INTRAVASCULAR CATHETERS

Abstract

The disclosure provides an intravascular catheter with a purge system that excludes biological fluids and may also include devices such as impellers that can be delivered over, and operated over, a guidewire. Catheters may include treatment devices suited to the treatment of edema and in which the guidewire aids in positioning the device while the purge system facilitates reliable operation.

Claims

1. A device comprising: a catheter dimensioned for insertion into a bodily lumen; a porous drive shaft extending from a motor through the catheter, wherein a portion of the drive shaft is housed within a tube comprising one or more through holes; and an infusion channel in fluid communication with the porous drive shaft and arranged such that purge fluid is discharged through the porous drive shaft and through the through holes of the tube.

2. The device of claim 1, wherein when the motor is not rotating, a static pressure of the purge fluid prevents bodily fluid from entering the housing.

3. The device of claim 1, wherein when the motor is rotating, the purge fluid is subject to centrifugal force along the drive shaft preventing bodily fluid from approaching the proximal portion of the catheter.

4. The device of claim 1, wherein the motor comprises a rotor disposed within a stator in a housing at a proximal portion of the catheter.

5. The device of claim 4, wherein the porous drive shaft is coupled to, and extends from, the rotor.

6. The device of claim 5, wherein a proximal end of the tube includes a proximal sealed connection around the drive shaft, and further wherein operation of the motor rotates the drive shaft within the tube.

7. The device of claim 6, wherein a distal end of the tube includes a distal sealed connection around the drive shaft.

8. The device of claim 7, wherein when the impeller is inserted into vasculature of a patient, the proximal sealed connection, the tube, and/or the distal sealed connection separate the purge fluid within the porous drive shaft from blood within the catheter outside of the tube.

9. The device of claim 4, wherein the impeller comprises one or more blades disposed along an impeller shaft coupled to the drive shaft, wherein the impeller shaft has an impeller shaft lumen therethrough and one or more holes along a side of the impeller shaft such that rotation of the impeller in a liquid subjects the liquid to centrifugal force at the one or more holes.

10. The device of claim 1, wherein the device further comprises one or more inflatable balloons disposed along the catheter, each in fluid communication with an inflation lumen extending along the catheter.

11. The device of claim 1, wherein when the impeller is disposed within vasculature of a patient and the motor is operated, the impeller pumps blood and the purge fluid rinses at least a portion of the impeller.

12. The device of claim 1, wherein the impeller and the drive shaft define a guidewire lumen that extends through the impeller and the drive shaft.

13. The device of claim 12, wherein the guidewire lumen extends through the motor, further wherein when the device is inserted into vasculature of a patient over a guidewire, operation of the motor rotates the impeller within the vasculature while the guidewire extends through the guidewire lumen.

14. The device of claim 13, wherein the device is operable when the guidewire extends distally out of a distal tip of device.

15. The device of claim 13, wherein when the device is inserted into the vasculature of the patient over the guidewire: the purge fluid continually purges the catheter when the motor is operated; and the purge fluid continually purges the catheter when the motor is not operated.

16. The device of claim 1, wherein when the impeller is inserted into vasculature of a patient, the purge fluid purges the catheter by hydrostatic pressure while the motor is not operated and the purge fluid purges the catheter by centrifugal force while the motor is operated.

17. A device comprising an impeller disposed at a distal portion of a catheter and dimensioned for insertion into vasculature of a patient, wherein when the impeller is inserted into the vasculature of a patient, a purge fluid purges the catheter by hydrostatic pressure while the impeller is not being rotated and the purge fluid purges the catheter by centrifugal force while the impeller is being rotated.

18. A device comprising: an impeller dimensioned for insertion into vasculature of a patient; a guidewire lumen extending through the impeller; and a drive mechanism operable to rotate the impeller while the impeller is in the vasculature with a guidewire extending through the lumen.

19. The device of claim 18, wherein the drive mechanism includes a hollow driveshaft extending proximally from the impeller to a motor.

20. The device of claim 19, wherein the hollow driveshaft extends through a catheter having a proximal portion and a distal portion, wherein the impeller is distal to the distal portion and the motor is proximal to the proximal portion.

