Interventional medical closure device

Abstract

An interventional medical closure device is suitable for assisting closure of an opening through a blood vessel wall after completion of an interventional procedure within the internal lumen of the blood vessel. The device comprises a closure element, a grasping element for grasping the closure element, and a delivery element for delivering the closure element into the internal lumen of the blood vessel. The closure element comprises a suture, and an engagement foot at a distal end of the suture. The grasping element is inter-engageable with the closure element to grasp the closure element. The delivery element comprises a main body portion, and a distal nose. The distal nose defines a reception space for carrying the engagement foot of the closure element. The delivery element also comprises an engagement foot which is movable relative to the main body portion between a low-profile delivery configuration and a protruding engagement configuration.

1 . A method of performing an interventional procedure, the method comprising the steps of:
 creating an opening through a tissue wall, the opening extending from an external surface of the tissue to an internal lumen of the tissue;   grasping a closure element within the lumen; and   moving the closure element through a first part of the tissue wall on a first side of the opening, across the opening, and through a second part of the tissue wall on a second side of the opening to assist in closure of the opening.   
   
   
       2 . A method as claimed in  claim 1  wherein the method comprises the step of passing a grasping element through the tissue wall to grasp the closure element within the lumen. 
   
   
       3 . A method as claimed in  claim 2  wherein the grasping element is passed across the opening. 
   
   
       4 . A method as claimed in  claim 3  wherein the grasping element is passed through the second part of the tissue wall on the second side of the opening, across the opening, and through the first part of the tissue wall on the first side of the opening. 
   
   
       5 . A method as claimed in any of  claims 1  to  4  wherein the longitudinal axis of the opening subtends an acute angle with the longitudinal axis of the lumen. 
   
   
       6 . A method as claimed in  claim 5  wherein the longitudinal axis of the opening subtends an angle of approximately 45° with the longitudinal axis of the lumen. 
   
   
       7 . A method as claimed in any of  claims 1  to  6  wherein the axis along which the closure element is moved subtends an acute angle with the longitudinal axis of the lumen. 
   
   
       8 . A method as claimed in  claim 7  wherein the axis along which the closure element is moved subtends an angle in the range of from 5° to 65° with the longitudinal axis of the lumen. 
   
   
       9 . A method as claimed in  claim 8  wherein the axis along which the closure element is moved subtends an angle in the range of from 15° to 55° with the longitudinal axis of the lumen. 
   
   
       10 . A method as claimed in  claim 9  wherein the axis along which the closure element is moved subtends an angle of approximately 30° with the longitudinal axis of the lumen. 
   
   
       11 . A method as claimed in any of  claims 1  to  10  wherein the longitudinal axis of the opening intersects the external surface of the tissue at a first intersection point, the axis along which the closure element is moved intersects the external surface of the tissue at a second intersection point, the longitudinal axis of the opening intersects the axis along which the closure element is moved at a third intersection point, and a transverse axis of the lumen extends perpendicular to the longitudinal axis of the lumen through the third intersection point, the first intersection point and the second intersection point being on opposite sides of the transverse axis. 
   
   
       12 . A method as claimed in any of  claims 1  to  11  wherein the axis along which the closure element is moved subtends an angle in the range of from 70° to 130° with the longitudinal axis of the opening. 
   
   
       13 . A method as claimed in  claim 12  wherein the axis along which the closure element is moved subtends an angle in the range of from 80° to 120° with the longitudinal axis of the opening. 
   
   
       14 . A method as claimed in  claim 13  wherein the axis along which the closure element is retracted subtends an angle of approximately 105° with the longitudinal axis of the opening. 
   
   
       15 . A method as claimed in any of  claims 1  to  14  wherein the opening comprises a puncture opening. 
   
   
       16 . A method as claimed in any of  claims 1  to  15  wherein the method comprises the step of dilating the opening. 
   
   
       17 . A method as claimed in any of  claims 1  to  16  wherein the method comprises the step of inserting the closure element into the lumen. 
   
