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US20020002376A1 Expired / Lapsed US ⏱️ 0.0 years remaining

Vascular incisor and method

Assignee: Edwards Lifesciences LLC
•
Filing: 2001-01-26
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Granted: —
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Expires: 2021-01-26
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Abstract

Abstract An improved vascular incisor and method for allowing a user to safely create an incision in a body lumen. The present invention provides an apparatus which can create an incision in a front wall of the ascending aorta while preventing the blade from creating an incision in surrounding body structures, such as the back wall of the ascending aorta. The incisor includes a surgical element such as a blade which is activated by an actuator. As the actuator is depressed, the blade is moved from a protected, retracted position to an exposed, deployed position. The exposed blade is pushed into a front wall of the ascending aorta to create an incision. As the actuator is depressed further, the blade is automatically moved to the retracted position to prevent the blade from incising the back wall of the aorta.

Inventors

  • 👤 James Gannoe
  • 👤 Meir Moshe

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 14:05
CPC Classifications
A; A61; A61B; A61B17/00; A61B17/32; A61B17/320016; A61B17/34; A61B17/3415; A61B17/3494; A61B17/3496; A61B17/11; A61B17/3209; A61B17/3211; A61B17/00234; A61B2017/00238; A61B2017/00243; A61B2017/1107; A61B2017/1135; A61B90/00; A61B90/08; A61B2090/0801; A61B2090/08021

Claims Analysis

Total Claims: 95
Claim 1
Independent Claim 145 words
1 . An apparatus for creating a vascular incision comprising: a body; a rod movable relative to the body and having a proximal end and a distal end; a surgical element disposed at the distal end of the rod, wherein the rod and surgical element are movable between a retracted position and a deployed position, wherein the rod and surgical element are biased in the retracted position; an actuator coupled to at least one finger which engages the proximal end of the rod, wherein activation of the actuator advances the surgical element from the retracted position to the deployed position; and a ramp on the body to engage the finger as the rod and surgical element move to the deployed position, wherein the ramp disengages the finger from the proximal end of the rod to allow the surgical element to move to the retracted position.
Claim 2
Dependent Claim 145 words
1 . An apparatus for creating a vascular incision comprising: a body; a rod movable relative to the body and having a proximal end and a distal end; a surgical element disposed at the distal end of the rod, wherein the rod and surgical element are movable between a retracted position and a deployed position, wherein the rod and surgical element are biased in the retracted position; an actuator coupled to at least one finger which engages the proximal end of the rod, wherein activation of the actuator advances the surgical element from the retracted position to the deployed position; and a ramp on the body to engage the finger as the rod and surgical element move to the deployed position, wherein the ramp disengages the finger from the proximal end of the rod to allow the surgical element to move to the retracted position.
Claim 3
Dependent Claim 36 words
2 . The apparatus of claim 1 further comprising a return spring, wherein the actuator is movable between an undepressed position and a depressed position, wherein the return spring biases the actuator to the undepressed position.
Claim 4
Dependent Claim 38 words
3 . The apparatus of claim 2 wherein the actuator defines a longitudinal axis and the rod defines a longitudinal axis, wherein the longitudinal axis of the actuator is substantially aligned with the longitudinal axis of the rod.
Claim 5
Dependent Claim 19 words
4 . The apparatus of claim 1 wherein the actuator is coupled to multiple fingers which engage the rod.
Claim 6
Dependent Claim 20 words
5 . The apparatus of claim 1 wherein the proximal end of the rod comprises an enlarged push rod cap.
Claim 7
Dependent Claim 19 words
6 . The apparatus of claim 5 wherein the finger comprises a protrusion which engages the push rod cap.
Claim 8
Dependent Claim 21 words
7 . The apparatus of claim 1 wherein the actuator is adapted to be engaged by a user's thumb or palm.
Claim 9
Dependent Claim 21 words
8 . The apparatus of claim 1 wherein the body comprises finger grips adapted to be held by the user's fingers.
