Patent Grant
10576192
This application is directed to catheter pumps for mechanical circulatory support of a heart.
Heart disease is a major health problem that has high mortality rate. Physicians increasingly use mechanical circulatory support systems for treating heart failure. The treatment of acute heart failure requires a device that can provide support to the patient quickly. Physicians desire treatment options that can be deployed quickly and minimally-invasively.
Intra-aortic balloon pumps (IABP) are currently the most common type of circulatory support devices for treating acute heart failure. IABPs are commonly used to treat heart failure, such as to stabilize a patient after cardiogenic shock, during treatment of acute myocardial infarction (MI) or decompensated heart failure, or to support a patient during high risk percutaneous coronary intervention (PCI). Circulatory support systems may be used alone or with pharmacological treatment.
In a conventional approach, an IABP is positioned in the aorta and actuated in a counterpulsation fashion to provide partial support to the circulatory system. More recently minimally-invasive rotary blood pump have been developed in an attempt to increase the level of potential support (i.e., higher flow). A rotary blood pump is typically inserted into the body and connected to the cardiovascular system, for example, to the left ventricle and the ascending aorta to assist the pumping function of the heart. Other known applications pumping venous blood from the right ventricle to the pulmonary artery for support of the right side of the heart. An aim of acute circulatory support devices is to reduce the load on the heart muscle for a period of time, to stabilize the patient prior to heart transplant or for continuing support.
There is a need for improved mechanical circulatory support devices for treating acute heart failure. Fixed cross-section ventricular assist devices designed to provide near full heart flow rate are either too large to be advanced percutaneously (e.g., through the femoral artery without a cutdown) or provide insufficient flow.
There is a need for a pump with improved performance and clinical outcomes. There is a need for a pump that can provide elevated flow rates with reduced risk of hemolysis and thrombosis. There is a need for a pump that can be inserted minimally-invasively and provide sufficient flow rates for various indications while reducing the risk of major adverse events. In one aspect, there is a need for a heart pump that can be placed minimally-invasively, for example, through a 15 FR or 12 FR incision. In one aspect, there is a need for a heart pump that can provide an average flow rate of 4 Lpm or more during operation, for example, at 62 mmHg of head pressure. While the flow rate of a rotary pump can be increased by rotating the impeller faster, higher rotational speeds are known to increase the risk of hemolysis, which can lead to adverse outcomes and in some cases death. Accordingly, in one aspect, there is a need for a pump that can provide sufficient flow at significantly reduced rotational speeds. These and other problems are overcome by the inventions described herein.
Further, there is a need for a motor configured to drive an operative device, e.g., a impeller, at a distal portion of the pump. It can be important for the motor to be configured to allow for percutaneous insertion of the pump's operative device.
There is an urgent need for a pumping device that can be inserted percutaneously and also provide full cardiac rate flows of the left, right, or both the left and right sides of the heart when called for.
In one embodiment, a catheter pump is disclosed. The catheter pump can comprise an elongate catheter body. An impeller assembly can be coupled to a distal portion of the elongate catheter body. The impeller assembly can comprise an impeller configured to rotate during operation of the catheter pump. The catheter pump can comprise an access channel extending through at least portions of the elongate catheter body and the impeller assembly. The access channel can extend distal the impeller and configured to remain in the portions of the elongate catheter body and the impeller assembly during operation of the catheter pump.
In another embodiment, a method of operating a catheter pump is disclosed. The method can comprise advancing a guidewire to a treatment location in a patient. The method can include disposing a distal end of a guidewire guide tube over the guidewire. The guidewire guide tube can be disposed in a catheter pump comprising a catheter body and an impeller assembly coupled to a distal portion of the catheter body. The method can comprise advancing the impeller assembly, the catheter body, and the guidewire guide tube along the guidewire to position the impeller assembly at the treatment location. The method can include activating the impeller assembly to pump blood while maintaining the guidewire guide tube in the catheter pump.
