FR3010319A1 - Device for fixing and stabilizing a catheter through a patient's dermat - Google Patents

Device for fixing and stabilizing a catheter through a patient's dermat Download PDF

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Publication number
FR3010319A1
FR3010319A1 FR1358575A FR1358575A FR3010319A1 FR 3010319 A1 FR3010319 A1 FR 3010319A1 FR 1358575 A FR1358575 A FR 1358575A FR 1358575 A FR1358575 A FR 1358575A FR 3010319 A1 FR3010319 A1 FR 3010319A1
Authority
FR
France
Prior art keywords
catheter
dermis
patient
stabilizing
device
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
FR1358575A
Other languages
French (fr)
Inventor
Andre Louis Alain Peyre
Francis Gadrat
Original Assignee
Francis Gadrat
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Francis Gadrat filed Critical Francis Gadrat
Priority to FR1358575A priority Critical patent/FR3010319A1/en
Publication of FR3010319A1 publication Critical patent/FR3010319A1/en
Application status is Pending legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02Holding devices, e.g. on the body
    • A61M25/04Holding devices, e.g. on the body in the body, e.g. expansible
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M2025/006Catheters; Hollow probes characterised by structural features having a special surface topography or special surface properties, e.g. roughened or knurled surface
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02Holding devices, e.g. on the body
    • A61M2025/0286Holding devices, e.g. on the body anchored in the skin by suture or other skin penetrating devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02Holding devices, e.g. on the body
    • A61M2025/0293Catheter, guide wire or the like with means for holding, centering, anchoring or frictionally engaging the device within an artificial lumen, e.g. tube

Abstract

The object of the invention is a device for fixing and stabilizing a catheter through the dermis of a patient, said catheter comprising a flexible tube (12) of which a distal portion is intended to be introduced through the dermis in a cavity of the patient, in particular a vein or an artery, which device is characterized in that it comprises a sleeve (26) of an inner diameter DI, greater than the diameter d of the flexible tube (12), said sleeve comprising means (30) for anchoring in said dermis.

Description

The present invention relates to a device for fixing and stabilizing a catheter through the dermis of a patient. The catheters consist of a tube of diameter adapted to penetrate through the dermis, in order to be implanted either in a vessel such as a vein or an artery, or in peri-nerves such as epidural, plexic or truncular in the most known way. This tube remains permanently implanted during a given period and protrudes outside the dermis. This catheter is provided with connection means for receiving conjugated connection means to allow injection into said vascular or peri-nervous space of a pharmaceutical composition. These conjugated connection means may be provided at the end of a syringe intended to administer a composition at one time, at the end of a tube connected to an infusion bag for administering a composition over a period of time. given or to a programmed injection device.

