AU2021200270B1

AU2021200270B1 - A line puller mechanism for an endo-luminal delivery device

Info

Publication number: AU2021200270B1
Application number: AU2021200270A
Authority: AU
Inventors: James Collins; Andrew Hutchinson; Chris Neoh; William Parke; Logan SMITH
Original assignee: Cook Medical Technologies LLC
Current assignee: Cook Medical Technologies LLC
Priority date: 2021-01-18
Filing date: 2021-01-18
Publication date: 2021-07-29
Anticipated expiration: 2041-01-18

Abstract

An endo-luminal intervention device 10 is disclosed. The device 10 has a handle assembly 200 at a distal end; an intervention assembly 100 at a proximal end; and a guide wire catheter 40 extending through the handle assembly 100. The handle assembly 200 comprises a line puller 50 comprising: a body 55; an intermediate member 60 rotatably mounted to the body 55, the intermediate member 60 comprising an intermediate line guide 61; an intermediate ratchet mechanism 63 operably interposed between the intermediate member 60 and the body 55; an outer ring 70 rotatably mounted for rotation around the body 55; an outer ratchet mechanism 73 operably interposed between the outer ring 70 and the intermediate member 60; and a line 80 threaded between the body 55 and the outer ring 70 so as to pass through the intermediate line guide 61,wherein, in use, a double ratchet effect is produced such that the line 80 is retracted during rotation of the outer ring 70 in both directions.

Description

A LINE PULLER MECHANISM FOR AN ENDO-LUMINAL DELIVERY DEVICE FIELD OF THE DISCLOSURE

[0001]The present disclosure relates to endo-luminal intervention devices, sometimes referred to as endo-luminal delivery devices. In particular, the present disclosure relates to endo-luminal delivery device assemblies capable of delivering prostheses into the lumen of a vessel.

BACKGROUND

[0002]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.

[0003]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 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. Prosthesis are deployed 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.

[0004]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 as well. Typically, some or all of the afore-mentioned steps require release using a trigger line, the line normally in the form of a thin wire. Mechanisms are provided to pull or actuate those trigger lines or wires.

[0005]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.

[0006]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.

[0007]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.

[0008] Rotatable actuators are known for wire pull mechanisms. In many situations, rotation of more than 60-80 degrees is required to achieve the required length of wire pull, for instance, at a proximal end of a delivery device. Given that operators of delivery devices can typically only comfortably rotate through about 60-80 degrees in a single gripping an twisting hand action, it is generally necessary to repeatedly grip, rotate, release, grip, rotate etc so as to achieve the required length of wire pull.

[0009]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.

[0010]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 vessel lumen in which such a deployment is necessary or desired.

[0011]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.

SUMMARY

[0012]According to an aspect of the disclosure, there is provided an endo-luminal intervention device comprising: a handle assembly at a distal end thereof; an intervention assembly at a proximal end thereof; and 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 intervention assembly, the handle assembly comprising a line puller comprising: a body; an intermediate member rotatably mounted to the body, the intermediate member comprising an intermediate line guide; an intermediate ratchet mechanism operably interposed between the intermediate member and the body; an outer ring rotatably mounted for rotation around the body; an outer ratchet mechanism operably interposed between the outer ring and the intermediate member; and a line threaded between the body and the outer ring so as to pass through the intermediate line guide, wherein the intermediate ratchet mechanism engages with the body to allow rotation of the intermediate member in a first rotation direction and to restrict rotation in a second rotation direction, the second rotation direction opposite to the first rotation direction, and wherein the outer ratchet mechanism engages with the intermediate member to allow rotation of the outer ring with respect to the intermediate member in the second rotation direction and is engagable with the intermediate member to impart rotation to the intermediate member in the first rotation direction.

[0013]In one form, the intermediate ratchet mechanism comprises a intermediate ratchet annulus and an intermediate pawl, one of the intermediate ratchet annulus and intermediate pawl on the intermediate member and the other of the intermediate ratchet annulus and intermediate pawl on the body.

