Patent Application
20230380819
Methods and device for wound closure and creating an anastomosis are provided.
Many surgical procedures involve creating punctures in tissue at a surgical site or anastomosing tissue to create an anastomosis, such as a bowel anastomosis or an arteriovenous fistula between an artery and a vein. In the case of fistula formation, the purpose of such a connection is to create either a high flow connection or to create a pathway for blood around an obstruction in a replacement conduit or bypass. The conduit or bypass can generally be a vein, artery, or prosthetic graft.
An anastomosis can be created during a surgical procedure by bringing two vessels or conduits—such as bowel—into direct contact with each other and then joining them with sutures, clips, or other means. The anastomosis can be end-to-end, end-to-side, or side-to-side. When done with blood vessels, the anastomosis is typically elliptical in shape and is joined by hand with a suture. Other methods of anastomosis creation can involve carbon dioxide lasers, prostheses, clips, and stents. One type of fistula, an arteriovenous fistula, is created by connecting an artery to a vein. This type of connection can be used for hemodialysis, an increase in exercise tolerance, the treatment of hypertension, maintenance of an opening in an artery or vein, as an access path for chemotherapy, and others.
Various apparatuses have been proposed for percutaneously sealing tissue openings or for joining hollow structures in a patient's body, including biodegradable plugs, sutures, surgical fasteners, and other devices. However, these devices and associated methods have a multitude of shortcomings, including surgical risks, high failure rates, complexity, and more. Accordingly, there remains a need for improved devices and associated methods for closing tissue punctures and anastomosing tissue structures in a patient's body, or for deploying such devices in a simple and effective manner.
In general, methods and systems for creating an anastomosis and wound closure are provided.
In one embodiment, a surgical assembly is provided and includes an actuator assembly having an elongate shaft including an outer shaft and an inner shaft concentrically disposed within the outer shaft to define a fluid flow path there between, and a deployable coupler coupled to a distal end of the outer shaft. The deployable coupler can have a plurality of proximal and distal slits formed therein and can be configured to form proximal and distal wing. The proximal and distal slits can be configured to allow blood to flow therethrough into the fluid flow path to a fluid outlet port formed in the actuator assembly.
The surgical assembly can vary in a number of ways and may include any of the following features, alone or in combination. For example, the actuator assembly can include a handle operably coupled to the deployable coupler. In some aspects, the handle can include an actuator rotatable in a first direction to cause deployment of the distal wing and rotatable in a second direction to cause deployment of the proximal wing. In another aspect, the handle can include a deployment lever configured to decouple the deployable coupler from the distal end of the outer shaft. For example, the surgical assembly can include a delivery sheath configured to couple to the actuator assembly. The delivery sheath can define a central lumen configured to receive the elongate shaft. For example, a distal end of the outer shaft can include at least two opposed longitudinal gaps to allow blood to flow from the deployable coupler into the fluid flow path. In some aspects, the outer shaft can include a crown disposed around the at least two opposed longitudinal gaps. In some variations, the crown can include castellations, and the deployable coupler can be coupled to the castellations. For example, each of the slits in the plurality of proximal and distal slits can be substantially s-shaped.
In another embodiment, a surgical method is provided. The surgical method can include inserting an elongate shaft of an actuator assembly through a guide assembly extending through a puncture hole in a body lumen to position a deployable coupler coupled to a distal end of the elongate shaft within the body lumen such that blood flows into the deployable coupler, through the elongate shaft, and out of a port at a proximal end of the actuator assembly. The surgical method can also include subsequently actuating the actuator assembly to cause a distal wing on the deployable coupler to deploy radially outward. The surgical method can further include retracting the actuator assembly to pull the distal wing against an inner wall of the body lumen to cause the blood to stop flowing into the deployable coupler. The surgical method can further include actuating the actuator assembly to cause a proximal wing on the deployable coupler to deploy radially outward adjacent to an outer wall of the body lumen, thereby sealing the puncture hole in the body lumen. The surgical method can further include decoupling the deployable coupler from the distal end of the elongate shaft.
The surgical method can vary in a number of ways and may include any of the following features, alone or in combination. For example, the surgical method can include, subsequent to actuating the actuator to cause the distal wing to deploy radially outward and prior to actuating the actuator assembly to cause the proximal wing to deploy radially outward, pivoting the elongate shaft to position the distal wing relative to the inner wall of the body lumen. For example, the elongate shaft can include an inner shaft and an outer shaft concentrically disposed around the inner shaft, and blood can flow between the inner shaft and the outer shaft. In some aspects, a distal end of the outer shaft can include a pair of welded C-tubes defining gaps through which blood flows. For example, deployment of the proximal wing can include rotating the actuator assembly in a first direction. In some aspects, deployment of the distal wing can include rotating the actuator assembly in a second direction opposite the first direction.
