US6733500B2 — Method and system for delivering a medical electr…

Claim 1

Independent Claim 147 words

A loading device for loading a guide wire within a medical electrical lead having a lead distal tip and a lumen for receiving the guide wire, the loading device comprising: a navigation portion, having an outer portion, and extending from a front end to a back end, and having an opening formed at the back end; an engagement cavity receiving and properly orienting the lead distal tip to align the lumen of the lead with the opening of the navigation portion during the loading of the guide wire within the lead; and a first side wall spaced from a second side wall to form a slot extending along the outer portion from the front end to the back end of the navigation portion, wherein the guide wire is advanced through the slot as the lead having the guide wire loaded therein is removed from the loading device.

Claim 2

Dependent Claim 147 words

A loading device for loading a guide wire within a medical electrical lead having a lead distal tip and a lumen for receiving the guide wire, the loading device comprising: a navigation portion, having an outer portion, and extending from a front end to a back end, and having an opening formed at the back end; an engagement cavity receiving and properly orienting the lead distal tip to align the lumen of the lead with the opening of the navigation portion during the loading of the guide wire within the lead; and a first side wall spaced from a second side wall to form a slot extending along the outer portion from the front end to the back end of the navigation portion, wherein the guide wire is advanced through the slot as the lead having the guide wire loaded therein is removed from the loading device.

Claim 3

Dependent Claim 28 words

The loading device of claim 1 , further comprising an insertion guide positioned on the loading device to properly position the lead distal tip within the engagement cavity.

Claim 4

Dependent Claim 24 words

The loading device of claim 1 , wherein the engagement cavity is shaped to form a minimum clearance fit about the lead distal tip.

Claim 5

Dependent Claim 35 words

The loading device of claim 3 , wherein the lead includes a lead body distal portion extending from the lead distal tip, wherein the lead body distal portion is fixedly engaged within the loading device.

Claim 6

Dependent Claim 55 words

The loading device of claim 1 , further comprising: a first opening formed at the front end of navigation portion; and a second opening formed at the back end of navigation portion and coupling the navigation portion with the engagement cavity, wherein the engagement cavity aligns the lumen of the lead with the second opening.

Claim 7

Dependent Claim 34 words

The loading device of claim 1 , wherein the engagement cavity is sized to extend approximately 0.002 inches from the lead distal tip when the lead distal tip is inserted within the engagement cavity.

Claim 8

Dependent Claim 14 words

The loading tool of claim 1 , wherein the lead is a side-lumen lead.

Claim 9

Dependent Claim 31 words

The loading tool of claim 7 , further comprising a ramp portion directing the guide wire out of the engagement cavity as guide wire is extended through the side lumen lead.

Claim 10

Dependent Claim 14 words

The loading tool of claim 1 , wherein the lead is an over-the-wire lead.

Claim 11

Independent Claim 175 words

A method of delivering a medical electrical lead within a coronary venous system, comprising the steps of: establishing venous access to the coronary venous system using an introducer tool kit; choosing a delivery sheath from a plurality of delivery sheaths corresponding to a desired approach to a coronary sinus of the coronary venous system; positioning the delivery sheath within the venous access; inserting the lead within a loading device; inserting a guide wire within a navigation portion of the loading device, the navigation portion directing the guide wire within a lumen of the lead; advancing the guide wire through a slot formed by a first side wall spaced from a second side wall and extending along an outer portion of the navigation portion to remove the lead having the guide wire inserted therein from the loading device; inserting the distal tip of the medical electrical lead within the delivery sheath; and guiding advancement of the distal tip of the medical electrical lead to a target site within the coronary venous system using the guide wire.

