Slotted Peritoneal Access Catheter

Abstract

Methods and design for a Slotted T-shaped PD Catheter are disclosed. The present invention includes a unique port design for peritoneal dialysis catheters that allows high outflow and inflow rates, with a minimum fluid velocity through the fluid entry ports. Features of this device include T-shaped catheter with subcutaneous tubing joining to an intraperitoneal portion that is essentially at right angles to the intraperitoneal tubing and slit shaped flow ports as opposed to round shaped flow ports.

Claims

1. A catheter for fluid infusion and drainage comprising: a cylindrical intraperitoneal tubing defining at least one slot-shaped port wherein the slot has a narrow width to prevent ingress of abdominal contents or tissue, wherein the slot has a length more than twice the slot's width to provide an area for fluid flow, wherein the tubing has a single interior opening large enough for unrestricted passage of fluid, and wherein the structure of the tubing and the port shape are stabilized by bridges of material between the slotted portions, joining adjacent sections of the cylindrical tubing without criss-crossing walls inside the tubing.

2. The catheter of claim 1 wherein the length of slots is shorter than the length of the intraperitoneal portion of the catheter and bridges are created by portions of the cylindrical wall between neighboring slots.

3. The catheter of claim 2, wherein the intraperitoneal tubing is created by injection molding.

4. The catheter of claim 3 wherein slots of the intraperitoneal tubing are defined by the injection molding.

5. The catheter of claim 3 wherein slots are cut into the intraperitoneal tubing.

6. The catheter of claim 1 wherein the slots extend for the length of the intraperitoneal portion of the catheter and bridges are created by U-shaped troughs beneath each slot, with holes for fluid passage in the bottom of each trough.

7. The catheter of claim 6 wherein the intraperitoneal tubing is made by extrusion.

8. The catheter of claim 7 wherein the holes draining the bridging troughs are made by drilling, punching, or by pins during the extrusion process.

9. The catheter of claim 1 wherein the subcutaneous exit tubing is fastened to the middle of the intraperitoneal portion, creating a T-shaped catheter to fix the position of all components of the catheter.

10. The catheter of claim 1 wherein the subcutaneous exit tubing is attached to one end of the intraperitoneal portion, creating a catheter that is linear in shape, or which can be made to be linear with an internal stylet.

11. The catheter of claim 10 wherein there is a 150 to 180 degree bend in the exit tubing centering on the abdominal musculature layer, to fix the position of all components of the catheter.

12. The catheter of claim 1 wherein the cylindrical intraperitoneal tubing has an 8 mm outside diameter and a 6 mm internal diameter.

13. The catheter of claim 1 wherein the cylindrical intraperitoneal tubing is approximately 13 cm to approximately 15 cm in length.

14. The catheter of claim 13 wherein the ends of the intraperitoneal tubing are closed by either flattening the tubing and gluing the sides together or fitting a molded silicone hemispherical piece to each end.

15. The catheter of claim 1 wherein the slot is linear.

16. The catheter of claim 1 wherein the slot is approximately 0.5 to approximately 1 mm wide and approximately 5 mm long.

17. The catheter of claim 1 wherein the slot is spaced 5 mm apart from another slot.

18. The catheter of claim 1 wherein a plurality of slots are arranged in six longitudinal lines spaced at 60 degree intervals around the intraperitoneal tubing.

19. The catheter of claim 1 wherein the intraperitoneal tubing has closed ends.

20. The catheter of claim 1 wherein the subcutaneous tubing has an approximately 6 mm outside diameter and an approximately 4 mm internal diameter.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0031] The above-mentioned and other features of this disclosure, and the manner of attaining them, will become more apparent and the disclosure itself will be better understood by reference to the following description of embodiments of the disclosure taken in conjunction with the accompanying drawings, wherein:

[0032] FIG. 1. Current designs of PD catheters. (From Ash S R, Carr D J, Diaz-Buxo J A. Peritoneal access devices: hydraulic function and biocompatibility. In: Nissenson, A R, Fine, R N, and Gentile, D E (eds.) Clinical Dialysis. Norwalk, Conn.: Appleton & Lange, 1995, pp. 295-321).