In one embodiment, a catheter pump is disclosed. The catheter pump can include a catheter assembly. The catheter assembly can include a drive shaft having a proximal end and a distal end. An impeller may be coupled with the distal end of the drive shaft. A driven magnet assembly may be coupled with the proximal end of the drive shaft. The driven magnet assembly can include a driven magnet housing having a driven magnet. The catheter pump can further include a drive system. The drive system can include a motor having an output shaft. The drive system can also include a drive magnet assembly coupled with the output shaft. The drive magnet assembly can include a drive magnet housing with a drive magnet disposed therein. A securement device can be configured to secure the driven magnet housing into engagement with the drive magnet housing during operation of the pump.
In another embodiment, a catheter pump is disclosed. The catheter pump can include a catheter assembly. The catheter assembly can comprise a drive shaft having a proximal end and a distal end. An impeller can be coupled with the distal end of the drive shaft. A rotatable magnet can be coupled with the proximal end. The rotatable magnet can be disposed in a driven magnet housing. Furthermore, the catheter pump can include a drive system comprising a plurality of motor windings configured to induce rotation of the rotatable magnet when the driven magnet housing is engaged with the drive system. A locking device can be configured to be engaged by insertion of the driven magnet housing into an opening of the drive system.
In yet another embodiment, a method is disclosed. The method can include inserting a proximal portion of a catheter assembly containing a magnet into a recess of a drive unit. The method can further include engaging a locking device to secure the proximal portion of the catheter assembly to the drive unit.
In another embodiment, a catheter assembly is disclosed. The catheter assembly can include a catheter body having a proximal portion and a distal portion. An operative device can be coupled to the distal portion of the catheter body. A tip member can be coupled to a distal portion of the operative device. The tip member can have a lumen comprising a first section and a second section connected to the first section. An inner diameter of the first section can be larger than an inner diameter of the second section.
In one embodiment, a catheter pump is provided that includes a catheter assembly and a drive system, and a securement device. The catheter assembly includes a drive shaft, an impeller, and a driven assembly. The drive shaft has a proximal end and a distal end. The impeller is coupled with the distal end of the drive shaft. The driven assembly may be coupled with the proximal end of the drive shaft, the driven assembly is disposed in a driven housing. The drive system includes a motor having an output shaft and a output drive assembly coupled with the shaft. The drive assembly includes a drive housing with at least one magnet disposed therein. The securement device is configured to prevent disengagement of the driven housing from the drive housing during operation of the pump.
In one embodiment, a catheter pump is provided that includes a catheter assembly and a drive system, and a damper. The catheter assembly includes a drive shaft, an impeller, and a driven member. The drive shaft has a proximal end and a distal end. The impeller is coupled with the distal end of the drive shaft. The driven member is coupled with the proximal end of the drive shaft. The drive system includes a motor having an output shaft and a drive member coupled with the output shaft.
In one variant, the catheter pump can have a damper disposed between the drive and driven member. The damper can be configured to isolate the drive member or the motor from vibration in the catheter assembly. The damper can be configured to suppress noise at or around the connection between the drive and drive members.
Preferably, the damper is disposed radially around the output shaft, e.g., completely surrounding the output shaft. The damper can be disposed between separable housings of the catheter assembly and drive system, e.g., abutting a distal face of a drive system housing and a proximal face of a driven member housing disposed on the proximal end of the catheter assembly.
This embodiment can be augmented in some embodiments with a disconnectable coupling between the drive and driven members. For example, a securement device can be configured to permit selective disengagement of these components from each other. The securement device can be configured to prevent disengagement of the driven housing from the drive housing during operation of the pump.
Connection of the drive and driven members can be by the mutual attraction of opposing poles of permanent magnets disposed therein. Alternatively, the driven member can be positioned to be acted upon magnetic fields generated in the winding, e.g., using commutation in the windings. In another embodiment, the drive and driven members are coupled using direct mechanical drive, such as with gears, splines or other abutting surfaces.
In another embodiment, a catheter pump is provided that has a catheter assembly, a drive system, and a locking device. The catheter assembly has a drive shaft that has a proximal end and a distal end. An impeller is coupled with the distal end of the drive shaft. A rotatable magnet is coupled with the proximal end of the drive shaft. The rotatable magnet is disposed in a driven magnet housing. The drive system has a plurality of motor windings configured to induce rotation of the rotatable magnet after the driven magnet housing is engaged with the drive system. The locking device is configured to be engaged by insertion of the driven magnet housing into a portion or recess of the drive system.
