US20230302270A1 - Minimally invasive vad installation system and method - Google Patents
Minimally invasive vad installation system and method Download PDFInfo
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- US20230302270A1 US20230302270A1 US18/126,178 US202318126178A US2023302270A1 US 20230302270 A1 US20230302270 A1 US 20230302270A1 US 202318126178 A US202318126178 A US 202318126178A US 2023302270 A1 US2023302270 A1 US 2023302270A1
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- shaft
- installation system
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
- A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
- A61M60/148—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
- A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
- A61M60/178—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/20—Type thereof
- A61M60/205—Non-positive displacement blood pumps
- A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
- A61M60/226—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller the blood flow through the rotating member having mainly radial components
- A61M60/232—Centrifugal pumps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/80—Constructional details other than related to driving
- A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
- A61M60/861—Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body
- A61M60/863—Apex rings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/80—Constructional details other than related to driving
- A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
- A61M60/865—Devices for guiding or inserting pumps or pumping devices into the patient's body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/80—Constructional details other than related to driving
- A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
- A61M60/89—Valves
- A61M60/892—Active valves, i.e. actuated by an external force
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
- A61B17/3421—Cannulas
- A61B17/3423—Access ports, e.g. toroid shape introducers for instruments or hands
- A61B2017/3425—Access ports, e.g. toroid shape introducers for instruments or hands for internal organs, e.g. heart ports
Definitions
- the claimed invention relates to surgical devices, and more specifically to surgical devices to assist with the minimally invasive installation of a ventricular assist device (VAD) such as a left ventricular assist device (LVAD).
- VAD ventricular assist device
- LVAD left ventricular assist device
- Heart disease Patients suffering from heart disease are often dealing with a progressively worsening situation when it comes to the viability of their heart. Due to underlying congenital and/or physical factors, the heart is continually pushed more and more until the point where the heart becomes unable to push hard enough to circulate blood effectively throughout the patient's body. At his point, if a patient does not receive a heart transplant, the patient will often die of congestive heart failure or one of a number of complicating scenarios. Unfortunately, the number of patients in need of a heart transplant far exceeds the number of donor hearts which are available.
- VAD ventricular assist device
- an inflow side of the VAD could be inserted through the heart wall into the left ventricle, while the outflow side of the VAD could be reconnected into the aorta which feeds blood to the rest of the patient's body.
- the left ventricle often is most in need of assistance for such patients, so for convenience, the remainder of this specification will discuss the inventive concepts herein with regard to left ventricular assist devices (LVADs). However, it should be understood that other types of VADs would be applicable, too.
- the traditional manner of installing an LVAD is via a full sternotomy.
- the full access provided to the patient's chest with a sternotomy makes it simpler for the LVAD to be installed, since typically, one surgeon is attaching the pump to the ventricle while another surgeon is creating an anastomosis for the outflow into the aorta.
- the LVAD is merely a bridge to transplant
- the adhesions and scar tissue under the healed sternotomy can be very difficult to cut through for the heart transplant. Therefore, it would be desirable to have a minimally invasive LVAD installation system and method which does not require a sternotomy, thereby improving patient outcomes.
- a minimally invasive VAD installation system has a curved hook having another hook at its distal end.
- the installation system also has a valve insertion tool having a gimbaled set of clamp jaws configured for releasably holding the inflow tube of a VAD pump.
- the installation system further has a pushing tool having a distal opening configured to pass over a tube.
- FIG. 1 illustrates an example ventricular assist device positioned for installation onto a flange which has been surgically attached to the apex of a heart.
- FIG. 2 is an enlarged view of the flange from FIG. 1
- FIGS. 3 A and 3 B are front and rear elevational views, respectively of a curved hook which can be manipulated through a thoracotomy and pivoted under each of the crossbars of a flange in turn to snare a suture and pull it under the crossbar and out of the thoracotomy.
- FIGS. 4 A and 4 B illustrate the process of using the curved hook to pull a suture under one of the flange crossbars while the flange is mounted to the heart.
- FIG. 5 illustrates one embodiment of a tube through which the ends of a flange-surrounding suture have been passed.
- FIG. 6 is a perspective view of one embodiment of an insertion tool for grasping a VAD pump.
- FIG. 7 is a partially exposed perspective view of the insertion tool of FIG. 6 , with a portion of the handle removed to show the inner workings.
- FIGS. 8 A- 8 E are exploded perspective views of portions of the insertion tool of FIGS. 6 and 7 which illustrate their assembly.
- FIG. 9 is a side view of the insertion tool of FIG. 6 illustrating the closing of the clamp jaws when the device lever is squeezed.
