US5639276A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Device for use in right ventricular placement and method for using same
Assignee: RAPID DEVELOPMENT SYSTEMS Inc
•
Filing: 1994-09-23
•
Granted: 1997-06-17
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Expires: 2014-09-23
Abstract
Abstract A device and method for rapid, atraumatic placement of medical devices in the right ventricle of a patient. The device includes an introducer sheath used as a passage for intravenous placement of a medical device in a patient's heart. The introducer sheath is of sufficient length to allow a proximal end thereof to be located outwardly from an incision in the skin of a patient over the cephalic vein when a distal end of the introducer sheath is at the apex of the right ventricle. The introducer sheath is of sufficient flexibility to pass through the tricuspid valve and through the narrow passage between the clavicle and first rib, and is of sufficient strength to allow the introducer sheath to be pushed along its length thereof through the tortuous path from the incision over the cephalic vein to the apex of the right ventricle. The introducer sheath has an inside diameter of sufficient size to slidably receive a balloon-tipped catheter, a guidewire, a pacing lead, or the like therein.
Inventors
- 👤 Barry S. Weinstock
- 👤 Christopher C. Maxson
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 03:18
CPC Classifications
A; A61; A61M; A61M25/00; A61M25/01; A61M25/09; A61M25/06; A61M25/0662; A61N; A61N1/00; A61N1/02; A61N1/04; A61N1/05; A61N1/056; A61N1/18; A61N1/32; A61N1/36; A61N1/372; A61M2025/09058; A61M2025/09083; A61N1/057; A61N2001/0578
Claims Analysis
Total Claims: 79
Claim 1
Independent Claim
162 words
A device for use in rapid, atraumatic placement of medical devices in a right ventricle of a patient comprising: an introducer sheath used as a passage for transvenous placement of a medical device in a patient's heart, the introducer sheath being of sufficient length to allow a proximal end thereof to be located outwardly from an opening in the skin of the patient over the cephalic vein when a distal end of said introducer sheath is at an apex of the right ventricle, said introducer sheath having a gradient of stiffness which decreases toward the distal end so as to be sufficiently soft and flexible distally to pass atraumatically through a tricuspid valve and have sufficient strength proximally to allow the introducer sheath to be pushed along the length thereof through a tortuous venous path to the apex of the right ventricle; said introducer sheath having an inside diameter of sufficient size to slidably receive a balloon-tipped catheter or pacing lead therethrough.
Claim 2
Independent Claim
162 words
A device for use in rapid, atraumatic placement of medical devices in a right ventricle of a patient comprising: an introducer sheath used as a passage for transvenous placement of a medical device in a patient's heart, the introducer sheath being of sufficient length to allow a proximal end thereof to be located outwardly from an opening in the skin of the patient over the cephalic vein when a distal end of said introducer sheath is at an apex of the right ventricle, said introducer sheath having a gradient of stiffness which decreases toward the distal end so as to be sufficiently soft and flexible distally to pass atraumatically through a tricuspid valve and have sufficient strength proximally to allow the introducer sheath to be pushed along the length thereof through a tortuous venous path to the apex of the right ventricle; said introducer sheath having an inside diameter of sufficient size to slidably receive a balloon-tipped catheter or pacing lead therethrough.
Claim 3
Dependent Claim
14 words
The device of claim 1 further comprising: a balloon-tipped catheter within said introducer sheath.
Claim 4
Dependent Claim
19 words
The device of claim 1 further comprising: a radio opaque marker at the distal end of said introducer sheath.
Claim 5
Dependent Claim
22 words
The device of claim 1 further comprising: at least one radio opaque marker spaced from the distal end of said introducer sheath.
Claim 6
Dependent Claim
20 words
The device of claim 1 wherein said introducer sheath is radio opaque along at least a portion of its length.
Claim 7
Dependent Claim
28 words
The device of claim 1 further comprising: a groove extending along said introducer sheath to weaken said introducer sheath to allow said introducer sheath to be split apart.
