US6821277B2 — Percutaneous vertebral fusion system

Claim 1

Independent Claim 320 words

A method of repositioning or fixing one or more unstable, separated or displaced vertebrae or one or more portions of one or more vertebrae in a patient's vertebral column, the method comprising: (a) identifying a patient who is a suitable candidate for undergoing the method; (b) making a stab incision in the patient's skin overlying the patient's vertebral column at or near the level of the vertebrae or portion of vertebrae to be repositioned or fixed; (c) creating a first tract from the incision to the posterior periosteal surface of the vertebrae; (d) incising the periosteum and extending the first tract into the cortex of the vertebrae; (e) inserting a first guidewire into the first tract; (f) advancing a bone screw comprising a portal and a tip, and screwdriver over the first guidewire; (g) applying torque to the bone screw using the screwdriver, thereby fixing part of the tip of the bone screw into the vertebrae while the portal of the bone screw is exterior and dorsal to the vertebrae and the portal is open parallel to the long axis of the vertebrae column; (h) removing the screwdriver and the first guidewire; (i) repeating (c) through (h) for at least one vertebrae which is neither unstable, separated or displaced and which is adjacent to the vertebrae or portion of the vertebrae that is being repositioned or fixed, or repeating (c) through (h) for the cranial-ward portion of the sacrum of the patient; (j) inserting an inflatable connection rod comprising a proximal end, a distal end and an inflatable balloon between the proximal end and the distal end, between the portals of the bone screws; and (k) inflating the inflatable balloon thereby creating a rigid structure between the inflated inflatable connection rod and the bone screws; thereby repositioning or fixing the one or more unstable, separated or displaced vertebrae or the one or more portions of one or more vertebrae unilaterally.

Claim 2

Independent Claim 320 words

A method of repositioning or fixing one or more unstable, separated or displaced vertebrae or one or more portions of one or more vertebrae in a patient's vertebral column, the method comprising: (a) identifying a patient who is a suitable candidate for undergoing the method; (b) making a stab incision in the patient's skin overlying the patient's vertebral column at or near the level of the vertebrae or portion of vertebrae to be repositioned or fixed; (c) creating a first tract from the incision to the posterior periosteal surface of the vertebrae; (d) incising the periosteum and extending the first tract into the cortex of the vertebrae; (e) inserting a first guidewire into the first tract; (f) advancing a bone screw comprising a portal and a tip, and screwdriver over the first guidewire; (g) applying torque to the bone screw using the screwdriver, thereby fixing part of the tip of the bone screw into the vertebrae while the portal of the bone screw is exterior and dorsal to the vertebrae and the portal is open parallel to the long axis of the vertebrae column; (h) removing the screwdriver and the first guidewire; (i) repeating (c) through (h) for at least one vertebrae which is neither unstable, separated or displaced and which is adjacent to the vertebrae or portion of the vertebrae that is being repositioned or fixed, or repeating (c) through (h) for the cranial-ward portion of the sacrum of the patient; (j) inserting an inflatable connection rod comprising a proximal end, a distal end and an inflatable balloon between the proximal end and the distal end, between the portals of the bone screws; and (k) inflating the inflatable balloon thereby creating a rigid structure between the inflated inflatable connection rod and the bone screws; thereby repositioning or fixing the one or more unstable, separated or displaced vertebrae or the one or more portions of one or more vertebrae unilaterally.

Claim 3

Dependent Claim 132 words

The method of claim 1 , where identifying a patient who is a suitable candidate comprises identifying a patient who has one or more unstable vertebrae, one or more portions of a vertebrae at least partly separated from the remainder of the vertebrae with potential or complete separation, or who has one or more vertebrae or a portion of one or more vertebrae displaced from its normal position relative to the vertebrae column, or who has one or more portions of a vertebrae at least partly separated from the remainder of the vertebrae and displaced from its normal position relative to the vertebrae column; and where the patient has either pain, loss of function or real or potential instability which is likely due to the separation or displacement, or separation and displacement.

Claim 4

Dependent Claim 31 words

The method of claim 1 , further comprising enlarging the first tract from the incision to the posterior periosteal surface using a high-pressure fascial dilator balloon after creating the first tract.

Claim 5

Dependent Claim 75 words

The method of claim 1 , where inserting an inflatable connection rod comprises: (i) percutaneously inserting a hollow needle and advancing the hollow needle to the portal of one of the bone screws; (ii) introducing a second guidewire through the lumen of the hollow needle and into the portal of one of the bone screws; and (iii) passing the second guidewire through all of the portals in the bone screws, thereby creating a second tract.

Claim 6

Dependent Claim 63 words

The method of claim 4 , further comprising: (i) dilating the second tract created by the second guidewire using a high pressure balloon; (ii) passing an introducer sheath over the guidewire along the entire guidewire second tract; (iii) removing the guidewire; and (iv) advancing the inflatable connection rod through the introducer sheath until the inflatable connection rod advances between the bone screw portals.