[0033] FIG. 2. Cross section appearance of current PD catheters. A: Merit Flexneck. B: Cruz (no longer available). C: Standard Tenckhoff. D. Advantage or T-fluted (no longer available).

[0034] FIG. 3: components of a straight Tenckhoff catheter and relation to body tissues.

[0035] FIG. 4A: a front cross sectional drawing of slotted catheter a staggered-slot catheter in which the slots exist as gaps in a cylindrical body. The slots are discontinuous and staggered in position around the catheter. A single central lumen exists in the slotted portion. In this figure, exit tubing is attached to the middle of the slotted portion, creating a T-shaped catheter that fixes the deep cuff in or near the abdominal musculature and the slotted portion against the parietal peritoneum.

[0036] FIG. 4B: a side cross sectional drawing of the staggered-slot slotted catheter of FIG. 4A.

[0037] FIG. 5: Photograph of the slotted catheter, a staggered-slot catheter prototype without Dacron cuffs, in the T-shape form.

[0038] FIG. 6: In vitro data on water flow rate through the staggered-slot catheter, in comparison to the standard Tenckhoff catheter and a catheter containing two 6 mm diameter fluted portions (similar to the Advantage catheter, but larger). Flow rate was by gravity with a 100 cm hydrostatic head through a drain tube. The desired flow rate for HIPEC procedures is 2000 mL/min, and this flow was obtained with the slotted catheter.

[0039] FIG. 7: Drawing of a continuous slot catheter, note Details A, B, & C.

[0040] FIG. 8: Drawing of the horizontal cross section of the exit portion (Detail A) of a continuous-slot catheter.

[0041] FIG. 9A: Drawings of the vertical cross sections of the exit portion (Detail A) of a continuous-slot catheter.

[0042] FIG. 9B: Drawings of the vertical cross sections of the entrance portion (Detail B) of a continuous-slot catheter.

[0043] FIG. 10: Drawing of the horizontal cross section of the overmold (Detail C) of a continuous-slot catheter.

[0044] FIG. 11: Drawing of an in vitro model developed to replicate the mechanical properties of the bowel and omental surfaces, and to simulate the way these surfaces surround the catheter during outflow of fluid.

[0045] FIG. 12: Chart of Tenckhoff free flow rate and total hydraulic pressure and outflow weight against time (with no bowel compression).

[0046] FIG. 13: Chart of Tenckhoff free flow rate and hydraulic resistance against time.

[0047] FIG. 14: Chart of Grooved catheters of the present embodiment, flow rate and total hydraulic pressure and outflow weight against time (with no bowel compression).

[0048] FIG. 15: Chart of Grooved catheters of the present embodiment, flow rate and hydraulic resistance against time.

[0049] FIG. 16: Chart comparing results for Tenckhoff Free and Grooved catheters of the present embodiment, flow rate versus weight causing bowel compression.

[0050] FIG. 17: Chart comparing results for Tenckhoff Free and Grooved catheters of the present embodiment, hydraulic resistance versus weight causing bowel compression.

[0051] FIG. 18: Chart comparing results for Tenckhoff Free and Slotted catheters of the present embodiment, flow rate versus weight causing bowel compression.

[0052] Corresponding reference characters indicate corresponding parts throughout the several views. Although the drawings represent embodiments of the present disclosure, the drawings are not necessarily to scale and certain features may be exaggerated in order to better illustrate and explain the present disclosure.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

[0053] The embodiments disclosed below are not intended to be exhaustive or limit the disclosure to the precise forms disclosed in the following detailed description. Rather, the embodiments are chosen and described so that others skilled in the art may utilize their teachings.

