DE10015323A1 - Anchor to hold a catheter in place at body tissue has a tube with a channel through it to take the catheter and projecting side wings to be held together by a thread for fixing in position - Google Patents

Abstract

An anchor, to secure a medical catheter, having a tube (28) with an outer surface (44) with a channel (36) through it from one end to the other, is new. Two wings (26) extend from the tube (28) on opposite sides of the channel. An anchor, to secure a medical catheter, having a tube (28) with an outer surface (44) with a channel (36) through it from one end to the other, is new. Two wings (26) extend from the tube (28) on opposite sides of the channel. The wings (26) are at an acute angle to each other, or the angle between them is 90[deg]. One end (32) of the tube is conical. The side walls (52) of the wings (26) each have notches (56) for a thread. Each wing (26) has a thread eyelet (54). The width of each wing (26) exceeds the whole length of the anchor by 30 %, and the wing (26) thickness is equal to half the tube (28) dia. An independent claim is included for a technique to secure a catheter (14) to body tissue, where the catheter (14) is inserted into the tube channel (36). A thread is laid round the wing notches (56), and the knot is tightened so that the wings (26) are flat against each other. A thread is passed through the eyelets (54) and the tissue where it is to be secured, to fix the anchor at the tissue.

Description

The invention relates generally to the field of Vorrich for introducing medication into selected Tissue areas and in particular a device for safe positioning of a drug or medication induction catheter after the catheter in the Ge brain, in the spinal epidural space, in the intrathecal space or in a peripheral nerve application or in a other tissue has been placed.

The introduction of medication into the brain, the back kenmark, the spinal fluid or other tissues throughout the body is sick for treating many diseases, illnesses and diseases. Through the Use of an implantable pump and an implan Petable catheters can deliver precise drug doses to be initiated directly in the area concerned the disease, the suffering or the illness or their Treat symptoms.

A controlled arrangement of drug delivery catheter at the position in question is highest desirable. This enables the introduction to be highly concentrated medicated or other drugs into one specific area in which the therapeutic effect is maximized because of the drug or the drug is highly concentrated. Furthermore, since only one in the area small amount of such a highly concentrated drug or medication is required to be therapeutic Side effects due to the  Intake of relatively high doses of the drug minimized by oral or intravenous route.

Since it is very desirable, the highly concentrated medicine agent or drug in a specific area initiate the movement of the catheter from the desired position out very problematic. This represents a known as "displacement" Problem represents. Displacement means that the distal Tip of the catheter so far from its desired position tion is moved that the therapy adversely affects becomes. With some therapies, for example intrathe kalen administration of drugs in the spinal cord can be on the order of 1.27 cm or less cause a noticeable decrease in therapy. In other cases, such as when a catheter is inserted into the is implanted in the tracheal space of the spinal cord Catheters leave the intrathecal space to make a change therapy. This can be up to about 20 cm (8 inch).

The anchor rarely moves relative to the tissue to which it is attached. It is more likely that the catheter moves (slips) relative to the anchor. If the catheter is implanted in the spine, an anchor is typically outside the spine arranged and anchored to a ligament. In this In this case, it is not uncommon for the catheter to come out of the Spine emerges and exactly distal to the anchor and between the anchor and the entrance to the spine "puffed up".

The shift causes the highly concentrated Medicines or other medicines not in the desired area is initiated. Hence the desired therapeutic effect not achieved. Next  The use of highly concentrated medicinal products can or drugs on other areas of unwanted effects genes. Hence a shift is too avoiding condition.

Doctors are currently pursuing several routes to: to solve the problem of displacement. There is a way in suturing the catheter to the tissue around the "Anchoring" the catheter to the tissue. A problem with this The solution is that the thread is often the catheter cuts or clogs, causing it to become Can no longer function. This will prevents the desired drug or Drug arrives at the distal end of the catheter the target area to be initiated. Still came the drug or drug then from the desired one Area what may have unwanted effects can cause.

