# Patent

## Title
Method for marking and connecting tissue

## Abstract

A surgical marker/connector can be provided in the form of a ring made of a fluoroscopic material, including a shape memory alloy such as NITINOL. The ring preferably includes a plurality of small suture attachments in the form of loops that are disposed on the periphery of the ring and which lie in a plane that includes the ring itself. The loops are large enough to receive sutures which, in turn, can be used to connect the ring to a portion of a patient's body, or to connect separate portions of a patient's body to each other using the marker/connector as an intermediate connector. If the ring is made of a shape memory alloy, the ring can be wrapped tightly about an elongate member such as a mandrel, which than can be inserted into the patient's body through a trochar or cannula. After insertion, the ring will change temperature and resume its original configuration where it can be sutured in place as desired. If the ring is not made of a shape memory alloy, the ring can be inserted into the patient's body by conventional surgical techniques and then sutured in place as desired.

## Background
REFERENCE TO RELATED APPLICATION
The present application is a division of application Ser. No. 11/696,901, filed Apr. 5, 2007 by Helmut Schreiber and Albert N. Santilli, entitled Surgical Marker/Connector and Method of Installation, which is a continuation-in-part of application Ser. No. 11/112,292, filed Apr. 22, 2005 by Helmut Schreiber and Albert N. Santilli, entitled Surgical Marker/Connector, the disclosures of which are incorporated herein by reference.


BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates to surgical procedures and, more particularly, to techniques for installing an implantable device that can be used as a fluoroscopic marker or as a fluoroscopic marker/tissue connector.
2. Description of the Prior Art
While the present invention has application in various types of surgical procedures, it will be described in the context of gastric bypass surgery as used for the treatment of obesity. The most common gastric bypass procedure performed today is known as the Roux-en-Y gastric bypass procedure (RYGB). In the RYGB procedure, a six-inch to eight-inch incision is made that extends from the end of the sternum to just above the navel. More recently, the RYGB has been performed laparoscopically in order to minimize trauma, healing time and risk of infection. The stomach is completely divided into two unequal portions—a small upper pouch and a large lower gastric pouch (excluded stomach). The upper pouch typically measures less than about one ounce, preferably about one-half ounce, or 15 cc, while the excluded stomach remains generally intact and continues to secrete stomach juices that flow through the intestinal tract.
The small intestine is severed at a location distal of the duodenum or proximal of the jejunum. The severed end of the small intestine then is brought from the lower abdomen, behind the colon and the bypassed stomach, and joined with the upper pouch to form an end-to-end anastomosis created through a half-inch opening, also called the stoma. This rerouted segment of the small intestine is called the “Roux loop” and carries food from the upper pouch to the remainder of the intestines where the food is digested. The severed end of the segment of the duodenum that is part of the excluded stomach is connected to the Roux loop by means of an anastomotic connection. The connection is located approximately 100 cm from the stoma, and typically is made by using a stapling instrument. Prior to completion of the surgical procedure, a gastropexy commonly is performed to attach the excluded stomach to the abdominal wall or to the diaphragm, primarily to prevent the excluded stomach from being displaced within the abdominal cavity.
The RYGB procedure described permits digestive juices from the bypassed stomach, pancreas and liver to join the food stream from the small upper pouch and Roux loop to begin digesting the food. The remainder of the intestinal tract is not disturbed. Due to the small size of the upper pouch, patients are forced to eat at a slower rate and are satiated much more quickly, thereby reducing their caloric intake. Moreover, because the food enters the intestines directly, certain undesirable foods such as sweets create unpleasant feelings of nausea, diarrhea, nervousness, and sweating, which in turn discourages patients from developing or maintaining unhealthy eating habits. The RYGB procedure typically demonstrates a loss of at least 50% of excess body weight; approximately 60% of the patients will be able to maintain this weight loss for at least five years.
In certain cases it is necessary to perform post-operative surgical procedures. For example, some patients require that the excluded stomach be decompressed post-operatively. In order to accommodate this possibility, it has been known to insert a gastrostomy tube through the abdominal wall and into the excluded stomach and leave it there for several days until the need for decompression passes. In such cases, the gastrostomy tube has been provided with a silastic ring having a metal marker. The metal marker permits the excluded stomach to be quickly and accurately located in the abdominal cavity by fluoroscopic examination. While the practice of inserting a gastrostomy tube is effective to avoid the need for post-operative decompression, it also is an unnecessary procedure for many patients. Experience with patients that have not been fitted with a gastrostomy tube at the time of surgery shows that decompression is needed only in about one out of every 50-75 patients.
A problem in performing decompression in patients that have not had a gastrostomy tube inserted at the time of surgery is that the large pouch cannot be located accurately and, once located, cannot be held in a stable position for purposes of inserting an endoscope or trochar/cannula. In order to deal with such problems, it has been known to perform the gastropexy by using a circular wire suture having a diameter of approximately one inch. Because the suture is made of metal, it serves as a marker for fluoroscopic location of the bypassed stomach. The suture also assists in stabilizing the excluded stomach for post-operative insertion of an endoscope or a trochar/cannula.
The use of markers to subsequently locate areas of surgical interest is well known, particularly in the field of breast biopsies. See, for example, U.S. Pat. Nos. 4,592,356; 5,059,197; 5,158,084; 5,197,482; 5,221,269; 5,409,004; 5,709,697; 5,989,265; 6,356,782 and 6,405,733. In general, these patents disclose the concept of using metallic tissue markers that are implanted or otherwise attached to an internal portion of a patient's body. FIGS. 2B and 2C of the '782 patent disclose ring-like markers, while the '269 patent discloses a helical wire marker. Many of the patents in question disclose barbs of various types to retain the marker in place.
A problem with prior markers is that they have been difficult to use and install. In particular, such markers have not facilitated the attachment of the marker to the portion of the body to be marked. Moreover, such markers have not facilitated the attachment of one portion of the body to another. Although the use of hooks or barbs makes the implantation of a marker easier to perform, such hooks or barbs are generally undesirable for purposes of long-term retention of the marker. The use of a wire suture, while effective as a marker and connector, generally is undesirable because it can be difficult to install. Moreover, a wire suture also may not provide an effective technique to hold tissue in place for purposes of inserting objects such as an endoscope or a trochar.
Desirably, a surgical marker/connector would be available that would be easy to use and install, and which would permit portions of the body that need to be connected to each other to be connected in a convenient and secure manner. Preferably the marker/connector would be made of a material that would facilitate location by fluoroscopic techniques. In the particular case of a gastropexy performed as part of the RYGB procedure, the marker/connector preferably would permit an endoscope or a trochar/cannula to be inserted quickly and accurately.
SUMMARY OF THE INVENTION
In response to the foregoing concerns, the present invention provides a new and improved technique for installing a surgical marker/connector. The marker/connector according to the invention is in the form of a ring. In order to serve as a fluoroscopic marker/connector, at least a portion of the marker/connector is made of a metal such as stainless steel, titanium, or alloys thereof. Preferably, the marker/connector is made of a shape memory alloy (also known as memory metal) due to the unique memory properties of this material.
In the preferred embodiment, the ring is circular and includes a plurality of suture attachments. The suture attachments preferably are in the form of small loops that are disposed about the periphery of the ring. The loops preferably lie in a plane that includes the ring itself. The loops are large enough to receive sutures which, in turn, can be used to connect the marker/connector to a portion of a patient's body, or to connect separate portions of a patient's body to each other using the marker/connector as an intermediate connector. For example, in the RYGB procedure, the marker/connector could be sewn to a portion of a patient's excluded stomach for which marking is desired, or it could be used as an intermediate connection between a desired portion of the patient's excluded stomach and another portion of the patient's body, such as the abdominal wall.
Installation of the marker/connector according to the invention can be accomplished easily. If the marker/connector is made of a shape memory alloy, it can be installed laparoscopically. In such an installation procedure, the marker/connector can be folded about an elongate member such as a mandrel or the jaws of a clip and then inserted into the abdominal cavity through a trochar or cannula. After the marker/connector is inside the abdominal cavity, it will be warmed to body temperature where it will unfold and resume its normal, generally flat configuration. The marker/connector then can be sutured into a desired location within the abdominal cavity.
If the marker/connector has suture attachments, such attachments make the marker/connector according to the invention easy to install. Because the marker/connector is made partially or entirely of metal, it can serve as an effective fluoroscopic marker. In the particular case of the RYGB procedure, because the ring is securely attached to the excluded stomach and to the abdominal wall or to the diaphragm, the ring can be a target through which an endoscope or a trochar/cannula can be inserted. The ring prevents the excluded stomach from moving as the endoscope or trochar is inserted, thereby greatly facilitating the procedure.
The foregoing and other features and advantages of the invention will be apparent from a review of the following description of the invention, taken together with the attached drawings.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a schematic view of a patient's stomach and small intestine after undergoing the RYGB procedure in which a surgical marker/connector according to the invention has been employed;
FIG. 2 is a top plan view of a surgical marker/connector according to the invention;
FIG. 3 is a side elevation view of the surgical marker/connector of FIG. 2;
FIG. 4 is a top plan view of a surgical marker/connector according to the invention in which loops are disposed about the inner periphery of a non-circular ring;
FIG. 5 is a top plan view of a surgical marker/connector according to the invention in which loops are incorporated as part of a ring;
FIG. 6 is a perspective view of a surgical marker/connector according to the invention made of a shape memory alloy which has been wrapped about an elongate member prior to laparoscopic installation; and
FIG. 7 is a perspective view of the surgical marker/connector of FIG. 6 after it has been warmed in a patient's body subsequent to laparoscopic installation.