In another embodiment, a surgical assembly is provided. The surgical assembly can include an actuator assembly including an elongate shaft a deployable coupler coupled to a distal end of the elongate shaft. The deployable coupler can include a plurality of proximal slits therein configured to form a set of proximal wing and a plurality of distal slits therein configured to form a set of distal wing. The actuator assembly can be configured to transform the deployable coupler from a delivery configuration in which the proximal wing and the distal wing are substantially parallel to the elongate shaft to a fully-deployed configuration in which one of the proximal and distal wings is substantially perpendicular to the elongate shaft and the other one of the proximal and distal wings is skew to the elongate shaft.
The surgical assembly can vary in a number of ways and may include any of the following features, alone or in combination. For example, each of the plurality of proximal slits can include first and second cuts having substantially equal lengths. The substantially equal lengths can cause the proximal wing to be substantially perpendicular to the elongate shaft in the deployed configuration. For example, each of the plurality of distal slits can include first and second cuts having substantially unequal lengths. The substantially unequal lengths can cause the distal wing to be substantially skew to the elongate shaft in the deployed configuration. For example, transformation of the deployable coupler from the delivery configuration to the deployed configuration can cause the proximal wing and the distal wing to fold about mid regions thereof. For example, the plurality of proximal slits and the plurality of distal slits can be substantially s-shaped. For example, the surgical assembly can include a secondary handle configured to couple to a proximal end of the actuator assembly. The secondary handle can have a distally extending plug configured to be passed through a central lumen at least partially defined by the elongate shaft and to be positioned within a central bore of the deployable coupler. In some aspects, the distally extending plug can be configured to seal the central bore.
In another embodiment, a surgical assembly is provided. The surgical assembly can include a delivery tool including an elongate shaft extending from a distal end thereof, and a deployable coupler coupled to a distal end of the elongate shaft. The deployable coupler can have proximal wing defined by first proximal and distal cuts and distal wing defined by second proximal and distal cuts. The delivery tool can be configured to transform the deployable coupler between a delivery configuration in which the elongate shaft is substantially parallel to the first and second wing and a deployed configuration in which the elongate shaft is substantially transverse to the first and second wing. A deployment angle of the proximal wing can be at least partially defined by a length ratio of the first proximal and distal cuts and a deployment angle of the distal wing can be at least partially defined by a length ratio of the second proximal and distal cuts.
The surgical assembly can vary in a number of ways and may include any of the following features, alone or in combination. For example, the length ratio of the first proximal and distal cuts can be substantially equal to 1 and can be configured to cause the deployment angle of the first wing to be approximately 90 degrees. For example, the length ratio of the second proximal and distal cuts can be substantially greater than 1 and can be configured to cause the deployment angle of the second wing to be substantially acute.
In another embodiment, a surgical coupler is provided. The surgical coupler can include a first tubular portion having a first plurality of longitudinal cuts, a second tubular portion having a second plurality of longitudinal cuts, and a connector portion disposed between the first and central tubular portions. Each of the longitudinal cuts in the first plurality of longitudinal cuts can have a proximal cut and a distal cut having a length ratio of approximately 1:1. Each of the longitudinal cuts in the second plurality of longitudinal cuts can have a proximal cut and a distal cut having a length ratio substantially less than 1:1. The first and second tubular portions and the connector portion can define a central lumen.
The surgical coupler can vary in a number of ways and may include any of the following features, alone or in combination. For example, the first tubular portion can be configured to reversibly form a wing that is substantially perpendicular to a longitudinal axis of the central lumen. For example, the second tubular portion can be configured to reversibly form a wing that is substantially skew to a longitudinal axis of the central lumen. For example, the connector portion can have a diameter that is greater than a diameter of the first tubular portion and a diameter of the second tubular portion. In some aspects, the diameter of the first tubular portion can be less than the diameter of the second tubular portion. For example, the coupler can be configured to couple with an actuator tool. The actuator tool can be configured to reversibly form the first and second tubular portions into wing. In some aspects, the actuator tool can be configured to receive a plug configured to prevent fluid flow the central lumen.
In another embodiment, a method is provided. The method can include inserting a delivery sheath over a guidewire through a puncture in an artery to position a deployable coupler coupled to a distal end of the delivery sheath within the artery. The method can also include pivoting the delivery sheath from an insertion orientation, in which blood can travel up the coupler, to an angled orientation, in which blood is prevented from traveling up the coupler. The method can further include actuating an actuator coupled to a proximal end of the delivery sheath to deploy a distal wing. The distal wing can be positioned within the artery adjacent to the puncture. The method can further include actuating the actuator to deploy a proximal wing on the deployable coupler such that the proximal wing are positioned outside of the artery adjacent to the puncture. The method can further include removing the guidewire from the central lumen. The method can further include advancing a plug into the central lumen of the deployable coupler to seal the puncture.