Claim 10
Dependent Claim 28 words
9 . The apparatus of claim 1 wherein the finger disengages from the rod when the rod and surgical element have been advanced to a fully deployed position.
Claim 11
Dependent Claim 25 words
10 . The apparatus of claim 1 wherein the finger is flexible and is resiliently biased radially inward towards the proximal end of the rod.
Claim 12
Dependent Claim 20 words
11 . The apparatus of claim 1 wherein the disengagement of the finger from the rod creates an audible click.
Claim 13
Dependent Claim 23 words
12 . The apparatus of claim 1 wherein the ramp forces the finger radially outward away from the proximal end of the rod.
Claim 14
Dependent Claim 14 words
13 . The apparatus of claim 1 wherein the surgical element is a blade.
Claim 15
Dependent Claim 20 words
14 . The apparatus of claim 13 wherein the blade has a width between approximately 4 mm and 6 mm.
Claim 16
Dependent Claim 19 words
15 . The apparatus of claim 13 wherein a leading edge of the blade has two outwardly facing edges.
Claim 17
Dependent Claim 19 words
16 . The apparatus of claim 13 wherein the rod is advanced at a 1:1 rate with the actuator.
Claim 18
Dependent Claim 25 words
17 . The apparatus of claim 1 further comprising an elongate housing which extends distally from the body to encase the rod and surgical element.
Claim 19
Dependent Claim 15 words
18 . The apparatus of claim 17 wherein the elongate housing and rod are flexible.
Claim 20
Dependent Claim 34 words
19 . The apparatus of claim 17 wherein the elongate housing comprises a tapered distal tip having an opening to allow the surgical element to move between the retracted position and the deployed position.
Claim 21
Dependent Claim 23 words
20 . The apparatus of claim 17 further comprising a cannula removably coupled to the elongate housing, the rod extending through the cannula.
Claim 22
Dependent Claim 27 words
21 . The apparatus of claim 20 wherein the cannula comprises a keying element to align the cannula in a predetermined orientation relative to the surgical element.
Claim 23
Dependent Claim 26 words
22 . The apparatus of claim 21 wherein the combination of the body, rod, surgical element, actuator, ramp, and rod spring are lighter than the cannula.
Claim 24
Dependent Claim 145 words
23 . An automatically retracting incisor comprising: a housing; a push rod having a proximal end and a distal end, wherein the push rod is movable between a retracted position and a deployed position, the push rod coupled to the housing and biased toward the retracted position; a surgical element disposed at the distal end of the push rod; a trigger pin releasably engaging the proximal end of the push rod; and a ramp on the housing engaging the trigger pin, wherein movement of the trigger pin moves the push rod and the surgical element from the retracted position towards the deployed position such that the trigger pin slides along the ramp, wherein the trigger pin reaches a top of the ramp and the trigger pin disengages from the push rod to allow the surgical element and push rod to return to the retracted position.
Claim 25
Dependent Claim 145 words
23 . An automatically retracting incisor comprising: a housing; a push rod having a proximal end and a distal end, wherein the push rod is movable between a retracted position and a deployed position, the push rod coupled to the housing and biased toward the retracted position; a surgical element disposed at the distal end of the push rod; a trigger pin releasably engaging the proximal end of the push rod; and a ramp on the housing engaging the trigger pin, wherein movement of the trigger pin moves the push rod and the surgical element from the retracted position towards the deployed position such that the trigger pin slides along the ramp, wherein the trigger pin reaches a top of the ramp and the trigger pin disengages from the push rod to allow the surgical element and push rod to return to the retracted position.
Claim 26
Dependent Claim 31 words
24 . The automatically retracting incisor of claim 23 wherein the trigger pin is coupled to an actuator, wherein the actuator is movable between an initial position and an actuated position.
Claim 27
Dependent Claim 15 words
25 . The automatically retracting incisor of claim 24 wherein the actuator comprises two handles.
Claim 28
Dependent Claim 18 words
26 . The automatically retracting incisor of claim 25 wherein the handles are pivotally coupled to the body.
