The Science. The Research.

Clinical Studies


Objective

Assess the safety and efficacy of intradiscal fibrin sealant in adults with chronic discogenic low back pain.

Design

Prospective, nonrandomized Food and Drug Administration approved pilot study.

Setting

Three centers in the United States.

Subjects

Fifteen adults with chronic, single, or contiguous two‐level lumbar discogenic pain confirmed through meticulous provocation discography.

Interventions

Volume‐ and pressure‐controlled intradiscal delivery of BIOSTAT BIOLOGX® Fibrin Sealant with the Biostat® Delivery Device into symptomatic lumbar disc(s).

Outcome Measures

Assessments were performed at baseline, 72 hours, and 1, 4, 13, 26, 52, and 104 weeks following intervention. Potential adverse events were evaluated with serial assessment of neurological status, radiographic, and magnetic resonance imaging (MRI). Efficacy measures included serial assessments of low back pain visual analog scale (VAS) measurements and the Roland‐Morris Disability Questionnaire (RMDQ).

Results

Safety neurological assessments, X‐ray, and MRI showed no significant changes. Adverse events were reported in nine subjects. Two instances of low back muscle spasm and one case of discitis were the only events considered related to the procedure or product.

Efficacy

Mean low back pain VAS scores (mm) decreased from 72.4 (95% confidence interval 64.6–80.3) at baseline to 31.7 (17.4–46.1), 35.4 (17.7–53.1), and 33.0 (16.3–49.6); mean RMDQ score improved from 15.2 (12.7–17.7) at baseline to 8.9 (5.3–12.5), 6.2 (3.4–9.1), and 5.6 (2.9‐8.4) at 26, 52, and 104 weeks, respectively.

Conclusion

Intradiscal injection of BIOSTAT BIOLOGX Fibrin Sealant with the Biostat Delivery Device appears safe and may improve pain and function in selected patients with discogenic pain.


Publications


Background context

Intradiscal electrothermal therapy (IDET) is a treatment for discogenic low back pain the efficacy of which has not been rigorously tested.

Purpose

To compare the efficacy of IDET with that of a placebo treatment.

Study design/setting

Randomized, placebo-controlled, prospective trial.

Patient sample

Patients were recruited by referral and the media. No inducements were provided to any patient in order to have them participate. Of 1,360 individuals who were prepared to submit to randomization, 260 were found potentially eligible after clinical examination and 64 became eligible after discography. All had discogenic low back pain lasting longer than 6 months, with no comorbidity. Thirty-seven were allocated to IDET and 27 to sham treatment. Both groups were satisfactorily matched for demographic and clinical features.

Methods

IDET was performed using a standard protocol, in which the posterior annulus of the painful disc was heated to 90 C. Sham therapy consisted of introducing a needle onto the disc and exposing the patient to the same visual and auditory environment as for a real procedure. Thirty-two (85%) of the patients randomized to the IDET group and 24 (89%) of those assigned to the sham group complied fully with the protocol of the study, and complete follow-up data are available for all of these patients.

Outcome measures

The principal outcome measures were pain and disability, assessed using a visual analog scale for pain, the Short Form (SF)-36, and the Oswestry disability scale.

Results

Patients in both groups exhibited improvements, but mean improvements in pain, disability and depression were significantly greater in the group treated with IDET. More patients deteriorated when subjected to sham treatment, whereas a greater proportion showed improvements in pain when treated with IDET. The number needed to treat, to achieve 75% relief of pain, was five. Whereas approximately 40% of the patients achieved greater than 50% relief of their pain, approximately 50% of the patients experienced no appreciable benefit. 

Conclusions

Nonspecific factors associated with the procedure account for a proportion of the apparent efficacy of IDET, but its efficacy cannot be attributed wholly to a placebo effect. The results of this trial cannot be generalized to patients who do not fit the strict inclusion criteria of this study, but IDET appears to provide worthwhile relief in a small proportion of strictly defined patients undergoing this treatment for intractable low back pain.


