Catheter Assembly Including Transitioning Lumens
A catheter assembly including an elongate catheter tube is disclosed. The number of lumens defined by the catheter tube can vary as a function of longitudinal length along the catheter tube. For instance, the catheter tube can define three lumens from the proximal end of the catheter tube and terminate one of the lumens at an intermediate termination point such that only two lumens are defined further distally along the catheter tube. A sensor can be placed in the terminating lumen so as to isolate it from the other lumens and from blood or other body fluids while still enabling the sensor to reside within the patient body when the catheter tube is positioned in the patient for use. In addition to this, various other lumen transition and sensor configurations are disclosed.
This application claims the benefit of U.S. Provisional Patent Application No. 62/313,047, filed Mar. 24, 2016, and titled “Catheter Assembly Including Transitioning Lumens,” which is incorporated herein by reference in its entirety.
BRIEF SUMMARYBriefly summarized, embodiments of the present invention are directed to a catheter assembly that includes one or more sensors that can detect and/or monitor various functions, characteristics, and/or vital measurements of a body of a patient in which the catheter assembly is placed. The sensors are placed in various positions in, on, or associated with the catheter assembly. For instance, one or more sensors can be placed so as to be in communication with one or more lumens defined by a catheter tube of the catheter assembly so as to be in contact with fluids present in the lumen(s). Yet other sensors are configured to be in proximity to the patient body but not in fluid communication therewith. Other locations are also possible and contemplated.
In one embodiment, the number of lumens defined by the catheter tube can vary as a function of longitudinal length along the catheter tube. For instance, the catheter tube can define three lumens from the proximal end of the catheter tube and terminate one of the lumens at an intermediate termination point such that only two lumens are defined further distally along the catheter tube. The terminating lumen in this case can merge with one of the other two lumens, or can simply end at a predetermined longitudinal length along the catheter tube. A sensor can be placed in the terminating lumen so as to isolate it from the other lumens and from blood or other body fluids while still enabling the sensor to reside within the patient body when the catheter tube is positioned in the patient for use. In addition to this and as will be shown further below, various other lumen transition and sensor configurations are possible.
In one embodiment, therefore, a catheter assembly is disclosed, comprising an elongate catheter tube defining at least one fluid-carrying lumen extending between a proximal end and a distal end of the catheter tube. The catheter tube further defines at least one terminating lumen defined by the catheter tube. The terminating lumen distally extends to a closed distal termination point positioned intermediately between the proximal and distal ends of the catheter tube. The termination point is defined by the catheter tube material. The terminating lumen is configured to be isolated from fluids.
These and other features of embodiments of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of embodiments of the invention as set forth hereinafter.
A more particular description of the present disclosure will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. Example embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
Reference will now be made to figures wherein like structures will be provided with like reference designations. It is understood that the drawings are diagrammatic and schematic representations of exemplary embodiments of the present invention, and are neither limiting nor necessarily drawn to scale.
For clarity it is to be understood that the word “proximal” refers to a direction relatively closer to a clinician using the device to be described herein, while the word “distal” refers to a direction relatively further from the clinician. For example, the end of a catheter placed within the body of a patient is considered a distal end of the catheter, while the catheter end remaining outside the body is a proximal end of the catheter. Also, the words “including,” “has,” and “having,” as used herein, including the claims, shall have the same meaning as the word “comprising.”
Embodiments of the present invention are generally directed to a catheter assembly that includes one or more sensors that can detect and/or monitor various functions, characteristics, and/or vital measurements of a body of a patient in which the catheter assembly is placed. The sensors are placed in various positions in, on, or associated with the catheter assembly. For instance, one or more sensors can be placed so as to be in communication with one or more lumens defined by a catheter tube of the catheter assembly so as to be in contact with fluids present in the lumen(s). Yet other sensors are configured to be in proximity to the patient body but not in fluid communication therewith. Other locations are also possible and contemplated.
