of a sliding esophageal distal hernia.
~ n object of still another aspect of the invention is to provide an improved surgical prosthesis which would, when positioned about the distal esophagus, maintain the desired position between the diaphragm and stomach.
An object of yet another aspect of the invention is to provide an improved prosthesis which would, when emplaced about the distal esophagus, maintain the accentuated curvature of the portion of esophagus between the stomach and diaphragm and which would not necessitate suturing the prosthesis to the stomach or to other anatomical structures.
- By a broad aspect of this invention, a prosthesis is provided comprising a generally C-shaped cushion prosthesis, the inside diameter of the prosthesis generally corresponding to the normal outside diameter of the distal esophagus, the C-shaped prosthesis being deformable to permit adjustment of the spacing of the free ends thereof at a selected distance; and means for fixing the free ends of the cushi.on prosthesis in the deforrnable position around the distal esophagus and for maintaining the spacing of the free ends, the prosthesis being maintained in the deformable pOSition free of any sutures interconnecting the prosthesis with the human body.
In one embodiment and aspect thereof, the prosthesis which is provided is for use in maintaining the intra-abdominal reduction of a sliding esophageal hiatal hernia by preventing extension of the gastric fundus into the thoracic cavity through an enlarged esophageal hiatus, and the prosthesis comprisi.~g: (a) generally C-shaped cushion prosthesis, the inside diameter of the prosthesis generally corresponding to the normal outside diameter of the distal esophagus and the outside diameter thereof being larger than the enlarged esophageal hiatus, the C-shaped prosthesis being deformable to permit adjustment of the spacing of the free ends thereof at a selected distance and having a generally constant cross-sectional area along the length thereof; and (b) means for fixing the free ends of the cushion prosthesis in operative position around the distal esophagus between the gastric fundus and the diaphragm and for maintaining the selected spacing of ~he free ends, the prosthesis being maintained int he operative position free of any sutures interconnecting the prosthesis with an organ of the human body.
75~Z3 `~" ` .
In another embodiment and aspect of this invention, the pros-thesis which is provided is for use in preventing gastro esophageal reflux when the gastro esophageal ~unction is positioned above the diaphragm, and the prosthesis comprises: (a) a generally C-shaped cushion prosthesis, the inside diameter of the prosthesis generally corresponding to the normal outside diameter of the distal esophagus, the C-shaped member being deformable to permit adjustment of the spacing of the free ends thereof at a selected distance; and (b) means for fixing the free ends of the prosthesis in the adjusted position to maintain the C-shaped cushion prosthesis in operative position around the distal esophagus gen-B
_ 4a -757~3 erally adjacent to the gastric fundus when the gastro esophageal junction is positioned above the diaphragm and to maintain the adjusted spacing of the free ends, the prosthesis being positioned a~ove the diaphragm free of any sutures interconnecting the prosthesis with the human body.
By one variant of these aspects, the cushion prosthesis is formed from a silicon èlastomer.
By another variant of these aspects, the C-shaped cushion prosthesis is filled with a gel liquid.
By a variation thereof, the gel liquid is a highly cross-linked silicone gel.
By another variant of these aspects, the means (b) comprises an elongate tape secured around the periphery of the cushion member, the free ends of the tape extending substantially beyond the free ends of the cushion member.
By a variation thereof, the tape is formed of a silicone-coated synthetic polymer.
By yet another variant of these aspects, the prosthesis includes a radiopaque determlnation of the position of the prosthesis after em-placement thereof.
By a variation thereof, the radiopaque indicia comprises a tantalum-filled silicone strip.
-~ - 5 -:
~5723 The means for fixing the free ends of the prosthesis in its operative position preferably comprises an elongate tape member secured around the periphery of the cushion member. ~he free ends of the tape extend substantially bevond the free ends of the C-shaped cushion member, i.e., a distance sufficient to allow the ends of the tape member to be tied together.
In the accompanying drawings, Figure 1 is a perspective view of the preferred embodiment of the prosthesis of an aspect of this invention for repairing a sliding esophageal distal hernia;
~ Figure 2 is a sectional side view of the prosthesis of Figure .. . . .
