Catheter anchoring system

IS 2 178 652 T3

DESCRIPTION

Catheter anchoring system.

This invention relates to a catheter anchor system.

More particularly, the present invention relates to a catheter anchor system for use in a percutaoneal catheterization system, which can safely interconnect an indwelling catheter with a tube system and securely anchor such an interconnect to the skin. of a patient.

The medical treatment of patients normally involves the use of catheters inserted percutaneously either to direct fluids directly into the bloodstream, to a specific organ, or to an internal point of the patient, or to control the vital functions of the patient. For example, intra-arterial catheters are commonly used to direct fluids and / or medication directly into the patient's bloodstream. Epidural catheters are commonly used to direct anesthesia into the epidural space to anesthetize a specific site on the patient. Intervascular catheters are commonly used to control arterial blood pressure.

Fluid (eg, parenteral fluid, medication, or anesthesia) is drained topically from a container placed on top of the patient. The fluid flows through the tube system into a permanent catheter. The catheter and fluid tubing system can normally be coupled so that they can be disassembled by a conventional bait-type connector, such as the type described in US Patent No. 4,224,937.

In common practice, the provider of healthcare, such as a nurse or physician (for ease of description, as used herein, the term "nurse" refers to healthcare providers generally and not will have a restrictive meaning), use adhesive or sterile tape to hold the catheter in position on the patient's skin. The connection between the tubing system and the catheter is also maintained through the use of tape.

The nurse could also form a safety loop in the tubing system so that any tension applied to the tubing system does not pass directly into the catheter cannula, but is rather absorbed by the safety loop clearance. The nurse usually fixes the loop loosely on the patient's skin.

The entire taping procedure takes up several minutes of the valuable time the healthcare provider has. In fact, nurses generally remove gloves when taping because most nurses find this type of taping procedure difficult and cumbersome when wearing gloves.

Often times, the catheterization process requires frequent disconnection between the catheter and the fluid supply tube. For example, intravenous catheterization is frequently maintained for several days, depending on the patient's condition. The catheter tubing system is generally replaced every 24 to 48 hours to maintain sterility of the fluid and free flow of fluid through the tubing system. Therefore, a nurse must change the tubing system frequently and re-tape the connection. On the other hand, the tape, which secures the catheter to the patient's skin, often covers the insertion point of the cannula. The nurse should remove the tape to inspect the insertion site for inflammation or infection, and then repeat the taping procedure described above.

Therefore, valuable time is spent applying large amounts of sterile tape to indwelling catheters. Frequent application and removal of sterile tape also commonly results in excoriation of the patient's skin in the area of ​​insertion.

Recently, several catheterization systems have been developed, which improve the stabilization of the catheter system and obviate the need for frequent application and removal of sterile tape. One such system is disclosed in US Patent No.^° 5,192,273 of the present Applicant.

The aforementioned patent 5,192,273 discloses an adapter that interconnects the catheter with a fluid supply tube system. The adapter is pressurized into the base attached to the patient's skin by means of an adhesive pad. Specifically, the nurse presses the adapter between the right legs of the base. Leg retainers move into the corresponding annular notches in the adapter to secure the adapter to the base.

Although the base holds the adapter fixed in position, a nurse may have difficulty positioning and aligning the annular notches on the adapter with the retainers on the base. Other stressful situations may further exacerbate the difficulties associated with proper placement of the adapter in the base. Some nurses and other healthcare providers may also have trouble determining how to attach the catheter adapter to the base.

Another catheterization system is described in US Patent No.^° 4,898,587. The aforementioned patent 4,898,587 discloses a device for holding a medical tube in the body. This device includes a base plate to adhere the device to a part of the body, pad bands that secure the medical tube to the base plate, and a cover that covers the base plate and a portion of the tube.

The objective of the present invention is to provide a catheter anchor system having an adapter retainer that is not position or technique sensitive. That is, the nurse just places the catheter adapter generally on top of the retainer and pushes the adapter into the retainer. To fit, you just have to proceed with the alignment of the adapter course with the retainer.

According to one aspect of the present invention, an anchoring system is provided that consists of: a catheter adapter that is defined between a distal end configured to allow coupling with the tube system or the proximal hub of a catheter or connector type bait and

ES 2 178 652 T3 a proximal end configured to engage a distal end of a tube, the catheter adapter having a generally tubular body; a retainer with a longitudinal channel configured to receive the tubular body of the catheter adapter so that it is snap fit; a flexible anchor pad including an adhesive bottom surface and the anchor pad holding the retainer; wherein the catheter adapter also comprises a radially extending member positioned along the tubular body, said radially extending member projecting from an outer surface of the tubular body; wherein the retainer consists of a pair of opposing longitudinally extending walls which define between it a longitudinal channel having a generally circular cross section truncated at an upper end to form a generally U-shaped channel having an upper opening and a series of grooves, calibrated to receive and hold said radially extending member, the series of grooves forming in each of the walls and each groove in one wall aligning with a corresponding groove in the other wall.

Following another aspect of the present invention, a method is provided to anchor an interconnection between a catheter adapter and a tube, which consists of:

a) provide a catheter adapter defined between a distal end configured to allow engagement with the tubing system or the proximal hub of a catheter or bait-type connector and a proximal end configured to engage a distal end of the tube, the adapter having catheter a generally tubular body;

b) providing a retainer having a longitudinal channel configured to receive the tubular body of the catheter adapter as a snap-fit;

c) providing a flexible anchor pad including an adhesive bottom surface (18); with the anchor pad supporting the retainer; wherein the catheter adapter also comprises a radially extending member positioned along the tubular body, said radially extending member projecting from an outer surface of the tubular body; and the retainer consists of a pair of opposing longitudinally extending walls which define between them a longitudinal channel having a generally circular cross-section truncated at an upper end to form a generally U-shaped channel having an upper opening and a series of grooves, calibrated to receive and hold said radially extending member, the series of grooves being formed in each of the walls and each groove in one wall aligning with a corresponding groove in the other walls;

d) positioning the radially extending portion of the catheter adapter above the series of grooves; and

e) inserting the tubular body of the catheter adapter into the longitudinal channel and the radially extending portion of the tubular body into one of the series of grooves.

The present invention will be further described below, by means of examples, with reference to the accompanying drawings, in which:

Figure 1 is a perspective view of a catheter anchor system following a preferred embodiment of the present invention, mounted on the back of a patient's hand;

Figure 2 is a top plan view of the catheter anchor system of Figure 1;

Figure 3 is a top plan view of a retainer of the catheter anchor system of Figure 2;

Figure 4a is a front elevation view of the retainer of Figure 3;

Figure 4b is a rear elevational view of the retainer of Figure 3;

Figure 5 is a side elevation view of the retainer of Figure 3;

Figure 6 is a top plan view of a catheter anchor system following another preferred embodiment of the present invention;

Figure 7a is a front elevational view of a retainer and rail assembly of the catheter anchor system of Figure 6;

Figure 7b is a side elevation view of the retainer and rail assembly of Figure 6;

Figure 8 is a cross-sectional view of the retainer and rail assembly taken along line 8-8 of Figure 7a;

Figure 9 is a top plan view of a catheter anchor system following an extra preferred embodiment of the present invention;

Figure 10 is a side elevational view of an S-jaw of the catheter anchor system of Figure 9 taken along line 10-10;

Figure 11 is a top perspective view of a catheter anchor system following a further preferred embodiment of the present invention;

Figure 12 is a top plan view of the catheter anchor system of Figure 11, showing an adapter held by a retainer;

Figure 13a is a side elevation view of the retainer of Figure 12;

Figure 13b is a top plan view of the retainer of Figure 12; and Figure 14 is a perspective view of an alternate representation of a catheter adapter that can be used with the anchoring system of Figure 11.