Background context

In a small prospective study assessing 10 symptomatic and 10 asymptomatic subjects, Schellhas et al. compared cervical discography to magnetic resonance imaging. Within that study he reported on the distribution of pain for the C3–C4 to C6–C7 levels. Four years later, Grubb and Ellis reported retrospective data from his 12-year experience using cervical discography from C2–C3 to C7–T1 in 173 patients. To date, no large prospective study defining pain referral patterns for each cervical disc has been performed.

Purpose

To conduct a prospective visual and statistical descriptive study of pain provocation of a cohort of subjects undergoing cervical discography.

Study design/setting

Prospective multicenter descriptive study.

Methods

Pain referral maps were generated for each disc level from patients undergoing cervical discography with at least two levels assessed. If concordant pain was reproduced in a morphologically abnormal disc, the subject immediately completed a pain diagram. An independent observer interviewed the subject and recorded the location of provoked symptoms. Visual data were compiled using a body sector bit map, which consisted of 48 clinically relevant body regions. Visual maps with graduated color codes and frequencies of symptom location at each cervical disc level were generated.

Results 

A total of 101 symptom provocation maps were recorded during cervical discography on 41 subjects. There were10 at C2–C3, 19 at C3–C4, 27 at C4–C5, 27 at C5–C6, 16 at C6–C7 and 2 at C7–T1. Predominantly unilateral symptoms were provoked just as often as bilateral symptoms. The C2–C3 disc referred pain to the neck, subocciput and face. The C3–C4 disc referred pain to the neck, subocciput, trapezius, anterior neck, face, shoulder, interscapular and limb. The C4–C5 disc referred pain to the neck, shoulder, interscapular, trapezius, extremity, face, chest and subocciput. The C5–C6 disc referred pain to the neck, trapezius, interscapular, suboccipital, anterior neck, chest and face. The C6–C7 disc referred pain to the neck, interscapular, trapezius, shoulder, extremity and subocciput. At C7–T1 we produced neck and interscapular pain. Visual maps with graduated color codes and frequencies of symptom location at each cervical disc level were generated.

Conclusions 

In conclusion, these results confirm the observations of prior investigators that cervical internal disc disruption can elicit axial and peripheral symptoms. The particular patterns of pain generation allow the discographer to preprocedurally anticipate disc levels to assess. With these data, the number of disc punctures that are required can be limited rather than routinely assessing all cervical discs.


Purpose

To evaluate relationships among ROM and self-reported clinical outcomes ins ingle or multilevel ProDisc-L patients.

Study Design/Setting

USE-FDA IDE trial, one site

Patient Sample

Randomized (RCT, n-59), Pilot (P, n=6), Continued Access (CA, n=147) and Compassionate Use (CU, n=37).

Outcome Measure

Oswestry Disability Index (ODI), Visual Analogue Scale for pain (VAS).

Conclusions

ROM was maintained throughout follow-up in Pro-Disc-L, patients. Importantly, greater ROM was strongly associated with greater functional ability, less pain, and greated satisfaction. This is the first report of these associations.


Study Design

This prospective study evaluated the diagnostic utility of historically accepted sacroiliac joint tests. A multidisciplinary expert panel recommended 12 of the "best" sacroiliac joint tests to be evaluated against a criterion standard of unequivocal gain relief after an intra-articular injection of local anesthetic into the sacroiliac joint.

Objectives

To identify a single sacroiliac joint test or ensemble of test that are sufficiently useful in diagnosing sacroiliac joint disorders to be clinically valuable.

Summary of Background Data

No previous research has been done to evaluate any physical test of sacroiliac joint pain against an accepted criterion standard.

Methods

Historical data was obtained, and the 12 tests were performed by two examiners on 85 patients who subsequently underwent sacroiliac joint blocks. Ninety percent or more relief was considered a positive response, and less then 90% relief was considered a negative response.

Results

There were 45 positive and 40 negative responses. No historical feature, none of the 12 sacroiliac joint tests, and no ensemble of these 12 tests demonstrated worthwhile diagnostic value.

Conclusion

Sacroiliac joint pain is resistant to identification by the historical and physical examination data from tests evaluated in this study.



