# Patent

## Title
Remote traction and guidance system for mini-invasive surgery

## Abstract

A guide and remote traction system for mini-invasive surgery in a body cavity that is easily positioned and hooked and causes lower injury, comprising:

    
    
        at least one detachable surgical endoclamp (10) with hooking means (11, 12), assembled with an introduction guide (20) and at an initially open position; and at a naturally closed position when detached from said introduction guide (20) by a detachment mechanism; said endoclamp (10) comprising a portion of ferromagnetic material at the end opposed to said hooking means (11, 12);
        a cylindrically-shaped introduction guide (20) assembled with said detachable surgical endoclamp (10), said introduction guide (20) comprising a mechanism to detach said endoclamp (10); and
        at least one remote traction means (30) for said endoclamp (10), acting through the application of an electromagnetic field over the ferromagnetic portion of said endoclamp (10).

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation of U.S. patent application Ser. No. 13/132,185, now U.S. Pat. No. 8,790,245, which is a National Stage Application of PCT/IB2009/054307, filed on Oct. 1, 2009, which claims the benefit of patent application Ser. No. 279-2009, filed Feb. 6, 2009, in Chile, all of which are hereby incorporated by reference in their entirety.


FIELD OF THE INVENTION
The present invention is directed to a guide and remote traction system for mini-invasive surgery or endocavitary surgery, said system being easily maneuvered, positioned, hooked and used, which diminishes the number of required incisions to perform surgical procedures. In particular, the present invention consists in a guide and remote traction system for mini-invasive surgery or endocavitary surgery that is easily positioned and hooked, comprising: a detachable surgical endoclamp; a detachable and self-closing introduction guide assembled together with said surgical endoclamp; and remote magnetic traction means for said endoclamp.
BACKGROUND OF THE INVENTION
Surgery is under constant change and development. Currently, surgical procedures and technologies are oriented to carry out surgeries that cause the lowest possible injury to the patient. The applied concept is to achieve advantages for the individual, such as lower pain, lower post-surgery recovery periods, shortened hospitalization, lower complications associated to the procedure and better cosmetic results, which results in a better life quality for the patient and savings for health insurance systems. With this inspiration, endoscopic or minimally invasive surgery has been developed, which allows carrying out surgical interventions through small incisions in the patient, hence avoiding larger incisions and the higher metabolic costs of open surgery.
A solution to this need is disclosed in U.S. Pat. No. 7,169,104, published on Mar. 18, 2004, which discloses a remote guide anchoring system including an hooking device that is hooked to a body part in a patient's body; a magnetic clamp made of a magnetic material that is connected to the hooking device; and a magnetic device located outside of the patient's body to guide the clamp, which produces a magnetic field to move said magnetic clamp. As can be seen in this document and its figures, the invention in this document requires a second clamp to close the magnetic clamp or to hook the clamp to the anchoring system. The former solution refers to a solution for digestive endoscopy that is very difficult to apply in laparoscopic surgery since the assembly solution for the clamp and its traction system is very difficult to carry out inside cavities.
Technical Problem
These surgery techniques need entrance points into the individual, which requires performing a total wall incision and generally inserting a working trocar (or port). Through these entrances, necessary elements are introduced, both optical (cameras for internal visualization) and surgical tools, e.g. clamps, electroscalpel, scissors, etc. In this type of surgery, it is necessary to detach and raise adjacent organs or tissues for a cleaner and more effective surgery result. Usually, this detachment and rising is performed by using clamps or hooking means, which are directly manipulated from the outside through a working port.
These working ports are the incision points that must be performed in the body wall of the individual, with the risks and complications associated to a total thickness body wall incision, mainly: important post-surgery pain, intra- and post-surgery bleeding risk, infection risk and risk of developing subsequent hernias. All these complications decrease the life quality of the patient and increase health insurance costs. Additionally, there is also an important aesthetical issue, since these incisions necessarily leave a subsequent scar as a sequel. Due to this, it is necessary to use the minimal possible number of incisions to perform the desired surgical procedure, therefore decreasing intra- and post-surgery complications and hence getting the best post-surgery results.
Solution to Problem
The present invention solves the problem of positioning and effectively hooking an endoclamp to an organ or tissue to be pulled, making the assembly easy to use, since it comprises a self-closing endoclamp actuated from the introduction guide. Subsequently, this endoclamp is moved by applying a magnetic force through the body wall using the remote traction means.
Advantageous Effects of Invention
The present invention has been realized, consisting in a guide and remote traction system for mini-invasive surgery with easy positioning and hooking and lower injury since it makes possible to eliminate one or several incisions performed with the previous art techniques, which brings about a benefit for patients. This allows a significant reduction on the recovery time of patients, removing potential risks associated to incisions and avoiding undesirable scars. Furthermore, the present invention proposes a guide and remote traction system comprising a hooking mechanism to the organ or tissue to be treated that is easily and safely operated, which facilitates its use by physicians. Therefore, the present invention is beneficial, since it decreases the number of incisions to perform the surgery and is easily used. The present invention solves a problem of positioning and effective hooking to the organ to be pulled, allowing an easy use and performing surgery with lower injury to the patient.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a schematic view of a mini-invasive surgery, particularly a laparoscopic cholecystectomy, according to the previous art.
FIG. 2 is a schematic view of a mini-invasive surgery with the guide system with remote traction according to the present invention. A decrease in the number of access points can be observed.
FIG. 3 is a schematic view of the guide system and remote traction according to the present invention in an initial configuration comprising an introduction guide and an assembled open clamp.
FIG. 4 is another schematic view of the guide system and remote traction according to the present invention in a detachment position with a closed clamp.
FIG. 5 is a schematic view of the endoclamp detached from the introduction guide in traction operative position.
FIG. 6 shows a plot of magnetic field density as a function of distance generated by a remote traction means according to the present invention.
FIG. 7 shows a plot of magnetic field force as a function of distance generated by said remote traction means over an endoclamp according to the present invention.
FIG. 8 shows a plot relating the magnetic induction of a traction means with a rare earth magnet with the force generated over an endoclamp by said magnetic induction, said traction means and said endoclamp according to the present invention.
FIG. 9 shows a plot of magnetic induction as a function of voltage over an electromagnet of a traction means according to the present invention.



