WO2008131128A1

WO2008131128A1 - Magnetic manipulation and retraction for surgical procedures

Info

Publication number: WO2008131128A1
Application number: PCT/US2008/060668
Authority: WO
Inventors: Christopher C. Thompson; Marvin Ryou
Original assignee: The Brigham And Women's Hospital, Inc.
Priority date: 2007-04-18
Filing date: 2008-04-17
Publication date: 2008-10-30

Abstract

Magnetic surgical visualization and manipulation systems are disclosed. The systems comprise one or more internal effectors that can be delivered into a body cavity and attached to structures within that body cavity, including tissues, organs, implants, and surgical instruments. At least a portion of each internal effector is responsive to magnetic fields, and can be caused to exert force on and manipulate the structure to which it is attached by an external magnetic manipulator placed outside of the body cavity. Also disclosed are methods of using the surgical visualization and manipulation systems in Natural Orifice Transluminal Endoscopic Surgery (NOTES). The systems and methods, for example, may be used to provide robust tissue manipulation during surgical procedures.

Description

Magnetic Manipulation and Retraction for Surgical Procedures Cross- Reference to Related Applications

This application claims priority to, and the benefit of, U.S. Provisional Patent Application No. 60/912,624, filed April 18, 2007, the contents of which are incorporated by reference herein in their entirety.

Technical Field

In general, the invention relates to surgical instruments, and in particular, to surgical instruments for creating and maintaining magnetic retraction.

Background of the Invention An endoscopic surgical procedure is a surgical procedure typically performed by inserting a long, flexible endoscope through a small incision in the skin to visualize and manipulate internal tissues and structures using the endoscope. One difficulty in endoscopic surgery is that it can be difficult to apply robust amounts of force to the organs and tissues, in part because the endoscope may buckle or move away if too much force is applied. The inability to apply robust amounts of force places technical limitations on the types and nature of endoscopic procedures that can be performed.

In Natural Orifice Transluminal Endoscopic Surgery (NOTES), a flexible endoscope is introduced through a natural orifice — such as the mouth, anus, or vagina— to create a controlled transvisceral incision for access into the peritoneal cavity. NOTES is potentially less invasive than laparoscopy because it eliminates abdominal incisions and incision-related complications such as wound infections, incisional hernias, post-operative pain, and adhesions.

NOTES procedures provide good examples of the difficulties in applying robust amounts of force. For example, when performing a NOTES cholecystectomy, it is difficult to exert sufficient distal force to manipulate the overlying liver in order to gain adequate exposure of the gallbladder. When pushing endoscopic instruments against a hepatic lobe, the endoscope can buckle or actually move away. This problem is particularly heightened via the transgastric approach when the unsupported endoscope is retroflexed and distal force is further diminished. In addition, multiple channels are required to accommodate instruments devoted to traction and counter- traction. Finally, force is largely applied along the same axis as the visual axis since the instrument channels are oriented in near-parallel fashion.

Summary of the Invention

One aspect of the invention relates to a surgical manipulation system. The system comprises an external manipulator and at least one internal effector. The external manipulator has a support portion and a positionable portion. The positionable portion is connected to and supported by the support portion and has a first end, a second end spaced from the first end, and at least one movable joint between the first and second ends. The movable joint is constructed and arranged to render the first end of the positionable portion movable relative to the second end. The first end of the positionable portion has one or more magnets connected thereto. The internal effector has an engaging portion adapted to engage an object to be manipulated within the body cavity and a magnetized or magnetic portion. The magnetized or magnetic portion is adapted to be magnetically influenced by and to cooperate with the one or more magnets of the external manipulator.

Another aspect of the invention relates to a surgical visualization and manipulation system. The system comprises an endoscope with at least one instrument channel, one or more internal effectors, and an external manipulator. The internal effectors are sized and adapted to fit within the instrument channel of the endoscope. Each of the internal effectors has an engaging portion adapted to engage structures within the body cavity and a magnetized or magnetic portion. The external manipulator includes a positionable portion and a first end connected to the positionable portion so as to be positioned in a user-defined location and orientation. The first end includes or is comprised of one or more magnets. The magnets of the external manipulator are constructed and arranged to magnetically influence the magnetized or magnetic portion of the internal effectors such that the internal effectors exert force on the structures with which they are engaged.