Co-Author, Encyclopedia of Pain: Ed. Gebhart, GF and Schmidt RF. Spring, 2013
Contributing author, i Spine: Evidence-Based Interventional Spine Care: Ed. DePalma, 2012
Contributing author, Back Pain: How to Treat Lower Back Pain, With America's Foremost Expert. Ed. Lieberman R. 2014 

System for Repairing Inter-Vertebal Discs

Patent number: 6428576
Abstract: A method of repairing a defect in an annulus fibrosus of an intervertebral disc, without excising the entire nucleus pulposus of the disc with an in situ curable, bio-compatible polymerizable or polymeric material, wherein at least one of said components is a cross linkable material and at least one other of said components is a cross linking agent for said cross linkable material.
Inventor: Kevin Pauza

Biological Bioadhesive Composition and Methods of Preparation and Use

Patent number: 6468527
Abstract: A biologic preparation (tissue adhesive) comprising fibrinogen, thrombin and a corticosteroid agent, wherein a solution containing the corticosteroid treatment agent is used to reconstitute the thrombin from a freeze-dried state.
Inventor: Kevin Pauza

Biological Bioadhesive Composition and Methods of Preparation and Use

Patent Number: 6921532
Absract: A biologic preparation (tissue adhesive) for injection into a human body comprising fibrinogen, thrombin and a corticosteroid agent.
Inventor: Kevin Pauza

Biological Bioadhesive Composition and Methods of Preparation and Use

Patent Number: 7229633
a. A method for delivering a biological tissue adhesive for injection in a human body comprising fibrinogen, thrombin and a corticosteroid agent.

b. A method for delivering a biological tissue adhesive for injection in a human body comprising: providing a spinal needle, a dual syringe, a freeze-dried fibrinogen component, a freeze-dried thrombin component, and a betamethasone-containing solution to form a system for delivering a biological tissue adhesive.
Inventor: Kevin Pauza

Biological Bioadhesive Composition and Methods of Preparation and Use

Patent Number: 7235255
a. A system for delivering a biological tissue adhesive, comprising: a fibrinogen component; a thrombin component, and a corticosteroid-containing solution.
b. A system for delivering a biological tissue adhesive, comprising: a fibrinogen component; a thrombin component, and a corticosteroid-containing solution, a spinal needle; and a dual syringe.
Inventor: Kevin Pauza

Injection of Fibrin Sealant Including an Anesthetic in Spinal Applications

Patent number: 7597687
Abstract: A method of treating a disc that is leaking nucleus pulposus through at least one defect in the annulus fibrosus. The method includes injecting a fibrin sealant into the disc to reduce at least a portion of the at least one defect, wherein the fibrin sealant injected into the disc comprises an anesthetic, fibrinogen and an activating compound, wherein at least a portion of the fibrin forms after injection, with the proviso that a corticosteroid is absent from the fibrin sealant injected into the disc.
Type: Grant
Filed: August 17, 2005
Issued: October 6, 2009
Assignee: Spinal Restoration, Inc.
Inventors: Kevin Pauza, Brian D. Burkinshaw, Steven I. Whitlock, Mark I. Richards, James B. Rogan

Apparatus and Method for Delivery of Biologic Sealant

Patent Number: 8047407
a. A device for delivery of biologic materials, comprising a cartridge having at least two cylinder bores for fluids of the biologic materials to be delivered.

b. A kit for treating a disc, comprising: fibrinogen, thrombin, and a device for delivery of biologic materials.
Inventor: Kevin Pauza

Enhanced Biological Autologous Tissue Adhesive Composition and Methods of Preparation and Use.

Patent Number: 8124075
a. The invention includes a method for treating a disc of a patient using a tissue sealant comprising a snake venom to convert the fibrinogen to fibrin and at least one supplement.
b. Supplements include a long "laundry list" of possible additives.
Inventor: Kevin Pauza

Injection of Fibrin Sealant Using Reconstituted Components in Spinal Applications