21-32. (canceled)

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0022] FIG. 1 shows a device of the disclosure.

[0023] FIG. 2 gives a cutaway view of a housing and a distal portion of a catheter of the device.

[0024] FIG. 3 shows the proximal section of the device.

[0025] FIG. 4 shows the middle section of the device.

[0026] FIG. 5 shows the distal section of the device.

[0027] FIG. 6 illustrates a device in use for treatment of a patient.

[0028] FIG. 7 gives a detail view of the distal portion and distal tip of the catheter.

[0029] FIG. 8 is a cross-sectional view through a tube portion of the device.

[0030] FIG. 9 diagrams a method of treating a patient using a device of the disclosure.

DETAILED DESCRIPTION

[0031] FIG. 1 shows a device 101 with an extended catheter 107, having a proximal portion 106 and a distal portion 108, extending from a housing 105. The catheter 107 is dimensioned for insertion into a bodily lumen, such as a vein of a patient. At a distal portion 108 of the catheter 107, a flexible, atraumatic tip 180 extends past the distal portion 108 of the catheter 107, terminating at a distal tip 181. A guidewire 177 is shown, extending from the distal tip 181 of the device 101.

[0032] An infusion channel 123 enters the housing 105, allowing a purge fluid 125 to enter the catheter by the infusion channel 123. As discussed in greater detail below, the device 101 may include one or more expandable members 163, e.g., located at the distal portion 108 of the catheter 107.

[0033] FIG. 2 gives a cutaway view of the housing 105 and the distal portion 108 of the catheter 107. The motor housing 105 houses a drive mechanism 130. Embodiments of the drive mechanism 130 include a motor 113 having a rotor 127 disposed within a stator 131. A porous drive shaft 111 extends from a motor 113 through the catheter 107. At least a portion of the drive shaft 111 is housed within a tube 119. The motor 113 comprises a rotor 127 disposed within a stator 131 in a housing 105 at a proximal portion 106 of the catheter 107.

[0034] The device 101 includes a porous drive shaft 111 extending from a motor 113 through the catheter 107. A portion of the drive shaft 111 is housed within a tube 119 that may extend from the housing 105 to the distal portion 108.

[0035] At the housing 105, an infusion channel 123 is in fluid communication with the porous drive shaft 111 and arranged such that a purge fluid 125 is discharged through the porous drive shaft 111 and towards the distal portion 108.

[0036] The distal portion 108 includes the distal end 120 of the tube 119, with an expandable membrane 168 and balloon 164 disposed about the catheter. Distal to the distal end 120 of the tube 119 is an impeller housing 144, housing an impeller 143, and a hollow atraumatic tip 180. The balloon 164 (when inflated), the expandable membrane 168 (which expands when the balloon 164 is inflated), and the impeller housing 144 collectively provide and include at least one inlet port 129 and outlet port 130, which provide a passage through the membrane 168 and impeller housing 144 through which the impeller 143 can pump a fluid such as blood.

[0037] The tube 119 extends from a proximal end 118 of the tube 119 (in the housing 105) to a distal end of 120 of the tube 119 (on the distal portion 108 of the catheter 107). The tube 119 surrounds a length of the hollow driveshaft 111 extending from the drive mechanism 130. Specifically, the hollow driveshaft 111 extends from the rotor 127 mounted within the stator 131.

[0038] The distal portion 108 includes the impeller 143, dimensioned for insertion into vasculature of a patient. A guidewire lumen 175 extends through the impeller 143. The drive mechanism 130 is operable to rotate the impeller 143 while the impeller 143 is in the vasculature with a guidewire extending through the guidewire lumen 175. Features and devices of the invention may be used in a variety of catheters and treatment devices and may, for example, be incorporated into any of those devices described in U.S. Pat. No. 9,901,722; U.S. Pub. 2016/0331378; U.S. Pub. 2015/0343186; U.S. Pub. 2015-0343136; U.S. Pub. 2017/0197021; Int'l Patent Appl. Pub. WO 2016/181217; Intl Patent Appl. Pub. WO 2015/186005; and Int'l Patent Appl. Pub. WO 2015/186003, the contents of each of which are incorporated by reference.

