WO2011061047A1

WO2011061047A1 - Sampling module and intestinal shuttle comprising said sampling module

Info

Publication number: WO2011061047A1
Application number: PCT/EP2010/066384
Authority: WO
Inventors: Roland Duffait; Denis Sauget
Original assignee: Institut Pierre Vernier
Priority date: 2009-11-18
Filing date: 2010-10-28
Publication date: 2011-05-26
Also published as: FR2952520B1; FR2952520A1

Abstract

The invention relates to a material sampling module including a first type of elementary body (1) including an opening (40), a cutting member (34), means for actuating the cutting member, means for triggering said actuation means, wherein the actuation means includes: a sliding axis (30) rigidly connected to the cutting member; pliers (31) provided with means (32) for stressing the axis rigidly connected to the cutting member and mounted so as to be capable of sliding inside the body; first linear means (33) being capable of moving from a compression state to a release state for interaction with the pliers; second linear means (34) capable of moving from a compression state to a release state, characterized in that said second linear means are mounted on the axis rigidly connected to the cutting member and interact with the cutting member, wherein said module further comprises: intermediate linking means (335) between the first linear means and the second linear means; the triggering means (38) being mounted so as to interact with the second linear means capable of moving from a compression state to a release state in order to release the sliding axis driving the cutting member into a first material suction position from an initial position and releasing the sliding axis of said pliers, said released sliding axis placing the cutting member into a second material sampling position by means of the first linear means capable of moving from a compression state to a release state and of acting on the second linear means via the intermediate means.

Description

Sampling module and intestinal shuttle comprising said sampling module.

The field of the invention is that of small sampling modules intended to be introduced into cavities of very small dimensions for the inspection and monitoring of sensitive conduits or human tissue, constituting the same modules of biopsy can advantageously be used in the field of intestinal endoscopy.

In this field, the intestinal shuttles still called intestinal endoscopic capsules can act in-vivo in the body by exploring almost all of the small intestine non-invasively.

To date, video capsules have been developed with a view in particular to the search for unexplained bleeding, screening for bowel cancer or even aid in the diagnosis of a disease such as Crohn's disease.

By way of example, there may be mentioned a type of capsule equipped with video means which, once ingested by the patient, progresses regularly and without pain along the gastrointestinal tract. During the gastrointestinal crossing, the capsule transmits video signals that are stored in a receiving unit. These signals also allow the system to follow the physical path of the capsule. The capsule is then eliminated spontaneously by natural routes.

A wireless recorder worn on a belt at the waist is provided, to capture the signals transmitted by the capsule via a set of antennas placed on the abdomen.

An IT workstation processes the data and produces a short video clip of the gut explored. The workstation thus offers the physician the ability to view, edit and archive the video as well as save individual images and / or short video clips.

In order to improve the diagnosis of certain pathologies, it is also necessary to be able to take samples in situ, to analyze certain malignant tissues, this examination being advantageously able to be carried out in synergy with the image processing. Therefore, it becomes particularly interesting to be able to design intestinal capsules with a sampling feature.

In this context, it has in particular been disclosed a number of solutions that have been the subject of patent applications such as the application WO 2005/1 12460. This application relates to a system comprising elementary devices including one includes an imager and means transmission of data collected in vivo and a sampling device. These means may also be coupled to a sampling device comprising an articulated collection arm intended to be projected out of a storage cavity, thereby constituting a bulky volume of sampling. In this type of device, the elements protruding from the body of the capsule (articulated arm in particular) may constitute a risk of blockage thereof in the intestine, thereby degrading the safety of operation.

It has also been disclosed in the patent application WO 2005/120325, a biopsy module comprising a cutting member movable in a first direction parallel to the sampling duct and coupled to a cavity comprising suction means in a direction perpendicular to said first direction, also constituting a relatively large space module.

Another type of biopsy module has also been described in the patent application FR 2,688,997. It is a functional exploration device comprising a tip, in the form of a cylinder provided with two chambers. and separated by a support flange of a knife. The chamber located in front of the knife is provided with an opening cooperating with a removable closure device, the cylindrical knife with a helical cutting edge making it possible to perform a biopsy of the mucosa for example. One of the chambers also comprises a spiral spring connected at its inner end to an axis integral with the knife support and connected at its other end to a through pin, in the locking position before sampling.