Another way to solve the displacement problem is to place an "anchor" around the catheter and then attach the anchor to the fabric. Thereby prevents the anchor that the catheter relative to the Anchor moves, and the anchor is prevented from moving itself moved relative to the tissue because it is on the tissue is attached.

An example of such an anchor is shown in FIGS. 1 to 4, in which the anchor is provided with the reference number 2 . The armature 2 has a tubular body 4 and a pair of opposing wings 6 . The body 4 has a central channel 8 . The central channel 8 typically has a diameter which is substantially equal to the outer diameter of a catheter 14 to be fastened by the anchor 2 . The body 4 often has a longitudinal slot 10 which extends over the entire length of the body 4 through the body. 4

The wings 6 each have an eyelet 12 . In use, a catheter 14 is placed through slot 10 in channel 8 . Because of the narrow diameter tolerance of the central channel 8 and the outer diameter of the catheter 14 , it is very difficult, if not impossible, to pull the catheter 14 through the channel 8 . The armature 2 is then moved to the desired position. The wings 6 are clamped together in the direction of the slot 10 . A thread 16 is laid through the eyelets 12 and the tissue 18 in order to fasten the catheter 14 in the anchor 2 and the anchor 2 to the tissue 18 (see FIG. 4).

A problem with this design of an anchor 2 is that the material of the body 4 develops peripheral stresses when the wings 6 are brought closer together. Circumferential tensions are tensions that develop when traction is exerted on a hoop and the hoop resists internal compression. In this case, the hoop forms the cross section of the body 4 of the armature 2 . The pulling force is the exertion of a force on the body 4 in order to bring the wings 6 closer together. These circumferential stresses take up a substantial amount of the energy applied for the mutual approximation of the wings 6 and store this as tension in the material of the body 4 . As a result, a greatly reduced amount of energy is available for making contact with the outer surface of the catheter, so that the frictional contact with the catheter holding it with respect to the anchor 2 is reduced.

Another problem arises because the anchor 2 is placed in a pocket 20 formed in the tissue 18 of a patient's body. A problem with this anchor 2 is that the wings 6 in the small opening created by the pocket in the fabric 18 are difficult to move from their 180 ° position to their assembled position. This problem is exacerbated when the surgeon has to open a slot 10 and place the catheter 14 in the central channel 8 . This is often achieved by bending the wings 6 together on the opposite side of the body 4 so that the slot 10 opens. This requires a very skillful maneuver in the small space provided by pocket 20 in tissue 18 . Several attempts are often necessary to position the catheter 14 in the central channel 8 through the slot 10 . This complicates the procedure and results in side effects or problems or complications.

The invention is therefore based on the object To create anchors for a medical catheter that the catheter without squeezing, kinking, clamping or Can keep clogging on a patient's tissue can be securely attached and is easy to use is to be handled.

This task is solved by an anchor for fastening gene of a catheter according to claim 1. Further developments of Invention are specified in the dependent claims.

According to a feature of the invention, a method for Attach a catheter to a tissue.

According to the invention, an anchor is created with which a Catheter with the drug or other medication in a desired area in the tissue in any part of a body or in the epidural space or in the tracheal space of the spinal cord or into the brain should be directed, is securely attached. The inventor contains anchor according to the invention in a preferred embodiment  a generally tubular body, the takes up the catheter and a pair of wings that hold the Support the device. The body owns a slit between the wings through the body runs. The wings and the slot act in this way together that the opposite edges of the slot just collide when the wings in together Contact. In this way, circumferential forces in substantially eliminated so that all the tension that is generated by approaching the wing onto the catheter is exercised so that the catheter is anchored to its Position is held by friction. The wings interact with the slot to keep the catheter in place Cavity of the tubular body to compress radially ren, so that the catheter in a fixed relationship with the tubular body is held. Still possible Lichen the wings that the device is sewn onto the fabric to attach the device to the tissue. On first thread is very close to the base of the wing the place where the wings meet the body of the Anchor are in contact. A second thread fastens the Wings together and the anchor on the patient's tissue. This thread runs through an eyelet in each of the wings. This will remove the normal tensions on the Catheter exercised by approaching the wings be maximized.