[0014]In one form, the intermediate ratchet annulus comprises an intermediate internally toothed ring.

[0015]In one form, the intermediate pawl comprises an arm and a tooth engaging portion.

[0016]In one form, the arm extends from the body and is cantilevered from the body.

[0017]The endo-In one form, the arm is resiliently bendable allowing the tooth engaging portion to be displaced radially.

[0018]In one form, the intermediate ratchet mechanism and the outer ratchet mechanism are longitudinally spaced apart.

[0019]In one form, the intermediate ratchet annulus comprises an intermediate internal friction ring.

[0020]In one form, the intermediate pawl comprises an arm and an internal friction ring engaging shoe.

[0021]In one form, the intermediate ratchet mechanism and the outer ratchet mechanism are longitudinally spaced apart.

[0022]In one form, the outer ratchet mechanism comprises a outer ratchet annulus and an outer pawl, one of the outer ratchet annulus and outer pawl on the outer ring and the other of the outer ratchet annulus and outer pawl on the intermediate member.

[0023]In one form, the outer ratchet annulus comprises an outer internally toothed ring.

[0024]According to a second aspect, there is provided an endo-luminal delivery device comprising: a handle assembly at a distal end thereof, the handle assembly comprising line (wire) pull mechanism: a body; an intermediate member rotatably mounted to the body, the intermediate member comprising an intermediate line guide; an intermediate ratchet mechanism operably interposed between the intermediate member and the body; an outer ring rotatably mounted for rotation around the body; an outer ratchet mechanism operably interposed between the outer ring and the intermediate member; and a line threaded between the body and the outer ring so as to pass through the intermediate line guide, 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, wherein the intermediate ratchet mechanism engages with the body to allow rotation of the intermediate member in a first rotation direction and to restrict rotation in a second rotation direction, the second rotation direction opposite to the first rotation direction, and wherein the outer ratchet mechanism engages with the intermediate member to allow rotation of the outer ring with respect to the intermediate member in the second rotation direction and is engagable with the intermediate member to impart rotation to the intermediate member in the first rotation direction.

[0025]In one form, the intermediate ratchet mechanism comprises a intermediate ratchet annulus and an intermediate pawl, one of the intermediate ratchet annulus and intermediate pawl on the intermediate member and the other of the intermediate ratchet annulus and intermediate pawl on the body.

[0026]In one form, the intermediate ratchet annulus comprises an intermediate internally toothed ring.

[0027]In one form, the intermediate pawl comprises an arm and a tooth engaging portion.

[0028]In one form, the arm extends from the body and is cantilevered from the body.

[0029]In one form, the arm is resiliently bendable allowing the tooth engaging portion to be displaced radially.

[0030]In one form, the intermediate ratchet mechanism and the outer ratchet mechanism are longitudinally spaced apart.

[0031]In one form, the line comprises a proximal end portion and a distal end portion, the proximal end portion at least partially within the handle portion and the distal end portion at least partially within the intervention assembly, and whereby the rotation in each of the first direction and the second direction retracts the proximal end portion, thereby releasing at least a portion of the endograft at the endograft receiving portion.

BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 is a rear perspective view of an endo-luminal intervention device with a handle assembly at the distal end of the device and a prosthesis on the proximal end of the device;

[0033]Figure 2A is a similar view to Figure 1 but shows an alternative endo-luminal intervention device having had a plurality of line puller mechanisms positioned at its distal end;

[0034]Figures 2B and 2C are side views of one of the line puller assemblies shown in Figure 2A in initial locked and then unlocked (and actuatable) positions respectively;

[0035]Figure 2D is a detailed view of a portion of an intervention assembly including a tip assembly located at a proximal end of the device shown in Figure 2A;

[0036]Figure 3 is an isometric view of one of the line puller assemblies shown in Figure 2A;