Patent number: 8206448
Abstract: A method of treating a disc that is leaking nucleus pulposus through at least one defect in the annulus fibrosus. The method includes injecting a fibrin sealant into the disc to reduce at least a portion of the at least one defect, wherein the fibrin sealant injected into the disc comprises fibrinogen and an activating compound, wherein at least a portion of the fibrin forms after injection, wherein the fibrinogen, the activating compound or both has been reconstituted with a solution containing at least one additive, with the proviso that a corticosteroid is absent from the fibrin sealant injected into the disc.
Type: Grant
Filed: August 17, 2005
Issued: June 26, 2012
Assignee: Spinal Restoration, Inc.
Inventors: Brian D. Burkinshaw, Steven I. Whitlock, Kevin Pauza, Mark I. Richards, James B. Rogan

Method for Repairing Intervertebral Discs

Patent Number: 835714

a. A method of repairing a defect in an annulus fibrosus of an intervertebral disc, without excising the entire nucleus pulposus of the disc, comprising: inserting an introducer needle having a tip through the annulus fibrosus, injecting an in situ curable, bio-compatible polymerizable or polymeric material composition that includes a cross-linking agent into the disc.

b. The method (above) further including a very long list of drugs, biologics and other additives.
Inventor: Kevin Pauza

Injection of Fibrin Sealant Including an Anesthetic in Spinal Applications

Patent number: 8394072
Abstract: A method of treating a disc that is leaking nucleus pulposus through at least one defect in the annulus fibrosus. The method includes injecting a fibrin sealant into the disc to reduce at least a portion of the at least one defect, wherein the fibrin sealant injected into the disc comprises an anesthetic, fibrinogen and an activating compound, wherein at least a portion of the fibrin forms after injection, with the proviso that a corticosteroid is absent from the fibrin sealant injected into the disc.
Type: Grant
Filed: October 5, 2009
Issued: March 12, 2013
Assignee: Spinal Restoration, Inc.
Inventors: Kevin Pauza, Brian D. Burkinshaw, Steven I. Whitlock, Mark I. Richards, James B. Rogan

Injection of Fibrin Sealant Including an Anesthetic in Spinal Applications

Patent number: 8403895
Abstract: A method of treating a disc that is leaking nucleus pulposus through at least one defect in the annulus fibrosus. The method includes injecting a fibrin sealant into the disc to reduce at least a portion of the at least one defect, wherein the fibrin sealant injected into the disc comprises an anesthetic, fibrinogen and an activating compound, wherein at least a portion of the fibrin forms after injection, with the proviso that a corticosteroid is absent from the fibrin sealant injected into the disc.
Type: Grant
Filed: October 5, 2009
Issued: March 26, 2013
Assignee: Spinal Restoration, Inc.
Inventors: Kevin Pauza, Brian D. Burkinshaw, Steven I. Whitlock, Mark I. Richards, James B. Rogan

Injection of Fibrin Sealant in the Absence of Corticosteroids in Spinal Applications

Patent number: 8403923
Abstract: A method and kit for treating a disc that is leaking nucleus pulposus through at least one defect in the annulus fibrosus. The method includes injecting a fibrin sealant into the disc to reduce at least a portion of the at least one defect, wherein the fibrin sealant injected into the disc comprises fibrinogen and an activating compound, wherein at least a portion of the fibrin forms after injection, with the proviso that a corticosteroid is absent from the fibrin sealant injected into the disc.
Type: Grant
Filed: August 17, 2005
Issued: March 26, 2013
Assignee: Spinal Restoration, Inc.
Inventors: Steven I. Whitlock, Brian D. Burkinshaw, Kevin Pauza

Apparatus and Method for Injection of Fibrin Sealant in Spinal Applications

Patent number: 8419722
Abstract: An apparatus for percutaneous delivery of a sealant comprising: at least two fluid reservoirs, an introducer needle having a distal tip that is in fluid communication with at least one reservoir, a fluid delivery tube that is in fluid communication with a second reservoir, wherein the fluid delivery tube has a tip and wherein the fluid delivery tube is configured so that the tip of the fluid delivery tube does not extend past the distal tip of the introducer needle during use.
Type: Grant
Filed: January 5, 2007
Issued: April 16, 2013
Assignee: Spinal Restoration, Inc.
Inventors: Mark Richards, Brian D. Burkinshaw, Kevin Pauza, James B. Rogan, John Wheeler