The assembly makes it possible to propose a complex solution combining translational and rotational movements constituting at the same time a solution of relatively large size, to consider a miniaturization.

It is also known from US patent 2001/051766, a material removal module comprising a cutting member and actuating means of this member. Nevertheless, this device has a little compact cutting mechanism.

In this context, the present invention relates to a sampling module, biopsy module type to solve the problem of miniaturization and simplicity and without any part beyond the body of the capsule, proposing to use operations suction and cutting of fabric only by exploiting linear mechanisms of back and forth.

More specifically, the subject of the present invention is a material sampling module comprising a first type of elementary body (1) equipped with an opening (40), a cutting member (34), actuating means of the cutter and trigger means of said actuating means, the actuating means comprising:

- An axis (30) sliding integral with the cutting member;

- A clamp (31) equipped with means (32) for constraining the integral shaft of the cutting member and mounted so as to slide within the body;

first linear means (33) capable of passing from a state of compression to a state of expansion cooperating with said clamp;

second linear means (34) capable of passing from a state of compression to a state of relaxation,

characterized in that said second linear means being mounted on the integral axis of the cutting member and cooperating with the cutting member, said module further comprises:

intermediate connecting means (335) between the first linear means and the second linear means;

the triggering means (38) being mounted to cooperate with the second linear means capable of passing from a state of compression to a state of expansion, so as to release the sliding axis driving the cutting member into a first position sucking material from an initial position and releasing the sliding axis of said clamp, said released sliding axis putting the cutting member in a second material removal position under the action of the first linear means capable of passing from a state of compression to a state of relaxation and to act via the intermediate means on the second linear means.

According to a variant of the invention, the first linear means capable of passing from a state of compression to a state of expansion are constituted by a first spring.

According to one variant of the invention, the second linear means capable of passing from a state of compression to a state of expansion are constituted by a second spring.

According to a variant of the invention, the module comprises a retaining ring of the clamp in the stress position at the sliding axis, this ring serving to facilitate the mounting of the clamp.

According to a variant of the invention, the clamp is positioned in a bore inside said body.

According to a variant of the invention, the cutting member is positioned in front of the opening of said body in the initial position and in the second position, the opening being disengaged in the first position of the cutting member and allowing the suction of species to be taken, the second position of the cutting member for taking and closing a sampling chamber within which can be maintained species taken.

According to a variant of the invention, the cutting member is a circular element having a sharp peripheral end.

According to a variant of the invention, the module further comprises two O-rings mounted on the circular cutting member.

According to a variant of the invention, the module further comprises a compartment containing a species conservation fluid to be sampled.

According to a variant of the invention, the compartment containing the preservation fluid comprises opening means co-operating with the second position of the cutting member and being able to be perforated by the cutting member so as to spread a preserving fluid. in said sampling chamber. According to one variant of the invention, the triggering means comprise a miniaturized system comprising active materials of the type of shape memory alloys or ferroelectric materials.

According to a variant of the invention, said first type of elementary body providing a first type of sampling functionality and other type (s) of elementary bodies providing another (s) type (s) of functionality.

According to a variant of the invention, another type of functionality is of the active agent release type

According to a variant of the invention, another type of functionality is of the imaging type.

According to a variant of the invention, the module comprises a body comprising a central body and peripheral elementary bodies.

According to a variant of the invention, the elementary body or bodies are molded in a unitary piece.

The invention also relates to an intestinal shuttle characterized in that it comprises a sampling module according to the invention.

The invention will be better understood and other advantages will become apparent on reading the description which follows given by way of non-limiting example and by virtue of the appended figures among which:

FIG. 1 illustrates an example of a biopsy module according to the invention;

FIGS. 2a, 2b and 2c illustrate the main components constituting an elementary body of a biopsy module;

FIGS. 3a, 3b and 3c illustrate the three positions in which a sampling module according to the invention can be found at rest and during operation;

FIG. 4 illustrates the body of an intestinal shuttle according to the invention comprising a central body dedicated to imaging and a set of peripheral elementary bodies dedicated to sampling operations according to the invention.

The present invention will be described in the context of sampling tissue and especially human tissue and this as part of a shuttle intestinal. Nevertheless, the sampling module of the invention can equally well be used for all types of sampling.

In general and as illustrated by the example of Figure 1, the biopsy module of the invention comprises an elementary body 3 comprising an opening 40, inside which are arranged a number of components presented more 2a, 2b and 2c.