In use, the catheter is in the central channel of the anchor arranged. Then the wings are brought together and sewn. Then the wings with the The patient's tissue is sewn.

The proposed design reduces movement of the Catheters relative to the anchor to a high degree, because the one another the approximated and fixed wing holding forces produce. Because the anchor is smaller and easier than  Known anchor is to be arranged, the doctor should use the anchor can be placed closer to the spine entry point. This should reduce the likelihood that the Ka is pulled out of the implantation site and puffs up when the patient moves.

Further features and advantages of the invention will become clear Lich preferred when reading the following description Embodiments referring to the accompanying drawing takes; show it:

Figure 1 shows the above-mentioned plan view of a conven- union catheter anchor.

Fig. 2 is the end view of the previously mentioned Chen catheter anchor according to Fig. 1;

Fig. 3, the above-mentioned plan view of the conventional catheter anchor of Figure 1 in use.

Figure 4 shows the side view of the catheter anchor according to Figure 1, as already mentioned, in use;

Fig. 5 is a perspective view of an armature according to a preferred embodiment of the invention;

Fig. 6 is a plan view of the armature of Fig. 5;

FIG. 7 shows an end view of the armature according to FIG. 5;

Fig. 8 is a cross-sectional view of the armature of Fig. 5;

Fig. 9 is an end view of the armature of Fig. 5 in its closed position;

. FIG. 10 is a perspective view of the anchor of Figure 5, which is prepared are hereby requested a catheter;

Figure 11 is a perspective view of the anchor of Figure 5 with the catheter in place and the wings sewn together;

Fig. 12 is a perspective view of the anchor of Figure 5, which is angeord net in the cavity of a patient, with the catheter inserted, the wings are sewn together and the anchor is sewn to the patient's weave. and

Fig. 13 is a plan view of an alternative execution form of the armature according to Fig. 5.

FIG. 5 shows a preferred embodiment of the anchor for a medical catheter and is generally designated by the reference number 22 . Armature 22 includes a shell or sleeve 24 and a pair of wings 26 . The anchor 22 is preferably molded from silicone or other flexible polymeric material such as urethane or other materials known to those skilled in the art.

As shown in FIGS. 5 through 8, the preferred sleeve 24 is essentially a cylindrical tube 28 that extends toward a longitudinal centerline 30 . The tube 28 has a first end 32 and a second end 34 , between which a channel 36 extends. The channel 36 preferably has a circular cross section and is preferably centered on the longitudinal center line 30 of the tube 28 . Although this is the preferred embodiment, other cross-sections could of course also be used, for example oval, egg-shaped, square, rectangular, pentagonal, hexagonal, octagonal or the like, to mention only a few possibilities. Furthermore, the channel 36 can be offset from the longitudinal center line 30 of the tube 28 . The channel 36 is defined by the inner surface 38 of the tube 28 . In the preferred embodiment, the diameter of the channel 36 is slightly larger than the diameter of the Ka theter 14 to be attached by the anchor 22 .

In the preferred embodiment, the first and second ends 32 , 34 extend into conical sections 42 starting from the center of the armature 22 . The taper has the meaning that the diameter of the outer surface 44 decreases with increasing distance from the center 40 . This taper enables the first and second ends 32 , 34 to act as stress relief for the catheter 14 used , as will be explained later.

A slot 46 is preferably formed in the outer surface 44 between the wings 26 . The slot 46 is preferably elongated in the direction of the longitudinal center line 30 and preferably extends from the outer surface 44 through the entire tube 28 . The slot 46 has side edges that form an angle to one another in a non-stressed configuration. As will be described later, an approximation of the wing 26 causes the side edges 48 to come into complete mutual surface contact. It is acceptable if the side edges 48 just touch. The crucial feature for the side edges 48 is that they are not compressed, so that circumferential stresses are avoided. The side edges 48 define the lateral dimensions of the slot 46 .