The method can vary in a number of ways and may include any of the following features, alone or in combination. For example, the plug can be operatively coupled to a secondary handle having a deployment lever thereon configured to deploy the plug into the deployable coupler. In some aspects, the method can include, after the plug is advanced into the central lumen, actuating the deployment lever to cause the plug to separate from the secondary handle. For example, the method can further include positioning the coupler relative to a puncture site using an external imaging system, the external imaging system detecting the radiopacity of the coupler.
In another embodiment, a surgical method is provided. The surgical method can include advancing a first coupler through a small intestine to a region of the small intestine proximate a gallbladder. The first coupler can be coupled to a distal end of an elongate shaft. The surgical method can also include piercing the region of the small intestine and the gallbladder using a penetrator advanced through the elongate shaft and the first coupler. The surgical method can further include advancing the first coupler at least partially within the gallbladder. The surgical method can further include deploying first distal wing of the first coupler within the gallbladder. The surgical method can further include retracting the elongate shaft to cause the first distal wing to contact an inner surface of the gallbladder. The surgical method can further include deploying first proximal wing of the first coupler within the small intestine to removably affix the first coupler to the gallbladder and the small intestine. The surgical method can further include ejecting the first coupler from the distal end of the elongate shaft.
The surgical method can vary in a number of ways and may include any of the following features, alone or in combination. For example, the surgical method can include advancing a second coupler through the small intestine into a distal ileal loop proximate a proximal ileal loop. The second coupler can be coupled to the distal end of the elongate shaft. The surgical method can also include piercing through an inner wall of the distal ileal loop to enter the proximal ileal loop using the penetrator advanced through the elongate shaft and the second coupler. The surgical method can further include deploying second distal wing of the second coupler within the proximal ileal loop. The surgical method can further include retracting the elongate shaft to cause the second distal wing to contact an inner surface of the proximal ileal loop. The surgical method can further include deploying second proximal wing of the second coupler within the distal ileal loop to removably affix the second coupler to the proximal ileal loop and the distal ileal loop. The surgical method can further include ejecting the second coupler from the distal end of the elongate shaft. For example, at least one of the first proximal wing and the first distal wing can deploy at an acute angle relative to a longitudinal axis of the elongate shaft. In some aspects, the other of the first proximal wing and the first distal wing can deploy at an acute angle relative to a longitudinal axis of the elongate shaft. In other aspects, a radial tip of the first proximal wing, in a deployed configuration, can contact an inner wall of the small intestine and a radial tip of the first distal wing, in a deployed configuration, contacts an inner wall of the gallbladder. For example, an angle of deployment of the first proximal wing and an angle of deployment of the first distal wing can be substantially equal. A length of the first proximal wing and a length of the first distal wing can be substantially equal. For example, the first proximal wing can include a first plurality of petals and the first distal wing can include a second plurality of petals. The first plurality of petals can be rotatably offset from the second plurality of petals.
In another embodiment, a method is provided. The method can include deploying, via an actuator tool having an elongate shaft and a first coupler coupled to a distal end of the elongate shaft, first distal wing of the first coupler within a gallbladder and first proximal wing of the first coupler within an ileum. The method can also include deploying, via the actuator tool having a second coupler coupled to the distal end, second distal wing of the second coupler within a first loop of the ileum distal to the deployed first coupler, and second proximal wing of the second coupler within a second loop of the ileum proximal to the deployed first coupler. The first coupler can define a first central lumen configured to fluidly join the gallbladder and the ileum therethrough. The second coupler can define a second central lumen configured to fluidly join the first and second loops therethrough.
The method can vary in a number of ways and may include any of the following features, alone or in combination. For example, the method can include piercing through a wall of the ileum and through a wall of the gall bladder with a penetrator coupled to the distal end of the elongate shaft to position the first coupler at least partially within the gallbladder and at least partially within the ileum. In some aspects, at least one of the first proximal wing and the first distal wing can deploy at an acute angle relative to a longitudinal axis of the elongate shaft. In some variations, the other of the first proximal wing and the first distal wing can deploy at an acute angle relative to a longitudinal axis of the elongate shaft. In other variations, a radial tip of the first proximal wing, in a deployed configuration, can contact an inner wall of the small intestine in and a radial tip of the first distal wing, in a deployed configuration, can contact an inner wall of the gallbladder. In other aspects, the angle of deployment of the first proximal wing and the angle of deployment of the first distal wing can be substantially equal. The length of the first proximal wing and the length of the first distal wing can be substantially equal. In further aspects, the first proximal wing can include a first plurality of petals and the first distal wing can include a second plurality of petals. The first plurality of petals can be rotatably offset from the second plurality of petals.
