US 20100331774 A2
A surgical device comprising a container and a tether used for delivering a sterile appliance into a body cavity during endoscopic procedures. Once positioned in the body cavity, a force is applied to the container through the tether. The force opens the container and releases the sterile appliance into the body cavity. In various embodiments, gas or liquid may be used to open the container.
1. A surgical device, comprising:
a container dimensioned to fit in an endoscopic overtube;
a tether having a proximal end and a distal end, the distal end coupled to the container;
a sterile appliance, the sterile appliance housed within the container;
wherein the container is structured to open responsive to a force applied through the tether and release the sterile appliance.
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13. A surgical device, comprising:
a container dimensioned to fit in an endoscopic overtube, the container having a seal and a sterile cavity defined by an outer wall;
a tether having an outer wall, a proximal end and a distal end, the outer wall defining a channel, wherein the channel is in fluid communication with the cavity;
a mesh patch, the mesh patch housed within the container;
wherein the container is structured to open responsive to a force applied through the tether at the proximal end and open the seal to release the mesh patch.
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19. A surgical device, comprising:
a container dimensioned to fit in an endoscopic overtube;
a tether having a proximal end and a distal end, the distal end coupled to the container;
wherein the container comprises a cavity dimensioned to house a sterile appliance, wherein the cavity is structured to open responsive to a force applied through the tether.
20. A method for using a surgical device, comprising:
inserting a container into a body cavity during a natural orifice translumenal endoscopic surgical procedure, wherein the container houses a sterile hernia patch;
applying a force through a tether coupled to the tether;
opening the container in the body cavity;
releasing the sterile hernia patch from the container into the body cavity; and
removing the container from the body cavity.
Endoscopy refers to looking inside the human body for medical reasons. Endoscopy may be performed using an instrument called an endoscope. Endoscopy is a minimally invasive diagnostic medical procedure used to evaluate the interior surfaces of an organ by inserting a small tube into the body, often, but not necessarily, through a natural body opening or through a relatively small incision. Through the endoscope, an operator may observe surface conditions of the organs, including abnormal or diseased tissue such as lesions and other surface conditions. The endoscope may have a rigid or a flexible tube and, in addition to providing an image for visual inspection and photography, the endoscope may be adapted and configured for taking biopsies, retrieving foreign objects, and introducing medical instruments to a tissue treatment region referred to as the work site. Endoscopy is a vehicle for minimally invasive surgery.
Laparoscopic surgery is a minimally invasive surgical technique in which operations are performed through small incisions (usually 0.5-1.5 cm), keyholes, as compared to larger incisions needed in traditional open-type surgical procedures. Laparoscopic surgery includes operations within the abdominal or pelvic cavities, whereas keyhole surgery performed on the thoracic or chest cavity is called thoracoscopic surgery. Laparoscopic and thoracoscopic surgery belong to the broader field of endoscopy.
A key element in laparoscopic surgery is the use of a laparoscope: a telescopic rod lens system that is usually connected to a video camera (single-chip or three-chip). Also attached is a fiber-optic cable system connected to a “cold” light source (halogen or xenon) to illuminate the operative field, inserted through a 5 mm or 10 mm cannula to view the operative field. The abdomen is usually insufflated with carbon dioxide gas to create a working and viewing space. The abdomen is essentially blown up like a balloon (insufflated), elevating the abdominal wall above the internal organs like a dome. Carbon dioxide gas is used because it is common to the human body and can be removed by the respiratory system if it is absorbed through tissue.
Minimally invasive therapeutic procedures to treat diseased tissue by introducing medical instruments to a tissue treatment region through a natural opening of the patient are known as Natural Orifice Translumenal Endoscopic Surgery (NOTES)™. In general, there are a variety of systems for inserting an endoscope through a natural opening in the human body, dissecting a lumen, and then, treating the inside of the abdominal cavity. For example, in U.S. Pat. No. 5,297,536, which is incorporated by reference herein, a sample treatment system is disclosed. This system is comprised of a dissecting device for perforating a lumen wall; an endoscope insert member for inserting an endoscope, a tube, an endoscope, and a pneumoperitoneum device for insufflating the abdominal cavity; and a closing device.
When surgery of the inside of the abdominal cavity is carried out using this system, the endoscope insert member and tube are first inserted through a natural opening in the human body (mouth, anus, vagina, etc.) and the tube may be absorbed to a required organ wall by vacuum pressure, thus being fixed thereon. Next, a pneumoperitoneum needle is inserted and the abdominal cavity is insufflated. Then, the dissecting device is inserted and the organ wall is perforated. After surgery of the inside of abdominal cavity is complete, the perforation in the organ wall may be closed by an O-ring, and the endoscope and tube are withdrawn from the body.
