FR2726993A1 - Inflatable separator for anatomical tissues during surgery - Google Patents

Abstract

The separator, designed for one-time use and especially for coelioscopic surgery, comprises a series of tubular fingers (A1, A2, A3) made from a synthetic, sterilisable and supple material such as polyethylene or polyurethane. The fingers are linked to a crown (C) and connected by intermediate tube (B) at right angles to them. The separator can occupy two positions one in which it is deflated and fitted inside a cylindrical applicator for insertion into an operation site, and a second in which it is inflated to form a truncated conical structure with an open base to delimit the operating field.

Description

INFLATABLE DEVICE FOR SINGLE USE FOR SPREADING
ANATOMIOUS TISSUES ESPECIALLY IN SURGERY
COELIOSCOPIOUE AND ITS APPLICATION EQUIPMENT.

 Given the current state of the art, performing surgical procedures by laparoscopy requires the use of carbon dioxide which keeps certain tissues apart from one another: the intervention being performed in this space.

Gas blowing imperatively requires sealing of the entry points of the instruments for which it is necessary to use special trocars allowing both the passage of the instruments and the return of the gas. The use of this technique, in particular in the detachment of peritin for certain laparoscopic approaches to inguinal hernias, is not without drawbacks: the main one being the absorption of carbon dioxide by the pre-peritoneal tissues resulting in high rates of this gas in the blood sometimes forcing to give up this technique.

Several solutions have been proposed:
~ On the one hand the wall suspenders which are generally metallic instruments passed through the wall to be lifted and which make it possible to maintain it in this position @ by hanging it for example on a poteace or on a more sophisticated system making it possible to dose the strong exerted. Their advantage is to be able to dispense with gas at least temporarily. There are many incouvémi @ nts necessity of gas use for their installation, several additional orifices and especially k risk of contact dc the traction zone with material not sterile
On the other hand, one of the solutions which made it possible to dispense with gas at least during the dissection times, is the use of dissection flasks, which are introduced empty via a trocar and then they are inflated with water or air. Their distension causes detachment of the pleas of the anatomical tissues, in particular between the peritoneum and the abdominal muscular wall. The advantage is to save time by avoiding a long and tedious dissection. several of these balloons is to carry out a detachment in the blind, risking to tear off certain fragile vessels from the wall. One of them allows the maintenance of an optic inside the gouging zone; the visual control is then done through the membrane of the balloon which gradually distends The disadvantage of this balloon remains the possibility of lesion of the vessels even if they are v @ s; the impossibility of intervening or perfecting the dissection as long as k balloon is in pla This; the need to remove the balloon and to breathe carbomic gas to resume dissection or carry out the rest of the intervention.

B. therefore seemed necessary to find a device allowing:
~ instrumental dissection during inflation which gradually creates the operating space
to continue and complete the intervention while leaving it in place
~ to serve as a retractor while maintaining the tissues
~ to do without carbon dioxide
~ not to necessarily use trocars
The device consists of a flexible material ~ polyethylene, polyurethane or any other synthetic material ~ which can withstand an inflation pressure by air or water. It is formed of several goolable tubular digitations deviating from each others as they are inflated. These digitations are joined together by transverse tubes also inflatable at the same time or separately. The aim being to spread the tissues, to maintain them and to free up an operating area sufficient to carry out a surgical intervention. The tmbal digitations are united on a common part also inflatable in the shape of a crown. On this is fixed a flexible tube long enough to be externalized from an abdominal wall and of a diameter sufficient to let pass an optic usual laparoscopy -10 to 12 12mm or louse
FIG. 1 represents the overall appearance of the device left in place in the surgical area: introduced by the incision (11), it is opened by inflation by the tube (4); it allows the operating region to be cleared ( 12) to which of
instraments can be directed from the incisions (9) and (10). The tubular digitations (A1, A2 and A3) are represented as well as the intermediate tubes (B1 and B2) .The tube (D), disturbing a tongue ( E) is externalized by the incision (11); it is integral with the crown (C) on which the tubular digitations (A1, A2 and A3) are attached.