Yet another aspect of the invention relates to a method of surgical remote manipulation. The method comprises attaching one or more internal effectors to a structure within a body cavity. Each of the internal effectors has at least a portion that is magnetic. The method further comprises exerting force on the structure using an external manipulator that creates a magnetic field capable of magnetically influencing the internal effectors from a position outside of the body cavity. The internal effectors may be placed with an endoscope, and the endoscope may be inserted directly or indirectly into the body cavity through a natural orifice.

Other aspects, features, and advantages will be set forth in the description of the invention that follows.

Brief Description of the Drawing Figures The invention will be described with respect to the following drawing figures, in which like numerals represent like features throughout the drawings, and in which:

FIG. 1 is a schematic top plan view of a surgical manipulation system illustrating its external manipulator and internal effectors in use according to one embodiment of the invention;

FIG. 2 is a side elevational view of the external manipulator of FIG. 1; and

FIG. 3 is a perspective view of the internal effector of FIG. 1; and

FIGS. 4-6 are perspective views of a variety of different types of internal effectors that may be used in embodiments of the present invention.

Detailed Description

FIG. 1 is a schematic top plan view of a surgical manipulation system, generally indicated at 10, according to one embodiment of the invention. More particularly, FIG. 1 depicts the surgical manipulation system 10 in use. The system 10 includes a magnetic external manipulator 12 and at least one magnetic internal effector 14. The external manipulator 12, as will be described below, is positioned proximate but external to a body cavity; the internal effectors 14 are placed within the body cavity. Both components 12, 14 will be described below in more detail. In general, the magnetic forces created by the external manipulator 12 cause the internal effectors 14, and any tissue or other structure to which they are attached, to be attracted to the external manipulator 12. Thus, by changing the position of the external manipulator 12, a user can exert force on the internal effectors 14 and the tissues or structures to which they are attached, causing them to move if desired.

In the exemplary schematic view of FIG. 1, a NOTES cholecystectomy is shown in progress; several magnetic internal effectors 14 are attached to the lobes of the liver 15 (i.e., the hepatic lobes), while the external manipulator 12 is positioned externally over the upper right quadrant of the abdomen. As will be explained below in greater detail, magnetic attractive forces exerted by the external manipulator 12 are causing the internal effectors 14 to retract the liver 15, thus exposing the gallbladder 17. An endoscope 19, which is used to perform the surgical procedure, is also visible in the view of FIG. 1. Generally speaking, the internal effectors 14 would be attached by means of the endoscope 19, as will be described below in more detail. In addition to movement and retraction, the system 10 may also be used to provide counter- traction (i.e., a counter force) on a tissue, organ or other structure while another tool is used to operate on that structure.

It should be understood that in an endoscopic surgical procedure such as that illustrated in FIG. 1, the internal organs such as the liver 15 and gallbladder 17 would only be visible through the endoscope 19 and would not be seen as they are illustrated

FIG. 1. However, the internal organs are shown in FIG. 1 in order to illustrate the function of the external manipulator 12 and the internal effectors 14 with more clarity.

FIG. 2 is a side elevational view of the external manipulator 12. As shown, the external manipulator 12 of the illustrated embodiment has the general form of a positionable arm. It includes a support portion 16 that is adapted to be anchored to a fixed surface, such as an operating room table or a floor, and a positionable portion 18 connected to and supported by the support portion 16. The positionable portion 18 itself has a first end 20 and a second end 22 that is spaced from the first end 20. Between the first end 20 and the second end 22 are one or more joints 24, 26, 28, 30. In the external manipulator 12 of FIG. 2, the joints 24, 26, 28, 30 are single and double ball joints; specifically, the two middle joints 26, 28 are double ball joints, while the joints proximate to the first and second ends 20, 22 are single ball joints. In other embodiments of the invention, the joints of the external manipulator 12 may be of essentially any sort, including ball joints, hinge joints, and sliding joints, to name a few.

