Kink and compression tolerant medical tubing
10918828 ยท 2021-02-16
Assignee
Inventors
Cpc classification
A61M1/28
HUMAN NECESSITIES
A61M2025/0031
HUMAN NECESSITIES
A61M25/003
HUMAN NECESSITIES
A61M2025/0059
HUMAN NECESSITIES
F16L11/121
MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
A61M1/1524
HUMAN NECESSITIES
A61M1/155
HUMAN NECESSITIES
A61M1/1561
HUMAN NECESSITIES
A61M2205/12
HUMAN NECESSITIES
F16L55/10
MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
A61M1/153
HUMAN NECESSITIES
International classification
Abstract
Medical fluid tubing described herein is configured to be advantageously tolerant of kinking and/or crushing. That is, the tubing is configured such that even if the tubing is kinked or fully compressed at least some portion of the lumen defined by the tubing will remain open, and some fluid will continue to flow through the tubing. Such kink and compression tolerant medical tubing can be advantageously used in association with medical fluid pumping systems (e.g., peritoneal dialysis systems and the like). In some examples, the tubing described herein is used in conjunction with, or as a part of, a medical fluid cassette that interfaces with such medical fluid pumping systems.
Claims
1. A medical tubing system, comprising: a medical tube defining a central longitudinal axis and including internal ribs extending inwardly from an inner wall of the tube toward the central longitudinal axis, an outer wall of the tube defining grooves in radial alignment with the internal ribs and extending longitudinally along the tube; and a tube closure device comprising: a sleeve defining an opening that slidingly receives the tube, the sleeve including an externally threaded portion; a set of jaws comprising three jaws that are each connected to and extending longitudinally from the externally threaded portion of the sleeve, each of the jaws including a ramp surface extending along an acute angle relative to the central longitudinal axis, and each of the jaws being radially deflectable in relation to the externally threaded portion of the sleeve; and a clamp collar positioned around at least portions of set of jaws, the clamp collar including an internally threaded portion that is threadedly coupled with the externally threaded portion of the sleeve, the clamp collar including an annular ramp surface that corresponds to and slidingly mates against the ramp surface of each of the jaws, the annular ramp surface extending from the internally threaded portion and defining an end opening of the clamp collar that is larger in diameter than the internally threaded portion.
2. The system of claim 1, wherein the clamp collar is longitudinally movable in relation to the set of jaws between: (i) a first position in which the set of jaws are in an open configuration and (ii) a second position in which the clamp collar deflects the set of jaws radially inward in comparison to the open configuration.
3. The system of claim 1, wherein while the tube closure device is positioned on the tube, each one of the internal ribs is radially alignable with a respective jaw of the set of jaws.
4. The system of claim 3, wherein the tube includes three internal ribs.
5. The system of claim 1, wherein each of the jaws is matingly positioned within a respective one of the grooves in the outer wall of the tube.
6. The system of claim 1, wherein each of the internal ribs includes an apex, and wherein the clamp collar can deflect the set of jaws radially inward such that the apices of the internal ribs meet each other at a center of the tube.
7. The system of claim 6, wherein the tube is fully closed when the apices of the internal ribs meet each other at the center of the tube.
Description
DESCRIPTION OF DRAWINGS
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DETAILED DESCRIPTION
(21) This disclosure relates generally to tubing that can be used in association with medical fluid pumping systems (e.g., PD systems, hemodialysis systems, hemofiltration systems, hemodiafiltration systems, etc.) and other medical devices/systems. In some examples, the tubing described herein is used in conjunction with, or as a part of, a medical fluid cassette that interfaces with such medical fluid pumping systems. In some cases the tubing described herein may be connected to a patient via a catheter, and may be used to convey fluids such as, but not limited to, dialysis solution (or dialysate), spent dialysate (or effluent), blood, saline, medications, water, ionized water, air, oxygen, other gasses, and so on. Such fluids may be conveyed to the patient from the medical system, or from the patient to the medical system or elsewhere.