In accordance with one embodiment, the number of lumens defined by the catheter tube can vary as a function of longitudinal length along the catheter tube. For instance, the catheter tube can define three lumens from the proximal end of the catheter tube and terminate one of the lumens at an intermediate termination point such that only two lumens are defined further distally along the catheter tube. The terminating lumen in this case can merge with one of the other two lumens, or can simply end at a predetermined longitudinal length along the catheter tube. A sensor can be placed in the terminating lumen so as to isolate it from the other lumens and from blood or other body fluids while still enabling the sensor to reside within the patient body when the catheter tube is positioned in the patient for use. In addition to this and as will be shown further below, various other lumen transition configurations are possible.
In yet another embodiment, various catheter tube lumen configurations are disclosed that enable a sensor to be placed proximate the distal end of the catheter tube, with an accompanying sensor wire(s) extending from the proximal end of the catheter tube to the distally-disposed sensor so as to provide for functionality of the sensor. The sensor wires can be provided a pathway via a dedicated sensor wire lumen, or by incorporation into the catheter tube wall of septum, in one embodiment. These pathways are provided in addition to one or more functional infusion/aspiration lumens also defined by the catheter tube. Placement of the sensor in this manner enables the sensor to be located within the patient body and proximate a desired location while still being included as part of the catheter assembly.
Reference is first made to
In accordance with one embodiment, one or more sensors, also referred to herein as a “sensor array” 30, are included with the catheter 10 to enable the detection of data relating to one or more physiological aspects of the patient and/or physical aspects of the catheter when the catheter tube 12 is disposed in the vasculature (as discussed here) or other suitable internal portion of the body of the patient. In the present embodiment, multiple sensors are included with the catheter 10, though the number, type, size, placement, function, and desired uses of the various sensors can vary from what is shown and described herein. Note that the sensor array 30 can, in one embodiment, include only one sensor. Note also that, where only one of a particular sensor is discussed below, it is appreciated that more than one of a particular type of sensor can be included, in the same or different locations within the catheter assembly.
As shown in
An ECG sensor 34, also referred to herein as an ECG electrode or electrical sensor, is also included with the catheter assembly to enable ECG signals emanating from the heart of the patient to be detected, in conjunction with an additional ECG sensor/electrode located on the patient's skin or external portion of the catheter assembly/proximate the catheter assembly, in one embodiment. As shown, in the present embodiment the ECG sensor 34 is also disposed within the hub 16 so as to be in direct contact with fluid present in the hub fluid passageway 26 and the lumen 14 of the catheter tube 12. Other ECG sensor locations can also be employed, including within the catheter tube 12, the extension leg 18, etc. In the present embodiment, the ECG sensor 34 includes a conductive wire that is able to detect ECG signals of the patient heart that are present in the fluid of the hub fluid passageway 26 and catheter tube lumen 14, though other types of ECG sensors can be employed. Further details regarding a system and method for using an ECG sensor for guiding the catheter assembly to a desired position within the body of a patient can be found in U.S. Pat. No. 8,849,382, entitled “Apparatus and Display Methods Relating to Intravascular Placement of a Catheter,” which is incorporated herein by reference in its entirety.
As described, the sensor array 30—including here the pressure sensor 32 and the ECG sensor 34—is disposed within the hub 16, which is sized to provide the needed volume for such sensors. Note that the size, shape, and configuration of the hub 16 can vary from what is shown and described in order to house the sensor(s). In other embodiments, the sensors can be located in other portions of the catheter 10, including along or at either end of the catheter tube 12, the extension leg(s) 18, etc. Also note that a variety of sensors for detecting body measurements, physiological aspects of the patient, and/or physical aspects of the catheter can be included with the catheter assembly, some of which are discussed further below.
In the present embodiment, the PCB 36 further includes a transmission module, such as a radio for enabling the PCB to transmit sensor data wirelessly to another receipt location, such as those referred to further above. Such wireless transmission can occur via Bluetooth, Wi-Fi, rF, near-field communication (“NFC”), GPS, ANT, ZigBee, or other manner utilizing electromagnetic radiation. In another embodiment, the sensor data can be transmitted from the catheter 10 via a physical connection, such as via a removable physical connection, wires, etc. In another embodiment and as mentioned, sensor data, e.g., central venous pressure, ECG signals, temperature, etc., are stored in a memory location included on the PCB 36, or other location on the catheter 10. In yet another embodiment, the PCB 36 includes a clock/timer circuit.