Rotation can be induced in the rotatable magnet by the mutual attraction of opposing poles of permanent magnets. The rotatable magnet can be an assembly having one or a first plurality of permanent magnets and one or a second plurality of permanent magnets can be mounted on a shaft of the motor having the motor windings. Pairing of opposite poles of two magnets or of the magnets of the first and second pluralities of permanent magnets can induce rotation that can be transferred to the drive shaft. Alternatively, the rotatable magnet can be positioned to be acted upon magnetic fields generated in the winding, e.g., using commutation in the windings.
In another embodiment, a method is provided. A proximal portion of a catheter assembly containing a magnet is inserted into a recess of a drive unit. A locking device is engaged to secure the proximal portion of the catheter assembly to a distal portion of the drive unit.
A more complete appreciation of the subject matter of this application and the various advantages thereof can be realized by reference to the following detailed description, in which reference is made to the accompanying drawings in which:
More detailed descriptions of various embodiments of components for heart pumps useful to treat patients experiencing cardiac stress, including acute heart failure, are set forth below.
This application is directed to apparatuses for inducing motion of a fluid relative to the apparatus. For example, an operative device, such as an impeller, can be coupled at a distal portion of the apparatus. In particular, the disclosed embodiments generally relate to various configurations for a motor adapted to drive an impeller at a distal end of a catheter pump, e.g., a percutaneous heart pump. The disclosed motor assembly may be disposed outside the patient in some embodiments. In other embodiments, the disclosed motor assembly can be miniaturized and sized to be inserted within the body.
A catheter system 80 that can be coupled with the motor 14 houses an impeller within a distal portion thereof. In various embodiments, the impeller is rotated remotely by the motor 14 when the pump 10 is operating. For example, the motor 14 can be disposed outside the patient. In some embodiments, the motor 14 is separate from the controller 22, e.g., to be placed closer to the patient. In other embodiments, the motor 14 is part of the controller 22. In still other embodiments, the motor is miniaturized to be insertable into the patient. Such embodiments allow a drive shaft conveying torque to an impeller or other operating element at the distal end to be much shorter, e.g., shorter than the distance from the aortic valve to the aortic arch (about 5 cm or less). Some examples of miniaturized motors catheter pumps and related components and methods are discussed in U.S. Pat. Nos. 5,964,694; 6,007,478; 6,178,922; and 6,176,848, all of which are hereby incorporated by reference herein in their entirety for all purposes. Various embodiments of a motor are disclosed herein, including embodiments having separate drive and driven assemblies to enable the use of a guidewire guide passing through the catheter pump. As explained herein, a guidewire guide can facilitate passing a guidewire through the catheter pump for percutaneous delivery of the pump's operative device to a patient's heart.
In some embodiments, the guidewire guide can be removable from the patient once the catheter pump is positioned in the anatomy. In other embodiments, the guidewire guide can be configured as an access port or access channel to provide access to the heart while the impeller is rotating. For example, the access channel or guidewire guide may be permanently or non-removably disposed in the catheter pump such that the guidewire guide remains in the catheter pump during operation. In other arrangements, the guidewire guide can remain in the catheter pump and patient during operation but can be removed by the clinician when desired. Providing such an access channel (e.g., a guidewire guide) can enable the clinician to have access to the heart during the procedure for various purposes. For example, one or more sensors can be disposed through the access channel to measure fluid properties during the procedure. Medications or other chemicals may be delivered through the access channel during the procedure. Furthermore, the use of a guidewire guide that remains in the patient during treatment can enable the clinician to reinsert the guidewire to reposition the catheter pump if the catheter pump becomes misaligned during the procedure. It should be appreciated that, although the guidewire guide may be described as permanent or non-removable in various embodiments, this is meant to designate a guidewire guide that is configured to remain in the catheter pump during operation of the catheter pump, even if the guidewire guide is physically capable of being removed from the catheter pump, e.g., by disassembly of the catheter pump and/or by suitable forces being applied to the guidewire guide. Indeed, in various embodiments, the access channel or guidewire guide is configured to be removed from the catheter pump when desired by the clinician.
In some embodiments, the impeller assembly 92 includes a self-expanding material that facilitates expansion. The catheter body 84 on the other hand preferably is a polymeric body that has high flexibility.
