Source: https://patents.google.com/patent/ES2689910T3/en
Timestamp: 2019-12-15 21:06:16
Document Index: 437028049

Matched Legal Cases: ['art 44', 'art 44', 'art 44', 'art 44', 'art 44', 'art 12', 'art 12', 'art 12', 'art 12', 'art 12', 'art 12', 'art 12', 'art 12', 'arts 12', 'arts 12', 'arts 12', 'art 12', 'art 12', 'arts 12', 'arts 12', 'art 12', 'art 12', 'art 44', 'art 44', 'art 44', 'art\n46', 'art 12', 'art 12']

ES2689910T3 - IV catheter apparatus - Google Patents
IV catheter apparatus Download PDF
ES2689910T3
ES2689910T3 ES16705703.3T ES16705703T ES2689910T3 ES 2689910 T3 ES2689910 T3 ES 2689910T3 ES 16705703 T ES16705703 T ES 16705703T ES 2689910 T3 ES2689910 T3 ES 2689910T3
ES16705703.3T
2015-06-27 Priority to IN1916DE2015 priority Critical
2015-06-27 Priority to IN1916DE2015 priority
2016-02-03 Application filed by Poly Medicure Ltd filed Critical Poly Medicure Ltd
2016-02-03 Priority to PCT/IB2016/050536 priority patent/WO2017001942A1/en
2018-11-16 Publication of ES2689910T3 publication Critical patent/ES2689910T3/en
Intravenous catheter apparatus (10), comprising: a catheter tube (14); a catheter hub (12) having a distal end (22) and a proximal end (24), wherein the distal end (22) is attached to the catheter tube (14) and the proximal end (24) defines a housing (48); 3 a needle (20) extending through the catheter hub (12) and the catheter tube (14) and defining an axial direction (A), wherein the needle (20) has ends opposite proximal and distal, the distal end forming a needle tip; a needle hub (16) attached to the proximal end of the needle (20); a needle guard (26) slidably disposed in the needle (20), wherein the needle guard (26) is held mobilely in the housing (48) of the catheter hub (12) when the needle (20 ) extends through the catheter hub (12) and the catheter tube (14), where the needle guard (26) is removable from the catheter hub (12) once the needle tip is housed in the shield (26) of needle when removing the needle (20) from the catheter tube (14), and where the housing (48) defines a chamber (54) at one of its ends which ensures that a first and a second arms (40 , 42) of the needle guard (26) do not contact or interact with an inner surface (56) of the chamber (54) before and during a patient's venipuncture; the chamber (54) being formed by a recess in the housing (48) to accommodate the first and second arms (40, 42), so that none of the arms (40, 42) deflected by the needle (20) contacts the inner surface (56) of the chamber (54), characterized in that the catheter hub (12) is formed by two parts, a proximal part (12a) with a distal end section (50) and a distal part (12b) with a proximal end section (52), wherein the inner surface (56) of the chamber (54) is defined by the proximal end section (52) of the distal part (12b).
Intravenous catheter apparatus Field of the invention
The invention generally relates to an intravenous catheter apparatus. More specifically, the invention relates to an intravenous catheter apparatus comprising a catheter hub disposed at a proximal end of a catheter tube and having an inner surface defining a housing; a needle that has a needle tip and extends through the housing and catheter tube in a prepared position; and a needle guard slidably disposed in the needle and housed in the housing when the needle is in its ready position, where the needle guard is configured to protect the needle tip when removing the needle from the catheter hub.
An intravenous device of this type is generally known. The needle guard serves to prevent a person who manipulates the intravenous catheter apparatus from accidentally contacting the needle tip after disposing the catheter tube in a patient's vein and subsequent removal of the needle from it. In this way, the intravenous catheter apparatus helps prevent unwanted transmission of blood-borne diseases.
Generally, when the needle is removed from the patient, the needle scratches or causes friction or friction when sliding / passing through a catheter, a catheter hub or through a needle shield, creating a friction or withdrawal force .
It is desirable to obtain an intravenous catheter apparatus that significantly decreases the necessary withdrawal force and friction caused when a needle is removed through a catheter hub protected by a needle shield.
