Cardiac treatment systems, methods, and devices using multiple pressure measuring catheters
Patent Information
- Application Number
- JP2024550625
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-02-24
- Filing Date
- 2023-02-22
- Publication Date
- 2025-03-13
Smart Images
Figure 2025506846000001_ABST
Abstract
Description
[Technical field]
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 313,700, filed February 24, 2022, and entitled “SYSTEMS, METHODS, AND DEVICES FOR CARDIAC DIAGNOSTICS WITH A DUAL LUMEN CATHETER,” which is incorporated by reference in its entirety.
[0002] 1. Field FIELD OF THE DISCLOSURE The present disclosure relates generally to devices for performing cardiac diagnostics. In at least one example, the present disclosure relates to a system including a catheter for transvalvular pressure measurement. [Background technology]
[0003] 2. Discussion of Related Technology In approximately half of cases of symptomatic aortic stenosis (i.e., narrowing of the aortic valve), there is ambiguity regarding the severity of the valve condition. In such cases, accurate diagnosis requires direct transvalvular pressure measurement by invasive cardiac catheterization. This involves simultaneously measuring pressure proximal and distal to the aortic valve. Some devices are capable of obtaining pressure measurements. However, such devices may require an additional step with an initial separate catheter / wire to advance through the aortic valve. Other devices, such as the Miller solid-state catheter, are large and require a significant capital investment to purchase a digital console and catheter, making this device less of a priority for clinical use. Additionally, these larger and more complex catheters are often difficult to advance through the aortic valve, so additional wires and steering catheters are typically used first to get the intended catheter through the aortic valve.
[0004] In current practice, there are several "workarounds" for obtaining simultaneous trans-aortic pressure measurements, for example, by performing an additional arterial puncture for use with a separate catheter. However, measurements obtained from these techniques may be inaccurate and may raise additional safety concerns due to the increased risk of bleeding and vascular injury associated with performing an extra arterial puncture.
[0005] It is with these observations, among others, in mind that the various aspects of the present disclosure have been conceived and developed. Summary of the Invention
[0006] The presently disclosed technology addresses the aforementioned problems by providing a multi-function diagnostic catheter, which may include a catheter with a pressure measurement device operable to perform coronary angiograms and pass through the aortic valve to measure transvalvular pressure gradients. The pressure measurement device may include a central pressure measurement path disposed at least partially within the catheter, the central pressure measurement path terminating in a first hub for connecting an end hole of the central pressure measurement path to a pressure transducer, and / or an outer pressure measurement path having a first portion disposed within the catheter and a second portion disposed outside the catheter, the second portion terminating in a second hub for connecting a side hole of the outer pressure measurement path to a pressure transducer, the side hole being located on a side of the catheter spaced a defined distance from an end of the catheter.
[0007] In some examples, the outer pressure measurement path is a pressure channel disposed within the interior material forming the central pressure measurement path. The distal tip can have a first inner diameter that is larger than an inner diameter of the central pressure measurement path. Additionally, the distal tip can be formed of a soft material. The prescribed distance can be a first prescribed distance, and / or the catheter can include a first radiopaque marker at an end hole of the central pressure measurement path and a second radiopaque marker around a side of the catheter spaced a second prescribed distance from the first radiopaque marker.
[0008] In some scenarios, the pressure measurement device is operable to measure left ventricular pressure using an end hole of the central pressure measurement path while measuring aortic pressure using a side hole of the outer pressure measurement path. The measurement of left ventricular pressure and aortic pressure can use two analog signals generated by two pressure transducers while eliminating the reliance on a digital-based pressure sensor console system. Also, the central pressure measurement path may be operable to receive a guidewire for passing through the aortic valve, and / or the guidewire may be removable from the central pressure measurement path once passing through the aortic valve while maintaining the central pressure path in the left ventricle. Additionally or alternatively, the central pressure measurement path is operable to inject contrast agent before passing through the aortic valve to perform selective coronary angiography. Furthermore, a first portion of the multi-function diagnostic catheter including the central pressure measurement path with the outer pressure measurement path can have a first inner diameter, and / or a second portion of the multi-function diagnostic catheter including the central pressure measurement path and omitting the outer pressure measurement path can have a second inner diameter larger than the first inner diameter.
[0009] In some examples, a multi-function diagnostic catheter may include a catheter with a multi-pressure channel device operable to perform coronary angiograms, pass through an aortic valve, and measure transvalvular pressure gradients. The multi-pressure channel device may include a central pressure measurement path disposed at least partially within the catheter. The central pressure measurement path may terminate in a first hub for connecting a distal end hole of the central pressure measurement path to one or more pressure transducers, and / or one or more outer pressure measurement paths are formed within a sidewall material of the central pressure measurement path. The one or more outer pressure measurement paths may terminate in a second hub for connecting one or more side holes of the one or more outer pressure measurement paths to one or more pressure transducers, the one or more side holes being located on a side of the catheter spaced one or more defined distances from an end of the catheter.
[0010] In some scenarios, the one or more side holes include at least three side holes in a staggered arrangement around the catheter. Additionally, the one or more outer pressure measurement paths may include at least three elongated elliptical channels. The multifunction diagnostic catheter may be a seven French (7Fr) catheter or a six French (6Fr) catheter. The multifunction diagnostic catheter may further include a first inner diameter at a mid-shaft portion of the multifunction diagnostic catheter extending from a proximal portion of the multifunction diagnostic catheter to a proximal-distal portion of the multifunction diagnostic catheter, and / or a second inner diameter at a distal portion of the multifunction diagnostic catheter, the second inner diameter being larger than the first inner diameter. By way of example, the central pressure measurement path may be operable to pass through a stenosed aortic valve using a guidewire disposed within the central pressure measurement path. Additionally, the multifunction diagnostic catheter may be operable to measure left ventricular pressure using a distal end hole of the central pressure measurement path while measuring aortic pressure using one or more side holes of the one or more outer pressure measurement paths as the guidewire is passed through the stenosed aortic valve.