- FIG. 10 is a side view of the insertion tool of FIG. 6 illustrating rotation of the shaft when the rotation fin is rotated.
- FIG. 11 is a side view of the insertion tool of FIG. 6 illustrating articulation of the articulation joint when the articulation knob is rotated.
- FIGS. 12 A- 12 D illustrate example positions of the gimbaled clamp jaws.
- the gimbaled clamp jaws are free to pivot on their pivot points.
- FIG. 13 shows a representation of the gimbaled clamp jaws holding the inflow tube of an HMIII LVAD.
- FIG. 14 is a perspective view of one embodiment of a pushing tool.
- FIGS. 15 A, 15 B, and 15 C are top, bottom, and side elevational views, respectively of the pushing tool from FIG. 14 .
- FIG. 16 illustrates an example where the pushing tool has been placed over such a tube coupled to a flange crossbar.
- HMIII LVAD HeartMate III
- FIG. 1 HeartMate III
- HMIII LVAD HeartMate III
- a flange 52 having a sewing cuff 54 is supplied by the manufacturer.
- the sewing cuff 54 is sutured to the apex of the heart 56 along a circle 58 marked on the cuff in black.
- the opening 60 at the center of the flange is cored to provide access into the left ventricle.
- HMIII pump 50 is shown ready to be inserted into the opening 60 in the flange 52 .
- This is attempted to be done through a small thoracotomy, however, rather than with a full sternotomy, it is difficult to work the pump 50 into the small thoracotomy access opening and further difficult to fit the pump inflow tube 62 into the flange opening 60 because this is done while the heart 56 is beating.
- FIG. 2 is an enlarged view of the flange 52 from FIG. 1 .
- the flange 52 has four crossbars 64 oriented radially every 90 degrees.
- the embodiments of VAD installation system and method disclosed herein are useful in helping to install the VAD onto the flange.
- Embodiments of the VAD installation system may comprise one or more of a curved hook, a valve insertion tool, and/or a pushing tool as disclosed in embodiments below.
- FIGS. 3 A and 3 B are front and rear elevational views, respectively of a curved hook 66 which can be manipulated through a thoracotomy and pivoted under each of the crossbars in turn to snare a suture and pull it under the crossbar and out of the thoracotomy.
- the curved hook 66 has a proximal end 66 P and a distal end 66 D.
- the proximal end 66 P has a textured grip 68 to assist with holding the curved hook 66 .
- the curved hook 66 has a main hook 69 .
- the proximal end 66 P also has an orientation feature 70 , which can assist a user of the curved hook 66 with maintaining awareness of where the main hook 69 is pointing. This is especially useful when the main hook 69 portion of the curved hook 66 is inside a patient and can't be directly visualized.
- the curved hook 66 also has an additional hook 72 at the end of the main hook 69 .
- FIGS. 4 A and 4 B illustrate the process of using the curved hook 66 to pull a suture 74 under one of the flange crossbars 64 while the flange is 52 mounted to the heart 56 .
- the main hook 69 is first hooked under the crossbar 64 , while the additional hook 72 is manipulated to hook onto the suture 74 .
- FIG. 4 B while curved hook 66 is manipulated so that the main hook 69 is pulled out from under the crossbar 64 while the additional hook 72 continues to hook the suture 74 .
- a suture 74 may be placed under each crossbar 64 of the flange 52 .
- the ends 74 E of the suture 74 may be brought out of the patient, where they can be snared through a tube 76 such as the MINI-RUMELTM Device from LSI Solutions, Inc., of Victor, NY. (www.lsisolutions.com).
- the suture ends 74 E exiting the tube 76 can be clamped or otherwise crimped with a mechanical fastener or held to effectively couple the tube 76 to the crossbar 64 .
- An example of such a tube 76 is shown in FIG. 5 .
- the tubes can be anchored to the outside of the patient's chest, for example, with a device such as the RAM® Ring provided by LSI Solutions, Inc. of Victor, NY (www.lsisolutions.com).
- the coupled and secured tubes can act as a tether to help stabilize the flange while the heart is beating.
- FIG. 6 is a perspective view of one embodiment of an insertion tool 78 for just such use.
- the insertion tool 78 has a handle 80 from which a shaft 82 extends.
- a set of gimballing clamp jaws 84 is coupled to the shaft 82 by an articulation joint 86 .
- the shaft 82 may be rotated by turning a rotation knob 88 , and the gimballing clamp jaws 84 may be articulated by rotating an articulation knob 90 .