US 2015/0151058 A1 describes a safety needle unit that has a first hub attached to a flexible tube and a second hub attached to a needle that extends through the flexible tube. A needle guard is disposed in an inner cavity of the first hub. The needle guard has a proximal wall that has an opening and two arms, each with one end, the two ends being separated and deflected with respect to the needle in a prepared position.
US 2009/0281499 A1 refers to a safety hook device for protecting and retaining the tip of an introduction needle following the introduction of a vascular catheter. The safety hook device includes a sleeve that has a locking system for locking the sleeve and catheter adapter together. The sleeve houses a safety hook, so that a part of the insertion needle extends through the safety hook and is pinched between the arm parts of the safety hook. As the tip of the insertion needle is removed from the catheter adapter, the tip of the insertion needle is retained on the safety hook, after which the safety hook is retained inside the sleeve and the sleeve remains released with respect to the catheter adapter for safe disposal.
WO 2013/190407 A1 refers to a needle guard for use in a medical device, specifically, for concrete use in a catheter device, which includes a base part having a needle passage extending into a axial direction from a proximal side of said base part, through said base part, to a distal side of said base part, a needle shank with a main outer profile can be disposed movable in said needle passage ; a first and a second arms that extend substantially in said axial direction from said distal side of said base portion, said first arm having a distal region and a proximal region; and a distal wall being arranged transversely in said distal region of said first arm.
EP 1 803 477 A2 describes a needle tip protection that includes a pair of opening elements with elastic arms that force the opening elements to be misaligned in order to create a barrier for the needle tip.
A main objective and advantage of the present invention is to disclose an intravenous catheter apparatus that significantly decreases the necessary withdrawal force and friction caused by removing a needle through a catheter hub protected by a needle shield.
Another objective and another advantage of the present invention are to disclose an improved intravenous catheter apparatus that is economical to manufacture, effective, effective and simple in its structure and use.
Accordingly, the present invention relates to an intravenous catheter apparatus comprising: a catheter tube; a catheter hub having a distal section and a proximal section, wherein the distal section is attached to the catheter tube and the proximal section defines a housing; a needle that extends through the bucket of
catheter and catheter tube and defining an axial direction, where the needle has opposite proximal and distal ends, the distal end forming a needle tip; a needle hub attached to the proximal end of the needle; a needle guard slidably disposed in the needle, wherein the needle guard is held mobilely in the catheter hub housing when the needle extends through the catheter hub and catheter tube, and where the needle guard is removable from the catheter hub once the needle tip is housed in the needle shield when the needle is removed from the catheter tube; and wherein the housing defines a camera at one of its ends which ensures that a first and a second arm of the needle guard do not contact or interact with an inner surface of the chamber before and during the venipuncture of a patient, as well as It is defined in claim 1.
As is well known in the art, the needle may have a needle element next to its tip that interacts with a proportional base of the needle guard, e.g. eg, a curve or a bump or any other profile change. In this way, it is possible to prevent the needle from being retracted out of the needle guard, which is known in the art.
In one embodiment, the catheter hub is formed by two parts, a first part having a distal end section and a second part having a proximal end section. The first and second parts define the housing to accommodate the needle guard, disposed in a mobile manner on the needle rod.
The chamber is formed by a recess in the housing to accommodate the first and second arms, so that none of the arms deflected by the needle contacts the inner surface of the chamber. By means of this recess, it is possible to keep the overall outer dimensions of the catheter housing and hub reduced, while achieving that the first and second arms of the needle guard do not contact the inner wall surface of the chamber.
In addition, the first and second parts of the catheter hub can be joined by complementary end portions, preferably extending at an angle to the axial direction. This ensures that both sides are concentrically aligned towards each other. In this way, it is possible to facilitate the assembly of this catheter hub.
These end parts may be staggered, which expands their contact area to obtain a better interconnection.
The first and second parts can form the chamber, specifically, the distal end section of the first part and the proximal end section of the second part can form the chamber, which ensures that it is not necessary to form any cuts in the first or the second part.