[0011] In some examples, a method of performing multiple diagnostic functions using a catheter with a multiple pressure measurement path device can include measuring left ventricular pressure using an end hole of a central pressure measurement path, the central pressure measurement path being disposed at least partially within the catheter and terminating at a first hub for connecting the end hole of the central pressure measurement path to a pressure transducer, the end hole of the central pressure measurement path being located at a distal end of the catheter. The method can include measuring aortic pressure using one or more end holes of one or more outer pressure measurement paths, the one or more outer pressure measurement paths being disposed within the catheter and terminating at a second hub for connecting the one or more end holes of the one or more outer pressure measurement paths to a pressure transducer, the one or more end holes being located along an outer sidewall of the catheter spaced one or more predetermined distances from the end hole of the central pressure measurement path.
[0012] In some scenarios, measuring the left ventricular pressure and the aortic pressure is performed using three or more side holes to measure the transvalvular pressure gradient while eliminating reliance on a pressure sensor console system. The method may further include performing a first pass through the aortic valve with the central pressure measurement path using a guidewire disposed within the central pressure measurement path. Additionally, the method may include injecting contrast into the coronary artery using the central pressure measurement path before or after measuring the transvalvular pressure gradient using the central pressure measurement path and the three or more side pressure measurement paths.
[0013] The above is intended to be illustrative and not limiting. Many features of the embodiments can be employed with or without reference to other features of any of the embodiments. Additional aspects, advantages, and / or utilities of the techniques of the present disclosure will be set forth in part in the following description, and in part will be apparent from the description, or may be learned by practice of the techniques of the present disclosure.
[0014] The above summary and the following detailed description will be better understood when read in conjunction with the accompanying drawings. For purposes of illustration, certain embodiments of the disclosed subject matter are shown in the drawings. It should be understood, however, that the disclosed subject matter is not limited to the precise embodiments and features shown. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate implementations of systems and methods consistent with the disclosed subject matter and, together with the description, serve to explain advantages and principles consistent with the disclosed subject matter. [Brief description of the drawings]
[0015] [Figure 1] 1 illustrates an exemplary system for performing a cardiac procedure using a multi-function catheter. [Diagram 2] 2 illustrates an exemplary system for performing a cardiac procedure using a multi-function catheter with a first hub and a second hub, which may form at least a portion of the system illustrated in FIG. 1. [Diagram 3]2 illustrates an exemplary system for performing a cardiac procedure using a multi-function catheter with a welded tip and radiopaque markers, which may form at least a portion of the system illustrated in FIG. 1. [Figure 4] 2 illustrates an exemplary system for performing a cardiac procedure using a multi-function catheter with a central lumen and an outer lumen, which may form at least a portion of the system illustrated in FIG. 1. [Diagram 5] 2 illustrates an exemplary system for performing a cardiac procedure using a multi-function catheter with a guidewire for passing through the aortic valve, which may form at least a portion of the system illustrated in FIG. 1. [Figure 6] 2 illustrates an exemplary method for performing a cardiac procedure using a multi-function catheter with a multi-lumen device that may be performed by at least the system illustrated in FIG. 1. [Figure 7A] 2 illustrates an exemplary system for performing a cardiac procedure using a multi-function catheter with a multi-lumen device, which may form at least a portion of the system illustrated in FIG. 1. [Figure 7B] 2 illustrates an exemplary system for performing a cardiac procedure using a multi-function catheter with a multi-pressure channel device, which may form at least a portion of the system illustrated in FIG. 1. [Figure 8] 2 illustrates an exemplary system for performing a cardiac procedure using a multi-function catheter having a distal section, a mid-shaft section, and a tapered tip, which may form at least a portion of the system illustrated in FIG. 1. [Figure 9] An exemplary system and method for performing cardiac entry surgery, cardiac diagnosis, and / or cardiac treatment using a multi-function catheter with a guidewire for passing through the aortic valve is shown, which can be performed by at least the system shown in FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0016] It will be understood that for simplicity and clarity of description, reference numerals have been repeated among different figures, where necessary, to indicate corresponding or similar elements. Furthermore, numerous specific details have been described to provide a thorough understanding of the embodiments described herein. However, those skilled in the art will understand that the embodiments described herein may be practiced without these specific details. In other instances, methods, procedures, and components have not been described in detail so as not to obscure the relevant features being described. Additionally, this description should not be considered as limiting the scope of the embodiments described herein. The drawings are not necessarily to scale, and the proportions of certain parts may be exaggerated to better show the details and features of the present disclosure.
[0017] I. Terminology The phraseology and terminology used herein are for the purpose of description and should not be considered as limiting. For example, the use of singular terms such as "a" is not intended to limit the number of items. Also, the use of relative terms such as, but not limited to, "top", "bottom", "left", "right", "upper", "lower", "down", "up" and "side" are used for clarity of description, with specific reference to the drawings, and are not intended to limit the scope of the technology of the present disclosure or the scope of the appended claims. Furthermore, it should be understood that any one of the features of the technology of the present disclosure may be used separately or in combination with other features. Other systems, methods, features, and advantages of the technology of the present disclosure will be or become apparent to one of ordinary skill in the art upon examination of the drawings and detailed description. All such additional systems, methods, features, and advantages are intended to be included in this description, be within the scope of the technology of the present disclosure, and be protected by the appended claims.
[0018] Furthermore, since the technology of the present disclosure is susceptible to embodiment in many different forms, the present disclosure is considered as an example of the principles of the technology of the present disclosure, and is not intended to limit the technology of the present disclosure to the specific embodiment shown and described. Any one of the features of the technology of the present disclosure can be used separately or in combination with any other feature. Reference to "embodiment", "embodiments", and / or similar terms in the description means that the referenced feature and / or features are included in at least one aspect of the description. Separate references to "embodiment", "embodiments", and / or similar terms in the description do not necessarily refer to the same embodiment, and are not mutually exclusive, unless so specified and / or readily apparent to one of ordinary skill in the art from the description. For example, features, structures, processes, steps, operations, etc. described in one embodiment may be included in other embodiments, but are not necessarily included. Thus, the technology of the present disclosure can include various combinations and / or integrations of the embodiments described herein. Moreover, not all aspects of the disclosure described herein are essential for its practice. Similarly, other systems, methods, features, and advantages of the disclosed technology will be, or will become, apparent to one of ordinary skill in the art upon examination of the drawings and description. It is intended that all such additional systems, methods, features, and advantages be included within this description, be within the scope of the disclosed technology, and be encompassed by the claims.