Preferably, the external manipulator 12 also includes structures to fix it in a desired position once that position has been set. In the illustrated embodiment, set screws 32, 34, 36, which are also useful as positioning handles, are provided. In other embodiments, the joints 24, 26, 28, 30 may employ friction to maintain the positionable portion 18 in position, or the positionable portion 18 may include counterweights or other conventional elements to maintain position. Additionally, any combination of conventional elements may be used to maintain position, particularly of the first end 20.

Generally speaking, aside from positionability and the ability to lock into or retain a particular position, the external manipulator 12 is preferably of a construction that can support relatively heavy loads (e.g., about 10 kg) in a desired position. It is also advantageous if the external manipulator 12 is made of a rigid, non- ferromagnetic material, such as aluminum.

At the first end 20 of the positionable portion 18 are one or more magnets 50. The magnets 50 may be permanent magnets, conventional coil electromagnets, or superconducting magnets (i.e., electromagnets cooled by cryogenic fluids to reduce electrical resistance in the coils). If the magnets 50 are permanent magnets, then they would generally be through-magnetized, such that there are north (N) and south (S) poles, allowing two or more of them to be stacked and magnetically adhered, clamped or otherwise cooperatively attached to increase the total magnetic field and magnetic force levels incrementally. Neodymium permanent magnets are one type of magnet that is suitable for use in embodiments of the present invention. Among other advantages, neodymium magnets are capable of producing strong forces relative to their size and also have a high degree of coercivity (i.e., resistance to demagnetization) . The magnets 50 may be attached to the first end 20 using adhesives (such as epoxy), clamps, straps, mechanical fasteners, or some other conventional method of attachment. (In the illustrated embodiment, the magnets 50 are secured by straps 51.) If adhesives are used to secure permanent magnets, it is advantageous if the chemical reactions involved in curing the adhesives are not strongly exothermic, as high temperatures may have a deleterious effect on the magnetic properties of permanent magnets. Likewise, if mechanical clamping or strapping is used, it is advantageous if the clamping or strapping force is kept as low as possible to avoid mechanical damage to the magnets.

In the illustrated embodiment, the first end 20 includes a generally flat attachment plate 52 that is connected to the joint 30 nearest the first end 20 and is thus itself positionable. In order to aid attachment, the attachment plate 52 may, in some embodiments, be ferromagnetic.

Whether permanent magnet or electromagnet, the magnets 50 may be covered by an appropriate cover so as to maintain sterility, prevent corrosion, and make cleaning easier. The cover itself may be removable and replaceable for easy cleaning, or it may be disposable.

As shown in FIG. 1, the system 10 also includes one or more internal effectors 14. Each internal effector 14 is made of a biocompatible material and is adapted to be placed within a body cavity. Generally speaking, an internal effector 14 may be any type of conventional endoscopic or general surgical grasping, clamping, pushing, or pulling implement that is responsive to magnetic forces and is thus attracted to the magnets 50 of the external manipulator 12. Two typical ways of rendering such instruments responsive to magnetic forces include physically connecting the instrument to a magnet or a ferromagnetic material or magnetizing the instrument or a portion thereof.

The internal effectors 14 of FIG. 1 are best seen in FIG. 1, a perspective view of the internal effectors 14 in isolation. Each effector 14 includes at least an engaging portion 62 adapted to engage tissue and a magnetized or magnetic portion 64 adapted to be attracted to and to cooperate with the magnets 50 of the external manipulator 12 such that the external manipulator 12 and the internal effector or effectors 14 are adapted to manipulate tissue. The engaging portion 62 of the internal effector 14 has the general form of an endoscopic clip with barbed jaws. Depending on the embodiment, the engaging portion 62 may be constructed and arranged relative to the endoscope with which it is used such that the engaging portion 62 may open and close one or more times to grasp tissue.

The magnetic portion 64 of the internal effector 12 comprises a stack of small cylindrical permanent magnets. The internal diameters of the cylindrical magnets are large enough to accommodate the jaw movement lock-and-release mechanism of typical endoscopic clips. Moreover, the outer diameters of the cylindrical permanent magnets 64 are small enough to fit within the existing plastic sheath that houses the entire apparatus. If internal effectors 14 are made using conventional endoscopic tools to which magnets have been retrofitted or added, it is advantageous if the total dimensions do not exceed the inner diameter of a conventional endoscope instrument channel. If the internal effectors 14 are small enough to fit within a standard endoscope instrument channel, then several effectors 14 can be introduced into a body cavity without removal of the endoscope. However, if larger internal effectors 14 are necessary, then in some embodiments, those larger effectors may be delivered into the body cavity by backloading them into the endoscope.