Many different medical conditions, including hernias, may be addressed transluminally using endoscopic techniques. A hernia is a weakening of the musculofascial tissues defining the structural wall of a body cavity such as the abdomen, resulting in a gap through which tissues can protrude. Typically a sac is formed confining the tissues at the musculofascial defect, which protrudes from the plane of the tissue wall. There is a possibility of constriction of the neck of the sac, and life-threatening infection if the hernia remains untreated.
A weakening or separation of the musculofascial tissues due to any cause can develop into a hernia. For example scarring from a previous incision or other trauma of the abdominal wall can develop into a hernia, or a hernia can form at the site of a passage through the musculofascial tissue, the passage becoming enlarged, for example, due to pressure of the viscera during muscular exertion. There are various forms of hernias, the inguinal hernia being a common example wherein the abdominal viscera and peritoneal sac protrude through the floor of the inguinal cavity at the point where the musculofascial tissue is relatively weakened due to the passage of the spermatic duct (in males) or the femoral blood vessels and the round ligament (in females). Another common site of a hernia is the umbilicus. Hernias can also develop in the diaphragm, and elsewhere.
Another form of hernia is a ventral hernia. When a ventral hernia occurs, it usually arises in the abdominal wall where a previous surgical incision was made. In this area the abdominal muscles have weakened thereby resulting in a bulge or a tear. The inner lining of the abdomen pushes through the weakened area of the abdominal wall to form a balloon-like sac. A loop of intestines or other abdominal contents may be pushed into the sac.
Hernias have been repaired surgically by suturing across the musculofascial defect to draw the opposite sides of the defect together, the sutures bridging across the defect. However, such a repair is not suitable at hernias occurring at the site of a passage for ducts, blood vessels or the like. Moreover, pulling the sides of the defect inwardly results in tension on the musculofascial tissue via the sutures. The site of the sutures defines a weakening of the tissue and leads to a high rate of recurrence of the hernia at the sutured edge of a previous repair.
According to one technique for repairing hernias, a patch having sufficient strength to resist the tendency of the sac to protrude is placed over the defect and sutured to the musculofascial tissue. This technique avoids tension on the musculofascial tissues and has been shown to be successful in minimizing recurrence of the hernia. Various materials have been used in experimental or clinical hernia repairs, including for example polypropylene mesh, DACRON® fabric, tantalum gauze, and the like. Such technique may be performed using an open procedure which relies on cutting the abdominal section of the patient. The patch is placed in between the peritoneum and the skin. Besides having a relatively large incision site, the patch may eventually migrate through the peritoneum, for example, and adhere to the bowel.
Hernia repairs have been undertaken by laparoscopic techniques. With a laparoscopic technique, however, a plurality of smaller incisions must be made to the patient's abdominal section in order to introduce the various laparoscopic tools into the peritoneal cavity. Through the incisions, a patch may be introduced and attached to the inner abdominal wall to address the hernia. The patch is attached through various techniques, such as clips, sutures, or tacks. While less invasive then open-type surgery, the incisions, or ports, necessary for the laparoscopic procedure are susceptible to the formation of future ventral hernias.
Repairing a hernia transluminally through endoscopic techniques reduces the likelihood of recurring ventral hernias by eliminating the need to create external ports during the procedure. Using this technique, the endoscope, along with the necessary tools and devices, are introduced into the body via a natural orifice and then the hernia site is accessed transluminally. If a mesh patch is used to treat the hernia, it must be introduced to the hernia site while maintaining its sterilization.
Accordingly, in the field of endoscopy, there remains a need for improved methods and devices for delivering a sterile appliance, such as a mesh patch, to a surgical site while maintaining the sterilization of the appliance.
The novel features of the various embodiments are set forth with particularity in the appended claims. The various embodiments, however, both as to organization and methods of operation may best be understood by reference to the following description, taken in conjunction with the accompanying drawings as follows.
The surgical device 10 also may be used in traditional laparotomy procedures as well as external noninvasive procedures to treat diseased or damaged tissue from outside the body. In one embodiment, the surgical device 10 may be configured to be positioned within a natural opening of the patient such as the mouth, anus, or vagina and subsequently advanced and positioned within internal body lumens such as the esophagus, colon, and/or uterus to reach the tissue treatment region or work site. Internal organs or cavities may be reached using trans-organ or trans-luminal surgical procedures. The surgical device 10 also may be configured to be positioned through a small incision or keyhole on the patient and can be passed through the incision to reach a tissue treatment region, cavity, or work site through a trocar. The treatment region may be located in various body lumens or organs such as the abdomen, esophagus, stomach, colon, liver, breast, brain, lung, and other organs or locations within the body.
