EP2306907A2

EP2306907A2 - Surgical instrument preferably with temperature control

Info

Publication number: EP2306907A2
Application number: EP09745854A
Authority: EP
Inventors: Jacques Deviere; Alain Delchambre; Nicolas Cauche; Sonia Dugardeyn; Philippe Dubois; Jean-Marie Raquez
Original assignee: Universite de Mons; Universite Libre de Bruxelles ULB
Current assignee: Universite de Mons; Universite Libre de Bruxelles ULB
Priority date: 2008-05-16
Filing date: 2009-05-18
Publication date: 2011-04-13
Also published as: WO2009138522A2; JP2011521677A; WO2009138522A3; AU2009248052A1; CA2724436A1; US20110125108A1

Abstract

The present invention firstly relates to a surgical needle with shape memory, secondly an endoscope tool for controlling the temperature of a foreign body or surgical instrument such as an endoscopic needle.

Description

SURGICAL INSTRUMENT OF PREFERENCE CONTROL IN TEMPERATURE

Application domain

The present invention relates to the field of surgical instruments.

In particular, according to a first aspect, the present invention refers to a surgical needle and in particular to an endoscopic needle whose access to the site to be treated will be performed endoscopically. [0003] The present invention also relates to di spos iti f for use ur said aiigui l the surgical. Access evening, the present invention relates, in a second aspect, the temperature control of a surgical instrument and in particular a therapeutic instrument, a diagnostic instrument or an implant. [0005] Preferably, the temperature control of the instrument or of the implant is carried out, in situ, inside the human body or the body of an animal. Advantageously, the access of the therapeutic or diagnostic instrument or the implant which constitutes a foreign body to the site to be treated is carried out endoscopically.

Finally, the present invention relates to a therapeutic treatment for using such surgical needles possibly associated with a temperature control tool. Technical problem

During a surgical operation, when suturing a mucosa such as a suture through a wall such as a suture purse, overlocked, a plication, or anastomosis, which is located at inside the human body, the surgeon uses a rigid and sharpened curved needle. The curved shape of this needle allows it by a rotational movement to pass the needle on the other side of the wall and bring it back without having to bend this wall. The suture can be performed only if the curved needle can be brought to the site to be treated and it can be manipulated with the different degrees of freedom necessary for the realization of the suture.

In some flexible endoscopy procedures such as, for example, the treatment of major gastric bleeding requiring suturing within the gastric cavity, these two conditions are not met. The gastroenterologist can not currently bring a curved needle to the gastric cavity because the natural access routes to the gastric cavity are too narrow or too sinuous. Therefore, when a suture must be performed within the gastric cavity, the patient must undergo a heavy surgery that must allow an opening of all tissues to reach the organ in question, which greatly increases the trauma, especially for obese patients or severely burned patients whose scarring is difficult. This represents one of the main limitations of flexible therapeutic endoscopy practiced by natural means. Several solutions for making the sutures have been proposed and can be classified as follows.

A first category includes sutures that are performed by making a fold - for example by sussion - and passing a straight needle in the fold. For example, these procedures are used to form kinks at specific locations in the gastric cavity or lower esophagus. [0012] Specifically, for the treatment of gastroesophageal reflux, several devices make it possible to perform a plication of the cardia (NDO®, Plicator®, Bard Therapeutic®, Endocinch®) or to place a sleeve around the cardia. These techniques use sophisticated equipment, either attached to the endoscope end or consisting of a complex instrument into which an endoscope is inserted. The purpose of these devices is to overcome the fact that the endoscopist is a one-handed surgeon who can not pull the tissue to make a suture. These devices designed to perform a plication of the cardia can capture the entire gastric wall and suture to another part of this wall.

[0013] Another category relates to the creation of anastomoses (gas tro-enterostomy) between the stomach and the small intestine, where a suture of both walls (seroserous) is necessary. Some techniques are currently developed (T Tags, T bars) but allow only point sutures and induce a risk of puncturing adjacent organs when using straight and rigid needles. The realization of a suture overlock is not possible in this case.

[0014] Several documents of the state of the art describe devices for bringing a needle curve inside the body of a patient. In particular, WO-9508296 and EP-0529675 disclose a needle which can transition between two stable shapes at two different temperature ranges. In WO-9508296, the needle is made of a shape memory alloy. The shape of the endoscopic needle is modified by the surrounding temperature so that at room temperature (defined in this document as between 0 ^° C. and 24 ° C.), the needle is straight and at a temperature between 25 ° C and 40 ⁰ C, the needle becomes curved.

In EP-0529675, the needle is made of shape memory alloy. The shape of the endoscopic needle is modified by external heat sources such as "illumination light", "laser" or "cautery" so that the needle is straight at a temperature below 25 ° C and the needle is curved at a temperature above 35 ° C. The needles described in the two documents cited above are not as rigid as curved needles usually used by surgeons. Indeed, in the examples cited in these two documents, the needles in their curved form are removed from the body of the patient by applying a mechanical stress through a tube.

For the needles described in the two documents cited above change their shape, they must be exposed to a heat source over a large part of their outer surface. These needles can only be used in their curved form in the body. This limits the therapeutic possibilities with respect to a needle that could be used both in its form curve and in its rectilinear form inside the human body.

The transition from a curved shape to a straight form inside the human body would increase the suture possibilities while using a stiffness needle equivalent to that offered for example the needles of the "Ethilon" type. ® CPX 1 (45 mm) "or" Ethilon® FS-3 (16 mm 3 / 8c) "supplied by Ethicon® (Johnson & Johnson®). For this purpose, it may be advantageous to provide temperature control (cool or heat quickly) of a foreign body and in particular a surgical instrument such as a needle located inside the human body and whose access is done endoscopically. This change in temperature of the foreign body must be carried out by preserving the integrity of the tissues located nearby and regardless of whether the foreign body is in direct contact with the body of the patient. Among the various heating devices, there are known diathermic needles that provide a point source of heat to a tissue. However, this principle can not be applied to heat an instrument in the body while preserving the integrity of the tissue.

