Fiber optic compatible stylet

Abstract

The catheter placement system includes a catheter placement device having an elongate body configured for insertion into a catheter lumen, the elongate body including a body lumen. A compartment at the proximal end of the body is in fluid communication with the body lumen. Saline disposed in the compartment and the body lumen defines an electrical pathway along the elongate body and an electrode at the distal end of the elongate body. A stylet extends along the elongate body and includes a multi-core optical fiber extending along the stylet. The multi-core optical fiber includes several fiber Bragg gratings disposed along the optical fiber to enable shape sensing of the optical fiber. A system module optically and electrically coupled to the catheter placement device displays the shape of the elongate body and the ECG waveform.

Description

[Background technology]

[0001] Traditionally, intravascular navigation of medical devices, such as guidewires and catheters, has relied on fluoroscopy to track the tip of the medical device and determine whether the distal tip is properly positioned within the target anatomical structure. However, such fluoroscopy exposes patients and their physicians to harmful x-ray radiation. Additionally, in some cases, patients are exposed to potentially harmful contrast agents required for fluoroscopy.

[0002] More recently, electromagnetic tracking systems have been used with stylets. Generally, electromagnetic tracking systems feature three components: a magnetic field generator, a sensor unit, and a control unit. The magnetic field generator uses several coils to generate a position-varying magnetic field that is used to establish a coordinate space. The sensor unit, attached to the stylet, for example, near the distal end (tip) of the stylet, contains small coils in which a current is induced through the magnetic field. Based on the electrical properties of each coil, the position and orientation of the medical device can be determined within the coordinate space. The control unit controls the magnetic field generator and captures data from the sensor unit.

[0003] While electromagnetic tracking systems avoid reliance on line-of-sight for tracking the stylet tip while eliminating the radiation exposure and potentially harmful contrast agents associated with fluoroscopy, electromagnetic tracking systems are susceptible to interference. More specifically, because electromagnetic tracking systems rely on measuring magnetic fields generated by a magnetic field generator, these systems are subject to electromagnetic field interference, which may be caused by the presence of many different types of consumer electronic devices, such as cell phones. In addition, electromagnetic tracking systems are subject to signal loss, rely on external sensors, and are limited in depth range. U.S. Patent Application Publication No. 2013 / 0129994, entitled "BRAGG GRATED FIBER OPTIC FLUCTUATION SENSING AND MONITORING SYSTEM," which illustrates and describes a fiber optic sensing system and method, is incorporated herein by reference in its entirety.

[0004] Disclosed herein is a catheter placement system that utilizes fiber optic shape sensing and electrical signal monitoring to assist in the placement of catheters and specific placement of catheter tip placement. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] US Patent Application Publication No. 2022 / 0034733 Summary of the Invention

[0006] Disclosed herein is a catheter placement system including a catheter placement device, according to several embodiments. The catheter placement device includes an elongate body configured for insertion into a catheter lumen, the elongate body including a body lumen extending between a proximal end and a distal end. The catheter placement device includes a compartment coupled to the elongate body at the proximal end, the compartment being in fluid communication with the body lumen. Saline is disposed in the compartment and the body lumen. A stylet extends along the elongate body and includes a multi-core optical fiber extending along the stylet. The multi-core optical fiber includes several fiber Bragg gratings disposed along the length of the multi-core optical fiber.

[0007] In some embodiments, the catheter placement device is optically coupled to the system module. In some embodiments, a distal portion of the stylet is disposed within the body lumen.

[0008] In some embodiments, the stylet includes an elongated opening extending along the distal portion, the opening defining an additional cross-sectional area of ​​the body lumen. In some embodiments, the system module is configured to determine the shape of the stylet based on a reflected optical signal emitted from the fiber Bragg grating.

[0009] In some embodiments, the system module is further configured to display the image acquired by the fiber optic. In some embodiments, the system module is configured to determine one or more of a temperature of the optical fiber, a movement of the optical fiber, or a displacement of a fluid adjacent to the optical fiber based on a reflected optical signal emitted from the fiber Bragg grating.

[0010] In some embodiments, the saline solution is electrically coupled to the system module and the patient. In some embodiments, the stylet extends through the compartment, with a proximal portion of the stylet extending proximally away from the fluid compartment.