The mechanical components rotatably supporting the impeller within the impeller assembly 92 permit high rotational speeds while controlling heat and particle generation that can come with high speeds. The infusion system 26 delivers a cooling and lubricating solution (sometimes referred to herein as an operating fluid) to the distal portion of the catheter system 80 for these purposes. However, the space for delivery of this fluid is extremely limited. Some of the space is also used for return of the operating fluid. Providing secure connection and reliable routing of operating fluid into and out of the catheter assembly 80 is critical and challenging in view of the small profile of the catheter body 84.
When activated, the catheter pump system can effectively increase the flow of blood out of the heart and through the patient's vascular system. In various embodiments disclosed herein, the pump can be configured to produce a maximum flow rate (e.g. low mm Hg) of greater than 4 Lpm, greater than 4.5 Lpm, greater than 5 Lpm, greater than 5.5 Lpm, greater than 6 Lpm, greater than 6.5 Lpm, greater than 7 Lpm, greater than 7.5 Lpm, greater than 8 Lpm, greater than 9 Lpm, or greater than 10 Lpm. In various embodiments, the pump can be configured to produce an average flow rate at 62 mmHg of greater than 2 Lpm, greater than 2.5 Lpm, greater than 3 Lpm, greater than 3.5 Lpm, greater than 4 Lpm, greater than 4.25 Lpm, greater than 4.5 Lpm, greater than 5 Lpm, greater than 5.5 Lpm, or greater than 6 Lpm.
Another example of a catheter assembly 100A is illustrated in
Moving from the distal end of the catheter assembly 100A of
The priming operation can proceed by introducing fluid into the sealed priming apparatus 1400 to expel air from the impeller assembly 116A and the elongate body 174A. Fluid can be introduced into the priming apparatus 1400 in a variety of ways. For example, fluid can be introduced distally through the elongate body 174A into the priming apparatus 1400. In other embodiments, an inlet, such as a luer, can optionally be formed on a side of the primer housing 1401 to allow for introduction of fluid into the priming apparatus 1400.
A gas permeable membrane can be disposed on a distal end 1404 of the primer housing 1401. The gas permeable membrane can permit air to escape from the primer housing 1401 during priming.
The priming apparatus 1400 also can advantageously be configured to collapse an expandable portion of the catheter assembly 100A. The primer housing 1401 can include a funnel 1415 where the inner diameter of the housing decreases from distal to proximal. The funnel may be gently curved such that relative proximal movement of an impeller housing of the impeller assembly 116A causes the impeller housing to be collapsed by the funnel 1415. During or after the impeller housing has been fully collapsed, the distal end 170A of the elongate body 174A can be moved distally relative to the collapsed housing. After the impeller housing is fully collapsed and retracted into the elongate body 174A of the sheath assembly, the catheter assembly 100A can be removed from the priming housing 1400 before a percutaneous heart procedure is performed, e.g., before the pump is activated to pump blood. The embodiments disclosed herein may be implemented such that the total time for infusing the system is minimized or reduced. For example, in some implementations, the time to fully infuse the system can be about six minutes or less. In other implementations, the time to infuse can be about three minutes or less. In yet other implementations, the total time to infuse the system can be about 45 seconds or less. It should be appreciated that lower times to infuse can be advantageous for use with cardiovascular patients.
With continued reference to
In addition,
In one approach, a guidewire is first placed in a conventional way, e.g., through a needle into a peripheral blood vessel, and along the path between that blood vessel and the heart and into a heart chamber, e.g., into the left ventricle. Thereafter, a distal end opening of the catheter assembly 100A or guidewire guide can be advanced over the proximal end of the guidewire 235 to enable delivery to the catheter assembly 100A. After the proximal end of the guidewire 235 is urged proximally within the catheter assembly 100A and emerges from the guidewire opening 237 and/or guidewire guide, the catheter assembly 100A can be advanced into the patient. In one method, the guidewire guide is withdrawn proximally while holding the catheter assembly 100A. The guidewire guide is taken off of the catheter assembly 100A so that guidewire lumens from the proximal end to the distal end of the catheter assembly 100A are directly over the guidewire. In other embodiments, as explained in more detail below, the guidewire guide may be coupled with the catheter assembly 100A such that the guidewire guide is not removed during operation of the catheter pump. In such arrangements, the guidewire guide can act as an access channel to the anatomy.