In another embodiment, a method is provided. The method can include introducing a first coupler into an ileum. The first coupler can be attached to an elongate shaft extending distally from an actuator tool. The first coupler and the elongate shaft can define a first central lumen therethrough. The method can also include contacting an outer wall of the ileum adjacent an outer wall of a gallbladder with a distal end of the first coupler. The method can further include extending a first penetrator through the first central lumen to pierce the inner wall of the ileum and the outer wall of the gallbladder. The method can further include advancing the first coupler from the ileum and into the gallbladder. The method can further include deploying, with the actuator tool, distal wing of the first coupler within the gallbladder. The method can further include retracting the first coupler to contact an inner wall of the gallbladder with the distal wing. The method can further include deploying, with the actuator tool, proximal wing of the first coupler within the ileum. The gallbladder and the ileum can be in fluid communication via the first coupler. The method can further include de-coupling the first coupler from the elongate shaft.
The method can vary in a number of ways and may include any of the following features, alone or in combination. For example, the method can include introducing a second coupler into a distal ileal loop distal of the first coupler. The second coupler can be attached to the elongate shaft. The second coupler and the elongate shaft can define a second central lumen therethrough. The method can also include incising a region of a proximal ileal loop proximal of the first coupler. The method can further include contacting an outer wall of the distal ileal loop adjacent the incised region of the proximal ileal loop. The method can further include extending a second penetrator through the second central lumen to pierce the inner wall of the distal ileal loop and the incised region. The method can further include advancing the second coupler from the distal ileal loop into the proximal ileal loop through the incised region. The method can further include deploying, with the actuator tool, distal wing of the second coupler within the proximal ileal loop. The method can further include retracting the second coupler to contact an inner wall of the proximal ileal loop with the distal wing. The method can further include deploying, with the actuator tool, proximal wing of the second coupler within the distal ileal loop. The proximal and distal ileal loops can be in fluid communication via the second coupler. The method can further include de-coupling the second coupler from the elongate shaft.
In another embodiment, a method is provided, including inserting a sheath through an ileum and into a gallbladder, advancing an expandable coupler coupled to a distal end of an actuator tool through the sheath and into the gallbladder, retracting the sheath from the gallbladder, deploying, with the actuator tool, a distal wing of the expandable coupler within the gallbladder, deploying, with the actuator tool, a proximal wing of the expandable coupler within the ileum, and de-coupling the expandable coupler from the actuator tool. The gallbladder and the ileum can be in fluid communication via the deployed expandable coupler.
The details of one or more variations of the subject matter described herein are set forth in the accompanying drawings and the description below. Other features and advantages of the subject matter described herein will be apparent from the description and drawings, and from the claims.
These and other features will be more readily understood from the following detailed description taken in conjunction with the accompanying drawings, in which:
It is noted that the drawings are not necessarily to scale. The drawings are intended to depict only typical aspects of the subject matter disclosed herein, and therefore should not be considered as limiting the scope of the disclosure.
Certain illustrative embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting illustrative embodiments and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one illustrative embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.
Further, in the present disclosure, like-named components of the embodiments generally have similar features, and thus within a particular embodiment each feature of each like-named component is not necessarily fully elaborated upon. Additionally, to the extent that linear or circular dimensions are used in the description of the disclosed systems, devices, and methods, such dimensions are not intended to limit the types of shapes that can be used in conjunction with such systems, devices, and methods. A person skilled in the art will recognize that an equivalent to such linear and circular dimensions can easily be determined for any geometric shape.
Surgical assemblies for use with anastomotic couplers and closure couplers are provided. In general, the surgical assembly can include an actuator device configured to deploy an anastomotic coupler within a patient to join and fluidly link tissue. The actuator device can include a handle having an elongate shaft extending distally therefrom. A distal end of the elongate shaft can have an anastomotic coupler affixed thereto, and the handle can be actuated to cause the affixed coupler to reversibly deploy one or more proximal and/or distal wing to couple the tissue therebetween. The coupler can then be decoupled from the elongate shaft. In the case of the closure coupler, prior to deployment of the one or more proximal and/or distal wing, the surgical assembly can employ a blood signal, which can be used to determine a position and/or orientation of the coupler relative to tissue in order to ensure proper deployment of the coupler. Depending upon the position of the coupler, blood can flow through the coupler and up the elongate shaft to provide a surgeon with a visual indicator of the position of the coupler.
In certain embodiments, the coupler can have a large, centrally disposed bore. The bore can facilitate fluid flow between joined regions of tissue, as may be needed for various surgical procedures. When fluid flow through the coupler is not desired, a plug can be advanced through the actuator device and into the large bore. The plug can then be permanently or reversibly affixed to the large bore to prevent fluid flow therethrough.