[0011] In some embodiments, the proximal portion of the stylet (i) is electrically conductive, (ii) is electrically coupled to the saline in the compartment, and (iii) is electrically coupled to the system module.

[0012] In some embodiments, the saline is electrically coupled to the system module via a wire, hi some embodiments, the wire extends from the sterile environment to the non-sterile environment through a sterile barrier.

[0013] In some embodiments, the catheter placement device further includes a fluid delivery device storing saline, the fluid delivery device being fluidly coupled to the compartment, hi some embodiments, the compartment includes a side port, and the fluid delivery device being fluidly coupled to the compartment via the side port.

[0014] In some embodiments, the system module is configured to display an electrocardiogram waveform, hi some embodiments, the system module is configured to identify a placement location of the distal end of the body within the patient's vasculature based on the electrocardiogram signal.

[0015] Also disclosed herein, according to some embodiments, is a method including inserting an elongate body of a catheter placement device into a lumen of a central catheter. The catheter placement device includes: (i) a body lumen extending along the elongate body; (ii) a compartment coupled to the elongate body at a proximal end thereof and in fluid communication with the body lumen; (iii) a saline solution disposed within the compartment and within the body lumen and defining an electrical pathway along the elongate body; and (iv) a stylet extending along the elongate body. The stylet includes a multi-core optical fiber extending along the stylet, the multi-core optical fiber including several fiber Bragg gratings disposed along the length of the multi-core optical fiber. In such embodiments, the catheter placement device is optically and electrically coupled to a catheter placement system module. The method further includes (i) advancing the central catheter along the patient's vasculature; (ii) determining a position of the central catheter within the patient's vasculature based on a shape of the multi-core optical fiber determined by an optical reflection signal emitted from the fiber Bragg grating; and (iv) determining a position of a distal end of the elongate body within the superior vena cava of the vasculature based on an electrocardiogram signal obtained from the patient via electrodes at the distal end.

[0016] In some embodiments of the method, saline within the body lumen adjacent the distal end defines an electrode. In some embodiments of the method, the stylet is disposed with the body lumen.

[0017] In some embodiments of the method, a syringe containing saline is fluidly coupled to the compartment. In some embodiments of the method, the saline is electrically coupled to the system module via a wire that extends through a sterile barrier between the sterile and non-sterile environments.

[0018] These and other features of the concepts provided herein will become more apparent to those skilled in the art upon consideration of the accompanying drawings and the following description, which describe in more detail certain embodiments of such concepts. [Brief explanation of the drawings]

[0019] [Figure 1] 1 illustrates a catheter placement system, according to some embodiments. [Figure 2] 2 shows an end view of a catheter placement device of the system of FIG. 1 according to some embodiments. [Figure 3A] 2 illustrates the catheter placement system of FIG. 1 in use on a patient, according to some embodiments. [Figure 3B] 2 shows a detailed view of a distal portion of the catheter placement device of FIG. 1 inserted into a patient's superior vena cava, according to some embodiments. [Figure 4] 1 shows a flowchart of an exemplary method for placing a catheter in a patient, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0020] Before some specific embodiments are disclosed in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein, and that the specific embodiments disclosed herein can have features that are easily separated from the specific embodiment and can be optionally combined with or substituted for features of any of several other embodiments disclosed herein.

[0021] With regard to the terms used herein, it should also be understood that the terms are intended to describe certain specific embodiments and do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps and do not impose sequential or numerical limitations. For example, "first," "second," and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. Designations such as "left," "right," "top," "bottom," "front," "back," etc. are used for convenience and are not intended to imply, for example, a specific fixed position, orientation, or direction. Instead, such designations are used to reflect, for example, a relative position, orientation, or direction. The singular forms "an," "a," and "the" include plural references unless the context clearly dictates otherwise. The singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0022] The phrases "connected to," "coupled with," and "in communication with" refer to any form of interaction between two or more entities, including, but not limited to, mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components may be coupled to one another even if they are not in direct contact with one another. For example, two components may be coupled to one another through an intermediate component.