[0019] Any term expressing a degree, such as "substantially" as used in the specification and the appended claims, should be understood to include, but not be limited to, an exact configuration or a similar but non-exact configuration. For example, "substantially planar" means having an exact plane or a similar but non-exact plane. Similarly, the term "about" or "approximately" as used in the specification and the appended claims should be understood to include the stated value or a value that is three times or one-third of the stated value. For example, about 3 mm includes all values from 1 mm to 9 mm, and about 50 degrees includes all values from 16.6 degrees to 150 degrees.
[0020] The term "coupled" is defined as connected, whether directly or indirectly through intervening components, and is not necessarily limited to a physical connection. The connection may be such that the objects are permanently connected or releasably connected. The terms "comprising," "including," and "having" are used interchangeably in this disclosure. The terms "comprising," "including," and "having" mean including, but are not necessarily limited to, what is so described. The term "real-time" or "real time" means substantially instantaneous.
[0021] Finally, the terms "or" and "and / or" as used herein are to be construed as being inclusive or meaning any one or any combination. Thus, "A, B or C" or "A, B and / or C" means any of "A", "B", or "C", "A and B", "A and C", "B and C", "A, B and C". Exceptions to this definition occur only when combinations of elements, features, steps or acts are in some way inherently mutually exclusive.
[0022] II. General Architecture The system disclosed herein improves upon previous technology by providing a multi-function catheter with a dual lumen device. The dual lumen device makes the multi-function catheter a cost-effective, easy-to-use, and reliable device for passing (across) the aortic valve and measuring the transvalvular pressure gradient. Additionally, the multi-function catheter can incorporate selective coronary infusion procedures into the current workflow for cardiac catheterization. Some examples of the multi-function catheters disclosed herein do not require a high pressure system, avoiding design issues that may create safety concerns with previous catheter designs. Additionally, unlike the Langston catheter, which must first pass the valve with another catheter and then be replaced with the Langston catheter, the multi-function catheter is operable to facilitate passing the aortic valve even when the aortic valve is narrowed (e.g., stenotic). Additionally, unlike the Miller catheter, some examples of the multi-function catheters disclosed herein do not require the purchase of a digital console for hemodynamic assessment. Rather, a more simplified and more efficient approach utilizes an analog pressure signal measured by a pressure transducer.
[0023] In some examples, the multifunction catheter includes one or more pressure measurement paths to provide pressure measurements to the transducer in addition to those provided by the central pressure path. For example, a dual lumen or multi-lumen device of the multifunction catheter includes a central lumen formed by an inner lumen and an outer lumen formed by an exterior. The central lumen has a first end hole that terminates at the distal end of the multifunction catheter, and the first end hole is connected to one or more pressure transducers via a first hub. The outer lumen has a second end hole as a side hole. For example, a lumen channel can be formed on the inner surface of the outer tube to define an outer lumen that terminates at a side of the catheter along the length of the multifunction catheter. When the distal end passes through the aortic valve, the first end hole is positioned in the left ventricle and the second end hole is positioned in the aorta. Thus, the transvalvular pressure gradient can be measured by determining a first pressure value corresponding to the aortic pressure and a second pressure value corresponding to the left ventricular pressure using one or more pressure transducers.
[0024] Additionally, a welded tip can be coupled to and / or define the distal end of the multi-function catheter to maintain a consistent diameter for the distal end. The welded tip can be a rigid material that, along with the consistent diameter, improves the ability to navigate the distal end through the aortic valve and / or achieve a desired positioning. Multiple radiopaque markers can identify different portions of the multi-function catheter to further aid in positioning the lumen end holes at various locations within the heart and / or through the aortic valve. Thus, the multi-function catheter can be used to perform multiple diagnostic procedures, such as coronary angiograms and transvalvular pressure gradient measurements, without relying on additional catheters or digital console systems.
[0025] Additionally, or alternatively, the multi-function catheter can include a multi-pressure channel device. The multi-pressure channel device can include one or more (e.g., three or more) pressure channels formed within the interior material of a central lumen or channel. The pressure channels can have an elongated oval profile and can include three or more pressure channels terminating in side holes arranged helically around the catheter.
[0026] Further advantages discussed herein will become apparent from the detailed description that follows.
[0027] 1 illustrates an exemplary system 100 for performing a cardiac diagnostic procedure using a multifunction diagnostic catheter 102. The multifunction diagnostic catheter 102 may include a catheter 104 (e.g., the body or outer sheath of the multifunction diagnostic catheter 102) having one or more fluid paths for measuring pressure, such as a multi-pressure channel device 105 and / or a dual lumen device 106 for performing coronary angiograms, passing through the aortic valve, and measuring transvalvular pressure gradients, as discussed in more detail below.
[0028] In some examples, the dual lumen device 106 includes a central lumen 108 that is at least partially disposed within the catheter 104, extends the length of the catheter 104, and terminates in a first hub 110 for connecting a first end hole 112 of the central lumen 108 to one or more pressure transducers 114. The first end hole 112 of the central lumen 108 can define an end hole of the catheter 104 at a distal end 116 of the catheter 104. The central lumen 108 can include a central tube or flexible pipe, such as a braided tube (as discussed in more detail below with respect to FIG. 3). The catheter 104 can also include an outer lumen 118 that is at least partially disposed within the catheter 104. The outer lumen 118 can be formed by an outer portion or outer tube 120 of the multifunction diagnostic catheter 102, with one or more interstices or lumen channels 122 disposed on an inner surface of the outer tube 120. Additionally or alternatively, the outer lumen 118 can be formed from a separate inner tube that extends within the catheter 104, at least partially across the length of the catheter 104, and is adjacent to the central lumen 108. The outer lumen 118 can terminate in a second hub 124 (e.g., separate from the first hub 110) for connecting an end hole of the outer lumen 118 (e.g., a second end hole 126 of the dual lumen device 106) to one or more pressure transducers 114. In some examples, the catheter 104 can be a 6 French catheter.