In the present embodiment of
In one embodiment, the securement device 50 includes additional functionality to provide power to the sensor array 30 and PCB 36. In detail, the securement device can include two posts, each of which is configured to serve as an electrical contact and each of which is operably connected with a battery, also included in the securement device. The posts are configured to be received within the corresponding suture holes 24 of the catheter suture wings 22 such that electrical contact is established with the electrical contacts 40 of the suture holes. The battery included on the securement device can, in this way, provide electrical power to the sensors 32, 34 and the PCB 36 of the catheter hub 16. Of course, other external power sources can be employed. In one embodiment, electrical contacts between the catheter and the securement device can also be utilized to transfer sensor data therebetween. In another embodiment, the securement device can include a radio or other mode for transmitting sensor data received from the catheter. In yet another embodiment, the PCB or a sensor can be included on the securement device. It is appreciated that the size, shape, and other configuration of the securement device can vary from what is shown and described herein. Further details regarding the catheter assembly 10 with one or more included sensors can be found in U.S. patent application Ser. No. 15/275,059, filed Sep. 23, 2016, and entitled “Catheter Assembly Including Monitoring Capabilities,” which is incorporated herein by reference in its entirety. Note that the principles discussed in the present disclosure can be employed in catheters and elongate tubular devices that include no sensor, or one or more sensors as may be appreciated.
Though shown in
Together with
It is thus appreciated that the lumen 14C is considered a terminating lumen as it extends from the proximal end 12A of the catheter tube 12 to the proximal end 300A of the reduced diameter portion 300, where it terminates at a closed, distal termination point, as seen in
As mentioned, the sensor 320 is placed in a distal portion of the terminating lumen 14C, as seen in
It is appreciated that in the present embodiment the terminating lumen 14C is isolated from fluids transported through the catheter tube 12 such that the sensor 320 is not in contact with such fluids. In other embodiments, however, fluids could be inserted into the lumen if desired, recognizing that no outlet exists for such fluids other than at the proximal portion of the catheter tube. Or a skive cut or other hole could be defined near the distal end of the terminating lumen in one embodiment to enable direct contact of the sensor with blood of the patient.
In yet another embodiment, the terminating lumen 14C could be extended in length and open near the distal end 12B of the catheter tube 12, extend proximally as a lumen, and terminate at a relatively more proximal portion of the catheter tube, effectively reversing the configuration shown in
Note that one or more of a variety of sensors can be included in the terminating lumen, including light-based sensors, glucose meters, blood oxygen sensors, SvO2 sensors, temperature sensors, pressure sensors, CVP sensors, lactic acid sensor, thermistors, etc. Note further that use of a terminating lumen as described herein obviates the use of potting to plug an otherwise patent lumen so a sensor could be placed therein. As such, the potential dislodgement of potting from the catheter tube lumen and entry into the vessel is avoided.
Note that the catheter assembly 10 of
It is appreciated that the catheter tube 12 and its lumen configuration as described above in connection with
Correspondingly, the lumen 14B as shown in
Reference is now made to
A sensor 320, such as those described further above, is disposed in a distal portion of the catheter tube 12 near a distal end 12B there. In the present embodiment, the sensor 320 is disposed in a pocket and is isolated from the lumens 14 so as to not be in fluid communication therewith, though in other embodiments it is appreciated that the sensor can be placed in fluid communication with one or more fluid-carrying lumens.
A sensor lumen 310 is also included and extends substantially the length of the catheter tube 12 so as to provide a route along which a sensor wire 324 can extend through the catheter tube to the sensor 320 disposed near the distal end 12B thereof. This enables the sensor 320 to be electrical powered and/or to provide a route by which data and/or measurements can be transmitted to outside the patient body. Note that the sensor wire 324 can extend past the proximal end 12A of the catheter tube 12 and include an appropriate connector to enable it to operably connect to a data measurement device or other suitable component, as may be appreciated.