Claim 8
Dependent Claim
30 words
The device of claim 1 further comprising: a plurality of perforations extending along said introducer sheath to weaken said introducer sheath to allow said introducer sheath to be peeled away.
Claim 9
Dependent Claim
18 words
The device of claim 1 further comprising: a flange attached to the proximal end of said introducer sheath.
Claim 10
Dependent Claim
76 words
The device of claim 8 further comprising: a dilator having a tapered distal end, a central bore of sufficient size to pass a guide member therethrough, and being of sufficient length to extend from a proximal end located at a point beyond said proximal end of said introducer sheath past the distal end of said introducer sheath; said introducer sheath having an inside diameter configured for a close fit of said dilator in said introducer sheath.
Claim 11
Dependent Claim
43 words
The device of claim 9 further comprising: a clip attached to the proximal end of said dilator for detachably mating with said flange attached to the proximal end of said introducer sheath to prevent separation of said dilator and introducer sheath during manipulation.
Claim 12
Dependent Claim
32 words
The device of claim 10 further comprising: a slitter for slitting said introducer sheath longitudinally from the proximal end to the distal end upon withdrawal of said introducer sheath from the patient.
Claim 13
Dependent Claim
175 words
The device of claim 9 wherein the gradient of stiffness comprises one of the following: a wall thickness of the introducer sheath which decreases from the proximal end to the distal end; a wall thickness of the introducer sheath which decreases along at least a portion of its length; an outside diameter of the introducer sheath which decreases from the proximal end to the distal end while the inside diameter of the introducer sheath remains constant; an outside diameter of the introducer sheath which decreases along at least a portion of its length while the inside diameter of the introducer sheath remains constant; stiffness which varies along the length of the introducer sheath from the proximal end to the distal end; stiffness which varies along at least a portion of the introducer sheath; stiffness which varies gradually; stiffness which varies in one incremental step; stiffness which varies in a plurality of steps; a material of varying density; a material of varying polymer or metal composition mixture; and a material having a varied degree of cross-linking.
Claim 14
Dependent Claim
19 words
The device of claim 12 wherein the dilator varies in stiffness along at least a portion of its length.
Claim 15
Dependent Claim
17 words
The device of claim 1 wherein said length of said introducer sheath is at least 40 cm.
Claim 16
Dependent Claim
16 words
The device of claim 1 wherein the inside of said introducer sheath is a low-friction surface.
Claim 17
Dependent Claim
18 words
The device of claim 1 wherein said inside diameter of said introducer sheath is at least 1.65 mm.
Claim 18
Dependent Claim
36 words
The device of claim 1 wherein said introducer sheath has a length sufficient to extend from the apex of the right ventricle to outwardly of an incision over the cephalic vein on the patient's right side.
Claim 19
Dependent Claim
36 words
The device of claim 1 wherein said introducer sheath has a length sufficient to extend from the apex of the right ventricle to outwardly of an incision over the cephalic vein on the patient's left side.
Claim 20
Dependent Claim
37 words
The device of claim 1 wherein a distal portion of the introducer sheath that extends from the superior vena cava to an area in the vicinity of the apex of the right ventricle is soft and flexible.
Claim 21
Independent Claim
163 words
A device for use in rapid, atraumatic placement of medical devices in a right ventricle of a patient comprising: an introducer sheath used as a passage for transvenous placement of a medical device in a patient's heart, said introducer sheath being of sufficient length to allow a proximal end thereof to be located outwardly from an opening in the skin of the patient over the cephalic vein when a soft and flexible distal end of said introducer sheath is at an apex of the right ventricle, said introducer sheath having sufficient flexibility to pass atraumatically through a tricuspid valve and having sufficient strength to allow the introducer sheath to be pushed along the length thereof through a tortuous venous path to the apex of the right ventricle; said introducer sheath having a gradient of stiffness which decreases toward the distal end along at least a portion of its length and an inside diameter of sufficient size to pass a removable flexible guidewire therethrough.
