Patent US6280433B1 successfully refreshed from Google Patents.
US6280433B1
Expired / Lapsed
US
⏱️ 0.0 years remaining
Introducer system
Assignee: Medtronic Inc
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Filing: 1999-09-09
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Granted: 2001-08-28
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Expires: 2019-09-09
Abstract
Abstract An introducer or guide catheter for directing an implantable medical device such as a lead or catheter to a desired location within a patient's body. In one embodiment of the invention, the introducer comprises a two-lumen tube. A first lumen is configured to receive the implantable medical device that is to be introduced. A second lumen is provided to receive an insertable, elongated guiding member such as a stylet, which may be shapable in various orientations, and which may be used to alter the configuration of the introducer. The second lumen may be provided with an internal coil or other tubular reinforcement member to prevent perforation of this lumen by the guiding member when the introducer is in the patient's body. In order to facilitate removal of the introducer over an implantable medical device having a connector or fitting that is larger than the internal diameter of the first lumen, the introducer may be adapted to be slit or split along its length. In some embodiments of the invention, the introducer may be rendered splittable by provision of a weakened zone along its length. According to yet another aspect of the invention, the introducer may be provided with a luer lock at its proximal end to facilitate connection of the introducer to a hemostasis valve, t-fitting, or the like.
Inventors
- 👤 Michael E. McIvor
- 👤 Kenneth C. Gardeski
- 👤 Pedro A. Meregotte
- 👤 Mathew D. Bonner
- 👤 Timothy G. Laske
- 👤 Linda L. Lach
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-24 20:50
CPC Classifications
A; A61; A61M; A61M25/00; A61M25/01; A61M25/06; A61M25/0662; A61M25/0668; A61M2025/0675
Claims Analysis
Total Claims: 40
Claim 1
Independent Claim
180 words
An introducer system adapted to introduce a device for placement into a desired portion of a patient's body and adapted to be removed by separating an outer wall using a removal instrument, comprising: an elongated sheath body extending between a distal end and a proximal end and having an outer wall adapted to be separated along its length; said sheath body having a first lumen adapted to receive the device to be introduced and having a second lumen disposed adjacent the first lumen, lined with a tubular reinforcement member adapted to receive an insertable guiding member; a handle coupled to the proximal end of the sheath body, said handle having a first lumen that is in alignment with the first lumen of the sheath body and having a second lumen, disposed adjacent the first lumen, into which extends the tubular reinforcement member lining the second lumen of the sheath body, and a slot in a surface of the handle, said slot being adapted to accept a removal instrument and direct it in separating the outer wall of the sheath body.
Claim 2
Dependent Claim
180 words
An introducer system adapted to introduce a device for placement into a desired portion of a patient's body and adapted to be removed by separating an outer wall using a removal instrument, comprising: an elongated sheath body extending between a distal end and a proximal end and having an outer wall adapted to be separated along its length; said sheath body having a first lumen adapted to receive the device to be introduced and having a second lumen disposed adjacent the first lumen, lined with a tubular reinforcement member adapted to receive an insertable guiding member; a handle coupled to the proximal end of the sheath body, said handle having a first lumen that is in alignment with the first lumen of the sheath body and having a second lumen, disposed adjacent the first lumen, into which extends the tubular reinforcement member lining the second lumen of the sheath body, and a slot in a surface of the handle, said slot being adapted to accept a removal instrument and direct it in separating the outer wall of the sheath body.
Claim 3
Dependent Claim
14 words
An introducer according to claim 1 wherein the tubular reinforcement member is a coil.
Claim 4
Dependent Claim
15 words
An introducer according to claim 2 wherein the tubular reinforcement member is a metal coil.
Claim 5
Dependent Claim
14 words
An introducer according to claim 1 wherein the tubular reinforcement member is a braid.
Claim 6
Dependent Claim
15 words
An introducer according to claim 2 wherein the tubular reinforcement member is a metal braid.
Claim 7
Dependent Claim
15 words
An introducer according to claim 1 wherein the tubular reinforcement member is a metal member.
Claim 8
Dependent Claim
25 words
An introducer according to claim 1 wherein a portion of the handle extends laterally from the tube in a direction diametrically opposite from the slot.
Claim 9
Dependent Claim
23 words
An introducer according to claim 7 wherein the second opening of the handle is located in the laterally extending portion of the handle.
Claim 10
Dependent Claim
21 words
The introducer system of claim 1 further comprising a curvable stylet for insertion within the second lumen of the sheath body.
Claim 11
Dependent Claim
19 words
The introducer system of claim 1 wherein the handle is molded to the proximal end of the sheath body.
Claim 12
Dependent Claim
26 words
The introducer system of claim 1 wherein the handle includes a luer fitting and wherein the slot extends along the top surface of the luer fitting.