[0039] FIG. 2 includes boxes to call out a proximal section 301 of the device 101, a middle section 401 of the device 101, and a distal section 501 of the device 101.

[0040] FIG. 3 shows the proximal section 301 of the device 101. The guidewire lumen 175 extends through the housing 105. A drainer 117 is in fluid communication with an interior space of the housing. At a proximal portion 104 of housing 105, is a Luer 106 providing access to a tapered port 115 that can guide a guidewire into the guidewire lumen 175. One or more sealed bearings 116 may be included to allow rotation of the driveshaft and minimize vibrations of the motor 113. The infusion channel 123 allows purge fluid 125 to enter the catheter 107.

[0041] FIG. 4 shows the middle section 401 of the device 101. A proximal end 118 of tube 119 includes a proximal tube seal 135 (a distal tube seal 139 is located at the other end) to seal the tube 119 around the drive shaft 111. The guidewire lumen 175 extends through the drive shaft 111, which connects to the motor 113 via a motor shaft 114. The tube 119 surrounds a sleeve 122 which sits around the drive shaft. The proximal end 118 of the tube 119 includes a proximal tube seal 135 around the drive shaft 111. Operation of the motor 113 rotates the drive shaft 111 within the tube 119.

[0042] FIG. 5 shows the distal section 501 of the device 101. The hollow drive shaft 111 terminates at the impeller 143 on an impeller shaft 149. The impeller shaft 149 has one or more through holes 157. The impeller shaft 149 may be seated in one or more distal sealed bearing 166. Extending through the impeller shaft 149 is an impeller shaft lumen 153, which is in fluidic communication with a surrounding environment at least through the one or more through holes 157. The tube 119 ends at the distal tube end 120, where it forms a distal tube seal 139 around the hollow drive shaft 111. The hollow drive shaft 111 and the impeller shaft lumen 153 cooperate to define or include at least a portion of the guidewire lumen 175. The impeller 143 is seated within the impeller housing 144 by means of one or more support rings 150, which may be, for example, open central rings supported within an outer ring by multiple spokes. The impeller 143 has one or a plurality of blades 145 to impel fluid through the impeller housing 144 when the impeller 143 rotates.

[0043] With reference back to FIGS. 1-5, the purge fluid 125 may be supplied in a reservoir, e.g., an IV bag, that may hang from a rack to be gravitationally higher than the device 101 when the device 101 is used bedside in a clinical setting. The porous drive shaft 111 is coupled to, and extends from, the rotor 127 of the motor 113. The porous, hollow drive shaft 111 that rotates when the motor 113 operates influences the fate of purge fluid 125 that enters the catheter 107 through the infusion channel 123. When the motor 113 is not rotating, a static pressure of the purge fluid 125 prevents bodily fluid from entering the housing 105. When the motor 113 is rotating, the purge fluid 125 is subject to centrifugal force along the drive shaft 111 preventing bodily fluid from approaching the proximal portion 106 of the catheter 107.

[0044] Components described herein thus provide a purge system for an intravascular treatment catheter, particularly for catheters that use rotational mechanisms such as impellers or ablation tools or for over-the-wire catheters that provide instruments that can be inserted into vasculature of a patient over a guidewire. Any suitable purge fluid 125, such as saline, may be used. The described components and features cooperate to prevent bodily fluids from entering the catheter when parts of the catheter are stationary and also when mechanical parts are operating.

[0045] In certain embodiments, when the impeller 143 is inserted into vasculature of a patient, the proximal tube seal 135, the tube 119, and/or the distal tube seal 129 separate the purge fluid 125 within the porous drive shaft 111 from blood within the catheter 107 outside of the tube 119. The impeller 143 may include one or more blades 145 disposed along an impeller shaft 149 coupled to the drive shaft 111, in which the impeller shaft 149 has an impeller shaft lumen 153 therethrough and one or more through-holes 157 along a side of the impeller shaft 149 such that rotation of the impeller 143 in a liquid subjects the liquid to centrifugal force at the one or more holes 157. That is, when the impeller 143 is disposed within vasculature of a patient and the motor 113 is operated, the impeller 143 pumps blood and the purge fluid 125 rinses at least a portion of the impeller 143. In such scenario, purge fluid in the catheter 107 (e.g., that flowed in under gravity while the impeller was not operating) would be driven out through the through-holes 157 while the motor 113 operates, thereby securely preventing any bodily fluid from entering the device 101.