Detailed description of preferred representations

Figure 1 shows in perspective view a catheter anchoring system (10) according to the present invention. The anchoring system (10) securely connects a tube (12) (e.g. a

ES 2 178 652 T3 fluid supply tube) to an indwelling catheter (14) and holds the catheter (14) in the desired permanent position. The anchoring system (10) is designed to achieve rapid coupling to the catheter (14) and the patient, without requiring precise alignment or placement of the components of the anchoring system (10).

On the other hand, the strong anchorage of the catheterization system is achieved without the use of sterile tape. For most catheterization procedures, the anchoring system is attached to the patient only once. Although the fluid supply tubing system (12) can be changed every 24 to 48 hours for an intravenous catheterization, the components of the anchoring system (10) attached to the patient remain in position. Thus, it is not necessary to apply and remove the sterile tape from the patient's skin multiple times.

The catheter anchor system (10) consists primarily of a flexible pad (16) having an adhesive underside (18) that engages the skin of a patient when worn. The pad (16) supports a retainer (20). The retainer (20) was configured to receive and secure in position a catheter adapter (22) that interconnects the hub (30) of a permanent catheter (14) and the fluid supply tube (12) connected to a supply container. fluid (not shown). The container holds the fluid to be administered to the patient, which is fed either by gravity or by pressure. A clamp (not shown) can be used to regulate the flow of fluid through the tube system (12). The pad (16) can also support a tube clamp (24) that is used to retain a portion of the tube system (12).

Although Figure 1 shows the catheter anchor system placed on the back of the patient's hand (illustrated in phantom lines), it is envisaged that the present invention can be used for catheterization in other parts of the patient's body. For example, the anchoring system can be used on the medial aspect of the wrist in connection with a radial artery. The anchoring system (10) can also be used for epidural catheterization, as discussed in detail below, and can be placed on the back of the patient's torso.

Figure 1 shows a longitudinal axis, a transverse axis and a lateral axis in relation to the catheter anchoring system (10) to facilitate the following description. Also, as used herein, "longitudinal direction" refers to a direction basically parallel to the longitudinal axis. "The lateral direction" and "the transverse direction" refer to the lateral axis and the transverse axis respectively. Similarly, "proximal" and "distal" refer to the proximity of the fluid supply container connected to the tube (12) (see Figure 1). The individual components of the catheter anchor system (10) will now be described in detail. Catheter adapter

Figure 1 shows the catheter adapter (22) interconnected to a catheter (14). Figure 2 shows the catheter adapter (22) disconnected from the catheter (14). Although these figures show adapter (22) as the type disclosed in US Patent No. 5,193,273, it is anticipated that other types of adapters may also be used with the present catheter anchor system (10). For example, the catheter adapter (22) would be a bait-type adapter, such as the type illustrated in Figure 11 and described below, or a bait-lock type catheter adapter (22), such as the type illustrated in Figure 14 and described below. It is expected that those skilled in the art could easily select the type of catheter adapter (22) to use with the present catheter anchor system (10) depending on the specific application (eg. venous, arterial, epidural, etc.) of the anchoring system (10).

As best seen in Figure 2, adapter (22) consists of a tubular body (25) defined between a distal end (26) and a proximal end (28). The proximal end (28) is adapted to receive a distal end of the tube (12). In an exemplary embodiment, at least a portion of the fluid supply tube is permanently attached to the proximal end of the body (28). As shown in Figure 2, the proximal end of the tubing system may then include a standard bait-type connector (29) for connection to a fluid supply line (12).

The distal end (26) is configured to connect with the proximal hub (30) of the catheter (14) (see Figure 1) or any bait type connector. Although Figure 2 shows the distal end of the adapter (22) as having a frusto-conical shape configured to connect with a hub of the standard bait-type catheter (30), it is expected that the distal end (26) can be configured as well as connecting with other types of catheter connectors, such as, for example, a Toughy-Bourst adapter.

A support arm (32) extends outwardly from the tubular body (25) in a cantilevered manner. The support arm (32) supports, at a radially outer end of the arm (32), a jaw support member (not shown) that extends generally parallel to, and at some distance from, a longitudinal axis of the tubular body ( 25).

Figure 2 also shows a jaw (34) of the catheter adapter. The jaw (34) engages and slides along the jaw support member in a longitudinal direction. The jaw (34) includes a distal fastener (36) that is generally bifurcated in shape to connect an outer surface of the distal end of the catheter hub (30) to a hub collar (38) (see Figure 1) to secure the adapter (22) securely to catheter hub (30).

The interconnecting structure (not shown) between the jaw support member and the jaw (34) allows the jaw (34) to slide in the proximal direction, but prevents the jaw (34) from sliding in the distal direction. Conveniently, the interconnecting element consists of a series of ratchet teeth (not shown) disposed on the upper surface of the jaw support element and a latch finger (not shown) connected to the jaw (34). Hitch finger extends Move jaw (34) cantilevered and engages

ES 2 178 652 T3 ratchet to prevent distal jaw movement, as discussed in more detail in US Patent No. 5,193,273.

The tubular body (25), the support arm (32) and the jaw support member are preferably formed from a molded plastic part, such as, for example, a clear polycarbonate, so that it is generally hard although somewhat flexible. Conveniently, the support arm (32) has sufficient elasticity to bend. Pressing the proximal end of the jaw (34) towards the tubular body (25) removes the fastener (36) from the jaw (34) of the tubular body (25). In this way, the jaw (34) rotates around the tubular body (25).

Referring back to Figure 2, the jaw support member preferably consists of a protrusion (40) positioned on the inner surface (42) of the jaw support member, close to the proximal end of the jaw (34). The protrusion is separated from the support arm by a distance L. The protrusion (40) prevents the jaw (34) from rotating when clamped with the retainer (20), as explained in detail below. The bulge (40) also limits the degree of deflection of the support arm (32) to reduce fatigue, as fully explained in U.S. Patent No.^° 5.193.273.

Retainer for catheter adapter

Figures 3 to 5 show the retainer (20). The retainer (20) has a generally parallelepiped shape that defines a central channel (44) interposed between a pair of opposing longitudinal walls (46). The central channel (44) extends through the retainer (20) along an axis that is generally parallel to the longitudinal axis of the retainer.

As best shown in Figure 4, the central channel (44) has a generally circular cross-sectional shape that truncates at its upper end to form a generally U-shaped channel which has an upper opening (47). The central channel (44) has a calibrated diameter to receive the tubular body (25) of the catheter adapter (22). In a preferred embodiment, the diameter of the central channel (44) generally coincides with that of the tubular body (25) or is slightly higher.

In transverse profile, the central channel (44) extends for an arc greater than 180^° along the axis of the channel, such that the transverse length of the opening (47) is less than the diameter of the central channel (44). In an exemplary representation, the central channel (44) spans an arc of about 200^° along the axis of the canal.