FIG. 2a relates to parts in volume, FIG. 2b illustrating the same parts in section, FIG. 2c relating to the cutter of the cylindrical knife type, associated with O-rings.

Thus all of these figures highlight:

an axis 30;

a clamp 31;

a retaining ring 32 of the clamp 31. This retaining ring only serves to facilitate the assembly of the latter, keeping it closed to introduce it into the bore 335. At the time of its assembly in this piece, it remains outside the bore, so it can not interfere with the operation;

a first spring 33;

connecting means 335 between the spring 33 and the spring 35;

a knife 34;

a second spring 35;

two O-rings 36 and 37;

- a trigger 38.

The cross-sectional view of the connecting piece 335 reveals a recessed portion at the inner periphery allowing the spring 33 to come to bear inside this part while the opposite end at the outside is dedicated to the support of the second spring 35.

The sectional view of FIG. 2c highlights the cutting member

34.

All of these parts are incorporated in a linear assembly of small size, in the elementary body 3, an end portion of the body being dedicated to the storage of the sampled material. The Applicant proposes a system based on the aspiration of tissues to be taken inside a storage chamber through a calibrated window.

The knife 34, integral with the sliding shaft 30, then cuts the tissues and close the chamber in which they were previously sucked.

The storage chamber is, if necessary, equipped with a micro-device for delivering a preservative liquid, not shown.

The operating principle is illustrated by FIGS. 3a, 3b and 3c.

Initial state :

Figure 3a illustrates this state: the flexible clamp 31, normally open at rest, is mounted in a closed position in a bore adapted in diameter and length through a ring 32 which traps the axis of the knife.

The flexible clamp 31 is held in closed position in a bore adapted in diameter and length, but in this position, the ring 32 no longer plays any role. It only serves to keep the clamp closed during mounting in the bore.

The first spring 33 said opening is maintained in a compressed state and secured to the second so-called cutting spring via the connecting member 335 which accommodates on one side the first spring and the other the second spring. The knife 34 is positioned in front of the opening 40, closing the latter in a sealed manner.

First state:

FIG. 3b illustrates this state: during actuation by the trigger 38, the axis of the knife is released by a thrust via the second spring and the connecting element, made on the first spring 33 said opening which thus pushes the knife 34 in the direction of opening the window by pressing on the base of the flexible clamp. The knife 34 is no longer opposite the opening 40, releasing the latter and outer tissues elementary bodies can be sucked by the depression created by the recoil of the knife, or (and) by an artificial depression additional, seals 36 and 37 properly placed ensuring the tightness necessary for the creation of this aspiration.

Second state:

Figure 3c illustrates this state: when the flexible clamp out of its bore, it opens, releasing the axis of the knife. The latter is violently pushed back in the direction of closing the window, cutting tissue sucked into the room.

As the knife moves back a greater length, it is possible for it to come, on the one hand, close the chamber completely leakproof next to the opening 40 and on the other hand, to come drill a container if necessary flexible and thin containing preservative liquid having been provided for this purpose. It should be noted that the sealing of the movable knife must be sufficient to carry out the suction inside the storage chamber of the tissues to be removed. If, however, this solution proves to be insufficient, an additional vacuum can easily be achieved, either in the storage chamber or in a chamber specifically provided for this purpose. The latter solution, however, is at the expense of the volume occupied by the biopsy system.

This biopsy module provides many benefits:

- It does not use electronics but a mechanical energy stored in the system;

all the components used makes it possible to envisage low-cost manufacturing and therefore to consider large series;

- It does not cause thermal release, allowing to consider meeting the constraints imposed by medical standards and meeting the limits allowed for intracorporeal devices;

- It offers perspectives of energy efficiency particularly interesting insofar as the expected return of the consumption of electrical energy is reduced to its maximum because all the energy necessary for the realization of the function has been previously stored; - It achieves its own aspiration using in particular two springs which exert a movement of go and come and therefore allow not to have a depression chamber;

finally, the linearity of the assembly constitutes a major asset allowing a greater miniaturization with respect to a rotary system such as that described in the patent application FR 2,688,997.