[0037]Figure 4 is an exploded isometric view of the line puller assembly shown in Figure 3;

[0038]Figure 5 is an isometric view of a line puller body forming part of the line puller assembly shown in Figure 3;

[0039]Figure 6 is an exploded isometric view of the line puller body shown in Figure 5;

[0040]Figure 7 is an isometric view of an intermediate member forming part of the line puller assembly shown in Figure 3;

[0041]Figure 8A is an isometric view of an outer ring forming part of the line puller assembly shown in Figure 3;

[0042]Figure 8B is an isometric view of an alternative outer ring forming part of the line puller assembly shown in Figure 3;

[0043]Figures 9A to 9E are diagrammatic cross-sectional views of the line puller assembly shown in Figure 3 in progressive positions as the outer ring is moved repeatedly one direction and then another opposite direction;

[0044]Figure 10 is an isometric cross-sectional view of an alternative line puller mechanism where a line is pulled from both ends;

[0045]Figure 11 is an isometric view illustrating a further alternative device to that shown in Figures 1 and 2A;

[0046]Figure 12 is a front perspective view of the delivery device shown in Figure 11, but showing the design of the delivery device with dashed lines showing parts of the design not forming part of the design;

[0047]Figure 13 is a rear perspective view of the delivery device shown in Figure 12;

[0048]Figure 14 is a side view of the delivery device shown in Figure 12;

[0049]Figure 15 is a rear view of the delivery device shown in Figure 12;

[0050]Figure16 is bottom view of the delivery device shown in Figure 12;

[0051]Figurel7 is top view of the delivery device shown in Figure 12;

[0052]Figure18 is side view of the delivery device shown in Figure 12;

[0053]Figure 19 is a front view of the delivery device shown in Figure 12

DETAILED DESCRIPTION

[0054]An endoluminal intervention device is shown in Figure 1. This particular intervention device is a delivery device 10 that includes a handle assembly 200 at a distal end 18 thereof. It also includes an intervention assembly in the form of a tip assembly 100 at a proximal end 12 thereof. At the proximal end 12 is an endograft receiving portion 48 distally adjacent to the tip assembly 100. A nose cone dilator 105 is also provided proximally of the endograft receiving portion 48. A sheath 510, which is retractable, is shown covering the endograft receiving portion 48.

[0055]A pair of rotatable rings 328,330 are disposed within the handle assembly 200. These rotatable rings 328 and 330 are used to retract distal and proximal trigger wires. Further detail and operation of the delivery device shown in Figure 1 can be found within published European Patent EP 3 138 538 titled Modular Handle for a Prosthesis Delivery Device. This document, EP 3 138 538, is hereby incorporated in its entirety by reference.

[0056]An alternative delivery device 10 is shown in Figure 2A. The delivery device shown in Figure 2A again has a handle assembly 200 and a tip assembly 100 at a distal end 18 thereof. The tip assembly 100 again includes a nose cone dilator 105. An endograft receiving portion 48 is also provided at or towards the proximal end 12. A sheath 510 covers the endograft receiving portion in an initial condition. An endograft 5 in a compressed condition is also shown in Figure 2A. A guide wire catheter 40 extends through the handle assembly 200. The guide wire catheter 40 is affixed at a distal end thereof to the handle assembly 200 and is affixed at a proximal end thereof to the tip assembly 100. Three line puller mechanisms 50, 50' and 50"are provided towards the distal end 18 of the delivery device 10.

[0057]A further alternative delivery device 10 is shown in Figure 11. It will be described more briefly, but has the same general features as delivery device 10 is shown in Figure 2A. The delivery device shown in Figure 11 again has a handle assembly 200 and a tip assembly 100 at a distal end 18 thereof. The tip assembly 100 again includes a nose cone dilator 105. An endograft receiving portion 48 is also provided at or towards the proximal end 12. A sheath 510 covers the endograft receiving portion in an initial condition (hiding the endograft receiving portion 48). An endograft 5 in a compressed condition is also provided. Three line puller mechanisms 50, 50' and 50"are provided towards the distal end 18 of the delivery device 10.