Main characteristic elements of the invention

A first object of the invention relates to a surgical shape memory needle comprising a needle body having two ends, distal and proximal, said body having at least two different stable shapes, a first form stable to a first temperature range and a second stable shape at a second temperature range, the first temperature range being strictly lower than the second temperature range; characterized in that the material constituting the body of the needle comprises at least one insulating shape memory material and at least one thermal and / or electrical conductive material; the entire body of the needle being able to be heated in situ by applying for example a source of heat and / or current. The temperature variation induced by the source of heat and / or current in the needle allows the passage of the first stable form to the second stable form and this inside the body.

By insulating material is meant a polymeric matrix having insulating properties. Preferably, this polymeric matrix is in the form of a multiblock copolymer which comprises at least two types of blocks.

Preferably, a first type of block has a low softening temperature and a second or second type of block has a high softening temperature. Preferably, the softening temperature of the first type of block is strictly less than the softening temperature of the second or second block type. By block is meant here a uniform monomer sequence, forming a homopolymer or a uniform statistical copolymer.

By softening temperature is meant either a glass transition temperature or a melting temperature. [0030] Preferably, the softening temperatures correspond to melting temperatures. Preferably, each of the types of blocks has at least two alcohol functions at the end of the chain. Preferably, the multiblocks are obtained as a reaction product of several blocks each comprising at least two end-of-the-chain alcohol functional groups with diisocyanates. More particularly, an insulating-type polymer results from the reaction of a first polymer (block) and a second or second polymer (block) with a diisocyanate in which both the first and the second or second polymer include alcohol functions at the end of the chain.

[0034] Preferably, the first polymer has a softening temperature that is strictly lower than that of the second or second polymer. [0035] Preferably, the softening temperature of the first polymer is between 38 ° C. and 60 ^° C.

Preferably, the softening temperature of the second or second polymer is greater than at least 10 ⁰ C to that of the first polymer. Preferably, the softening temperature of the second or second polymer is at least 20 ^° C higher than the softening temperature of the first polymer. [0038] Preferably, the softening temperature of the first polymer is the transition temperature between the two stable forms of the needle (switching temperature).

[0039] Preferably, the first polymer and the second or second polymer form separate phases, preferably co-continuous phases.

[0040] Preferably, the polymers are selected from biocompatible polymers. Preferably, these polymers are biocompatible according to the ISO 10993-1: 1997 standard. [0042] Preferably, the two polymers are selected from the group consisting of aliphatic polyesters, aliphatic polycarbonates, aliphatic polyester-alters, poly (ethylene glycol) and all combinations thereof.

[0043] Preferably, the two polymers are selected from the group consisting of polycaprolactone, poly (para-dioxanone), poly (ethylene glycol), random copolymer of polycaprolact one-polylactide, random copolymer poly (para-dioxanone-caprolactone), polycaprolactone-polyglycolide random copolymer, polycaprolactone-polylactide-polyglycolide random copolymer, polylactide, polycaprolactone-poly (.beta.-hydrobutyrate acid) random copolymer, polyl (.beta.-tetrahydroxybutyric acid), and their combinations.

[0044] Preferably, the diisocyanate is selected from the group consisting of 4,4'-diphenyl methylene diisocyanate, toluene-2,4-diisocyanate, toluene-2,6-diisocyanate, hexamethylene-1,6 diisocyanate, isophorone diisocyanate, hydrogenated 4,4'-diphenylmethane diisocyanate and mixtures thereof. Preferably, the multiblock polymer is composed of a random or regular alternation of polycaprolactone type blocks, having a melting temperature of about 40 to 45 ° C., and blocks of a random copolymer of caprolactone and of polyester-alt-ether such as poly (para-dioxanone) having a melting point between 60 and 70 ^° C.

The multiblock polymer may have different architectures ranging from linear to starred structures. Preferably, the thermal and / or electrical conductive material may be an electrical connection.

Preferably, the thermal and / or electrical conductive material is a thermal and / or electrical conductor wire.

Preferably, the thermal and / or electrical conductive material is in the form of a thermal and / or electrical conductive filler embedded in the polymer matrix, said filler being present at a concentration greater than its percolation threshold. . Percolation threshold means the concentration from which the charge forms a continuous conductive network. Preferably, the thermal and / or electrical conductive filler is in the form of powder, fiber or sheets of dimensions preferably between about 10 microns and 5 nm. [0052] Preferably, the conductive filler will be selected from the group consisting of carbon blacks, carbon fibers, carbon nanofibers, carbon nanotubes, graphene sheets (exfoliated graphite), or a mixture thereof. By insulator means a resistivity greater than 10 ⁸ Ohm. m while driver means a resistivity less than 10 ³ Ohm. m

Stable form means a geometric shape which remains unchanged essentially for temperatures belonging to a temperature range. Advantageously, this needle will not undergo any change in shape or structure if light mechanical forces of the order of 10 N are applied to it which correspond to a human manipulation. Preferably, this needle will not undergo any change in shape or structure if light mechanical forces of the order of 5 N are applied to it which correspond to a human manipulation.

[0057] Preferably, the first stable form is rectilinear.

[0058] Preferably, the second stable form is curved. Preferably, the first stable form is a rectilinear shape and the second stable form is a curved shape of the needle.

Preferably, the entire body of the needle is adapted to be cooled by applying a source of cold.

Preferably, the temperature variation induced by the cold source in the needle allows the passage of the second stable form at a second temperature range to a third stable form at a third temperature range.

Advantageously, this third stable form corresponds to the first stable form.

Alternatively, the temperature of the needle is raised to a temperature higher than the softening temperature (high) of the second or second polymer and belonging to a fourth temperature range, before cooling to the third range of temperature. Preferably, the needle is exerted mechanically when it reaches the fourth temperature range.

Alternatively, the temperature variation induced by the source of cold in the needle allows the passage of the second temperature range to the third. temperature range by preserving the second stable form and increasing the mechanical properties of the needle.

Preferably, said source of heat and / or current is in direct contact with one of the ends, preferably the proximal end of the needle.

[0067] Preferably, said cold source is in direct contact with one of the ends, preferably the proximal end of the needle.

Preferably, at least one of the ends, and preferably the proximal end of said needle is made of a thermal and / or electrical conductive material which may be different or identical to the thermal and / or electrical conductive material constituting the body of the the needle. Said proximal end is preferably in direct contact with said conductive material contained in the rest of the needle.