- the insertion tool 78 also has a lever 92 which is pivotable relative to the handle 80 . When the lever 92 is in the position illustrated in FIG. 6 , the gimbaled clamp jaws 84 are open as also illustrated. When the lever 92 is squeezed towards the handle 80 , the gimballed clamp jaws 84 close.
- FIG. 7 is a partially exposed perspective view of the insertion tool 78 of FIG. 6 , with a portion of the handle 80 removed to show the inner workings.
- the lever 92 is kept in its normal position (corresponding to the gimballed clamp jaws 84 being open) by a biasing element or spring 94 .
- the lever 92 has a lever gear 92 G which engaged a drive gear 96 .
- the drive gear 96 has a receiver 96 R which is coupled to a drive wire 98 which extends down the shaft 82 where it is also coupled to the opening clamp arm 100 .
- the rotation knob 88 is coupled to the shaft 82 and also extends into the handle 80 where it is rotatably supported by a rotation adapter 104 .
- FIGS. 8 A- 8 E are exploded perspective views of portions of the insertion tool 78 of FIGS. 6 and 7 which illustrate their assembly.
- the rotation knob 88 is shown attached to the shaft 82 .
- the faceted portion 88 F of the rotation knob 88 which is rotatably supported by the rotation adapter 104 is visible.
- An articulation wire 106 is placed into the shaft 82 , and a slideable drive gear 108 is placed into a slot 110 in shaft 82 where it is coupled to a proximal end 106 P of the articulation wire 106 .
- the articulation knob 90 is slid over the shaft 82 , is threaded onto the threads 108 T of the slideable drive gear 108 , and then also held constrained by a snap interference with one or more grooves 112 on the shaft 82 . This ensures the articulation knob 90 can rotate around the shaft 82 but can't slide up and down the shaft 82 . The result is that rotating the articulation knob 90 in one direction will cause the slideable drive gear 108 to pull the articulation wire 106 into the shaft 82 , while rotating the articulation knob 90 in an opposite direction will cause the slideable drive gear to push the articulation wire 106 out of the shaft 82 .
- a proximal end 98 P of the drive wire 98 is placed into the shaft 82 where it exits an opening 114 in the assembly from FIG. 8 A .
- the proximal end 98 P of the drive wire 98 has a ball connector 116 which engages the drive gear receiver 96 R discussed previously.
- a collar 118 may also be placed over the shaft 82 and attached in place to help prevent the articulating knob 90 from sliding up and down the shaft 82 . In such embodiments, the grooves 112 discussed previously would not be needed because the collar 118 can handle the necessary restraining.
- an articulation joint 120 is placed over the drive wire 98 and the articulation wire 106 and into the shaft 82 .
- a barrel connector 122 is coupled to the distal end 98 D of the drive wire 98 .
- the fixed clamp arm 102 is attached around the articulation joint 120 such that it is pivotable around pivot point 124 also being connected to the barrel connector 126 on the end of the articulation wire 106 .
- the term “fixed” as applied to the fixed clamp arm 102 does not mean that the clamp arm 102 does not move at all. In fact, the fixed clamp arm 102 is able to pivot around the articulation joint 120 at an angle determined by the position of the articulation wire 106 as driven by the articulation knob 90 .
- the “fixed” aspect of the fixed clamp arm 102 is that it does not move relative to the movable clamp arm 100 when the lever 92 is squeezed.
- movable clamp arm 100 which is movable towards the fixed clamp arm 102 in this embodiment.
- a cam plate 128 is also coupled to the opposite side of the articulation joint 120 to add additional support for the barrel connector 126 .
- one of the gimballing clamp jaws 84 B is pivotably coupled to the fixed clamp arm 102 at point 130 with a post 132 .
- the movable clamp arm 100 is pivotably coupled to the fixed clamp arm 102 at pivot point 134 by a pin 136 .
- the movable clamp arm 100 is also coupled to the barrel connector 122 by another pin 138 .
- the movable clamp arm 100 is rotated about the cam surface 128 C of cam plate 128 into the open position illustrated in FIG. 7 where clamp jaws 84 A and 84 B are apart.
- the movable clamp arm 100 is rotated into a closed position where the clamp jaws 84 A and 84 B come towards each other and therefore may hold onto a portion of a VAD.
- one of the gimballing clamp jaws 84 A is pivotably coupled to the movable clamp arm 100 at point 140 with a post 142 .
- FIG. 9 is a side view of the insertion tool 78 of FIG. 6 illustrating the closing of the clamp jaws 84 A, 84 B when the device lever 92 is squeezed 144 .