[0054] We have designed a peritoneal catheter that should allow much more rapid fluid flow into and out of the peritoneum, a fixed position of components relative to the abdominal musculature, and a lower incidence of outflow failure. The key advance is the use of slots for passage of fluid from the peritoneal space to the internal lumen of the catheter.

[0055] The slotted catheter will initially be constructed from silicone tubing, although later versions may be in various copolymers. The current staggered-slot design is shown in FIGS. 4A and B and a photograph provided in FIG. 5. It is shown in the T-shaped configuration, with the exit tubing connected to the middle of the slotted portion. The components are: intraperitoneal (IP) portion-8 mm OD and 6 mm ID tubing of 50 durometer, 13-15 cm long; linear slots 0.5-1 mm wide and 5 mm long, spaced 5 mm apart, arranged in six longitudinal lines spaced at 60 degree intervals around the IP portion and with each row of slots staggered versus the next row; Closed ends of the IP portion, by one of two methods: flattening the tubing and gluing the sides together, or fitting a molded silicone hemispherical piece to each end; Exit (subcutaneous, or SQ) tubing-6 mm OD and 4 mm ID tubing of 50 durometer, about 12 cm long; Connection of the SQ and IP tubings (end to side) by one of two methods: creating overlapping portions of the two tubings and gluing them together, or over-molding a 0.5-1 mm thick layer of silicone over the junction; Dacron cuffs glued to the SQ tubing, 1 cm long, one beginning 0.7 cm distal the top of the IP tubing and the other 5 cm distal to the first; and Connector on the SQ tubing to fit into PVC tubing for drainage and infusion of fluid during HIPEC procedures. We also envision that the IP tubing can be injection molded in a circle or a loop. Slots may be defined in the mold or cut into the IP tubing after injection molding.

[0056] The design of the slotted catheter has many features that make in suitable for use in high flow rate CFPD or HIPEC, but also will allow much faster in-out exchanges during peritoneal dialysis. A primary need in HIPEC is a high flow rate of fluid through the peritoneum, preferably over 2000 mL/min. As shown in FIG. 6, during in vitro tests using gravity drainage, the staggered-slot catheter provided flow rate at over 2 liters per minute at 100 cm hydrostatic head. This is about twice as much as the flow through a standard Tenckhoff and an enlarged version of the Advantage catheter (circle fluted). The reason for the high flow rate is the large diameter of the IP portion (6 mm) and the SQ portion (4 mm). Also, the numerous slits of 0.5-1 mm diameter add up to a very large area for fluid transfer. In fact this area is so large that it presents virtually no resistance to fluid flow at all. The flow rate for the slotted catheter is exactly the same in flow test results whether the IP portion is attached or not. The very large area of the slits means that the linear velocity of fluid flow remains very low, even when the overall flow rate is high. This means the catheter will have less tendency to pull omentum or other peritoneal contents towards it at high outflow rate. The slot-shaped ports should avoid omental attachment in a manner similar to the grooves of the Advantage catheter, and for the same reason, there is a high ratio of open area to circumferential area (edges to which the omentum can attach) but there is also a small width of the slot (preventing the ingress of large abdominal contents or their protrusions). The result should be a catheter that avoids outflow failure and allows high flow rates into and out of the peritoneum during all types of peritoneal dialysis procedures, including CAPD, automated PD, CFPD and HIPEC.

[0057] In one embodiment, each slot in the continuous-slot catheter is bridged by a U-shaped trough beneath the slot. The bridges support the catheter's cylindrical surface. Circular holes pass fluid into and out of each bridge, at some distance from the surface of the catheter. Exit tubing is attached to one end of this catheter, creating a catheter that can be made linear with an internal stylet. The sharp bend of the catheter holds the deep cuff on or near the abdominal musculature and the slotted portion near the parietal peritoneum.