Claim 22
Independent Claim
163 words
A device for use in rapid, atraumatic placement of medical devices in a right ventricle of a patient comprising: an introducer sheath used as a passage for transvenous placement of a medical device in a patient's heart, said introducer sheath being of sufficient length to allow a proximal end thereof to be located outwardly from an opening in the skin of the patient over the cephalic vein when a soft and flexible distal end of said introducer sheath is at an apex of the right ventricle, said introducer sheath having sufficient flexibility to pass atraumatically through a tricuspid valve and having sufficient strength to allow the introducer sheath to be pushed along the length thereof through a tortuous venous path to the apex of the right ventricle; said introducer sheath having a gradient of stiffness which decreases toward the distal end along at least a portion of its length and an inside diameter of sufficient size to pass a removable flexible guidewire therethrough.
Claim 23
Dependent Claim
17 words
The device of claim 20 further comprising: a removable flexible guidewire slidably received in said introducer sheath.
Claim 24
Dependent Claim
15 words
The device of claim 21 wherein said removable flexible guidewire is an angled, J-tipped guidewire.
Claim 25
Dependent Claim
19 words
The device of claim 20 further comprising: a radio opaque marker at the distal end of said introducer sheath.
Claim 26
Dependent Claim
22 words
The device of claim 20 further comprising: at least one radio opaque marker spaced from the distal end of said introducer sheath.
Claim 27
Dependent Claim
20 words
The device of claim 20 wherein said introducer sheath is radio opaque along at least a portion of its length.
Claim 28
Dependent Claim
28 words
The device of claim 20 further comprising: a groove extending along said introducer sheath to weaken said introducer sheath to allow said introducer sheath to be split apart.
Claim 29
Dependent Claim
30 words
The device of claim 20 further comprising: a plurality of perforations extending along said introducer sheath to weaken said introducer sheath to allow said introducer sheath to be peeled away.
Claim 30
Dependent Claim
18 words
The device of claim 20 further comprising: a flange attached to the proximal end of said introducer sheath.
Claim 31
Dependent Claim
75 words
The device of claim 28 further comprising: a dilator having a tapered distal end, a central bore of sufficient size to pass said guidewire therethrough, and being of sufficient length to extend from a proximal end located at a point beyond said proximal end of said introducer sheath past the distal end of said introducer sheath; said introducer sheath having an inside diameter configured for a close fit of said dilator in said introducer sheath.
Claim 32
Dependent Claim
43 words
The device of claim 29 further comprising: a clip attached to the proximal end of said dilator for detachably mating with said flange attached to the proximal end of said introducer sheath to prevent separation of said dilator and introducer sheath during manipulation.
Claim 33
Dependent Claim
32 words
The device of claim 29 further comprising: a slitter for slitting said introducer sheath longitudinally from the proximal end to the distal end upon withdrawal of said introducer sheath from the patient.
Claim 34
Dependent Claim
19 words
The device of claim 29 wherein the dilator varies in stiffness along at least a portion of its length.
Claim 35
Dependent Claim
17 words
The device of claim 20 wherein said length of said introducer sheath is at least 40 cm.
Claim 36
Dependent Claim
16 words
The device of claim 20 wherein the inside of said introducer sheath is a low-friction surface.
Claim 37
Dependent Claim
18 words
The device of claim 20 wherein said inside diameter of said introducer sheath is at least 0.66 mm.
Claim 38
Dependent Claim
36 words
The device of claim 20 wherein said introducer sheath has a length sufficient to extend from the apex of the right ventricle to outwardly of an incision over the cephalic vein on the patient's right side.
Claim 39
Dependent Claim
36 words
The device of claim 20 wherein said introducer sheath has a length sufficient to extend from the apex of the right ventricle to outwardly of an incision over the cephalic vein on the patient's left side.