Figure 5 shows the axis of the channel which is preferably oblique in relation to the base surface (48) of the retainer (20). An incident angle θ formed between the base surface (48) and the channel axis is less than 45^°. The incident angle θ varies preferably between 0^° y30^°. In an exemplary representation for intravenous use, the angle θ is preferably equal to 7^° approximately. In another exemplary representation for arterial use, the incident angle θ is preferably equal to about 22^°. In another exemplary representation, for peripherally inserted central catheters (PICC), the incident angle θ is preferably equal to 0^°.

The longitudinal walls (46) are substantially identical. Each wall (46) has a thickness measured in the lateral direction less than the length of the support arm (32). Thus, the wall (46) is interposed between the tubular body (25) and the jaw (34) when the tubular body (25) is inserted into the central channel (44). The length of each wall (46), measured in the longitudinal direction, is preferably coextensive with the length of the retainer (20).

Each wall (46) consists of a uniform series of grooves (50). The series consists of at least two [2] grooves (50), and not more than twenty [20] grooves (50). Most preferably, the series consists of less than seven [7] slots (50). In an exemplary representation, as shown in the application figures, the series consists of four [4] slots (50).

Each slot (50) was calibrated to receive the support arm (32) of the catheter adapter (22) to prevent longitudinal displacement of the adapter (22), as indicated below in detail. Each slot (50) is preferably rectangular in shape. As seen in Figure 3, the grooves (50) extend from an outer surface (52) through the wall (44), and open into the central channel (44). The width of each slot (50) (measured longitudinally) is preferably somewhat greater than the width of the support arm (32), measured in the longitudinal direction to receive the support arm (32), as indicated below.

As shown in Figure 5, each slot (50) has a height as measured in the transverse direction between an upper edge (54) of the longitudinal wall (46) and the lower part (56) of the central channel (44). The height of the slot (50) is preferably equal to the approximate width of the support arm (32), such that the support arm (32) does not protrude from the retainer (20) in the transverse direction.

The distance S between the grooves (50), in the center, is preferably equal to approximately half the distance L (see Figure 2) between the support arm (32) and the protrusion (40) of the catheter adapter (22 ).

As shown in Figure 3, a distance X between the distal móas slot (50) and the distal end of the retainer (20) is less than the longitudinal distance Y (see Figure 2) between the support arm (32) and the fastener ( 36) placed in its most proximal position. This distance allows the support arm (32) to rest in the more distal slot (50) with the holder (36) retaining a catheter hub (30) distal from the distal end of the retainer.

Figure 5 shows the upper edge (50) of the longitudinal wall (46), which consists of a series of bevels (58), each of which descends forming a groove (50). That is, the upper edge portion (50) of longitudinal wall (46) surrounding a slot (50) includes a pair of bevels (58), with a bevel (58) being positioned on either side of the slot (50). The bezels (58) descend towards the slot (50) to facilitate the insertion of the support arm (32) of the adapter

ES 2 of catheter (22) in slot (50), as indicated below.

As Figures 3 and 5 show, each longitudinal wall (46) also consists of a recess (60) positioned at the proximal end of the retainer (20). The recess (60) is calibrated to receive the protrusion (40) of the adapter (22). The depth of the recess (60) measured in the lateral direction is preferably somewhat greater than the height of the protrusion (40) (ie, the distance by which the protrusion protrudes from the inner surface (42)).

The recess (60) is spaced in the longitudinal direction from the most proximal groove (50) by a distance approximately equal to the distance S between the grooves (50). Thus, the protuberance (40) rests in the recess (60) placing the support arm (32) in either of the two more proximal grooves (50), as indicated below in detail.

Figures 3 and 4 show a keyway notch (62) of the retainer (20). The keyway notch (62) facilitates removal of the catheter adapter (22) from the retainer (20), as detailed below. The keyway notch (62) is at the proximal end of the retainer (20). The keyway notch (62) extends into the retainer (20), and toward the base surface of the retainer (48) from the bottom surface (56) of the center channel (44). The keyway groove (62) has a transverse width less than the diameter of the central channel (44), and more preferably has a width approximately equal to two-thirds of the diameter of the central channel (44). The longitudinal length of the keyway groove (62) is preferably equal to the approximate longitudinal length of the recesses (60) in the longitudinal walls (46).

The retainer (20) is made of relatively hard plastic material (eg polycarbonate), but is somewhat flexible, such that the adapter (22) forces the upper edges (54) of the longitudinal walls (46) outward when the nurse presses the adapter (24) into the center channel (44) of the retainer (20). When the adapter (22) seats in the center channel (44), the upper edges (54) of the walls (46) will spring inward into their original position to securely grip the adapter (22) within the retainer (20). .

An adhesive attaches the retainer (20) to the base pad (16). Alternatively, the retainer (20) could be attached to the base pad (16) with the use of similar means (eg by embedding or otherwise placing the retainer (20) in a zigzag on the base pad (16)) as well. Base pad

As shown in Figure 1, the flexible base pad (16) consists of a laminar structure consisting of an upper layer of paper or other woven or non-woven cloth (64), an inner layer of cellulose foam (66), and the bottom adhesive layer (18). Alternatively, the flexible base pad (16) may consist of an adhesive bottom layer and a cellulose foam top layer. An upper surface of the foam layer is roughened by corona treatment with a low electrical load, as described above.

652 T3 10 meet in art. The porous or rough upper surface of the base pad (16) enhances the epoxy adhesion when the retainer (20) is attached to the pad (16).

A removable paper or plastic backing (not shown) preferably covers the adhesive bottom layer (18) before use. The backrest preferably resists tearing and is divided into a plurality of pieces to facilitate coupling of the pad (16) to the patient's skin, as explained below. Preferably, the backing is divided along the center line of the flexible base pad (16) in order to only expose one half of the adhesive bottom surface (18) at a time. The backing also favorably extends past at least one edge of the base pad (16) to facilitate removal of the backing from the adhesive layer (18).

As seen in Figure 2, one or more tabs (67) could be attached to the portion of the backrest that extends past the flexible base pad (16). In an exemplary representation, the tabs (67) have the same laminar structure as the flexible base pad (16). The tab (67) could also include indicia (69) in the form of dots, words, figures or the like to indicate finger placement when the backing of the base pad (16) is removed.

A nurse grasps the tab (67), preferably the part where there are indications (69), and peels off the backing of one half of the adhesive layer (18). The nurse then places the bottom layer (18) against the patient's skin to adhere the base pad (16) to the patient. A slight pressure on the top layer (64) ensures good adhesion between the base pad (16) and the patient's skin. The base pad (16), due to its flexibility, conforms to the contours of the topical surface, to which the base pad (16) adheres. The nurse then repeats this procedure for the other half of the pad (16). Alternatively, the nurse could fully remove the backing of the pad (16) before gluing the pad (16) to the patient's skin.

The base pad (16) preferably consists of a recess (68) positioned distal to the location of the retainer (20) in the pad (16) and adjacent to the insertion point of the catheter cannula. The recess (68) is calibrated to allow visual inspection of the catheterized site.

As seen in Figure 2, the base pad (16) preferably consists of an arrow-shaped indication (70), which indicates the proper orientation of the base pad (16) with reference to the catheterized point. Although the figures show the indications in the form of an arrow, it is to be expected that other forms of indications, such as, for example, words or other graphics, may also be used. Using it properly, as shown in Figure 1, the indications (70) should point in the proximal direction, towards the indwelling catheter (14), or else indicate the proper location of the catheter.

ES 2 pad (16) with reference to the indwelling catheter (14).