[0058] FIGS. 7-10 include several drawings of the current version of the continuous-slot catheter design. It is shown in the linear catheter design, with the exit (SQ) tubing attached to one end of the slotted portion. The components are an extruded cylindrical tubing of 8 mm OD, 6 mm ID (at maximum), with 1 mm diameter grooves on its surface. Under each groove is a U-shaped trough that connects with the outer walls of the cylinder, to support the cylinder walls and the slots. The trough depth is 1 mm. At 1 cm intervals there are 0.5 mm holes drilled into the bottom of each trough. The catheter is shown in the linear design, with the SQ tubing fastened to the slotted portion with an overmold. The SQ tubing has a 150 degree bend at the location which passes through the abdominal musculature. This is the position of the deep cuff, within or just outside the abdominal musculature. The slotted portion lies just below the parietal peritoneum and the outer SQ portion lies just above the abdominal musculature. These locations tend to fix the deep cuff in position.

[0059] For standard PD therapy, one slotted catheter would be placed, allowing input and output of peritoneal dialysis fluid through one catheter. The HIPEC procedure utilizes continuous flow of dialysate through two catheter locations, similar to Continuous Flow Peritoneal Dialysis (CFPD). In HIPEC two of these catheters would be placed during the laparotomy of the HIPEC procedure, at opposite ends of the peritoneal space. One may be placed over the place of origin of the cancer (if known) and the other one at a distant location in the peritoneum. To attain the desired outflow rate using gravity alone, two catheters could be placed for drainage of the abdomen, with a parallel connection to the draining tubing. The catheters could be placed inside out with the SQ tubing being drawn through an opening in the rectus muscle and the IP portion then coming to lie against the parietal peritoneum. They would be used for peritoneal perfusion during the HIPEC procedure, with gravity drainage through a diameter PVC tubing into a drainage reservoir 100 cm below the patient. Flow rate would be 2 liters per minute. At the end of the procedure the catheters would be filled with saline and capped. On a weekly basis, they would be flushed with saline. Repeat HIPEC procedures could be done at one month and monthly for up to 6 months. Removal of the slotted catheter will be by dissection to the rectus muscle of the abdominal wall, freeing the deep cuff from surrounding tissue, enlarging the defect in the rectus muscle, and pulling on the SQ tubing to collapse and remove the IP portion.

[0060] The slot-shaped ports of the slotted catheter are described here for a T-shaped catheter with a SQ portion attaching to a perpendicular IP portion. However, the function of virtually all existing tubular peritoneal dialysis catheters would be improved by using ports that are not cylindrical but rather oblong or slit-shaped. A single 5 mm slit provides area for flow that far exceeds that of 5 circular holes of similar width. More surface area for flow means lower velocity of PD fluid at any given outflow or inflow rate.

[0061] Besides high outflow rate with low velocity at the entry slots, the slotted catheter has other advantages as a chronic catheter: Fixed position with the IP portion against the parietal peritoneum, avoiding possibility for extrusion of the catheter or its cuffs, and avoiding migration of the IP portion within the peritoneum; The large diameter of the IP portion, which naturally tends to hold abdominal contents away from the slits; and Position of slits completely around the IP portion, assuring that most will avoid contact with the parietal peritoneum or abdominal contents.

[0062] Example: Comparison of Outflow Properties

[0063] The Tenckhoff catheter (Maxflow) was evaluated against the Grooved catheter extruded section, with 1 and 3 holes/cm by S. R. Ash and D. J. Carr of HemoCleanse Technologies LLC.

[0064] A frustrating feature of Tenckhoff catheters is that they drain the abdomen slowly and as the intraperitoneal volume decreases, there is a decrease in outflow rate. This demonstrates that there is an increasing hydraulic resistance to flow through the tissues around the catheter. With a continually decreasing flow rate, it is impossible to tell how much fluid remains to be drained from the peritoneum, and in fact the space is never completely drained. Often 300-800 ml of dialysate fluid remains in the abdomen at the end of outflow, whether the outflow is directed by manual exchanges or by cycler machines. Further making peritoneal dialysis difficult, the outflow drainage of the catheters varies cycle by cycle.

