United States Patent Francisoud et al.
Dec. 2, 1975 DEVICE FOR HOLDING A CATHETER IN AN EXTENDED CONDITION Primary Examiner-Lawrence W. Trapp [75] Inventors: Jacques Francisoud, Oullins; Andre Attorney Agent or Flrmstevens Davls Mluer &
Mosher Sausse, Sceaux, both of France [73} Assigneez Rhone-Poulenc S.A., Paris, France [57] ABSTRACT [22] F'led: 1974 A device for holding, in a longitudinally extended 211 App] 536 796 state, a catheter e.g. of the Malecot or Pezzer type, having an open proximal end, a closed distal end and an elastic bulge adjacent the distal end. The device {30] Forelgn Apphcatlon Pnonty Data comprises a mandrel which is insertable into the cath- Jan. 3, 1974 France 74.00145 t r to move the distal end of the catheter away from the proximal end and a bearing component for the [52] US. Cl. 128/348 mand l having at least one latching member mounted [51 Int. Cl. A61M 25/00 th r on which is releasably connectable to the proxi- [58] Field Of Search l28/348-35l, ma] end f the catheter to hold the mandrel in the 26 catheter when the latter is in its extended position. An
assembly is also described in which the bearing com- [56l R f r n C d ponent is permanently secured to the proximal end of UNITED STATES PATENTS the catheter, the bearing component having a seat in 3 380,448 4/1968 Sadove et al. 128 348 x which the Proximal end of the mandrel can be releas- 3,469,579 9/19 9 Hubert 128/348 x y in$erted- 3,554,580 l/l97l Goyke 128/348 X R25,788 6/1965 Sheridan 128/348 15 10 DrawmgF'gures F 10 1 2 8 L A l l 7 l 1 I 10 I 3 US. Patent Dec. 2, 1975 Shee t10f3 3,923,066
US. Patent Dec. 2, 1975Sheet 2 of3 3,923,066
9 I %J 1 F FIG. 4
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US. Patent Dec. 2,1975Sheet 3 of3 3,923,066
DEVICE FOR HOLDING A CATHETER IN AN EXTENDED CONDITION The present invention relates to a device for holding a catheter in an extended condition.
When a catheter which, at rest, possesses one or more bulges, for example a catheter of the Malecot or Pezzer type, has to be placed in position or withdrawn, it is desirable to be able to smooth out this-bulge or these bulges and to do this the distal end can be moved away from the proximal end by means of a non-rigid axial mandrel which rests at the distal end of the internal wall of the catheter. By pulling the proximal end of the catheter backwards relative to the mandrel, the catheter is stretched and the bulge or bulges are thus momentarily smoothed out. It is thus possible to move the catheter inside the body of the patient without running the risk of injuring the flesh, either in order to introduce the catheter or to withdraw it. Furthermore, it is necessary for the catheter to be kept in the extended condition all the time it is being moved.
According to the present invention we provide a device for holding, in a longitudinally extended state, a catheter having an open proximal end, a closed distal end and an elastic bulge adjacent the distal end, the said device comprising a mandrel insertable into the catheter, to move the distal end of the catheter away from its proximal end, a bearing component for the mandrel connected to the proximal end of the mandrel and at least one latching member mounted on the bearing component and releasably connectable to the proximal end of the catheter.
With such a device it is possible to maintain the relative positions of a catheter and the mandrel, with the catheter in the stretched condition.
According to another aspect of the invention there is provided an assembly comprising a catheter having an open proximal end, a closed distal end and an elastic bulge adjacent the distal end, a bearing component including an arm connected to the proximal end of the catheter, a mandrel insertable into the catheter to move the distal end of the catheter away from its proximal end and a seat on the bearing component for releasable insertion of the proximal end of the mandrel into the bearing component.
In order that the invention will more readily be understood, the following description is given, merely by way of example, reference being made to the accompanying drawings, in which:
FIG.- 1 is a perspective view of one embodiment of device according to the invention;
FIG. 2 is a cross-section along an axial plane of a catheter which carries a leakproofing cap and is equipped with a device according to FIG. 1;
FIGS. 3 to 6 are each perspective views of four further embodiments of device according to the invention; and
FIGS. 7 to are each perspective views of four embodiments of assembly according to the invention.