[0070] Preferably, the shape of the needle at the first temperature range is rectilinear. [0071] Preferably, the shape of the needle at the second temperature range is curved.

[0072] Preferably, the shape of the needle at the third temperature range is rectilinear.

Advantageously, the transition between the first and the second stable form takes place at a first transition temperature Tsi.

Advantageously, the transition between the second and the third stable form takes place at a second transition temperature TS2. In a particularly advantageous manner, the first transition temperature corresponds to the second transition temperature. Advantageously, the first temperature range is strictly less than the first transition temperature.

[0077] Advantageously, the third temperature range is strictly less than the second transition temperature.

Advantageously, the second temperature range is strictly greater than the first and the second transition temperature. Advantageously, the transition between said first and second forms takes place at a transition temperature Tsi between a minimum temperature corresponding to a temperature just above body temperature, ie about 38 ° C., and a maximum temperature of about 60 ^° C., preferably at a transition temperature Tsi of between 40 ^° C. (maximum temperature of the human body) and 45 ° C.

Advantageously, the transition between the second and third embodiments takes place at a transition temperature TS2 between a minimum temperature just above the body temperature of about 38 ° C and a temperature of about 60 ⁰ C and preferably between 40 ° C and 45 ° C. Preferably, below its transition temperature (s), the needle is rectilinear.

Preferably, above its transition temperature or temperatures, the needle is curved. Preferably, when the temperature is strictly below a temperature just above body temperature 38 ° C) the needle is found in its rectilinear form. Preferably, when the temperature is strictly greater than 45 ° C the needle is found in the curved shape.

Preferably, the distal end of the needle is sharpened.

Preferably, the distal end of the needle has a metal or ceramic insert to ensure the integrity of its sharpening. Preferably, the proximal end of the needle accommodates surgical wire.

[0088] A second aspect of the present invention relates to an endoscopic tool for controlling the temperature of a foreign body or surgical instrument such as an endoscopic needle and in particular the needle described above. This tool is composed of at least three parts: a distal end - end penetrating the human or animal body - the body - flexible or rigid - of the tool and a proximal end - end remaining outside the human or animal body . The tool is designed so that the distal end of the tool comes into contact with the foreign body. The distal end of the tool is adapted to attach to the foreign body, such as a needle, to heat (or cool). Preferably, the distal end has at least one conductive portion - electrical and thermal - which can be heated and cooled in a controlled manner. Advantageously, this conductive part is part of the contact interface with the foreign body. Advantageously, this conductive portion is in contact with the foreign body.

The shape of this conductive portion is preferably adapted to optimize the surface of the contact with the foreign body so as to optimize the heat transfer by conduction.

Preferably, the conductive part (s) are connected to two conductive connections isolated from the rest of the tool and its environment.

Preferably, these two connections are in the form of son to perform a closed current loop through the conductive part or parts with or without the foreign body. Preferably, the current flowing in this or these conductive parts also passes into the foreign body and heated by Joule effect. The conductive part of the tool, according to the second aspect of the invention, is then heated by conduction. Alternatively, the current flowing in the conductive part (s) heats this or these conductive parts by Joule effect and the foreign body is then heated by conduction. [0099] Alternatively, the two aforementioned ways are combined.

The conductive part or parts may be cooled by spraying them or by putting them in contact with a refrigerated fluid preferably coming from a supply tube whose distal end preferably coincides with the distal end of the tool according to the second aspect of the invention.

Preferably, the refrigerated fluid is sprayed or is in contact with the foreign body and the foreign body is then cooled by convection. The conductive part of the tool according to the second aspect of the present invention is then cooled by conduction.

Alternatively, the refrigerated fluid is sprayed or in contact with the conductive part (s). which are then cooled by convection and which then cools the foreign body by conduction.

[0103] Alternatively, the two aforementioned ways are combined. Preferably, the conductive part (s), with the exception of the two connections, are thermally and electrically insulated from the remainder of the tool according to the second aspect of the invention. Preferably, at least one temperature sensor is present on one of the conductive parts of the tool according to the second aspect of the invention. This sensor makes it possible to measure the temperature of the foreign body and is intended to allow temperature control. [0106] Preferably, this temperature sensor is a thermocouple.

The distal end of the tool may be a clamp.

[0108] Preferably, the distal end of the tool comprises a clamp. The distal end of the tool may be a clamp with at least two inner jaws.

Preferably, the distal end of the tool comprises a clamp with at least two inner jaws The distal end of the tool may be a clamp with at least two outer jaws.

Preferably, the distal end of the tool comprises a clamp with at least two outer jaws. [0113] The distal end of the tool may coincide with the end of a catheter. The distal end of the tool may be an inflatable balloon. [0115] Preferably, the distal end of the tool comprises an inflatable balloon.

The distal end of the tool may be a vacuum. [0117] Preferably, the distal end of the tool comprises a vacuum.

The distal end of the tool used for temperature control may correspond to the distal end of most conventional instruments used in endoscopy.

Preferably, the body of the tool according to the second aspect of the invention is designed to allow placing the distal end of this tool at the site to be treated. The body of the tool is designed in relation to the functionality of the distal part of this tool.

For example, in the case where the distal end is a two-jaw clamp, the body of the tool comprises a force transfer means for opening and closing the clamp. This means for transferring the force between the distal end and the proximal end may be, for example, in the case of an endoscopic clamp, a flexible metal rod sliding in a flexible metal sheath. Preferably, the body of the tool comprises at least one transport means (tube (s) and / or electrical son) of the energy necessary to cool and / or heat the conductive part or parts. [0123] Preferably, the energy transport means consist of a conduit for supplying a fluid (water or gas) for cooling the foreign body and two conductive connections making it possible to bring electric current or power. 'thermal energy. Preferably, the body of the tool comprises at least one transfer means for measuring the temperature. This means for transferring the measurement of the temperature between the proximal end and the distal end may for example be two insulated conductors son of a thermocouple.

Preferably, the proximal end of the tool is related to the functionalities of the distal portion of this tool. Preferably, the proximal end of the tool comprises at least connectors necessary to connect the tool according to the second aspect of the invention to at least one energy source, in particular a first source of energy. (hot) and a second or second source of energy (cold).