[0029] In some examples, the multifunction diagnostic catheter 102 with the dual lumen device 106 is operable to perform various diagnostic procedures on a patient's heart 128. For example, the multifunction diagnostic catheter 102 may include a welded tip 130 having a specific design that facilitates performing coronary angiograms and passing through an aortic valve 132 without relying on a second catheter, as discussed in more detail below. Once through the aortic valve 132 (e.g., as discussed in more detail below with respect to FIG. 5), the first end hole 112 of the central lumen 108 may be positioned within the left ventricle 134 with the second end hole 126 (e.g., a side hole) of the outer lumen 118 positioned in the aorta 136 above the aortic valve 132. In this transvalvular position, a first pressure corresponding to the left ventricle 134 can be measured by the central lumen 108 and first end hole 112 using one or more pressure transducers 114, and a second pressure corresponding to the aorta 136 can be measured by the outer lumen 118 using the second end hole 126. Thus, the multifunction diagnostic catheter 102 can perform coronary angiograms and transvalvular pressure gradient measurements without the need to remove the multifunction diagnostic catheter 102 from the patient between these operations. Any of the lumen functions or arrangements discussed herein can be performed by or applied to one or more pressure channels or pathways formed in the inner wall material of the central lumen 108, such as the inner material 710 of the multi-pressure channel device 105 discussed below.
[0030] Figure 2 illustrates an exemplary system 200 for performing a diagnostic procedure using a multi-function diagnostic catheter 102, which may form at least a portion of the system 100 shown in Figure 1. Figure 2 illustrates additional details of the first hub 110 and the second hub 124.
[0031] For example, the first hub 110 may be the main hub of the multifunction diagnostic catheter 102 for connecting the first end hole 112 of the distal end 116 to one or more pressure transducers 114. The first hub 110 and the distal end 116 may define a length of the multifunction diagnostic catheter 102. The central lumen 108 may be contained completely and / or at least partially within the multifunction diagnostic catheter 102 between the distal end 116 where the first hub 110 mates with the one or more pressure transducers 114 and one end of the first hub 110. The second hub 124 may be a second hub that is separate or branched from the first hub 110 (e.g., the main hub). The connector tube 202 may connect the second hub 124 to the first hub 110 and / or the catheter 104 to provide a fluid pathway between the second hub 124 and a portion of the outer lumen 118 disposed within the catheter 104. Thus, the outer lumen 118 can have a first portion within the catheter 104 (e.g., between the second end hole 126 and the second hub joint 204) and a second portion outside the catheter 104 formed by the connector tube 202. These components can together define a multi-function diagnostic catheter 102.
[0032] Figure 3 illustrates an exemplary system 300 for performing a diagnostic procedure using a multi-function diagnostic catheter 102, which may form at least a portion of the system 100 illustrated in Figure 1. The system 300 illustrated in Figure 3 may include a weld tip 130 forming the distal end 116 of the multi-function diagnostic catheter 102.
[0033] In some examples, the multifunction diagnostic catheter 102 includes a central lumen 108 formed by an inner tube 302 and an outer lumen 118 formed between the inner tube 302 and the outer tube 120 (e.g., forming an outer portion of the catheter 104). A weld tip 130 can be formed on the inner tube 302 at the distal end 116, with a tip length 304 defined by the distal end 116. The distal end 116 of the multifunction diagnostic catheter 102 can be a first end 306 of the weld tip 130, and the weld tip 130 can include a second end 308. The outer tube 120 can have a terminating outer end 310 that mates with the second end 308 of the weld tip 130. In some examples, the outer tube 120 can have a first outer diameter 312 that corresponds to a second outer diameter 314 of the distal end 116 of the multifunction diagnostic catheter 102 formed by the weld tip 130.
[0034] For example, the first outer diameter 312 of the portion of the catheter 104 formed by the outer tube 120 may be the same or nearly the same as the second outer diameter 314 of the portion of the catheter 104 formed by the weld tip 130, such that the weld tip 130 forms a continuous, constant diameter of the catheter 104 to the distal end 116 (e.g., omitting any tapered features). The inner tube 302 forming the central lumen 108 may be constructed of a braided tube (e.g., metal, plastic, ceramic, composites thereof, etc.), and the outer tube 120 may be constructed of a non-braided tube (e.g., nylon, plastic, or other flexible material). The weld tip 130 can be welded to the inner tube 302 along the tip length 304 or at least a portion of the tip length 304, and / or the weld tip 130 can be welded or glued to the outer tube 120 with a second end 308 of the weld tip 130 mating with a terminating outer end 310 of the outer tube 120. The transition from the flexible non-braided outer tube 120 to the more rigid weld tip 130, along with the consistent continuous diameter created by the weld tip 130, can improve the functionality of the multifunction diagnostic catheter 102. This arrangement allows the multifunction diagnostic catheter 102 to be inserted or slid through the aortic valve 132 more easily than other catheters. Other catheters can have tapered / narrowed ends or flexible tips, making the tips of other catheters more difficult to navigate to a desired location. In contrast, the multifunction diagnostic catheter 102 may be easily inserted into the aorta 136, through the aortic valve 132 and into a desired location within the left ventricle 134 (e.g., using a guidewire insertable and removable from the central lumen 108, as discussed below with respect to FIG. 5). In other words, the weld tip 130 may be considered an extended tip because it maintains a consistent diameter of the multifunction diagnostic catheter 102 rather than tapering or narrowing the distal end 116 (even though the material changes, e.g., from the flexible material of the outer tube 120 to the rigid material of the weld tip 130).Additionally, as discussed in more detail below with respect to FIG. 8, the weld tip 130 may include an expanded or larger inner diameter than the inner diameter of the central lumen 108 in other portions of the catheter 104 .