13/533,450 - Injection of Fibrin Sealant Using Reconstituted Components in Spinal Application

a. A method of treating a disc comprising injecting a fibrin sealant into the disc, wherein neither the nucleus pulposus nor the annulus fibrosus has been heated...and wherein the injecting occurs by inserting an introducer needle having a tip into an intra-discal space, inserting a second needle or a polymeric catheter through the introducer needle up to but not beyond the tip of the introducer needle, and injecting the fibrinogen through the introducer needle and injecting the activating compound through the second needle or polymeric catheter, or injecting the activating compound through the introducer needle and injecting the fibrinogen through the second needle or polymeric catheter.

b. The method (above) further including a very long list of drugs, biologics and other additives.

c. A method of treating a disc comprising injecting a fibrin sealant into the disc, wherein neither the nucleus pulposus nor the annulus fibrosus has been heated...and wherein the fibrin sealant does not include a corticosteroid, and wherein normal hydrostatic pressure in the disc is restored or normal disc height is restored or both.

d. The method (above) wherein the injecting occurs by inserting an introducer needle having a tip into the nucleus pulposus, inserting a second needle having a tip into the nucleus pulposus, and injecting the fibrinogen through the introducer needle and injecting the thrombin through the second needle, or injecting the thrombin through the introducer needle and injecting the fibrinogen through the second needle.
Inventor: Kevin Pauza

11/650306 - Fibrin Sealant Delivery Device Including Pressure Monitoring, and method and kits thereof

a. An apparatus for delivering a biocompatible sealant, comprising: at least two reservoirs for fluids to be delivered, an actuation assembly that causes the fluids to flow out of the reservoir through an exit port in the reservoir, and a pressure monitor coupled to the delivery device to measure pressure within the device.
Inventor: Kevin Pauza.

Injection of Fibrin Sealant Using Reconstituted Components in Spinal Applications

Application number: 20120328600
Abstract: A method of treating a disc that is leaking nucleus pulposus through at least one defect in the annulus fibrosus. The method includes injecting a fibrin sealant into the disc to reduce at least a portion of the at least one defect, wherein the fibrin sealant injected into the disc comprises fibrinogen and an activating compound, wherein at least a portion of the fibrin forms after injection, wherein the fibrinogen, the activating compound or both has been reconstituted with a solution containing at least one additive, with the proviso that a corticosteroid is absent from the fibrin sealant injected into the disc.
Type: Application
Filed: June 26, 2012
Issued: December 27, 2012
Inventors: Brian D. Burkinshaw, Steven I. Whitlock, Kevin Pauza, Mark I. Richards, James B. Rogan

Injection of Fibrin Sealant in the Absence of Corticosteroids in Spinal Applications

Application number: 20110213464
Abstract: A method and kit for treating a disc that is leaking nucleus pulposus through at least one defect in the annulus fibrosus. The method includes injecting a fibrin sealant into the disc to reduce at least a portion of the at least one defect, wherein the fibrin sealant injected into the disc comprises fibrinogen and an activating compound, wherein at least a portion of the fibrin forms after injection, with the proviso that a corticosteroid is absent from the fibrin sealant injected into the disc.
Type: Application
Filed: October 22, 2010
Issued: September 1, 2011
Inventors: Steven I. Whitlock, Brian D. Burkinshaw, Kevin Pauza, John L. Wheeler, Kevin Thorne

Injection of Fibrin Sealant Using Reconstituted Components in Spinal Applications

Application number: 20120328600
Abstract: A method of treating a disc that is leaking nucleus pulposus through at least one defect in the annulus fibrosus. The method includes injecting a fibrin sealant into the disc to reduce at least a portion of the at least one defect, wherein the fibrin sealant injected into the disc comprises fibrinogen and an activating compound, wherein at least a portion of the fibrin forms after injection, wherein the fibrinogen, the activating compound or both has been reconstituted with a solution containing at least one additive, with the proviso that a corticosteroid is absent from the fibrin sealant injected into the disc.
Type: Application
Filed: June 26, 2012