1 taken along sectlon llne 2-2 thereof;
Figure 3 is a top view of the prosthesis of Figure l;
Figure 4 is a perspective anatomical drawing illustrating the - 5a -initial steps according to the procedure of reduction of the hiatal hernia using the prosthesis of an aspect of this invention;
Figure 5 is a perspective anatomical drawing illustrating the prosthesis of Figures 1 - 3 located in a proper operative position to prevent recurrence of the hiatal hernia;
Figure 6 is a cross-sectional view of the stomach, diaphragm and esophagus illustrating a typical sliding esophageal hernia;
Figure 7 is a perspective view of a preferred embodiment of the prosthesis for use in a procedure for preventing gastro esophageal reflux;
Figure 8 is a sectional perspective view of the prosthesis of Figure 7 taken at section line 7-7 thereof;
Figure 9 is a perspective anatomical drawing illustrating the initial steps in the implantation of the prosthesis of Figures 7 - 8; and Figure 10 is a perspective anatomical drawing illustrating the prosthesis of Figures 7 - 8 located in its proper operative position to prevent gastro esophageal reflux.
Turning now to the drawings, Figure 1 depicts the preferred embodiment of the surgical prosthesis which is utilized to maintain the reduction of an esophageal hiatal hernia. The prosthesis consists of a generally C-shaped cushion member Zl, the inside dimensions of which generally correspond to ~he normal outside dimensions of the distal esophagus (reference character 17, Figure 5). In a typical prosthesis, the inside dimensions will equal 3.1 by 2.5 centimeters, although pros-thetic devices having somewhat larger and somewhat sm~ller inside dimen-sions should be provided to the surgeon for use where the patient may have an esophagus somewhat larger or somewhat smaller than normal.
The outside dimensions of the prothesis are sized to be sub-stantially larger than the enlarged esophageal hiatus (reference character 12, Figure 5~, and in a tyFical prosthesis, the outsi-lc dimensions will .
~ 5723 equal 6.0 by 7.0 centimeters. Obviously, these outside dimensions are also variable in accordance with the size of the enlarged esophageal hiatus of a particular patient.
In accordance with the prosthesis as shown in Figures 1 - 3, the cushion member has a generally circular cross-section and is of generally constant cross-sectional area along the length thereof. The pro-thesis is preferably constn~cted by filling outer flexible integement 24 with a gel liquid 25 such that the entire cushion mernber 21 is deformable to permit adjustment of the spacing of the free ends 23 at a selected distance which will permit the normal expansion of the esophagus during swallowing. The precise materlals of construction of the integement 24 and the filler 25 of the C-shaped cushion member 21 are not highly critical so long as they are compatible with body tissues, i.e., do not induce rejection or cause other body reaction. In the presently preferred embo-diment of the present invention, a silicone elastomer shell filled with a highly cross-linked silicone gel manufactured by Dow Chemical Company and sold under the trade mark SILASTIC is used. A tape 26, preferably a silicone-coated synthetic material known by the trade mark DACRON is secured to the C-shaped cushion member 21 around the outer periphery thereof and the free ends 27 of the tape extend substantially beyond the free ends 23 of the C-shaped cushion member 21 to a distance sufficient to allow the free ends 27 of the tape 26 to be tied together.
Preferably, the prosthesis is provided with a tantalum filled silicone strip 28 on tape 26 such that after implantation of the prosthe-sis, radiographic examination will reveal whether the prosthesis is in its proper operative position.
The method of use of the prosthesis of Figures 1 - 3 is illus-trated in Figures 4 and 5. That procedure consists of opening the abdominal cavity with an upper midline incislon and exposing the area of ~7~ 23 the diaphragmatic hiatus by medially retracting the left lobe of the liver.
The peritoneum and sac of the hiatal hernia 12 are then incised and the hernia 12 is reduced by retracting the stomach 43 intra-abdominally. As shown in Figure 4, the prosthesis 20 of Figures 1 - 3 is then placed around the distal esophagus 17 in~ediately above the gastric fundus 45.