The device represented in FIG. 1 consists of abearing component 1 carrying twolatching members 2 and 3 equipped withjaws 4 and 5 at one of their ends; thelatching members 2 and 3 are parallel to one another and substantially perpendicular to the bearing component and extend from the ends of the bearing component which is substantially centrally located with respect to the arms to form an H-shaped construction.
Themandrel 6 for extending the catheter is carried by the centre of the bearing component. The mandrel and the two jaws are situated on the same side relative to the bearing component, so that the entire construction is symmetrical relative to the axis of the mandrel.
FIG. 2 is an axial cross-section of a catheter with a device as described above, illustrated in elevation, placed at the proximal end of the catheter. Thejaws 4 and 5 grip the proximal end of a catheter which also has 0 anendpiece 7 carrying anannular bead 8 which has a substantially rectangular cross-section and makes it possible to latch the jaws thereon.
The proximal end of the catheter is equipped with acap 9 which provides leakproofness between the catheter and the extension mandrel during operations involving the placing of the catheter in position and its withdrawal. It consists of a hollow cylindrical element closed at one of its ends by a wall having an orifice for the mandrel, the free end being terminated by a bead. The leakproofing cap is made of a thin flexible and elastic material.
The shape of the bearing component is not generally critical. The thickness of the bearing component is such that the mechanical strength is sufficiently great, the thickness being usually between 0.5 and 10 mm and preferably between 1 and 5 mm.
The number of latching members can be between one and five, and is advantageously two. The cross-section of the latching members can be a simple geometric shape, and is preferably rectangular.
The length of the latching members is such that it makes it possible, firstly, for the jaws to grip the proximal end of the catheter, the jaws locking over the annular bead carried by the end-piece, and secondly, for a force (F) applied perpendicular to the latching members at the ends opposite thejaws 10 to allow the proximal end to be freed by unclamping the jaws, the junction between the latching members and the bearing component serving as a fulcrum of a lever formed by the latching members.
Themandrel 6 has a cross-section of simple geometric shape and is preferably cylindrical; its diameter is usually equal to half the diameter of the internal passage of the unstretched catheter and its length is such that it makes it possible to stretch the catheter, by pressing against the distal end, in order to smooth out the bulges situated at the distal end. Advantageously, the diameter of the mandrel can be chosen so that it is substantially equal to the internal diameter of the catheter in the stretched position. Leakproofness between the mandrel and the catheter is then ensured by contact between the internal surface of the catheter and the mandrel. The use of a leakproofing cap as described above is then no longer necessary. The mandrel can fit into a recessed hole in the bearing component, the hole being centred on the axis of the latter, and the crosssection of this hole is suited to the cross-section of the mandrel. The combination consisting of the bearing component, the latching members and the jaws can then be suited to various sizes of catheter. It is also possible to produce the mandrel, the bearing zone, the latching members and the jaws in a single piece.
In the device represented in FIG. 3 the fulcrum can consist of an element in the form of a circular ring 11 which allows the mandrel to pass through it; thebearing component 12 and thejaws 13 are situated on either side of the circular ring. Pressure exerted on the latching members between the bearing component and the circular ring, in the direction of the arrows F, frees the jaws. The mandrel and the device may or may not be in a single piece.
According to FIG. 4, the catheter can optionally be fitted at its proximal end with arigid nozzle 14 having abead 26 which enables the jaws to grip. The latching members rest at 15 on the end of the rigid nozzle which thus serves as a fulcrum. A pinching movement at 16, in the direction of the arrows F, frees the jaws. The mandrel l8 and thebearing component 17 are integral with the latching members and the jaws.
The device represented in FIG. 5 also uses a rigid nozzle situated at the proximal end of the catheter as the fulcrum; pressure exerted on the resilient latching member, in the direction of the arrows F, at a point situated between thebearing component 19 and the fulcrum situated on the rigid nozzle, makes it possible to free the jaws.
The device represented in FIG. 6 can comprise amovable element 20, the longitudinal movement of which, parallel to the axis of the mandrel, in the direction from thebearing component 21 towards the jaws, makes it possible to move the latter apart; a movement in the opposite direction enables the jaws to grip the proximal end of the catheter.Flanges 22 prevent any lateral movement of the movable element.
The assembly illustrated in FIG. 7, includes theendpiece 7 of a catheter having two integral arms which form a handle l0,'produced during the molding process, and a lateral movement in the direction of M of the proximal end of theextension mandrel 6 ensures that the catheter is placed in the stretched position by introducing the proximal end of the extension mandrel into aseal 31, formed in the portion of the bearing component at the end of the handle.