Claim 29
Dependent Claim 34 words
27 . The automatically retracting incisor of claim 26 wherein the handles in the initial position are outwardly separated from the body and the handles in the actuated position are adjacent to the body.
Claim 30
Dependent Claim 24 words
28 . The automatically retracting incisor of claim 27 wherein the handles in the actuated position move the surgical element to the deployed position.
Claim 31
Dependent Claim 18 words
29 . The automatically retracting incisor of claim 27 wherein the handles are biased towards the initial position.
Claim 32
Dependent Claim 45 words
30 . The automatically retracting incisor of claim 24 wherein the push rod defines a longitudinal axis and the actuator defines a longitudinal axis of motion, wherein the longitudinal axis of motion of the actuator is parallel to the longitudinal axis of the push rod.
Claim 33
Dependent Claim 19 words
31 . The automatically retracting incisor of claim 24 wherein the actuated position is distal of the initial position.
Claim 34
Dependent Claim 21 words
32 . The automatically retracting incisor of claim 24 wherein the actuator comprises a thumb switch sidably coupled to the body.
Claim 35
Dependent Claim 18 words
33 . The automatically retracting incisor of claim 24 wherein the actuator is biased to the initial position.
Claim 36
Dependent Claim 23 words
34 . The automatically retracting incisor of claim 23 wherein the trigger pin is removably received in an aperture in the push rod.
Claim 37
Dependent Claim 28 words
35 . The automatically retracting incisor of claim 34 wherein the trigger pin is biased into the aperture and is urged out of the aperture by the ramp.
Claim 38
Dependent Claim 16 words
36 . The automatically retracting incisor of claim 23 wherein the surgical element is a blade.
Claim 39
Dependent Claim 27 words
37 . The automatically retracting incisor of claim 23 wherein movement of the surgical element from the deployed position to the retracted position makes an audible sound.
Claim 40
Dependent Claim 30 words
38 . The automatically retracting incisor of claim 23 wherein the push rod and surgical element are encased by an elongate housing, the elongate housing being attached to the body.
Claim 41
Dependent Claim 145 words
39 . An incisor comprising: a body; an elongate rod coupled to the body, the elongate rod comprising a proximal end and a distal end; a surgical element positioned at the distal end of the rod, wherein the surgical element and rod are movable between a retracted position and a deployed position, the rod and surgical element being biased to the retracted position; a hammer positioned in the body; a hammer spring in engagement with the hammer; an actuator coupled to a cam having a surface which engages the hammer, wherein movement of the actuator from an initial position to an actuated position moves the hammer to compress the hammer spring, wherein the cam disengages from the hammer, to allow the hammer spring to expand and push the hammer distally against the push rod so as to move the surgical element to the deployed position.
Claim 42
Dependent Claim 145 words
39 . An incisor comprising: a body; an elongate rod coupled to the body, the elongate rod comprising a proximal end and a distal end; a surgical element positioned at the distal end of the rod, wherein the surgical element and rod are movable between a retracted position and a deployed position, the rod and surgical element being biased to the retracted position; a hammer positioned in the body; a hammer spring in engagement with the hammer; an actuator coupled to a cam having a surface which engages the hammer, wherein movement of the actuator from an initial position to an actuated position moves the hammer to compress the hammer spring, wherein the cam disengages from the hammer, to allow the hammer spring to expand and push the hammer distally against the push rod so as to move the surgical element to the deployed position.
Claim 43
Dependent Claim 20 words
40 . The incisor of claim 39 further comprising a actuator spring which biases the actuator in the initial position.
Claim 44
Dependent Claim 41 words
41 . The incisor of claim 39 wherein the surgical element and rod are biased to the retracted position by a rod spring, the rod spring immediately biasing the surgical element and rod from the deployed position to the retracted position.
Claim 45
Dependent Claim 16 words
42 . The incisor of claim 39 wherein the hammer is decoupled from the elongate rod.