Alternatively, the clinician can thus insert the guidewire 235 through the proximal guidewire opening 237 and urge the guidewire 235 along the guidewire guide tube until the guidewire 235 extends from a distal guidewire opening (not shown) in the distal end of the catheter assembly 100A. The clinician can continue urging the guidewire 235 through the patient's vascular system until the distal end of the guidewire 235 is positioned in the desired chamber of the patient's heart. As shown in
After removing at least the guidewire 235, the clinician can activate a motor to rotate the impeller and begin operation of the pump.
One problem that arises when using the guidewire 235 to guide the operative device to the heart is that a central lumen or tube (e.g., a guidewire guide) is typically formed to provide a path for the guidewire 235. In some implementations, it may be inconvenient or inoperable to provide a motor or drive assembly having a lumen through which the guidewire 235 can pass. Moreover, in some implementations, it may be desirable to provide the motor or drive assembly separate from the catheter assembly 100A, e.g., for manufacturing or economic purposes. Thus, it can be advantageous to provide a means to couple the drive assembly 203 to the driven assembly 201, while enabling the use of a guidewire guide through which a guidewire may be passed. Preferably, the drive assembly 203 can be securely coupled to the driven assembly 201 such that vibratory, axial, or other external forces do not decouple the drive assembly 203 from the driven assembly 201 during operation. Moreover, the coupling should preferably allow a motor to operate effectively so that the drive shaft is rotated at the desired speed and with the desired torque.
The drive assembly 203 can include a drive housing or a motor housing 211 having an opening 202 in a cap 212 of the motor housing 211. The motor housing 211 can also have a sliding member 213, which can be configured to couple to the patient's body by way of, e.g., a connector 291 coupled to an adhesive or bandage on the patient's body. Because the motor and motor housing 211 can have a relatively high mass, it can be important to ensure that the motor housing 211 is stably supported. In one implementation, therefore, the motor housing 211 can be supported by the patient's body by way of the sliding member 213 and the connector 291 shown in
To couple the drive assembly 203 to the driven assembly 201, the clinician or user can insert the proximal portion of the flow diverter 205 into the opening 202 in the cap 212 of the motor housing 212. After passing through the opening 202, the proximal portion of the flow diverter can reside within a recess formed within the motor housing 211. In some implementations, a securement device is configured to lock or secure the drive assembly 203 to the driven assembly 201 once the driven assembly 201 is fully inserted into the drive assembly 203. In other implementations, the securement device can be configured to secure the drive assembly 203 to the driven assembly 201 by inserting the driven assembly 201 into the drive assembly 203 and then rotating the drive assembly 203 with respect to the driven assembly 201. In some implementations, coupling the drive assembly 203 to the driven assembly 201 may be irreversible, such that there may be no release mechanism to decouple the drive assembly 203 from the driven assembly 201. In implementations without a release mechanism, the catheter assembly 100A (including the driven assembly 201) and the motor housing 211 may be disposable components. In other implementations, however, a release mechanism may be provided to remove the drive assembly 203 from the driven assembly 201. The drive assembly 203 can thereby be used multiple times in some embodiments.
In
Turning to
When the driven assembly 201 is inserted into the opening 202, the first and second projections 240a, 240b can pass through the opening and engage the locking recess 244. In some implementations, the projections 240a, 240b and the locking recess 244 can be sized and shaped such that axial translation of the projections 240a, 240b through the opening 202 causes a flange or tab 248 at a distal end of each projection 240a, 240b to extend over the locking recess 244. Thus, in some embodiments, once the projections 240a, 240b are inserted through the opening 202, the tabs 248 at the distal end of the projections 240a, 240b are biased to deform radially outward to engage the locking recess 244 to secure the driven assembly 201 to the drive assembly 203.
Once the driven assembly 201 is secured to the drive assembly 203, the flow diverter housing 207 can be rotated relative to the motor cap 212. By permitting relative rotation between the driven assembly 201 and the drive assembly 203, the clinician is able to position the impeller assembly 116A within the patient at a desired angle or configuration to achieve the best pumping performance. As shown in
In one embodiment, once the catheter assembly 100A is secured to the motor housing 211, the connection between the driven assembly 201 and the drive assembly 203 may be configured such that the drive assembly 203 may not be removed from the driven assembly 201. The secure connection between the two assemblies can advantageously ensure that the motor housing 211 is not accidentally disengaged from the catheter assembly 100A during a medical procedure. In such embodiments, both the catheter assembly 100A and the drive assembly 203 may preferably be disposable.