As can be seen in FIG. 3, the internal effector 14 has an engaging portion 62 with teeth for grasping and holding tissue. Other engaging mechanisms may be used; generally, internal effectors according to embodiments of the invention may use any mechanism for engaging or grasping, and it may be advantageous in some embodiments for internal effectors to have engaging portions that are less likely to damage tissue or cause bleeding.

For that reason, the internal effector 66 illustrated in FIG. 4 has an engaging portion 68 with flatter grasping portions. The engaging portion 68 may also be coated with rubber or with another material to increase frictional forces between the gripped tissue or structure and the internal effector 66. The internal effector 66 of FIG. 4 has a magnetic portion 70 that is similar to that of the internal effector 14 of FIGS. 1 and 3. Whereas FIGS. 3 and 4 illustrate internal effectors 62, 66 with engaging portions 62, 68 in the form of grasping jaws, FIGS. 5 and 6 illustrate additional embodiments of internal effectors with engaging portions that more closely resemble those of retractors.

In particular, the internal effector 74 of FIG. 5 includes a curved, scoop-like engaging portion 72 similar to that of a conventional retractor. The internal effector 74 also includes a magnetized magnetic portion 76. That is, instead of adding external permanent magnets as in the other internal effectors 14, 66, the material of which the magnetic portion 76 is made is itself magnetic or magnetized. Of course, in some embodiments, particularly where weaker forces are sufficient for the application, it may be sufficient for the magnetic portion 76 merely to be made of a ferromagnetic material. Of course, the type of magnetic portion 76 shown in FIG. 5 may be implemented in any internal effector.

FIG. 6 illustrates another internal effector 78 with a curved, scoop-like engaging portion 80 that is divided into individual projections or teeth, and a magnetic or magnetized portion 82 similar to that of the effector 72 of FIG. 5.

In addition to the structure shown in FIGS. 1 and 3-6, all of the types of internal effectors 14, 66, 72, 78 may include coatings or coverings, particularly over the magnets or magnetic portions, to protect them from corrosion and to render them biocompatible.

As shown in FIG. 1, internal effectors 14 are attached to a piece of tissue or another structure and, once so attached, the external manipulator 12 is brought into a position of magnetic influence over the internal effectors 14 on the exterior of the body. The internal effector 14 is then caused by magnetic attraction to exert force on the structure. If the amount of force exerted is sufficient, both the internal effector 14 and the structure to which it is attached may move. Thus, as was noted earlier, the system 10 may provide movement, retraction, or counter- traction (i.e., a counter force) on a tissue, organ or other structure. The degree of movement and the amount of force exerted depend on the strength of the magnets 50, the proximity of the external manipulator 12 to the internal effectors 14, and on other factors. Those factors can be altered to produce greater or lesser degrees of force, as necessary. For example, stronger or weaker magnets may be used for different applications and types of surgical procedures.

Generally speaking, it may be advantageous if the other surgical tools and implements that are used with the system 10 are non-ferromagnetic, so that they are not inadvertently or undesirably influenced by the magnetic fields created by the external manipulator 12 and the internal effectors 14.

The internal effectors 14, 66, 72, 78 illustrated in FIGS. 1 and 3-6 act on single points or small areas of tissue and other structures to apply retractive or manipulative forces during a surgical procedure. However, internal effectors according to embodiments of the invention are not so limited. In addition to being attached to tissues, organs, and other anatomical and non-anatomical structures, an internal effector 14, 66, 72, 78 may also be attached to a surgical implement, prosthesis, or other element to manipulate it using magnetic force. For example, U.S. Provisional Patent Application Nos. 60/971,883 and 60/975,982, both of which are incorporated by reference herein in their entireties, disclose the use of magnetic prosthetic materials, and the techniques and materials disclosed therein may be used with embodiments of the present invention. Particular examples of implants and prosthetic materials to which internal effectors 14 may be attached include prosthetic meshes, such as expanded poly(tetrafluoroethylene) (PTFE) / polypropylene meshes used for hernia repair.