In an exemplary representation, the laminar structure of the base pad is preferably formed by winding a paper tape, such as microporous rayon tape, which can be purchased as MICRO-PORE tape from 3M (Art. No. 1530) , on top of medical grade polyvinyl chloride foam tape, such as the one available for sale at 3M (Art.^° 9777L). The foam tape preferably includes the bottom liner or backing. The base pad (16) and tabs (67) of the laminated sheet of foam and paper are then stamped. However, it is desirable not to cut the backing between the tabs and the base pad, so that the tabs (67) remain attached to the backing that covers the adhesive section (18) of the base pad (16). The backrest is then cut into two pieces along the center line of the pad (16) and between the tabs (67).

Tube clamp

Figures 1 and 2 show the tube clamp (24). The jaw (24) secures the fluid supply tube (12) to form a safety loop, as is known in the art.

The tube jaw has a plate-like base (72) attached or recessed to the base pad (16). The tube clamp (24) can be positioned on the base pad (16) on either side of the retainer (20) to accommodate a left or right mount. As shown in Figure 6, the anchoring system (10) may also include a second tube jaw (24) located on the other side of the retainer (20) from the first tube jaw (24).

Jaw (24) defines a channel (74) having a generally circular transverse configuration truncated to form an upper hole (76). The diameter of the channel (74) is preferably slightly smaller than that of the fluid supply tube (12) so as to ensure a secure interconnection. The channel (74) receives a portion of the fluid supply tube (12) through the orifice (76) by applying slight pressure or pulling the tube system (12) through and through the orifice (76) of the tube clamp. (24), as explained below. The jaw (24) surrounds a significant portion of the tube system (12) placing the tube system (12) in the channel (74).

As seen in Figure 2, the upper edge of the channel includes conical ends (77) at the proximal and distal ends of the jaw (24). Each tapered end (77) forms a smooth transition between the lateral edge of the channel (74) and the upper edge, and tapers in lateral width from the lateral edge toward the center of the tube jaw (24). The conical ends (77) help guide the fluid supply tube (12) into the channel (74) when a nurse pulls the tube through the jaw (24). Thus, the nurse does not have to pinch the tube (12) to insert it into the clamp (24). Likewise, the nurse's gloves do not stick to the jaw (24) when the tube (12) is inserted, as is often the case in the case where the nurse is required to pinch the tube (12) to insert it into the mor652 T3 12 daza (24).

Slide clamp

As shown in Figures 1 and 2, the catheter anchor system (10) preferably further includes a sliding clamp (78) to adjust the flow of fluid through the tubing system, as is known in the art. The clamp (78) includes, at one end, an opening (80) that receives the fluid supply tube (12), and, at the other end, a tab (82). The clamp (78) is generally forked in shape formed by a pair of claws (84) defining the opening (80). The tube (12) passes under pressure between the claws (84) and from there to the opening (80) which has a diameter slightly greater than that of the fluid supply tube (12).

The claws (84) converge together in the direction of the tab (82) to form a conical groove (86) which opens into the opening (80). The claws (84) pinch the tube (12) closed, the tube (12) being in the slot (86) in such a way as to block the flow of the fluid that passes through it. However, the clamp (78) slides over the tube (12), placing the tube (12) through the opening (80).

Preferably, the tab (82) has a rectangular shape that generally corresponds to the shape of the keyway notch (62) in the retainer (20). The tab (82) preferably has a thickness greater than that of the distal end of the keyway notch (62), measured in the transverse direction, so that it can lift the adapter (22) from the retainer (20). As explained in more detail below, the tab (82) could be used to remove the catheter adapter (22) from the retainer (20).

Retainer Location Adjustment Mechanism

Figure 6 to 8 shows a catheter anchor system (10a) according to another preferred embodiment of the present invention. Where appropriate, equal numbers with the suffix "a" have been used to indicate similar parts of the two representations for ease of understanding.

The catheter anchoring system (10a) is essentially identical to the anchoring system (10) described above, in addition to a retainer (90) location adjustment mechanism.

As best seen in Figure 8, the location adjustment mechanism (90) consists of a base (92) and an interconnection mechanism (94) which interconnects the base (92) and the retainer (20a). The retainer (20a) slides over the base (92) and the interlocking mechanism (94) secures the retainer (20a) to the base (92) in various longitudinal positions. Thus, the adjustment mechanism allows precise positioning of the retainer (20) in relation to the catheter (14) after the pad (16) is glued to the patient's skin.

The base (92) is generally parallelepoped in shape and consists of a rail (96). Figure 7a better shows that rail (96) preferably has a "dovetail" configuration in cross section. That is, the rail (96) has a transverse shape with a flat upper edge (98) and a pair of opposite side edges (100), each edge (100) twisting into a 7

ES 2 178 652 T3 runs inward from the top edge (98) towards the middle of the rail (96). The rail (96) extends the longitudinal length of the base (92) from the distal end (102) of the base (92) to a point just a short distance from the proximal end of the base (104). The base (92) includes a pair of stops (106) at the proximal end (104) which close the proximal end of the rail (96).

An adhesive attaches the base (92) to the base pad (16a). Alternatively, the base (92) may be attached to the base pad (16a) by similar means (eg, by embedding or otherwise zigzagging the base (92) into the base pad (16a)) as well.

The retainer (20a), configured according to the above-mentioned description, also consists of a notch (108) having a transverse shape corresponding to that of the rail (96). The notch in the retainer (108) receives the base rail (96) in a way that allows the retainer (20a) to slide through the base (92), while preventing the retainer (20a) from moving in the transverse direction away from the base ( 92). The base stops (106) also limit longitudinal displacement of the retainer in a proximal direction.

The interlocking mechanism (94) consists of a plurality of teeth (110) disposed on an upper surface (112) of the base (92), and a latch finger (114) connected to the retainer (20a). Preferably, the teeth (110) have generally rectangular cross-sectional shapes, and extend successively along the longitudinal axis of the base (92). The top edge of each tooth (110) includes a chamfer (112) to facilitate engagement of the engagement finger (114) with a cavity (116) formed between adjacent teeth (110), as noted below. The longitudinal length of each tooth (110) preferably extends from what is generally normal to the longitudinal axis of the base (92).

Engagement finger (114) is shaped to insert into and engage cavity (116) which is defined between teeth (110). Preferably, the latch finger (114) has a width, measured in the longitudinal direction, slightly less than that of the cavity (116).

The retainer (20a) consists of an opening (118) that extends between the base surface of the retainer (48a) and the bottom surface of the channel (56a). A flexible finger (120) extends from the retainer (20a) in the cantilevered manner and into the opening of the retainer (118). Flexible finger (120) supports hooking finger (114) at its distal end. Although Figure 8 shows the finger (120) as extending in the distal direction, it is envisioned that the finger (120) may alternatively extend in the proximal direction as well.

The flexible finger (120) preferably consists of a protrusion (122) which extends vertically beyond the lower surface of the channel (56a) and into the central channel (44a) with the finger (120) in a non-state. deflected. The cantilevered nature of finger (120) allows finger (120) to deflect downwardly such that protrusion (122) is below the lower surface of retainer (56a). With the finger (120) deflected in this manner, the engagement finger (114) engages the series of teeth (110). That is, the engagement finger (114) penetrates a cavity (116) defined between the teeth (110). The intercoupling between the hooking finger (114) and the teeth (110) prevents the retainer (20a) from sliding on the base (92).

S-jaw

Figures 9 and 10 show a catheter anchor system (10b) following another embodiment of the present invention. Where appropriate, equal numbers with the suffix "b" have been used to indicate similar parts of the representations for ease of understanding.