Since the catheter is placed for a minimum of several days, a number of problems arise due to the fact that the penetrating part of the catheter tube is flexible and all the mechanical forces are exerted on the peripheral edge of the catheter hole. penetration of said catheter into the dermis. This causes redness, itching, irritations with inflammations that come on the one hand to participate in the discomfort of the patient but also remain a source of infection on the other hand, including providing a gateway for pathogenic microorganisms in The organism. It is also noted that the catheter tube remains free to move in translation through the dermis, except to be temporarily fixed to its surface, generally with unsuitable means, namely an adhesive means. Displacements are thus limited but nevertheless existing. As a result, the care is more difficult to perform and the maintenance of this zone in a sufficient state of asepsis remains delicate. The adhesive means should be changed regularly, leaving the catheter in place and attempting to maintain its initial position without translational movement. It is especially noted that it is difficult to enforce the catheter tube a satisfactory geometry, that is to say a penetration angle corresponding to the direction of implantation relative to the vein or the artery concerned. Finally the stabilization of the tube is difficult because of its flexibility, flexibility 15 necessary for its function but penalizing for the external part of the catheter out of the dermis. The end of the catheter receives connection means intended to cooperate with the diffusion means of the pharmaceutical compositions. These connection means are known, for example through a commercial name "Lueur Lock". These connection means increases the weight and increases the amplitude of the displacements of the introduced tube, especially with the movements of the patient himself. Finally, the end of the tube is intended to be very often connected to an infusion and therefore to a connecting pipe with the pocket concerned, which also strengthens the weight and the traction exerted on said infusion tube. The object of the present invention and to provide a device which overcomes the disadvantages of the prior art and which facilitates the stabilization of the catheter, which provides a mechanical hold compared to the pulls exerted, which is easy to set up, which maintains the implantation geometry, which is perfectly biocompatible, which makes it possible to receive the already existing and commonly used connection means, which completes the installation of the catheter but does not in any way modify the use by the practitioners. The device is now described in detail according to a particular embodiment, not limiting, this description being developed with reference to the accompanying drawings, drawings in which the various figures represent: - Figure 1: a schematic perspective view of a catheter placed according to FIG. 2 is a sectional view through a vertical plane of a catheter with the device according to the prior art; FIG. 3 is a schematic perspective view of a catheter with the device according to the present invention; 4 is a cross-sectional view through a vertical plane of a catheter with the device according to the present invention as in FIG. 3; FIG. 5 is a perspective view of the fixing and stabilizing device according to the present invention, FIG. and FIG. 6 is a longitudinal sectional view of the fixing and stabilizing device according to the present invention of FIG. 4. FIG. 7 is a longitudinal sectional view of the device. fixing and stabilizing device according to the present invention according to a double winding variant. With reference to FIG. 1, it is possible to take cognizance of the arrangement of a catheter 10 according to the prior art. This catheter 10 comprises a tube 12 intended to be partially introduced by its distal end into a cavity of the patient's body, generally in a vessel or peri-nerve 14, this through the dermis 16.

The catheter 10 is completed at the outer end 18, proximal, of the flexible tube, by connection means 20, intended to allow a fluid connection with any material for introducing any pharmaceutical composition, syringe, dosing pump or infusion bag. to name only the most famous materials. The tube 12 is made of polymer material tube, flexible, biocompatible, a diameter suitable for the intended application, the type of laying, the class of the patient in particular and the products to be injected. In Figure 1, there is shown in broken lines an adhesive tape 22, adapted to retain the tube and to limit its movements especially in translation. Said adhesive tape is attached to the skin and straddles the tube. On the section of Figure 2, there is the presence of the inner end, or distal, within the vessel or peri-nerve 14. Even maintained by the adhesive means, there are found some difficulties to retain said tube which has the primary feature of being anti-adhesive to allow its removal of the dermis when it became unnecessary. Moreover, its diameter is very thin, which limits the contact surface of said adhesive means with said tube, this surface being substantially only a generatrix said tube. If the peripheral movements of the tube are made during the various mechanical stresses, inflammation of the dermis occurs peripherally to the tube. A known solution is to make a point across the dermis to retain the connection means, which limits the movement without being able to prohibit. In Figure 3, there is shown the arrangement with the fixing device 24 and stabilization according to the present invention.

This device 24 for fixing and stabilizing is in the form of a sleeve 26, with a body 28 with an inner diameter DI slightly greater than the diameter d of the tube of the catheter to be applied. For example, for a catheter tube diameter of tenths of a millimeter an inside diameter of 12 tenths of millimeters will be used for the sleeve. This sleeve 26 has at its distal end, intended to come into the dermis, means 30 for anchoring in said dermis. These anchoring means 30 are preferably in the form of a penetrating screw 32.