The following examples set forth particular aspects of systems, apparatus and methods according to embodiments of the invention. Certain of the examples pertain specifically to NOTES surgical procedures, although as those of skill in the art will understand, embodiments of the invention may be broadly applied to different types of surgical procedures.

Example 1 : Construction of a surgical manipulation system

An external manipulator 12 was constructed with four neodymium block magnets 50, each measuring 4 inches by 2 inches in width and length, stacked on top of each other. Each magnet was magnetized through thickness, with a pull force of 640.50 lbs, surface field measuring 5,120 Gauss, and Br_max (i.e., residual flux density) of 13,200 Gauss. The magnets 50 were attached to a multi-articulating, lockable external manipulator 12, essentially as illustrated in FIGS. 1 and 2, which clamped to the edge of a standard operating table.

The internal effectors 14 comprised neodymium ring magnets sutured to a

RESOLUTION endoscopic clip (Boston Scientific, Inc., Natick, MA, United States) using 2-0 Vicryl suture. Each of the magnets measured 3/16 inch in outer diameter, 1/16 inch in inner diameter, and 1/16 inch thick, and each was nickel-plated, axially magnetized (i.e., the poles were on the flat ends so that several would stack into a column), and weighed 0.189 g. Each magnet had a pull force of 1.48 lbs, surface field of 2275 Gauss and Br_max of 13,200 Gauss. Three magnets were stacked together and sutured to the clip.

Example 2: Force Testing of the Surgical Manipulation System

The force distance relationship of the magnetic system of Example 1 was determined using a digital tension/compression gauge (Chatillon, Largo, FL, United

States) mounted on a test stand. A 2 cm full thickness segment of porcine abdominal wall was interposed between the two magnetic assemblies to detect any attenuation of force. This was compared to maximal, sustained push forces generated by biopsy forceps (Olympus, Inc.) attached to the digital gauge sensor. Maximal forces were measured as a function of scope diameter (i.e., a single-channel gastroscope GIF

Q140 versus a double-channel colonoscope GIF 2T1000) and scope orientation (i.e., straight away versus maximal retroflexion). Five independent values were recorded for each test condition, and the mean value was reported.

Over a separation distance of 5.0 cm to 0.25 cm, the magnetic force of the system increased exponentially from 3 to 90 gram Force (gF). Force did not diminish with intervening soft tissue. In comparison, a biopsy forcep emerging from a single- channel gastroscope exerted a sustained maximum force of 330 gF when the gastroscope was in a linear configuration, and 142 gF when the gastroscope was in a fully retroflexed configuration. When emerging from a double-channel colonoscope, the biopsy forcep exerted a mean sustained maximum force of 242 gF with the colonoscope in a linear configuration, and 127 gF when the colonoscope was fully retroflexed.

Example 3: Transcolonic Endoscopic Cholecystectomy

Five non-survival female Yorkshire pigs weighing 28-34 kg were used. In order to determine technical feasibility, the first two surgeries were performed in recently deceased animals that had undergone orthopedic procedures. The final three surgeries were performed in anesthetized, intubated animals that were sacrificed immediately following surgery.

The transcolonic approach was performed in a similar manner to that described in Fong, D. G., et al. "Transcolonic endoscopic cholecystectomy: a NOTES survival study in a porcine model (with video)," Gastrointest Endosc. 2006 Sep; 64(3):428-34 and Fong, D. G., et al., "Transcolonic endoscopic abdominal exploration: a NOTES survival study in a porcine model." Gastrointest Endosc. 2006 Dec 13, the contents of both of which are incorporated by reference herein in their entireties. A double-channel colonoscope (GIF 2T1000; Olympus Optical Co, Ltd, Tokyo, Japan) was used for each procedure. Reusable endoscopic tools used throughout the procedure included cold and hot biopsy forceps, snares, a hook knife, and insulated-tip and regular needle knives. For the final three procedures, general anesthesia was induced with Telazole (4.4 mg/kg IV; Fort Dodge Animal Health, Fort Dodge, Iowa), Xylazine (2.2 mg/kg IV), and Atropine sulfate (0.04 mg/kg IV). After endotracheal intubation, the pigs were maintained throughout surgery on semiclosed circuit inhalation of 1% to 3% Isoflurane. Sterile technique was not followed given our focus on determining technical feasibility.