The catheter anchoring system (10b) is, essentially, identical to the anchoring system (10) described firstly above, with the addition of an S-shaped clamp (124) to retain a system of tubes (126) of small or small inner diameter. inner microdiameter. The inner microdiameter tube system is commonly used, for example, with epidural catheterization procedures, as explained below in detail.

The S-jaw (124) consists of a generally U-shaped channel (128) defined by a pair of arcuate vertical walls (130) extending from a base plate (132). As best seen in Figure 10, the S-jaw (124) also consists of a plurality of retainers (134), each retainer (134) having a spherical head (136) supported by a cylindrical stem (138). The rods (138) extend from the base plate (132). The retaining rods (138) are positioned from one another and from the vertical walls (130) with a distance slightly greater than the diameter of the inner micro-diameter tube system (126). The retainers (134) are also positioned in such a way that the spherical heads (136) of the retainers (134) are positioned from each other and from the vertical walls (130) with a distance slightly less than the microdiameter tube system. interior (126). As best seen in Figure 10, the retention heads (136) prevent the inner micro-diameter tube system (126) from disengaging from the S-jaw (124) in the transverse direction once the micro-diameter tube system interior (126) has been inserted between the retainers (134) and the vertical walls (130).

An adhesive attaches the base plate (132) of the S-jaw (124) to the base pad (16b). Alternatively, the base plate (132) may be attached to the base pad (16b) by similar means (eg, by embedding or otherwise by zigzagging the base plate (132) into the base pad (16b)) as well.

The components of the anchoring system (10), except the base pad (16) (i.e., the retainer (20), the tube clamp (24), the adapter (22), the slide clamp (78), the base (92) and the S-jaw (124), can be created in different ways well known to those of ordinary skill in the art. For example, each individual component may be integrally molded, such as injection molding. The components preferably consist of a durable and flexible material, and more preferably

ES 2 178 652 T3 of a generally inert non-toxic material. In a preferred embodiment, the components are plastic molded, such as polycarbonate, polyvinylchloride, polypropylene, polyurethane, tetrafluoroethylene (eg TEFLON®), polytetrafluoroethylene (known as PTFE), acetal resin (eg DELRIN ®), chlorotrifluoroethylene (eg KEL-F®), nylon or similar polymers. Method of use

The following comment on the method of use was made with reference to Figures 1 and 2, and was initially made in the context of intravenous catheterization. However, as the following comment will show, it is understood that the anchoring system (10) can be used in other catheterization procedures as well. The discussion of the method of use is intended to augment the above description of the invention and should therefore be read in conjunction.

A nurse usually begins the catheterization process by placing the catheter (14) at a desired point above a vein. The nurse inserts a needle or other stylet through a cannula portion of the catheter (14) and into the patient's skin at the desired angle of incidence. For intravenous use, the catheter (14) normally has an incidence angle of approximately 7^°. The nurse then inserts the catheter cannula (14) into the patient and removes the needle or stylet. The catheter hub (30) remains exposed above the skin.

The nurse inserts the distal end of the adapter (26) into the catheter hub (30). The jaw (34) has been mounted by sliding it into the most distal position, so that it does not interfere with the insertion of the distal end of the adapter (26) in the catheter hub (30).

The nurse then slides the jaw (34) in a proximal direction to engage the catheter hub (30). In this manually selected position, the jaw (34) couples the adapter (22) securely to the catheter (14). The ratchet teeth of the adapter (22) cooperate with the engagement finger to resist distal movement of the jaw (34) and to hold the jaw (34) in the manually selected position.

The nurse removes the paper backing that initially covers the adhesive bottom surface (18) of the base pad (16), and sticks the pad (16) to the patient's skin near the permanent catheter (14). Specifically, the nurse grasps the tab of the backrest (67) next to the retainer (20). The indications (69) on the tab (67) indicate where the nurse should grasp the tab (67). The nurse then pulls the tab (67) and peels off the backing of one half of the bottom adhesive layer (18). The nurse places the slot (68) of the pad (16) around the cannula of the catheter (14) with the instruction indications (70) (eg pointer arrow) pointing in the direction of the catheter (14). The nurse then places the bottom layer (18) against the patient's skin to adhere the base pad (16) to the patient. A slight pressure on the top layer (64) ensures good adhesion between the base pad (16) and the patient's skin. The base pad (16), due to its flexibility, conforms to the contours of the topical surface, to which the base pad (16) adheres.

The nurse then repeats this procedure for the other half of the pad (16). Alternatively, the nurse could completely remove the backing of the pad (16) before gluing the pad (16) to the patient's skin.

The nurse orients the adapter (22) with the jaw (34) placed on one side of the tubular body (25) (that is, with the support arm (32) extending in the lateral direction) and placed the support arm of the adapter (32) above the series of slots in the retainer (50) with the fastener (36) positioned distally of the distal end of the retainer.

Then the nurse presses the adapter (22) into the retainer (20) that is near the recess in the pad (68). As this is done, the adapter (22) is pressed between the longitudinal walls (46) of the retainer (20) with the support arm (32) extending in a lateral direction. As the nurse places the adapter (22) on the retainer (20), the beveled edges (58) around the slots (50) of the longitudinal wall (46) guide the support arm (32) into one of the slots ( fifty).

As mentioned above, the opening (47) of the channel (46) has a smaller width measured in the lateral direction than the diameter of the tubular body (25). Thus, the side walls (46) curve outward in a lateral direction. Once the tubular body (25) of the adapter (22) rests in the central channel (44) of the retainer (20), the side walls (46) spring up again to place the adapter (22) in position. Thus, the walls (46) of the retainer (20) prevent involuntary transverse and lateral movement of the adapter (22).

In this position, the protrusion (40) of the adapter (22) rests in a slot (50) or in the recess (60), proximal to the slot (50) through which the support arm (32) passes. The protrusion (40) connects to a portion of the longitudinal wall (46), which forms the recess (60) or the slot (50), to prevent the jaw (34) from rotating relative to the tubular body (25). . In this way, the protrusion (40) ensures that the holder (36) remains connected to the catheter hub (30).

The slot (50), through which the support arm (32) passes, prevents the adapter (22) from sliding in the longitudinal direction. That is, the groove (50) prevents the longitudinal displacement of the adapter (22) when it has been fixed in the central channel (44).

The ergonomic design of the retainer (20) takes into account different positions of the adapter (22) in the retainer (20) so that the retainer (20) is not sensitive to position or technique. That is, a nurse can simply tighten the adapter (22) into the retainer (20), regardless of the side on which the support arm (32) is located, and regardless of the position of the support arm (32). relative to a specific slot (50). Whenever the support arm (32) is positioned above the series of grooves (50), the beveled edges (58) of the wall (46)

ES 2 178 652 T3 guided the support arm (32) into a slot (50). The protrusion (40) of the adapter (22) also fits into an adjacent slot (50) or recess (60).

With the support arm (32) extending through a slot (50) in the retainer (20), the adapter (22) remains in a "low profile" position. That is, the support arm (32) of the adapter (22) is extended in the lateral direction to reduce the total height of the anchoring system (10), measured in the transverse direction. This position of the adapter (22) reduces the risk that the system (10) interferes with the activities around it. However, the retainer (20) allows the adapter (22) to rotate to a position where the support arm (32) extends in the transverse direction, or to a position of 180^° so that the original position can place the adapter jaw (34) on the opposite face of the retainer (20).