DESCRIPTION OF THE PREFERRED EMBODIMENT
Referring to FIGS. 1-3, a surgical marker/connector according to the invention is indicated generally by the reference numeral 10. As shown in FIGS. 2 and 3, the marker/connector 10 includes a circular ring 12 from which a plurality of small loops or suture attachments 14 project about the periphery thereof. The ring 12 is approximately one inch in diameter. The loops 14 are generally elliptical in shape, being defined by circular inner side portions 16 approximately 0.0413 inch in diameter, whose centers are separated by approximately 0.0075 inch. As can be seen in FIG. 3, the ring 12 and the loops 14 lie in a common plane.
It is expected that the marker/connector 10 can be made of any material suitable for use in the human body and which will perform a fluoroscopic marking function and a mechanical connector function. The marker/connector 10 can be made in any type of manufacturing operation. The entire marker/connector 10 can be made of metal such as stainless steel, titanium, or alloys thereof in a stamping or laser cutting operation, although only portions of the marker/connector 10 need to be made of metal provided the remainder is strong enough to perform a mechanical connector function. The marker/connector 10 also can be made of a shape memory alloy metal (memory metal) such as NITINOL. This material can be reconfigured into a new shape which will be maintained at room temperature. If the temperature should increase to a pre-determined temperature that can be selected by the user (e.g. body temperature), the material will resume its original configuration.
The marker/connector 10 can be made in any desired thickness, as indicated by the reference numeral 18 in FIG. 3, although a thickness of about 0.0085 inch is preferred. The width of the ring 12 and the loops 14, as indicated by the reference numeral 19 in FIG. 2, is about 0.010 inch. The size and shape of the ring 12, the size and shape of the loops 14, and the relative sizes thereof can be chosen to fit the surgical procedure at hand. As a general design constraint, however, the ring 12 should be large enough to be an effective fluoroscopic marker/connector, an effective tissue connector, and a target for an endoscope or a trochar. The loops 14 should be large enough to enable the surgeon to easily pass a needle and suture therethrough.
Although the ring 12 has been described as circular, it will be understood that the ring 12 can be any desired shape, including non-circular shapes such as elliptical, square, etc. See FIG. 4, for example, where the ring 12 is slightly elliptical. In addition, the loops 14 could be shapes other than generally elliptical, such as round, square, etc. See FIG. 5, for example, where the loops 14 are circular. By way of further example, some or all of the loops 14 could be disposed on the inner diameter of the ring 12 (see FIG. 4) or some or all of the loops 14 could be formed as part of the ring 12 itself (see FIG. 5). Furthermore, although use of the loops 14 is preferred and highly desired, it will be understood that the ring 12 could be used without loops 14, if necessary or desired. Such a loopless ring 12 would not enjoy all of the benefits of the present invention, except as noted hereinafter.
Referring now particularly to FIG. 1, the use of the marker/connector 10 in the RYGB procedure is illustrated. The patient's stomach 20 is completely divided into two unequal portions—a small upper pouch 22 and a large lower gastric pouch 24 (or excluded stomach). The upper pouch 22 typically measures less than about one ounce, preferably about one-half ounce, or 15 cc, while the larger lower pouch 24 remains generally intact and continues to secrete stomach juices that flow through the intestinal tract.
The small intestine 26 is severed at a location distal of the duodenum 28 or proximal of the jejunum (not shown). The severed end 30 of the small intestine then is brought from the lower abdomen, behind the colon and the bypassed stomach, and joined with the upper pouch 22 to form an end-to-end anastomosis 32 created through a half-inch opening, also called the stoma. This rerouted segment 34 of the small intestine is called the “Roux loop” and carries food from the upper pouch 22 to the remainder of the intestines where the food is digested. The severed end 36 of the segment of the duodenum 28 that is attached to the lower pouch 24 of the stomach 20 is connected to the Roux loop 34 by means of an anastomotic connection indicated at 38. The connection 38 is located approximately 100 cm from the stoma 32, and typically is made by using a stapling instrument.
A gastropexy is performed, whereby the excluded stomach 24 is connected to the abdominal wall 40 by means of the marker/connector 10. Sutures 42 are passed through the loops 14 and through the tissue of the adjacent pouch 24 and the abdominal wall 40. The marker/connector 10 thus serves as a fluoroscopic marker as well as a mechanical connector between the excluded stomach 24 and the abdominal wall 40. If it is necessary to insert an endoscope or a trochar into the excluded stomach 24, the endoscope or trochar can be inserted through the ring 12 which will serve as a target as well as a means for holding the excluded stomach 24 in place as the endoscope or trochar is inserted therethrough.
Referring now to FIGS. 6 and 7, the marker/connector 10 illustrated therein is made of a shape memory alloy (memory metal) such as NITINOL, preferably with a relax or “resume” temperature of about 98 degrees Fahrenheit. If the ring 12 is made of such a material, it can be wrapped tightly about an elongate member 50 and will retain its position there as shown in FIG. 6. The member 50 can be a specially formed mandrel, one or both jaws of a clip, or a similar elongate, slender object. After the ring 12 has been wrapped about the member 50, it can be inserted into a patient's abdominal cavity laparoscopically, typically by passing it through a trochar or cannula (not shown). After the marker/connector 10 has been inserted into the abdominal cavity and warmed to body temperature, it will resume its original shape (see FIG. 7), whereupon the marker/connector 10 can be sutured in place using conventional laparoscopic suturing techniques. If the ring 12 is not provided with loops 14, the loopless ring 12 still can be installed laparoscopically, but suturing of the ring 12 will be more difficult as indicated previously. Accordingly, use of the loops 14 is preferred.
As will be apparent from the foregoing description, the surgical marker/connector 10 according to the invention is easy to install. The marker/connector 10 avoids the use of undesirable hooks or barbs, while permitting the surgeon to securely attach the marker/connector to a desired portion of a patient's body. In those instances where the marker/connector 10 is used as a mechanical connector between adjacent portions of the patient's body, the connection is easy to make and is quite secure and strong. The ring 12 provides a target through which an endoscope or a trochar can be inserted, if necessary
Although the invention has been described in its preferred form with a certain degree of particularity, it will be understood that the present disclosure of the preferred embodiment has been made only by way of example and that various changes may be resorted to without departing from the true spirit and scope of the invention as hereinafter claimed. It is intended that the patent shall cover, by suitable expression in the appended claims, whatever features of patentable novelty exist in the invention disclosed.