In an alternative embodiment shown in FIG. 13, a slot 50 extends through the tube 28 . The slot 50 preferably extends radially from the longitudinal center line 30 . The slot 50 enables the catheter 14 to be arranged in the channel 36 by slightly deforming the slot 50 so that it opens and so that the catheter 14 can be moved into the channel 36 through the slot 50 .

A pair of vanes 26 extend from the outer surface 44 of the tube 28 . In the preferred embodiment, the angle between the wings 26 is approximately 90 °. This configuration enables easy use by the surgeon, as will be explained later. It also results in a smaller protruding foot surface of the device, which gives the surgeon more space to handle the anchor 22 in the pocket 20 .

It is important that the wings 26 are sufficiently far apart from each other in the non-stressed position so that when the wings 26 are approached, sufficient stress is generated to hold the catheter 14 in the armature 22 appropriately by friction . Furthermore, the angle between the wings 26 could exceed 90 °. In fact, it is within the scope of the invention that the angle between the wings 26 ranges up to about 360 °, although angles greater than 180 ° are difficult for the surgeon to handle.

The wings 26 include opposite side walls 52 . In the preferred embodiment, wings 26 extend substantially radially from outer surface 44 along rays from longitudinal center line 30 . The wings 26 are preferably substantially in planes that are parallel to the longitudinal center line 30 . As shown in Fig. 3, the wings 26 preferably form an acute angle to each other.

Furthermore, the width "A" of the wings 26 preferably exceeds approximately 30% of the total length "B" of the armature 22 ( Fig. 8). Under these conditions, the area of the armature 22 , which effects the attachment of the catheter 14 , is increased compared to previously known designs. The larger dimensions of the width "A" in combination with the slot 46 enable a size rer portion is radially compressed in the slot 46 and engages with the catheter 14 in contact than would be possible with a smaller width "A".

In addition, the greater the thickness "C" of wings 26 , the higher the stress levels that can be applied to catheter 14 . However, patients and doctors prefer that the anchor 22 be as small as possible. Therefore, if the combined vanes 26 are thicker than the outer diameter of the tube 28 , the armature 22 will be larger than is desirable. Therefore, it is most preferred to make the width "C" approximately equal to half the diameter of the tube 28 ( Fig. 7). In this way, the maximum stress can be applied to the catheter 14 ergrei fen without increasing the overall dimensions of the anchor 22 .

The wings 26 each have a thread eyelet 54 and a pair of opposite thread notches 56 . For a reason that will be explained later, the thread eyelets 54 preferably run through the entire wing 26 . The thread counters ben 56 run into the side wall 52 of the wings 26 for a reason which will also be explained later. In the preferred embodiment, the thread notches 56 are as close as possible to the outer surface 44 . As a result, the stress on the catheter 14 is increased when a thread is attached, as will be described later. The normal stress between catheter 14 and anchor 22 has been found to be inversely proportional to the distance between the centerline of catheter 14 and the location of the point at which wings 26 are attached to one another. The friction between catheter 14 and anchor 22 is proportional to the normal stress between catheter 14 and anchor 22 . The Kathe ter 14 is held in a fixed relationship to the anchor 22 by the friction.

Although the wings 26 are preferably substantially flat, this need not be so. Other configurations of blades 26 can be used. Regardless of the configuration of the wings 26 , the wings have three key functions. First, the vanes 26 cooperate with the slot 46 in such a way that the effective circumference of the tube 28 is changed in order to exert a radial compressive force on the catheter 14 when the vanes 26 are brought together. Second, wings 26 provide a means for securing anchor 22 to tissue 18 . The use of wings 26 eliminates the need for a thread with which the tube 28 is attached directly to the tissue 18 , which could cut or clog the catheter 14 . Finally, wings 26 form "handles" that allow the surgeon to grip and manipulate anchor 22 .