[0035] In some examples, the multifunction diagnostic catheter 102 can include one or more radiopaque markers 316 (e.g., barium sulfate, bismuth compounds, tungsten, platinum, etc.) at various locations on the catheter 104. The one or more radiopaque markers 316 can determine different specific locations at predetermined interval distances such that the one or more radiopaque markers 316 can be used to determine the location of the distal end 116 of the multifunction diagnostic catheter 102 (e.g., including the first end hole 112 of the central lumen 108), the location of the weld tip 130 (e.g., the first end 306 and / or the second end 308 of the weld tip 130), the location of the second end hole 126 (e.g., a side hole) of the outer lumen 118, and / or other locations or distances along the catheter 104 that may be useful to identify while navigating the multifunction diagnostic catheter 102. For example, the weld tip 130 can have a first radiopaque marker 318 at the distal end 116. The first radiopaque marker 318 can extend a first distance 320 along the weld tip 130 (which can be less than the tip length 304) from the distal end 116. The first radiopaque marker 318 can be used to identify the location of the distal end 116 when the multifunction diagnostic catheter 102 is inserted into a patient.
[0036] Additionally, the multifunction diagnostic catheter 102 may include radiopaque markers 316 disposed at various portions of the outer tube 120. A second radiopaque marker 322 may be disposed at the terminal outer end 310 of the outer tube 120. For example, the second radiopaque marker 322 may extend a second distance 324 along the outer tube 120 from the terminal outer end 310. The outer tube 120 may include a first gap between the second radiopaque marker 322 and a third radiopaque marker 326, the first gap being defined by a first separation distance 328. The third radiopaque marker 326 may be disposed proximate the second end hole 126, and a second gap defined by a second separation distance 330 may separate the third radiopaque marker 326 from the fourth radiopaque marker 332. The fourth radiopaque marker 332 is positioned proximate the second end hole 126, e.g., on an opposite side from the third radiopaque marker 326, such that the third radiopaque marker 326 and the fourth radiopaque marker 332 sandwich the second end hole 126. Additionally, the multi-function diagnostic catheter 102 can include a weld tip gap defined by a weld tip gap distance 334 that separates the first radiopaque marker 318 from the second radiopaque marker 322 on the weld tip 130.
[0037] In some examples, the arrangement of different radiopaque markers 316, along with various predetermined distances between the radiopaque markers 316, provides an improved ability to track the location of the distal end 116 and the second end hole 126 as the multifunction diagnostic catheter 102 is inserted into a patient and navigated to various locations discussed herein. For example, the radiopaque markers 316 and the predetermined distances can be used to insert the multifunction diagnostic catheter 102 into the aorta 136 to a desired location for performing an angiogram (e.g., injecting contrast agent into the aorta 136). Additionally, the radiopaque markers 316 and the desired distances can be used to navigate the distal end 116 through the aortic valve 132 to a desired location within the left ventricle 134 while positioning the second end hole 126 at a desired location within the aortic valve 132 for performing a transvalvular pressure gradient measurement and / or angiogram of the left ventricle 134.
[0038] Figure 4 illustrates an exemplary system 400 for performing a diagnostic procedure using a multi-function diagnostic catheter 102, which may form at least a portion of the system 100 illustrated in Figure 1. The system 400 illustrated in Figure 4 may include a central lumen 108 to provide a dual lumen device 106 and one or more outer lumens 118.
[0039] In some examples, the dual lumen device 106 includes a central lumen 108 that defines an end hole at a distal end 116 of the multifunction diagnostic catheter 102. The multifunction diagnostic catheter 102 can also include an outer lumen 118 formed by the outer tube 120 of the multifunction diagnostic catheter 102 having one or more interstices or lumen channels 122 disposed on an inner surface 402 of the outer tube 120. For example, the one or more lumen channels 122 can be formed in the inner surface 402 and can extend the length of the catheter 104 from the one or more pressure transducers 114 to a second end hole 126 (e.g., and / or to the distal end 116). In some examples, the second end hole 126 may be formed in a side of the multifunction diagnostic catheter 102 and the occlusion or stopper 404 may be located proximate the second end hole 126 (e.g., opposite the one or more pressure transducers 114 and / or in a direction toward the distal end 116) such that the outer lumen may form a closed pressure system between the one or more pressure transducers 114 and the second end hole 126. In some examples, multiple lumen channels 122 may be formed (e.g., substantially evenly spaced) in the interior surface 402. Although only a single one of the lumen channels 122 may be used to form the outer lumen 118, the outer lumen channel 122 may provide a consistent 360° flexibility for the multifunction diagnostic catheter 102 such that the multifunction diagnostic catheter 102 may be reliably movable in either direction when the multifunction diagnostic catheter 102 is positioned for a procedure. In some examples, the central lumen 108 has a first diameter that is greater than a second diameter of the outer lumen 118. The first diameter may be at least twice the second diameter. Additionally or alternatively, the second diameter may be between 5% and 50% of the first diameter.
[0040] Figure 5 illustrates an exemplary system 500 for performing a diagnostic procedure using a multifunction diagnostic catheter 102, which may form at least a portion of the system 100 illustrated in Figure 1. The system 500 illustrated in Figure 5 may include techniques for navigating the distal end 116 of the multifunction diagnostic catheter 102 to one or more desired locations in the heart 128.
[0041] In some examples, the system 500 can include an aortic valve crossing procedure 502 for navigating the multifunction diagnostic catheter 102 (e.g., the distal end 116 including the first end hole 112 of the central lumen 108) through the aortic valve 132 and into the left ventricle 134. The aortic valve crossing procedure 502 can be performed after an aortic diagnostic procedure. For example, the distal end 116 is inserted and positioned within the aorta 136 prior to crossing the aortic valve 132. With the distal end 116 and / or the first end hole 112 positioned within the aorta 136, an aortic diagnostic procedure can be performed. The aortic diagnostic procedure can include injecting contrast into the aorta 136 via the central lumen 108 (e.g., coronary angiography). The aortic valve crossing procedure 502 may be performed after the aortic diagnostic procedure to move the distal end 116 from the aorta 136, through the aortic valve 132 and into the left ventricle 134 (e.g., using a radiopaque marker 316 for guiding visualization). In some examples, the guidewire 504 may be slid into the central lumen 108 by inserting into the first hub 110 (e.g., which may be detached from the one or more pressure transducers 114). The guidewire 504 may extend from the distal end 116 and be pushed through the aortic valve 132 first, such that the distal end 116 may slide along the guidewire 504 and follow it into the left ventricle 134. Once the distal end 116, including the first end hole 112, of the central lumen 108 is within the left ventricle 134, the guidewire 504 is pulled back and / or retracted from the central lumen 108 and removed or at least partially removed from the multifunction diagnostic catheter 102. In some examples, the guidewire 504 can be used to pass through a stenotic aortic valve 132 and / or to pass through an obstruction 506 within the aorta 136 and / or aortic valve 132. Once through the aortic valve 132, the guidewire 504 is removable from the central lumen 108 while maintaining the central lumen 108 within the left ventricle 134.Benefits may arise from the ability to cross the aortic valve 132, a stenosed aortic valve 132, and / or an obstruction 506 using the same multi-function diagnostic catheter 102 that is also used to perform a diagnostic procedure (e.g., rather than inserting a first catheter and / or steering system into the patient to perform the crossing and then using a different catheter to perform a different diagnostic procedure).