[0065] Also, as the volume of the peritoneum becomes less, there is less space for fluid flow between surfaces of adjacent abdominal structures, as shown in the adjacent drawing. Peritoneal surfaces will almost always occlude the lumen at the tip of the catheter during outflow. The holes of Tenckhoff catheters should not be much larger than 0.5 mm diameter, to avoid attachment of omentum directly to the holes. This results in very small area of each hole and subsequently a quite high velocity of fluid through each hole (5 cm/sec at only 100 ml/min) The reason that a slotted catheter will work better when near to peritoneal surfaces is that its total area for fluid flow is much greater than that of the small Tenckhoff holes, for example 400 mm.sup.2 versus only 32 mm.sup.2. This means that velocity into the grooves (if distributed evenly) would be 0.4 cm/sec at 100 ml/min overall flow. The ratio of velocities for entry of fluid to the Tenckhoff catheter and the slotted catheter is thus 12:1. Since Bernoulli (suction) forces are proportional to the square of velocity, the Tenckhoff catheter would create 144 times as much suction force on surrounding tissues as the slotted catheter. Of course the catheter with continuous slots also has 0.5 mm holes, but these are in the bottom of each slot (or, groove), and should therefore be protected from coming next to peritoneal surfaces. Further, there will be many more 0.5 mm holes than in a Tenckhoff catheter. The prototypes tested below have 1 hole per cm, or 40 in a 10 cm section (with 4 grooves). It is envisioned that other prototypes will have 3 holes per cm, or 30 per 10 cm groove, making 120 in a 10 cm section. The increase in number of holes will diminish hydraulic resistance further. Also, linear velocity will be diminished at the holes, which means that flow should be more uniform along the length of the grooves.

[0066] Some years ago we developed in vitro model to replicate the mechanical properties of the bowel and omental surfaces, and to simulate the way these surfaces surround a peritoneal catheter during outflow of fluid. We found that cellulosic dialysis tubing worked very well as an exceedingly soft and pliable material which came in cylindrical shape, with a diameter of 1. This tubing was cut to lengths of 6-12 inches, and one end was tied off. Water was added to the tubing until it was filled about 50%, and then the other end was tied off. Enough of these tubings were made so that they filled 3 liters of a 5 liter container, when all lying together. A shortened peritoneal catheter was placed between layers of the tubings, at the level of about 1 liter fill of the container. The catheter was connected to a vinyl tube using a large bore connector. The vinyl tube was placed over the lip of the container, and the distal end extended downward to a point 40 below the level of the catheter. A container below the tip of the catheter collected effluent and the container was weighed on a scale. Pressure was measured at the level of the catheter. Weight, time and pressure data was transferred in real time to a LabView data collection system. About 1.5 liters of water was then added to the top of the container, and the vinyl tubing was primed with water. Outflow was begun by unclamping the vinyl tubing. The gravity pressure head thus simulated that used in peritoneal dialysis. A drawing of the experimental setup as tested is shown in FIG. 11.

[0067] It was noted that on addition of the extra fluid to the container the cellulose tubings tended to separate and some floated to the top of the fluid level. The spacing between the cellulose tubes was greater than would occur between bowel loops and omentum during peritoneal dialysis, even with very large fill volumes (less than 1 mm space, on average). In the first test there was no effort made to hold the bowel loops next to the catheter. This test was performed using a standard Tenckhoff catheter. The coiled MaxFlow catheter was chosen because it has a larger diameter than any of the other Tenckhoff catheters (3.5 mm vs 2.5 mm ID). FIG. 12 shows the outflow fluid weight (volume in ml), the outflow rate in grams (ml) per minute, and the overall hydrostatic pressure head. The X axis is time of outflow, in seconds. When the air-fluid interface reached the catheter, the vinyl tubing filled with air and flow stopped. FIG. 13 shows the same curve for catheter flow rate, and also the calculated hydraulic resistance of the whole drainage system.

