Abstract
An all-purpose drainage catheter which includes an all-purpose drainage catheter lumen, an extension tubing, a collection bag, a catheter hub, a Luer valve. The extension tubing inserted into the all-purpose drainage catheter lumen. The collection bag is fluidly coupled to the extension tubing. The Luer valve facilitates nephrostomy care so that when the all-purpose drainage catheter is in place urine flows from the renal pelvis into the all-purpose drainage catheter lumen, the extension tubing and the collection bag. The Luer valve employs a scalloped Luer-style male connector which, when screwed into the catheter hub, further allows urine to flow from the renal pelvis into the all-purpose drainage catheter lumen, the extension tubing and the collection bag. The all-purpose drainage catheter includes an outer catheter hub, an inner catheter hub coupled to the Luer valve at one end thereof and insertedly coupled to the outer catheter hub. A gear rack has a set of ratchet teeth and is disposed on and coupled to the inner catheter hub. A ratchet pawl disposed on and coupled to the outer catheter hub and aligned with the gear rack so that the ratchet pawl engages one of the ratchet teeth to secure the inner catheter hup to the outer catheter hub.
Claims
1. An all-purpose drainage catheter which includes: a. an all-purpose drainage catheter lumen; b. an extension tubing inserted into the all-purpose drainage catheter lumen; c. a collection bag fluidly coupled to the extension tubing; and d. a Luer valve to facilitate care so that when the all-purpose drainage catheter is in place urine flows from the renal pelvis into the all-purpose drainage catheter lumen, the extension tubing and the collection bag, said improvement comprising: i. an outer catheter hub; ii. an inner catheter hub coupled to the Luer valve at one end thereof and insertedly coupled to said outer catheter hub; iii. a gear rack which has a set of ratchet teeth, and which is disposed on and coupled to said inner catheter hub; and iv. a ratchet pawl disposed on and coupled to said outer catheter hub and aligned with said gear rack so that said ratchet pawl engages one of said ratchet teeth to secure said inner catheter hub to said outer catheter hub.
Description
DESCRIPTION OF THE DRAWINGS
[0053] FIG. 1 is a schematic drawing of an all-purpose drainage catheter system having an all-purpose drainage catheter lumen and a catheter hub to facilitate nephrostomy care while eliminating the need for the 3-way stopcock assembly by employing a novel retention system that employs coaxial sleeves with radial deployment of the distal outer sleeve for renal anchoring mechanism over the wire according to the present invention.
[0054] FIG. 2 is a schematic drawing of a collection bag and an extension tubing which is fluidly coupled to the collection bag and which is inserted into the all-purpose drainage catheter lumen of FIG. 1.
[0055] FIG. 3 is a schematic drawing of a Luer-activated needleless valve which connects to hub of the all-purpose drainage catheter of FIG. 1.
[0056] FIG. 4 is a schematic drawing of a cross-sectional diagram along the long axis of the device in “anchored” configuration demonstrating the two-part hub securing the coaxial sleeves in relative position.
[0057] FIG. 5 is a schematic drawing of a cross-sectional diagram along the long axis of the device in anchored configuration. 1) outer coaxial sleeve, continuous with anchoring ribs at the distal, intra-corporal end of the catheter; 2) inner coaxial sleeve, continuous with the drainage side-holes at the distal end of the catheter; 3A) male-threaded inner component of hub, containing a circumferential slot within which the inner sleeve is inserted as well as a beveled outer surface; 36) female-threaded outer component of hub, which serves as a lockring securing the two coaxial sleeves in relative position.
[0058] FIG. 6 is a schematic drawing of a conceptual prototype. Several longitudinal slits were created in the distal portion of an 8-French vascular sheath, representing the outer coaxial sleeve. An 8-French all-purpose drainage catheter (lighter shade of blue) was inserted within the lumen of the vascular sheath, representing the inner coaxial sleeve. Draining side-holes of the inner sleeve are not visualized in this photograph.
[0059] FIG. 7 is a schematic drawing of a cross-sectional (long axis) representation of the distal portion of the device in anchored configuration.
[0060] FIG. 8 is a schematic drawing of a color-coded cross-sectional (long axis) representation of the device in anchored configuration.