The closure assembly can be used in various surgical procedures. For example, the closure assembly can be used for the percutaneous closure of the common femoral arteriotomy or venotomy following diagnostic and/or interventional therapeutic intra-arterial procedures, such as peripheral or coronary angiography, arterial stents, balloon angioplasty, and atherectomy procedures where the arteriotomy is in the common femoral artery and closure assemblies have been used. Further, the closure assembly can be used in additional procedures, including, for example, in procedures promoting weight loss and/or the treatment of Type-2 diabetes.
The actuator assembly 100 can include a proximal actuator 102 and a distal flexible guide tube 120 extending therefrom. The proximal actuator 102 can include a substantially cylindrical body 104 with a proximal handle 106 rotatably coupled thereto. The proximal handle 106 can be rotated in either a first or a second direction (e.g., clockwise and counter-clockwise) to reversibly deploy one or more portions of the deployable coupler 140, depending upon the needs of a surgical procedure. An ejection lever 108 can extend outward and upward from the cylindrical body 104 and can be pivoted relative thereto. Actuation of the ejection lever 108 can cause the proximal actuator 102 to eject the deployable coupler 140. In order to prevent premature actuation of the proximal handle 106, a removable locking tab 110 can be affixed to the cylindrical body 104 and the proximal handle 106. The removable locking tab 110 can rotatably fix the proximal handle 106 relative to the cylindrical body 104. The removable locking tab can affix to both the cylindrical body 104 and the proximal handle 106 via one or more protrusions and/or recesses found on an underside of the proximal actuator 102 (not shown). The removable locking tab 110 can further wrap around the proximal handle 106 to be secured to the proximal actuator 102 until removal by an operator. An operator can remove the removable locking tab 110 from the cylindrical body 104 and the proximal handle 106, and then the operator can actuate the proximal handle 106 and/or the ejection lever 108 as desired. The proximal actuator 102 can include information for guiding a user through a surgical procedure. For example, arrows can be included on the proximal actuator 102 indicating an actuation direction and order for use during a surgical procedure, i.e., an arrow marked “1” pointing in a first direction to indicate that the proximal handle 106 should first be turned in that direction, and an arrow marked “2” pointing in a second direction to indicate that the proximal handle 106 should next be turned in that direction.
A pair of sheath latches 112 can extend from the distal side of the cylindrical body 104. The sheath latches 112 can take on various forms and arrangements, but they can generally be a single or pair of opposed, linear prongs with inward-facing ends 114 configured to grip and retain the introducer sheath 150, as will be described in greater detail below. A blood signal outlet 116 can be located on the upper side of the cylindrical body 104, as shown in
The flexible guide tube 120 extends distally from the cylindrical body 104, between the sheath latches 112, and it can be substantially linear in form. In some variations, the flexible guide tube 120 can be rigid in structure. The flexible guide tube 120 can include a central dowel 122 surrounded by an outer sheath 124 to define a flow path 126 in a space between the central dowel 122 and the outer sheath 124. The flow path 126 can run the entire length of the flexible guide tube 120. The central dowel 122 can include a distal end cap 128 that flares outward, as shown in greater detail in
The seated deployable coupler 140 can reversibly transform between a delivery configuration and a deployed configuration. In the delivery configuration, the seated deployable coupler 140 can have a substantially linear formation, as shown, for example, in
Transformation between the delivery configuration and the deployed configuration can occur via actuation of the proximal handle 106. During the transformation process, the proximal handle 106 can be rotated in a first direction to cause the outer sheath 124 of the flexible guide tube 120 to rotate as well. Rotation of the flexible guide tube 120 can result in the meshed castellations of both the retainer 132 and the seated deployable coupler 140 undergoing a torsional force. The meshed castellations 134, 141 of the both the retainer 132 and the seated deployable coupler 140 can cause the outer sheath 124 to apply a torsional force to the seated deployable coupler 140. Simultaneously, a linear compressive force can be applied to the seated deployable coupler 140 in a proximal direction, originating with the distal end cap 128. For example, the proximal handle 106 can be rotated in a first direction (e.g., clockwise or counter-clockwise) to rotate the end cap 128 in the first direction to torque and then compress the seated deployable coupler 140 and cause the distal end 140D to splay radially outward, thereby forming a distal wing 148D. When the deployable coupler 140 is adequately compressed and the distal wing 148D is formed, which occurs via an actuator spring (not shown) coupled to the proximal handle 106 to provide the necessary forces to compress the deployable coupler 140, the proximal wing 148P can be formed. The proximal handle 106 can be rotated in a second direction (which may be the same as or different than the first direction) to further compress the coupler and apply a torque in an opposite direction to cause the proximal end 140P to splay outward, thereby forming a proximal wing 148P. The proximal and distal wings 148P, 148D can have a variety of forms. For example, the wings 148P, 148D may include one or more petals or segments forming the shape of the wings 148P, 148D.angle
Together, the seated deployable coupler 140 and the proximal actuator 102 can define a blood flow path, which can be used during a surgical procedure as a blood signal to inform a surgeon about the position and/or orientation of the seated deployable coupler 140 within a patient's body. Proper positioning and orientation of the seated deployable coupler 140 can ensure that the wing of the seated deployable coupler 140 are not improperly deployed in a way that could be ineffective or harmful.