Once in the low profile position, the adapter (22) will normally remain in this position until the adapter (22) and its associated tubing system (12) are disassembled and replaced by others.

As Figure 1 shows, the nurse can also form a safety loop in the fluid supply tube system (12), as is known in the art, and secure the safety loop to the patient by introducing a part of the tube system. (12) in the tube clamp (24). The safety loop absorbs any stress applied to the fluid supply tube to prevent pulling on the adapter (22) and / or the catheter (14).

A nurse can use the slide clamp (78) to remove the adapter body (25) from the retainer (20). The nurse inserts the tab (82) of the slide clamp (78) into the keyway notch (62) in the proximal end of the retainer (20). Since the tab (82) has a width greater than the depth of the keyway notch (62), measured in the transverse direction, the tab (62) lifts the tubular body (25) from the center channel (44) when Nurse inserts the tab (82) into the keyway notch (62) in the distal direction. The nurse may also use the slide clamp (78) to remove the proximal end of the tubular body (25) from the upper opening (47) of the retainer (20). Once the proximal end of the adapter (22) is displaced from the retainer (20), the nurse could easily remove the distal end of the adapter from inside the retainer (20). Alternatively, the nurse could also remove the tubular body (25) by lifting on the part of the tubing system (12) while holding the pad (16) in place with the other hand.

Figures 6 to 8 show the catheter anchor system (10a) especially suitable for arterial catheterization. Due to the criticality of the angle of incidence (that is, the angle at which the catheter (14a) projects into the patient) to which the catheter (14a) must be maintained, it is advantageous to place the retainer (20a) precisely so that the retainer (20a) holds the catheter (14a) at the desired angle of incidence.

The desired range of the angle of incidence is normally about 5^°-30^° for arterial catheterization. The angle of incidence varies, preferably between about 15^° and about 25^°, and more preferably equals about 22^°.

A nurse inserts the catheter cannula (14a) into an artery in a manner similar to that described above in connection with intravenous catheterization. The nurse then connects the adapter (22a) to the indwelling catheter (14a) as previously described. The nurse also attaches the flexible pad (16a) to the patient in the manner described above. If desired, the nurse can remove one of the wings (140) from the pad (16a) before attaching the pad (16a) to the patient, tearing the pad (16a) along the perforation lone (142).

The nurse orients the adapter (22a) with the jaw (34a) positioned on the side of the tubular body (25a) (that is, with the support arm (32a) extending in the lateral direction) and positions the support arm of the adapter ( 32a) above the series of retainer grooves (50a) with the fastener (36a) positioned distally from the distal end of the retainer. If the nurse places the pad (16a) too close to or too far from the indwelling catheter (14a), the nurse can slide the retainer (20a) in the desired direction to position the retainer slots (50a) under the adapter support arm. (32a).

Then, the nurse presses the adapter (22a) into the retainer (20a) proximal to the recess in the pad (68a). In doing so, the beveled edges (58a) around the grooves (50a) of the longitudinal wall (46a) guide the support arm (32a) into one of the grooves (50a). The retainer (20a) automatically slides longitudinally to place a corresponding slot (50a) under the support arm (32a). Thus, adapter 22a enters retainer 20a without causing catheter 14a to move substantially.

The tubular body (25a) contacts the protrusion (122) of the finger (120) and causes the finger (120) to deflect downward when the tubular body of the adapter (25a) is clamped in the central channel (44a) . For its part, the hooking finger (114) is coupled to the series of teeth (110) which prevents the longitudinal movement of the retainer (20a) while holding the adapter (20a). If the nurse removes the adapter (22a), preferably using the tab (82a) of the slide clamp, the finger (120) returns to its undeviated state and the retainer (20a) slides freely on the rail (96). The hitch finger (114) does not normally engage the series of teeth (110).

The ability to precisely position the retainer (20a) under the catheter adapter (22a) connected to the catheter (14a) allows the nurse to hold the catheter (14a) in an engaging position and ensures that the retainer (20a) holds the adapter (22a), and thus the catheter (14a), at the exact angle of incidence. Without the ability to adjust the longitudinal position of the retainer (20a), the nurse could perform a series of positioning iterations prior to inserting the pad10

ES 2 178 652 T3 adequately base pad (16a), and thus retainer (20a), relative to permanent catheter (14a).

For epidural catheterization, an anesthesiologist, for example, inserts the distal end of the inner microdiameter tube system (126) through the hard membrane into the epidural space. The proximal end of the inner microdiameter tube system (126) traditionally includes a Toughy-Bourst adapter (144) to mate with the fluid supply tube (12b) carrying the anesthesia. It is imperative that the connection between the inner microdiameter tube system (126) and the fluid supply tube system (144) remain intact, and that the distal end of the inner microdiameter tube system (126) remains in position. Since, if the hard membrane is exposed to airborne microbes, meningitis may develop. Therefore, there should be a secure interconnection between the inner microdiameter tube system (126) and the fluid supply (12b), and the inner microdiameter tube system (126) should be isolated from any existing stresses either in the tube. fluid supply (12b), as well as in the adapter (22b).

Figures 9 and 10 show the catheter anchoring system (10b), especially suitable for epidural catheterization. A doctor uses the present anchoring system (10b) in a similar way to that described above in connection with intravenous catheterization, with the exception that the doctor connects the adapter (22b) to the system of internal microdiameter tubes (126) and adheres the base pad (16b) to the back of the patient's torso.

Subsequently, the doctor passes the inner microdiameter tube system (126) through the S-clamp (124) by first squeezing the tube system (126) between a retainer (134) and the wall (130), and then wrapping the tube system (126) between the first and second retainer (134). A slight pressure forces the tube (126) through the retainers (134). The doctor then wraps the tube (126) back between the second retainer (134) and the second wall (130) and squeezes the tube (126) between them. The S-clamp (124) secures the inner microdiameter tube (126) in position and isolates the inner microdiameter tube (126) from any stress that is placed on the adapter (22b) and / or the fluid supply tube ( 12b) with the inner microdiameter tube (126) inserted accordingly.

Additional representations

As mentioned above, it is envisioned that other types of adapters may be used with the present catheter anchor system as well as that described above. Figures 11 and 12 show a catheter anchor system (10c) following another embodiment of the present invention, which includes a different style of catheter adapter. Where appropriate, equal numbers with the suffix "c" have been used to indicate similar parts of the representations for ease of understanding.

Like the catheter anchor systems described above, the present catheter anchor system (10c) mainly consists of a flexible anchor pad (16c) having an adhesive underside (18c), which is glued to the patient's skin. The pad (16c) supports a retainer (20c). The retainer (20c) is configured to receive and secure a catheter adapter (22c) in position, which connects to a permanent catheter (14c). The pad (16a) may also hold a tube clamp (24c) which is used to retain a portion of the tube system (12c).

Figure 11 shows the adapter (22c), which consists of a generally tubular body (25c) defined between a distal end (26c) and a proximal end (28c). The proximal end (28c) is adapted to receive a distal end of the tube (12c). In an exemplary embodiment, at least a portion of the fluid supply tube (12c) is permanently attached to the proximal end of the body (28c).

The distal end (26c) is configured to engage a proximal end of the permanent catheter (14c) (not shown). Although Figures 11 and 12 show the distal end (26c) of adapter (22c) as having a frustocoenic shape configured to engage a standard bait-type catheter hub (30c) (not shown), it is to be anticipated that the end distal 26c may also be configured to mate with other types of connectors.