(22) As described further below, the tubing described herein is designed and configured to be advantageously tolerant of kinking and/or crushing. That is, even if the tubing is kinked or compressed (or crushed), at least some portion of the lumen defined by the tubing will remain open and some fluid will continue to flow through the tubing.
(23) The kink and compression tolerant tubing is described below using the example context of a PD system. It should be understood, however, that a PD system is merely one of the contexts in which the kink and compression tolerant tubing described herein can be beneficially used.
(24) Referring to
(25) Dialysis solution bags 122 are suspended from fingers on the sides of the cart 104, and a heater bag 124 is positioned on the heater tray 116. The dialysis solution bags 122 and the heater bag 124 are connected to the cassette 112 via dialysis solution bag lines 126 and a heater bag line 128, respectively. The dialysis solution bag lines 126 can be used to pass dialysis solution from dialysis solution bags 122 to the cassette 112 during use, and the heater bag line 128 can be used to pass dialysis solution back and forth between the cassette 112 and the heater bag 124 during use. In addition, a patient line 130 and a drain line 132 are connected to the cassette 112. The patient line 130 can be connected to a patient's abdomen via a catheter, and can be used to pass dialysis solution back and forth between the cassette 112 and the patient during use. The drain line 132 can be connected to a drain or drain receptacle and can be used to pass dialysis solution from the cassette 112 to the drain or drain receptacle during use. The spent dialysate is also referred to as effluent herein.
(26) The cassette 112 generally includes a rigid plastic molded base member and a flexible membrane 113 attached to the base. The base and the membrane 113 of the cassette 112 cooperate to define various dialysis solution channels and dialysis solution chambers integrally within the cassette 112. The cassette 112 is configured to align with various valve actuators, sensors and other components of the PD cycler 102 when the cassette 112 is coupled with the PD cycler 102. The cassette 112 can be a single-use disposable element used for a PD treatment.
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(28) Still referring to
(29) After draining the spent dialysis solution from the patient, heated dialysis solution is transferred from the heater bag 124, through the cassette 112, and to the patient via the patient line 130. To do this, the motor or motors of the PD cycler 102 is/are activated to cause the pistons 133A, 133B to reciprocate and certain inflatable members 142 of the PD cycler 102 are inflated to cause the warmed dialysis solution to be drawn into the fluid pump chambers 138A, 138B of the cassette 112 from the heater bag 124 via the heater bag line 128. The warmed dialysis solution is then pumped from the fluid pump chambers 138A, 138B to the patient via the patient line 130.
(30) Once the dialysis solution has been pumped from the heater bag 124 to the patient, the dialysis solution is allowed to dwell within the patient for a period of time. During this dwell period, toxins cross the peritoneum of the patient into the dialysis solution from the patient's blood. As the dialysis solution dwells within the patient, the PD cycler 102 prepares fresh dialysate for delivery to the patient in a subsequent cycle. In particular, the PD cycler 102 pumps fresh dialysis solution from one of the four full dialysis solution bags 122 into the heater bag 124 for heating. To do this, the pump of the PD cycler 102 is activated to cause the pistons 133A, 133B to reciprocate and certain inflatable members 142 of the PD cycler 102 are inflated to cause the dialysis solution to be drawn into the fluid pump chambers 138A, 138B of the cassette 112 from the selected dialysis solution bag 122 via its associated line 126. The dialysis solution is then pumped from the fluid pump chambers 138A, 138B to the heater bag 124 via the heater bag line 128.
(31) After the dialysis solution has dwelled within the patient for the desired period of time, the spent dialysis solution is pumped from the patient through the patient line 130, and then to the drain via drain line 132. The heated dialysis solution is then pumped from the heater bag 124 and through the patient line 130 to the patient where it dwells for a desired period of time. These steps are repeated with the dialysis solution from two of the three remaining dialysis solution bags 122. The dialysis solution from the last dialysis solution bag 122 is typically delivered to the patient via the patient line 130 and left in the patient until the subsequent PD treatment.