The assembly of FIG. 8 includes the end-piece 7 of a catheter having asemi-rigid arm 32, and the catheter is placed in the stretched position by introducing the proximal end of the extension mandrel into arecessed hole 33 in the bearing component formed at the free end of the arm.
FIG. 9 shows an assembly having two arms forming ahandle 35 hinged on two swivel-pins 34 carried by theendpiece 7 of the catheter. The extension mandrel is held in position by introducing its proximal end into an orifice 36 present in a reinforced bearing component of the handle, after pivoting the latter, the catheter being in the stretched condition.
According to FIG. 10, the assembly includes the endpiece of the catheter, which carries anarm 37 which is anchored, by means of anorifice 39, on alug 38 carried by the end-piece. Theextension mandrel 6 rests in aseat 40 carried by the arm. Thearm 37 can be connected permanently to the end-piece or can be removable.
The catheter can be held in the extended position by the use of a pin which passes through the end-piece of the catheter and immobilises the mandrel at its proximal end. Advantageously, the pin is connected to the end-piece of the catheter by means of a tab.
In order to achieve leakproofness between the catheter and the extension mandrel, it is possible to use a mandrel of diameter equal to the internal diameter of the catheter in the stretched condition.
The materials used to produce the device or assembly are compatible with biological fluids and especially blood. Moreover, they possess sufficient elasticity to make it possible, for example, for the latching members or arms to play the role of a lever and possess the necessary rigidity for the jaws and the mandrel. Thermoplastic materials or elastomers, and preferably silicone elastomers, can be used as the material. The devices can be sterilised by radiation, and those made from polytetrafluoroethylene can advantageously be sterilised by means of dry heat.
The device for holding a catheter in the extended position, which is the subject of the invention, makes it possible to keep the bulges of a catheter of the Pezzer or Malecot type momentarily smoothed out.
The use of the device is particularly advantageous when the catheter is being placed in position or withdrawn and considerably facilitates these operations.
We claim:
1. A device for holding, in a longitudinally extended state, a catheter having an open proximal end, a closed distal end and an elastic bulge adjacent the distal end, the said device comprising a mandrel having a distal end and a proximal end insertable into the catheter, to move the distal end of the catheter away from its proximal end, a bearing component for the mandrel connected to the proximal end of the mandrel and at least one latching member mounted on the bearing component and releasably connectable to the proximal end of the catheter.
2. A device as claimed inclaim 1, and further comprising locking jaws on the latching member for gripping the proximal end of the catheter when the latter is in its stretched condition.
3. A device as claimed inclaim 1, wherein the latching member is pivotally mounted on the bearing component in the manner of a lever.
4. A device as claimed inclaim 3, wherein the bearing component includes a central member and two parallel latching members extending therefrom and carrying attheir free ends locking jaws for gripping the proximal end of the catheter.
5. A device as claimed inclaim 4, wherein the bearing component is placed centrally of the two parallel arms to provide an I-I-shaped configuration.
6. A device as claimed inclaim 4, wherein the bearing component is arranged at the remote end of the latching members from the jaws and further comprising an element intermediate the bearing component and the jaws.
7. A device as claimed inclaim 6, wherein the element is slidable parallel to the latching members.
8. A device as claimed inclaim 3, wherein the latching member is controllable by pressure exerted perpendicularly to its length.
9. A device as claimed inclaim 1, wherein the bearing component is firmly fixed to the mandrel.
10. A catheter assembly comprising a catheter having an open proximal end, a closed distal end and an elastic bulge adjacent the distal end, a bearing component including an arm connected to the proximal end of the catheter, a mandrel having a distal end and a proximal end insertable into the catheter to move the distal end of the catheter away from its proximal end and a seat on the bearing component for releasable insertion of the proximal end of the mandrel into the bearing component.
11. An assembly as claimed inclaim 10, and further comprising a frame firmly fixed to the arm.
12. An assembly as claimed inclaim 10, wherein the bearing component is connected by two arms to the proximal end of the catheter and the arms are pivotally 14. An assembly as claimed inclaim 10, wherein the assembly is constructed of a silicone elastomer.
15. An assembly as claimed inclaim 10, wherein the assembly is constructed of a thermoplastic material.