[0023] The terms "proximal" and "distal" refer to opposite ends of a medical device, including the devices disclosed herein. As used herein, the proximal portion of a catheter placement device is the portion closest to the practitioner during use, while the distal portion is the portion at the opposite end. For example, the distal end of a catheter placement device is defined as the end closest to the patient during use of the catheter placement device. The proximal end is the end opposite the distal end.

[0024] The term "logic" may refer to hardware, firmware, or software configured to perform one or more functions. As hardware, the term logic may refer to or include circuitry having data processing and / or storage capabilities. Examples of such circuitry may include, but are not limited to or restricted to, a hardware processor (e.g., a microprocessor, one or more processor cores, a digital signal processor, a programmable gate array, a microcontroller, an application-specific integrated circuit "ASIC," etc.), semiconductor memory, or combinational elements.

[0025] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. Similar references are made throughout this specification, such as by use of the term "substantially." For each such reference, it is understood that in some embodiments, the value, feature, or characteristic may be specified without the similar. For example, when modifiers such as "about" and "approximately" are used, these terms include within their scope the modified word without the modifier. For example, when the term "substantially linear" is described with respect to a feature, it is understood that in further embodiments, the feature may be in a strictly linear configuration.

[0026] Any method disclosed herein comprises one or more steps or actions for performing the described method. Method steps and / or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of an embodiment, the order and / or use of specific steps and / or actions may be modified.

[0027] 1 generally illustrates a catheter placement system configured to assist a clinician during placement of a catheter within a patient's vasculature. More specifically, catheter placement system (system) 100 can (i) assist a clinician during advancement of a catheter along the vasculature and (ii) assist a clinician during placement of a distal tip of the catheter within the vasculature, such as within the superior vena cava. System 100 generally includes a catheter placement device 120 coupled to a system module 110 that includes a display 111.

[0028] In some instances, system 100 may be deployed in conjunction with a sterile environment. Thus, portions of system 100 (e.g., catheter placement device 120) may be deployed within sterile environment 51, while other portions (e.g., system module 110) may be deployed within non-sterile environment 52, i.e., outside of sterile environment 51. In some examples, a sterile barrier 50 can separate sterile environment 51 from non-sterile environment 52. In some examples, sterile barrier 50 may include a fabric panel, such as, for example, a drape. Some components of system 100 may extend through sterile barrier 50.

[0029] The catheter placement device 120 includes an elongate body 125 configured for placement within a catheter lumen, such as the lumen of a central catheter, such as a central venous catheter (CVC) or a peripherally inserted central catheter (PICC). The elongate body 125 may have a length sufficient to extend between the distal tip of the catheter and the extension leg hub of the catheter. In other words, during use, the body distal end 125B may be positioned adjacent the distal tip of the catheter, while the body proximal end 125A may be positioned proximal to the extension leg hub of the catheter. The elongate body 125 includes a body lumen 124 extending along the length of the elongate body 125.

[0030] Catheter placement device 120 further includes a compartment 126 coupled to elongate body at body proximal end 125A, whereby compartment 126 is in fluid communication with body lumen 124. Saline solution 140 is disposed within compartment 126 and body lumen 124. Saline solution 140 within body lumen 124 defines an electrical pathway 141 extending between body distal end 125B and compartment 126. Body lumen 124 is open at body distal end 125B to allow saline solution 140 to directly and electrically contact the patient. More specifically, saline solution 140 adjacent body distal end 125B defines a saline electrode 142. Saline electrode 152 is configured to acquire electrical signals, such as electrocardiogram signals, from the patient.

[0031] The catheter placement device 120 includes a fluid delivery device 150, such as a syringe. The fluid delivery device 150 stores saline solution 140. The fluid delivery device 150 is fluidly coupled to the compartment 126. In some embodiments, the fluid delivery device 150 may be coupled to the compartment 126 via a tube 155 that is coupled to a side port 127 of the compartment 126. During use, the fluid delivery device 150 may be provided with saline solution 140 therein. The fluid delivery device 150 may then be coupled to the compartment 126, and the fluid delivery device 150 may dispense the saline solution 140 into the compartment 126 and along the body lumen 124.