Preferably, the proximal end of the tool comprises at least one connector for connecting the transfer means of the measurement of the temperature located in the body of the tool to a data acquisition system which is linked to a temperature controller.

Advantageously, the first energy source is a power supply.

[0130] Advantageously, the first source of energy is a heat supply.

Advantageously, the first source of energy is a power supply and heat.

Advantageously, the second or second energy source is a cooling fluid supply. Advantageously, the second or second source of energy is a supply of cold water. Preferably, one of the conductive connections defined above makes it possible to supply the energy required to the foreign body to perform electrocoagulation by diathermy. Preferably, a third conductive connection is provided for connecting the conductive part of the tool according to the second aspect of the present invention so as to be able to supply the energy required for the foreign body to perform electro-agulation. by diathermy.

The present invention also relates to the use of the needle and / or the tool for therapeutic or diagnostic procedures.

Brief description of the figures

Figures la and Ib represent the three stable forms of the needle - curved shape (stable form 2 shown in Figure la) and straight form (stable form 1 and 3 shown in Figure Ib) - according to a first embodiment preferred embodiment of the first aspect of the present invention.

Figures 2a and 2b show the three stable forms of the needle - curved shape (stable form 2 shown in Figure 2a) and straight form (stable form 1 and 3 shown in Figure 2b) - according to a second embodiment preferred embodiment of the first aspect of the present invention. Figure 3a-c shows a needle according to various preferred embodiments of the first aspect of the present invention. FIG. 4 represents a side view of the tool according to a preferred embodiment of the second aspect of the present invention, the tool comprising a pair of jaws. FIG. 5 represents a side view of the tool according to a preferred embodiment of the second aspect of the present invention, the tool comprising a three-jaw clamp. FIG. 6 represents a side view of the tool according to a preferred embodiment of the second aspect of the present invention, the tool comprising a catheter provided with an inflatable balloon.

FIG. 7 represents a side view of the tool according to a preferred embodiment of the second aspect of the present invention, the tool comprising a catheter comprising two conductive surfaces. FIG. 8 represents a diagram of an example of equipment (current generator, cold water supply source, temperature measuring device, user interface, temperature controller, etc.) connected to the proximal end of the tool according to the second aspect of the present invention.

Detailed description of several aspects of the invention

A first aspect of the invention relates to a needle made of preferably composite material containing conductive elements - a mixture of shape-memory polymers and electrically and / or thermally conductive particles and / or (nano) fibers - having (at less) two stable forms. The first form (stable) of work is a rectilinear or straight form. The second form (stable) of work is a form necessarily comprising a curved portion and optionally a straight portion.

The curved portion is rigid, sharpened and its general shape is for example similar to a circular arc. The angle formed by the two radii joining the two ends of the curved portion is between about 120 ° and about 200 °. This form may be equivalent to the needle of the type "Ethilon® CPX 1 (45 mm)" or "Ethilon® FS-3 (16 mm 3 / 8c)" provided by Ethicon® (Johnson & Johnson®). Preferably, the radius of curvature of the curved needle is between about 2.5 mm and about 22.5 mm. Preferably, one end of the needle is sharpened so as to easily penetrate the tissue.

[0153] Preferably, a surgical suture may be attached to the other end of the needle. The bending rigidity of a needle can be characterized by multiplying the Young's modulus (E) of the needle material by the moment of inertia (I) of the cross-section of the needle relative to the needle. neutral axis. Therefore, in order to obtain a flexural rigidity equivalent to conventional needles for example "Ethilon® CPX 1 (45 mm)" or "Ethilon® FS-3 (16 mm 3 / 8c)" provided by Ethicon® (Johnson & Johnson ®), the EI product must be preserved. We must therefore verify that:

E _a I _a = E _b I _b

E _a : Young's modulus of a needle conventionally used in surgery. I _a : Moment of inertia of the cross section of a needle, conventionally used in surgery, with respect to the neutral axis.

E _b : Young's modulus of the needle described in the present invention.

I _b : Moment of inertia of the cross section of the needle described in the present invention with respect to the neutral axis.

Preferably, the numerical value of the product EI is in the interval between 0.1 10 ^{~ 3} Nm ² and 10 ^{~ 2}

Nm ²

Preferably, the diameter of the circle circumscribing the section of the needle will not exceed about 4 mm. Even more preferably, the diameter of the circle circumscribing the section of the needle will not exceed about 3 mm.

The constituent material of the needle is a composite shape memory material which may comprise a multiblock copolymer and any type of particles and / or electrical and / or thermal conductive fibers.

[0159] Preferably, the polymers are selected from biocompatible polymers.

The surface of one end of the needle is electrically and / or thermally conductive so as to provide (or withdraw) rapid heat energy to the needle by allowing a temperature change by conduction of the entire the needle.

Said surface is connected to the particles and / or electrical and / or thermal conductive fibers constituting the needle. Said surface is connected to the particles and / or electrical and / or thermal conducting fibers included in the needle.

Preferably, the surface of the other end of the needle may be conductive so as to provide (or withdraw) quickly heat energy to the needle by allowing a temperature change by conduction of the entire body. 'needle.

Said surface is connected to the particles and / or electrical and / or thermal conductive fibers constituting the needle.

Said surface is connected to the particles and / or electrical and / or thermal conductive fibers included in the needle. The transition from the straight form to the curved shape is done when the temperature of the needle reaches a first transition temperature Tsi which is between about 38 and about 50 degrees Celsius.

Inversely, the passage of the curved needle to the right needle is done when the temperature of the needle reaches a second transition temperature TS ₂ which is between about 38 and about 50 degrees.

Celsius.

In this way, by controlling the temperature of one of the conductive surfaces, it is possible, thanks to the particles and / or conductive fibers included in the composite material, to control the shape of the needle and to modify it rapidly at any time.

[0169] Advantageously, Tsi = Ts ₂ = TS. Preferably, the surface of the needle can be treated to obtain a low coefficient of friction and thus facilitate penetration into the tissues. The composite material used has a sufficient thermal conductivity so that the temperature change is effected throughout the needle within a maximum of about 15 seconds, when heating or cooling the needle. .