Claim 7

Dependent Claim 26 words

The method of claim 4 , further comprising using a guidewire directing device to direct the advancing second guidewire through at least one bone screw portal.

Claim 8

Dependent Claim 22 words

The method of claim 4 , further comprising using a guidewire capture device to pull the second guidewire through the patient's skin.

Claim 9

Dependent Claim 21 words

The method of claim 1 , where inflating the inflatable balloon comprises inflating the balloon with a rapid setting, liquid polymer.

Claim 10

Dependent Claim 14 words

The method of claim 8 , where the liquid polymer is light activated polymer.

Claim 11

Dependent Claim 43 words

The method of claim 8 , further comprising repeating (c) through (h) for one additional vertebrae, where the one additional vertebrae is either unstable, separated or displaced, or where one ore more portions of the one additional vertebrae is unstable, separated or displaced.

Claim 12

Dependent Claim 50 words

The method of claim 1 , further comprising repeating (b) through (k) on the opposite side of the spinous processes of the patient's vertebrae column, thereby repositioning or fixing the one or more unstable, separated or displaced vertebrae or the one or more portions of one or more vertebrae bilaterally.

Claim 13

Dependent Claim 17 words

The method of claim 1 , further comprising using a directing sheath to position the bone screws.

Claim 14

Dependent Claim 28 words

The method of claim 1 , where the bone screw comprises a central lumen and where the method further comprises injecting bone matrix material into the central lumen.

Claim 15

Independent Claim 112 words

A method of repositioning or fixing a first vertebrae that is unstable, separated or displaced or that has one or more unstable, separated or displaced portions, the method comprising: (a) fixing one or more than one bone screw in the first vertebrae and one or more than one bone screw in a second vertebrae; (b) inserting an inflatable balloon between the portal of the bone screw in the first vertebrae and the portal of the bone screw in the second vertebrae; and (c) inflating the inflatable balloon thereby creating a rigid structure between the balloon and the bone screws; thereby repositioning or fixing the first vertebrae or portion of the first vertebrae.

Claim 16

Independent Claim 112 words

A method of repositioning or fixing a first vertebrae that is unstable, separated or displaced or that has one or more unstable, separated or displaced portions, the method comprising: (a) fixing one or more than one bone screw in the first vertebrae and one or more than one bone screw in a second vertebrae; (b) inserting an inflatable balloon between the portal of the bone screw in the first vertebrae and the portal of the bone screw in the second vertebrae; and (c) inflating the inflatable balloon thereby creating a rigid structure between the balloon and the bone screws; thereby repositioning or fixing the first vertebrae or portion of the first vertebrae.

Claim 17

Dependent Claim 17 words

The method of claim 14 , further comprising advancing each bone screw over a guidewire before (a).

Claim 18

Dependent Claim 22 words

The method of claim 14 , where (a) comprises applying torque to each bone screw using a screwdriver advanced over a guidewire.

Claim 19

Dependent Claim 18 words

The method of claim 14 , where (c) comprises inflating the balloon with a rapid setting, liquid polymer.

Claim 20

Dependent Claim 50 words

The method of claim 14 , further comprising repeating (a) through (c) on the opposite side of the spinous processes of the patient's vertebrae column, thereby bilaterally repositioning or fixing the one or more unstable, separated or displaced vertebrae or the one or more portions of one or more vertebrae.

Claim 21

Dependent Claim 19 words

The method of claim 14 , further comprising using a directing sheath to position the bone screws before (a).

Claim 22

Independent Claim 87 words

A method of repositioning or fixing a first vertebrae that is unstable, separated or displaced or that has one or more unstable, separated or displaced portions, the method comprising: fixing a first bone screw having a portal in the first vertebrae; fixing a second bone screw having a portal in a second vertebrae; and inserting a guidewire through a tissue tract and through the portal of the first bone screw in the first vertebrae and through the portal of the second bone screw in the second vertebrae.

Claim 23

Independent Claim 87 words

A method of repositioning or fixing a first vertebrae that is unstable, separated or displaced or that has one or more unstable, separated or displaced portions, the method comprising: fixing a first bone screw having a portal in the first vertebrae; fixing a second bone screw having a portal in a second vertebrae; and inserting a guidewire through a tissue tract and through the portal of the first bone screw in the first vertebrae and through the portal of the second bone screw in the second vertebrae.

Claim 24

Dependent Claim 24 words

The method of claim 20 , further comprising advancing each bone screw over a guidewire before the bone screw is fixed in a vertebrae.

Claim 25

Dependent Claim 25 words

The method of claim 20 , wherein fixing each bone screw comprises applying torque to each bone screw using a driver advanced over a guidewire.

Claim 26

Dependent Claim 36 words

The method of claim 20 , further comprising inserting an inflatable balloon between the portal of the first bone screw in the first vertebrae and the portal of the second bone screw in the second vertebrae.