 FIG. 2 shows the appearance of the device from its lower part. There are 6 tubular digitations and intermediate tubes here.

 The whole delimits an operating space (ZO) of hexagonal shape.

 Figure N 3 shows k inflated and unfolded device bers of the anatomical operating area: the tubular digitations (A1,2 ... 6) starting from the crown (C) peeled away from their ends by ks intermediate tubes (B1,2 .... 6), form a frustoconical structure whose apex is the crown (C) and the base the operating space (ZO). Without modifying its shape, the device can include additional intermediate tubes (B ').

 Figure N04 shows k detail of the end of the tubular digitations on which are attached spinning panels (1) which allow the deflated device to be temporarily secured to the application system. Each tab, fixed at each end of (A) is formed by a body (1), flexible, perforated with an orifice (2); it is welded or in continuity with (A) at the level of the zone (3) .

 Figure N05 represents tubular digitations which can be reinforced at their lower part either by a second tube (7) or by thickening (8) making it possible to arch the tube (A).

 Figure N06 shows the possibility of using 2 separate inflation tubes (41) and (42). One inflating the crown (C) and the tubes (A), the other the intermediate tubes (B).

 Figure N07 shows the possibility of attaching accessory tubes (Z1) and (Z2) for the passage of surgical instruments, at the level of the tubular digitations, for example (Al) and (A3).

 Figure N 8 shows the application system of the device consisting of an axis (J) and a rigid tube (K). The axis (J) is terminated by a thread (I) which can be screwed onto the area (H); at the other end a small sphere (L) carrying two lateral fins (M) allows the axis to rotate on itself. The rigid tube (K) carries at its lower end a warhead (N). It is windowed immediately above the warhead through two openings (G).

 Figure N 9 shows another possibility of temporary attachment of the axis (J) and rigid tube (K) at their upper ends two thin metal blades (O) terminated by a lug (P) are fixed apart and other of the sphere (L) When the axis (J) is pressed into the rigid tube (K) the lugs (r) are blocked in the two openings (r) of the rigid tube (K).

 Figure N010 shows the detail of the blocking of the fixing lugs (1) on the axis (J) passing through the orifices (2). Only two ends of the tabs (A) have been shown.

 Figure N011 shows the entire device inserted on its application system Above the warhead (N) the deflated tubular digitations (A) extend over their entire length.The application system is passed through the tube (D) and the crown (C) also deflated. The lugs (P) locked in the openings (r) secure the axis (J) to the rigid tube (K).

 Figure N 12 shows on the device seen from its lower part, the insertion of a strip (ZA) of flexible material made it possible to join the two ends of the tubes (Al) and (A6).

 Figure N013 shows a device comprising 4 tubes (A) joined two by two by their distal end at an area (AA). The assembly also delimits an operating area (ZO).

 Figure N014 shows the device in place for operative use, for example a pre-peritoneal operation of an inguinal hernia. Seen in a longitudinal section: the tubular digitations (A2) and (AS) push forward the elements of the abdominal wall and behind the peritoneum.

An optic has been shown passed through the tube (D) and the crown (C).

 The device can be used in laparoscopic surgery, for example for the treatment of an inguinal hernia (Fig. N 14), adopting the following steps: surgical opening of the pre-peritoneal space; the device fixed on its system application is introduced in this espaoe, the anterior speak the warhead (N) ~ allowing to make a passage Removal of the axis which maintains k devicesoit quoted the sphere ((L) was helped by the fins (M), or by pressing simultaneously on the 2 tabs (O) to release the pins (P) from the openings (r). The axis being removed, the device is partially inflated by means of the tap (5); the tabs (1) are released from the openings (G). It is then possible to remove the rigid tube (K). An optic is then introduced dais k tube (D) remained exteriorized from the wall; it allows the dissection to continue under the control of hv @ e while continuing to inflate the device, which, when fully inflated, keeps the tissues apart leaving the operating area (ZO) free; the tubule digitations (A) and the intermediate tubes (B) repel had the Se-ents of the abdominal wall k, behind the peritoneum and intestinal loops..In some cases it may also be necessary to exteriorize tables (Zl) and (Z2) to facilitate the introduction of cylindrical laparoscopic instruments.