[0058]With each of the delivery devices described above, a guide wire catheter 40 extends through the handle assembly 200. The guide wire catheter is affixed at a distal end thereof to the handle assembly 200 and it is affixed at a proximal end thereof to the tip assembly 100. An endograft receiving portion 50 is also provided for receiving an endograft 5 distally adjacent to the tip assembly

[0059]The delivery devices 10 shown in Figures 2A and 11 , includes improvements, modifications or at lease differences over the delivery device of afore-mentioned European Patent EP3138538, as shown in Figure 1. All of the delivery devices 10 shown in Figures 1, 2A and 10 include a plurality of line puller mechanisms. These line puller mechanisms will now be described.

[0060]In the case of Figure 1, the line puller 50 sits underneath the rotatable ring 328, whereas in the case of the delivery devices 10 shown in Figure 2A and 11, the line puller 50 sits underneath the rotatable ring 222. The rotatable ring 222 is most clearly seen in Figures 2B and 2C.

[0061]The line puller 50 of Figures 2A, 2B and 2C will now be described with reference to those Figures, together with Figures 3, 4, 5, 6, 7, 8A, 8B, and the sequential Figures 9A to 9E. Line puller 50 includes a body 55. The body 55 is shown in an exploded view in Figure 6. Figure 6 shows that the body 55 is of a two-piece construction having halves 55a and 55b. In other embodiments, a unitary body may be provided. The line puller may be injection moulded or 3D printed from any suitable material.

[0062] The line puller 50 includes an intermediate member 60 rotatably mounted to the body 55, as can be seen in the exploded view of Figure 4. The intermediate member 60 is also shown in Figure 7. Intermediate member 60 is constructed from two halves, 61a and 61b. In other embodiments of invention, not shown, the intermediate member 60 may be a unitary component.

[0063]The intermediate member 60 comprises an intermediate line guide 61 shown in Figures 4 and 7. The intermediate line guide 61 may be a single line guide or the two line guides 61a and 61b illustrated. There are several benefits in providing two line guides 61a and 61b instead of single line guide 61. The benefits include an ability to choose which of the two line guides 61a, 61b to utilise as will be made clear below. Another benefit of having two line guides is that they can both be used, as is shown in Figure 10, either for one line or for two separate lines. The line guide 61 or line guides 61a, 61b, are radiused on both sides to reduce friction and to facilitate easy movement of the line 80 there-through.

[0064] The line pull mechanism further includes an intermediate ratchet mechanism operably interposed between the intermediate member 60 and the body 55.

[0065]An outer ring 70 rotatably mounted for rotation around the body 55 is also provided as is shown most clearly in Figure 8A. This outer ring 70 is constructed from two halves 70a and 70b, although again, in other embodiments of the invention, may be of a unitary construction.

[0066]The outer ring 70 also has an aperture 71. This aperture is also shown in Figure 3 and allows the line 80 to extend from within the outer ring 70 to outside the outer ring 70. In some embodiments of the invention, a line anchor 89 may be provided as is illustrated in Figure 9A.

[0067]An outer ratchet mechanism is operably interposed between the outer ring 70 and the intermediate member 60. This ratchet mechanism, which can be seen in the exploded view of Figure 4, will be explained in further detail below.

[0068]A line 80 is threaded between the body 55 and the outer ring 70 so as to pass through the intermediate line guide 61 as is most clearly shown in Figures 9A to 9E. The intermediate ratchet mechanism engages with the body 55 to allow rotation of the intermediate member 60 in a first rotation direction and to restrict rotation in a second rotation direction, the second rotation direction opposite to the first rotation direction. The outer ratchet mechanism engages with the intermediate member 60 to allow rotation of the outer ring 70 with respect to the intermediate member 60 in the second rotation direction and is engagable with the intermediate member 60 to impart rotation of the intermediate member 60 in the first rotation direction. This can be seen in the progressive figures of Figures 9A to 9E.