Referring back to
During an exemplary surgical procedure, shown in
With reference now to
In some embodiments, the sheath retainer 232 can include a central track having a plurality of engagement zones (not shown) configured to engage the introducer sheath 250 at a plurality of distances, thereby allowing for the guide tube 220 to be inserted into the introducer sheath 250 at substantially discrete insertion depths to facilitate blood flow through a blood signal outlet 216. The actuator 202 can have a variable number of engagement zones, such as one, two, three, or more. The assembly 200 can also include a removable sheath stop 213 configured to prevent over-insertion of the guide tube 220 into the introducer sheath 250. The removable sheath stop 213 can be coupled to the actuator 202 near the sheath retainer 232, and it can block the more-proximal engagement zone(s) to prevent over-insertion of the guide tube 220 into the introducer sheath 250. More than one removable sheath stop 213 can be used if more than one more-proximal engagement zone is used. When additional depth is required, the removable sheath stop 213 can be decoupled from the actuator 202 to expose the more-proximal engagement zone(s). After coupling with the introducer sheath 250, the guide tube 220 can then be inserted further into the introducer sheath 250. The blood signal outlet 216 can be located on a side of the body 204. The blood signal outlet 216 can include a blood signal cap 216A to seal off the blood signal outlet 216.
The guide tube 220 can extend distally from the actuator 202. The guide tube 220 can be substantially tubular and can couple a large bore coupler 240 on an end thereof.
The coupler 240 can be generally cylindrical in form and can include a substantially tubular first end 240A and a substantially tubular second end 240B joined by a mid-region 241. The mid-region 241 can take the form of a press ring or similar structure. Together, the first end 240A, the second end 240B, and the mid-region 241 can define a central lumen 242 running through the center of the coupler 240 about a longitudinal axis thereof, which can be co-linear with the central lumen 203 of the actuator assembly 200. The first and second ends 240A, 240B can have the same or different diameters as shown, for example, in
Each of the first end 240A and the second end 240B can include a plurality of slits 244. The slits 244 can vary in shape, but as seen, for example, in
The coupler 240 can be transformable between a delivery configuration and a deployed configuration, similar to the deployable coupler 140, as explained above. In the delivery configuration, seen in
During a surgical procedure, as introduced above, the plug tool 260 can be coupled to the actuator 202 and used to plug the central lumen 242 of the coupler 240 in order to prevent or occlude fluid flow therethrough. After the guidewire 30 has been removed from the central lumen 203 of the actuator assembly 200, the plug tool 260 can be extended, plug 268 first, into the central lumen 203. The plug tool 260 can be inserted until the handle 206 of the actuator assembly 200 is secured within the crevice 266 of the plug tool 260 and until the prongs 267 couple with the removable lever lock 211. At this depth, the ejectable plug 268 can be disposed centrally within the central lumen 242 of the coupler 240. During a removal process, the plug tool 260 can be decoupled from the actuator 202. Decoupling the plug tool 260 from the actuator 202 can leave the prongs 267 coupled to the removable lever lock 211 such that removal of the plug tool 260 also removes the removable lever lock 211 in one stroke. An exemplary surgical procedure using the plug tool 260 will be described in more detail below.
The guidewire 30 can be inserted into an arterial lumen 32, proximate to a surgical site. The introducer sheath 250 can be inserted over the guidewire 30 and into the arterial lumen 32. During insertion, the introducer sheath 250 can have a dilator 251 inserted therethrough to plug the central lumen of the introducer sheath 250 and prevent the backflow of blood. Removal of the dilator 251 can allow blood to flow up the introducer sheath 250 through the blood inlet 253 and throught the inner lumen 254 and out the valve assembly 259. The valve assembly 259 can be closed as needed. The tip of the elongate shaft 252 of the actuator assembly 200, having a coupler 240 affixed to a distal end thereof, can be inserted into the introducer sheath 250. The actuator assembly 200 can be advanced until the actuator assembly 200 connects with the delivery sheath 250 and the deployable coupler 240 is within the artieral lumen.