[0046] The purge system may have particular applicability on devices used in different bodily systems, such as the circulatory system and the lymphatic system. E.g., the purge fluid prevents blood from entering the device 101, so that if the device 101 is subsequently entered into a thoracic duct, blood is not brought into that area.

[0047] In certain depicted embodiments, the device 101 includes one or more inflatable balloons 163 disposed along the catheter 107, each in fluid communication with an inflation lumen 164 extending along the catheter 107.

[0048] In certain embodiments, the device 101 is designed as an over-the-wire device in that it can be delivered to a location in the vasculature of a patient by following a guidewire that has been navigated to the intended location. Preferably, the impeller 143 and the drive shaft 111 define or include a guidewire lumen 175 that extends through the impeller 143 and the drive shaft 111.

[0049] In some embodiments (see, e.g., FIG. 2), the guidewire lumen 175 extends through the motor 113. When the device 101 is inserted into vasculature of a patient over a guidewire 177, operation of the motor 113 rotates the impeller 143 within the vasculature while the guidewire 177 extends through the guidewire lumen 175. In certain embodiments, the device 101 is operable when the guidewire 177 extends distally out of a distal tip 181 of device 101 (that is, even with the guidewire 177 extending out of the distal tip, the motor 113 can be operated to drive the impeller 143). The over-the-wire impeller embodiments of the device 101 may include a purge system. In such embodiments, when the device 101 is inserted into the vasculature of the patient over the guidewire, the purge fluid 125 continually purges the catheter 107 when the motor 113 is operated and the purge fluid 125 continually purges the catheter 107 when the motor 113 is not operated. Preferably, when the impeller 143 is inserted into vasculature of a patient, the purge fluid 125 purges the catheter 107 by hydrostatic pressure while the motor 113 is not operated and the purge fluid 125 purges the catheter by centrifugal force while the motor 113 is operated.

[0050] Thus the disclosure provides a device 101 having an impeller 143 disposed at a distal portion 108 of a catheter 107 and dimensioned for insertion into vasculature of a patient, wherein when the impeller 143 is inserted into the vasculature of a patient, a purge fluid 125 purges the catheter 107 by hydrostatic pressure while the impeller 143 is not being rotated and the purge fluid 125 purges the catheter 107 by centrifugal force while the impeller 143 is being rotated.

[0051] Additionally, the disclosure provides a device 101 with an impeller 143 dimensioned for insertion into vasculature of a patient, a guidewire lumen 175 extending through the impeller 143, and a drive mechanism 130 operable to rotate the impeller 143 while the impeller 143 is in the vasculature with a guidewire 177 extending through the guidewire lumen 175. The drive mechanism 130 may include a hollow driveshaft 111 extending proximally from the impeller 143 to a motor 113. The hollow driveshaft 111 preferably extends through a catheter 107 having a proximal portion 106 and a distal portion 108, in which the impeller 143 is distal to the distal portion 108 and the motor 113 is proximal to the proximal portion 106 (see, e.g., FIG. 2). In some embodiments, the motor 113 sits in a housing 105 connected to the proximal portion 106 of the catheter 107. The motor 113 may include a stator 131 housed within the housing 105 and a rotor 127 disposed within the stator 131, with the guidewire lumen 175 extending through the impeller 143, through the driveshaft 111, and through the rotor 127. Optionally, the guidewire lumen 175 opens to a tapered port 115 at a proximal portion 104 of the housing 105. The device 101 may include a hollow atraumatic tip 180 extending distally from the impeller 143. The hollow driveshaft 111 may extend through an extended catheter 107, with the impeller 143 disposed at a distal portion 108 of the catheter 107 and preferably with the motor 113 disposed at a proximal portion 106 of the catheter 107.