Figure 14 shows an alternative configuration of the distal end (26d) of the catheter adapter (22d). Again, for the sake of consistency, like numbers with the suffix "d" have been used to indicate similar parts of the catheter adapter of Figure 11 and the catheter adapter of Figure 14.

The catheter adapter (22d) includes a standard bait locking type fitting (220) coupled to the body (25d) of the catheter adapter (22d) so as to circumscribe the distal end (26d) of the catheter adapter (22d). The primer lock fitting (220) is preferably coupled in such a way as to allow the fitting (220) to rotate around the body of the catheter adapter (25d).

In the depiction shown, fitting (220) has a generally tubular shape with a closed proximal end (222). The closed end (222) includes an opening (224) of sufficient size to receive a portion of the adapter body (25d), as described below. The fitting (220) includes conventional internal threads (226) to engage the corresponding threads of a conventional female bait lock fitting (not shown).

The adapter body (25d) preferably includes an annular groove (228) that receives a closed end portion (222) of the fitting (220) to interconnect the fitting (220) and the adapter body (25d). This interconnection also allows the fitting (220) to rotate around the body of the adapter (25d).

To mount the catheter adapter (22d), the cone-shaped distal end (26d) of the body (25d) is inserted into the opening (224) in the closed end of the fitting (222). Then the body (25d) is forced into the accessory (220) pa11

The closed end (222) should be slightly deflected until the closed end (222) engages the annular groove (228) in the body (25d). In this position, the body (25d) holds a part of the accessory (220) to couple these elements.

Referring to Figure 11, adapter (22c) includes an annular collar (200) interposed between the proximal and distal ends (28c, 26c) of the tubular body (25c). The adapter (22d) of Figure 14 also includes a similar annular collar (200d). It is expected that the collar (200) of the adapter (22c) of Figure 11 and the collar (200d) of the adapter (22d) of Figure 14 will be basically identical, and therefore, the description herein will be understood as that it applies equally to both representations.

Collar (200) is preferably positioned closer to distal end (26c) than proximal end (28c). Preferably, the distance between the distal end (26c) and the collar (200) is approximately equal to the distance between the distal end (26) and the support arm (32) of the above-described adapter (22). Thus, the present retainer 20c can be used with all of the styles of catheter adapters described above.

The annular collar (200) opens radially outward and circumscribes the tubular body (25c). The annular collar (200) has a thickness, measured in the longitudinal direction, which is slightly less than the width of a slot (50c) in a wall of the retainer (46c) so that the collar (200) fits into the slot. (50c) of a wall of the retainer (46c), as described further below in detail.

The adapter (22c) is preferably formed of a durable, biocompatible plastic material. Most preferably, the adapter (22c) is formed with transparent plastics so that a nurse can see bubbles or back flow through the adapter (22c). In an exemplary embodiment, the adapter is formed of polycarbonate by injection molding; however, those skilled in the art will readily appreciate that the adapter can be formed by other production methods known in the art.

Figures 11 and 12 also show the retainer (20c) which is basically identical to the retainer (20) described above. The retainer (20c) consists of a central channel (44c) interposed between a pair of opposite longitudinal walls (46c). The central channel (44c) extends through the retainer (20c) along an axis which is generally parallel to a longitudinal axis of the retainer (20c).

The center channel axis (44c) has a generally circular cross-sectional shape which truncates at an upper end to form an opening (47c). The central body (44c) has a gauge calibrated to receive the tubular body (25c) of the catheter adapter (22c). In a preferred embodiment, the diameter of the central channel (44c) generally coincides with that of the tubular body (25c).

In cross section, the central canal (44c) extends for an arc greater than 180^° around the axis of the channel, such that the lateral length of the opening (47c) is less than the diameter of the central channel (44c). In an exemplary representation, the transverse shape of the central canal (44c) spans an arc of about 200^°around the channel axis.

As best seen in Figure 13a, the axis of the channel is preferably oblique relative to the base surface (48c) of the retainer (20c). An angle of incidence θ formed between the base surface (48c) and the axis of the channel is less than 45^°. The angle of incidence θ varies preferably between 5^° y30^°. In an exemplary representation for intravenous use, the angle θ is preferably equal to 7^° approximately.

The longitudinal walls (46c) are basically identical. Each wall (46c) has a thickness, measured in the lateral direction, less than the length of the support arm (32) of the adapter (22), since it is desirable that the current retainer (20c) accepts both the adapter (22) described above which consists of a support arm (32) connected to a jaw (34), such as the present adapter (22c) which consists of an annular collar (200). Preferably, the thickness of the wall (46c), measured in the lateral direction, is greater than the radially measured distance that the collar (200) extends beyond the outer surface of the tubular body (25c) (i.e., a radial height). The length of each wall (46c), measured in the longitudinal direction, is preferably coextensive with the length of the retainer (20c).

Each wall (46c) consists of a uniform series of grooves (50c). The series consists of at least two [2] slots (50c) and no more than twenty [20] slots (50c). Most preferably, the series consists of less than seven [7] slots (50c). In an exemplary representation, as shown in the figures, the series consists of four [4] slots (50c).

As discussed above, each slot (50c) is calibrated to receive the collar (200) of the adapter (22c), as well as the support arm (32) of the catheter adapter (22), to avoid longitudinal displacement of the adapter. respective 22, 22c. Each slot 50c is preferably rectangular in shape. As can be seen in Figure 12, the grooves (50c) extend from an outer surface (52c), through the wall (46c), and open into the central channel (44c). The width of the slot (50c), measured in the longitudinal direction, is preferably somewhat greater than the width of the support arm (32) and the width of the collar (200).

As Figure 13a shows, each slot (50c) extends in the transverse direction from an upper edge (54c) of the longitudinal wall (46c) to a point below the lower part (56c) of the central channel (44c). ). The height of the groove (50c), measured in the transverse direction, is therefore greater than the distance between the upper edge (54c) and the lower part of the channel (56c) of the retainer (20c). As seen in Figure 13b, the retainer (20c) also includes a series of side notches (202) that extend between opposing slots (50c) into the retainer (20c) from the lower surface of the channel (56c). . Thus, the opposing grooves (50c) and notch (202) form a lateral channel which extends through the retainer (20c) in the

It is laterally directed and penetrates the retainer (20c) from the upper edge (54c) to a point below the lower surface of the channel (56c). The notch (202) is preferably calibrated to receive a portion of the collar (200) such that with the tubular body (25c) positioned in the central channel (44c), the collar (200) extends between the opposing grooves. (50c) and into the notch (202). Thus, the notch (202) has a depth, measured between the bottom surface (56c) of the central channel (44c) and the bottom of the notch in the transverse direction, that is greater than the radial height of the annular collar (200).

Figure 13b shows that the distance S between the grooves (50c), in the center, is preferably equal to approximately half of the distal L (see Figure 2) between the support arm (32) and the protrusion (40) of the catheter adapter (22). The position of the grooves in relation to the proximal and distal ends (26c, 28c) of the retainer (20c) is preferably configured according to the distance and located above in connection with the retainer (22) described above, in such a way that the current retainer (22c) can be used with the adapter (22) described above, including a jaw (34).