[0068] The next experiments were with the Grooved catheter, containing one hole per cm length of each groove (48 holes altogether). The section was 16 cm long. The distal end was open. The catheter section was attached to the same large bore connector and ID vinyl tubing as the Tenckhoff catheter, described above. In the first experiment with the Grooved catheter, the cellulose tubings were not restrained in position. As illustrated in FIGS. 14 and 15, outflow of the catheter was higher than with the Tenckhoff catheter (about 1400 ml/min vs. 1000 ml/min). More importantly, the outflow rate didn't change as the air-fluid level went down and cellulose tubings were exposed above the fluid. At about 80 seconds, the air-fluid level reached the catheter and outflow of fluid stopped.

[0069] In the next experiment, the Delrin disc (weighing about 500 grams) was placed on top of the pile of cellulose tubings, and fluid was added around and above the disc. As opposed to the Tenckhoff catheter, outflow rate was not diminished, and there was no deceleration of flow as the air-fluid level progressed downward through the container (exposing some of the cellulose tubings). Outflow of fluid continued until the air-fluid level reached the catheter segment and air entered the vinyl drain tube. Hydraulic resistance was essentially unchanged throughout the drainage cycle, as shown in FIG. 18.

[0070] The final experiment was done with addition of a 2 kg weight to the top of the Delrin disc. As in the previous experiments, outflow was unimpeded, and remained at 1200-1300 ml/min until the fluid above the catheter was completely drained. There was no deceleration of flow rate as the fluid level declined. Although 2 kg seems like a large amount of weight, with its distribution over the Delrin disc it resulted in pressure of approximately 10 cm H.sub.2O, which is similar to the normal human intraperitoneal pressure.

[0071] As a summary, FIG. 16 shows the average flow rate of catheters in these experiments, graphed versus the weight placed above the cellulose tubes (simulated bowel loops). The average outflow rate was averaged from beginning of flow to the end of flow, so for Tenckhoff catheters the average flow value doesn't clearly display the decrease in flow that occurred near the end of outflow (when the flow rate reduced due to contact of the cellulosic tubings with the catheter). Nonetheless the results demonstrate that the Grooved catheter maintained high outflow values in spite of the presence of the simulated cellulosic tubes around it, and in spite of compression of the simulated bowel loops.

[0072] The FIG. 17 shows the average hydraulic resistance of the catheters and associated vinyl tubing, versus the amount of weight which compressed the simulated bowel loops. It is apparent that the Grooved catheter has significantly less hydraulic resistance than the Tenckhoff catheter. The hydraulic resistance of the Tenckhoff catheter increases with increasing compression of the bowel loops (which brings the bowel loop surfaces closer to the catheter surfaces). The hydraulic resistance of the Grooved catheter is unaffected by this bowel compression.

CONCLUSION

[0073] This test model is a realistic simulation of the peritoneum during peritoneal dialysis. The Tenckhoff catheter in the model has an outflow pattern similar to the same catheter when used in peritoneal dialysis. Flow at the start of outflow is brisk, but as the peritoneal volume diminishes, the flow rate also diminishes. The catheter fails to drain all of the dialysate within the peritoneum, especially when the simulated bowel loops are compressed against the catheter. In contrast, in this model the Grooved catheter has outflow rate that is higher than the Tenckhoff, does not have a diminution of flow rate as fluid volume diminishes, and flow does not decelerate as the fluid volume diminishes.

[0074] Were we to use exactly the same Grooved catheter segment in patients as used in these experiments, it could deliver 2 liters per minute outflow rate with gravity drainage if the resistance of the subcutaneous tubing and machine tubing were low enough. This was demonstrated in the previous study of inflow flow rates. The model we plan to use clinically will have two to three times as many 0.5 mm diameter holes as the catheter tested in this study. With this change and with a low-resistance subcutaneous tubing segment, we expect the Grooved catheter to deliver the outflow rate needed for intraperitoneal hyperthermia (2 L/min). Importantly, it should be able to deliver this flow rate without need for a large intraperitoneal volume of fluid.