A position of the coupler 240 within the arterial lumen can be determined with an external imaging system, such as ultrasound. The press ring 241 can be positioned as close to the puncture site as possible, with a proximal portion of the coupler 240 located at least partially outside of the external lumen. Proper positioning of the coupler 240 can be determined as needed.
In some embodiments as explained above, the actuator assembly can include one or more engagement zones for use with a blood signal outlet 216. The actuator assembly 200 can be inserted until the introducer sheath 250 engages with the sheath retainer 232 and is positioned within the first of the engagement zones In this position, the coupler 240 can remain concealed by the introducer sheath 250. Once properly positioned, blood can flow out of the blood outlet 216 on the actuator 202, in addition to flowing out the introducer sheath 250, so long as the valve assembly 259 is opened. The entire assembly, introducer sheath 250 and actuator assembly 200 together, can be pulled back until the blood signal disappears. The disappearance of the blood signal can be used to confirm proper positioning of the assembly within tissue.
Once in position, the assembly 200 can be pivoted upward and away from a surface of the patient's tissue until an angle B between the introducer sheath 250 and the surface is at least degrees. In some embodiments, the angle B can be between approximately 50 and 60 degrees, as seen in
If included, while in the elevated position, the removable sheath stop 213 can be removed from the actuator assembly 200, and the introducer sheath 250 can be and locked within the second engagement zone 232A in the central track, thereby exposing the coupler 240 from a distal end of the introducer assembly 250. While maintaining the elevated angle, the locking tab 210 can be removed and the handle 206 of the actuator 202 can be rotated in a first direction (e.g., clockwise) to deploy the distal wing 248D of the coupler 240 within the arterial lumen 32. Deployment of the distal wing 248D can be observed under fluoroscopy, ultrasound, angiography and/or other imaging techniques. Successful deployment of the distal wing 248D can result in the handle 206 advancing proximally to create a gap 206A between the handle 206 and the body 204 of the actuator 202. Once the distal wing 248D is deployed, the assembly can be withdrawn until resistance is felt, indicating that the distal wing 248D has contacted an inner surface of the arterial lumen 32. While maintaining this resistance, the handle 206 can be actuated in a second direction (e.g., counter-clockwise) opposite the first direction to deploy the proximal wing 248P and “sandwich” tissue 40 between the distal wing 248D and proximal wing 248P, as seen in
The contrast port 270, can be connected to the actuator assembly 200 in advance of the procedure, can be advanced over the guidewire 30. The contrast port 270 can generally include a linking arm 272 with a valve system extending therefrom. The linking arm 272 can be configured to removably couple to the handle 206 of the actuator assembly 200, such as via a luer lock, threading, a snap fit, a friction fit, etc. The valve system 274 can include a flexible tubing 276 connected to the linking arm 272 at one end and connected to a valve 274 at the other. The contrast port 270 can include a flow path (not shown) therethrough that can be in fluid communication with the central lumen 203 of the actuator assembly 200. During a surgical procedure, contrast fluid or other fluid can be injected into the valve 274 and then flow through the tubing 276, the linking arm 272 and the central lumens 203, 242. The injected contrast fluid can be used to check for leaks or improper coupling, etc. The linking arm 272 can be coupled and decoupled to the handle 206 as needed during a surgical procedure.
Contrast fluid can be injected through the contrast port 270 to confirm that the arterial lumen 32 is in proper condition prior to plugging the central lumen 242 of the coupler 240 and while the guidewire is still in place. If the contrast fluid indicates an issue, such as damage to the arterial lumen 32, improper coupler 240 positioning, etc., the coupler 240 can be returned to the delivery configuration, if necessary, or additional measures can be taken to correct the indicated issue. The process can then proceed from any point thus far, following correction.
In embodiments relying upon the use of the contrast port 270, following injection of contrast and confirmation of position, or if the contrast port 270 is not used, the procedure can proceed. The guidewire 30 and the contrast port 270 can be removed from the actuator assembly 200, and the plug tool 260 can advance the ejectable plug 268 into the proximal end of the actuator 202. The plug tool 260 can be advanced so that the handle 206 of the actuator 202 is fully received by the distal crevice 266 of the plug tool 260 and the prongs 267 couple with the removable lever lock 211, as seen in
During surgical procedures, the coupler 240 can be incorrectly deployed entirely within an arterial lumen 32, also known as “total intra-arterial deployment.” If this deployment occurs, the coupler 240 can be collapsed to a substantially pre-deployment state and then removed from the patient, leaving the guidewire 30 in place.
To collapse the coupler 240, as shown in
Both the deployable coupler 140 and the coupler 240 are described being used in exemplary procedures to couple a portion of an arterial lumen 32. These couplers 140, 240, as well as the various embodiments described herein, can be used in a number of procedures to achieve various desired outcomes.