Injection of Fibrin Sealant Including an Anesthetic in Spinal Applications

Application number: 20100233148
Abstract: A method of treating a disc that is leaking nucleus pulposus through at least one defect in the annulus fibrosus. The method includes injecting a fibrin sealant into the disc to reduce at least a portion of the at least one defect, wherein the fibrin sealant injected into the disc comprises an anesthetic, fibrinogen and an activating compound, wherein at least a portion of the fibrin forms after injection, with the proviso that a corticosteroid is absent from the fibrin sealant injected into the disc.
Type: Application
Filed: October 5, 2009
Issued: September 16, 2010
Inventors: Kevin Pauza, Brian D. Burkinshaw, Steven I. Whitlock, Mark I. Richards, James B. Rogan

Injection of Fibrin Sealant Including an Anesthetic in Spinal Applications

Application number: 20100143327
Abstract: A method of treating a disc that is leaking nucleus pulposus through at least one defect in the annulus fibrosus. The method includes injecting a fibrin sealant into the disc to reduce at least a portion of the at least one defect, wherein the fibrin sealant injected into the disc comprises an anesthetic, fibrinogen and an activating compound, wherein at least a portion of the fibrin forms after injection, with the proviso that a corticosteroid is absent from the fibrin sealant injected into the disc.
Type: Application
Filed: October 5, 2009
Issued: June 10, 2010
Inventors: Kevin Pauza, Brian D. Burkinshaw, Steven I. Whitlick, Mark I. Richards, James B. Rogan

Injection of Fibrin Sealant Including an Anesthetic in Spinal Applications

Application number: 20100137816
Abstract: A method of treating a disc that is leaking nucleus pulposus through at least one defect in the annulus fibrosus. The method includes injecting a fibrin sealant into the disc to reduce at least a portion of the at least one defect, wherein the fibrin sealant injected into the disc comprises an anesthetic, fibrinogen and an activating compound, wherein at least a portion of the fibrin forms after injection, with the proviso that a corticosteroid is absent from the fibrin sealant injected into the disc.
Type: Application
Filed: October 5, 2009
Issued: June 3, 2010
Inventors: Kevin Pauza, Brian D. Burkinshaw, Steven I. Whitlock, Mark I. Richards, James B. Rogan

Method For Treating Herniated Discs

Application number: 20080294261
Abstract: A method is effective for treating herniated discs. The method includes (a) surgically remove a herniated portion of disc annulus from a herniated disc, or surgically depressing and holding a herniated portion of disc annulus within original boundaries of the herniated disc, and (b) re-enforcing the surgically treated disc with an effective amount of a biocompatible degradable polymeric compound, such as a fibrin sealant.
Type: Application
Filed: May 24, 2007
Issued: November 27, 2008
Inventors: Kevin Pauza, Brian Burkinshaw, James Rogan

Fibrin Sealant Delivery Device Including Pressure Monitoring, and Method and Kits Thereof

Application number: 20070213660
Abstract: Apparatus for delivering biologic sealant device that includes a pressure monitor coupled to the delivery device to measure pressure within the device. A method of treating a disc using the device as well as a kit including the device is described.
Type: Application
Filed: January 5, 2007
Issued: September 13, 2007
Inventors: Mark Richards, Brian Burkinshaw, Kevin Pauza, James Rogan

Apparatus and Method for Injection of Fibrin Sealant in Spinal Applications

Application number: 20070191781
Abstract: An apparatus for percutaneous delivery of a sealant comprising: at least two fluid reservoirs, an introducer needle having a distal tip that is in fluid communication with at least one reservoir, a fluid delivery tube that is in fluid communication with a second reservoir, wherein the fluid delivery tube has a tip and wherein the fluid delivery tube is configured so that the tip of the fluid delivery tube does not extend past the distal tip of the introducer needle during use.
Type: Application
Filed: January 5, 2007
Issued: August 16, 2007
Inventors: Mark Richards, Brian Burkinshaw, Kevin Pauza, James Rogan, John Wheeler

Injection of Fibrin Sealant in the Absence of Corticosteroids in Spinal Applications