- FIG. 10 is a side view of the insertion tool 78 of FIG. 6 illustrating rotation of the shaft 82 when the rotation knob 88 is rotated 146 . It should be noted that lever 92 is shown still squeezed in this view, but the lever 92 does not have to be squeezed in order for the rotation knob 88 to be rotated.
- FIG. 11 is a side view of the insertion tool 78 of FIG. 6 illustrating articulation at the articulation joint 120 when the articulation knob 90 is rotated 148 . It should be noted that lever 92 is shown still squeezed in this view, but the lever 92 does not have to be squeezed in order for the articulation knob 90 to be rotated.
- FIGS. 12 A- 12 D illustrate example positions of the gimbaled clamp jaws 84 A, 84 B.
- the clamp jaws 84 A, 84 B are in the closed or clamped position around a non-visible tube of a VAD. This explains why the clamp jaws 84 A, 84 B which are free to gimbal independently of each other are tracking with each other in the different views of FIGS. 12 A- 12 D .
- This gimballing action while the clamp jaws 84 A, 84 B are closed provides helpful mobility as a surgeon is using the insertion tool to place a VAD into a patient through a mini thoracotomy.
- FIG. 13 shows a representation of the gimbaled clamp jaws 84 holding the inflow tube 62 of an HMIII LVAD 50 .
- the jaws 84 are sized so that a portion of the pump inflow 62 still protrudes from them when the insertion tool is holding the pump 50 . In this way, the inflow tube 62 may still be worked into the opening 60 in the flange 52 where the pump 50 should be inserted.
- the insertion tool may release the pump 50 and be removed from the patient.
- the pump 50 is pushed fully against the flange 52 and attached in the usual fashion (known to those skilled in the art) from this point.
- FIG. 14 is a perspective view of one embodiment of a pushing tool 150 .
- FIGS. 15 A, 15 B, and 15 C are top, bottom, and side elevational views, respectively of the pushing tool from FIG. 14 .
- the pushing tool 150 has a proximal end 150 P and a distal end 150 D.
- the proximal end 150 P has a textured grip 152 to assist with holding the pushing tool 150 .
- the pushing tool 150 is designed to have a distal opening 154 in communication with a side opening 156 .
- the proximal end 150 P also has an orientation feature 158 , which can assist a user of the pushing tool 150 with maintaining awareness of where the side opening 156 is pointing. This is especially useful when the side opening 156 of the pushing tool 150 is inside a patient and can't be directly visualized.
- the distal opening 154 and the side opening 156 are sized to fit over the MINI-RUMELTM tubes 76 installed and described earlier. This allows the pushing tool 150 to ride down the tube 76 and contact the crossbar 64 of the frame 52 , since the tube 76 has been cinched against the frame's crossbar 64 .
- FIG. 16 illustrates an example where the pushing tool 150 has been placed over such a tube 76 .
- a surgeon can use the pushing tool 150 to manipulate the frame 52 in a mainly blind situation when working through a mini thoracotomy while still having confidence that she will not be pushing on the heart itself.
- the Rumel tube 76 acts as a guide for the pushing tool 150 to ensure it aligns with the crossbar 64 .
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Abstract
A minimally invasive VAD installation system includes a curved hook having another hook at its distal end. The installation system also has a valve insertion tool having a gimbaled set of clamp jaws configured for releasably holding the inflow tube of a VAD pump. The installation system further has a pushing tool having a distal opening configured to pass over a tube.
Description
- This application claims priority to U.S. patent application Ser. No. 16/846,087 filed Apr. 10, 2020, which claims priority to U.S. Provisional Patent Application No. 62/831,860 filed Apr. 10, 2019, each of which is hereby incorporated by reference in its entirety.
- The claimed invention relates to surgical devices, and more specifically to surgical devices to assist with the minimally invasive installation of a ventricular assist device (VAD) such as a left ventricular assist device (LVAD).
- Patients suffering from heart disease are often dealing with a progressively worsening situation when it comes to the viability of their heart. Due to underlying congenital and/or physical factors, the heart is continually pushed more and more until the point where the heart becomes unable to push hard enough to circulate blood effectively throughout the patient's body. At his point, if a patient does not receive a heart transplant, the patient will often die of congestive heart failure or one of a number of complicating scenarios. Unfortunately, the number of patients in need of a heart transplant far exceeds the number of donor hearts which are available.