Claim 13
Dependent Claim
21 words
The introducer system of claim 1 wherein the handle includes a grip portion adapted to be grasped by a human hand.
Claim 14
Dependent Claim
35 words
The introducer system of claim 1 wherein the second handle lumen is curved and includes a conical member at its proximal end that provides an opening into which an insertable guiding member can be introduced.
Claim 15
Dependent Claim
20 words
The introducer system of claim 1 wherein the tubular reinforcement member lining the second sheath body lumen is a coil.
Claim 16
Dependent Claim
35 words
The introducer system of claim 14 wherein the handle includes a conical member coupled to the coil and providing an opening through which an insertable guiding member can be passed and advanced into the coil.
Claim 17
Dependent Claim
25 words
The introducer system of claim 15 wherein the conical member has a generally tubular extension around which the proximal end of the coil is mounted.
Claim 18
Dependent Claim
24 words
The introducer system of claim 1 wherein the distal end of the sheath body includes a plug to close the second sheath body lumen.
Claim 19
Dependent Claim
15 words
The introducer system of claim 1 wherein the device is a catheter or a lead.
Claim 20
Dependent Claim
76 words
A lead/catheter introducer system comprising: an implantable lead or catheter; an introducer having an elongated first lumen through which the lead or catheter passes and a second lumen, extending parallel to the first lumen along at least a distal portion thereof; a tubular reinforcement member located within the second lumen of the tube, the tubular reinforcement member in turn having an internal lumen; and a curvable stylet, located in the lumen of the tubular reinforcement member.
Claim 21
Dependent Claim
76 words
A lead/catheter introducer system comprising: an implantable lead or catheter; an introducer having an elongated first lumen through which the lead or catheter passes and a second lumen, extending parallel to the first lumen along at least a distal portion thereof; a tubular reinforcement member located within the second lumen of the tube, the tubular reinforcement member in turn having an internal lumen; and a curvable stylet, located in the lumen of the tubular reinforcement member.
Claim 22
Dependent Claim
14 words
A system according to claim 19 wherein the tubular reinforcement member is a coil.
Claim 23
Dependent Claim
15 words
A system according to claim 20 wherein the tubular reinforcement member is a metal coil.
Claim 24
Dependent Claim
14 words
A system according to claim 19 wherein the tubular reinforcement member is a braid.
Claim 25
Dependent Claim
15 words
A system according to claim 22 wherein the tubular reinforcement member is a metal braid.
Claim 26
Dependent Claim
15 words
A system according to claim 19 wherein the tubular reinforcement member is a metal member.
Claim 27
Independent Claim
96 words
A method of locating a lead or catheter in a desired location within a patient's body, comprising: inserting the lead or catheter into a first longitudinal lumen of a guide sheath; inserting a stylet into a second longitudinal lumen of the guide sheath; advancing the guide sheath, stylet and the catheter or lead to the desired location in the patient's body; removing the stylet; and removing the guide sheath from the lead or catheter by opening an outer wall of the first lumen along its length and removing the guide sheath from the lead or catheter.
Claim 28
Independent Claim
96 words
A method of locating a lead or catheter in a desired location within a patient's body, comprising: inserting the lead or catheter into a first longitudinal lumen of a guide sheath; inserting a stylet into a second longitudinal lumen of the guide sheath; advancing the guide sheath, stylet and the catheter or lead to the desired location in the patient's body; removing the stylet; and removing the guide sheath from the lead or catheter by opening an outer wall of the first lumen along its length and removing the guide sheath from the lead or catheter.
Claim 29
Dependent Claim
22 words
A method according to claim 25 , wherein the step of opening the wall of the guide sheath comprises slitting the wall.
Claim 30
Dependent Claim
31 words
A method according to claim 26 , wherein the step of slitting the wall comprises slitting the wall along a portion of the wall located diametrically opposite the second longitudinal lumen.
Claim 31
Independent Claim
103 words
A method of locating a lead or catheter in a desired location within a patient's body, comprising: inserting the lead or catheter into a first longitudinal lumen of a guide sheath; inserting a stylet into a second longitudinal lumen of the guide sheath having a tubular reinforcement member located therein; advancing the guide sheath, stylet and the catheter or lead to the desired location in the patient's body; removing the stylet; and removing the guide sheath from the lead or catheter by opening an outer wall of the first lumen along its length and removing the guide sheath from the lead or catheter.
Claim 32
Independent Claim
103 words
A method of locating a lead or catheter in a desired location within a patient's body, comprising: inserting the lead or catheter into a first longitudinal lumen of a guide sheath; inserting a stylet into a second longitudinal lumen of the guide sheath having a tubular reinforcement member located therein; advancing the guide sheath, stylet and the catheter or lead to the desired location in the patient's body; removing the stylet; and removing the guide sheath from the lead or catheter by opening an outer wall of the first lumen along its length and removing the guide sheath from the lead or catheter.