   
       18 . A method as claimed in  claim 17  wherein the closure element is inserted through the opening into the lumen. 
   
   
       19 . A method as claimed in any of  claims 1  to  18  wherein the method comprises the step of maintaining the position of the closure element substantially fixed within the lumen prior to grasping. 
   
   
       20 . A method as claimed in any of  claims 1  to  19  wherein the method comprises the step of passing one or more medical devices through the opening into the lumen to perform at least one interventional procedure within the lumen. 
   
   
       21 . A method as claimed in any of  claims 1  to  20  wherein the closure element is moved to engage an internal surface of the tissue. 
   
   
       22 . A method as claimed in  claim 21  wherein the closure element engages the internal surface of the tissue on the first side of the opening and on the second side of the opening. 
   
   
       23 . A method as claimed in any of  claims 1  to  22  wherein the method comprises the step of engaging the external surface of the tissue. 
   
   
       24 . A method as claimed in  claim 23  wherein the external surface of the tissue is engaged on the first side of the opening and on the second side of the opening. 
   
   
       25 . A method as claimed in any of  claims 1  to  24  wherein the method comprises the step of applying a compressive force to the external surface of the tissue and/or to the internal surface of the tissue. 
   
   
       26 . A method as claimed in  claim 25  wherein the compressive force is applied on the first side of the opening and on the second side of the opening. 
   
   
       27 . A method of performing an interventional procedure, the method comprising the steps of:
 creating an opening through a tissue wall;   moving a closure element through a first part of the tissue wall on a first side of the opening, across the opening, and through a second part of the tissue wall on a second side of the opening to assist in closure of the opening.   
   
   
       28 . A method as claimed in  claim 27  wherein the longitudinal axis of the opening intersects an external surface of the tissue at a first intersection point, the axis along which the closure element is moved intersects the external surface of the tissue at a second intersection point, the longitudinal axis of the opening intersects the axis along which the closure element is moved at a third intersection point, and a transverse axis of the lumen extends perpendicular to the longitudinal axis of the lumen through the third intersection point, the first intersection point and the second intersection point being on opposite sides of the transverse axis. 
   
   
       29 . A method of performing an interventional procedure substantially as hereinbefore described with reference to the accompanying drawings. 
   
   
       30 . An interventional medical closure device comprising:
 a closure element; and   a grasping element for grasping the closure element within an internal lumen of a tissue;   the grasping element being configured to move the closure element through a first part of the tissue wall on a first side of an opening through the tissue wall, across the opening, and through a second part of the tissue wall on a second side of the opening to assist in closure of the opening.   
   
   
       31 . A device as claimed in  claim 30  wherein the grasping element is engageable with the closure element to grasp the closure element. 
   
   
       32 . A device as claimed in  claim 31  wherein the grasping element is engageable with the closure element in a snap-fit manner. 
   
   
       33 . A device as claimed in  claim 31  or  32  wherein a distal end of the grasping element is engageable with a proximal end of the closure element. 
   
   
       34 . A device as claimed in any of  claims 30  to  33  wherein the device comprises a guide element for guiding passage of the grasping element. 
   
   
       35 . A device as claimed in  claim 34  wherein the guide element is configured to guide passage of the grasping element across an opening through a tissue wall. 
   
   
       36 . A device as claimed in  claim 35  wherein the guide element is configured to guide passage of the grasping element through a second part of a tissue wall on a second side of an opening through the tissue wall, across the opening, and through a first part of the tissue wall on a first side of the opening. 
   
   
       37 . A device as claimed in any of  claims 35  to  36  wherein the guide element comprises an outlet part out of which the grasping element may pass. 
   
   
       38 . A device as claimed in  claim 37  wherein the outlet part is movable relative to a main body portion of the guide element. 
   
   
       39 . A device as claimed in  claim 38  wherein the outlet part is movable between a delivery configuration and a guiding configuration. 
   
   
       40 . A device as claimed in any of  claims 30  to  39  wherein the device comprises an introducer sheath to dilate an opening through a tissue wall. 
   