The endoscope was introduced through the anus and advanced to 10-15 cm from the anal verge. Using lower abdominal palpation as a guide, a needle-knife was used to create a subcentimeter linear incision across the colonic wall. The endoscope was then advanced through this incision, and the endoscope air pump was used to induce and maintain pneumoperitoneum. A Veress needle was also placed percutaneously into the abdomen and connected to a standard laparoscopic insufflator in order to maintain intra-peritoneal pressures of 10-12 mm Hg.

Because the internal effectors 14 were too large to fit down the instrument channels, they were back-loaded into the endoscope. The internal effectors 14 were deployed in serial fashion along the inferior edge of the hepatic lobes. Three to five internal effectors were used per animal. With the animal in the supine position, the external manipulator 12 was positioned over the right upper quadrant in order to lift the hepatic lobes and expose the gallbladder.

A large grasping forceps was used to pull the gallbladder away from the fossa. In addition, numerous tools (hook knife, hot biopsy forceps, and insulated-tip needle- knife) were used to separate the fibrotic layers of attachment. The technique of hydro- dissection was also used, whereby sterile water was injected via a sclerotherapy needle into the fibrotic layers in order to enhance separation of tissue planes. Once resected, the gallbladder was retrieved from the abdominal cavity and removed through the colotomy in one piece. The resection site was washed and inspected for residual defects, bleeding, and bile leakage. Adjacent organs were evaluated for evidence of laceration, perforation, and hemorrhage. When present, hemostasis was accomplished with electrocatuery. The internal effectors 14 were retrieved by grasping forceps. The colotomy was not closed. The procedure time was recorded and compared to historical controls.

The animals were immediately sacrificed following surgery and laparotomy performed. The resection sites were again carefully inspected for bleeding and bile leakage. The liver was carefully examined for evidence of laceration and hemorrhage.

Transcolonic peritoneal access was achieved rapidly and without complications in all 5 pigs. The internal effectors 14 were successfully attached to the inferior edge of the targeted hepatic lobe in all animals. By positioning the external magnet over the right upper quadrant, the targeted hepatic lobe rose immediately and remained suspended for the entire duration of the procedure. The gallbladder was fully exposed in 4 of the 5 animals, allowing for easy and immediate identification and ligation of the cystic duct and artery (i.e. identification of Calot's triangle-first approach). In 1 of the 5 pigs, the duct and artery could only be identified after careful dissection of the organ from the fossa was completed (i.e. fundus-first approach). Despite the force required to "peel off the gallbladder, the magnetically- retracted liver never once buckled. The gallbladder was successfully resected in one piece in all five animals. All internal effectors 14 were successfully retrieved by a simple tug of endoscopic graspers, and any minimal bleeding from the hepatic surface was controlled using electrocautery. The mean procedure time (from entrance into the peritoneal cavity until gallbladder removal from the anal orifice) was shortened 27% from the present inventors' historical mean of 68 minutes (range 42 to 90; n=5) to 49.6 minutes (range 33 to 61; n=5).

Example 4: Transcolonic Endoscopic Mesh Implantation

A combination expanded polytetrafluoroethylene (ePTFE) / monofilament polypropylene mesh (Composix mesh, C. R. Bard, Inc., Murray Hill, NJ, United States) was introduced into the peritoneal cavity via the transcolonic route using a prototype introducer. The 2" x 4" ePTFE mesh was implanted into the anterior abdominal wall to simulate ventral hernia repair. Internal effectors as described in Example 3 above were affixed to the corners of the mesh, which was then stabilized by the external manipulator 12 for implantation. The procedure was performed in three female Yorkshire pigs weighing 28-32 kg, and these animals were survived for 2 weeks.