- Fortunately, a technology called a ventricular assist device (VAD) has been developed to help provide a “bridge to transplant”. A VAD is a pump which is coupled between a patient's ventricle and the circulatory structure which the ventricle was meant to supply with blood. In the case of the right ventricle, an inflow side of the VAD could be inserted through the heart wall into the right ventricle, while the outflow side of the VAD could be reconnected into the pulmonary artery which feeds blood to the lungs. In the case of the left ventricle, an inflow side of the VAD could be inserted through the heart wall into the left ventricle, while the outflow side of the VAD could be reconnected into the aorta which feeds blood to the rest of the patient's body. The left ventricle often is most in need of assistance for such patients, so for convenience, the remainder of this specification will discuss the inventive concepts herein with regard to left ventricular assist devices (LVADs). However, it should be understood that other types of VADs would be applicable, too.
- The traditional manner of installing an LVAD is via a full sternotomy. The full access provided to the patient's chest with a sternotomy makes it simpler for the LVAD to be installed, since typically, one surgeon is attaching the pump to the ventricle while another surgeon is creating an anastomosis for the outflow into the aorta. Unfortunately, there are at least two major downsides to installing an LVAD through a full sternotomy. First, the patient will experience significant post-operative pain and a long recovery time with the full sternotomy. Second, since the LVAD is merely a bridge to transplant, if a transplant heart later becomes available for the patient, the adhesions and scar tissue under the healed sternotomy can be very difficult to cut through for the heart transplant. Therefore, it would be desirable to have a minimally invasive LVAD installation system and method which does not require a sternotomy, thereby improving patient outcomes.
- A minimally invasive VAD installation system is disclosed. The installation system has a curved hook having another hook at its distal end. The installation system also has a valve insertion tool having a gimbaled set of clamp jaws configured for releasably holding the inflow tube of a VAD pump. The installation system further has a pushing tool having a distal opening configured to pass over a tube.
-
FIG. 1 illustrates an example ventricular assist device positioned for installation onto a flange which has been surgically attached to the apex of a heart. -
FIG. 2 is an enlarged view of the flange fromFIG. 1 -
FIGS. 3A and 3B are front and rear elevational views, respectively of a curved hook which can be manipulated through a thoracotomy and pivoted under each of the crossbars of a flange in turn to snare a suture and pull it under the crossbar and out of the thoracotomy. -
FIGS. 4A and 4B illustrate the process of using the curved hook to pull a suture under one of the flange crossbars while the flange is mounted to the heart. -
FIG. 5 illustrates one embodiment of a tube through which the ends of a flange-surrounding suture have been passed. -
FIG. 6 is a perspective view of one embodiment of an insertion tool for grasping a VAD pump. -
FIG. 7 is a partially exposed perspective view of the insertion tool ofFIG. 6 , with a portion of the handle removed to show the inner workings. -
FIGS. 8A-8E are exploded perspective views of portions of the insertion tool ofFIGS. 6 and 7 which illustrate their assembly. -
FIG. 9 is a side view of the insertion tool ofFIG. 6 illustrating the closing of the clamp jaws when the device lever is squeezed. -
FIG. 10 . is a side view of the insertion tool ofFIG. 6 illustrating rotation of the shaft when the rotation fin is rotated. -
FIG. 11 is a side view of the insertion tool ofFIG. 6 illustrating articulation of the articulation joint when the articulation knob is rotated. -
FIGS. 12A-12D illustrate example positions of the gimbaled clamp jaws. The gimbaled clamp jaws are free to pivot on their pivot points. -
FIG. 13 shows a representation of the gimbaled clamp jaws holding the inflow tube of an HMIII LVAD. -
FIG. 14 is a perspective view of one embodiment of a pushing tool. -
FIGS. 15A, 15B, and 15C are top, bottom, and side elevational views, respectively of the pushing tool fromFIG. 14 . -
FIG. 16 illustrates an example where the pushing tool has been placed over such a tube coupled to a flange crossbar. - It will be appreciated that for purposes of clarity and where deemed appropriate, reference numerals have been repeated in the figures to indicate corresponding features, and that the various elements in the drawings have not necessarily been drawn to scale in order to better show the features
- For convenience, this specification will discuss VAD installation within the context of use with a HeartMate III (HMIII)
