The present disclosure relates to endografts and their delivery systems, sometimes referred to as endo-luminal delivery device assemblies. In particular, the present disclosure relates to endo-luminal delivery device assemblies capable of delivering prostheses, endografts or stent-grafts into the lumen of a vessel.
This disclosure relates generally to medical devices and methods of using the medical devices, and more particularly, to an endo-luminal prosthesis delivery device and methods for placement and deployment of the prosthesis in the lumen of a vessel.
The use of delivery devices or introducers employing catheters has long been known for a variety of medical procedures, including procedures for establishing, re-establishing or maintaining passages, cavities or lumens in vessels, organs or ducts in human and veterinary patients, occlusion of such vessels, delivering medical treatments and other interventions. For these procedures, it has also long been known to deliver an implantable medical device by means of a catheter, often intraluminally. For example, a stent, stent-graft, vena cava filter or occlusion device may be delivered intraluminally from the femoral artery, via a transapical approach and/or using other acceptable delivery locations and methods for deployment of the prosthesis.
For procedures in which a prosthesis or other medical device is implanted into a patient, the prosthesis to be implanted is normally held on a carrier catheter or cannula of the introducer in a compressed state and then released from the cannula so as to expand to its normal operating state, prior to withdrawal of the cannula from the patient to leave the implant in position. In many devices, the steps to carry out the implantation my occur, for example, first by retracting a retractable sheath to expand or partially expand the prosthesis, and then performing further steps to, for example, release one or both ends of the prosthesis, deploy an anchoring stent, or the like. Often diameter reducing ties are employed which requires release using a trigger line, the line normally in the form of a thin wire.
Prosthesis and delivery devices are used in minimally invasive aortic intervention. They are used by surgeons to treat aneurysms and to repair regions of the aorta, including the aortic arch, the thoracic aorta, the abdominal aorta and the aortic bifurcation.
Delivery devices used for minimally invasive aortic intervention allow deployment of intraluminal prostheses or endografts into the lumen of a patient from a remote location.
Numerous devises and procedures have been developed that involve the percutaneous insertion of a prosthesis into a body lumen, such as a blood vessel or duct, of a patient's body. Such a prosthesis may be introduced into the lumen by a variety of known techniques. For example, a wire guide may be introduced into a blood vessel using the Seldinger technique. This technique involves creating a surgical opening in the vessel with a needle and inserting a wire guide into the vessel through a bore of the needle. The needle can be withdrawn, leaving the wire guide in place. A delivery device is then inserted over the wire guide and into the vessel. The delivery device may be used in conventional fashion to insert into the blood vessel a variety of prostheses, such as stents, stent-grafts, catheters, cardiac leads, balloons, and the like.
For example, the delivery device may be used to deliver and deploy an expandable prosthesis, such as a stent-graft, to an aneurysmal blood vessel site. A stent-graft is usually formed from a tubular body of a biocompatible graft material with one or more stents mounted into or onto the tubular body to provide support therefor. The stents may be balloon expandable stents and/or self-expanding stents. The deployment of the prosthesis into the lumen of a patient from a remote location by the use of an introducer delivery and deployment device is described in, for example, U.S. Pat. No. 7,435,253 to Hartley entitled “A Prosthesis and a Method and Means of Deploying a Prosthesis”, which is incorporated herein by reference in its entirety. These, and many other means or devices for delivering endo-luminal grafts typically employ pullable lines in the form of wires. These lines or wires require mechanisms for their actuation.
Endovascular delivery devices require significant expertise and experience to operate. Ease of operation and correct sequencing of various manual operations performed outside the body (at a distal end of a delivery device) are required for successful and optimum deployment of an endograft. It is desirable to make operation as intuitive and foolproof as possible.
Endovascular delivery devices should, where ever possible, avoid catch points and should be robust against misuse or damage.
There is a need to provide an improved endo-luminal delivery device and/or to provide an improved line or wire puller assembly for an endo-luminal delivery device.
While this disclosure may be generally discussed in relation to a delivery device for a stent-graft and method of deployment thereof into one or more specific arteries, including the aorta and iliac arteries, it is also contemplated that the disclosure is not so limited and may relate to any prosthesis and/or any body or vessel lumen in which such a deployment is necessary or desired.