The catheters 14 are typically manufactured according to specifications that include the minimum radius by which the catheter 14 must be bent without permanently changing the shape or causing kinks or breaks. Where the catheter 14 never exits the anchor 22 at the sleeve 24 at an angle to the longitudinal center 30 , as shown in FIGS. 10 and 11, the tapered first and second ends 32 and 34 are flexible so that they are flexible the first and second ends 32 , 34 can deform slightly in the direction of the course of the catheter 14 . This causes the first and second ends 32 , 34 to adapt to the direction of the catheter 14 , where it exits the armature 22 . In this way, the stress on the catheter 14 in the event of a deviation from the longitudinal axis is not concentrated at the point at which the catheter 14 emerges from the first end 32 or the second end 34 , but instead is distributed over the entire conical section 42 .

In use, the catheter 14 is inserted into the anchor 22 ( Fig. 10). The catheter 14 is placed in the central channel 36 by being inserted into either the first end 32 or the second end 34 , being moved through the central channel 36 and being moved out of the other of the first and second ends 32 , 34 . The invention allows a greater tolerance between the catheter 14 and the inner surface 38 than in conventional anchors, so that the catheter 14 in the anchor 22 can slide to the desired position. In the alternative embodiment with slot 50 , catheter 14 can be placed in anchor 22 by opening slot 50 and placing catheter 14 in central channel 36 such that longitudinal axis 54 of catheter 14 is coaxial with longitudinal center line 30 of tube 28 .

The wings 26 should be sewn together, as shown in Fig. 11, by threading a thread 58 around the notches 56 and tightening the knot so that the wings 26 lie flat against each other. When the wings 26 are contracted, the side edges 48 of the slot 46 approach each other. The side edges 48 preferably touch when the wings 26 just touch each other. In this way, no circumferential stresses arise when the wings 34 approach each other. As a result, substantially all of the stress exerted on the armature 22 by bringing the wings 26 closer together is used to hold the catheter 14 in frictional contact with the armature 22 .

Furthermore, since the side edges 48 meet only when the wings 26 touch, there is no risk of "over-tensioning" the armature 22 , which would result in material being guided inwards and coming into contact with the catheter 14 , thereby the catheter 14 could be squeezed, clogged, or otherwise blocked.

In a stress-free configuration, tube 28 has a certain outer circumference. The slot 46 represents a discontinuity in the circumferential direction of the tube 28 when the tube 28 is in the non-claimed configuration. When the side edges 48 are brought together in complete surface contact, the circumference of the tube 28 is smaller than in the non-claimed configuration of the tube 28 , since the width of the slot 46 is eliminated. Because of the direct relationship between the circumference and the radius, the radius decreases as the circumference decreases. If the radius of the tube 28 is smaller than the outer radius of the catheter 14 when the wings 26 are approached, the inner surface 38 of the tube 26 exerts normal compression forces on the outer surface of the catheter 14 . As a result, the catheter 14 is fixed with respect to the anchor 22 .

The slot 46 is formed by removing material from the tube 28 . Therefore, when the side edges 48 contact each other, no material is deformed inwardly into undesirable contact with the catheter 14 . At this time, the inner surface 38 of tube 28 is moved into gripping contact with the outer surface of catheter 14 to prevent longitudinal movement of catheter 14 with respect to anchor 22 .

If the slot 46 were not present, the space between the wings 26 would be reduced if the wings 26 were brought closer together. Therefore, the material in tube 28 would be "folded" between wings 26 . Part of this "folded" material would likely come into contact with catheter 14 and could compress or clog catheter 14 . Although the preferred embodiment of the armature 22 has a slot 46 , the invention can of course also be implemented without a slot 46 .

As mentioned above, the wings 26 preferably form an acute angle to one another. This makes it easier to sew the wings together, as described above, because the wings 26 are closer together than in the case where they are separated by 180 ° or more.

Finally, thread 60 is attached through eyelets 54 and tissue 18 at the location of attachment to secure anchor 22 to fabric 18 ( FIG. 12). This prevents the armature 22 from moving relative to the tissue 18 , so that the interaction of the catheter 14 with the armature 22 and the armature 22 with the tissue 18 also prevents the catheter 14 from moving relative to the tissue 18 emotional.