[0069]The intermediate ratchet mechanism comprises an intermediate ratchet annulus 64 and an intermediate pawl 66. The intermediate ratchet annulus 64 is most clearly shown in Figure 7, whereas the intermediate pawl 66 can be seen in Figure 5. Referring now to Figures 4 and 6, it can be seen that two pawls 66a and 66b may be provided.

[0070]It can be seen that one of the intermediate ratchet annulus 64 and intermediate pawl 66 are located on the intermediate member 60 and the other of the intermediate ratchet annulus 64 and intermediate pawl 66 is located on the body 55. In the embodiment illustrated, it is the pawl 66 that is located on the body 55 and the intermediate ratchet annulus 64 that is located on the intermediate member 60. However, in other embodiments of the invention, the location of these two components may be swapped around so that the pawl is located on the intermediate member and the ratchet is located on the body 55.

[0071]Turning again to Figure 7, it can be seen that the intermediate ratchet annulus 64 comprises an intermediate internally toothed ring 65.

[0072]The intermediate pawl 66 comprises an arm 67 and a tooth engaging portion 69 as is illustrated in Figure 5. The arm 67 extends from body 55 and is cantilevered from the body 55. The arm 67 is resiliently bendable allowing the tooth engaging portion 69 to be displaced radially. With the embodiment illustrated, the entire intermediate pawl 66 is part of the intermediate member 60.

[0073]It can be seen from the exploded drawing Figure 4 that the intermediate ratchet mechanism and the outer ratchet mechanism are longitudinally spaced apart.

[0074]Now turning to Figures 8A, it can be seen that the line pull assembly has an outer ratchet mechanism comprising an outer ratchet annulus 74 and an outer pawl 76, one of the outer ratchet annulus and outer pawl on the outer ring 70 and the other of the outer ratchet annulus 74 and the outer pawl 76 on the intermediate member 60.

[0075]In the embodiment illustrated, it is the pawl 76 that is located on the intermediate member 60 as can be seen in Figure 7 and the outer ratchet annulus 74 that is located on the outer ring 70. However, in other embodiments of the invention, the location of these two components may be swapped around so that the pawl is located on the outer ring 70 and the ratchet annulus is located on the intermediate member 60.

[0076]Now turning to Figure 8B, an alternative outer ratchet annulus 74 to the outer ratchet annulus 74 shown in Figure 8A is shown. With the embodiment shown in Figure 8B, the outer ratchet annulus comprises an intermediate internal friction ring 75f. With this embodiment, the outer pawl 76 comprises an arm and internal friction ring engaging shoe.

[0077]While not shown, the intermediate ratchet annulus 64 may also comprise an intermediate internal friction ring and the intermediate pawl may comprise an arm and internal friction ring engaging shoe as well

[0078] Referring to Figure 10, a variant of the invention is shown where the wire 80 comprises a looped portion having one end 89a positioned opposite another end 89b. With this looped arrangement, increased pulling force may be provided. While various wire routings may be used, in one embodiment, a proximal line portion 82 is connected as is illustrated in Figure 10. This proximal line portion 82 extends at a single wire through to the tip assembly 100.

[0079]Now referring to Figures 2A and 11, a further element of the line puller actuator assembly 50 is shown. This further element, ring grip 222, is hand graspable by an operator for actuation of the line puller actuator assembly 50. The provision of a separate outer ring grip 222 allows for an additional optional locking feature to be added to the actuator assembly. Referring to Figure 11, it can be seen that the ring grip 222 is slidable from the position shown in Figure 2B to the position shown in Figure 2C. In the position shown in Figure 2B, the line puller actuator assembly 50 is locked with respect to the body 55. In contrast, in the position shown in Figure 2C, where the ring grip 222 has been moved across to the flange 59, the line puller actuator assembly 50, and its outer ring 70, is rotatably unlocked with respect to the body 55. This allows an operator, such as a surgeon, to actuate the line puller mechanism 50, but only after positively sliding the ring grip 222 axially in a distal direction from the position shown in Figure 2B to the position shown in Figure 2C.