This penetrating screw 32 has a limited length, adapted to screw into the dermis, without damaging the artery or vein in which the catheter must be placed. Preferably, the tip 34 of this penetrating screw 32 is of a shape adapted to ensure easy penetration into the dermis, for example with a tip having a 30 ° bevel. Advantageously, the body 28 of this sleeve is made in the form of a spring 36 with contiguous turns and the penetrating screw 32 consists of at least one non-contiguous turn 38 coming from the same spring 36. The idea is to provide an outer sleeve diameter OD of 17 tenths of a millimeter, an ID inner diameter of 12 tenths of a millimeter, for a spring wire diameter of 0.25 tenths of a millimeter, a length of screw 32 of 40 tenths of a millimeter with 6 turns, accepting a diameter d of catheter tube of 10 tenths of millimeters. The total length of the sleeve is of the order of 600 millimeters. The placement of the device according to the present invention is as follows. The operator lays the catheter in the usual way, once the catheter is placed, the operator assures a mounting of the sleeve on the flexible part of the catheter tube which is free. The operator ensures a translation of the sleeve on the tube until the sleeve comes into contact with the dermis, more particularly until the tip 34 comes into contact with the dermis. The operator then exerts a slight pressure and ensures rotation of the sleeve relative to the tube. The tip enters the dermis and the rotation ensures the screwing of the turns 38 not joined in the dermis. The screwing is interrupted when the operator deems it necessary, the penetration being in any case limited by the length of the screw 32. Indeed, when the contiguous turns come into abutment on the dermis, penetration becomes impossible, except to tear the dermis.

The catheter tube is of suitable length to protrude out of the sleeve end of the sleeve so as to be able to cut to the right length, depending on the connection means provided. The tube is connected to the connecting means 20 and the sleeve 26 also by its free end, opposite the tip.

The tube 12 of the catheter and the sleeve 26 are thus secured to the same connection means, so that the relative movements of the tube 12 vis-à-vis the sleeve 26 are impossible and as the sleeve is immobilized relative to the dermis then the tube 12 is immobilized relative to the dermis. The removal of the fixation and stabilization device according to the present invention is effected by removing the connection means, by unscrewing the sleeve 26 of said device and then removing the dermis catheter. The trauma of the dermis is very limited because the penetration of the tip is extremely little traumatic because of the diameter of the wire. Then, because it is a very small diameter wire that passes through the same penetration hole in the dermis. The dermis around the sleeve retains its nature first because the irritation related to the movements of the tube have been removed or at least very severely limited.

Alternatively, it is also possible to provide means 40 for immobilization in translation of the tube in the sleeve. For this purpose, it is possible to provide a ring 42 of elastomer formed at the free end of said sleeve.

This ring has the role of increasing the friction of the tube in the sleeve, thus limiting movement in translation, without such a ring can impede the rotation or sliding of the sleeve on the tube during installation by the operator . This can be an aid before and during the installation of the connection means. Similarly, according to an important embodiment, to reduce the flexibility of the sleeve and thus ensure maintenance in shape without risk of kinking, it is possible to achieve the sleeve 26 with two windings El and E2 parallel, the same diameter, interleaved. The turns of each of the windings are therefore contiguous along the length of the body, as shown in FIG. 7. One of the windings E2 is interrupted while the other is continued for a length equal to that of the maximum penetration envisaged and the screw 32 of this winding E2 is machined only to form a tip 34, bevel preferably.

The penetrating part of the winding E2 has turns spaced by a value equal to the diameter of the wire of the winding El. The nature of the material constituting the fixing and stabilizing device according to the invention and more particularly of the sleeve 26 is advantageously stainless steel, biologically compatible specificity, used for implantable surgical material, more exactly at least one shaped stainless steel wire.

Claims (10)