[0061] FIG. 9 is a schematic drawing of a close-up cross-sectional (long axis) diagram of the distal end of the catheter in anchored configuration. The inner and outer coaxial sleeves are permanently attached to each other at their distal ends, around their circumference, forming the distal end-hole (not pictured: drainage side-holes in the inner sleeve).
[0062] FIG. 10 is a schematic drawing of a cross-sectional diagram of the distal portion of the device in anchored configuration. Drainage side-holes of the inner coaxial sleeve are depicted and labeled as such.
[0063] FIG. 11 is a schematic drawing of a cross-sectional diagram of the distal portion of the device in anchored configuration with detailed, three-dimensional depiction of the portion of the inner coaxial sleeve containing the drainage side-holes.
[0064] FIG. 12 is a schematic drawing of a cross-sectional diagram of the distal portion of the device in anchored configuration with detailed, three-dimensional depiction of the portion of the inner coaxial sleeve containing the drainage side-holes.
[0065] FIG. 13 is a schematic drawing of a cross-sectional diagram displaying the mechanism of the needleless valve at the hub site. When the valve is not connected to a flush or bag tubing it remains closed. When a flush or bag tubing is screw onto the valve, the valve will open, allowing flow.
[0066] FIG. 14 is a longitudinal cross-sectional diagram of the catheter hub of FIG. 1 which is in an undeployed configuration, a deployed configuration, n and a recaptured configuration and which includes an inner catheter hub, a gear rack on the inner catheter hub, a releasable ratchet pawl, an outer catheter hub, and a Luer-lock style connector which is coupled to the collection bag through the extension tubing of FIG. 2 according to the present invention.
[0067] FIG. 15 is a longitudinal cross-sectional diagram of the catheter hub of FIG. 14 in the undeployed configuration in more details.
DESCRIPTION OF THE PREFERRED EMBODIMENT
[0068] In the prior art an all-purpose catheter includes an all-purpose drainage catheter lumen, an extension tubing, a collection bag, a 3-way stopcock assembly and a catheter hub. The primary function of a 3-way stopcock assembly is to enable flushing of the catheter lumen without disconnecting the extension tubing from the collection bag. Unfortunately, the 3-way stopcock assembly and the catheter hub are bulky and uncomfortable, partly contributing to decreased quality of life for patients. “Distal” refers to end of catheter within the patient. “Proximal” refers to the opposite end where the hub/valve/drainage bag are located.
[0069] Referring to FIG. 1 an improved percutaneous all-purpose drainage catheter system 10 provides refinements in its design which center around the primary goals of improving patient comfort/user friendliness and enabling simple, lower risk and inexpensive clinic or bedside repair in the case of fracture of the external catheter.
[0070] Referring to FIG. 2 in conjunction with FIG. 1 the all-purpose drainage catheter system 100 includes an all-purpose drainage catheter lumen 11, an extension tubing 12, a collection bag 13 which is fluidly coupled to the extension tubing 12 at the distal end 16 and a catheter hub assembly 14. A Luer valve 15 is fluidly coupled to the extension tubing 12 at the proximal end 17 and which facilitates nephrostomy care so that when the improved percutaneous nephrostomy system 10 is in place urine flows from the renal pelvis into the all-purpose drainage catheter lumen 11, the extension tubing 12 and the collection bag 13. The catheter hub assembly 14 includes an inner catheter hub 21 and an outer catheter hub 22. The catheter hub assembly also includes an inner catheter 23 and an outer catheter 24. The inner catheter 23 is inserted into the outer catheter 24.
[0071] Still referring to FIG. 1 a retention system employs coaxial sleeves with radial deployment of the distal outer sleeve for renal anchoring mechanism over the wire (OTW).
[0072] Referring to FIG. 3 is a Luer-activated needleless valve which connects to the hub of the all-purpose drainage catheter.
[0073] Referring to FIG. 4 the valve employs a proprietary scalloped Luer-style male connector which, when screwed into the hub 14 allows flow. When the extension tubing 12 is attached to the catheter hub 14, urine flows from the all-purpose drainage catheter into the collection bag. In preparation for flushing the improved percutaneous all-purpose drainage catheter system 10, a scalloped Luer-style male adaptor is attached to the standard saline flush syringe and the adaptor-syringe combination is screwed into the catheter hub 14. As with the extension tubing 12, the scalloped male connector compresses the valve allowing flow. When connected to the proprietary scalloped male connector, the valve design allows for bidirectional flow.