PREFERRED EMBODIMENT OF THE INVENTION
The present invention consists in a guide and remote traction system for mini-invasive surgery in a body cavity that is easily positioned and hooked and causes lower injury, comprising:
at least one endoclamp with surgical hooking means, assembled with a guide and at an initially open position; and at a naturally closed position when detached from said guide by the detachment mechanism; said endoclamp comprising a portion of ferromagnetic material at the end opposed to said hooking means;
a cylindrically-shaped introduction guide assembled with said detachable surgical endoclamp, said guide comprising a mechanism to detach said endoclamp;
at least one remote traction means for said at least one endoclamp, acting through the application of an electromagnetic field over the ferromagnetic portion of said endoclamp from outside of said body cavity.
As observed in FIG. 1, a mini-invasive laparoscopic-like surgery is performed by techniques of the prior art in which, in this case, 4 incisions are practiced in the abdominal wall to place the trocars, wherein 1 trocar (a) is used for insertion of an endoscopic camera, and 3 trocars (b, c and d) are used to rise, manipulate and section the organ to be treated, e.g. the gall bladder (v), with hooking means such as conventional laparoscopic clamps.
Instead, FIG. 2 shows a mini-invasive surgery using the guide system and remote traction according to the present invention; wherein it can be appreciated that only one incision is carried out in the abdominal wall for only one trocar (a), through which one or more clamps (p) are introduced, which are driven by one or more magnets or electromagnets (e) to manipulate the organ (v); the endoscopic camera to visualize the mini-invasive surgery is introduced through this same trocar, as well as an element to dissect and subsequently extract the tissue or organ.
As illustrated in FIG. 3, the guide and remote traction system for mini-invasive surgery in a body cavity that is easily positioned and hooked and causes lower injury, comprises: an introduction guide (20) assembled with a detachable surgical endoclamp (10) and a remote traction means (30) of said endoclamp (10) to move said endoclamp by applying a magnetic field over an end of said clamp from the outside of said body cavity, e.g. an electromagnet.
Said endoclamp (10) comprises two separate pieces substantially at its center and rotatable about an axis (11), each of said separate pieces defining a hooking end (12) and a handling end (13) with a radial spring (not shown in the Figures) that holds the endoclamp (10) in its naturally closed position. A first handling end (13) is joined to a projection (14) coupled to a cylindrical butt means (15) with a diameter wider than projection (14), and said butt means (15) extends to an anchoring means (16) introduced inside the guide (20); wherein the butt means (15) and anchoring means (16) comprise a portion made of a ferromagnetic material, e.g. iron, nickel, cobalt, iron oxides, etc.
Said detachment mechanism of said introduction guide (20) comprises a securing ring (21) joined to a first end of a substantially rod-like connecting piece (22), said connecting piece (22) passing through the inside of a guide tube (23), said guide tube (23) connecting at one end to the anchoring means (16) of the endoclamp (10) and at the other end to a detaching set (24) to detach said endoclamp (10); said connection piece (22) is joined at its second end to an unlocking piece (28) connected to a tensioned spring (26) fixed to the rear wall (25) of the detaching set (24); said unlocking piece (28) having a perforation with a pin (29) passing therethrough. Said pin (29) is fixed at its end to an actuator (27) that is rotatable around a central axis (27a) that defines an operative end (27b) and an actuator end (27c).
In an initial position, said rotatable actuator (27) is in a first position with the operative end (27b) closer to the unlocking set (24) than the actuator end (27c), which is far away from the unlocking set (24); the pin (29) passes through the perforation of the unlocking piece (28) and the unlocking piece is located at a distance from the rear wall (25) longer than the natural spring length (26) in such a way as to hold the spring in tension in its first position. In this initial position, the connecting piece (22) holds the securing ring (21) around and joining the handling ends (13) in such a way as to hold the endoclamp (10) open, i.e. with separated hooking ends (12).