In one embodiment, the surgical device 10 may be employed in conjunction with a flexible endoscope, such as the GIF-100 model available from Olympus Corporation. The flexible endoscope may be introduced into the patient trans-anally through the colon, orally through the esophagus, vaginally through the uterus, or the abdomen via an incision or keyhole and a trocar, for example. The endoscope assists the surgeon to guide and position the surgical device 10 near the tissue treatment region to treat diseased or damaged tissue in various body lumens and organs such as the abdomen, esophagus, stomach, colon, liver, breast, brain, lung, and other internal tissue treatment regions.
In one embodiment, the surgical device 10 comprises a container 14 and a tether 16. The container 14 may be of any suitable shape, such as cylindrical, spherical, teardrop, for example. In various embodiments, the container is dimensioned to fit through an endoscopic overtube. In one example embodiment the outer dimension of the container 14 does not exceed 14 mm in order to fit through a 14.5 mm overtube. An outer wall 22 of the container 14 defines a cavity 24. The cavity 24 is suitable for containing the sterile appliance 12. As may be appreciated by one of ordinary skill in the art, the container 14 may be constructed of any suitable material. In various embodiments, the container 14 may be comprised of a thin semiflexible plastic, such as polyethylene, polypropylene, polyurethane, or silicone. The container 14 also may be either clear, opaque, or a combination of both.
In the illustrated embodiment, the tether 16 is a hollow tube coupled to the container 14 with an outer wall 18 of the tether 16 defining a channel 20. The tether 16 has a proximal end 26 and a distal end 28. The distal end 28 is coupled to the container 14. As shown, the distal end 28 of the tether 16 is coupled to the proximal end 30 of the container 14 at a coupling 31. In other embodiments, the tether 16 may be coupled to a different portion of the container 14. In some embodiments, the tether 16 and the container 14 may be constructed from a unitary piece of material. Through the coupling 31, the channel 20 of the tether 16 is in fluid communication with the cavity 24 of the container 14. The tether 14 is generally flexible so as to allow navigation through the tortuous pathway of a body lumen during an endoscopic procedure. The tether 14 can be constructed from any suitable materials, such as polyvinyl chloride (PVC), silicone, TYGON®, or vinyl. In various embodiments, the tether 14 may be constructed with reinforcement, such as braiding or ribbing, to increase the strength of the tether 14. As appreciated by one of ordinary skill in the art, the outer diameter of the tether 14 may be of any suitable diameter.
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The opening 29 may be defined by a door 32. The door 32 may further comprise a flap 34. In various embodiments, the flap 34 may contain an adhesive strip 36 used to seal the opening 29 when the door 32 is moved in direction 38. The opening 29 may also be located in any suitable location, such as near the proximal end 30 or the distal end 40 of the container 14. Furthermore, instead of using a door, other sealable configurations might be used, such as a screw cap or snap-fit connection, for example. Additionally, instead of using an adhesive strip 36, other suitable techniques for sealing may be used, such as a re-sealable zipper type connection, similar to a ZIPLOC® re-sealable zipper connection. In some embodiments a valve, such as a duckbill valve, will allow for the sterile appliance 12 to be loaded into the container 14.
The container 14 may comprise at least one seal 42, or otherwise structurally weakened area, such as a groove or indention, for example. The seal 42 may be in any configuration. For instance, the seal 42 may be a spiral (
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The progression of the operation of an embodiment of the surgical device 10 is shown in
In various embodiments of the present method and system, the proximal end 26 of the tether 16 remains outside the patient's body, protruding from the proximal end 78 of the overtube 60. Once positioned in the desired location, such as the body cavity 66, a force can be applied to the container 14 through the proximal end 28 of the tether 16. If liquid or gas is used to deliver the force, once the cavity 24 has reached a sufficient pressure, the seal 42 will rupture. As shown in
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Using the surgical device, a sterile appliance, such as a mesh patch, can be delivered from a sterile field outside the body to a desired body cavity while maintaining a sterile state. Once placed in the proper location, the sterile appliance can be released and manipulated accordingly.
The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by the cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of the particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon the cleaning and/or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that the reconditioning of a device can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. The use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.
Preferably, the various embodiments described herein will be processed before surgery. First, a new or used device is obtained and, if necessary, cleaned. The instrument can then be sterilized. In one sterilization technique, the device is placed in a closed and sealed container, such as a plastic or TYVEK® bag. The container and device are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation kills bacteria on the instrument and in the container. The sterilized device can then be stored in the sterile container. The sealed container keeps the instrument sterile until it is opened in the medical facility. It is preferred that the device is sterilized. This can be done by any number of ways known to those skilled in the art, including beta or gamma radiation, ethylene oxide, or steam.
Although the various embodiments have been described herein in connection with certain disclosed embodiments, many modifications and variations to those embodiments may be implemented. Also, where materials are disclosed for certain components, other materials may be used. The foregoing description and following claims are intended to cover all such modifications and variations.
Any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.