Claim 40
Dependent Claim
100 words
The device of claim 20 wherein the varying stiffness comprises one of the following: a wall thickness of the introducer sheath which decreases from the proximal end to the distal end; an outside diameter of the introducer sheath which decreases from the proximal end to the distal end while the inside diameter of the introducer sheath remains constant; stiffness which varies gradually; stiffness which varies in one incremental step; stiffness which varies in a plurality of steps; a material of varying density; a material of varying polymer or metal composition mixture; and a material having a varied degree of cross-linking.
Claim 41
Dependent Claim
37 words
The device of claim 20 wherein a distal portion of the introducer sheath that extends from the superior vena cava to an area in the vicinity of the apex of the right ventricle is soft and flexible.
Claim 42
Dependent Claim
182 words
A kit for rapid, atraumatic right ventricular placement of medical devices comprising: a guide member; a dilator having a tapered distal end and a central bore of sufficient size for passing the guide member therethrough; and an introducer sheath used as a passage for transvenous placement of a medical device in a patient's heart, said introducer sheath being of sufficient length to allow a proximal end thereof to be located outwardly from an opening in the skin of the patient over the cephalic vein when a distal end is at an apex of the right ventricle, said introducer sheath having a gradient of stiffness which decreases toward the distal end so as to be sufficiently soft and flexible distally to pass atraumatically through a tricuspid valve and have sufficient strength proximally to allow the introducer sheath to be pushed along the length thereof through a tortuous venous path to the apex of the right ventricle, and having an inside diameter configured for a close fit of said dilator therein; said dilator having a length greater than the length of the introducer sheath.
Claim 43
Dependent Claim
182 words
A kit for rapid, atraumatic right ventricular placement of medical devices comprising: a guide member; a dilator having a tapered distal end and a central bore of sufficient size for passing the guide member therethrough; and an introducer sheath used as a passage for transvenous placement of a medical device in a patient's heart, said introducer sheath being of sufficient length to allow a proximal end thereof to be located outwardly from an opening in the skin of the patient over the cephalic vein when a distal end is at an apex of the right ventricle, said introducer sheath having a gradient of stiffness which decreases toward the distal end so as to be sufficiently soft and flexible distally to pass atraumatically through a tricuspid valve and have sufficient strength proximally to allow the introducer sheath to be pushed along the length thereof through a tortuous venous path to the apex of the right ventricle, and having an inside diameter configured for a close fit of said dilator therein; said dilator having a length greater than the length of the introducer sheath.
Claim 44
Dependent Claim
49 words
The kit of claim 40 further comprising: a flange on the proximal end of said introducer sheath; and a clip attached to a proximal end of said dilator for detachably mating with said flange of said introducer sheath to prevent separation of said dilator and introducer sheath during manipulation.
Claim 45
Dependent Claim
17 words
The kit of claim 41 further comprising a balloon-tipped catheter sized to fit within said introducer sheath.
Claim 46
Dependent Claim
22 words
The kit of claim 41 further comprising: at least one radio opaque marker spaced from the distal end of said introducer sheath.
Claim 47
Dependent Claim
13 words
The kit of claim 40 wherein said guide member is a flexible guidewire.
Claim 48
Dependent Claim
13 words
The kit of claim 44 wherein said flexible guidewire is angled and J-tipped.
Claim 49
Dependent Claim
21 words
The kit of claim 40 further comprising a hollow needle having an inside diameter sufficient to pass said guide member therethrough.
Claim 50
Dependent Claim
11 words
The kit of claim 40 further comprising a permanent pacemaker set.
Claim 51
Dependent Claim
19 words
The kit of claim 40 further comprising: a radio opaque marker at the distal end of said introducer sheath.
Claim 52
Dependent Claim
20 words
The kit of claim 40 wherein said introducer sheath is radio opaque along at least a portion of its length.