Figure 5 illustrates the prosthesis 20 in position after the free ends 27 of the tape 26 are anteriorly tied at 46 to locate the free ends 23 of the prosthesis 20 at the proper spacing and the tape end remnants are cut leaving an inch of length. Suturing of the free ends to the stomach or to other anatomical structures is not required to maintain the prosthesis 20 in its proper operative position around the distal esophagus 17 bet~een the gastric fundus 45 and the diaphragm 13.
The prosthesis shown in United States Patent No. 3,875,928 has tapered ends and a larger sized center portion. In the proper operational position, the center portion of the tapered prosthesis is situated behind the distal esophagus 17 to increase the curvature of the esophagus.
Increased curvature of the esophagus apparently tends to reduce gastro esophageal reflux. When the sutures binding the free ends of the DACRON
tape to the stomach free themselves, the tapered ends of the C-shaped cushion prosthesis tend to rotate to a position behind the esophagus 17 and above the gastric fundus 45. Since the size of the tapered ends of the prosthesis is insufficient to accentuate the curvature of the esopha-gus, the lessening of gastro esophageal reflux achieved when the tapered prosthesis also initially placed in the proper operative position is lost.
In addition, after rotating to a position above the gastric fundus, the tapered ends tend to enter the hiatal hernia 12 and promote upward migra-tion of the prosthesis through the diaphragmatic hiatus 12.
In contrast to the tapered prosthesis described in the above-identified United States Patent No. 3,875,928, the prosthesis herein ~ ~75723 illustrated in Figures l - 3 is of generally constant cross-sectional --- area-along its entire length, î.e., the ends of the prosthesis are not substantially tapered. Consequently, even if the prosthesis rotates about the distal esophagus, the accentuation of the curvature of the esophagus 17 is maintained. Further, in the great majority of hiatal hernias, the consistent size of the prosthesi~ of an aspect of the present invention along the length thereof eliminates upward migration of the prosthesis into and through the diaphragmatic hiatus. The prosthesis generally maintains the proper operative position between diaphragm 13 and stomach 43.
In sum, in the presently preferred embodiment of the present invention, the prosthesis need not be sutured in position effectively to maintain the reduction of a sliding esophageal hiatal hernia.
Figure 6 depicts a typical sliding esophageal hiatal hernia and shows the gastric fundus 10 extending into the thoracic cavity 11 through the enlarged esophageal hiatus 12 of the diaphragm 13. In this position, the lesser sphincter 14 of the esophagus 15, being transposed into the chest from its normal position just below the esophageal hiatus 12 operates less effectively. This permits gastro esophageal reflux of stomach acids and foods which are not evacuated by esophageal peristalsis and which remain in the lower esophagus for prolonged periods causing irritation and damage to the lower esophagus mucosa 16.
Figures 7 and 8 depict the prosthesis device which is utilized in the preferred embodiment of the present invention for preventing gastro esophageal reflux. The prosthesis consists of a generally C-shaped cushion member 21, the inside dimensions of which generally correspond to the normal outside dimensions of the distal esophagus (reference character 17, Figure 6) In a typical prosthesis, the inside dimensions will equal 6.25 by 5.25 centimeters, although prosthetic devices having _ g _ ( ~757Z3 ( ., '~ . .
somewhat larger a~d somewhat smaller inner and outer dimensions should be . .
-~~ pFovided~to the surgeon for use where the patient may have an esophagus somewhat larger or somewhat smaller than normal.
In accordance with the prosthesis shown in ~igures 7 and 8, the cushion member has a generally circular cross-section and is tapered from the central portion 22 toward the free ends 23 thereof. The prothesis is preferably constructed by filling outer flexible integement 24 with a gel liquid 25 such that the entire cushion member 21 is deformable to permit adjust~ent of the spacing of the free ends 23 at a selected distance which will permit the normal expansion of the esophagus during swallowing.