If the catheter 14 needs to be repositioned, the doctor can remove the threads 58 and 60 and slide the catheter 14 into the new desired position. Then threads 58 and 60 are reattached as described above.

The invention has been described above in connection with specific embodiments. The expert he knows that 22 Abwandlun conditions can be made on the anchor described here, without deviating from the true inven tion idea and from the scope of the invention. Furthermore, although the anchor 22 has been described in connection with the safe positioning of a catheter 14 , it can also be used to position a wire, such as is used for electrical stimulation of the nervous system or the heart.

The true idea of the invention and the scope of this Be are defi by the appended claims niert, in the light of the foregoing description are interpreting. Therefore, the following decide Claims this description to the subject of the invention particularly emphasize.

Claims (14)

1. Anchor for medical catheters, characterized by
a tube ( 28 ) having an outer surface ( 44 ), a first end ( 32 ), a second end ( 34 ) and a channel ( 36 ) running through the tube ( 28 ) from the first end ( 32 ) to the second end ( 34 ) , and
a pair of wings ( 26 ) extending from the tube ( 28 ). 2. Anchor according to claim 1, characterized in that the tube ( 28 ) has a slot ( 46 ) which extends from the outer surface ( 44 ) of the tube ( 28 ) through the entire tube ( 28 ) and has side edges ( 48 ), and the two wings ( 26 ) are on opposite sides of the slot ( 46 ). 3. Anchor according to claim 2, characterized in that the angle between the two wings ( 26 ) is acute. 4. Anchor according to claim 3, characterized in that the angle between the two wings ( 26 ) is approximately 90 °. 5. Anchor according to claim 1, characterized in that the angle between the two wings ( 26 ) is acute. 6. Anchor according to claim 5, characterized in that the angle between the two wings ( 26 ) is approximately 90 °. 7. Anchor according to claim 1, characterized in that the first end ( 32 ) is conical. 8. Anchor according to claim 1, characterized in that the tube ( 28 ) has a slot ( 46 ) extending through the tube ( 28 ). 9. Anchor according to claim 1, characterized in that each of the two wings ( 26 ) has opposite side walls ( 52 ). 10. Anchor according to claim 1, characterized in that the wings ( 26 ) in the side walls ( 52 ) each have a pair of opposite thread notches ( 56 ). 11. Anchor according to claim 1, characterized in that the width (A) of each of the wings exceeds approximately 30% of the total length of the anchor ( 22 ). 12. Anchor according to claim 1, characterized in that each of the wings ( 26 ) has a thickness (C) which is approximately equal to half the diameter of the tube ( 28 ). 13. Anchor according to claim 1, characterized in that the wings ( 26 ) each have a thread eyelet ( 54 ). 14. A method for attaching a catheter ( 14 ) to a tissue ( 18 ), characterized by the following steps:
Providing an anchor ( 22 ) that includes:

• - A tube ( 28 ) with an outer surface ( 44 ), a first end ( 32 ), a second end ( 34 ) and a through the tube ( 28 ) from the first end ( 32 ) to the second end ( 34 ) extending channel ( 36 ), the tube ( 28 ) having a slot ( 46 ) which extends from the outer surface ( 44 ) through the entire tube ( 28 ) and has side edges ( 48 ), and
• - A pair of wings ( 26 ) extending from the tube ( 28 ) on either side of the slot ( 46 ) and having opposite side walls ( 52 ), each having a pair of opposed thread notches ( 56 ), each of the wings ( 26 ) one Has a seam eyelet ( 54 ),

Placing the catheter ( 14 ) in the channel ( 36 ),
Laying a thread ( 58 ) around the thread notches ( 56 ) and tightening the knot so that the wings ( 26 ) lie flat against each other, and
Passing a thread ( 60 ) through the seam eyelets ( 54 ) and the fabric ( 18 ) at the location of the attachment to secure the anchor ( 22 ) to the fabric ( 18 ).