LVAD pump 50, such as the one illustrated inFIG. 1 . It should be understood that the HMIII LVAD is just one example of a VAD which could be used with the embodiments of a minimally invasive VAD installation system that are described herein. Aflange 52 having asewing cuff 54 is supplied by the manufacturer. Thesewing cuff 54 is sutured to the apex of theheart 56 along acircle 58 marked on the cuff in black. The opening 60 at the center of the flange is cored to provide access into the left ventricle. AnHMIII pump 50 is shown ready to be inserted into the opening 60 in theflange 52. When this is attempted to be done through a small thoracotomy, however, rather than with a full sternotomy, it is difficult to work thepump 50 into the small thoracotomy access opening and further difficult to fit thepump inflow tube 62 into the flange opening 60 because this is done while theheart 56 is beating. -
FIG. 2 is an enlarged view of theflange 52 fromFIG. 1 . In this example, theflange 52 has fourcrossbars 64 oriented radially every 90 degrees. The embodiments of VAD installation system and method disclosed herein are useful in helping to install the VAD onto the flange. Embodiments of the VAD installation system may comprise one or more of a curved hook, a valve insertion tool, and/or a pushing tool as disclosed in embodiments below. -
FIGS. 3A and 3B are front and rear elevational views, respectively of acurved hook 66 which can be manipulated through a thoracotomy and pivoted under each of the crossbars in turn to snare a suture and pull it under the crossbar and out of the thoracotomy. Thecurved hook 66 has aproximal end 66P and adistal end 66D. Theproximal end 66P has a texturedgrip 68 to assist with holding thecurved hook 66. Thecurved hook 66 has amain hook 69. In this embodiment, theproximal end 66P also has anorientation feature 70, which can assist a user of thecurved hook 66 with maintaining awareness of where themain hook 69 is pointing. This is especially useful when themain hook 69 portion of thecurved hook 66 is inside a patient and can't be directly visualized. Thecurved hook 66 also has anadditional hook 72 at the end of themain hook 69. -
FIGS. 4A and 4B illustrate the process of using thecurved hook 66 to pull asuture 74 under one of theflange crossbars 64 while the flange is 52 mounted to theheart 56. As shown inFIG. 4A , themain hook 69 is first hooked under thecrossbar 64, while theadditional hook 72 is manipulated to hook onto thesuture 74. As shown inFIG. 4B , whilecurved hook 66 is manipulated so that themain hook 69 is pulled out from under thecrossbar 64 while theadditional hook 72 continues to hook thesuture 74. In this way, asuture 74 may be placed under eachcrossbar 64 of theflange 52. - Once a
suture 74 has been hooked behind across bar 64, theends 74E of thesuture 74 may be brought out of the patient, where they can be snared through atube 76 such as the MINI-RUMEL™ Device from LSI Solutions, Inc., of Victor, NY. (www.lsisolutions.com). The suture ends 74E exiting thetube 76 can be clamped or otherwise crimped with a mechanical fastener or held to effectively couple thetube 76 to thecrossbar 64. An example of such atube 76 is shown inFIG. 5 . - Since the surgeon is working through a mini thoracotomy, the tubes can be anchored to the outside of the patient's chest, for example, with a device such as the RAM® Ring provided by LSI Solutions, Inc. of Victor, NY (www.lsisolutions.com). The coupled and secured tubes can act as a tether to help stabilize the flange while the heart is beating.
- An
insertion tool 78 may be provided for grasping the HMIII pump by its inflow tube.FIG. 6 is a perspective view of one embodiment of aninsertion tool 78 for just such use. Theinsertion tool 78 has ahandle 80 from which ashaft 82 extends. At thedistal end 78D of thedevice 78, a set ofgimballing clamp jaws 84 is coupled to theshaft 82 by an articulation joint 86. Theshaft 82 may be rotated by turning arotation knob 88, and thegimballing clamp jaws 84 may be articulated by rotating anarticulation knob 90. Theinsertion tool 78 also has alever 92 which is pivotable relative to thehandle 80. When thelever 92 is in the position illustrated inFIG. 6 , thegimbaled clamp jaws 84 are open as also illustrated. When thelever 92 is squeezed towards thehandle 80, thegimballed clamp jaws 84 close. -
FIG. 7 is a partially exposed perspective view of theinsertion tool 78 ofFIG. 6 , with a portion of thehandle 80 removed to show the inner workings. Thelever 92 is kept in its normal position (corresponding to thegimballed clamp jaws 84 being open) by a biasing element orspring 94. Thelever 92 has alever gear 92G which engaged adrive gear 96. Thedrive gear 96 has areceiver 96R which is coupled to adrive wire 98 which extends down theshaft 82 where it is also coupled to theopening clamp arm 100. When thelever 92 is squeezed, thelever gear 92G rotates, causing thedrive gear 96 also to rotate, by which thedrive gear receiver 96R pulls thedrive wire 98, which therefore causes themovable clamp arm 100 to pivot towards the fixedclamp arm 102. This brings the first andsecond clamp jaws rotation knob 88 is coupled to theshaft 82 and also extends into thehandle 80 where it is rotatably supported by arotation adapter 104. -