[0042] In some examples, the transvalvular pressure gradient measurements can be generated using a first end hole 112 of the central lumen 108 in the left ventricle 134 for measuring a first pressure value (e.g., a left ventricular pressure value) and a second end hole 126 of the outer tube 120 in the aortic valve 132 for measuring a second pressure value (e.g., an aortic pressure value). Measuring the left ventricular pressure value and the aortic pressure value includes generating analog signals (e.g., two analog signals) using one or more pressure transducers 114 corresponding to these pressure values. Because the multifunction diagnostic catheter 102 includes the dual lumen device 106 and one or more pressure transducers 114, additional electronic systems such as a digital-based console system may not be required. As such, a more complex digital-based pressure sensor console system can be omitted, resulting in an easier and simpler process for performing a diagnostic procedure (e.g., with high efficiency and low cost).
[0043] Additionally, the dual lumen device 106 (and other aspects of the multi-function diagnostic catheter 102, for example) can provide various diagnostic procedures in various arrangements and / or sequences. For example, the trans-aortic valve procedure 502 can be performed before or after performing a coronary angiogram. The transvalvular pressure measurements can be determined before or after performing a coronary angiogram. In some examples, multiple coronary angiograms can be performed and / or multiple transvalvular pressure measurements can be calculated in various sequences (e.g., alternating between different diagnostic procedures and / or multiple coronary angiograms followed by multiple transvalvular pressure measurements, or combinations thereof).
[0044] FIG. 6 illustrates an exemplary method 600 for performing a diagnostic procedure using the multi-function diagnostic catheter 102 that may be performed by the system 100 shown in FIG.
[0045] In operation 602, the method 600 can insert a multifunction diagnostic catheter into the patient's aorta, where a central lumen of the multifunction diagnostic catheter has a first end hole at a distal end of the multifunction diagnostic catheter. In operation 604, the method 600 can perform a first pass through the aortic valve with the distal end. In operation 606, the method 600 can measure a left ventricular pressure using a first end hole of the central lumen, where the first end hole connects to a pressure transducer via a first hub. In operation 608, the method 600 can measure an aortic pressure using a second end hole of an outer lumen disposed within the multifunction diagnostic catheter, where the outer lumen connects to a transducer via a second hub. In operation 610, the method 600 can measure a transvalvular pressure gradient based on the simultaneous measurements of left ventricular pressure and aortic pressure (e.g., of operations 606 and 608). In operation 612, the method 600 can inject contrast into the central lumen to perform a coronary angiogram.
[0046] It should be understood that the particular order or hierarchy of steps in the methods depicted in FIG. 6 and throughout this disclosure are examples of example approaches and may be rearranged while remaining within the disclosed subject matter. For example, any of the operations depicted in FIG. 6 and throughout this disclosure may be omitted, repeated, performed in parallel, performed in a different order, and / or combined with any other of the operations depicted in FIG. 6. For example, method 600 may perform operation 612 before and / or after operations 604-610. Additionally, any of the systems or methods depicted in FIGS. 1-6 may be combined together and / or form at least a portion of system 100 depicted in FIG. 1.
[0047] Figures 7A and 7B show an exemplary system 700 that may be identical to or form at least a portion of the system 100 shown in Figure 1. The system 700 shown in Figures 7A and 7B includes a multi-function diagnostic catheter 102 having a multi-pressure channel device 105.
[0048] 7A shows a 7 French (7Fr) catheter 702 including a cross-sectional view of a distal portion 704 at the distal end 116 and a cross-sectional view at a mid-shaft portion 706. The distal portion 704 can include a central lumen 108 having a distal portion inner diameter 708 of 0.067 inches (1.702 mm) and / or a distal portion outer diameter 709 of 0.093 inches (2.362 mm). At the mid-shaft portion 706, the catheter 104 can include outer lumen channels 122 formed in the interior material 710 between the central lumen 108 and an outer surface 711 of the sidewall material forming the central lumen 108. These outer lumens or lumen channels 122 can have a curved, elongated opening cross-sectional profile such that the lumen channels 112 are curved, elongated elliptical channels 712. Additionally, the lumen channel 122 can have an angular dimension 714 of approximately 95° (e.g., 94.93°). Additionally, in some examples, the catheter 104 includes three lumen channels 122 terminating in three side openings 806, e.g., at different distances, to form a staggered or spiral arrangement of the side openings 806 about the outer surface 711 of the catheter 104.
[0049] Additionally, some examples can include less than three or more than three (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, etc.) lumen channels 122 formed within the inner material with a corresponding number of side openings 806. The lumen channels 122 can be evenly distributed and / or evenly spaced about the inner material 710.
[0050] In some examples, the distal portion 704 has two or more side openings 806, which can improve the pressure fidelity of the pressure transducer measurement. Portions of the catheter 104 with multiple lumens can have at least one side opening 806 drilled in each pressure lumen to improve pressure fidelity. The side openings 806 can wrap around the catheter 104 in a spiral manner so that one or more of the side openings 806 are not obstructed by tissue and can freely transmit pressure. In the proximal portion of the catheter 104, the pressure lumens (e.g., the outer lumen 118 or the lumen channel 122) can enter a common reservoir connected (e.g., at the second hub 124) to a lateral pressure tube.