Preferably, this time will be at most about 10 seconds.

Even more preferably, this time will be at most about 5 seconds. At one end of the needle is preferably attached a surgical suture wire conventionally used in surgery.

[0175] Advantageously, this needle can be used as a diathermic needle. [0176] Advantageously, the needle according to the present invention may also be used by other access routes than flexible therapeutic endoscopy such as for example through pediatric trocars.

FIGS. 1a and 1b show the three stable forms of the needle - curved form (stable form 2 shown in FIG. 1a) and straight form (stable form 1 and 3 shown in FIG. 1b) - according to a first embodiment preferred embodiment of the first aspect of the present invention. In this preferred embodiment, the end 1 of the needle is extended by a rectilinear segment.

The transition temperature between these forms is approximately 40 ^° C. The radius R of the curved shape of the needle is approximately 12.5 mm. The angle α formed by the radii joining the two ends of the curved portion of this needle is about 180 °.

The section of the needle is an equilateral triangle of height h equal to about 1.6 mm.

The needle comprises conductive fibers embedded in a polymeric material with shape memory.

The conductive fibers are bonded to the two conductive surfaces located at both ends of the needle.

[0185] At its end 2, the needle thins to form a bevel

[0186] At its end 1 is attached a surgical wire. Figures 2a and 2b show the three stable forms of the needle - curved shape (stable form 2 shown in Figure 2a) and straight form (stable form 1 and 3 shown in Figure 2b) - according to a second embodiment preferred embodiment of the first aspect of the present invention.

In this preferred embodiment, the end 1 of the needle does not extend by a rectilinear segment.

The end 2 of the needle is sharpened bevel.

The transition temperature between these forms is about 45 ° C.

The radius R of the curved shape of the needle is about 20 mm. The angle α formed by the radii joining the two ends of the curved portion of this needle is about 160 °. The section of the needle is a circle whose diameter d is about 2.8 mm.

The needle is made of a shape memory polymer material containing a co-continuous distribution of particles and / or conductive fibers.

At its end 2, the needle thins to form a tip.

[0196] At its end 1 is attached a surgical wire. As shown in FIG. 3a, the needle

100 may also be in the form of a shape memory polymer matrix 102 including isotropic conductive fillers 101 (e.g., carbon blacks).

As shown in FIG. 3b, the needle 301 may also be in the form of a shape memory polymer matrix 302 comprising conductive fibers (e.g., nanotubes).

As shown in FIG. 3, the needle may also be in the form of a coextruded polymer profile comprising at least two polymer layers 201,

202, the layers having distinct softening temperatures.

[0200] Preferably, a first polymer layer has a low softening temperature and a second polymer layer has a high softening temperature.

Preferably, the softening temperature of the second or second polymer is at least 100 ^° C. higher than that of the first polymer. Preferably, the softening temperature of the second or second polymer is at least 20 ^° C. higher than the softening temperature of the first polymer. [0203] Advantageously, the coextruded layers are in concentric form.

[0204] Preferably, the layer having a lower softening temperature is an inner or intermediate layer of the profile.

Advantageously, the profile further comprises a conductive core 203, formed of a wire or a layer of a conductive polymeric composite material. [0206] Preferably, another layer of the profile 201, isolated from the conducting core, is conductive, forming a coaxial conductor 204.

[0207] Preferably, at the needle head, the core layer 203 and the second conductive layer may be connected so as to form a circuit. [0208] Preferably, at the tail end, said layers are connected to current source so as to be able to generate Joule heating. Preferably, the connection between the conductive layers 201,203 at the needle head comprises a conductive metal insert 205.

[0210] Advantageously, the insert has a sharp shape.

The needle may for example be produced in the following manner: a poly-phase copolymer, having separate phases which can be co-continuous, is extruded using a die having the desired needle profile; a temperature above the melting temperature of the phase having the highest melting point;

the rod is formed directly in its curved form at the desired radius of curvature in the curved shape at a temperature greater than the melting temperature of the phase with the highest melting temperature;

The rod is solidified in its curved form by bringing it to a temperature between the melting temperature of the phase having the highest melting temperature and the melting temperature of the phase having the lowest melting point; the rod is formed in its straight form by applying an external mechanical stress and is cooled to a temperature below the melting temperature of the phase having the lowest melting point. The external mechanical stress is then removed and the right rod is obtained; - Cut the right ring to the desired length and sharpen it to get a needle;

[0212] Figure 4 depicts a two-jaw endoscopic forceps for grasping a foreign body located in the human body according to an embodiment of the second aspect of the present invention. Each of the jaws contains, on its inner part, a conductive surface (401) isolated from the rest of the clamp. To each conductive surface is soldered a conductive wire (402) which is connected to a current generator (406) located outside the patient's body. The current loop is closed by the foreign body.

The outlet (404a) of the fluid supply tube (404) is directed on one of the conductive parts (401) of the clamp.

The other end of the tube is connected to a tank (409) via a pump (407) controlled by a controller (408).

A thermocouple (405) is placed on one of the conductive parts and is connected to a measuring device temperature (410) related to a temperature control system (411) connected to a user interface (412). [0216] The user interface allows the user to enter the desired temperature setpoint and to display the temperature measured by the thermocouple (405).

The controller (411) allows a temperature regulation of the conductive parts of the clamp by acting on the controller (408) driving the pump (407) and / or on the current generator (406) as described in FIG. 8 Fig. 5 discloses a three-jaw clamp for holding a cylinder, for example, by its inner surface according to an embodiment of the second aspect of the present invention.

Each jaw contains, on its outer portion, a conductive surface (401) isolated from the rest of the clamp. On two of these conductive surfaces is welded a conductive wire (402) which is connected to a current generator (406) located outside the patient's body.

The current loop is closed by the foreign body. The outlet (404a) of the fluid delivery tube (404) is directed to one of the conductive portions (401) of the clamp.

A thermocouple (405) is placed on one of the conductive parts and is connected to a temperature measuring device (410) connected to a temperature control system (411) connected to a user interface (412). [0223] The user interface allows the user to enter the desired temperature setpoint and to display the temperature measured by the thermocouple (405).