The inner surface of the chamber may be parallel with respect to the axial direction and be defined only by the first or the second part. Preferably, the inner surface of the chamber is defined by the distal end section of the first part or by the proximal end section of the second part. More preferably, the inner surface of the chamber is defined by the proximal end section of the second part. The advantage of the above described consists in the fact that only one of the two parts that form the catheter hub must be sized very precisely in order to ensure that an inner surface with a well controlled and sufficiently large diameter is obtained, so that none of the arms contact said inner surface. In this regard, it is advantageous that the inner surface of the chamber is defined by the second part comprising the fluid passage 11. In this case, only the second part requires more precise manufacturing, while the first part can be manufactured without the need to use strict tolerances.
The intravenous catheter apparatus according to an embodiment of the invention may be configured so that a first or second part comprises a surface attached to the inner surface of the other first or second part, said surface being inclined towards the inside of the housing in one direction proximal of the catheter hub, the surface having a smaller inner diameter at its innermost end than the distance between the outermost points of the arms in their deviated state inside the chamber. Preferably, the first part comprises the surface attached to the inner surface of the second part. Preferably, the distal end section of the first part comprises the surface attached to the inner surface of the proximal end section of the second part. Such a surface functions as a stop for the arms in their deviated state, so that they cannot be removed from the catheter hub in the proximal axial direction if the needle deflects them out in the prepared position of the needle guard . On the other hand, the inclination of the surface supports that the arms are directed inwards when the needle guard is removed in the retracted position, even if they have been plastically deformed by the needle in its deviated state.
The foregoing objectives, features and advantages of the invention, as well as additional ones, will be apparent from the following detailed description, in combination with the accompanying drawings, in which:
Fig. 1 is a top view of the intravenous catheter apparatus according to the present invention.
Fig. 2 is a sectional side view of the two parts that form a catheter hub according to the present invention.
Fig. 3 is a sectional side view of the two parts joined together and forming the catheter hub with a needle shield according to the present invention.
Embodiments of the invention described herein will be described in detail below with reference to the drawings, in which similar reference numbers indicate identical or corresponding elements. In the drawings and in the description, the term "proximal" refers to a region of the device or its parts or a location in the nearest device, for example, to the user using the device. Instead, the term "distal" refers to a region of the device that is furthest from the user, for example, the distal region of the needle will be the region of the needle that contains the tip of the needle to be introduced, e.g. eg, in a patient's vein.
Referring to Figs. 1-3, an intravenous catheter apparatus 10 according to the invention is shown. The intravenous catheter apparatus 10 includes a catheter hub 12 having a fluid passage 11, a catheter tube 14 and a needle 20. The catheter hub 12 has a distal end 22 and a proximal end 24, the tube being disposed Catheter 14 adjacent to the distal end 22 of catheter hub 12. The needle 20 has a needle rod 28, a needle tip in a distal section of the needle rod 28 and a needle hub 16 attached to a proximal section 36 of the needle rod 28. An extension (not shown) of the needle 20 is provided between the distal section and the proximal section 36 of the needle rod 28. The enlargement has a maximum dimension in a transverse direction with respect to the needle rod 28, which is larger than the outside diameter of the distal or proximal section 36. For example, the enlargement can be performed by bending the needle rod 28.
Before using the catheter apparatus 10, the needle 20 is housed in the catheter hub 12 and the catheter tube 14, so that the needle rod 28 extends through the length of the catheter tube 14. A needle shield 26 is disposed mobilely in the needle rod 28 and retained in the catheter hub 12 before using the catheter apparatus 10, as shown in Fig. 3. The needle shield 26 has a base part 44,
a first arm 40, a second arm 42 and a distal wall 18. The distal wall 18 is disposed at a distal end of the first arm 40 and extends in a transverse direction with respect to an axial direction A of the needle 20. An element Tension 46, for example, a rubber band or the like, surrounds the first and second arms 40, 42. The first and second arms 40, 42 of the needle guard 26 generally extend in the axial direction A from a distal side 60 of the base part 44, that is to say generally parallel to the needle rod 28.