   
       41 . A device as claimed in any of  claims 30  to  40  wherein the device comprises a delivery element to deliver the closure element into an internal lumen of a tissue. 
   
   
       42 . A device as claimed in  claim 41  wherein the delivery element is engageable with an internal surface of a tissue to maintain the position of the closure element substantially fixed within an internal lumen of the tissue prior to grasping. 
   
   
       43 . A device as claimed in  claim 42  wherein the delivery element comprises an engagement element for engagement with an internal surface of a tissue. 
   
   
       44 . A device as claimed in  claim 43  wherein the engagement element is movable relative to a main body portion of the delivery element. 
   
   
       45 . A device as claimed in  claim 44  wherein the engagement element is movable between a delivery configuration and an engagement configuration. 
   
   
       46 . A device as claimed in any of  claims 30  to  45  wherein the closure element is engageable with an internal surface of a tissue. 
   
   
       47 . A device as claimed in  claim 46  wherein the closure element comprises an engagement element for engagement with an internal surface of a tissue. 
   
   
       48 . A device as claimed in any of  claims 30  to  47  wherein the device comprises an external engagement element for engagement with an external surface of a tissue. 
   
   
       49 . An interventional medical closure device substantially as hereinbefore described with reference to the accompanying drawings. 
   
   
       50 . A method of accessing an interior of a body part, the method comprising the steps of:
 creating an incision in a wall of the body part with at least one flap of tissue wall at a side of the incision;   moving the flap aside to form an opening to the interior of the body part; and   inserting at least one medical device through the opening to access the interior of the body part.   
   
   
       51 . A method as claimed in  claim 50  wherein the longitudinal axis of the incision is inclined relative to the plane of the wall of the body part. 
   
   
       52 . A method as claimed in  claim 51  wherein the angle subtended between the longitudinal axis of the incision and the plane of the wall of the body part is in the range of from 10° to 80°. 
   
   
       53 . A method as claimed in  claim 52  wherein the angle subtended between the longitudinal axis of the incision and the plane of the wall of the body part is approximately 45°. 
   
   
       54 . A method as claimed in any of  claims 50  to  53  wherein the method comprises the step of engaging the flap to move the flap aside to form the opening. 
   
   
       55 . A method as claimed in  claim 54  wherein the flap is pushed distally to form the opening. 
   
   
       56 . A method as claimed in  claim 54  or  55  wherein the flap is engaged by an introducer sheath, and/or a delivery catheter, and/or a guide catheter. 
   
   
       57 . A method as claimed in any of  claims 50  to  56  wherein the method comprises the step of performing a medical procedure using the medical device. 
   
   
       58 . A method as claimed in any of  claims 50  to  57  wherein the method comprises the step of withdrawing the medical device from the interior of the body part. 
   
   
       59 . A method as claimed in any of  claims 50  to  58  wherein the method comprises the step of sealing across the opening. 
   
   
       60 . A method as claimed in  claim 59  wherein the flap is moved back to seal across the opening. 
   
   
       61 . A method as claimed in  claim 60  wherein the method comprises the step of engaging the flap to move the flap back to seal across the opening. 
   
   
       62 . A method as claimed in  claim 61  wherein the flap is pulled proximally to seal across the opening. 
   
   
       63 . A method as claimed in  claim 61  or  62  wherein the flap is engaged by a part of an engagement element. 
   
   
       64 . A method as claimed in  claim 63  wherein the method comprises the step of moving the part of the engagement element from a delivery configuration to a deployed configuration before engaging the flap. 
   
   
       65 . A method as claimed in  claim 64  wherein the part of the engagement element is expanded from the delivery configuration to the deployed configuration. 
   
   
       66 . A method as claimed in  claim 65  wherein the part of the engagement element is inflated from the delivery configuration to the deployed configuration. 
   
   
       67 . A method as claimed in any of  claims 64  to  66  wherein the method comprises the step of moving the part of the engagement element from the deployed configuration to the delivery configuration after sealing across the opening. 
   