Figures 11 and 13a show the upper edge of each longitudinal wall (46c), which consists of a series of bevels (58c) formed and positioned in the manner indicated above in connection with the retainer (20). As noted above, the bezels (58c) slope downward toward the slot (50c) to facilitate insertion of the support arm (32) of the catheter adapter (22) described above or the annular collar (200) of the present catheter adapter (22c) in slot (50c).

As Figures 11-13b show, each longitudinal wall (46c) may further comprise a recess (60c) positioned at the proximal end of the retainer (20c). The configuration and placement of the recess (60c) is carried out, preferably, following the previous description of the retainer (20). Figure 11 also shows that the retainer (20c) may further comprise a keyway notch (62c) to facilitate removal of the catheter adapter (22c) from the retainer (20c), as discussed above. The keyway notch (62c) is also positioned and configured, preferably as shown above in relation to the retainer (20).

The retainer (20c) is made of relatively hard plastic material, although somewhat flexible so that the adapter (22c) forces the upper edges (54c) of the longitudinal walls (46c) outward when the nurse tightens the adapter (22c) in the central channel (44c) of the retainer (20c). The retainer (20c) is preferably formed from injection molding polycarbonate. When the adapter (22c) seats in the central channel (44c), the upper edges (54c) of the walls (46c) close back to their original position to firmly hold the adapter (22c) within the retainer (20c).

An adhesive preferably couples the retainer (20c) to the anchor pad (16c). Alternatively, the retainer (20c) may also be attached to the anchor pad (16c) with similar means, eg, by embedding or otherwise placing the retainer in a zigzag on the anchor pad (16c).

Figure 11 shows the anchor pad (16c) as consisting of a flexible laminar structure consisting of an upper layer of paper or other woven or non-woven cloth (64c) and a lower adhesive layer (18c), with a layer of inner cellulose foam (66c) interposed between them. Alternatively, the flexible base pad (16) may consist of an adhesive bottom layer (18) and a cellulose foam top layer. An upper surface of the foam layer is roughened by corona treatment with a low electrical load, as is known in the art. The foam layer (66c) forms a bearing between the patient's skin and the rigid plastic retainer (20c) and the tube clamp (24c). The adhesive layer (18c) could consist of a coating of diaphoretic or non-diaphoretic material, depending on the condition of the patient's skin. A medical grade foam tape with a diaphoretic adhesive is available from NDM Manufacturers.

The removable paper or plastic backing (not shown) preferably covers the adhesive bottom layer (18) before use. As discussed above and shown in Figure 12, the backrest is preferably divided into a plurality of pieces and includes tabs (67c) to facilitate removal of the backrest from the pad (16). The tabs (67c) include indicia (69c) (eg, dots, text, arrows, etc.) to indicate where to grasp the corresponding tab (67c) when stripping the removable backing of the pad (16c). .

As best seen in Figure 12, anchor pad 16 preferably has a generally trapezoidal shape with rounded corners. A distal edge (206) of anchor pad (16c) preferably has a width, measured in the lateral direction, wider than that of the proximal edge (204). The longer distal edge (206) offers a longer adhesive surface on a rough contact surface, such as, for example, on knuckles, vertebrae, or the like. However, the generally trapezoidal shape minimizes the entire size of the anchor pad 16c attached to the patient. The trapezoidal shape also provides the same surface air as a square pad with the appearance of a smaller pad. The longitudinal faces 208 of the anchor pad 16c preferably taper from the proximal edge 206 to the distal edge 204, and more preferably have concave shapes.

The anchor pad includes a recess (68c) positioned along the proximal edge (204) of the anchor pad (16c) and adjacent to the insertion point of the catheter cannula. Preferably, the recess (68c) is symmetrically positioned around the axis of the channel (44c) of the retainer (20c) coupled to the anchor pad (16c). The recess (68c) is calibrated to allow visual inspection of the catheterized site and is large enough to allow variable placement of the pad (16c) relative to the insertion site. That is, the rebate

ES 2 178 652 T3 (68c) is large enough that a nurse does not need to precisely place the pad on the patient's skin relative to the indwelling catheter (14c) (not shown).

As seen in Figures 11 and 12, the anchor pad (16c) preferably consists of indications (70c) sometimes in the form of an arrow which indicates the proper orientation of the anchor pad (16) with reference to the catheterized site. When used properly, the indications (70c) point toward the indwelling catheter (14c) (not shown).

The anchor pad (16c) preferably supports a clamp (24c) that secures the fluid supply tube (12c) to the anchor pad (16c). As seen in Figure 12, the fluid supply tube (12c) is preferably looped in a proximal direction and inserted into the jaw (24c) to form a safety loop, as is known in the art. The tube clamp (24c) is preferably configured according to the previous description. The jaw (24c) can be made in different sizes to accommodate the various gauges of the fluid flow tube system (12c).

When in use, a nurse typically uses the catheter anchor system (10c) in conjunction with an indwelling catheter (14c) (not shown). The catheter (14c) is introduced into a lumen of the body, such as a vein, following the description indicated above. The nurse then inserts the distal end (26c) of the adapter (22c) into a catheter hub (30c) (not shown) to connect the adapter (22c) to the catheter (14c).

The nurse removes the paper backing that initially covers the adhesive bottom surface (18c) of the anchor pad (16c), as described above, and attaches the anchor pad (16c) to the patient's skin near the patient. permanent catheter (14c). The nurse specifically places the recess (68c) of the pad (16c) around the cannula of the catheter (14c) with the indicator arrow (70c) pointing in the direction of the catheter (14c). Generally, the nurse aligns the proximal edge (204) of the anchor pad (16c) with the insertion site.

The nurse places the adapter (22c) over the series of slots (50c) in the retainer, and snaps the adapter (22c) into the retainer (20c). In doing so, the adapter (22c) is squeezed between the longitudinal walls (46c) of the retainer (20c) with the annular collar (200) extending into opposite grooves (50c) and into the corresponding notch (202) of the retainer (20c). . As the nurse tightens the adapter into the retainer (20c), the chamfered edges (58c) around the grooves (50c) of the longitudinal walls (46c) guide the annular collar (200) into the grooves (50c). The retainer (20c) secures the adapter (20c) as previously described.

With the annular collar (200) placed in the. opposing grooves (50c), the adapter (22c) is prevented from sliding in a longitudinal direction.

Like the previously described representations of the retainer, the ergonomic design of retainer 20c provides various positions of adapter 22c in retainer 20c so that retainer 22c is not sensitive to technique or position. That is, the nurse can simply tighten the adapter (22c) into the retainer (20c), regardless of the position in which the annular collar (20) is located in relation to a specific slot (50c) of the retainer (20c). . Whenever the annular collar (200) is positioned above the series of grooves (50c), the beveled edges (58c) of the wall (46c) will guide the annular collar (200) into a groove (50c).

The present representation of the retainer (20c), as mentioned above, can also be used with the adapter (22) described above which has the jaw (34). A nurse wears the present retainer with the above-described adapter (22) in the same manner as that described above in connection with the above-described retainer (20).

If the catheter hub (30) (see Figure 1) is a standard female bait locking fixture, the bait locking fixture (220) (Figure 14) on the body of the adapter (22d) rotates with the distal end (26d) inserted in the catheter hub (30) to immobilize the corresponding accessories (222, 30) in the known manner. The catheter adapter (22d) is then used with the anchoring system in a manner similar to that described above.

Although this invention has been described in terms of certain preferred representations, other representations apparent to those skilled in the art may also be included in the scope of this invention. Accordingly, it is expected that only the claims detailed below define the scope of the invention.