Claim 53
Dependent Claim
28 words
The kit of claim 40 further comprising: a groove extending along said introducer sheath to weaken said introducer sheath to allow said introducer sheath to be split apart.
Claim 54
Dependent Claim
30 words
The kit of claim 40 further comprising: a plurality of perforations extending along said introducer sheath to weaken said introducer sheath to allow said introducer sheath to be peeled away.
Claim 55
Dependent Claim
32 words
The kit of claim 40 further comprising: a slitter for slitting said introducer sheath longitudinally from the proximal end to the distal end upon withdrawal of said introducer sheath from the patient.
Claim 56
Dependent Claim
175 words
The kit of claim 40 wherein the gradient of stiffness comprises one of the following: a wall thickness of the introducer sheath which decreases from the proximal end to the distal end; a wall thickness of the introducer sheath which decreases along at least a portion of its length; an outside diameter of the introducer sheath which decreases from the proximal end to the distal end while the inside diameter of the introducer sheath remains constant; an outside diameter of the introducer sheath which decreases along at least a portion of its length while the inside diameter of the introducer sheath remains constant; stiffness which varies along the length of the introducer sheath from the proximal end to the distal end; stiffness which varies along at least a portion of the introducer sheath; stiffness which varies gradually; stiffness which varies in one incremental step; stiffness which varies in a plurality of steps; a material of varying density; a material of varying polymer or metal composition mixture; and a material having a varied degree of cross-linking.
Claim 57
Dependent Claim
19 words
The kit of claim 40 wherein the dilator varies in stiffness along at least a portion of its length.
Claim 58
Dependent Claim
20 words
The kit of claim 40 wherein said guide member is a balloon-tipped catheter sized to fit within said introducer sheath.
Claim 59
Dependent Claim
10 words
The kit of claim 40 further comprising a flexible guidewire.
Claim 60
Dependent Claim
13 words
The kit of claim 56 wherein said flexible guidewire is angled and J-tipped.
Claim 61
Dependent Claim
37 words
The kit of claim 40 wherein a distal portion of the introducer sheath that extends from the superior vena cava to an area in the vicinity of the apex of the right ventricle is soft and flexible.
Claim 62
Independent Claim
248 words
A method for rapid, atraumatic right ventricular placement of medical devices across a tricuspid valve to an apex of a right ventricle in the heart of a patient comprising: providing a guide member and a hollow needle having an inside diameter sufficient to pass said guide member therethrough; providing an introducer sheath used for transvenous placement of a medical device in a patient's heart, said introducer sheath being of sufficient length to allow a proximal end thereof to be located outwardly from an opening in the skin of the patient over the cephalic vein when a distal end is at an apex of the right ventricle, said introducer sheath having a gradient of stiffness which decreases toward the distal end so as to be sufficiently soft and flexible distally to pass atraumatically through a tricuspid valve and have sufficient strength proximally to allow the introducer sheath to be pushed along the length thereof through a tortuous venous path to the apex of the right ventricle, and having an inside diameter of sufficient size to pass said guide member therethrough; inserting said needle into a vein of the patient; passing said guide member through said needle into the vein and into a superior vena cava; removing said needle; advancing said guide member across the tricuspid valve to a vicinity of the apex of the right ventricle; and advancing the introducer sheath over said guide member across the tricuspid valve into the vicinity of the apex of the right ventricle.