When introducing the introduction guide (20) assembled with the endoclamp (10) through a trocar installed in a body cavity subjected to mini-invasive surgery, the introduction guide (20) and the endoclamp (10) can be guided, introduced and alignedly actuated through said trocar. When the endoclamp (10) is in its initial position, the endoclamp is open and is directed toward the organ or tissue (v) to be treated. When the endoclamp (10) is correctly placed at the organ or tissue (v), the endoclamp is put into a, unlock position, shown in FIG. 4, which is achieved by pressing the actuator end (27c) as to remove the pin (29) from the perforation of the unlocking piece (28); in this way, the restriction imposed on the spring (26) is released and the spring returns to its natural position, bringing together the unlocking piece (28) and the rear wall (25), and removing the securing ring (21) from the endoclamp (10) by means of the connection piece (22). In turn, the endoclamp (10) is released into its natural position, and the hooking ends (12) are closed, thus trapping the organ or tissue (v).
As shown in FIG. 5, when the endoclamp (10) is fixed to the organ or tissue (v), the introduction guide (20) is removed from the trocar and it can be used to introduce another element into the body cavity; furthermore, the endoclamp (10) is brought close to the body cavity wall (50) near the remote traction means (30) and the magnetic field is activated in such a way as to make said endoclamp (10) to be attracted by said remote traction means (30) and orienting its butt means (15) and the hooking means (16) toward the inner side of the body cavity wall (50). In this way, the remote traction means (30) can guide and position the endoclamp (10) remotely from the outside of the body cavity.
Then, in the aforementioned way, an organ or tissue in a body cavity can be manipulated with one or more endoclamps by repeating the described procedure. The organ remains located in an optimal position to carry out the corresponding surgical intervention with only one incision to install a single trocar.
Said one or more endoclamps remain fixed at their position or can be moved along the body cavity, thanks to one or several remote traction means of said endoclamp by applying an electromagnetic field over the ferromagnetic portion of said endoclamp from the outside of said body cavity.
Preferably, said remote traction means generates an electromagnetic field with a magnetic induction ranging from 0.1 to 1 Tesla (1,000 to 10,000 Gauss) in the surroundings of said traction means, to generate a force ranging from 2.94 to 4.9 N (300 and 500 grams) over the endoclamp according to the present invention at a distance ranging from 10 to 30 mm of the abdominal wall; reaching a body wall width of up to 80 mm in case of obesity. For this end, said remote traction means comprises a permanent magnet such as, e.g. a magnetized steel or Alnico (alloy comprising 24% by weight of cobalt, 8% by weight of aluminum, 14% by weight of nickel, 51% by weight of iron and 3% by weight of copper) or ferrite (80% by weight of iron oxide and 20% by weight of strontium oxide) magnet.
More preferably, said traction means comprises a rare earth mineral magnet, e.g.: RE—M5- and RE2M17-type, wherein “RE” is samarium (Sm), promethium (Pr) and neodymium (Nd) and “M” is a mixture of cobalt (Co) with metals such as iron (Fe), copper (Cu), zirconium (Zr), titanium (Ti), hafnium (Hf) and manganese (Mn); e.g. SmCo5 made by GE Research Lab in Schenectady, N.Y. (EEUU), or “neodymium-iron-boron”, Nd2Fe14B, developed in 1983 by Sumitomo (Japan) and General Motors (EEUU).
Embodiment of the Invention
According to another preferred embodiment of the invention, said remote traction means can comprise an electromagnet and a voltage regulator to vary the magnetic induction generated by varying the voltage on the electromagnet. Preferably, said electromagnet generates an electromagnetic field with a magnetic induction ranging from 0.1 to 1 Tesla (1,000 to 10,000 Gauss) in the surroundings of said traction means, to generate the required force over the endoclamp according to the present invention at a distance ranging from 10 to 30 mm.
According to another preferred embodiment of the invention, said remote traction means can comprise an electromagnet and an electric current regulator to vary the generated magnetic induction by varying the electric current intensity over the electromagnet, said magnetic induction ranging from 0.1 to 1 Tesla (1,000 to 10,000 Gauss) according to the present invention.