[0074] Referring to FIG. 3 in conjunction with FIG. 2 catheter repair involves cutting off the damaged section and installing a new hub. This process would also cut the retention suture holding the pigtail shape. The improved percutaneous all-purpose drainage catheter system 10 employs a retention system which is like the coaxial Malecot catheter design with some key differences. Actuation of the retention system into the expanded “fixation” position, versus the collapsed “introduction or removal” position, depends on the relative position of the two coaxial sleeves that make up the catheter. The outer sleeve has several longitudinal perforations located around the circumference of its distal end, forming struts oriented radially. The inner sleeve is reinforced and contains multiple side holes in the same region of the longitudinal perforations of the outer sleeve. The two sleeves are fused at the distal end-hole. To prevent formation of a tissue bridge which can hinder removal, our proposed design includes a thin, flexible synthetic membrane, either silicone or ePTFE, forming a partial web over the angles between the proximal struts. Following advancement into the renal pelvis, the outer sleeve is driven toward the patient and the inner sleeve is maintained static, causing the struts of the outer sleeve to flare outwards radially in an inverted “V” shape and the sleeves can be clamped to maintain their position relative to one another. The catheter (both inner and outer sleeves) is cut to a custom length chosen according to the specific ergonomic needs of the patient. At this point the hub containing the spring-loaded ball valve within the female end of the Luer-style connection is fastened to the catheter employing a system in a similar fashion to repairable venous access devices or implantable infusion ports. Repair of the all-purpose drainage catheter simply involves clamping the catheter with padded or atraumatic hemostat or clamp to secure “deployed” shape of the retention system within the renal pelvis, cutting the catheter proximal to the site of damage, and attaching a new hub as described above. The two-piece connector would serve dual duty, connecting the catheter tube to the valve component and holding the two catheter sleeves in their relative positions to maintain the “deployed” configuration of the distal anchoring mechanism (the “Malecot-style” system). The device is in “anchored” configuration demonstrating the two-part hub securing the coaxial sleeves in relative position.
[0075] Referring to FIG. 5 the device is in anchored configuration with an outer coaxial sleeve, continuous with anchoring ribs at the distal, intra-corporal end of the catheter; inner coaxial sleeve, continuous with the drainage side-holes at the distal end of the catheter; male-threaded inner component of hub, containing a circumferential slot within which the inner sleeve is inserted as well as a beveled outer surface; and female-threaded outer component of hub, which serves as a lockring securing the two coaxial sleeves in relative position.
[0076] Referring to FIG. 6 in a conceptual prototype several longitudinal slits were created in the distal portion of an 8-French vascular sheath, representing the outer coaxial sleeve. An 8-French all-purpose drainage catheter (lighter shade of blue) was inserted within the lumen of the vascular sheath, representing the inner coaxial sleeve. Draining side-holes of the inner sleeve are not visualized in this photograph.
[0077] Referring to FIG. 7 there is a representation of the distal portion of the device in anchored configuration.
[0078] Referring to FIG. 8 there is a color-coded representation of the device in anchored configuration.
[0079] Referring to FIG. 9 the distal end of the catheter is in an anchored configuration. The inner and outer coaxial sleeves are permanently attached to each other at their distal ends, around their circumference, forming the distal end-hole (not pictured: drainage side-holes in the inner sleeve).
[0080] Referring to FIG. 10 a cross-sectional diagram of the distal portion of the device is shown in anchored configuration. Drainage side-holes of the inner coaxial sleeve are depicted and labeled as such.
[0081] Referring to FIG. 11 a cross-sectional diagram of the distal portion of the device is shown in anchored configuration with detailed, three-dimensional depiction of the portion of the inner coaxial sleeve containing the drainage side-holes.
[0082] Referring to FIG. 12 a cross-sectional diagram of the distal portion of the device is shown in anchored configuration with detailed, three-dimensional depiction of the portion of the inner coaxial sleeve containing the drainage side-holes.
[0083] Referring to FIG. 13 a cross-sectional diagram displaying the mechanism of the needleless valve at the hub site. When the valve is not connected to a flush or bag tubing it remains closed (3a). When a flush or bag tubing is screw onto the valve, the valve will open, allowing flow (3b).