Claim 46
Dependent Claim 58 words
43 . A method of deploying and retracting a surgical element, the method comprising: depressing a plunger substantially along a longitudinal axis of the device to move the surgical element from a retracted position to a deployed position; and moving the surgical element from the deployed position to the retracted position independently of further movement of the plunger.
Claim 47
Dependent Claim 58 words
43 . A method of deploying and retracting a surgical element, the method comprising: depressing a plunger substantially along a longitudinal axis of the device to move the surgical element from a retracted position to a deployed position; and moving the surgical element from the deployed position to the retracted position independently of further movement of the plunger.
Claim 48
Dependent Claim 16 words
44 . The method of claim 43 further comprising biasing the plunger to an undepressed position.
Claim 49
Dependent Claim 18 words
45 . The method of claim 43 comprising informing the user that the surgical element has been retracted.
Claim 50
Dependent Claim 19 words
46 . The method of claim 45 wherein the informing step is carried out by making an audible click.
Claim 51
Dependent Claim 16 words
47 . The method of claim 43 further comprising positioning the surgical element through a cannula.
Claim 52
Dependent Claim 20 words
48 . The method of claim 43 wherein an incision in the tissue structure is created during the depressing step.
Claim 53
Dependent Claim 22 words
49 . The method of claim 48 comprising advancing a cannula through the incision before removing the surgical element from the incision.
Claim 54
Dependent Claim 21 words
50 . The method of claim 49 wherein the plunger is depressed in the same direction as the cannula is advanced.
Claim 55
Dependent Claim 20 words
51 . The method of claim 49 wherein the depressing step and the advancing step are carried out substantially simultaneously.
Claim 56
Dependent Claim 24 words
52 . The method of claim 43 further comprising releasing the plunger to move the plunger from a depressed position to an undepressed position.
Claim 57
Dependent Claim 26 words
53 . The method of claim 43 wherein the moving step is carried out by disengaging the plunger from a rod attached to the surgical element.
Claim 58
Dependent Claim 14 words
54 . The method of claim 43 wherein the surgical element is a blade.
Claim 59
Dependent Claim 68 words
55 . A method of inserting a cannula into a blood vessel comprising: positioning an incisor adjacent the blood vessel; activating an actuator to move a surgical element from a retracted position to a deployed position to create an incision in the blood vessel wall; and automatically moving the surgical element from the deployed position to the retracted position while simultaneously inserting the cannula into the blood vessel.
Claim 60
Dependent Claim 68 words
55 . A method of inserting a cannula into a blood vessel comprising: positioning an incisor adjacent the blood vessel; activating an actuator to move a surgical element from a retracted position to a deployed position to create an incision in the blood vessel wall; and automatically moving the surgical element from the deployed position to the retracted position while simultaneously inserting the cannula into the blood vessel.
Claim 61
Dependent Claim 22 words
56 . The method of claim 55 further comprising maintaining the position of the incisor within the cannula during the moving step.
Claim 62
Dependent Claim 17 words
57 . The method of claim 55 further comprising automatically returning the actuator to an initial position.
Claim 63
Dependent Claim 34 words
58 . The method of claim 55 wherein the actuator is coupled to the surgical element through a rod, wherein the moving step is carried out by biasing the rod to the retracted position.
Claim 64
Dependent Claim 22 words
59 . The method of claim 55 wherein the actuator is advanced distally to move the surgical element to the retracted position.
Claim 65
Dependent Claim 21 words
60 . The method of claim 55 wherein the cannula is inserted in the same direction as the actuator is advanced.
Claim 66
Dependent Claim 19 words
61 . The method of claim 55 wherein the activating step is carried out by squeezing two handles together.
Claim 67
Dependent Claim 49 words
62 . A method of creating an incision comprising: placing a distal tip of a device adjacent a vessel wall; activating an actuator to compress a spring; expanding the spring to deploy a surgical instrument to create an incision in the vessel wall; and automatically retracting the surgical element.