[0052] FIG. 6 illustrates a device 101 in use for treatment of a patient 601. The device 101 has been inserted into vasculature of the patient 601 such that the housing 105 sits outside the patient 601 and the distal portion 108 of the catheter sits in the left jugular vein 611 near the junction with the left subclavian vein 607, thereby servicing an outflow of the thoracic duct 619. The impeller sits over the guidewire 177 and can operate (rotate) while sitting over the guidewire 177. The purge fluid 125 is provided through the catheter and washes the impeller 143 and prevents bodily fluid from entering the device 101.

[0053] FIG. 7 gives a detail view of the distal portion 108 and distal tip 180 of the catheter 107 on the device 101. The impeller 143 sits in the impeller housing 144, preferably just downstream of an expandable membrane 168, which is connected to an inflatable balloon 164. When the balloon 164 is inflated, it forms a torus surrounding the catheter 107 and it forms the expandable membrane 168 into a tapered conduit. A proximal end of the expandable membrane 168, ringed by the toroidal balloon 164, forms an inlet port 129 to the conduit, and the conduit continues into the impeller housing 144 to one or more outlet ports 130, which may be disposed along one or more sides of the housing 144. A guidewire 177 may be extended through the device, through the guidewire lumen 175. The impeller 143 is connected to a drive mechanism 130 (not pictured) through a hollow drive shaft 111. A hollow, atraumatic tip 180 sits distal to the impeller and completes the guidewire lumen 175. The guidewire 177 extends from the tip 180. The impeller housing 144 is connected to the distal portion 108 of the catheter 107. As shown, the device 101 includes at least one inlet port 129 proximal to the impeller 143 and at least one outlet port 130 distal to the impeller 143, such that rotation of the impeller 143 impels liquid through the impeller housing 144. For the at least one expandable member 163 (e.g., the balloon 164) on the distal portion 108 of the catheter 107, at least one inflation lumen 160 extends through the catheter 107. As shown, the expandable member 163 may include a substantially toroidal balloon 164 connected to the catheter 107 or impeller housing 144 by an expandable membrane 168. When the catheter 107 is inserted over a guidewire 177 into the vasculature, the balloon 164 can be inflated and the impeller 143 the can be rotated by operation of the motor 113 while the guidewire 177 extends through the device 101.

[0054] FIG. 8 is a cross-sectional view through the tube 119, showing the drive shaft 111 extending from the motor 143 to the impeller 143. The tube 119 surrounds a sleeve 122 which sits around the drive shaft 111. The purge fluid 125 arrives through the porous drive shaft 111 and is under either or both of hydrostatic pressure and centrifugal force to prevent blood from entering the catheter.

[0055] FIG. 9 diagrams a method 901 of treating a patient that may be performed using a device 101 of the disclosure. The method 901 includes inserting 907 a distal portion 108 of the catheter 107 into vasculature of a patient (over a guidewire 177) and navigating the distal portion 108 to a treatment site, such as an outlet of a thoracic duct 619. The method 901 may include purging 913 the catheter 107 by hydrostatic pressure of the purge fluid 125 while the device sits in the vasculature (e.g., within the jugular vein 611). The device may be operated 925 while over the wire. For example, the impeller 143 may be rotated by driving the motor 113, even while the guide wire 177 extends through the impeller shaft lumen. While the device is operated 925, the device 101 is purged 929 by centrifugal force and other forces of fluid dynamics. The purging 913, 929 by the purge fluid 125 allows the impeller 143 to operate 925 reliably, and the positioning over-the-wire (OTW) places the distal portion 108 in the correct location proximal to an outflow of a thoracic duct 619. By such means, the device 101 decreases 935 pressure at the thoracic duct 619, thereby relieving edema and aiding in the treatment of congestive heart failure.

INCORPORATION BY REFERENCE

[0056] References and citations to other documents, such as patents, patent applications, patent publications, journals, books, papers, web contents, have been made throughout this disclosure. All such documents are hereby incorporated herein by reference in their entirety for all purposes.

EQUIVALENTS

[0057] Various modifications of the invention and many further embodiments thereof, in addition to those shown and described herein, will become apparent to those skilled in the art from the full contents of this document, including references to the scientific and patent literature cited herein. The subject matter herein contains important information, exemplification, and guidance that can be adapted to the practice of this invention in its various embodiments and equivalents thereof.