[0084] Referring to FIG. 14 in conjunction with FIG. 1, FIG. 2, and FIG. 15 the all-purpose drainage catheter system 100 includes the all-purpose drainage catheter lumen 11, the extension tubing 12, the collection bag 13 which is fluidly coupled to the extension tubing 12 at the distal end 16, and a Luer valve 15, which is fluidly coupled to the extension tubing 12 at the proximal end 17 of FIG. 1 and FIG. 2. The Luer valve 15 facilitates nephrostomy care so that when the improved percutaneous nephrostomy system 100 is in place urine flows from the renal pelvis into the all-purpose drainage catheter lumen 11, the extension tubing 12 and the collection bag 13. The improved percutaneous all-purpose drainage catheter system 100 also includes catheter hub assembly which includes an inner catheter hub 101, a gear rack 102 which has ratchet teeth, and which is disposed on and is coupled to the inner catheter hub 101, a hub assembly and an outer catheter hub 103 which includes a releasable ratchet pawl 104. The ratchet pawl 104 is disposed on and coupled to the outer catheter hub 103 and is aligned with the gear rack 102 so that the ratchet pawl 104 engages one of the ratchet teeth of the gear rack 102 to secure the inner catheter hub 101 to the outer catheter hub 103.
[0085] Referring again to FIG. 14 in conjunction with FIG. 2 and FIG. 15 the all-purpose drainage catheter system 100 further includes a drainage catheter system which consists of two coaxial flexible hollow tubular catheters, i.e., an inner catheter 105 and an outer catheter 106, which are mechanically coupled to each other at the distal (intracorporeal) aspect. The outer catheter 106 is for intracorporeal fixation within the fluid collection. There are linear slits 107 at the distal aspect of the outer catheter 106 which allow the catheter material between the slits to flare out radially when the outer catheter is advanced relative to the inner catheter 105. The outer catheter 106 is permanently mechanically coupled to the outer component of the hub assembly. The inner catheter is for drainage of fluid contents. Several oval perforations in the distal few centimeters of the inner catheter allow fluid contents to flow into the lumen of the inner catheter and towards the hub, to which a valve and the collection bag are connected. The inner catheter is permanently mechanically coupled to the inner component of the hub assembly. A two-piece hub assembly locks the coaxial catheters in place relative to one another via releasable ratchet system. Once the drainage catheter system is advanced into desired position within the patient, the inner catheter/inner hub unit is retracted out of the body while the outer catheter/outer hub is maintained in static position, resulting in outward/radial flaring of the distal aspect of the outer catheter into the “deployed” configuration. As the inner catheter is retracted, the ratchet system in the hub locks the inner and outer catheter hub units in relative linear position, effectively locking the deployed configuration at the distal aspect of the outer catheter. This deployed configuration of the distal outer catheter allows for anchoring of the system within the desired intracorporeal position. This design also allows de-deployment (recapture) of the outer catheter configuration via movable pawl on the outer component of the outer hub, allowing for repositioning within, or removal from, the patient. The hub assembly consists of two hollow and tubular components oriented coaxially, termed “outer hub” and “inner hub.” The outer hub is mechanically coupled to the outer catheter at the distal aspect of the hub and contains pawl which engages ratchet teeth on the inner hub component as the inner catheter/hub is retracted, allowing for fixation of the hub components and their respective catheters in position relative to one another. The pawl is movable in a way that enables disengagement from the ratchet teeth of the inner component to recapture original tubular configuration. The movable pawl is lockable to prevent inadvertent disengagement with the ratchet teeth and subsequent recapture of the anchoring mechanism at the distal outer catheter. Inner component of the hub is mechanically coupled to the inner catheter at the distal aspect of the hub component. The inner hub has ratchet teeth oriented circumferentially and perpendicular to the axis of the hub and catheter. The inner hub employs a threaded connection (e.g., Luer lock) at its proximal aspect for connection with a valve and collection bag of existing, commercially available design.
[0086] From the foregoing an improvement to a percutaneous nephrostomy system has been described. It should be noted that the sketches are not drawn to scale and that distances of and between the figures are not to be considered significant.
[0087] Accordingly, it is intended that the foregoing disclosure and showing made in the drawing shall be considered only as an illustration of the principle of the present invention.
REFERENCES
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