Claim 68
Dependent Claim 49 words
62 . A method of creating an incision comprising: placing a distal tip of a device adjacent a vessel wall; activating an actuator to compress a spring; expanding the spring to deploy a surgical instrument to create an incision in the vessel wall; and automatically retracting the surgical element.
Claim 69
Dependent Claim 20 words
63 . The method of claim 62 wherein the expanding step is performed independently of further activating of the actuator.
Claim 70
Dependent Claim 24 words
64 . The method of claim 62 wherein during the activating step the actuator engages a protrusion on a hammer with a cam surface.
Claim 71
Dependent Claim 42 words
65 . The method of claim 64 wherein the expanding step is carried out by moving the cam surface beyond the protrusion on the hammer such that the hammer is released and the spring moves the hammer to deploy the surgical element.
Claim 72
Dependent Claim 28 words
66 . The method of claim 62 further comprising biasing the actuator to an initial position, wherein the actuator in the initial position is ready for repeat actuation.
Claim 73
Dependent Claim 192 words
67 . An assembly for creating an incision in a blood vessel, the assembly comprising: a cannula having a lumen; an incisor having an automatically retracting surgical element, the incisor being removably receivable within the lumen of the cannula, the incisor comprising: a body; a push rod coupled to the surgical element, the push rod and surgical element being movable relative to the body between a retracted position and a deployed position, wherein the push rod and surgical element are biased in the retracted position; an actuator coupled to the push rod, the actuator facilitates the movement of the push rod and surgical element from the retracted position to the deployed position; a fixed release mechanism positioned on the body, wherein movement of the actuator to a first position moves the push rod and surgical element from the retracted position to the deployed position so as to create an incision in the blood vessel, wherein activation of the actuator to a second position causes the fixed release mechanism to disengage the push rod from the actuator and allow the push rod and surgical element to be biased back to the retracted position.
Claim 74
Dependent Claim 192 words
67 . An assembly for creating an incision in a blood vessel, the assembly comprising: a cannula having a lumen; an incisor having an automatically retracting surgical element, the incisor being removably receivable within the lumen of the cannula, the incisor comprising: a body; a push rod coupled to the surgical element, the push rod and surgical element being movable relative to the body between a retracted position and a deployed position, wherein the push rod and surgical element are biased in the retracted position; an actuator coupled to the push rod, the actuator facilitates the movement of the push rod and surgical element from the retracted position to the deployed position; a fixed release mechanism positioned on the body, wherein movement of the actuator to a first position moves the push rod and surgical element from the retracted position to the deployed position so as to create an incision in the blood vessel, wherein activation of the actuator to a second position causes the fixed release mechanism to disengage the push rod from the actuator and allow the push rod and surgical element to be biased back to the retracted position.
Claim 75
Dependent Claim 17 words
68 . The assembly of claim 67 wherein the actuator is biased back to an initial position.
Claim 76
Dependent Claim 42 words
69 . The assembly of claim 67 wherein the actuator comprises handles pivotally connected to the body, wherein the handles in the first position are outwardly separated from the body and the handles in the second position are adjacent to the body.
Claim 77
Dependent Claim 21 words
70 . The assembly of claim 67 wherein the incisor comprises finger grips adapted to be held by a user's fingers.
Claim 78
Dependent Claim 14 words
71 . The assembly of claim 67 wherein the actuator comprises a thumb switch.
Claim 79
Dependent Claim 22 words
72 . The assembly of claim 67 wherein the actuator is coupled to the push rod with at least one flexible finger.
Claim 80
Dependent Claim 26 words
73 . The assembly of claim 67 wherein a trigger pin on the actuator releasably engages an aperture on the proximal end of the push rod.
Claim 81
Dependent Claim 159 words
74 . An assembly for creating an incision in a blood vessel, the assembly comprising: a cannula having a lumen; an incisor having an automatically retracting surgical element, the incisor being removably receivable within the lumen of the cannula, the incisor comprising: a body; a rod having the surgical element at a distal end, wherein the surgical element and rod are movable between a retracted position and a deployed position, the rod and surgical element being biased to the retracted position; a hammer coupled to the body; a hammer spring in engagement with the hammer; a movable cam having a surface which engages the hammer, wherein movement of the cam surface from an initial position to an actuated position moves the hammer to compress the hammer spring, wherein disengagement of the cam surface from the hammer causes the hammer spring to expand and push the hammer distally against the rod to move the surgical element to the deployed position.