In other embodiments, however, it may be desirable to utilize a re-usable drive assembly 203. In such embodiments, therefore, the drive assembly 203 may be removably engaged with the catheter assembly 100A (e.g., engaged with the driven assembly 201). For example, the lip 242 may be sized and shaped such that when the drive assembly 203 is rotated relative to the driven assembly 201, the tabs 248 are deflected radially inward over the lip 242 such that the driven assembly 201 can be withdrawn from the opening 202. For example, the lip 242 may include a ramped portion along the sides of the lip 242 to urge the projections 240a, 240b radially inward. It should be appreciated that other release mechanisms are possible.
Turning to
In further embodiments, a damping material can also be applied around the motor 220 to further dampen vibrations. The damping material can be any suitable damping material, e.g., a visco-elastic or elastic polymer. For example, the damping material may be applied between the motor mount 226 and the motor 220 in some embodiments. In addition, the damping material may also be applied around the body of the motor 220 between the motor 220 and the motor housing 211. In some implementations, the damping material may be captured by a rib formed in the motor housing 211. The rib may be formed around the motor 220 in some embodiments.
Turning to
In the implementation of
In some implementations, a guidewire (not shown in
Furthermore, the drive assembly 403 can mechanically couple to the driven assembly 401. For example, a distal end portion 479 of the extension shaft 471 may be inserted into an opening in a flow diverter housing 455. The distal end portion 479 of the extension shaft 471 may be positioned within a recess 451 and may couple to a proximal end of a drive cable 450 that is mechanically coupled to the impeller assembly. A rotary seal 461 may be positioned around the opening and can be configured to seal the motor 420 and/or motor housing 475 from fluid within the flow diverter 405. Advantageously, the embodiments of
Turning to
The distal tip member 304 can comprise a flexible, central body 306, a proximal coupling member 308, and a rounded tip 310 at the distal end of the tip member 304. The central body 306 can provide structural support for the distal tip member 304. The proximal coupling member 308 can be coupled to or integrally formed with the central body 306. The proximal coupling member 308 can be configured to couple the distal end of the cannula housing 302 to the distal tip member 304. The rounded tip 310, also referred to as a ball tip, can be integrally formed with the central body 306 at a distal end of the tip member 304. Because the rounded tip 310 is flexible and has a round shape, if the tip member 304 contacts or interacts with the patient's anatomy, the rounded tip 310 can have sufficient compliance so as to deflect away from the anatomy instead of puncturing or otherwise injuring the anatomy. As compared with other potential implementations, the distal tip member 304 can advantageously include sufficient structure by way of the central body 306 such that the tip member 304 can accurately track the guidewire 235 to position the impeller assembly within the heart. Yet, because the tip member 304 is made of a flexible material and includes the rounded tip 310, any mechanical interactions with the anatomy can be clinically safe for the patient.
One potential problem with the embodiment of
Additionally, as explained herein, the cannula housing 302 (which may form part of an operative device) may be collapsed into a stored configuration in some embodiments such that the cannula housing is disposed within an outer sheath. When the cannula housing 302 is disposed within the outer sheath, a distal end or edge of the outer sheath may abut the tip member 304. In some cases, the distal edge of the outer sheath may extend over the tip member 304A, or the sheath may have an outer diameter such that the distal edge of the outer sheath is exposed. When the sheath is advanced through the patient's vasculature, the distal edge of the outer sheath may scratch, scrape, or otherwise harm the anatomy. There is a therefore a need to prevent harm to the patient's anatomy due to scraping of the distal edge of the sheath against the vasculature.