   
       68 . A method as claimed in  claim 67  wherein the part of the engagement element is contracted from the deployed configuration to the delivery configuration. 
   
   
       69 . A method as claimed in  claim 68  wherein the part of the engagement element is deflated from the deployed configuration to the delivery configuration. 
   
   
       70 . A method as claimed in any of  claims 63  to  69  wherein the method comprises the step of piercing the engagement element through the flap. 
   
   
       71 . A method as claimed in any of  claims 63  to  70  wherein the method comprises the step of piercing the engagement element through the wall of the body part at the opposite side of the incision. 
   
   
       72 . A method as claimed in  claim 70  or  71  wherein the engagement element is pierced through the flap and/or through the wall of the body part by piercing the flap and/or the wall of the body part with a needle and passing the engagement element through the needle. 
   
   
       73 . A method as claimed in  claim 72  wherein the method comprises the step of removing the needle from the flap and/or from the wall of the body part to leave the engagement element pierced therethrough. 
   
   
       74 . A method as claimed in any of  claims 70  to  73  wherein the engagement element is pierced through the flap and/or through the wall of the body part before the incision is created. 
   
   
       75 . A method as claimed in  claim 74  wherein the incision is created around the engagement element pierced through the flap and/or through the wall of the body part. 
   
   
       76 . A method as claimed in  claim 74  or  75  wherein the method comprises the step of protecting the engagement element during the step of creating the incision. 
   
   
       77 . A method as claimed in any of  claims 70  to  76  wherein the method comprises the step of withdrawing the engagement element from the flap after sealing across the opening. 
   
   
       78 . A method as claimed in any of  claims 71  to  77  wherein the method comprises the step of withdrawing the engagement element from the wall of the body part at the opposite side of the incision after sealing across the opening. 
   
   
       79 . A method as claimed in any of  claims 59  to  78  wherein the flap moves between a sealing configuration, in which the flap seals across the opening, and an access configuration, in which the flap is moved aside to reveal the opening. 
   
   
       80 . A method as claimed in  claim 79  wherein the flap moves relative to the wall of the body part. 
   
   
       81 . A method as claimed in  claim 79  or  80  wherein the flap moves in a substantially hinging manner. 
   
   
       82 . A method as claimed in  claim 81  wherein the axis of hinging is substantially parallel to the plane of the wall of the body part. 
   
   
       83 . A method as claimed in any of  claims 79  to  82  wherein in the access configuration, the flap is located substantially within the interior of the body part. 
   
   
       84 . A method as claimed in any of  claims 79  to  83  wherein in the sealing configuration, the flap engages the wall of the body part at the opposite side of the incision. 
   
   
       85 . A method as claimed in any of  claims 79  to  84  wherein the flap is anchored in the sealing configuration. 
   
   
       86 . A method as claimed in any of  claims 50  to  85  wherein the medical device comprises a guidewire, and/or an introducer sheath, and/or a delivery catheter, and/or a guide catheter. 
   
   
       87 . A method as claimed in any of  claims 50  to  86  wherein the body part comprises a blood vessel. 
   
   
       88 . A method as claimed in any of  claims 50  to  87  wherein the incision is substantially arch-shaped in profile. 
   
   
       89 . A method of accessing an interior of a body part substantially as hereinbefore described with reference to the accompanying drawings. 
   
   
       90 . A medical device comprising an incising element for creating an incision in a wall of a body part with at least one flap of tissue wall at a side of the incision. 
   
   
       91 . A device as claimed in  claim 90  wherein the incising element is configured to create an incision with the longitudinal axis of the incision inclined relative to the plane of a wall of a body part. 
   
   
       92 . A device as claimed in  claim 90  or  91  wherein the incising element is configured, to create an incision in a wall of a body part, the wall having a medical element pierced through the wall. 
   
   
       93 . A device as claimed in  claim 92  wherein the incising element is configured to create the incision around the medical element pierced through the wall of the body part. 
   
   
       94 . A device as claimed in  claim 93  wherein the incising element is movable between an open configuration and a closed configuration to create the incision around the medical element. 
   