[0032] The catheter placement device 120 further includes a stylet 130 extending along the elongate body 125. In the illustrated embodiment, the stylet 130 is disposed within the body lumen 124. However, in other embodiments, the stylet 130 may extend along the exterior of the elongate body 125, or the stylet 130 may be disposed within a different lumen (not shown). The stylet 130 defines (i) a proximal portion 130C extending between the stylet proximal end 130A and the compartment 126, and (ii) a distal portion 130D extending between the compartment 126 and the stylet distal end 130B. In some embodiments, the stylet distal end 130B may be disposed adjacent to the body distal end 125B. In the illustrated embodiment, the stylet 130 is generally not electrically conductive. Accordingly, the stylet 130 may be formed of a non-conductive polymeric material. In some embodiments, distal portion 130D may have a greater stiffness than proximal portion 130C. When distal portion 130D is positioned along elongate body 125 and the catheter, the stiffer distal portion 130D may assist the clinician during advancement of the catheter through the vasculature. Because proximal portion 130C is generally positioned outside elongate body 125, the greater flexibility of proximal portion 130C allows the clinician to more easily manipulate the catheter during advancement.

[0033] The stylet 130 extends through an end wall 126A of the compartment 126. In the illustrated embodiment, the compartment 126 includes a coupling member 128 configured to sealably couple the stylet 130 to the compartment 126. The coupling member 128 includes an opening 128A through which the stylet 130 is disposed. In some embodiments, the coupling member 128 may couple the stylet 130 to the compartment 126 in a manner that prevents longitudinal displacement of the stylet 130 relative to the compartment 126, including the elongate body 125. In other embodiments, the coupling member 128 may couple the stylet 130 to the compartment 126 in a manner that allows slidable displacement of the stylet 130 relative to the compartment 126. In some embodiments, the coupling member 128 may include an elastomeric septum, and the opening 128A may be a slit extending through the septum.

[0034] In the illustrated embodiment, catheter placement device 120 includes wire 145 extending between compartment 126 and system module 110. Wire electrode 146 electrically couples wire 145 to saline 140 within compartment 126. In summary, during use, the patient's anatomy adjacent body distal end 125B is electrically coupled to system module 110 via saline 142, saline 140 along body lumen 124, saline 140 within compartment 126, wire electrode 146, and wire 145. In some instances, wire 145 may extend through sterile barrier 50.

[0035] The stylet includes an optical fiber 135 extending along the stylet 130. The optical fiber 135 is a multi-core optical fiber including a plurality of fiber Bragg gratings 136 arranged along the length of the optical fiber 135. The optical fiber 135 is configured to enable shape sensing of the optical fiber 135 based on reflected optical signals emitted (i.e., reflected) from the fiber Bragg gratings 136. When the optical fiber 135 extends along the stylet 130, when the stylet 130 extends along the elongated body 125, and when the elongated body 125 is disposed within a lumen of the catheter, the optical fiber 135 enables sensing of the shape of the catheter.

[0036] In some embodiments, the fiber Bragg grating 136 may be configured to define an optical reflection signal based on a condition of the optical fiber 135, such as, for example, the temperature of the optical fiber 135, movement of the optical fiber 135, or displacement of a fluid adjacent to the optical fiber 135, such as due to the Doppler effect. Although not shown, in some embodiments, the optical fiber 135 may extend distally beyond the stylet distal tip 130B.

[0037] In some embodiments, optical fiber 135 may be configured to project illumination light from stylet distal tip 130B and receive imaging light that enters optical fiber 135 at stylet distal tip 130B. Thus, optical fiber 135 can acquire images of the patient's anatomy adjacent stylet distal tip 130B during use.

[0038] In the illustrated embodiment, the optical fiber 135 extends away from the proximal portion 130C of the stylet 130 so that the optical fiber 135 can be optically coupled to the system module 110, for example, via an optical connection member (not shown). In some cases, the optical fiber 135 or the optical connection member may extend through the sterility barrier 50.