However, unlike the embodiment of
Furthermore, the guidewire guide tube 312A of
The embodiment illustrated in
The clinician may insert the proximal end of the guidewire (such as the guidewire 235 described above) proximally through the distal lumen 313 passing through the rounded tip 310A at the distal end of the tip member 304A. Because the tip member 304A is flexible, the clinician can easily bend or otherwise manipulate the distal end of the tip member 304A to accommodate the small guidewire. Unlike the guidewire guide tube 312A, which may be generally stiffer than the tip member 304A, the clinician may easily deform the tip member 304A to urge the guidewire into the distal lumen 313. Once the guidewire is inserted in the distal lumen 313, the clinician can urge the guidewire proximally past the stepped portion 311 and into the larger guidewire guide tube 312A, which may be positioned within the proximal lumen 315. Furthermore, since most commercial guidewires include a coating (e.g. a hydrophilic or antomicrobial coating, or PTFE coating), the exemplary guide tube and shoulder advantageously avoid damaging or removing the coating. When the wall thickness of the guidewire guide tube 312A is less than the height of the step or shoulder 311, the shoulder 311 may substantially prevent the guidewire guide tube 312A from scraping the exterior coating off of the guidewire. Instead, the guidewire easily passes from the distal lumen 313 to the proximal lumen 315. The guidewire may then be urged proximally through the impeller and catheter assembly until the guidewire protrudes from the proximal end of the system, such as through the proximal guidewire opening 237 described above with reference to
The guidewire guide tubes 312, 312A described above with reference to
However, in some arrangements, it may be advantageous to provide a tubular access port or access channel that provides access to the heart during treatment. The access channel can comprise a body having a lumen therethrough, such as a tube or similar structure. In some embodiments, the access channel can comprise a guidewire guide configured to remain in the catheter pump (and therefore the patient's vascular system) during treatment. In some embodiments, the guidewire guide may be non-removable or permanent; in other embodiments, the guidewire guide can be removed by the clinician if required or desired. In some arrangements, the guidewire guide may be fixed or secured to the catheter assembly such that the guidewire guide remains coupled to the catheter assembly during insertion and during the treatment procedure (e.g., when the impeller rotates at operational speeds). Thus, in some embodiments, a guidewire can be inserted through the guidewire guide as explained above. The guidewire may be advanced through the vasculature of the patient to the desired treatment region (e.g., the left ventricle in some embodiments). The catheter assembly with the guidewire guide may pass over the guidewire through the vasculature of the patient to position the impeller assembly and cannula in a chamber of the heart. The guidewire can be removed before operation of the pump, but the guidewire guide may remain disposed in the catheter assembly during the treatment procedure.
Advantageously, an access channel (e.g., a tube, such as a guidewire guide, comprising an internal channel) can give the clinician access to the heart during treatment. For example, if the cannula and impeller assembly become misaligned during treatment, the clinician can simply reinsert the guidewire through the access channel (e.g., a guidewire guide), and can move the catheter assembly to the desired position. In addition, one or more sensors can be disposed through the access channel to measure and transmit various fluid properties (e.g., pressure, temperature, flow rate, concentration, etc.) to a console or system controller. The access channel can also enable delivery of various chemicals and/or medications to the heart during a treatment procedure. Such medications may include, but are not limited to, antithrombotics, antiplatelets, anticoagulants (e.g. heparin or warfarin), superaspirins, thrombolytics, inotropes, vasopressors and vasodilators, diuretics, and anitretrovirals. The exemplary structure described above advantageously allows easy delivery of medication to the left ventricle or right ventricle, whichever the case may be, without requiring a separate catheter.
In some embodiments, the access channel can be similar to the guidewire guide 312A shown in
In particular, a guidewire can be inserted through the access channel 312B (e.g., a guidewire guide), as described above with respect to guidewire guide 312A. However, unlike the guidewire guide 312A described above, the access channel 312B can remain disposed in the catheter assembly as the catheter assembly is advanced through the vascular system of the patient. Further, the access channel 312B can remain disposed in the catheter assembly while the impeller rotates to pump blood through the catheter assembly. In some embodiments, the access channel 312B (e.g., a stationary guidewire guide) can remain substantially stationary relative to the impeller, such that the impeller rotates about the access channel 312B.
During operation of the impeller, the clinician may use the access channel 312B to access the heart. As explained above, the impeller assembly 92 may become misaligned during a procedure. To re-align and/or reposition the impeller assembly 92, the clinician may reinsert a guidewire through the access channel 312B, and can move the impeller assembly 92 proximally or distally relative to the guidewire to reposition the impeller assembly 92. Furthermore, the clinician may deliver medications or chemicals through the access channel 312B during a treatment. Various types of sensors may also pass through the access channel 312B to measure properties of blood flowing through the pump, such as pressure, flow rate, temperature, chemical or biological composition, etc.