In one of the preferred embodiments, by removing the needle 20 from the catheter tube 14 and the catheter hub 12, the needle rod 28 moves relative to the needle guard 26 until the needle tip is housed in the 26 needle guard. Once the needle tip is housed in the needle guard 26, the enlargement of the needle rod 28 is attached to the base part 44 of the needle guard 26 through a stopper element 38, so that the Needle guard 26 can be removed from catheter hub 12 together with needle 20. At this time, the axial movement of needle 20 relative to needle guard 26 is limited, since the distal wall 18 blocks the tip of the needle axially and the joint between the extension and the base part 44 through the stopper element 38 prevents the needle tip from being withdrawn through the base part 44, that is, the needle tip is surrounded safely by needle guard 26.
Referring in this case to Fig. 2, the catheter hub 12 is formed by two parts, that is, a first part 12a and a second part 12b comprising the fluid passage 11. The first part 12a has a distal end section 50 and the second part 12b has a proximal end section 52. The first part 12a forms part of a housing 48 to accommodate a needle guard 26 that is movably disposed in the needle stem 28 of the needle 20. The distal end 22 of the second part 12b is connected to a tube 14 of catheter.
The distal end section 50 of the first part 12a is configured for mounting in the proximal end section 52 of the second part 12b in various ways and in a fluid tight manner, such as by adhesive sealing, ultrasonic welding, hot die, sealing by radiofrequency, mechanical sealing (snap fit), insert molding, laser welding, etc., ensuring the achievement of a leak-free joint. It is also possible to join the two parts 12a, 12b together, for example, using threads, interference or snap fit. Specifically, as can be seen in Figs. 2 and 3, the first and second parts 12a and 12b are joined by complementary staggered end parts.
As shown in Figs. 2 and 3, the housing 48 is defined by the first and second parts 12a and 12b of the catheter hub 12 which houses the needle guard 26 and is configured so that it defines a chamber 54 at one end of the second part 12b. The chamber 54 is configured to form an enclosure / space for needle protection 26 in its ready position. The chamber 54 is formed by a recess in the housing 48 to accommodate the first and second arms 40 and 42, so that none of the arms 40 and 42 deflected by the needle 20 contacts the inner surface 56 of the chamber 54. In this embodiment, chamber 54 is arranged in
the proximal end section 52 of the second part 12b and is defined by the first and second parts 12a and 12b, which are joined together in axial direction by stepped surface areas 57, 59 of the two parts 12a, 12b.
In this prepared position, the first arm 40 is deflected outwardly with respect to the needle guard 26, so that the distal wall 18 of the first arm 40 is supported on the needle rod 28. Furthermore, in this prepared position, the first and second arms 40, 42 do not join or interact with respect to an inner wall / surface 56 of the chamber 54 before and during a patient's venipuncture. The inner surface 56 is parallel with respect to the axial direction A and is defined only by the second part 12b. This absence of contact of the first and second arms 40, 42 with the inner surface 56 of the chamber 54 significantly decreases the necessary withdrawal force and friction caused by removing a needle 20 through a catheter hub 12 protected by a protection 26 of needle after use. In addition, the first part 12a comprises a surface 58 that is inclined towards the inside of the housing 48 in a proximal direction of the catheter hub 12. This chamfered surface 58 forms a radial edge and functions as an axial stop in the proximal direction of the catheter hub 12 for the arms 40, 42 in its prepared position. The surface 58 has a smaller inner diameter at its innermost end than the distance between outermost points of the arms 40 and 42 in their deviated state inside the chamber 54. In other words, the arms 40, 42 cannot passing this surface 58 in the prepared position, as shown in Fig. 3. However, in this retracted position, the arms 40, 42 have swung radially inwards and can pass the chamfered surface 58.