Claim 82
Dependent Claim 159 words
74 . An assembly for creating an incision in a blood vessel, the assembly comprising: a cannula having a lumen; an incisor having an automatically retracting surgical element, the incisor being removably receivable within the lumen of the cannula, the incisor comprising: a body; a rod having the surgical element at a distal end, wherein the surgical element and rod are movable between a retracted position and a deployed position, the rod and surgical element being biased to the retracted position; a hammer coupled to the body; a hammer spring in engagement with the hammer; a movable cam having a surface which engages the hammer, wherein movement of the cam surface from an initial position to an actuated position moves the hammer to compress the hammer spring, wherein disengagement of the cam surface from the hammer causes the hammer spring to expand and push the hammer distally against the rod to move the surgical element to the deployed position.
Claim 83
Dependent Claim 56 words
75 . A method of occluding an aorta comprising: deploying a surgical element to create an opening in the aorta; automatically retracting the surgical element; inserting the cannula through the opening and into the aorta; withdrawing the surgical element from the cannula; and positioning an aortic occlusion device in at least a portion of the aorta.
Claim 84
Dependent Claim 56 words
75 . A method of occluding an aorta comprising: deploying a surgical element to create an opening in the aorta; automatically retracting the surgical element; inserting the cannula through the opening and into the aorta; withdrawing the surgical element from the cannula; and positioning an aortic occlusion device in at least a portion of the aorta.
Claim 85
Dependent Claim 18 words
76 . The method of claim 75 wherein the retracting step and inserting step are performed substantially simultaneously.
Claim 86
Dependent Claim 26 words
77 . The method of claim 75 wherein the surgical element is moved from the retracted position to the deployed position through activation of an actuator.
Claim 87
Dependent Claim 21 words
78 . The method of claim 77 wherein the retracting step is carried out independently of further activation of the actuator.
Claim 88
Dependent Claim 23 words
79 . The method of claim 75 wherein the cannula is inserted into the aorta before removing the surgical element from the incision.
Claim 89
Dependent Claim 16 words
80 . The method of claim 75 further comprising expanding an occluding member to occlude aorta.
Claim 90
Dependent Claim 84 words
81 . An assembly for treating the ascending aorta comprising: a cannula having a lumen; an incisor having an automatically retracting surgical element, the incisor being removably received in the lumen of the cannula, wherein the surgical element is positioned near a distal end of the cannula to create an incision in the ascending aorta; and an aortic occlusion device insertable through the lumen of the cannula and into the incision in the ascending aorta after the incisor has been removed from the cannula.
Claim 91
Dependent Claim 84 words
81 . An assembly for treating the ascending aorta comprising: a cannula having a lumen; an incisor having an automatically retracting surgical element, the incisor being removably received in the lumen of the cannula, wherein the surgical element is positioned near a distal end of the cannula to create an incision in the ascending aorta; and an aortic occlusion device insertable through the lumen of the cannula and into the incision in the ascending aorta after the incisor has been removed from the cannula.
Claim 92
Dependent Claim 18 words
82 . The assembly of claim 81 wherein the cannula and incisor are simultaneously inserted through the incision.
Claim 93
Dependent Claim 21 words
83 . The assembly of claim 82 wherein the aortic occlusion device comprises at least one lumen and an occluding member.
Claim 94
Dependent Claim 14 words
84 . The assembly of claim 83 wherein the occluding member comprises a balloon.
Claim 95
Dependent Claim 37 words
85 . The assembly of claim 81 wherein the surgical element is attached to a push rod, wherein an actuator facilitates movement of the push rod and surgical element from a retracted position and a deployed position.

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