The access channel 312C can include one or more windows 337A, 337B formed through a side wall of the access channel 312C. The windows 337A, 337B can provide fluid communication between an internal channel of the access channel 312C and blood flowing through the impeller assembly 92. For example, in some embodiments, a sensor connector 335 can pass through the channel of the access channel 312C, and a sensor tip 336 at a distal end of the connector 335 can be disposed adjacent a window 337A, 337B (e.g., window 337B as shown in
In other arrangements, the sensor tip 336 can be advanced through the access channel 312C to a location near a distal opening 339 of the access channel 312C. The distal opening 339 can provide fluid communication between the sensor tip 316 and distal opening 338 of the tip member 304A. For example, the sensor tip 316 can measure properties of the blood through the distal opening 339 of the access channel 312C and the distal opening 338 of the tip member 304A. In still other arrangements, the clinician can supply a chemical or medication to the heart during treatment by passing the chemical or medication through the internal channel of the tube 312C and into the patient by way of the window 337A or 337B or the distal openings 339, 338 of the tube 312C and tip member 304A, respectively. Although the windows 337A, 337B are shown as distal the impeller in
The access channel 312B, 312C disclosed herein can have walls sufficiently thick to support the tube 312B, 312C as it traverses the anatomy, e.g., the aortic arch. For example, the tube 312B, 312C can comprise a nitinol tube having a wall thickness of about 0.020″×0.025″, or about 0.020″×0.023″, in various arrangements. In addition, one or more fluid seals can be disposed along the guidewire guide 312B, 312C to prevent fluid from flowing out proximally of the catheter assembly. The seal(s) can be disposed near the impeller assembly 316A in some arrangements, while in other arrangements, the seal(s) can be disposed in the catheter body 84.
Accordingly, as explained herein, a tubular access channel can permit the clinician to have access to the heart during a treatment procedure, e.g. while the impeller is rotating. During a treatment procedure, for example, the clinician may insert a guidewire through an access channel (e.g., a guidewire guide tube). The access channel can be disposed in a catheter pump comprising a catheter body and an impeller assembly coupled to a distal portion of the catheter body. The clinician can advance the guidewire to a treatment location in a patient, such as a left ventricle of the patient's heart. The clinician can advance at least the impeller assembly, the catheter body, and the tubular access channel along the guidewire to position the impeller assembly at the treatment location. The clinician can activate the impeller assembly to pump blood while maintaining the access channel in the catheter pump.
The clinician can remove the guidewire from the patient before activating the impeller assembly. In some embodiments, the clinician can insert a sensor through the access channel and can advance the sensor to a location near the treatment location. The sensor can measure a property of the pumped blood. In some arrangements, the impeller assembly may become misaligned from the desired treatment location. The clinician can re-align the impeller assembly by deactivating the impeller assembly and inserting a second guidewire through the access channel while the access channel remains in the patient. The clinician can reposition the impeller assembly using the second guidewire. In some embodiments, the clinician can dispense a chemical or medication to the treatment location through the access channel. Advantageously, the access channel can provide the clinician with access to the heart during a treatment procedure.
Although the inventions herein have been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present inventions. It is therefore to be understood that numerous modifications can be made to the illustrative embodiments and that other arrangements can be devised without departing from the spirit and scope of the present inventions as defined by the appended claims. Thus, it is intended that the present application cover the modifications and variations of these embodiments and their equivalents.
This application is a Continuation of U.S. patent application Ser. No. 14/687,382 filed on Apr. 15, 2015, now issued U.S. Pat. No. 9,827,356, which claims the benefit of priority to U.S. Provisional Patent Application No. 61/979,952 filed on Apr. 15, 2014, each of which is hereby incorporated herein by reference in its entirety.
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| Number | Date | Country | |
|---|---|---|---|
| 20180055980 A1 | Mar 2018 | US |
| Number | Date | Country | |
|---|---|---|---|
| 61979952 | Apr 2014 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 14687382 | Apr 2015 | US |
| Child | 15794609 | US |