## Claims

1. A method of marking the location of an area of surgical interest of a patient and/or joining two portions of a patient's body together, comprising the steps of:
a. providing an elongate member;
b. providing a ring made of a shape memory alloy having a relax temperature of about 98 degrees Fahrenheit;
c. wrapping the ring about the elongate member, the ring being wrapped sufficiently tightly to remain on the elongate member while at room temperature;
d. providing a trochar or cannula;
e. inserting the trochar or cannula into the patient's body;
f. inserting the elongate member and the ring into the patient's body through the trocar or cannula;
g. permitting the ring to warm up to body temperature and resume its pre-wrapped configuration;
h. providing a needle with a suture attached thereto;
i. placing the ring in the area of surgical interest; and
j. suturing the ring in place within the patient's body.

2. The method of claim 1, wherein the shape memory alloy is NITINOL.

3. The method of claim 1, wherein;
the step of providing a ring includes providing suture attachments about a periphery of the ring; and
the step of suturing the ring in place includes threading a suture through at least one of the suture attachments.

4. The method of claim 3, wherein the ring is circular and the suture attachments are in the form of generally elliptical loops.

5. The method of claim 3, wherein the shape memory alloy is NITINOL.

6. The method of claim 3, wherein the suture attachments are in the form of loops disposed about an outer periphery of the ring, loops disposed about an inner periphery of the ring, loops incorporated as part of the ring itself, or combinations thereof.

7. The method of claim 3, wherein the suture attachments and the ring lie in a common plane.

8. The method of claim 3, wherein the suture attachments are smaller than the ring.

9. The method of claim 3, wherein the ring and the suture attachments are made in a laser cutting or a stamping operation.

10. The method of claim 3, wherein the ring and/or the suture attachments are made of a material suitable for fluoroscopic marking.