Claim 63
Independent Claim
248 words
A method for rapid, atraumatic right ventricular placement of medical devices across a tricuspid valve to an apex of a right ventricle in the heart of a patient comprising: providing a guide member and a hollow needle having an inside diameter sufficient to pass said guide member therethrough; providing an introducer sheath used for transvenous placement of a medical device in a patient's heart, said introducer sheath being of sufficient length to allow a proximal end thereof to be located outwardly from an opening in the skin of the patient over the cephalic vein when a distal end is at an apex of the right ventricle, said introducer sheath having a gradient of stiffness which decreases toward the distal end so as to be sufficiently soft and flexible distally to pass atraumatically through a tricuspid valve and have sufficient strength proximally to allow the introducer sheath to be pushed along the length thereof through a tortuous venous path to the apex of the right ventricle, and having an inside diameter of sufficient size to pass said guide member therethrough; inserting said needle into a vein of the patient; passing said guide member through said needle into the vein and into a superior vena cava; removing said needle; advancing said guide member across the tricuspid valve to a vicinity of the apex of the right ventricle; and advancing the introducer sheath over said guide member across the tricuspid valve into the vicinity of the apex of the right ventricle.
Claim 64
Dependent Claim
12 words
The method of claim 59 wherein said vein is a cephalic vein.
Claim 65
Dependent Claim
12 words
The method of claim 59 wherein said vein is a subclavian vein.
Claim 66
Dependent Claim
13 words
The method of claim 59 wherein said guide member is a flexible guidewire.
Claim 67
Dependent Claim
11 words
The method of claim 62 further comprising removing said flexible guidewire.
Claim 68
Dependent Claim
13 words
The method of claim 63 wherein said flexible guidewire is angled and J-tipped.
Claim 69
Dependent Claim
100 words
The method of claim 59 wherein: said guide member comprises a balloon-tipped catheter; said method further comprises: advancing said balloon-tipped catheter in said introducer sheath until a distal end of said balloon-tipped catheter exits the distal end of said introducer sheath in proximity to the tricuspid valve; inflating a balloon on the distal end of said balloon-tipped catheter; advancing said balloon-tipped catheter across the tricuspid valve to the apex of the right ventricle; and advancing said introducer sheath over said balloon-tipped catheter across the tricuspid valve into the vicinity of the apex of the right ventricle and deflating said balloon.
Claim 70
Dependent Claim
114 words
The method of claim 59 further comprising: providing a dilator having a taper at a distal end, a central bore of sufficient size for passing the guide member therethrough, an outside diameter configured for a close fit of said dilator in said introducer sheath, and having a length greater than the length of said introducer sheath; positioning said dilator fully in said introducer sheath so that the taper at the distal end of said dilator extends past said distal end of said introducer sheath; sliding said dilator and said introducer sheath together over said guide member through the subclavian vein into the superior vena cava; and removing said dilator from the superior vena cava.
Claim 71
Dependent Claim
78 words
The method of claim 59 further comprising: providing a permanent pacemaker set having a ventricular pacing lead; inserting said ventricular pacing lead into said introducer sheath; advancing said ventricular pacing lead through said introducer sheath to the distal end of said introducer sheath; removing said introducer sheath; attaching said ventricular pacing lead to the apex of the right ventricle; connecting said ventricular pacing lead to said permanent pacemaker set; and implanting said permanent pacemaker set into the patient.
Claim 72
Dependent Claim
60 words
The method of claim 67 wherein: said introducer sheath further comprises a groove extending along said introducer sheath to weaken said introducer sheath to allow said introducer sheath to be split apart; and the method further comprising removing said introducer sheath by withdrawing said introducer sheath over said ventricular pacing lead and splitting said introducer sheath apart along said groove.
Claim 73
Dependent Claim
62 words
The method of claim 67 wherein: said introducer sheath further comprises a plurality of perforations extending along said introducer sheath to weaken said introducer sheath to allow said introducer sheath to be peeled away; and the method further comprising, removing said introducer sheath by withdrawing said introducer sheath over said ventricular pacing lead and peeling said introducer sheath apart along said perforations.
Claim 74
Dependent Claim
61 words
The method of claim 67 further comprising: providing a slitter for slitting said introducer sheath longitudinally from the proximal end to the distal end upon withdrawal of said introducer sheath from the patient; and the method further comprising, removing said introducer sheath by withdrawing said introducer sheath over said ventricular pacing lead and slitting said introducer sheath apart with the slitter.