According to an embodiment of the present invention, said electromagnet can comprise a paramagnetic material core that comprises one or several of the following materials: air, aluminum, magnesium, titanium, ferric chloride and tungsten.
According to another embodiment of the present invention, said electromagnet can comprise a ferromagnetic material core that comprises one or several of the following materials: iron, nickel, cobalt, aluminum, iron-silicon or alnico and permalloy alloys, this latter comprising 20% by weight of steel and 80% by weight of nickel.
In a first example of the present invention, FIG. 6 shows a plot of magnetic field density as a function of distance generated by a remote traction means according to the present invention which comprises a rare earth magnet. FIG. 7 shows a plot of magnetic field force as a function of distance generated by said remote traction means over an endoclamp according to the present invention. From FIG. 7, a characteristic magnet curve can be interpolated using equation: (a) F=5.3757e−0.0967d; with a quadratic fit with R2=0.9897, being F the force (in N) generated over the endoclamp and d the distance (in mm) between the remote traction means and the endoclamp; a magnet with these characteristics can generate 1.76 N (180 grams) at a distance of 11 mm according to the width requirements of the body cavity and the organ to be manipulated with the endoclamp of this first example.
According to the thickness of the patient's body cavity and the weight of the organ to be manipulated, in a second example a 2.94 N (300 grams) can be required to maintain and manipulate an organ through a body cavity of 20 mm. Thanks to FIG. 7 and equation (a), a new characteristic curve can be easily interpolated: 2.94=5.3757e−0.0967*20+B; therefore B=2.1628; and the resulting equation is: (b) F=5.3757e−0.0967*d+2.1628; wherein for a 0 mm distance, said magnet must generate a force of 7.5385 N (739 grams) over said endoclamp.
FIG. 8 shows a plot relating the magnetic induction of a rare earth magnet with the force generated over the endoclamp according to the present invention, with the equation: (c) B=0.0917*F0.66; with a quadratic fit with R2=0.9915, wherein F is the force in Newtons and B is the magnetic induction in Teslas; for this second example, the magnet required for the remote traction means according to the present invention should be dimensioned for a magnetic induction of 0.3478 Teslas (3478 Gauss).
According to another preferred embodiment of the invention, said remote traction means can comprise an electromagnet and a voltage regulator to vary the magnetic induction generated by varying the voltage on the electromagnet. FIG. 9 shows a plot of magnetic induction as a function of voltage over an electromagnet with a 2 A current I; a path length of 8.3 cm; a spire number of 4.245; and a cold-laminated steel core with a diameter of 10 mm and permeability 1.99. Said plot of FIG. 9 allows obtaining a characteristic electromagnet curve represented by equation: (d) B=0.1621*V0.5018; with a quadratic fit having R2=0.9956, wherein B is the magnetic induction in Teslas at a distance of 0 mm from the electromagnet and V is the voltage in Volts applied over said electromagnet.
For the aforementioned example, where a 2.94 N (300 grams) force must be generated over the endoclamp according to the present invention through a body wall of 20 mm, a magnetic induction of 0.3478 Teslas (3478 Gauss) should be produced at a distance of 0 mm; therefore, according to the plot in FIG. 9 and using equation (d), the required voltage is V=(0.3478/0.1621)1/0.5018=4.58 Volts. Hence, the voltage regulator of said traction means must be regulated to get the deduced 4.58 Volts voltage. In this way, the traction means that comprises an electromagnet with a voltage regulator or a current regulator can be adjusted to apply the minimal necessary force over the endoclamp to hold it firmly at its position against the body cavity without applying an excessive force that could damage the tissues and other organs of the body cavity under surgery.
INDUSTRIAL APPLICABILITY
The present invention has industrial applicability in the manufacturing industry of mini-invasive surgery or endocavitary surgery tools. The present invention is especially useful in videolaparoscopic cholecystectomy, but is not limited to this procedure.