Claim 12

Independent Claim 175 words

A method of delivering a medical electrical lead within a coronary venous system, comprising the steps of: establishing venous access to the coronary venous system using an introducer tool kit; choosing a delivery sheath from a plurality of delivery sheaths corresponding to a desired approach to a coronary sinus of the coronary venous system; positioning the delivery sheath within the venous access; inserting the lead within a loading device; inserting a guide wire within a navigation portion of the loading device, the navigation portion directing the guide wire within a lumen of the lead; advancing the guide wire through a slot formed by a first side wall spaced from a second side wall and extending along an outer portion of the navigation portion to remove the lead having the guide wire inserted therein from the loading device; inserting the distal tip of the medical electrical lead within the delivery sheath; and guiding advancement of the distal tip of the medical electrical lead to a target site within the coronary venous system using the guide wire.

Claim 13

Dependent Claim 55 words

The method of claim 10 , further comprising the steps of: coupling a hemostasis valve over a proximal portion of the delivery sheath; and decoupling the hemostasis valve from the delivery sheath and advancing the hemostasis valve over a connector of the medical electrical lead to remove the hemostasis valve from the medical electrical lead.

Claim 14

Dependent Claim 62 words

The method of claim 11 , further comprising the step of inserting a stylet, having a stylet knob, within the lead to assist in guiding the advancement of the lead to the target site, and wherein the step of decoupling the hemostasis valve includes advancing the hemostasis valve over the stylet knob to remove the hemostasis valve from the medical electrical lead.

Claim 15

Dependent Claim 27 words

The method of claim 11 , wherein the step of decoupling the hemostasis valve includes advancing the hemostasis valve over an anchoring sleeve positioned on the lead.

Claim 16

Dependent Claim 35 words

The method of claim 11 , wherein the step of positioning the delivery sheath includes inserting the delivery sheath within the coronary venous system using one of a steerable catheter and an introducer guide wire.

Claim 17

Dependent Claim 47 words

The method of claim 14 , further comprising the step of securing excess length of one of the guide wire and the introducer guide wire to prevent the excess length from entering a sterile field while allowing repositioning of the guide wire and the introducer guide wire.

Claim 18

Dependent Claim 13 words

The method of claim 11 , wherein the connector is an IS-1 connector.

Claim 19

Dependent Claim 24 words

The method of claim 11 , wherein the plurality of delivery sheaths include a left-sided venous access delivery sheath and a right-sided delivery sheath.

Claim 20

Dependent Claim 21 words

The method of claim 11 , wherein the medical electrical lead is one of an over-the-wire lead and a side-lumen lead.

Claim 21

Independent Claim 284 words

A system for delivering a medical electrical lead within a coronary venous system, the medical electrical lead extending from a connector to a distal tip and having a lead lumen located at the distal tip, the system comprising: an introducer kit establishing venous access to the coronary venous system; a plurality of delivery sheaths, each corresponding to a desired approach to a coronary sinus of the coronary venous system, establishing a navigation pathway within the coronary venous system through the venous access; a hemostasis valve coupled to a delivery sheath of the plurality of delivery sheaths; and a loading device loading a guide wire insertable within the lead lumen, the loading device including a navigation portion, having an outer portion, and extending from a front end to a back end, and having an opening formed at the back end, an engagement cavity receiving and properly orienting the lead distal tip during the loading of the guide wire within the lead, and a first side wall spaced from a second side wall to form a slot extending along the outer portion from the front end to the back end of the navigation portion, wherein the guide wire is advanced through the slot as the lead having the guide wire loaded therein is removed from the loading device, and wherein the guide wire guides delivery of the distal tip of the medical electrical lead to a target site within the coronary venous system through the hemostasis valve and the delivery sheath, wherein, subsequent to the distal tip being delivered to the target sight, the hemostasis valve is advanced over the connector of the medical electrical lead to remove the hemostasis valve from the medical electrical lead.