- The biopsy module is sufficiently miniaturizable to be included in the intestinal shuttle;

several samples are possible because several modules can be distributed around the intestinal shuttle which, on the one hand, has the advantage of facilitating manipulations by reducing the orientation operations in the vicinity of a sampling zone (at the at least four windows can select the sampling area, which is why the trigger must be selective) and, secondly, to allow the repetition of biopsy operations during the same intestinal transit;

- The module can also advantageously include a conservative liquid device (layout of the area where the sample is stored).

Example of an intestinal shuttle comprising biopsy modules according to the invention:

FIG. 4 thus illustrates an example of an intestinal shuttle comprising a body 1, comprising a central body 2, and a set of elementary bodies 3, 4, 5 and 6 distributed peripherally.

Each elementary body constitutes a sampling module, or even in the present case: a biopsy module, advantageously the central body can be equipped with shooting means and this operating at 360 degrees.

This type of configuration is particularly interesting in the measurement, where during an exploration phase, it allows to perform successive sampling throughout the intestinal tract. Indeed, it is particularly relevant to be able to selectively control this or that elementary module of biopsy in connection with collected images. without having to introduce movements of the capsule integrating all the bodies, always source of inconvenience and complication in the context of an intestinal exploration.

Typically, the dimensions of a single biopsy module may be of the order of 3 mm for the diameter of an elementary body and 20 mm in length.

In this configuration, four elements can be inserted into the intestinal shuttle or capsule, providing a central free space of about 4 to 5 mm in diameter over the entire length of the intestinal capsule.

According to other variants of the invention, the capsule comprises a higher number of elementary biopsy module, typically this number may be 6 or even 8.

Claims

1. Material sampling module comprising a first type of elementary body (1) equipped with an opening (40), a cutting member (34), means for actuating the cutting member and triggering means said actuating means, the actuating means comprising:

- An axis (30) sliding integral with the cutting member;

the triggering means (38) being mounted to cooperate with the second linear means capable of passing from a state of compression to a state of expansion, so as to release the sliding axis driving the cutting member into a first position suction of material from an initial position and releasing the sliding axis of said clamp, said sliding axis released putting the cutting member in a second material removal position under the action of the first linear means likely to pass from a state of compression to a state of relaxation and to act via the intermediate means on the second linear means.

2. sampling module according to claim 1, characterized in that the first linear means capable of passing from a compression state to a state of expansion are constituted by a first spring.

3. sampling module according to one of claims 1 or 2, characterized in that the second linear means capable of passing from a compression state to a state of relaxation are constituted by a second spring.

4. sampling module according to one of claims 1 to 3, characterized in that it comprises a retaining ring of the clamp in the stress position at the sliding axis.

5. sampling module according to one of claims 1 to 4, characterized in that the clamp is positioned in a bore inside said body.

6. sampling module according to one of claims 1 to 5, characterized in that the cutting member is positioned in front of the opening of said body in the initial position and in second position, the opening being disengaged in the first position of the cutting member and allowing the aspiration of species to be taken, the second position of the cutting member for constituting a sampling chamber within which can be maintained the sampled species.

7. sampling module according to claim 6, characterized in that the cutting member is a circular element having a sharp peripheral end.

8. sampling module according to claim 7, characterized in that it further comprises two O-rings mounted on the circular cutting member.

9. Sampling module according to one of claims 1 to 8, characterized in that it further comprises a compartment containing a species of conservation fluid to be taken.

The sampling module according to claim 9, characterized in that the compartment containing the preservation fluid comprises opening means cooperating with the second position of the cutting member and being perforated by the cutting member so as to spread the preservation fluid in said sampling chamber.

1 1. Sampling module according to one of claims 1 to 10, characterized in that the triggering means comprise a miniaturized system comprising active materials type memory alloys or ferroelectric materials.

12. Sampling module according to one of claims 1 to 1 1, characterized in that it comprises said first type of elementary body providing a first type of sampling functionality and other type (s) body elementals providing another type (s) of functionality.

13. Sampling module according to claim 12, characterized in that another type of functionality is of the active ingredient release type.

14. Sampling module according to claim 12, characterized in that another type of functionality is of the imaging type.

15. Sampling module according to one of claims 12 to 14, characterized in that it comprises a body (1) comprising a central body (2) and peripheral elementary bodies (3, 4, 5, 6).

16. Sampling module according to one of claims 1 to 15, characterized in that the body or the elementary bodies are molded in a unitary piece.

17. intestinal shuttle characterized in that it comprises a sampling module according to one of claims 1 to 16.