   
       95 . A device as claimed in  claim 94  wherein in the closed configuration, the incising element has an opening for receiving the medical element therethrough. 
   
   
       96 . A device as claimed in any of  claims 90  to  95  wherein the incising element is configured to create an incision having an arch-shape in profile. 
   
   
       97 . A device as claimed in any of  claims 90  to  96  wherein the incising element has a cutting part movable between a first configuration and a second configuration. 
   
   
       98 . A device as claimed in  claim 97  wherein the cutting part is biased towards the second configuration. 
   
   
       99 . A device as claimed in  claim 98  wherein the incising device has a restraining part to restrain the cutting part in the first configuration. 
   
   
       100 . A device as claimed in  claim 99  wherein the cutting part is movable relative to the restraining part to release the cutting part to move to the second configuration. 
   
   
       101 . A device as claimed in  claim 99  or  100  wherein the restraining part comprises an outer sheath. 
   
   
       102 . A device as claimed in any of  claims 97  to  101  wherein the first configuration is a contracted configuration. 
   
   
       103 . A device as claimed in any of  claims 97  to  102  wherein in the first configuration, the cutting part is substantially tubular. 
   
   
       104 . A device as claimed in any of  claims 97  to  103  wherein the second configuration is an expanded configuration. 
   
   
       105 . A device as claimed in any of  claims 97  to  104  wherein in the second configuration, the cutting part is at least partially substantially frusto-conical. 
   
   
       106 . A device as claimed in  claim 105  wherein the cutting part is substantially frusto-conical around only part of the circumference of the part. 
   
   
       107 . A device as claimed in  claim 106  wherein the cutting part has a recess around part of the circumference of the part. 
   
   
       108 . A device as claimed in any of  claims 90  to  107  wherein the device comprises an engagement element, a part of the engagement element being engagable with a flap of tissue wall at a side of an incision to move the flap to seal across the opening through the incision. 
   
   
       109 . A medical device comprising an engagement element, a part of the engagement element being engagable with a flap of tissue wall at a side of an incision to move the flap to seal across an opening through the incision. 
   
   
       110 . A device as claimed in  claim 108  or  109  wherein the part of the engagement element is movable between a delivery configuration and a deployed configuration. 
   
   
       111 . A device as claimed in  claim 110  wherein the part of the engagement element is expandable I contractible between the delivery configuration and the deployed configuration. 
   
   
       112 . A device as claimed in  claim 111  wherein the part of the engagement element is inflatable/deflatable between the delivery configuration and the deployed configuration. 
   
   
       113 . A device as claimed in any of  claims 108  to  112  wherein the part of the engagement element is biodegradable. 
   
   
       114 . A device as claimed in any of  claims 108  to  113  wherein the device comprises one or more protective elements for protecting at least part of the engagement element during creation of an incision. 
   
   
       115 . A device as claimed in  claim 114  wherein the protective element is configured to cover at least part of the engagement element. 
   
   
       116 . A device as claimed in  claim 115  wherein the protective element comprises a protective sheath extendable over the engagement element. 
   
   
       117 . A device as claimed in  claim 115  or  116  wherein the protective element is movable relative to the engagement element between a protecting configuration, in which the protective element covers at least part of the engagement element, and an uncovered configuration. 
   
   
       118 . A device as claimed in any of  claims 108  to  117  wherein the engagement element is pierceable through a flap of tissue wall. 
   
   
       119 . A device as claimed in any of  claims 108  to  118  wherein the engagement element is substantially elongate. 
   
   
       120 . A device as claimed in any of  claims 108  to  119  wherein the device comprises an anchor to anchor the flap sealed across the opening. 
   
   
       121 . A device as claimed in  claim 120  wherein the engagement element carries the anchor. 
   
   
       122 . A device as claimed in  claim 120  or  121  wherein the anchor is configured to be located on an external surface of the flap. 
   
   
       123 . A medical device substantially as hereinbefore described with reference to the accompanying drawings.