Application number: 20060106364
Abstract: A method and kit for treating a disc that is leaking nucleus pulposus through at least one defect in the annulus fibrosus. The method includes injecting a fibrin sealant into the disc to reduce at least a portion of the at least one defect, wherein the fibrin sealant injected into the disc comprises fibrinogen and an activating compound, wherein at least a portion of the fibrin forms after injection, with the proviso that a corticosteroid is absent from the fibrin sealant injected into the disc.
Type: Application
Filed: August 17, 2005
Issued: May 18, 2006
Inventors: Steven Whitlock, Brian Burkinshaw, Kevin Pauza

Injection of Fibrin Sealant Including an Anesthetic in Spinal Applications

Application number: 20060095016
Abstract: A method of treating a disc that is leaking nucleus pulposus through at least one defect in the annulus fibrosus. The method includes injecting a fibrin sealant into the disc to reduce at least a portion of the at least one defect, wherein the fibrin sealant injected into the disc comprises an anesthetic, fibrinogen and an activating compound, wherein at least a portion of the fibrin forms after injection, with the proviso that a corticosteroid is absent from the fibrin sealant injected into the disc.
Type: Application
Filed: August 17, 2005
Issued: May 4, 2006
Inventors: Kevin Pauza, Brian Burkinshaw, Steven Whitlock, Mark Richards, James Rogan

Injection of Fibrin Sealant Using Reconstituted Components in Spinal Applications

Application number: 20060095075
Abstract: A method of treating a disc that is leaking nucleus pulposus through at least one defect in the annulus fibrosus. The method includes injecting a fibrin sealant into the disc to reduce at least a portion of the at least one defect, wherein the fibrin sealant injected into the disc comprises fibrinogen and an activating compound, wherein at least a portion of the fibrin forms after injection, wherein the fibrinogen, the activating compound or both has been reconstituted with a solution containing at least one additive, with the proviso that a corticosteroid is absent from the fibrin sealant injected into the disc.
Type: Application
Filed: August 17, 2005
Issued: May 4, 2006
Inventors: Brian Burkinshaw, Steven Whitlock, Kevin Pauza, Mark Richards, James Rogan

Concentrated Fibrin (Discseel® procedure) Study Summaries
Disc Pain:

  • Disc pain is among the largest sources of low back pain
  • No conservative or non-surgical therapy, including physical therapy, is scientifically proven to relieve disc pain
  • Long term surgical success is less than 50%

Disc Degeneration Causes:

  • Vertebral endplate sclerosis
  • Accumulation of painful and damaging inflammatory proteins and proteolytic enzymes
  • Nucleus Pulposis death
  • Disc reduction in proteoglycan and water content
  • Nucleus Pulposis fibrosis

Chronic Disc Pain Associates With:

  • Accumulation of radial and concentric anulus fibrosis tears
  • Vascular and painful nerve in-growth into anular tears
  • Increased sensitivity to pain stimuli of exposed nerves

Discseel® Procedure Characteristics:

  • The Biologic flows into the disc's tears and fissures, thus sealing them with a resorbable tissue matrix
  • Concentrated fibrin (Discseel® Procedure) is uniquely formulated for disc healing

Healing with Concentrated Fibrin:

  • Builds a naturally conductive tissue scaffold
  • Metabolically reduces inflammation
  • Improves anabolic catabolic balance
  • Enhanced disc healing by concentrated fibrin

Pain Relief Resulting From Concentrated Fibrin (Discseel® Procedure):

  • Concentrated fibrin binds to degenerated disc tissue, sealing anular leaks
  • Inhibits inflammatory cytokines and proteolytic enzymes
  • Pre-programmed degradation of concentrated fibrin stimulates tissue repair via chemotaxis
  • The disc tissue repair provides sustained pain relief

Conclusion:

  • The FDA study proves concentrated fibrin heals degenerated discs
  • Catalyze the natural soft tissue repair process
  • The Discseel® Procedure is a non-surgical, percutaneous procedure
  • Unlike fusions or artificial discs, the Discseel® Procedure does not damage adjacent discs.
  • FDA NASS Outstanding Study of the Year supports concentrated fibrin used in the Discseel® Procedure beneficial physical and metabolic modes of action