As shown in Figs. 2 and 3, before using the intravenous catheter apparatus 10, the needle guard 26 is disposed in the catheter hub 12 next to a proximal end 24 of the needle rod 28. In this situation, the needle 20 extends fully through the needle guard 26, thereby diverting the first arm 40 of the needle shield 26 outward, that is, forming an angle with respect to the axial direction A, so that the distal wall 18 of the first arm 40 is supported on the needle rod 28. After the introduction of the catheter tube 14 into a patient, the needle 20 is removed from the catheter tube 14 and the needle rod 28 moves through the needle guard 26 while the needle guard 26 is retained in the hub 12 catheter Once the tip of the needle passes the transverse distal wall 18 of the needle guard 26, in retraction state, so that the needle rod 28 no longer supports the distal wall 18, a recovery force of the tension element 46 and the inherent elasticity of the first arm 40 ensures that the first arm 40 of the needle guard 26 is again aligned with the axial direction A, so that the needle tip is blocked by its axial coverage by the distal wall 18 of the needle guard 26, that is, the needle tip cannot protrude axially with respect to the needle guard 26.
The catheter apparatus 10 is especially economical to manufacture if the base part 44, the first and the second arms 40, 42 are integrally formed from a first material. For example, the first material may be a plastic material. Therefore, the base part 44, the first and second arms 40, 42 could be manufactured by injection molding.
Alternatively, the base part 44 and one of the first and second arms 40, 42 could be integrally formed from a first material, e.g. eg, a plastic material, and the first or second remaining arms 40, 42 could be formed from a second material different from said first material. For example, said first or second remaining arm 40, 42 could include a strip of material with elastic properties, e.g. eg, a strip of sheet metal, obtaining the inherent elasticity mentioned above.
The structure and shape of the improved intravenous catheter apparatus 10 of the present description allow a simple configuration to be obtained. The simple design of the intravenous catheter apparatus 10 is advantageous in a clinical environment, since it facilitates the catheterization process as a whole, thereby reducing injuries or discomfort in the patient. In addition, such a design greatly reduces manufacturing costs and is efficient, effective and simple in its structure and use.
Although this invention has been described in the context of some preferred embodiments and examples, those skilled in the art will understand that the present invention extends beyond the embodiments specifically described to other alternative embodiments and obvious modifications thereof. Therefore, from the foregoing description, it will be apparent to a person of ordinary skill in the art that it is possible to carry out numerous changes and modifications therein without departing from the scope of the invention, described in the claims.
Accordingly, it is not intended that the scope of the following description be limited to the exact previous description, but that said description be construed as comprising the features included in the present invention.
The scope of the present invention described herein is not limited by the specific embodiments described above, but is determined only by an objective reading of the appended claims.
10 Intravenous catheter apparatus
11 Fluid passage
12 catheter bucket
12a First part of catheter hub
12b Second part of catheter hub
16 Needle Cube
18 Distal Wall
24 Proximal end
26 Needle protection
28 Needle Stem
36 Proximal section
38 Stopper element
42 Second arm
44 Base part
46 Tension Element
50 Distal Extreme Section
52 Proximal Extreme Section
56 Interior surface / wall
57 Stepped surface of part 12a
58 Inclined interior surface
59 Stepped surface of part 12b
60 Distal side
1. Intravenous catheter apparatus (10), comprising: a catheter tube (14);
a catheter hub (12) having a distal end (22) and a proximal end (24), wherein the distal end (22) is attached to the catheter tube (14) and the proximal end (24) defines a housing (48);
a needle (20) extending through the catheter hub (12) and the catheter tube (14) and defining an axial direction (A), wherein the needle (20) has opposite proximal and distal ends, the distal end forming a needle tip;
a needle hub (16) attached to the proximal end of the needle (20);
a needle guard (26) slidably disposed in the needle (20), wherein the needle guard (26) is held mobilely in the housing (48) of the catheter hub (12) when the needle (20 ) extends through the catheter hub (12) and the catheter tube (14), where the needle guard (26) is removable from the catheter hub (12) once the needle tip is housed in the shield (26) of needle when removing the needle (20) from the catheter tube (14), and where the housing (48) defines a chamber (54) at one of its ends which ensures that a first and a second arms (40 , 42) of the needle guard (26) do not contact or interact with an inner surface (56) of the chamber (54) before and during a patient's venipuncture;
the chamber (54) being formed by a recess in the housing (48) to accommodate the first and second arms (40, 42), so that none of the arms (40, 42) deflected by the needle (20) contacts the inner surface (56) of the chamber (54),
characterized in that the catheter hub (12) is formed by two parts, a proximal part (12a) with a distal end section (50) and a distal part (12b) with a proximal end section (52), wherein the surface The interior (56) of the chamber (54) is defined by the proximal end section (52) of the distal part (12b).