The precise materials of construction of the integement 24 and the filler 25 of the C-shaped cushion member 21 are not highly critical so long as they are compatible with body tissues, i.e., do not induce rejection or cause other body reaction. In the presently preferred prothesis, a silicone elastomer shell filled with a highly cross-linked silicone gel~
is used. A tape 26, preferably a silicone-coated synthetic material known by the Trade Mark D~CRON, is secured to the C-shaped cushion member 21 around the outer periphery thereof and the free ends 27 of the tape extend substantially beyond the free ends 23 of the C-shaped cushion member 21 to a distance sufficient to allow the free ends 27 of the tape 26 to be tied together.
Preferably, the prosthesis is provided with a tantalum-filled silicone strip 28 on tape 26 such that after implantation of the prosthe-sis, radiographic examination will reveal whether the prosthesis is in its proper operative position.
The prosthesis shown in Figures 1 and 2 also may be employed in the method disclosed hereinabove. Obviously, a variety of variously sizes and shaped prosthetic devices could be employed in this improved method for preventing gastro esophageal reflux.
~ le method of use of the prosthesis of Figures 7 and 8 is ' ~3 .
illustrated in Figures 9 and 10. That procedure consists of opening the abdominal cavity with an upper midline incision and exposing the area of the diaphragmatic hiatus. As shown in Figure 9, the prosthesis 20 is then placed around the distal esophagus 17 immediately above the gastric fundus 45. Figure lO illustrates the prosthesis 20 in position after the free ends 27 of the tape 26 are anteriorly tied at 46 to locate the free ends 23 of the prosthesis 20 at the proper spacing and after the tape end remnants are cut leaving about an inch of length. The prosthesis 20, when emplaced around the distal esophagus immediately above the stomach, acts as a mechanical valve and generally precludes regurgitation while permitting the regular downward flow of food from the esophagus to the stomach.
Intra-abdominal retraction of the stomach 43 through the esophageal hiatus 12 prior to emplacement of the prosthesis 20 is not required. Similarly, reduction of or suturing of the diaphragmatic hiatus 12 is not necessary before or after the prosthesis 20 is in opera-tive position.
In order to prevent gastro esophageal reflux; the method des-cribed in Uni.:ed States Patent No. 3,875,928 attempted to preclude upward migration of the stomach through the esophageal hiatus by suturing a pros-thesis emplaced around the esophagus to the stomach. As described herein, the method described herein, without any suturing whatsoever and without reduction of the hiatal hernia, prevents gastro esophageal reflux by placing a prosthesis around ~-e esophagus when the gastro esophageal junction is located above the diaphragmatic hiatus.
Claims (10)
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. A prosthesis comprising:
(a) a generally C-shaped cushion prosthesis, the inside diameter of said prosthesis generally corresponding to the normal outside diameter of the distal esophagus, said C-shaped prosthesis being deformable to permit adjustment of the spacing of the free ends thereof at a selected distance; and (b) means for fixing the free ends of said cushion prosthe-sis in said deformable position around the distal eso-phagus and for maintaining said spacing of said free ends, said prosthesis being maintained in said deformable position free of any sutures interconnecting said pros-thesis with the human body.
(a) a generally C-shaped cushion prosthesis, the inside diameter of said prosthesis generally corresponding to the normal outside diameter of the distal esophagus, said C-shaped prosthesis being deformable to permit adjustment of the spacing of the free ends thereof at a selected distance; and (b) means for fixing the free ends of said cushion prosthe-sis in said deformable position around the distal eso-phagus and for maintaining said spacing of said free ends, said prosthesis being maintained in said deformable position free of any sutures interconnecting said pros-thesis with the human body.
2. A prosthesis as claimed in claim 1 for use in maintaining the intra-abdominal reduction of a sliding esophageal hiatal hernia by preventing extension of the gastric fundus into the thoracic cavity through an enlarged esophageal hiatus, said prosthesis comprising:
(a) a generally C-shaped cushion prosthesis, the inside diameter of said prosthesis generally corresponding to the normal outside diameter of the distal esophagus and the outside diameter thereof being larger than said enlarged esophageal hiatus, said C-shaped prosthesis being deformable to permit adjustment of the spacing of the free ends thereof at a selected distance and having a generally constant cross-sectional area along the length thereof; and (b) means for fixing the free ends of said cushion prosthe-sis in operative position around the distal esophagus between the gastric fundus and the diaphragm and for maintaining the selected spacing of said free ends, said prosthesis being maintained in said operative position free of any sutures interconnecting said prosthesis with an organ of the human body.