The controller (411) allows a temperature regulation of the conductive parts of the clamp by acting on the controller (408) driving the pump (407) and / or on the current generator (406) as described in FIG. 8 .

[0225] At the third conductive portion is connected a conductive wire (403) for providing the necessary energy to the foreign body to perform electrocoagulation by diathermy.

Figure 6 depicts a catheter with an inflatable balloon (114) according to an embodiment of the second aspect of the present invention. The balloon (414) can be inflated by a fluid coming from the tube (415). The balloon (414) makes it possible, for example, to hold a cylinder by its inner surface. The ball

(414) is provided with two conductive surfaces (401) connected by a heating resistor (413), on its outer part, isolated from the rest of the catheter. On each of these conductive surfaces (401) is welded a conductive wire (402) which is connected to a current generator (406) located outside the body of the patient.

The outlet (404a) of the fluid supply tube (404) is directed on one of the conductive portions (401) of the balloon. The other end of the tube is connected to a tank

(409) via a pump (407) driven by a controller (408).

A thermocouple (405) is placed on the heating resistor (413) and is connected to a temperature measuring device (410) linked to a control system temperature (411) connected to a user interface (412).

[0230] The user interface allows the user to enter the desired temperature setpoint and to view the temperature measured by the thermocouple (405).

The controller (411) allows temperature regulation of the conductive portions (401) of the balloon (414) by acting on the controller (408) driving the pump (407) and / or the current generator (406) as described in Figure 8.

FIG. 7 depicts a catheter whose distal end surface comprises two conductive surfaces (401) connected by a heating resistor (413) isolated from the remainder of the catheter according to an embodiment of the second aspect of the present invention.

At the ends of this heating resistor are soldered two conductor wires (402) which are connected to a current generator (406) located outside the body of the patient. The outlet (404a) of the fluid supply tube (404) is directed to the heating resistor (413).

The other end of the tube is connected to a tank (409) via a pump (407) controlled by a controller (408). A thermocouple (405) is placed on the heating resistor (413) and is connected to a temperature measuring device (410) connected to a temperature control system (411) connected to a user interface

(412). The user interface allows the user to enter the desired temperature setpoint and to view the temperature measured by the thermocouple (405). The controller (411) allows a temperature regulation on the heating resistor (413) by acting on the pump (407) and / or on the current generator (406) as described in FIG. 8.

Examples

1. Transmural gastric plication

The needle shown in FIGS. 1a and 1b was used to perform a transmural gastric plication on an ex vivo pig stomach.

[0239] Said needle being inserted into the endoscope, in the right form, the experimenter pushes it through the wall located a few centimeters below the line Z.

Once inserted two-thirds through the gastric wall, it is heated to bend at 180 °.

The needle is then removed using the endoscope and its end 2 has been gripped by a clamp introduced into the second operator channel.

After completion of this first passage, the needle is cooled, returned, reinserted through the wall of the stomach, and heated again to return to its 180 ° curve.

This maneuver is performed three times consecutively in order to obtain a triple plication of

1 stomach.

The needle was then cooled and recovered straight through the operating channel of the endoscope.

A suture was performed on the 2 strands of the thread attached to the needle. 2. Overcast gastric suture

The needle shown in FIGS. 1a and 1b was used to perform a gastric plication in overlock on an ex vivo pig stomach.

[0246] In a first step, said needle is inserted in its straight form in the posterior face of

The antrum. [0247] It is then heated to bend to

180 °, recovered with the second operating channel of the endoscope, after having crossed, from the outside towards the inside, the gastric wall.

The needle and its thread are then brought back to a length of about 25 cm in the gastric cavity and the

2 strands emerging from the gastric wall are joined via the second channel operator.

The needle is then cooled, reinserted into the anterior wall of the stomach, reheated, recovered in the gastric cavity, cooled, reinserted into the posterior wall of the stomach, reheated and recovered in the gastric cavity, and thus immediately to obtain a suture of five or six sutures, to affix the posterior face of the stomach to its anterior face. [0250] At the end of the overlock, the needle is recovered in the gastric cavity, bent under the effect of heat and inserted between the stitches of the last overlock, to achieve a double surgical knot.

3. NOTES template

[0251] In a model of NOTES (Natural Orifice Transluminal Endoscopy Surgery), on a living animal, a Iatrogenic perforation of the gastric cavity is performed using a diathermic needle and a balloon dilation of about 18 mm.

The endoscope is inserted into the peritoneum and, at the removal of the latter, the needle, described in Figures la and Ib, is inserted in its straight form into the endoscope, the gastric wall having been punctured.

At this time, the needle is heated to bend at 180 °. Its end then punctures the contralateral external wall of the stomach, with respect to the orifice.

[0255] The needle is recovered in the gastric cavity and is then cooled.

A new puncture is performed, shifted by 90 ° from the previous one, with the needle in its straight form.

The needle is then warmed, recovered in the gastric cavity and, on the two strands resulting from this cross point, a suture is applied.

4. Suture in rigid endoscopy

The needle shown in Figures la and Ib is inserted in its right form, in the peritoneum of a living animal, through a pediatric trocar. Once in the peritoneum, it is heated to bend at 180 °. We then have a curved needle in the peritoneum that we can use as a conventional surgical needle to perform a suture. Once the suture is done, the needle is cooled to its right shape. It is thus removed from the peritoneal cavity through the pediatric trocar. [0260] If one has a straight needle that can be inserted into a pediatric trocar and which has the distinction of being formed of a material changing its configuration to a higher temperature (for example above the maximum temperature of the body human (> 40 ° C)), the right needle can be grasped by the present invention, inserted straight into the peritoneal cavity through the pediatric trocar, heated through the present invention, resulting in its flexion. A curved needle is then placed in the peritoneal cavity that can be used as a conventional surgical needle to perform a suture. Once the suture is performed, the needle is cooled through the tool according to the second aspect of the present invention to its right shape and can thus be removed from the peritoneal cavity through the pediatric trocar.