Preparation for surgery was similar to the methods outlined for our cholecystectomy protocol with the following modifications to optimize sterility: since the animals were to be survived, the endoscopes and equipment necessary for transluminal exploration were cleaned by using high-level chemical disinfection in 2.4% glutaraldehyde (Cidex; Johnson and Johnson, Irvine, CA, United States) before each procedure. The animals themselves were deprived of food for 48 hours before surgery. They received preoperative Cefazolin Ig intravenously. Following induction and intubation as described above, the pigs were administerd two sequential 300-mL sterile water enemas followed by endoscopic inspection of the distal colon to 45 cm from the anus. Particulate matter was removed with snares, aggressive washing, and suctioning. Next, a Cefazolin suspension (1 g in 500 niL normal saline solution) was instilled endoscopically into the distal colon and rectum and allowed to sit for ten minutes. Finally, the distal colon, rectum, and anal orifice were prepped with both internal instillations of Betadine (Purdue Pharma LP, Stamford, CT, United States) and an external Betadine scrub followed by appropriate draping.

Following the creation of the transcolonic incision as described above, a 0.35mm Jag guide-wire was deployed in the peritoneal cavity and the endoscope withdrawn over it. The ePTFE mesh was loaded into a sterile introducer, which was advanced through the anus and into the peritoneal cavity over the Jag guidewire. The mesh was then deposited inside the peritoneal cavity, and the introducer withdrawn. The endoscope was then re-inserted over the guide-wire and secured the mesh using graspers. Using the guidance of abdominal palpation, the mesh was positioned over a suitable location in the mid-abdomen such that its ePTFE surface was exposed to the viscera. The external manipulator 12 was positioned on the abdominal surface in order to stabilize the mesh, and, in some cases, to help re-position it. A modified Endocinch hollow needle and T-tag suturing system (C. R. Bard, Inc., Murray Hill, NJ, United States) was utilized to implant the mesh. Four to six T-tags were employed for each mesh.

The colonic incision was closed using a single Endoloop. After close endoscopic inspection of the closure, residual air was evacuated from the peritoneum via the external percutaneous catheter, and the catheter was removed.

The three pigs were kept alive for 2 weeks before necropsy. The peritoneal cavity was examined for evidence of infection, bleeding, perforation, or adhesions. Particular attention was paid to the colonic access site and the site of mesh implantation. The mesh was resected to gauge depth of T-tag penetration.

Transcolonic peritoneal access was again successful in all animals. The ePTFE mesh was successfully deposited into the peritoneal cavity using the prototype introducer. In previous attempts by the present inventors at non-magnetic-assisted mesh implantation, it was difficult to subsequently locate and manipulate the mesh. However, with the assistance of the external manipulator 12, we were able to quickly retrieve the deposited mesh by floating the external magnet over the abdominal cavity. Once the mesh was located, the external magnet easily stabilized it against the abdominal wall, and at times helped to reposition it. The problem of inadvertent mesh movement was not encountered once the magnet had secured the mesh in an optimal location, and attention could be completely shifted to mesh implantation. Four to six T-tags were implanted per mesh without complications. In both this and our cholecystectomy experience, some of the ferromagnetic instruments, such as the grasper or hollow needle, could occasionally be drawn "off-course" toward the external manipulator 12, requiring a repeat, more careful approach to its intended target. The colonic incision was closed with an Endoloop without incident.

All 3 animals flourished in the post-operative period with appropriate weight gain, feeding, and activity levels. Upon necropsy, the contents of the peritoneum of all 4 pigs appeared pink and healthy, with no signs of infection, bleeding, or organ injury. The mesh had peritonealized over in all 3 animals without adhesions. The T- tags were discovered to have penetrated the fascia at a rate of 67%. Colo- vesicular adhesions were seen in all three specimens.

In the description and examples above, one external manipulator 12 was used to create essentially unidirectional forces. However, in some embodiments, multiple external manipulators 12 could be used. With multiple external manipulators 12, it would be possible to move internal effectors 14, instruments, and tissue in more than one plane. If multiple external manipulators 12 are used, those manipulators 12 may or may not be placed under computer control, depending on the embodiment and the particular circumstances.