Throughout this document, when referring to a prosthesis delivery device, “proximal” refers to the part of the delivery device that is furthest from the operator and intended for insertion in a patient's body (and usually that part being placed proximal to the target site within the patient) and “distal” refers to that part of the delivery device closest to the operator (and usually that part being placed most distal to the target site within the patient). With regard to the prosthesis being delivered to by the delivery device, the term “proximal” refers to that part of the prosthesis that is closest to the proximal end of the delivery device and “distal” refers to the opposite end of the prosthesis.
According to an aspect of the disclosure, a line puller assembly for an endo-luminal delivery device comprises:
a line puller body having a proximal end, a distal end and an intermediate portion between the proximal and distal ends;
a line puller actuator assembly mounted to the line puller body for rotation about the line puller body, the line puller actuator assembly including a line deflector ring located between the proximal and distal ends of the line puller body, the line deflector ring including a first deflector line guide;
a line anchor location on the line puller body;
a first body line guide on the line puller body, the line anchor location and the first body line guide positioned on opposite sides of the line deflector ring; and
a line having an end portion anchored at the line anchor location on the line puller body, the line extending through the first line deflector ring, whereby a line path extends from the anchor location, through the first deflector line guide and past the first body line guide, the line path having a variable length,
wherein rotation of the line puller actuator assembly relative to the line puller body from an initial position to an actuated position lengthens the line path, thereby pulling the line.
In one form, the first deflector line guide of the line deflector ring comprises a first arcuate guide surface.
In one form, the first arcuate guide surface is shaped such that the radius through which the line travels around the first arcuate guide surface does not fall below 3 mm as the line puller actuator assembly is rotated through an initial 45 degrees of rotation relative to the line puller body.
In one form, line puller assembly further comprises a ratchet assembly arranged and constructed to allow rotation of the line deflector ring about the line puller body in a first direction only and to limit rotation about a second direction, the second direction opposite to the first direction.
In one form, the ratchet assembly comprises a pawl depending from the line puller actuator assembly and a gear depending from the line puller body.
In one form, the line puller actuator assembly comprises an actuator frame engaged with the line deflector ring, the actuator frame extending axially over the line deflector ring, whereby an annular cavity is formed between an inner wall of the actuator frame and the line puller body.
In one form, the line puller actuator assembly comprises a ring grip, the ring grip engaged with the actuator frame for rotation therewith and being hand graspable by an operator for actuation of the line puller actuator assembly.
In one form, the ring grip is slidable from: a locked position in which the line puller actuation assembly is locked with respect to the body, to an unlocked position in which the line puller actuation assembly is unlocked with respect to the body.
In one form, the line puller assembly further comprises:
a second deflector line guide in the line deflector ring, the second deflector line guide circumferentially spaced apart from the first deflector line guide; and
a second body line guide on the line puller body,
whereby the line path extends from the anchor location, through the first deflector line guide, past the first body line guide before extending through the second deflector line guide and past the second body line guide.
In one form, the second deflector line guide of the line deflector ring comprises a second arcuate guide surface.
In one form, the second arcuate guide surface is shaped such that the radius through which the line travels around the second arcuate guide surface does not fall below 3 mm as the line puller actuator assembly is rotated through an initial 45 degrees of rotation relative to the line puller body.
In a further aspect of the disclosure, an endo-luminal delivery device comprises:
a handle assembly at a distal end thereof, the handle assembly comprising a line puller assembly as described above;
a tip assembly at a proximal end thereof;
a guide wire catheter extending through the handle assembly, the guide wire catheter being affixed at a distal end thereof to the handle assembly and being affixed at a proximal end thereof to the tip assembly; and
an endograft receiving portion for receiving an endograft distally adjacent to the tip assembly.
In one form, the first deflector line guide of the line deflector ring comprises a first arcuate guide surface.
In one form, the first arcuate guide surface is shaped such that the radius through which the line travels around the first arcuate guide surface does not fall below 3 mm as the line puller actuator assembly is rotated through an initial 45 degrees of rotation relative to the line puller body.
In one form, the line puller assembly further comprises a ratchet assembly, the ratchet assembly arranged and constructed to allow rotation of the line deflector ring about the line puller body in a first direction only and to limit rotation about a second direction, the second direction opposite to the first direction.
In one form, the ratchet assembly comprises a pawl depending from the line puller actuator assembly and a gear depending from the line puller body.