(32) PD treatments (e.g., as described above) usually occur at night while the patient is sleeping. A PD treatment typically involves several fills and drains of many liters of dialysate fluid, and may occur over the entire night. In some circumstances, the patient line 130 (connected to the patient) may inadvertently become obstructed to fluid flow because of unintentional kinking or pinching (crushing) of the patient line 130 tubing. For example, the patient may simply roll over while sleeping, causing the patient line 130 to become partially or fully kinked or crushed. In that case, the PD treatment can be partially or fully inhibited, disrupted, and/or discontinued.
(33) Most PD systems have one or more pressure sensors to monitor the fluid pressure in the patient line 130. Those pressure sensors can detect when the patient line 130 has become obstructed because of being partially or fully kinked or crushed. In such a case, the PD system (e.g., the PD cycler 102) may pause the treatment and deliver an alert/alarm in attempt to wake the patient. An awakened patient will then need to check for kinks and/or compression of the patient line 130, resolve the problem, and then resume treatment. Unfortunately for the patient, this scenario may repeat itself many times during a night.
(34) One potential way to mitigate the problem of the patient line 130 becoming obstructed because of kinking or crushing is to make the patient line 130 stiff so that it is very resistant to bending and compression. In some cases, metal wires are embedded in the wall of tubing for such purposes. However, if the tubing used for the patient line 130 is made very stiff (resistant to bending and compression), then the tubing tends to be very uncomfortable for the patient to use. For example, when the patient rolls over during sleep, the stiff tube used for the patient line 130 will likely cause substantial stress and pain to the patient via lateral forces exerted by the catheter to the patient.
(35) Accordingly, making the patient line 130 flexible while also tolerant to kinking and crushing will provide a more effective PD treatment (e.g., with less interruptions), and a better patient experience (e.g., with fewer alarms and fewer required interventions). That is, tubing that is flexible and that will allow for flow through the tubing even while kinked or crushed will provide many benefits when used as the patient line 130 for the PD system 100 (and for other medical uses).
(36) Referring to
(37) The tubing 300 can be made from any suitable polymeric material, such as polyvinyl chloride (PVC). In some embodiments, the PVC material has a durometer of shore 70. In some embodiments, the durometer of the PVC material is in a range of shore 65 to shore 75, or shore 60 to shore 80, or shore 55 to shore 85. The tubing 300 is preferably sufficiently flexible and compliant so that movements of the patient that result in bending of the tubing 300 do not induce stress at the location where the tubing 300 is percutaneously attached to the patient (e.g., via a catheter). In the depicted embodiment, there is no reinforcing wire/material within the wall of the tubing 300.
(38) The tubing 300 is scalable to any suitable size. In one example embodiment the outer diameter of the tubing 300 is 6.0 mm and the inner diameter of the tubing 300 is 4.0 mm (hence, the inner radius 320 is 2.0 mm). The tubing 300 can be made to have any suitable length.
(39) The tubing 300 defines a single lumen 302 through which fluid can flow. The lumen 302 is the open space within the tubing 300. The tubing 300 includes three internal ribs 310a, 310b, and 310c (or collectively ribs 310a-c). In the depicted embodiment, the ribs 310a-c are triangular projections that extend inward from the inner wall of the tubing. Each of the triangular ribs 310a-c includes an apex, and the ribs 310a-c are arranged such that the apices are pointed towards a geometric center 301 of the tubing 300. The triangular ribs 310a-c are arranged at about 120 degrees relative to each other around the 360 degree inner circumference of the tubing 300. A central longitudinal axis of the tubing 300 extends along the geometric center 301.
(40) In the depicted embodiment, the ribs 310a-c and the wall of the tubing 300 are contiguous and made of the same material (e.g., by extrusion). The lumen 302 is the open space within the tubing 300 (and does not include the area of the ribs 310a-c).
(41) Each of the ribs 310a-c extends inward from the inner wall of the tubing 300 for a distance that is referred to as the rib height 330. The rib height 330 is less than the inner radius 320. As described further below, the inventors have discovered that when the rib height 330 is 43% of the inner radius 320, the size of the lumen 302 is maximized while the tubing 300 is fully compressed.