Those of skill in the art will also realize that although the description and examples above focus on the use of the external manipulator 12 and the internal effectors 14 to create attractive magnetic forces, the sense of the force is not so limited. In some embodiments, the poles of the various magnets may be arranged so as to produce repulsive magnetic forces instead of attractive forces. Moreover, if multiple external manipulators 12 are provided, the arrangements of their magnets 50 may be different, such that some manipulators 12 attract the internal effectors 14 and other manipulators 12 repel the internal effectors 14.

Although the invention has been described with respect to certain embodiments, the embodiments are designed to be exemplary, rather than limiting. Modifications and changes may be made within the scope of the invention, which is defined by the claims.

Claims

What is claimed is:

1. A surgical manipulation system, comprising: an external manipulator having a support portion, and a positionable portion connected to and supported by the support portion, the positionable portion having a first end, a second end spaced from the first end, and at least one movable joint between the first end and the second end, the at least one movable joint being constructed and arranged to render the first end of the positionable portion movable relative to the second end, the first end of the positionable portion having one or more magnets connected thereto; and at least one internal effector adapted to be placed within a body cavity, the at least one internal effector having an engaging portion adapted to engage an object to be manipulated within the body cavity; and a magnetized or magnetic portion adapted to be magnetically influenced by and to cooperate with the one or more magnets of the external.

2. The surgical manipulation system of claim 1, wherein the object to be manipulated is tissue.

3. The surgical manipulation system of claim 1, wherein the object to be manipulated is a surgical implement.

4. The surgical manipulation system of claim 1, wherein the one or more magnets are permanent magnets, electromagnets, or superconducting magnets.

5. The surgical manipulation system of claim 4, wherein the one or more magnets are permanent magnets.

6. The surgical manipulation system of claim 5, wherein the permanent magnets are neodymium permanent magnets.

7. The surgical manipulation system of claim 1, wherein the engaging portion of the at least one internal effector is a clip.

8. The surgical manipulation system of claim 7, wherein the clip has blunt jaws.

9. The surgical manipulation system of claim 1, wherein the engaging portion of the at least one internal effector includes a curved blade adapted to retract tissue.

10. The surgical manipulation system of claim 9, wherein the curved blade is divided into one or more teeth.

11. The surgical manipulation system of claim 1, further comprising an endoscope.

12. The surgical manipulation system of claim 11, wherein at least one internal effector is constructed and adapted to fit through an instrument channel in the endoscope so as to be placed within the body cavity by the endoscope.

13. A surgical visualization and manipulation system, comprising: an endoscope having at least one instrument channel; one or more internal effectors sized to fit within the at least one instrument channel so as to be placed within a body cavity by the endoscope, each of the one or more internal effectors having an engaging portion adapted to engage structures within the body cavity and a magnetized or magnetic portion; and an external manipulator including a positionable portion and a first end connected to the positionable portion so as to be positioned in a user-defined location and orientation, the first end including or being comprised of one or more magnets; wherein the one or more magnets of the external manipulator are constructed and arranged to magnetically influence the magnetized or magnetic portion of the one or more internal effectors such that the internal effectors exert force on the structures with which they are engaged.

14. The surgical visualization and manipulation system of claim 13, wherein the internal effectors are constructed and adapted to engage tissue within the body cavity.

15. The surgical visualization and manipulation system of claim 13, wherein the internal effectors are constructed and adapted to engage surgical implements.

16. The surgical visualization and manipulation system of claim 13, wherein the one or more magnets are permanent magnets, electromagnets, or superconducting magnets.

17. The surgical visualization and manipulation system of claim 16, wherein the one or more magnets are neodymium permanent magnets.

18. A method of surgical remote manipulation, comprising: attaching one or more internal effectors to a structure within a body cavity, each of the one or more internal effectors having at least a portion that is magnetic; and exerting force on the structure using an external manipulator that creates a magnetic field capable of magnetically influencing the one or more internal effectors from a position outside of the body cavity.

19. The method of claim 18, further comprising placing the one or more internal effectors using an endoscope.

20. The method of claim 19, wherein the endoscope is inserted directly or indirectly into the body cavity through a natural orifice.