(a) a generally C-shaped cushion prosthesis, the inside diameter of said prosthesis generally corresponding to the normal outside diameter of the distal esophagus and the outside diameter thereof being larger than said enlarged esophageal hiatus, said C-shaped prosthesis being deformable to permit adjustment of the spacing of the free ends thereof at a selected distance and having a generally constant cross-sectional area along the length thereof; and (b) means for fixing the free ends of said cushion prosthe-sis in operative position around the distal esophagus between the gastric fundus and the diaphragm and for maintaining the selected spacing of said free ends, said prosthesis being maintained in said operative position free of any sutures interconnecting said prosthesis with an organ of the human body.
3. A prosthesis as claimed in claim 1 for use in preventing gastro esophageal reflux when the gastro esophageal junction is positioned above the diaphragm, said prosthesis comprising:
(a) a generally C-shaped cushion prosthesis, the inside diameter of said prosthesis generally corresponding to the normal outside diameter of the distal esophagus, said C-shaped member being deformable to permit adjustment of the spacing of the free ends thereof at a selected distance; and (b) means for fixing the free ends of said cushion prosthesis in said adjusted position to maintain said C-shaped cushion `
prosthesis in operative position around the distal esophagus generally adjacent to the gastric fundus when the gastro esophageal junction is positioned above said free ends, said prosthesis being positioned above said diaphragm free of any sutures interconnecting said prosthesis with the human body.
(a) a generally C-shaped cushion prosthesis, the inside diameter of said prosthesis generally corresponding to the normal outside diameter of the distal esophagus, said C-shaped member being deformable to permit adjustment of the spacing of the free ends thereof at a selected distance; and (b) means for fixing the free ends of said cushion prosthesis in said adjusted position to maintain said C-shaped cushion `
prosthesis in operative position around the distal esophagus generally adjacent to the gastric fundus when the gastro esophageal junction is positioned above said free ends, said prosthesis being positioned above said diaphragm free of any sutures interconnecting said prosthesis with the human body.
4. The prosthesis of claims 2 or 3 wherein said cushion pros-thesis is formed from a silicon elastomer.
5. The prosthesis of claims 2 or 3 wherein said C-shaped cushion prosthesis is filled with a gel liquid.
6. The prosthesis of claims 2 or 3 wherein said C-shaped cushion prosthesis is filled with a gel liquid and wherein said gel liquid is a highly cross-linked silicone gel.
7. The prosthesis of claims 2 or 3 wherein said means (b) com-prises an elongate tape secured around the periphery of said cushion member, the free ends of said tape extending substantially beyond the free ends of said cushion member.
8. The prosthesis of claims 2 or 3 wherein said means (b) com-prises an elongate tape secured around the periphery of said cushion member, the free ends of said tape extending substantially beyond the free ends of said cushion member and wherein said tape is formed of a silicone-coated synthetic polymer.
9. The prosthesis of claims 2 or 3 including a radiopaque indicia to facilitate radiographic determination of the position of the prosthesis after emplacement thereof.
10. The prosthesis of claims 2 or 3 including a radiopaque in-dicia to facilitate radiographic determination of the position of the prosthesis after emplacement thereof and wherein said radiopaque indicia comprises a tantalum-filled silicone strip.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA000374517A CA1175723A (en) | 1981-04-02 | 1981-04-02 | Method and prosthesis for prevention of gastro esophageal reflux |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA000374517A CA1175723A (en) | 1981-04-02 | 1981-04-02 | Method and prosthesis for prevention of gastro esophageal reflux |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1175723A true CA1175723A (en) | 1984-10-09 |
Family
ID=4119622
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000374517A Expired CA1175723A (en) | 1981-04-02 | 1981-04-02 | Method and prosthesis for prevention of gastro esophageal reflux |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA1175723A (en) |
-
1981
- 1981-04-02 CA CA000374517A patent/CA1175723A/en not_active Expired
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