FIGS. 8A-8E are exploded perspective views of portions of theinsertion tool 78 ofFIGS. 6 and 7 which illustrate their assembly. ReferencingFIG. 8A , therotation knob 88 is shown attached to theshaft 82. Thefaceted portion 88F of therotation knob 88 which is rotatably supported by therotation adapter 104 is visible. Anarticulation wire 106 is placed into theshaft 82, and aslideable drive gear 108 is placed into aslot 110 inshaft 82 where it is coupled to aproximal end 106P of thearticulation wire 106. Thearticulation knob 90 is slid over theshaft 82, is threaded onto thethreads 108T of theslideable drive gear 108, and then also held constrained by a snap interference with one ormore grooves 112 on theshaft 82. This ensures thearticulation knob 90 can rotate around theshaft 82 but can't slide up and down theshaft 82. The result is that rotating thearticulation knob 90 in one direction will cause theslideable drive gear 108 to pull thearticulation wire 106 into theshaft 82, while rotating thearticulation knob 90 in an opposite direction will cause the slideable drive gear to push thearticulation wire 106 out of theshaft 82. - As shown in
FIG. 8B , a proximal end 98P of thedrive wire 98 is placed into theshaft 82 where it exits anopening 114 in the assembly fromFIG. 8A . In this embodiment, the proximal end 98P of thedrive wire 98 has aball connector 116 which engages thedrive gear receiver 96R discussed previously. Acollar 118 may also be placed over theshaft 82 and attached in place to help prevent the articulatingknob 90 from sliding up and down theshaft 82. In such embodiments, thegrooves 112 discussed previously would not be needed because thecollar 118 can handle the necessary restraining. - As shown in
FIG. 8C , an articulation joint 120 is placed over thedrive wire 98 and thearticulation wire 106 and into theshaft 82. Abarrel connector 122 is coupled to thedistal end 98D of thedrive wire 98. - As shown in
FIG. 8D , the fixedclamp arm 102 is attached around the articulation joint 120 such that it is pivotable aroundpivot point 124 also being connected to thebarrel connector 126 on the end of thearticulation wire 106. The term “fixed” as applied to the fixedclamp arm 102 does not mean that theclamp arm 102 does not move at all. In fact, the fixedclamp arm 102 is able to pivot around the articulation joint 120 at an angle determined by the position of thearticulation wire 106 as driven by thearticulation knob 90. The “fixed” aspect of the fixedclamp arm 102 is that it does not move relative to themovable clamp arm 100 when thelever 92 is squeezed. Instead, it is themovable clamp arm 100 which is movable towards the fixedclamp arm 102 in this embodiment. Acam plate 128 is also coupled to the opposite side of the articulation joint 120 to add additional support for thebarrel connector 126. Additionally, one of thegimballing clamp jaws 84B is pivotably coupled to the fixedclamp arm 102 atpoint 130 with apost 132. - As shown in
FIG. 8E , themovable clamp arm 100 is pivotably coupled to the fixedclamp arm 102 atpivot point 134 by apin 136. Themovable clamp arm 100 is also coupled to thebarrel connector 122 by another pin 138. When the drive wire moves thebarrel connector 122 distally, themovable clamp arm 100 is rotated about thecam surface 128C ofcam plate 128 into the open position illustrated inFIG. 7 whereclamp jaws barrel connector 122 proximally, themovable clamp arm 100 is rotated into a closed position where theclamp jaws gimballing clamp jaws 84A is pivotably coupled to themovable clamp arm 100 atpoint 140 with apost 142. -
FIG. 9 is a side view of theinsertion tool 78 ofFIG. 6 illustrating the closing of theclamp jaws device lever 92 is squeezed 144. -
FIG. 10 . is a side view of theinsertion tool 78 ofFIG. 6 illustrating rotation of theshaft 82 when therotation knob 88 is rotated 146. It should be noted thatlever 92 is shown still squeezed in this view, but thelever 92 does not have to be squeezed in order for therotation knob 88 to be rotated. -
FIG. 11 is a side view of theinsertion tool 78 ofFIG. 6 illustrating articulation at the articulation joint 120 when thearticulation knob 90 is rotated 148. It should be noted thatlever 92 is shown still squeezed in this view, but thelever 92 does not have to be squeezed in order for thearticulation knob 90 to be rotated. -
FIGS. 12A-12D illustrate example positions of thegimbaled clamp jaws clamp jaws clamp jaws FIGS. 12A-12D . This gimballing action while theclamp jaws - The insertion tool provides articulation, clamping, and a gimbaled set of clamp jaws to provide mobility when inserting the pump through a small thoracotomy which the human hand would be too large to provide in minimally invasive surgery.