Claim 75
Dependent Claim
18 words
The method of claim 59 wherein said needle is inserted into the vein on the patient's right side.
Claim 76
Dependent Claim
18 words
The method of claim 59 wherein said needle is inserted into the vein on the patient's left side.
Claim 77
Dependent Claim
30 words
The method of claim 59 further comprising: making an incision in the skin of the patient; and inserting the needle through the incision and into the vein of the patient.
Claim 78
Independent Claim
293 words
A method for rapid, atraumatic right ventricular placement of medical devices across a tricuspid valve to an apex of a right ventricle in the heart of a patient comprising: providing a balloon-tipped catheter and a hollow needle having an inside diameter sufficient to pass said balloon-tipped catheter therethrough; providing an introducer sheath used for transvenous placement of a medical device in a patient's heart, said introducer sheath being of sufficient length to allow a proximal end thereof to be located outwardly from an opening in the skin of the patient over the cephalic vein when a distal end is at an apex of the right ventricle, said introducer sheath having a gradient of stiffness which decreases toward the distal end so as to be sufficiently soft and flexible distally to pass atraumatically through a tricuspid valve and have sufficient strength proximally to allow the introducer sheath to be pushed along the length thereof through a tortuous venous path to the apex of the right ventricle, and having an inside diameter of sufficient size to pass said balloon-tipped catheter therethrough; inserting said needle into a vein of the patient; passing said balloon-tipped catheter through said needle into the vein and into a superior vena cava; removing said needle; advancing said balloon-tipped catheter in said introducer sheath until a distal end of said balloon-tipped catheter exits the distal end of said introducer sheath in proximity to the tricuspid valve; inflating a balloon on the distal end of said balloon-tipped catheter; advancing said balloon-tipped catheter across the tricuspid valve to a vicinity of the apex of the right ventricle; advancing said introducer sheath over said balloon-tipped catheter across the tricuspid valve into a position adjacent the inflated balloon; deflating said balloon; and withdrawing the balloon-tipped catheter.
Claim 79
Independent Claim
293 words
A method for rapid, atraumatic right ventricular placement of medical devices across a tricuspid valve to an apex of a right ventricle in the heart of a patient comprising: providing a balloon-tipped catheter and a hollow needle having an inside diameter sufficient to pass said balloon-tipped catheter therethrough; providing an introducer sheath used for transvenous placement of a medical device in a patient's heart, said introducer sheath being of sufficient length to allow a proximal end thereof to be located outwardly from an opening in the skin of the patient over the cephalic vein when a distal end is at an apex of the right ventricle, said introducer sheath having a gradient of stiffness which decreases toward the distal end so as to be sufficiently soft and flexible distally to pass atraumatically through a tricuspid valve and have sufficient strength proximally to allow the introducer sheath to be pushed along the length thereof through a tortuous venous path to the apex of the right ventricle, and having an inside diameter of sufficient size to pass said balloon-tipped catheter therethrough; inserting said needle into a vein of the patient; passing said balloon-tipped catheter through said needle into the vein and into a superior vena cava; removing said needle; advancing said balloon-tipped catheter in said introducer sheath until a distal end of said balloon-tipped catheter exits the distal end of said introducer sheath in proximity to the tricuspid valve; inflating a balloon on the distal end of said balloon-tipped catheter; advancing said balloon-tipped catheter across the tricuspid valve to a vicinity of the apex of the right ventricle; advancing said introducer sheath over said balloon-tipped catheter across the tricuspid valve into a position adjacent the inflated balloon; deflating said balloon; and withdrawing the balloon-tipped catheter.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2000-06-16 | 2000-12-16 | 2001-06-17 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2004-06-16 | 2004-12-16 | 2005-06-17 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2008-06-16 | 2008-12-16 | 2009-06-17 | $7700.00 | Window Closed / Lapsed |