[0039] The system module 110 is operably coupled to the catheter placement device 120. More specifically, the system module 110 is (i) optically coupled to the optical fiber 135 and (ii) electrically coupled to the saline solution 140. In the illustrated embodiment, the system module 110 is configured to provide information regarding catheter placement to a clinician, such as displaying information and / or images (i.e., representing images or information on the display 111). The system module 110 may include a console having several processors and logic stored in memory (e.g., a non-transitory computer-readable medium). The logic, when executed by the processor, governs the operation of the system module 110. The system module 110 further includes a light source and an optical receiver.

[0040] System module 110 is configured to (i) identify a shape 115 of optical fiber 135 based on the reflected optical signal emitted from fiber Bragg grating 136, where shape 115 represents the shape of the catheter, and (ii) display shape 115, i.e., display an image of shape 115 on display 111. In some embodiments, system module 110 can display shape 115 in real time during advancement of the catheter along the vasculature to assist a clinician in catheter placement.

[0041] The system module 110 is configured to receive an electrical signal from the catheter placement device 120. In some instances, the electrical signal originates from a patient, such as, for example, an electrocardiogram (ECG) signal. In some embodiments, the system module 110 may display an ECG waveform 116. In some examples, the ECG waveform 116 may vary according to the position of the body distal tip 125B within the vasculature, such as within the superior vena cava. In some embodiments, logic may compare the ECG waveform 116 to ECG waveforms stored in memory, which are consistent with the placement of the body distal tip 125B within the lower third of the superior vena cava. As a result of the comparison, the logic may determine that the body distal tip 125B is located within the lower third of the superior vena cava. Generally speaking, the system module 110 may be configured to identify the placement location of the body distal tip 125B (and, associated, the distal tip of the catheter) within the patient's vasculature based on the ECG signal.

[0042] According to another embodiment, the proximal portion 130C of the stylet 130 may be electrically conductive and define an electrical pathway within the wire 145 and the wire electrode 146. In such an embodiment, the optical fiber 135 and / or optical connecting member may include a conductive element 137 extending therealong. The conductive element 137 may be electrically coupled to the proximal portion 130C and extend between the proximal portion 130C and the system module 110. In summary, during use, the patient's anatomy adjacent the body distal end 125B is electrically coupled to the system module 110 via the saline solution 142, the saline solution 140 along the body lumen 124, the saline solution 140 in the compartment 126, the proximal portion 130C, and the conductive element 137.

[0043] 2 is a distal end view of elongate body 125, including an end view of distal portion 130D of stylet 130. To maximize the cross-sectional area of ​​body lumen 124, distal portion 130D may include elongate openings 131 (i.e., grooves or slots) extending along distal portion 130D. Thus, the cross-sectional area of ​​elongate openings 131 adds to the annular cross-sectional area of ​​lumen 124.

[0044] FIG. 3A shows the system 100 in use with a patient 300. A catheter 360 (e.g., a PICC in the illustrated example) is advanced along the vasculature of the patient 300. The elongated body 125 of the catheter placement device 120 is inserted into the lumen of the catheter 360 via the hub 362 of the extension leg of the catheter 360. The body distal end 125B is positioned adjacent to the distal tip 361 of the catheter 360. The fluid delivery device 150 stores saline solution 140, which is dispensed into the compartment 126 and along the lumen 124 ( FIG. 1 ). A sterile barrier 50 is positioned between the system module 110 and the catheter placement device 120, and the optical fiber 135 and wire 145 pass through the sterile barrier 50. The system module 110 displays an image of the shape 115 on the display 111.

[0045] 3B, a detailed view of the distal portion of elongate body 125 is shown, with body distal end 125B and distal tip 361 of catheter 360 positioned within superior vena cava 304, according to some embodiments. Also shown is system module 110, including display 111. FIG. 3B shows a detailed perspective view of the vasculature proximate to heart 303 of patient 300, as well as the anatomical structure of heart 303. Saline electrodes 142 are positioned within superior vena cava 304 to acquire ECG signals from heart 303. A waveform 116 of the ECG signal is depicted on display 111.

[0046] 4 shows a flowchart of an exemplary method for placing a central catheter within a patient's body, which may include all or any subset of the following steps, actions, or processes. Method 400 may include inserting an elongate body of a catheter placement device into a lumen of the central catheter (block 410). The catheter placement device is optically and electrically coupled to a catheter placement system module.