Claims

claims

A surgical shape memory needle comprising a needle body: having two ends (1,2), a proximal end (1) and a distal end (2),

said body having at least two different stable forms, a first form stable at a first temperature range (T1) and a second form stable at a second temperature range (T2), the first temperature range being strictly less than the second temperature range; temperature range, characterized in that:

the material constituting the body of the needle comprises at least one insulating material with shape memory and at least one conductive material or a conductive thermal and / or electrical charge,

the entire body of the needle is able to be heated or cooled.

2. Surgical needle according to claim 1 characterized in that the entire body of the needle is heated by applying a source of heat and / or current to obtain a transformation of the first to the second stable form.

3. Surgical needle according to claim 1 or 2 characterized in that the insulating material comprises a polymeric matrix, and in particular a multi-block copolymer which comprises at least two types of block defining two polymers.

4. Surgical needle according to claim 3 characterized in that the first type of block has a low softening temperature and the second or second type of block has a high softening temperature.

5. Surgical needle according to claim 4 characterized in that the softening temperature of the first type of block is lower than the softening temperature of the second or second type of block.

6. Surgical needle according to claims 4 or 5 characterized in that the softening temperature is either a glass transition temperature or a melting temperature.

7. Surgical needle according to any one of claims 3 to 6 characterized in that each of the block types has at least two functions end alcohols.

8. Surgical needle according to any one of the preceding claims 3 to 7, characterized in that the multiblocks are obtained as a reaction product of several blocks comprising at least two terminal alcohol functions each with diisocyanates.

9. Surgical needle according to any one of the preceding claims 3 to 8, characterized in that the polymeric matrix results from the reaction of a first polymer and a second or second polymer with a diisocyanate in which both the first and second the second polymers include alcohol functions at the end of the chain.

10. Surgical needle according to any one of the preceding claims 3 to 9 characterized in that the softening temperature of the first polymer is between 30 and 60 ⁰ C, preferably between 38 and

50 ⁰ C, preferably between 40 and 45 ° C.

11. Surgical needle according to any one of the preceding claims 3 to 10 characterized in that the softening temperature of the first polymer is the transition temperature between the two stable forms of the needle.

Surgical needle according to any one of the preceding claims 3 to 11, characterized in that the softening temperature of the second or second polymer is at least 100 ^° C. higher than that of the first polymer and preferably at least 20 ^° C. ⁰ C to that of the first polymer.

13. Surgical needle according to any one of the preceding claims 3 to 12 characterized in that the first polymer and the second or second polymer form separate phases.

Surgical needle according to any one of the preceding claims 3 to 13, characterized in that the two polymers are selected from the group consisting of aliphatic polyesters, aliphatic polyester-alters, aliphatic polycarbonates, poly (ethylene glycol) and all their combinations.

15. Surgical needle according to any one of the preceding claims 3 to 14, characterized in that the two polymers are selected from the group consisting of polycaprolactone, poly (para-dioxanone), poly (ethylene glycol), random copolymer of polycaprolactone-polylactide poly (para-dioxanone-caprolactone) random copolymer, polycaprolactone-polyglycolide random copolymer, polycaprolactone-polylactide-polyglycolide random copolymer, polylactide, random copolymer of polycaprolactone-poly (.beta.-hydroxybutyric acid), poly (.beta. - hydroxybutyric acid), and combinations thereof.

Surgical needle according to one of the preceding claims 3 to 15, characterized in that the diisocyanate is selected from the group consisting of 4,4'-diphenyl methylene diisocyanate, toluene-2,4-diisocyanate, toluene-2,6 diisocyanate, hexamethylene-1,6-diisocyanate, isophorone diisocyanate, 4,4'-diphenylmethane diisocyanate hydrogenated and mixtures thereof.

Surgical needle according to any one of the preceding claims 3 to 16, characterized in that the multiblock polymer is composed of a statistical alternation of polycaprolactone type blocks, preferably having a melting point of between 40 ° and 45 ° C., and blocks of a random copolymer of caprolactone and polyester-alt-ether preferably having a melting point between 60 and 70 ^° C.

18. Surgical needle according to any one of the preceding claims, characterized in that the thermal and / or electrical conductive material is an electrical connection.

19. Surgical needle according to any one of the preceding claims, characterized in that the thermal and / or electrical conductive material is a thermal and / or electrical conductor wire.

20. Surgical needle according to any one of the preceding claims characterized in that the thermal and / or electrical conductive filler is embedded in the insulating material, said filler being present at a concentration greater than its percolation threshold.

21. Surgical needle according to claim 20, characterized in that the percolation threshold is the concentration from which the charge forms a continuous conductive network.

22. Surgical needle according to any one of the preceding claims, characterized in that the thermal and / or electrical conductive filler is in the form of powder, fiber or sheets preferably of dimensions between about 10 microns and 1 nm.

Surgical needle according to any one of the preceding claims, characterized in that the conductive filler is selected from the group consisting of carbon blacks, carbon fibers, carbon nanofibers, carbon nanotubes, graphene sheets (exfoliated graphite), or a mixture of these.

24. Surgical needle according to any one of the preceding claims, characterized in that the first stable form is rectilinear.

Surgical needle according to any one of the preceding claims, characterized in that the second stable form is curved.

26. Surgical needle according to any one of the preceding claims characterized in that the first stable form is a rectilinear shape, while the second stable form is a curved shape.

27. Surgical needle according to any one of the preceding claims, characterized in that the entire body of the needle is able to be cooled by applying a source of cold.

28. Surgical needle according to claim 27, characterized in that the temperature variation induced by the cold source in the needle allows the transition from the second stable form to a second temperature range to a third stable form to a third range of temperatures. temperature.

Surgical needle according to claim 28, characterized in that the third stable form corresponds to the first stable form.

30. Surgical needle according to any one of the preceding claims, characterized in that said source of heat and / or current is in direct contact with one of the ends, preferably the proximal end of the needle.

31. Surgical needle according to any one of the preceding claims 27 to 30 characterized in that said source of cold is in direct contact with one of the ends, preferably the proximal end of the needle.

32. Surgical needle according to any one of the preceding claims, characterized in that at least one of the ends, and preferably the proximal end of said needle is made of a thermal and / or electrical conductive material which is different or identical to the material. thermal and / or electrical conductor included in the body of the needle.

33. Surgical needle according to any one of the preceding claims characterized in that said proximal end is in direct contact with said conductive material included in the body of the needle.