Note that the catheter tube 12 including the distally placed sensor 320 shown in
Variations to the configuration of the catheter tube 12 as depicted in
The size, shape, location, and other configuration of the sensor lumen 310 can vary from that shown in
It is appreciated that placement and configuration of the integrated sensor wire locations and/or sensor lumen can be implemented in a variety of ways. In one embodiment, the sensor wires can be integrated with the septum 322 instead of the catheter tube wall 302. Also, more than one sensor wire or sensor lumen can be included to operably connect one or more sensors. The wire can include one or more wires, such as in a twisted pair configuration, for example. The number of fluid-carrying lumens can also vary in size, shape, number, etc., as can the size, placement, and configuration of the sensor lumen itself. In addition, note that the size, position, and type of sensors included with the catheter tube can vary from what is shown and described, as can the outlets of the fluid-carrying lumens.
Embodiments of the invention may be embodied in other specific forms without departing from the spirit of the present disclosure. The described embodiments are to be considered in all respects only as illustrative, not restrictive. The scope of the embodiments is, therefore, indicated by the appended claims rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.
Claims
1. A catheter assembly, comprising:
- an elongate catheter tube formed of a catheter tube material, the catheter tube defining at least one fluid-carrying lumen extending between a proximal end and a distal end of the catheter tube; and
- at least one terminating lumen defined by the catheter tube, the terminating lumen extending to a closed termination point positioned intermediately between the proximal and distal ends of the catheter tube, the termination point being defined by the catheter tube material, the terminating lumen configured to be isolated from fluids.
2. The catheter assembly as defined in claim 1, wherein the terminating lumen distally extends from a proximal end of the catheter tube.
3. The catheter assembly as defined in claim 1, wherein the catheter tube is configured to be inserted into a body of a patient.
4. The catheter assembly as defined in claim 3, wherein the termination point of the terminating lumen is disposed within the body of a patient when the catheter assembly is disposed within the body of the patient.
5. The catheter assembly as defined in claim 1, further comprising a sensor disposed in the terminating lumen.
6. The catheter assembly as defined in claim 5, wherein the sensor is disposed proximate the termination point of the terminating lumen.
7. The catheter assembly as defined in claim 5, wherein the sensor is at least one of a light-based sensor, a glucose meter, a blood oxygen sensor, a temperature sensor, and a thermistor.
8. The catheter assembly as defined in claim 5, further comprising at least one wire that extends along the terminating lumen configured to operably connect the sensor to an apparatus separate from the catheter assembly.
9. The catheter assembly as defined in claim 1, wherein an outer diameter of the catheter tube is reduced in size distal to the termination point of the terminating lumen.
10. The catheter assembly as defined in claim 1, wherein the catheter tube includes a plurality of fluid-carrying lumens.
11. The catheter assembly as defined in claim 10, wherein a cross-sectional size of at least one of the fluid-carrying lumens changes at a point distal to the termination point of the terminating lumen relative to a point proximal to the termination point of the terminating lumen.
12. The catheter assembly as defined in claim 10, wherein cross-sectional sizes of the fluid-carrying lumens remain substantially the same at a point distal to the termination point of the terminating lumen relative to a point proximal to the termination point of the terminating lumen.
13. The catheter assembly as defined in claim 1, wherein the terminating lumen includes an access port on a proximal portion of the catheter assembly.
14. A catheter assembly, comprising:
- an elongate catheter tube;
- at least one fluid-carrying lumen extending between a proximal end and a distal end of the catheter tube;
- at least one sensor disposed in a distal portion of the catheter tube, the at least one sensor configured to be isolated from fluids; and
- at least one sensor wire extending between a proximal portion of the catheter tube and the at least one sensor.
15. The catheter assembly as defined in claim 14, wherein the at least one sensor wire is disposed in a sensor lumen, the sensor lumen being centrally disposed in the catheter tube.