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(43) It can be seen that the cross-section of the lumen 302 is shaped differently in each of the depicted differing states of compression. Actually, the lumen 302 is divided up into multiple separated portions while the tubing 300 is in the fully compressed state (shown in
(44) The tubing 300 is kink and compression tolerant because, as
(45) Referring to
(46) In order to investigate and discover the optimal rib height for kink and compression tolerance, the inventors created a solid model of each design of the tubing 400a-j. Then, using finite element analysis (FEA), the fully compressed state for each design of the tubing 400a-j was simulated (as shown). From there, the fully compressed open area of each design of the tubing 400a-j was calculated.
(47) Referring also to
(48) The graph 500 shows that the tubing 400f yields the greatest amount of open area when fully compressed. The ribs of the tubing 400f are each 43% of the inner radius of tubing 400f. The open area of the tubing 400f while it is in the fully compressed state is about 20% of the uncompressed open area of the tubing 400f The fit line 510 shows that the open area while fully compressed is effectively optimal in a range of about 40% to about 46% in terms of rib height as a percentage of inner radius.
(49) The inventors also experimented with the kink and compression tolerance effects of various numbers of ribs in the tubing. For example, the inventors experimented with zero ribs, two ribs, three ribs, four ribs, five ribs, six ribs, and seven ribs. The results of such experiments demonstrated that the three rib design was superior than the others.
(50) Referring to
(51) Referring also to
(52) The externally threaded sleeve 710 defines an opening that slidingly receives the tubing 600. Three jaws 712a, 712b, and 712c are connected to and extend longitudinally from the externally threaded sleeve 710 like cantilevered beams. The jaws 712a, 712b, and 712c are radially deflectable in relation to the externally threaded sleeve 710.
(53) Each of the three jaws 712a, 712b, and 712c includes a respective ramp surface 714a, 714b, and 714c. The internally threaded clamp collar 720 includes a corresponding annular ramp surface 722 that slidingly mates against the ramp surfaces 714a, 714b, and 714c.
(54) The internally threaded clamp collar 720 can be threadedly adjusted in relation to the externally threaded sleeve 710 such that the ramp surface 722 adjustably exerts pressure on each of the three jaws 712a, 712b, and 712c to force the jaws 712a, 712b, and 712c radially inward. For example, in
(55) In the depicted embodiment, the tubing 600 defines three longitudinally-extending grooves 612a, 612b, and 612c extending along the outer surface of the tubing 600. The three longitudinally-extending grooves 612a, 612b, and 612c are in radial alignment with the three internal ribs of the tubing 600 (see e.g., the example internal ribs 310a, 310b, and 310c of tubing 300 as shown in
(56) The three jaws 712a, 712b, and 712c are matingly positioned within the three longitudinally-extending grooves 612a, 612b, and 612c. That is, the jaw 712a is positioned within the groove 612a, the jaw 712b is positioned within the groove 612b, and the jaw 712c is positioned within the groove 612c. When the externally threaded sleeve 710 is slid longitudinally along the tubing 600, the three jaws 712a, 712b, and 712c slide within the three longitudinally-extending grooves 612a, 612b, and 612c.
(57) Because the three longitudinally-extending grooves 612a, 612b, and 612c are in radial alignment with the three internal ribs of the tubing 600, and because the three jaws 712a, 712b, and 712c are positioned within the three longitudinally-extending grooves 612a, 612b, and 612c, it follows that the three jaws 712a, 712b, and 712c are in radially alignment with the three internal ribs of the tubing 600. Accordingly, when the three jaws 712a, 712b, and 712c are forced radially inward by the internally threaded clamp collar 720, the three internal ribs of the tubing 600 are forced toward the center of the tubing 600. The apices of the three internal ribs of the tubing 600 meet each other at the center of the tubing 600. As a result the tubing 600 becomes fully closed (there is no open portion of the lumen of the tubing 600).
(58) Again, in the arrangement of
(59) A number of embodiments of the invention have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the invention. For example,
(60) While the tubing 300 has been described as being made from PVC, in some embodiments, the tubing 300 can be made from any other suitable polymeric material such as, but not limited to, polyethylene, polyurethanes, nylons, fluoropolymers, natural rubber, natural rubber latex, synthetic rubber, thermoplastic rubbers, silicone, and the like, and combinations thereof.