34. Surgical needle according to any one of the preceding claims, characterized in that the transition between the first and the second stable form takes place at a first transition temperature.

Surgical needle according to one of the preceding claims 28 to 34, characterized in that the transition between the second and the third form stable is carried out at a second transition temperature.

36. Surgical needle according to any one of the preceding claims, characterized in that the transition between said first and second forms takes place at a transition temperature between a minimum temperature corresponding to a temperature just above body temperature of about 38 ° C. ° C and a temperature of about 50 ⁰ C, preferably at a transition temperature between 40 ⁰ C and 45 ° C.

37. Surgical needle according to any one of the preceding claims, characterized in that the distal end of the needle is sharpened.

38. A surgical needle according to any preceding claim characterized in that the distal end of the needle has a metal or ceramic insert to ensure the integrity of its sharpening.

39. An endoscopic tool for controlling the temperature of a foreign body or surgical instrument such as an endoscopic needle and in particular according to any one of the preceding claims, characterized in that it is composed of three parts:

a distal end which is the end penetrating into the human or animal body and comprising at least one conductive part;

a flexible or rigid body comprising a conductive part; a proximal end which is the end remaining outside the human or animal body.

40. Tool according to claim 39 characterized in that the distal end is in contact with the foreign body.

41. Tool according to claim 39 or 40 characterized in that the distal end of the tool is adapted to attach to the foreign body, such as a needle, to heat or cool.

42. Tool according to any one of the preceding claims 39 to 41 characterized in that the distal end has at least one conductive portion preferably electrical and / or thermal which is heated or cooled in a controlled manner.

43. Tool according to any one of the preceding claims 39 to 42 characterized in that the conductive portion is part of the contact interface with the foreign body.

44. Tool according to any one of the preceding claims 39 to 43 characterized in that the conductive portion is in contact with the foreign body.

45. Tool according to any one of the preceding claims 39 to 44 characterized in that the conductive portion or portions are connected to two conductive connections isolated from the rest of the tool and its environment.

46. Tool according to claim 45 characterized in that these two connections in the form of son to perform a closed current loop through the conductive part or parts with or without the foreign body.

47. Tool according to claim 46 characterized in that the current flowing in this or these conductive parts also passes into the foreign body and heated by Joule effect.

48. Tool according to any one of the preceding claims 39 to 47, characterized in that the conductive part (s) are cooled by spraying them or putting them in contact with a refrigerated fluid preferably coming from a supply tube whose The distal end coincides with the distal end of the tool.

49. Tool according to any one of the preceding claims 39 to 48, characterized in that the conductive part (s), with the exception of the two connections, are thermally and electrically insulated from the remainder of the tool.

50. Tool according to any one of the preceding claims 39 to 49 characterized in that at least one temperature sensor is present on one of the conductive parts of the tool, this sensor for measuring the temperature of the foreign body to allow a temperature control of the foreign body.

51. Tool according to claim 50 characterized in that this temperature sensor is a thermocouple.

52. Tool according to any one of the preceding claims 39 to 51 characterized in that the distal end comprises a clamp.

53. Tool according to any one of the preceding claims 39 to 52 characterized in that the distal end is a clamp.

54. Tool according to any one of the preceding claims 39 to 51 characterized in that the distal end comprises a clamp with at least two inner jaws.

55. Tool according to any one of the preceding claims 39 to 51 characterized in that the distal end is a clamp with at least two inner jaws.

56. Tool according to any one of the preceding claims 39 to 51 characterized in that the distal end comprises a clamp with at least two outer jaws.

57. Tool according to any one of the preceding claims 39 to 51 characterized in that the distal end is a clamp with at least two outer jaws.

58. Tool according to any one of the preceding claims 39 to 51 characterized in that the distal end coincides with the end of a catheter.

59. Tool according to any one of the preceding claims 39 to 51 characterized in that the distal end comprises an inflatable balloon.

60. Tool according to any one of the preceding claims 39 to 51 characterized in that the distal end is an inflatable balloon.

61. Tool according to any one of the preceding claims 39 to 51 characterized in that the distal end comprises a vacuum.

62. Tool according to any one of the preceding claims 39 to 51 characterized in that the distal end is a vacuum.

63. Tool according to any one of the preceding claims 39 to 62, characterized in that the distal end which serves for temperature control corresponds to the distal end of most of the conventional instruments used in endoscopy.

64. Tool according to any one of the preceding claims 39 to 63 characterized in that the body of the tool comprises at least one transport means such as a tube and / or electrical son to transport the energy necessary to cool and / or to heat the conductive part or parts.

65. Tool according to claim 64 characterized in that the energy transport means are constituted by a conduit for supplying a fluid such as water or a gas for cooling the foreign body and by two conductive connections for supplying electric power or thermal energy.

66. Tool according to any one of the preceding claims 39 to 65, characterized in that the body of the tool comprises at least one transfer means for measuring the temperature.

67. Tool according to any one of the preceding claims 39 to 66 characterized in that the proximal end comprises at least connectors necessary for connecting it to at least one energy source.

68. Tool according to any one of the preceding claims 39 to 67 characterized in that the proximal end of the tool comprises at least one connector for connecting the transfer means of the measurement of the temperature located in the body of the body. tool to a data acquisition system that is linked to a temperature controller.

69. Tool according to claim 67 or 68 characterized in that a first energy source is a power supply.

70. Tool according to claim 67 or 68 characterized in that the first source of energy is a heat supply.

71. Tool according to claim 67 or 68, characterized in that the first energy source is a supply of current and heat.

72. Tool according to any one of the preceding claims 67 to 71, characterized in that the second energy source is a supply of cooling fluid.

73. Tool according to any one of the preceding claims 67 to 71 characterized in that the second energy source is a cold water supply.

74. Tool according to any one of the preceding claims 39 to 73, characterized in that one of the conductive connections makes it possible to supply the energy required for the foreign body to perform electrocoagulation by diathermy.

75. Tool according to any one of the preceding claims 39 to 74, characterized in that a third conductive connection is provided for connecting the conductive part of the tool so as to be able to supply the energy required by the foreign body to carry out the electrocoagulation by diathermy.