Claim 22

Independent Claim 284 words

A system for delivering a medical electrical lead within a coronary venous system, the medical electrical lead extending from a connector to a distal tip and having a lead lumen located at the distal tip, the system comprising: an introducer kit establishing venous access to the coronary venous system; a plurality of delivery sheaths, each corresponding to a desired approach to a coronary sinus of the coronary venous system, establishing a navigation pathway within the coronary venous system through the venous access; a hemostasis valve coupled to a delivery sheath of the plurality of delivery sheaths; and a loading device loading a guide wire insertable within the lead lumen, the loading device including a navigation portion, having an outer portion, and extending from a front end to a back end, and having an opening formed at the back end, an engagement cavity receiving and properly orienting the lead distal tip during the loading of the guide wire within the lead, and a first side wall spaced from a second side wall to form a slot extending along the outer portion from the front end to the back end of the navigation portion, wherein the guide wire is advanced through the slot as the lead having the guide wire loaded therein is removed from the loading device, and wherein the guide wire guides delivery of the distal tip of the medical electrical lead to a target site within the coronary venous system through the hemostasis valve and the delivery sheath, wherein, subsequent to the distal tip being delivered to the target sight, the hemostasis valve is advanced over the connector of the medical electrical lead to remove the hemostasis valve from the medical electrical lead.

Claim 23

Dependent Claim 27 words

The system of claim 19 , further comprising an insertion guide positioned on the loading device to properly position the lead distal tip within the engagement cavity.

Claim 24

Dependent Claim 23 words

The system of claim 19 , wherein the engagement cavity is shaped to form a minimum clearance fit about the lead distal tip.

Claim 25

Dependent Claim 34 words

The system of claim 21 , wherein the lead includes a lead body distal portion extending from the lead distal tip, wherein the lead body distal portion is fixedly engaged within the loading device.

Claim 26

Dependent Claim 54 words

The system of claim 19 , further comprising: a first opening formed at the front end of navigation portion; and a second opening formed at the back end of navigation portion and coupling the navigation portion with the engagement cavity, wherein the engagement cavity aligns the lumen of the lead with the second opening.

Claim 27

Dependent Claim 33 words

The system of claim 22 , wherein the engagement cavity is sized to extend approximately 0.002 inches from the lead distal tip when the lead distal tip is inserted within the engagement cavity.

Claim 28

Dependent Claim 46 words

The system of claim 19 , further comprising a ramp portion positioned within the engagement cavity, wherein the lead is a side-lumen lead and the ramp portion directs the guide wire out of the engagement cavity as guide wire is extended through the side lumen lead.

Claim 29

Dependent Claim 51 words

The system of claim 19 , further comprising a stylet, having a stylet knob, inserted within the lead to assist in guiding the advancement of the lead to the target site, wherein the hemostasis valve is advanced over the stylet knob to remove the hemostasis valve from the medical electrical lead.

Claim 30

Dependent Claim 35 words

The system of claim 26 , further comprising an anchoring sleeve position along the lead, wherein the hemostasis valve is advanced over the anchoring sleeve to remove the hemostasis valve from the medical electrical lead.

Claim 31

Dependent Claim 46 words

The system of claim 19 , wherein the tool kit includes a steerable catheter and an introducer guide wire, and wherein the delivery sheath is inserted within the coronary venous system through the venous access using one of the steerable catheter and the introducer guide wire.

Claim 32

Dependent Claim 83 words

The system of claim 28 , further comprising a guide wire clip capable of being positioned in one of a non-engaging open position and an engaging closed position, the guide wire clip securing excess length of one of the guide wire and the introducer guide wire to prevent the guide wire and the introducer guide wire from entering a sterile field while allowing repositioning of the guide wire and the introducer guide wire when the guide wire clip is in the closed position.

Claim 33

Dependent Claim 24 words

The system of claim 19 , wherein the plurality of delivery sheaths include a left-sided venous access delivery sheath and a right-sided delivery sheath.

Claim 34

Dependent Claim 21 words

The system of claim 19 , wherein the medical electrical lead is one of an over-the-wire lead and a side-lumen lead.

Claim 35

Dependent Claim 13 words

The system of claim 19 , wherein the connector is an IS-1 connector.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	2007-05-11	2007-11-10	2008-05-11	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2011-05-11	2011-11-10	2012-05-11	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2015-05-11	2015-11-10	2016-05-11	$7700.00	Window Closed / Lapsed

Method and system for delivering a medical electrical lead within a venous system

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