[0047] According to method 400, a catheter placement device includes a body lumen extending along an elongate body and a compartment coupled to the elongate body at a proximal end of the elongate body, the compartment being in fluid communication with the body lumen. Saline is disposed in the compartment and the body such that the saline defines an electrical pathway along the elongate body. In some embodiments of method 400, a syringe containing saline is fluidly coupled to the compartment. In some embodiments of method 400, the saline in the body lumen adjacent the distal end defines an electrode. In some embodiments of method 400, the saline is electrically coupled to a system module via a wire. The wire extends through a sterile barrier between a sterile environment and a non-sterile environment.

[0048] The stylet extends along the elongate body, and the stylet includes a multi-core optical fiber extending along the stylet. The multi-core optical fiber includes several fiber Bragg gratings disposed along the length of the multi-core optical fiber. In some embodiments of method 400, the stylet is disposed within the body lumen.

[0049] The method 400 further includes advancing the central catheter along the patient's vasculature (block 420). The method 400 may further include determining a position of the central catheter within the patient's vasculature based on a shape of the multi-core optical fiber (block 430). The shape is determined by optical reflection signals emitted from the fiber Bragg grating. The method 400 may further include determining a position of a distal end of the elongate body within the superior vena cava based on electrocardiogram signals obtained from the patient via saline electrodes at the distal end (block 440).

[0050] Although some specific embodiments have been disclosed herein, and the specific embodiments have been disclosed in some detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications may be apparent to those skilled in the art, and the broader aspects encompass these adaptations and / or modifications as well. Thus, departures may be made from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. 1. A catheter placement system comprising: a catheter placement device, the catheter placement device comprising: an elongate body configured for insertion into a catheter lumen, the elongate body including a body lumen extending between a proximal body end and a distal body end; a compartment coupled to the elongate body at the body proximal end, the compartment being in fluid communication with the body lumen; a saline solution disposed within the compartment and the body lumen; a stylet extending along the elongate body, the stylet including a multi-core optical fiber extending along the stylet, the multi-core optical fiber including several fiber Bragg gratings arranged along a length of the multi-core optical fiber.

2. The system of claim 1 , wherein a distal portion of the stylet is disposed within the body lumen.

3. The system of claim 2 , wherein the stylet includes an elongated opening extending along the distal portion, the opening defining an additional cross-sectional area of ​​the body lumen.

4. The system of any one of claims 1 to 3, wherein the catheter placement device is optically coupled to a system module.

5. The system of claim 4 , wherein the system module is configured to identify a shape of the stylet based on a reflected optical signal emitted from the fiber Bragg grating.

6. The system of claim 5 , wherein the system module is configured to display the shape.

7. The system of claim 4 , wherein the system module is further configured to display an image acquired by the optical fiber.

8. The system module determines, based on the reflected optical signal emitted from the fiber Bragg grating, the temperature of the optical fiber; movement of the optical fiber; or a displacement of a fluid adjacent to the optical fiber.

9. The system of claim 4 , wherein the saline solution is electrically coupled to the system module and the patient.

10. The system of claim 9 , wherein the saline solution is electrically coupled to the system module via a wire.

11. The system of claim 10 , wherein the wire extends through a sterile barrier between a sterile environment and a non-sterile environment.

12. 10. The system of claim 9, wherein the system module is configured to identify the patient's electrocardiogram signal and display an electrocardiogram waveform.

13. The system of claim 12 , wherein the system module is configured to determine a placement location of the body distal end within the patient's vasculature based on the electrocardiogram signal.

14. the stylet extends through the compartment; The system of any preceding claim, wherein a proximal portion of the stylet extends proximally away from the fluid compartment.

15. The proximal portion of the stylet is It is conductive, electrically coupled to the saline solution in the compartment; The system of claim 14 electrically coupled to the system module.

16. The system of any one of claims 1 to 15, wherein the catheter placement device further comprises a fluid delivery device storing the saline solution, the fluid delivery device being fluidly coupled to the compartment.

17. the compartment includes a side port; The system of claim 16 , wherein the fluid delivery device is fluidly coupled to the compartment through the side port.

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