To begin the procedure, one or more incisions can be made in a patient to provide access to the patient's small intestine 50 and gall bladder 60. A surgeon can then grab a section of the patient's ileum 52 and bring it to an antecolic or retrocolic position, proximate the gall bladder as seen in
Once in position, a penetrator 321 (e.g., a cutting needle, a radiofrequency probe, or an equivalent known in the art) can be inserted through the actuator assembly 300 all the way to the distal tip 320D, emerging from a central lumen 322 thereof, to penetrate both the ileum 52 and the gall bladder 60. This penetration can be seen in
Following successful penetration and advancement of the coupler 340 into the gall bladder 60, the penetrator 321 can be partially retracted from the gall bladder 60 in preparation for deployment of the anastomotic coupler 340. A locking tab 310, which prevents premature deployment of the anastomotic coupler 340, can be removed from the actuator assembly 300. With the locking tab 310 removed, a handle 304 on the actuator assembly 300 can be actuated, such as, for example, with a clockwise turn to deploy a distal wing 344D of the coupler 340 within the gall bladder 60, as seen in
Following deployment of the proximal wing 344P, the penetrator 321 can be fully removed from the actuator assembly 300. Then, a dye, such as methylene blue or similar, can be injected through the same lumen 322 through which the penetrator 321 was inserted in order to check for leakage of the anastomosis. If a leak is detected, either one or both of the proximal and distal wings 344P, 344D of the anastomotic coupler 340 can be re-actuated to partially return to a pre-deployment state, and the anastomotic coupler 340 can be re-deployed in a more suitable position. If necessary, the actuator assembly 300 can be removed prior to redeployment, in order to address any additional challenges causing an improper joinder of the ileum and gall bladder 60.
If the joinder is a success, an ejection lever 308 located on the actuator assembly 300 can be actuated in order to eject the anastomotic coupler 340 from the actuator assembly 300. The anastomotic coupler 340 has a central lumen 341, which can cause the gall bladder 60 to be in fluid communication with the ileum 50.
In some embodiments the wings 344P, 344D can be made to touch each other (such as by increasing the lengths and/or by altering deployment angles thereof), thereby contributing to the creation of a compressive anastomosis, which can result in tissue necrosis. During a healing process of such a necrosis, the outer walls of the ilium and the gallbladder can fuse to each other. The anastomotic coupler 340 can slough off and pass distally through the ileum to be expelled from the patient and leaving a temporary or permanent fluid path therebetween.
After ejection of the anastomotic coupler 340, the actuator assembly 300 can be removed entirely from the patient.
From there, the entero-entero anastomosis can be performed, as shown in
The actuator assembly 300 can then be oriented as shown in to contact a portion of the ileum 52 while aligning the contacted portion with the second incision 55. Once aligned, the penetrator 321 can be inserted through the actuator assembly 300, as described above, and an incision can be made in the distal ileal loop proximate the second incision 55. The anastomotic coupler 340′ can then be inserted, joining both ileal loops 52D, 52P, and the penetrator 321 can be partially withdrawn, as seen in
Following that, the anastomotic coupler 340′ can be deployed in a similar manner as described above. As shown in
The joinder can be checked using a process similar to the one described previously using methylene blue. From there, the lever 308 of the actuator assembly 300 can be actuated to cause the actuator assembly 300 and the anastomotic coupler 340′ to separate. The actuator assembly 300 can then be withdrawn from the patient, and the various incisions made during the procedure can be closed.
Certain illustrative implementations have been described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the systems, devices, and methods disclosed herein. One or more examples of these implementations have been illustrated in the accompanying drawings. Those skilled in the art will understand that the systems, devices, and methods specifically described herein and illustrated in the accompanying drawings are non-limiting illustrative implementations and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one illustrative implementation may be combined with the features of other implementations. Such modifications and variations are intended to be included within the scope of the present invention. Further, in the present disclosure, like-named components of the implementations generally have similar features, and thus within a particular implementation each feature of each like-named component is not necessarily fully elaborated upon.
Approximating language, as used herein throughout the specification and claims, may be applied to modify any quantitative representation that could permissibly vary without resulting in a change in the basic function to which it is related. Accordingly, a value modified by a term or terms, such as “about,” “approximately,” and “substantially,” are not to be limited to the precise value specified. In at least some instances, the approximating language may correspond to the precision of an instrument for measuring the value. Here and throughout the specification and claims, range limitations may be combined and/or interchanged, such ranges are identified and include all the sub-ranges contained therein unless context or language indicates otherwise.
One skilled in the art will appreciate further features and advantages of the invention based on the above-described implementations. Accordingly, the present application is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated by reference in their entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63346151 | May 2022 | US |