[0080]Now referring to Figure 11, a delivery device 10 is shown having a number of improved features over the delivery device shown in Figures 1 and 2A. The delivery device 10 of Figure 11 has, in particular, an improved handle assembly 200. A sheath retraction knob 520 is provided, together with ring grips 222 and 222'. The ring grips 222 and 222' operate line pullers 50 and 50' of the type described above. With the device of Figure 11, an improved locking mechanism is provided whereby the triangular shaped portions of the handle engage with mutually shaped notches formed within the ring grips 222 and 222'. The engagement of the triangular shaped portions with the mutually shaped notches locks the ring grips 222 and 222' against rotation. Unlocking is achieved through sliding the ring grips 222 and 222' distally so that the triangular shaped portions disengage with the mutually shaped notches, thereby allowing rotation to occur and allowing actuation of the corresponding line pullers 50, 50'. While triangular shaped portions are provided in the embodiments shown, any shape or arrangement that will prevent substantial rotation of the rings, if not disengaged by pulling back, can be provided.

[0081]Figures 12 through to 19 are design patent drawings which show the aesthetic features of the handle assembly 200. The portion of the handle 200 illustrated in dashed lines forms no part of the design patent monopoly.

[0082]Operation of the line pull assembly described above will now be described with reference to Figures 9A through to 9E. These figures show the line pull mechanism of Figures 2A to 2C, 3, 4, 5, 6, 7 and 8A in a series of sequential operational steps.

[0083] Referring first to Figure 9A, the line pull mechanism 55 is shown in an initial position where the line 80, typically a wire 80, extends from a line anchor 89 which cannot pass through an aperture 71, extends through line guide 61b, most clearly shown in Figure 7 and through body line guide 56, most clearly shown in Figure 4. The routing of the line wire 80 is most clearly shown in Figure 3. It can be seen that in Figure 9A, the path of the wire 80 from outside the outer ring 70 through the intermediate member 60 and into the internal portion 58 of the body 55 is a straight path. In use, the operator, typically a surgeon or a surgical assistant, rotates the outer ring 70, either directly, or by rotating an element engaged with the outer ring 70, in a direction indicated by the arrows on Figure 9A. With reference to Figure 9A, it can be seen that this initial rotation is in an anticlockwise direction. This rotation from the position shown in Figure 9A to the position shown in Figure 9B lengthens the path through which the wire 80 passes before reaching the inside of the line puller body 55. The effect of this is that the proximal end, typically located at the proximal end 12 of a delivery device such as is illustrated in Figure 2A, is pulled in a distal direction. Without needing to release his or her grip, the operator can then rotate the outer ring 70 back in a clockwise direction as indicated by the arrow on Figure 9B to a position shown in Figure 9C. This again lengthens the path through which the line 80 passes before reaching the internal portion 58 of the line puller body 55.

[0084]This process can be repeated numerous times as is indicated in the progressive drawings of Figures 9A through to 9E, each time lengthening the path for the wire 80 and therefore pulling the line 80 into the line or wire pull mechanism 50.

[0085]As can be seen in Figures 3 and 2D, the line 80 has a proximal end portion that is within the handle portion that is drawn into the handle portion as the line puller mechanism 55 is actuated as described in the preceding paragraphs. This causes the distal end portion 88 which is at least partially within the intervention assembly, or tip assembly 100, as is shown in Figure 2D, to be retracted.

[0086]Use or operation of the endo-luminal intervention device in the form of the delivery device 10 that includes the line pull assembly described above will now be described as it is used in a medical procedure.