2. Intravenous catheter apparatus (10) according to claim 1, wherein the proximal and distal portions (12a, 12b) define the housing (48) to accommodate the needle guard (26) that is movably disposed in the needle (twenty).
3. An intravenous catheter apparatus (10) according to claim 1 or 2, wherein a distal end section (50) of the proximal part (12a) is attached to a proximal end section (52) of the distal part (12b) of fluid tight way.
4. Intravenous catheter apparatus (10) according to any one of claims 1 to 3, wherein the proximal and distal portions (12a, 12b) are joined by complementary end portions (57, 59).
5. Intravenous catheter apparatus (10) according to claim 4, wherein the end portions (57, 59) are staggered.
6. An intravenous catheter apparatus (10) according to any one of claims 1 to 5, wherein the proximal and distal portions (12a, 12b) form the chamber (54).
7. An intravenous catheter apparatus (10) according to claim 6, wherein the inner surface (56) of the chamber (54) is parallel with respect to the axial direction (A) and is defined only by the distal part (12b) .
8. An intravenous catheter apparatus (10) according to claim 7, wherein the proximal part (12a) comprises a surface (58) attached to the inner surface (56) of the distal part (12b), said surface being inclined (58 ) towards the inside of the housing (48) in a proximal direction of the catheter hub (12), where the surface (58) has an inner diameter smaller at its innermost end than a distance between outermost points of the arms ( 40, 42) in its deviated state inside the chamber (54).
ES16705703.3T 2015-06-27 2016-02-03 IV catheter apparatus Active ES2689910T3 (en)
IN1916DE2015 2015-06-27
PCT/IB2016/050536 WO2017001942A1 (en) 2015-06-27 2016-02-03 Intravenous catheter apparatus
ES2689910T3 true ES2689910T3 (en) 2018-11-16
ID=55521756
ES16705703.3T Active ES2689910T3 (en) 2015-06-27 2016-02-03 IV catheter apparatus
US (1) US10335579B2 (en)
EP (1) EP3131614B1 (en)
ES (1) ES2689910T3 (en)
WO (1) WO2017001942A1 (en)
EP1803477A3 (en) 2004-02-13 2007-07-18 Smiths Medical ASD, Inc. Catheter with needle tip protector
JP2015519984A (en) 2012-06-19 2015-07-16 ポリー メディキュア リミテッド needle guard
US20150306349A1 (en) * 2014-04-29 2015-10-29 B. Braun Melsungen Ag Valved catheter assemblies and related methods
2016-02-03 EP EP16705703.3A patent/EP3131614B1/en active Active
2016-02-03 WO PCT/IB2016/050536 patent/WO2017001942A1/en active Application Filing
2016-02-03 US US15/022,458 patent/US10335579B2/en active Active
2016-02-03 ES ES16705703.3T patent/ES2689910T3/en active Active
EP3131614B1 (en) 2018-08-22
US10335579B2 (en) 2019-07-02
WO2017001942A1 (en) 2017-01-05
US20170197062A1 (en) 2017-07-13
EP3131614A1 (en) 2017-02-22
ES2351233T5 (en) 2014-06-16 Needle safety device
ES2328794T3 (en) 2009-11-18 Security catheter.
CA2904919C (en) 2017-07-04 Needle guard
ES2361980T3 (en) 2011-06-24 Device and procedure for retaining a point protector on a needle with a curved point.
JP2007521080A (en) 2007-08-02 Safety needle shield device
US20110218500A1 (en) 2011-09-08 Automatic injection device with audible indicator of completed injection
ES2536536T3 (en) 2015-05-26 Needle tip spring guard
ES2490255T3 (en) 2014-09-03 Tip guard for a safety catheter
ES2456953T3 (en) 2014-04-24 Catheter assembly and components thereof