[0051] Additionally, in some scenarios, the catheter 104 at the mid shaft section 706 can have a mid shaft inner diameter 716 that is smaller than the distal section inner diameter 708 at the distal section 704. For example, the mid shaft inner diameter 716 may be 0.059 inches (1.499 mm). Thus, the inner diameter of the central lumen 108 can transition from the mid shaft inner diameter 716 to the distal section inner diameter 708 at the inner diameter transition 804. Additionally, or alternatively, the mid shaft section can have an outer diameter 719 that is the same as the outer diameter 709 at the distal section 704.
[0052] In some examples, as shown in FIG. 7B, the system 700 includes a 6 French (6Fr) catheter 718 with a distal portion 720 (cross-sectional view) and a mid-shaft portion 722. The distal tip 720 can have a distal portion inner diameter 708 of 0.054 inches (1.372 mm) ± 0.002 inches (0.0508 mm) and / or a distal portion outer diameter of 0.079 inches (2.007 mm) ± 0.002 inches (0.0508 mm). Additionally, the mid-shaft portion 722 can have a mid-shaft inner diameter 716 of 0.079 inches (2.007 mm) ± 0.002 inches (0.0508 mm) and a mid-shaft inner diameter 716 of 0.046 inches (1.168 mm) ± 0.002 inches (0.0508 mm). Thus, the outer diameter of the mid-shaft section 722 may be greater than the outer diameter at the distal section 720 and / or the inner diameter of the mid-shaft section 722 may be less than the inner diameter at the distal section 720. Additionally or alternatively, the 6Fr catheter 718 may include five lumen channels 122 (e.g., the curved elongated oval channel 712) extending along the mid-shaft section 722 and / or terminating in five side holes at a first end and a second hub 124 at a second end. The 6Fr catheter 718 may include more or less than five lumen channels 122 in some examples.
[0053] Figure 8 illustrates an exemplary system 800 that may be identical to, or form at least a portion of, the system 100 illustrated in Figure 1. System 800 illustrates a multi-function diagnostic catheter 102 with a multi-pressure channel arrangement 105.
[0054] In some examples, a section 802 of the catheter 104 shows an inner diameter transition 804 of a mid-shaft inner diameter 716 of the mid-shaft portion 706 to a distal portion inner diameter 708 of the distal portion 704. Additionally, the section 802 shows one or more side holes 806 where the lumen channels 122 terminate. In some scenarios, such as those including multiple lumen channels 122 extending along the mid-shaft portion 706, the side holes 806 can be spaced apart by a side hole distance 808 such that the side holes form a staggered or helical arrangement 810 about the mid-shaft portion 706.
[0055] In some examples, the catheter 104 can include a distal tip 812. For example, the distal section 704 can extend a length 814 from an inner diameter transition 804 to a distal tip transition 816, at which point the distal section inner diameter 708 can transition to a section having a distal tip inner diameter 818 that is continuous with the distal section inner diameter 708, and maintains the expanded diameter until the end hole 112. Thus, sliding friction of the guidewire 504 can be reduced by increasing the configuration of the inner lumen diameter, creating additional sliding space for the guidewire 504. The distal tip 812 can be a soft material (e.g., silicone, rubber, mesh, etc.) in the catheter 104 to prevent tissue damage from mounting to the expanded tip.
[0056] FIG. 9 illustrates an exemplary system 900 including a catheter 104 and methods for performing various cardiac procedures 902 that can be performed by any of the systems 100-800 disclosed herein.
[0057] In some examples, in operation 904, the catheter 104 can be positioned with the distal end 116 in the aorta 136, and a guidewire 504 (e.g., a straight guidewire 504) can be inserted from the distal end 116 through the central lumen 108. In operation 906, the cardiac entry procedure 902 can include extending the guidewire 504 from the distal end 116 through the aortic valve 132 and into the left ventricle 134. The guidewire 504 can exit the distal tip 116 and pass through the mid-shaft inner diameter 716 to the wider distal portion inner diameter 708 of the central lumen 108 before probing / passing the aortic valve 132. In operation 908, the cardiac entry procedure 902 can include extending the catheter 104 through the aortic valve 132 using the guidewire 504 by sliding the outer lumen 118 over the guidewire 504. The guidewire 504 can remain with its guidewire tip 907 within the left ventricle 134 until the distal end 116 of the catheter 104 passes through the aortic valve 132 (e.g., a blocked aortic valve 132) and retracts the guidewire 504 at least partially or completely back into the central lumen 108. Operation 908 can also include moving the distal end 116 of the catheter 104 through the aortic valve 132 until the first end hole 112 and / or the one or more side holes 806 are positioned within the left ventricle 134 while retracting the guidewire 504 into the central lumen 108. Additionally, the cardiac procedure 902 can include withdrawing or removing the guidewire 504 from the central lumen 108 while the catheter 104 remains positioned through the left ventricle 134. Additionally or alternatively, the cardiac procedure 902 may include performing one or more cardiac entry diagnostic and / or therapeutic procedures using the central lumen 108 and / or lumen channel 122 with the side holes 806 and / or end holes 112 positioned in the aorta 136 and / or left ventricle 134 (e.g., trans-aortic pressure measurement, angiography procedures, etc.).
[0058] In some scenarios, smooth wire passage provides the practitioner with significant tactile feedback and allows safe advancement through a diseased aortic valve. The geometry of the catheters disclosed herein can be optimized to pass through aortic valves, including diseased aortic valves. Additionally, the catheter 104 may be multi-functional by using the guidewire to pass through the aortic valve 132, positioning the guidewire within the aorta 136, while performing multiple operations to accommodate the guidewire, provide a central lumen 108 for retracting the guidewire 504 from the left ventricle 134 and / or the patient, and perform aortic pressure measurements simultaneously on both sides of the aortic valve 132. Thus, the confusion and trauma caused to the patient by inserting two separate catheters for the guidewire (e.g., inserting and withdrawing the guidewire before inserting the catheter) is reduced. Additionally, the system disclosed herein uses pressure openings fluidly coupled to pressure transducers at the hub to determine pressure values, thus reducing bulk, complexity, and cost by eliminating sensors along the catheter 104, eliminating electronic consoles, and improving operational efficiency.