Claim 27

Dependent Claim 12 words

The method of claim 23 , further comprising inflating the inflatable balloon.

Claim 28

Independent Claim 245 words

A method of repositioning or fixing one or more unstable, separated or displaced vertebrae or one or more portions of one or more vertebrae in a patient's vertebral column, the method comprising: identifying a patient who is a suitable candidate for undergoing the method; making a stab incision in the patient's skin overlying the patient's vertebral column at or near the level of the vertebrae or portion of vertebrae to be repositioned or fixed; creating a first tract from the incision to the posterior periosteal surface of the vertebrae; incising the periosteum and extending the first tract into the cortex of the vertebrae; inserting a first guidewire into the first tract; advancing a bone screw comprising a portal and a tip, and a driver over the first guidewire; applying torque to the bone screw using the driver, thereby fixing part of the tip of the bone screw into the vertebrae while the portal of the bone screw is exterior and dorsal to the vertebrae and the portal is open parallel to the long axis of the vertebrae column; removing the driver and the first guidewire; repeating (c) through (h) for at least one vertebrae which is neither unstable, separated or displaced and which is adjacent to the vertebrae or portion of the vertebrae that is being repositioned or fixed, or repeating (c) through (h) for the cranial-ward portion of the sacrum of the patient; and inserting a guidewire between the portals of the bone screws.

Claim 29

Independent Claim 245 words

A method of repositioning or fixing one or more unstable, separated or displaced vertebrae or one or more portions of one or more vertebrae in a patient's vertebral column, the method comprising: identifying a patient who is a suitable candidate for undergoing the method; making a stab incision in the patient's skin overlying the patient's vertebral column at or near the level of the vertebrae or portion of vertebrae to be repositioned or fixed; creating a first tract from the incision to the posterior periosteal surface of the vertebrae; incising the periosteum and extending the first tract into the cortex of the vertebrae; inserting a first guidewire into the first tract; advancing a bone screw comprising a portal and a tip, and a driver over the first guidewire; applying torque to the bone screw using the driver, thereby fixing part of the tip of the bone screw into the vertebrae while the portal of the bone screw is exterior and dorsal to the vertebrae and the portal is open parallel to the long axis of the vertebrae column; removing the driver and the first guidewire; repeating (c) through (h) for at least one vertebrae which is neither unstable, separated or displaced and which is adjacent to the vertebrae or portion of the vertebrae that is being repositioned or fixed, or repeating (c) through (h) for the cranial-ward portion of the sacrum of the patient; and inserting a guidewire between the portals of the bone screws.

Claim 30

Independent Claim 86 words

A method of repositioning or fixing a first vertebrae that is unstable, separated or displaced or that has one or more unstable, separated or displaced portions, the method comprising: fixing a first bone screw having a portal in the first vertebrae; fixing a second bone screw having a portal in a second vertebrae; inserting an inflatable balloon through the portal of the first bone screw in the first vertebrae and through the portal of the second bone screw in the second vertebrae; and inflating the balloon.

Claim 31

Independent Claim 86 words

A method of repositioning or fixing a first vertebrae that is unstable, separated or displaced or that has one or more unstable, separated or displaced portions, the method comprising: fixing a first bone screw having a portal in the first vertebrae; fixing a second bone screw having a portal in a second vertebrae; inserting an inflatable balloon through the portal of the first bone screw in the first vertebrae and through the portal of the second bone screw in the second vertebrae; and inflating the balloon.

Claim 32

Dependent Claim 21 words

The method of claim 23 , additionally comprising inflating the inflatable balloon by introducing a curable media into the inflatable balloon.

Claim 33

Dependent Claim 23 words

The method of claim 23 , additional comprising inflating the inflatable balloon by introducing a rapid setting, liquid polymer into the inflatable balloon.

Claim 34

Dependent Claim 16 words

The method of claim 20 , wherein the first and second vertebrae are adjacent each other.

Claim 35

Dependent Claim 12 words

The method of claim 20 , wherein the method is accomplished percutaneously.

Claim 36

Dependent Claim 30 words

The methods of claim 20 , additionally comprising the step of advancing an implant through the portal in the first bone screw and the portal in the second bone screw.

Claim 37

Dependent Claim 20 words

The method of claim 26 , wherein inflating the inflatable balloon comprises introducing a curable media into the inflatable balloon.

Claim 38

Dependent Claim 22 words

The method of claim 26 , wherein inflating the inflatable balloon comprises introducing a rapid setting, liquid polymer into the inflatable balloon.

Claim 39

Dependent Claim 16 words

The method of claim 26 , wherein the first and second vertebrae are adjacent each other.

Claim 40

Dependent Claim 12 words

The method of claim 26 , wherein the method is accomplished percutaneously.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	2007-11-23	2008-05-24	2008-11-23	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2011-11-23	2012-05-24	2012-11-23	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2015-11-23	2016-05-24	2016-11-23	$7700.00	Window Closed / Lapsed

Percutaneous vertebral fusion system

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