## Claims

1. A method for performing a surgical procedure, comprising:
creating an opening into a body cavity;
introducing an introduction guide assembled with a detachable clamp through the opening, wherein the clamp comprises a ferromagnetic material at least partially held within the introduction guide and the introduction guide comprises a detachment mechanism longitudinally slidable within the introduction guide;
fixing the clamp to tissue within the body cavity and releasing the clamp from the introduction guide, wherein retracting the detachment mechanism away from the clamp both fixes and releases the clamp;
removing the introduction guide from the body cavity; and
moving the clamp while fixed to the tissue relative to the body cavity using a magnetic field.

2. The method of claim 1, wherein the introduction guide is introduced through a port.

3. The method of claim 1, further comprising introducing a tool to dissect the tissue through the opening.

4. The method of claim 1, further comprising using the introduction guide to introduce a second clamp into the body cavity.

5. The method of claim 1, further comprising introducing a camera through the opening.

6. The method of claim 1, wherein the magnetic field is generated by a permanent magnet or electromagnet located outside the body cavity.

7. The method of claim 1, further comprising adjusting the magnetic field.

8. The method of claim 1, wherein the clamp comprises a first piece and a second piece, each piece defining an end for engaging tissue and a handling end, wherein the handling end of the first piece of the clamp is detachably attachable to the introduction guide.

9. The method of claim 8, wherein the handling end of the first piece of the clamp comprises a portion made of ferromagnetic material.

10. The method of claim 9, wherein the introduction guide holds around and joins the handling end of the first piece of the clamp.

11. The method of claim 8, wherein the clamp has open and closed positions, wherein the first piece and second piece of the clamp are rotatable relative to an axis between the open and closed positions, and wherein the introduction guide comprises an actuator to move the clamp between the open and closed positions.

12. The method of claim 8, wherein the handling end of the first piece of the clamp is rotatable relative to an axis, and the detachment mechanism comprises a rod held against the handling end of the first piece of the clamp when the introduction guide is assembled with the clamp.

13. The method of claim 1, wherein moving the clamp using the magnetic field further comprises attracting the clamp to a magnet located outside the body cavity.

14. The method of claim 1, wherein the clamp comprises a first end for engaging tissue, a second end opposite the first end, and a projection coupled therebetween, wherein the detachment mechanism comprises a rod extending longitudinally out of the introduction guide, the rod held against the first end of the clamp when the introduction guide is assembled with the clamp.

15. The method of claim 1, further comprising actuating an actuator end of the detachment mechanism toward the clamp to retract the detachment mechanism away from the clamp.

16. The method of claim 1, wherein a predetermined amount of retraction of the detachment mechanism both fixes and releases the clamp.