16. The catheter assembly as defined in claim 14, wherein the at least one sensor wire is disposed in a sensor lumen, the sensor lumen being disposed in an offset configuration in the catheter tube.
17. The catheter assembly as defined in claim 14, wherein the at least one fluid-carrying lumen includes a side hole opening proximate a distal end of the catheter tube, the at least one sensor disposed distal to the side hole opening.
18. The catheter assembly as defined in claim 14, wherein the catheter tube includes at least two fluid-carrying lumens, at least one of the fluid-carrying lumens including a side hole opening proximate a distal end of the catheter tube, the at least one sensor disposed distal to the side hole opening, at least one of the fluid-carrying lumens including a distal end opening at the distal end of the catheter tube.
19. The catheter assembly as defined in claim 14, wherein the sensor wire is integrated into at least one of a septum and a tube wall of the catheter tube.
20. A catheter assembly, comprising:
- an elongate catheter tube defining at least one fluid-carrying lumen extending between a proximal end and a distal end of the catheter tube;
- at least one terminating lumen defined by the catheter tube, the terminating lumen distally extending from a proximal portion of the catheter tube to a closed distal termination point positioned intermediately between the proximal and distal ends of the catheter tube, the terminating lumen configured to be isolated from fluids;
- a sensor disposed in the terminating lumen; and
- a sensor wire operably connected to the sensor.
21. The catheter assembly as defined in claim 20, wherein the sensor is disposed proximate the termination point of the terminating lumen.
22. The catheter assembly as defined in claim 21, wherein the terminating lumen distally extends from a proximal end of the catheter tube.
23. The catheter assembly as defined in claim 22, wherein the catheter tube is configured to be inserted into a body of a patient.
24. The catheter assembly as defined in claim 23, wherein the termination point of the terminating lumen is disposed within the body of a patient when the catheter assembly is disposed within the body of the patient.
25. The catheter assembly as defined in claim 23, wherein the sensor is at least one of a light-based sensor, a glucose meter, a blood oxygen sensor, a temperature sensor, and a thermistor.
26. The catheter assembly as defined in claim 20, wherein the at least one fluid-carrying lumen increases in cross-sectional size at a point distal to the termination point of the terminating lumen.
27. The catheter assembly as defined in claim 20, wherein an outer diameter of the catheter tube is reduced in size distal to the termination point of the terminating lumen.
28. The catheter assembly as defined in claim 20, wherein the catheter tube includes a plurality of fluid-carrying lumens.
29. The catheter assembly as defined in claim 28, wherein a cross-sectional size of at least one of the fluid-carrying lumens changes at a point distal to the termination point of the terminating lumen relative to a point proximal to the termination point of the terminating lumen.
30. The catheter assembly as defined in claim 28, wherein cross-sectional sizes of the fluid-carrying lumens remains substantially the same at a point distal to the termination point of the terminating lumen relative to a point proximal to the termination point of the terminating lumen.
31. The catheter assembly as defined in claim 20, wherein the sensor wire is disposed along an outer surface of the catheter tube.
32. The catheter assembly as defined in claim 31, wherein the sensor wire is covered by a cover material including at least one of a polyurethane film and a shrink material.
33. A method for manufacturing a catheter tube, the method comprising:
- extruding continuous tubing defining a plurality of lumens from an extrusion material along an extrusion pathway, the extrusion pathway including a plurality of extrusion pins;
- while extruding the continuous tubing, removing at least one of the extrusion pins from the extrusion pathway to reduce the number of lumens defined by the continuous tubing;
- altering at least one of a extrusion pull rate and an injection air pressure employed in extruding the continuous tubing after removal of the at least one extrusion pin; and
- cutting the continuous tubing to define the catheter tube, the catheter tube including at least one terminating lumen that terminates at an intermediate position between a proximal end and a distal end of the catheter tube.
Type: Application
Filed: Mar 24, 2017
Publication Date: Sep 28, 2017
Inventors: Gidon Ofek (Salt Lake City, UT), Blake Allen (South Jordan, UT), Todd P. McFarland (Herriman, UT)
Application Number: 15/469,225