Notas

Presentación

Esquema

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2	Model 8731 Intrathecal Catheter Features
3	Improved catheter material with markings and pre-attached pump connector
4	Catheter tip
5	Pre-attached catheter anchor with sutureless catheter connections
6	Longer introducer needle with markings and catheter passer
7	Impact of catheter complications Catheter related complications range in incidence from 10-89% Complication are reported in most clinical studies as occurring in approximately 20-25% of implanted systems Catheter related complications: May place patient at risk for injury (e.g., from abrupt cessation of intrathecal drug therapy) Are a source of inconvenience to the physician and patient Diminish the cost-effectiveness of the therapy
8	Potential impact of catheter complications # of new patients 20,000 implanted/year Catheter complication rate 25% Estimated # of catheter revisions/ 5,000 repairs per year Average cost per catheter $10,000 revision/repair Total annual cost of catheter $50,000,000 revisions/repairs
9	Impact of catheter complications on therapy adoption
10	Technique variations
11	Technique variations
12	Catheter complications from three Medtronic sponsored clinical studies
13	Primary Sources of Catheter Complications Catheter fracture from midline needle placement
14	Primary Sources of Catheter Complications Catheter fracture in introducer needle Pulling the catheter back through the introducer needle may shear or create holes in the catheter
15	Primary Sources of Catheter Complications Catheter kinks
16	Primary Sources of Catheter Complications Catheter holes
17	Primary Sources of Catheter Complications Catheter dislodgements
18	Complication research outcomes Major Findings: Fractures Occur in spinous process area with midline catheter placement Occur when catheter is withdrawn through needle Kinks Occur at connections and anchors from lack of slack or not using a strain relief sleeve Holes Occur due to missing or failed strain relief sleeve at pump connector on one-piece Catheter Several reports of small holes in one-piece catheter under pump. No reports of holes under the pump with the two-piece catheter Dislodgements Occur from pump movement and lack of slack at pump and catheter causing the catheter to slip through anchor Occur from ligament motion or CSF pressure and no anchor or purse string suture at fascial entry point
19	Bench Test Data to Support Model 8731 Intrathecal Catheter and Low Complication Implant Technique
20	Model 8731 Intrathecal Catheter Improved Performance
21	Model 8731 Intrathecal Catheter Improved Performance
22	Model 8731 Intrathecal Catheter Improved Performance
23	Model 8731 Intrathecal Catheter Improved Performance
24	Implant technique consensus statement Authored by: Dr. Ken Follett Dr. Kim Burchiel Dr. Tim Deer Dr. Stuart Du Pen Dr. Joshua Prager Dr. Michael Turner Dr. Robert Coffey
25	Low Complication Catheter Implant Technique
26	Overview for low complication implant technique
27	Prep the patient
28	Place the needle
29	Place the needle – continued
30	Place the needle – continued
31	Thread the catheter through the needle
32	Thread the catheter through the needle – continued
33	Cut down to the lumbo-dorsal fascia
34	Undermine the incision
35	Remove the needle and guide wire
36	Place the V-wing anchor
37	Prepare the pump pocket
38	Tunnel and pass the catheter
39	Trim the distal catheter
40	Anchor the catheter strain-relief sleeve
41	Place and suture pump into the pocket, coiling excess catheter behind pump
42	Disclosure