[0059] Although the present disclosure has been described with reference to various implementations, it will be understood that these implementations are exemplary and that the scope of the disclosure is not limited thereto. Many variations, modifications, additions, and improvements are possible. More generally, implementations according to the present disclosure are described in the context of specific implementations. Functionality is separated or combined separately or described in different terms in various implementations of the present disclosure. These and other variations, modifications, additions, and improvements may be included within the scope of the present disclosure, as defined in the following claims.
Claims
1. A multi-function diagnostic catheter, comprising: a catheter having a pressure measuring device operable to perform a coronary angiogram, pass through the aortic valve and measure a transvalvular pressure gradient, said pressure measuring device comprising: a central pressure measurement pathway disposed at least partially within the catheter, the central pressure measurement pathway terminating in a first hub for connecting an end bore of the central pressure measurement pathway to a pressure transducer; an outer pressure measurement path having a first portion disposed within the catheter and a second portion disposed outside the catheter, the second portion terminating in a second hub for connecting a side hole of the outer pressure measurement path to the pressure transducer, the side hole being located on a side of the catheter a specified distance away from an end of the catheter.
2. The multi-function diagnostic catheter of claim 1 , wherein the outer pressure measurement path is a pressure channel disposed within an interior material forming the central pressure measurement path.
3. The multi-function diagnostic catheter of claim 2 , wherein the distal tip has a first inner diameter that is greater than an inner diameter of the central pressure measurement path.
4. The multifunction diagnostic catheter of claim 3 , wherein the distal tip is formed of a soft material.
5. the prescribed distance is a first prescribed distance, 5. The multifunction diagnostic catheter of claim 4, wherein the catheter includes a first radiopaque marker at the end hole of the central pressure measurement path and a second radiopaque marker about the side of the catheter spaced a second predetermined distance from the first radiopaque marker.
6. 2. The multi-function diagnostic catheter of claim 1, wherein the pressure measurement device is operable to measure left ventricular pressure using the end hole of the central pressure measurement path while measuring aortic pressure using the side hole of the outer pressure measurement path.
7. 7. The multifunction diagnostic catheter of claim 6, wherein the measurements of the left ventricular pressure and the aortic pressure use two analog signals generated by two pressure transducers, eliminating reliance on a digitally based pressure sensor console system.
8. the central pressure measurement pathway is operable to receive a guidewire for passage through the aortic valve; 10. The multi-function diagnostic catheter of claim 1, wherein the guidewire is detachable from the central pressure measurement path once it has passed through the aortic valve while maintaining the central pressure path within the left ventricle.
9. 10. The multi-function diagnostic catheter of claim 1, wherein the central pressure measurement path is operable to inject contrast agent prior to passing through the aortic valve to perform selective coronary angiography.
10. a first portion of the multi-function diagnostic catheter including the central pressure measurement path with the outer pressure measurement path having a first inner diameter; 2. The multifunction diagnostic catheter of claim 1, wherein a second portion of the multifunction diagnostic catheter, including the central pressure measurement path and excluding the outer pressure measurement path, has a second inner diameter larger than the first inner diameter.
11. A multi-function diagnostic catheter, comprising: a catheter having a multi-pressure channel device operable to perform coronary angiography, pass through the aortic valve and measure a transvalvular pressure gradient, said multi-pressure channel device comprising: a central pressure measurement path disposed at least partially within the catheter, the central pressure measurement path terminating in a first hub for connecting a distal end bore of the central pressure measurement path to one or more pressure transducers; and one or more outer pressure measurement paths formed in a sidewall material of the central pressure measurement path, the one or more outer pressure measurement paths terminating in a second hub for connecting one or more side holes of the one or more outer pressure measurement paths to the one or more pressure transducers, the one or more side holes being located on a side of the catheter spaced one or more specified distances from an end of the catheter.
12. The multifunction diagnostic catheter of claim 11 , wherein the one or more side holes include at least three side holes in a staggered arrangement around the catheter.
13. The multi-function diagnostic catheter of claim 12 , wherein the one or more outer pressure measurement paths include at least three elongated elliptical channels.
14. 14. The multifunction diagnostic catheter of claim 13, wherein the multifunction diagnostic catheter is a seven French (7Fr) catheter or a six French (6Fr) catheter.
15. a first inner diameter of an intermediate shaft portion of the multifunction diagnostic catheter extending from a proximal portion of the multifunction diagnostic catheter to a proximal-distal portion of the multifunction diagnostic catheter; 12. The multifunction diagnostic catheter of claim 11, further comprising: a second inner diameter of a distal portion of the multifunction diagnostic catheter, the second inner diameter being greater than the first inner diameter.
16. the central pressure measurement path is operable to pass through a stenosed aortic valve using a guidewire disposed within the central pressure measurement path; 12. The multifunction diagnostic catheter of claim 11, wherein the multifunction diagnostic catheter is operable to measure left ventricular pressure using the distal end hole of the central pressure measurement path while measuring aortic pressure using the one or more side holes of the one or more outer pressure measurement paths as the guidewire is passed through the stenosed aortic valve.
17. 1. A method of performing multiple diagnostic functions using a catheter with a multiple pressure measurement path arrangement, comprising: measuring left ventricular pressure using an end hole of a central pressure measurement path disposed at least partially within the catheter and terminating in a first hub for connecting the end hole of the central pressure measurement path to a pressure transducer, the end hole of the central pressure measurement path being located at a distal end of the catheter; measuring an aortic pressure using one or more end holes of one or more outer pressure measurement paths disposed on the catheter and terminating in a second hub for connecting one or more end holes of the one or more outer pressure measurement paths to a pressure transducer, the one or more end holes being at positions along an outer sidewall of the catheter spaced one or more predetermined distances from the end hole of the central pressure measurement path; A method comprising:
18. 18. The method of claim 17, wherein the steps of measuring the left ventricular pressure and the aortic pressure are performed using three or more side ports to measure transvalvular pressure gradients while eliminating reliance on a pressure sensor console system.
19. 20. The method of claim 17, further comprising making a first pass through the aortic valve with the central pressure measurement pathway using a guidewire disposed in the central pressure measurement pathway.
20. 20. The method of claim 17, further comprising the step of injecting contrast agent into a coronary artery using the central pressure measurement path before or after measuring a transvalvular pressure gradient using the central pressure measurement path and three or more outer pressure measurement paths.