[0087] Referring first to Figure 2A and its companion Figures 2B, 2C and 2D , the delivery device 10 is shown together with a sheath assembly in a configuration ready for use.

[0088] Typically, one of the first major steps in a procedure undertaken by a vascular surgeon would be to introduce a guide wire into a blood vessel, such as the femoral artery, using the Seldinger technique. This technique involves creating a surgical opening in the vessel of the needle and inserting a wire guide into the vessel through a bore of the needle. The needle is then withdrawn leaving the guide wire in place. The delivery device 10, as shown in Figures 2A and 2D, is then inserted over the guide wire and into the vessel.

[0089]Once the surgeon has positioned the proximal end 12 of the delivery device 10 near the target delivery area for the endograft 5, the sheath assembly can be withdrawn to the position shown in Figures 2A and 2B. In this position, the sheath 510 of the sheath assembly has been pulled back over the compressed endograft for stent graft 5 so as to expose it. This step is conducted by holding the handle 200 while rotating the knob 520.

[0090]Typically, a next step in operating the delivery device 10 would be causing the stent graft to expand from its reduced condition to an expanded condition. This next step causes removal of the reducing trigger wire, the distal end of which can be seen most clearly in Figure 2D. In order to commence this step, the surgeon grips the ring grip 222 in its position shown in Figure 2B. He or she then slides the ring grip 222 distally from its locked position (where it is locked against rotational movement). This sliding movement can be seen in the progression from the positions shown in Figures 2B to 2C.

[0091]Next, the surgeon or operator rotates the ring grip 222. This has the effect of rotating the outer ring 70 pulling the line or wire 80, releasing at least a portion of the endograft at the endograft receiving portion. For instance the wire may be a reducing trigger wire 1032, the end of which is shown in Figure 2D. The reducing trigger wire 1032 is pulled in a distal direction and its proximal end, moves free from the endograft 5 allowing it to expand.

[0092]Typically, the next step in the procedure would be to release the proximal trigger wire 2022 illustrated in Figure 2D.

[0093]This is done by actuating the second line puller 55'which functions in the same way as the line puller 55 already described.

[0094]Actuation of the line puller 55' causes the proximal trigger wire 2022 shown in Figure 2D to be detached from the tip assembly 100.

[0095]Depending on the delivery device used, the remainder of the procedure may include actuation of a tip assembly actuator as is described in the applicant's earlier Australian provisional patent application number AU2017904881 titled AN ENDOGRAFT DELIVERY DEVICE ASSEMBLY filed on 5 December 2017.

[0096]Throughout this specification, including in the claims, 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.

[0097] 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.

Claims

1. An endo-luminal intervention device comprising: a handle assembly at a distal end thereof; an intervention assembly at a proximal end thereof; and 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 intervention assembly, the handle assembly comprising a line puller comprising: a body; an intermediate member rotatably mounted to the body, the intermediate member comprising an intermediate line guide; an intermediate ratchet mechanism operably interposed between the intermediate member and the body; an outer ring rotatably mounted for rotation around the body; an outer ratchet mechanism operably interposed between the outer ring and the intermediate member; and a line threaded between the body and the outer ring so as to pass through the intermediate line guide, wherein the intermediate ratchet mechanism engages with the body to allow rotation of the intermediate member in a first rotation direction and to restrict rotation in a second rotation direction, the second rotation direction opposite to the first rotation direction, and wherein the outer ratchet mechanism engages with the intermediate member to allow rotation of the outer ring with respect to the intermediate member in the second rotation direction and is engagable with the intermediate member to impart rotation to the intermediate member in the first rotation direction.

2. The endo-luminal intervention device as claimed in claim 1 wherein the intermediate ratchet mechanism comprises a intermediate ratchet annulus and an intermediate pawl, one of the intermediate ratchet annulus and intermediate pawl on the intermediate member and the other of the intermediate ratchet annulus and intermediate pawl on the body.