In one form, the line puller actuator assembly comprises an actuator frame engaged with the line deflector ring, the actuator frame extending axially over the line deflector ring, whereby an annular cavity is formed between an inner wall of the actuator frame and the line puller body.
In one form, the line puller actuator assembly comprises a ring grip, the ring grip engaged with the actuator frame for rotation therewith and being hand graspable by an operator for actuation of the line puller actuator assembly.
In one form, the ring grip is slidable from: a locked position in which the line puller actuation assembly is locked with respect to the body, to an unlocked position in which the line puller actuation assembly is unlocked with respect to the body.
In a further aspect of the disclosure, an endo-luminal delivery device comprises:
a handle assembly at a distal end thereof, the handle assembly comprising a line puller assembly comprising:
a tip assembly at a proximal end thereof;
a guide wire catheter extending through the handle assembly, the guide wire catheter being affixed at a distal end thereof to the handle assembly and being affixed at a proximal end thereof to the tip assembly; and
an endograft receiving portion for receiving an endograft distally adjacent to the tip assembly.
Referring to
Referring now to
A line anchor location 89 on the line puller body is illustrated in
Referring now to
It can be seen that the first deflector line guide 63 of the line deflector ring 61 comprises a first arcuate guide surface 64. This first arcuate guide surface 64 is shown in
Again referring to
So far, the embodiment described is relatively simple in that a line 85 is only deflected by one deflector line guide, the first deflector line guide 63. In a further embodiment of the disclosure, that will now be described in detail, a second deflector line guide 65 is employed. With this embodiment, illustrated in
With the line puller assembly illustrated in
The line puller assembly further comprises a ratchet assembly which is shown in
Again referring to
In other embodiments of the disclosure, the pawl or pawls can be located on the line puller body and the gear or rack may be located on an element of the actuator assembly.
The line puller actuator assembly 60 will now be described in more detail with reference to
A key 224, best shown in
The line path for line 85 will now be described in more detail with reference to
Operation of the line assembly 50 will now be described with reference to
The line guides on the body 55 described above are provided by protrusions. In other embodiments, the line guides on the body 55 may be grooves or other elements for guiding the line 85.
In many applications of this disclosure, the line 85 will be a thin wire 85. In such applications the line puller may be better described as a wire puller. Specifically, in many applications trigger wires for diameter reducing ties, proximal and distal releases may be employed. The term line is used to include non-limiting examples of single strand wire, multi-strand wire, plastic cord or other elongate line of any suitable type.
The disclosure addresses a problem with existing delivery devices that employ rotating actuators, such as spools. Specifically, devices that employ a rotating actuator for retracting actuation wires (such as the diameter reducing tie wires, proximal and distal wires and/or tip retrieving wires) sometimes require a large degree of rotation to achieve the required wire pull, in some cases more than 360 degree. For instance, to achieve 250 mm of wire pull with less than 360 degrees of rotation would require unacceptably large diameter spools with current designs. Larger spools would make the handle too bulky and unwieldy. Embodiments of the disclosure described above address the problem of how to pull back a longer length (in the order of 250 mm) while only requiring the operator to rotate the actuator a ‘reasonable’ amount (less than 360 degrees). This can be seen in
Referring again to
The line puller assembly shown in
The ‘gearing’ of approximately four (4) times described above is achieved with just two deflector line guides. In other embodiments, a larger number of deflector line guides may be employed. For instance, six or eight line guides may be employed to provide effectively greater gearing within the mechanism.
An additional benefit of the disclosure is that less than 360 degrees of rotation is required to achieve the required pull, which means that simple hard stops and indicators can be used without the need for complex mechanical switches that would otherwise be required in mechanisms where more than a full revolution (greater than 360 degrees) is needed.
Throughout this specification, unless the context requires otherwise, the words “comprise” and “include” and variations such as “comprising” and “including” will be understood to imply the inclusion of an item or group of items, but not the exclusion of any other item or group items. While various embodiments have been described, it will be apparent to those of ordinary skill in the art that many more examples and implementations are possible within the scope of the present disclosure. Furthermore, although various indications have been given as to the scope of this present disclosure, the present disclosure is not limited to any one of these but may reside in two or more of these combined together. Accordingly, the present disclosure is not to be restricted except in light of the attached claims and their equivalents.