FIG. 13 shows a representation of thegimbaled clamp jaws 84 holding theinflow tube 62 of anHMIII LVAD 50. Thejaws 84 are sized so that a portion of thepump inflow 62 still protrudes from them when the insertion tool is holding thepump 50. In this way, theinflow tube 62 may still be worked into theopening 60 in theflange 52 where thepump 50 should be inserted. Once theinflow tube 62 is aligned with theflange opening 60, the insertion tool may release thepump 50 and be removed from the patient. Thepump 50 is pushed fully against theflange 52 and attached in the usual fashion (known to those skilled in the art) from this point. - During the installation of the pump, if it becomes necessary to push down on the flange, a pushing
tool 150 is also provided.FIG. 14 is a perspective view of one embodiment of a pushingtool 150.FIGS. 15A, 15B, and 15C are top, bottom, and side elevational views, respectively of the pushing tool fromFIG. 14 . The pushingtool 150 has aproximal end 150P and adistal end 150D. Theproximal end 150P has atextured grip 152 to assist with holding the pushingtool 150. The pushingtool 150 is designed to have adistal opening 154 in communication with aside opening 156. In this embodiment, theproximal end 150P also has anorientation feature 158, which can assist a user of the pushingtool 150 with maintaining awareness of where theside opening 156 is pointing. This is especially useful when theside opening 156 of the pushingtool 150 is inside a patient and can't be directly visualized. - The
distal opening 154 and theside opening 156 are sized to fit over theMINI-RUMEL™ tubes 76 installed and described earlier. This allows the pushingtool 150 to ride down thetube 76 and contact thecrossbar 64 of theframe 52, since thetube 76 has been cinched against the frame'scrossbar 64.FIG. 16 illustrates an example where the pushingtool 150 has been placed over such atube 76. With this feature, a surgeon can use the pushingtool 150 to manipulate theframe 52 in a mainly blind situation when working through a mini thoracotomy while still having confidence that she will not be pushing on the heart itself. TheRumel tube 76 acts as a guide for the pushingtool 150 to ensure it aligns with thecrossbar 64. - Various advantages of a minimally invasive LVAD installation system and method have been discussed above. Embodiments discussed herein have been described by way of example in this specification. It will be apparent to those skilled in the art that the forgoing detailed disclosure is intended to be presented by way of example only and is not limiting. Various alterations, improvements, and modifications will occur and are intended to those skilled in the art, though not expressly stated herein. These alterations, improvements, and modifications are intended to be suggested hereby, and are within the spirit and the scope of the claimed invention. Additionally, the recited order of processing elements or sequences, or the use of numbers, letters, or other designations therefore, is not intended to limit the claims to any order, except as may be specified in the claims. Accordingly, the invention is limited only by the following claims and equivalents thereto.
Claims (3)
1. A method of assembling a surgical instrument, the method comprising:
pivotably coupling a lever to a handle, the lever being displaceable relative to the handle between a first position and a second position;
coupling a proximal end of a shaft to the handle;
coupling a clamp jaw assembly to a distal end of the shaft, the clamp jaw assembly having a base member coupled to the distal end of the shaft, a first arm coupled to the base member, and a second arm pivotably coupled to the base member; and
coupling the second arm to the lever such that when the lever is in the first position, the second arm is in a first position relative to the first arm and when the lever is in the second position, the second arm is in a second position relative to the first arm.
2. The method of claim 1 , further comprising:
rotatably coupling a first jaw member to a portion of the first arm such that the first jaw member is rotatable about an axis extending through the portion of the first arm; and
rotatably coupling a second jaw member to a portion of the second arm such that the second jaw member is rotatable about an axis extending through the portion of the second arm.
3. The method of claim 1 , further comprising:
coupling an articulating joint to the distal end of the shaft, wherein a distal end of the articulating joint is pivotably coupled to a proximal portion of the base member of the clamp jaw assembly such that the base member is pivotable relative to the articulating joint.
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US18/126,178 US20230302270A1 (en) | 2019-04-10 | 2023-03-24 | Minimally invasive vad installation system and method |
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US201962831860P | 2019-04-10 | 2019-04-10 | |
US16/846,087 US11612736B2 (en) | 2019-04-10 | 2020-04-10 | Minimally invasive VAD installation system and method |
US18/126,178 US20230302270A1 (en) | 2019-04-10 | 2023-03-24 | Minimally invasive vad installation system and method |
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