Claim 33
Dependent Claim
22 words
A method according to claim 28 , wherein the step of opening the wall of the guide sheath comprises slitting the wall.
Claim 34
Dependent Claim
31 words
A method according to claim 29 , wherein the step of slitting the wall comprises slitting the wall along a portion of the wall located diametrically opposite the second longitudinal lumen.
Claim 35
Independent Claim
103 words
A method of locating a lead or catheter in a desired location within a patient's body, comprising: inserting the lead or catheter into a first longitudinal lumen of a guide sheath; inserting a stylet into a second longitudinal lumen of the guide sheath having a coiled reinforcement member located therein; advancing the guide sheath, stylet and the catheter or lead to the desired location in the patient's body; removing the stylet; and removing the guide sheath from the lead or catheter by opening an outer wall of the first lumen along its length and removing the guide sheath from the lead or catheter.
Claim 36
Independent Claim
103 words
A method of locating a lead or catheter in a desired location within a patient's body, comprising: inserting the lead or catheter into a first longitudinal lumen of a guide sheath; inserting a stylet into a second longitudinal lumen of the guide sheath having a coiled reinforcement member located therein; advancing the guide sheath, stylet and the catheter or lead to the desired location in the patient's body; removing the stylet; and removing the guide sheath from the lead or catheter by opening an outer wall of the first lumen along its length and removing the guide sheath from the lead or catheter.
Claim 37
Dependent Claim
22 words
A method according to claim 31 , wherein the step of opening the wall of the guide sheath comprises slitting the wall.
Claim 38
Dependent Claim
31 words
A method according to claim 31 , wherein the step of slitting the wall comprises slitting the wall along a portion of the wall located diametrically opposite the second longitudinal lumen.
Claim 39
Dependent Claim
276 words
An introducer system adapted to introduce a device into the vasculature of a patient's body and adapted to be removed by separating an outer wall using a removal instrument, comprising: an elongated sheath body extending between a distal end and a proximal end and having an outer wall adapted to be separated along its length; said sheath body having a first lumen adapted to receive the device to be introduced and having a second lumen, disposed adjacent the first lumen, lined with a tubular reinforcement member adapted to receive an insertable guiding member; a handle with an extending grip portion coupled to the proximal end of the sheath body, said handle having a first lumen that is in alignment with the first lumen of the sheath body and having a second lumen, disposed adjacent the first lumen, through which extends the reinforcement member of the second lumen of the sheath body; a substantially conical shape member mounted within the second handle lumen and coupled to the tubular reinforcement member lining the second sheath body lumen, said conical member being adapted to direct the distal tip of a guiding member into the tubular reinforcement member; a leur fitting coupled to said handle and adapted for connection to a hemostasis valve, said leur fitting having a wall surrounding an internal lumen aligned with the first handle lumen; and a slot in a surface of the leur fitting that is disposed on the opposite side of the first handle lumen from where the second handle lumen is disposed; said slot being adapted to accept a removal instrument and direct it in separating the outer wall of the sheath body.
Claim 40
Dependent Claim
276 words
An introducer system adapted to introduce a device into the vasculature of a patient's body and adapted to be removed by separating an outer wall using a removal instrument, comprising: an elongated sheath body extending between a distal end and a proximal end and having an outer wall adapted to be separated along its length; said sheath body having a first lumen adapted to receive the device to be introduced and having a second lumen, disposed adjacent the first lumen, lined with a tubular reinforcement member adapted to receive an insertable guiding member; a handle with an extending grip portion coupled to the proximal end of the sheath body, said handle having a first lumen that is in alignment with the first lumen of the sheath body and having a second lumen, disposed adjacent the first lumen, through which extends the reinforcement member of the second lumen of the sheath body; a substantially conical shape member mounted within the second handle lumen and coupled to the tubular reinforcement member lining the second sheath body lumen, said conical member being adapted to direct the distal tip of a guiding member into the tubular reinforcement member; a leur fitting coupled to said handle and adapted for connection to a hemostasis valve, said leur fitting having a wall surrounding an internal lumen aligned with the first handle lumen; and a slot in a surface of the leur fitting that is disposed on the opposite side of the first handle lumen from where the second handle lumen is disposed; said slot being adapted to accept a removal instrument and direct it in separating the outer wall of the sheath body.
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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) | 2004-08-27 | 2005-02-26 | 2005-08-28 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2008-08-27 | 2009-02-26 | 2009-08-28 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2012-08-27 | 2013-02-26 | 2013-08-28 | $7700.00 | Window Closed / Lapsed |