  1. REVENDICATIONS1. A device for securing and stabilizing a catheter through the dermis of a patient, said catheter comprising a flexible tube (12) having a distal portion for insertion through the dermis (16) into a patient's cavity, in particular a vein or an artery (14), characterized in that it comprises a sleeve (26) with an inner diameter greater than the diameter d of the flexible tube (12), said sleeve comprising means (30) ) anchoring in said dermis (16).
  2. 2. Device for fixing and stabilizing a catheter through the dermis of a patient, according to claim 1, characterized in that the anchoring means 10 comprises a screw (32) penetrating.
  3. 3. A device for fixing and stabilizing a catheter through the dermis of a patient, according to claim 2, characterized in that the screw (32) consists of turns (38) not contiguous.
  4. 4. Device for securing and stabilizing a catheter through the dermis of a patient, according to claim 2 or 3, characterized in that the screw (32) has a tip (34).
  5. 5. Device for fixing and stabilizing a catheter through the dermis of a patient, according to any one of the preceding claims, characterized in that the sleeve (26) consists of a body (28) with turns 20 joined.
  6. Device for mutating and stabilizing a catheter through the dermis of a patient, according to claim 5, characterized in that the body (28) of the sleeve (26) is in the form of a spring (36). ) with contiguous turns and the penetrating screw (32) consists of at least one non-conductive turn (3) coming from the same spring (36)
  7. 7. Device for fixing and stabilizing a catheter through the dermis of a patient, according to any one of claims 1 to 4, characterized in that the sleeve (26) consists of a body (28) comprising two windings (E1, E2), contiguous turns, of the same diameter, interleaved.
  8. 8. Device for fixing and stabilizing a catheter through the dermis of a patient, according to claim 7, characterized in that one of the windings (El) is interrupted and the other of the windings (E2) is extended to constitute the penetrating screw (32).
  9. A device for securing and stabilizing a catheter through the dermis of a patient as claimed in any one of the preceding claims, characterized in that the proximal outer end (18) receives means (20) for connection, intended to allow a fluid connection with any material to introduce any pharmaceutical composition, syringe, dosing pump or infusion bag. 15
  10. 10. A device for fixing and stabilizing a catheter through the dermis of a patient, according to any one of the preceding claims, characterized in that it consists of a stainless steel wire, bio compatible , shaped.
FR1358575A 2013-09-06 2013-09-06 Device for fixing and stabilizing a catheter through a patient's dermat Pending FR3010319A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
FR1358575A FR3010319A1 (en) 2013-09-06 2013-09-06 Device for fixing and stabilizing a catheter through a patient's dermat

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
FR1358575A FR3010319A1 (en) 2013-09-06 2013-09-06 Device for fixing and stabilizing a catheter through a patient's dermat

Publications (1)

Publication Number Publication Date
FR3010319A1 true FR3010319A1 (en) 2015-03-13

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
FR1358575A Pending FR3010319A1 (en) 2013-09-06 2013-09-06 Device for fixing and stabilizing a catheter through a patient's dermat

Country Status (1)

Country Link
FR (1) FR3010319A1 (en)

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5344439A (en) * 1992-10-30 1994-09-06 Medtronic, Inc. Catheter with retractable anchor mechanism
US5755697A (en) * 1995-11-22 1998-05-26 Jones; Calvin E. Self-tunneling, self-securing percutaneous catheterization device and method of use thereof
WO2000025850A1 (en) * 1998-10-30 2000-05-11 Windsor Ting Medicinal agent administration catheter device
US20090163862A1 (en) * 2007-12-21 2009-06-25 Kauphusman James V Tissue anchoring catheter systems and methods
WO2009141822A1 (en) * 2008-05-21 2009-11-26 The Medical Research, Infrastructure, And Health Services Fund Of The Tel Aviv Medical Center A device and method for crossing occlusions
US20100076264A1 (en) * 2005-05-04 2010-03-25 Stephen Tallarida Rotate-to-advance catheterization system
US20110034986A1 (en) * 2007-07-18 2011-02-10 Chou Tony M Systems and methods for treating a carotid artery

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5344439A (en) * 1992-10-30 1994-09-06 Medtronic, Inc. Catheter with retractable anchor mechanism
US5755697A (en) * 1995-11-22 1998-05-26 Jones; Calvin E. Self-tunneling, self-securing percutaneous catheterization device and method of use thereof
WO2000025850A1 (en) * 1998-10-30 2000-05-11 Windsor Ting Medicinal agent administration catheter device
US20100076264A1 (en) * 2005-05-04 2010-03-25 Stephen Tallarida Rotate-to-advance catheterization system
US20110034986A1 (en) * 2007-07-18 2011-02-10 Chou Tony M Systems and methods for treating a carotid artery
US20090163862A1 (en) * 2007-12-21 2009-06-25 Kauphusman James V Tissue anchoring catheter systems and methods
WO2009141822A1 (en) * 2008-05-21 2009-11-26 The Medical Research, Infrastructure, And Health Services Fund Of The Tel Aviv Medical Center A device and method for crossing occlusions

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