3. The endo-luminal intervention device as claimed in claim 2 wherein the intermediate ratchet annulus comprises an intermediate internally toothed ring.

4. The endo-luminal intervention device as claimed in claim 3 wherein the intermediate pawl comprises an arm and a tooth engaging portion.

5. The endo-luminal intervention device as claimed in claim 4 wherein the arm extends from the body and is cantilevered from the body.

6. The endo-luminal intervention device as claimed in claim 5 wherein the arm is resiliently bendable allowing the tooth engaging portion to be displaced radially.

7. The endo-luminal intervention device as claimed in claim 1 wherein the intermediate ratchet mechanism and the outer ratchet mechanism are longitudinally spaced apart.

8. The endo-luminal intervention device as claimed in claim 2 wherein the intermediate ratchet annulus comprises an intermediate internal friction ring.

9. The endo-luminal intervention device as claimed in claim 2 wherein the intermediate pawl comprises an arm and an internal friction ring engaging shoe.

10. The endo-luminal intervention device as claimed in claim 1 wherein the intermediate ratchet mechanism and the outer ratchet mechanism are longitudinally spaced apart.

11. The endo-luminal intervention device as claimed in claim 1 wherein the outer ratchet mechanism comprises a outer ratchet annulus and an outer pawl, one of the outer ratchet annulus and outer pawl on the outer ring and the other of the outer ratchet annulus and outer pawl on the intermediate member.

12. The endo-luminal intervention device as claimed in claim 11 wherein the outer ratchet annulus comprises an outer internally toothed ring.

13.An endo-luminal delivery device comprising: a handle assembly at a distal end thereof, the handle assembly comprising line (wire) pull mechanism: a body; an intermediate member rotatably mounted to the body, the intermediate member comprising an intermediate line guide; an intermediate ratchet mechanism operably interposed between the intermediate member and the body; an outer ring rotatably mounted for rotation around the body; an outer ratchet mechanism operably interposed between the outer ring and the intermediate member; and a line threaded between the body and the outer ring so as to pass through the intermediate line guide, 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, wherein the intermediate ratchet mechanism engages with the body to allow rotation of the intermediate member in a first rotation direction and to restrict rotation in a second rotation direction, the second rotation direction opposite to the first rotation direction, and wherein the outer ratchet mechanism engages with the intermediate member to allow rotation of the outer ring with respect to the intermediate member in the second rotation direction and is engagable with the intermediate member to impart rotation to the intermediate member in the first rotation direction.

14.The endo-luminal delivery device as claimed in claim 1 wherein the intermediate ratchet mechanism comprises a intermediate ratchet annulus and an intermediate pawl, one of the intermediate ratchet annulus and intermediate pawl on the intermediate member and the other of the intermediate ratchet annulus and intermediate pawl on the body.

15.The endo-luminal delivery device as claimed in claim 14 wherein the intermediate ratchet annulus comprises an intermediate internally toothed ring.

16. The endo-luminal delivery device as claimed in claim 15 wherein the intermediate pawl comprises an arm and a tooth engaging portion.

17. The endo-luminal delivery device as claimed in claim 4 wherein the arm extends from the body and is cantilevered from the body.

18. The endo-luminal delivery device as claimed in claim 17 wherein the arm is resiliently bendable allowing the tooth engaging portion to be displaced radially.

19. The endo-luminal delivery device as claimed in claim 13 wherein the intermediate ratchet mechanism and the outer ratchet mechanism are longitudinally spaced apart.

20. The endo-luminal delivery device as claimed in claim 13 wherein the line comprises a proximal end portion and a distal end portion, the proximal end portion at least partially within the handle portion and the distal end portion at least partially within the intervention assembly, and whereby the rotation in each of the first direction and the second direction retracts the proximal end portion, thereby releasing at least a portion of the endograft at the endograft receiving portion.

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