The device is removed after deflation.

The possible separation of inflation by the tubes (41) and (42) allows dais a first time to go @ fler the crown (C) and the digitations (A) to be able to dissociate the application material and start the dissection. tubes (B) progressively repelling the tubes (A) completes the dissection by extending laterally into the areas of least resistance then from hait to bu
The ends of the digitations pressing strongly on the walls push the whole device upwards keeping the crown (C) applied on both sides of the orifice of iitrodiction. 1 tube (D) always remains externalized it can be fitted with a sealing valve and gas access if the device is to be used in another anatomical location.

Claims (2)

CLAIMS for the required period. hard capable of repelling the anatomical tissues and keeping them apart ~ polyethylene, polyurethane or lair ~ inflatable to give it a consistency ~ by its composition in synthetic material, sterilizable, simple surgical interventions, in particular in laparoscopic surgery, characterized:  1 = Single-use device intended to separate the anatomical tissues from the  from the outside.  the co-column (C) in the tube (D) allowing access to the operating area (ZO)  open base defining an operating area (ZO), the aperture opening through  introduced into the tissues to be operated; swollen forming a frustoconical structure  application (J) and (K) of cylindrical shape of small diameter, which can be  the set can take two different aspects: deflated, fixed sar on its system  crown (C) and intermediate tubes (B) arranged perpendicular to (A),  ~ by longitudinal tubular digitations (A), combined on a  thickening (8) of the material.  lower of the tubular digitations (A) of an additional tube (7) or of a  4 = Device according to claims 1 and 2 characterized by the addition to the face  metallic (O) entered canopy openings (r),  (H), either at its upper part by lugs (P) ends of the tongues  on the rigid tube (K) either at its front part by a thread (I) screwed into  (A), passing through the holes (2) through the females (G), which can be blocked  window (G), ~ an axis (J) which can be slid into the tube (K), blocking the tabs (1) of the tabes  rounded, semi-spherical or olive-shaped, above which two open  ~ a rigid tube (K) left at its anterior end a warhead (N) of shape  in that it is composed by:  3 = device application system according to claims 1 and 2 characterized  (J) introduces into the holes (2),  (A); can be temporarily blocked on the application system by the axis  perforated with holes (2) integral with the zone (3) at the free ends of the tubes  2 = Device according to claim 1 characterized by fixing lugs (1)  inflation of the tubes (B) by the tube (42).  separate the goaflage from the tubes (A) and the crown (C) by the tube (41) and the  5 = Device according to claims 1,2 and 4 characterized by the possibility of  additional tubes (B ') parallel to the tubes (B).  6 = Device according to the preceding claims characterized by the addition of 7 = Device according to ks preceding claims characterized by the possibility of having a number of tubular digitations (A) variable from 2 (A) to n (A) in even or odd quantity. 8 = Device according to the preceding claims characterized by the meeting two by two of the ends of 4 tubes (A) at a zone (AA). 9 = Device according to claims 1,2,4,5,6 and 7 characterized by the union of 2 tubular digitations (A) by a strip (ZA) of the same material extending from the ends of the tubes (Al) to (An ). 10 = Device according to the preceding claims characterized by the addition of flexible, hollow tubes (Z1) and (Z2) fixed on the tubes (Al) and (An), which can be exteriorized outside the anatomical tissues and allowing passage of cylindrical instruments for laosurgery. 11 = Device according to any one of the preceding claims characterized by the addition of a sealing valve and a blowing valve at the level of the tube (D).