(61) While the tubing 300 has been described as having an outer diameter of 6.0 mm, in some embodiments, the tubing 300 has an outer diameter in a range of 1.0 mm to 5.0 mm, or 3.0 mm to 7.0 mm, 5.0 mm to 9.0 mm, or 7.0 mm to 1.1 cm, or 9.0 mm to 1.3 cm, or 1.1 cm to 1.5 cm, or 1.3 cm to 1.7 cm, or 1.5 cm to 1.9 cm, or 1.7 cm to 2.1 cm, and/or more than 2.1 cm. While the tubing 300 have been described as having an inner diameter of 4.0 mm, in some embodiments, the tubing 300 has an inner diameter in a range of 1.0 mm to 5.0 mm, or 3.0 mm to 7.0 mm, 5.0 mm to 9.0 mm, or 7.0 mm to 1.1 cm, or 9.0 mm to 1.3 cm, or 1.1 cm to 1.5 cm, or 1.3 cm to 1.7 cm, or 1.5 cm to 1.9 cm, or 1.7 cm to 2.1 cm, and/or more than 2.1 cm.
(62) While in the depicted embodiment of the tubing 300 there is no reinforcing wire/material within the wall of the tubing 300, in some embodiments, one or more wires or other types of reinforcing materials can be included within the wall of the tubing 300.
(63) While the depicted embodiment of the tubing 300 includes three internal ribs 310a-c, in some embodiments, one, two, four, five, six, seven, or more than seven ribs are included.
(64) While the depicted embodiment of the tubing 300 the rib height 330 is 43% of the radius 320 of the tubing 300, in some embodiments, the rib height 330 is in a range of 42% to 44%, or 40% to 46%, or 38% to 48%, or 36% to 50%, or 34% to 38%, or 36% to 40%, or 38% to 42%, or 40% to 44%, or 42% to 46%, or 44% to 48%, or 46% to 50%, or 48% to 52%, or 50% to 54% of the radius 320 of the tubing 300.
(65) While the ribs 310a-c have been described as triangular shaped, in some embodiments, other shapes as used such as, but not limited to, rectangular, ovular, and so on. While in the depicted embodiment the ribs 310a-c are solid, in some embodiments, the ribs 310a-c are hollow (have open space within the boundaries of the ribs 310a-c).
(66) While the PD system 100 has been described and illustrated as including piston pumps, in some embodiments, a PD system that is otherwise similar in construction and function to the PD system 100 may include one or more peristaltic pumps instead of piston pumps.
(67) The cartridge 2 includes a pumping element 1, a first hub chamber 7, and a second hub chamber 8. The first chamber 7 includes a pump inlet 26 that can be connected to the pumping element 1 via a pump enter line, a liquid supply port 9 with a valve that can be connected to a liquid supply container via a liquid supply line, and a patient port 10 with a valve that can be connected to a patient via a patient line 5. In some embodiments, the patient line 5 can be kink and compression tolerant tubing (e.g., like the tubing 300 described above in reference to
(68) The cartridge 2 further forms a cavity 15, which forms part of a pressure sensor. The first hub chamber 7 has three liquid supply ports 9, one patient port 10, one pump inlet 26, and a cavity 36 that forms part of a pressure sensor. The second hub chamber 8 has a patient port 18, a drain port 11, and a pump outlet 27. The cartridge 2 also includes a warmer chamber 17, which includes a warmer port 19 and a patient port 16. The warmer port 19 is connected to a warmer 28 (shown in
(69) The pumping element 1 includes a pump casing 45, which contains three rollers 22 maintained around a center of the pump casing 45 by a roller separator 12. The space between the roller separator 12 and the pump casing 45 defines a pump race 21 in which a flexible tube 37 is disposed. The flexible tube 37 is connected to the pump enter line 56 and the pump exit 57 line. The rollers 22 may be motor driven by a shaft 52 (shown in
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(72) Other embodiments are within the scope of the following claims.