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Design of a mechanical clutch-based needle-insertion device.

ABSTRACT: Insertion of trocars, needles, and catheters into unintended tissues or tissue compartments results in hundreds of thousands of complications annually. Current methods for blood vessel cannulation or epidural, chest tube, and initial trocar placement often involve the blind pass of a needle through several layers of tissue and generally rely on distinguishable anatomic landmarks and a high degree of clinical skill. To address this simply and without the use of electronics, a purely mechanical clutch system was developed for use in medical devices that access tissue and tissue compartments. This clutch utilizes the surface contact of a buckled filament inside an S-shaped tube to transmit force from the filament (catheter/guide wire) to the tube (needle). Upon encountering sufficient resistance at the tip, such as dense tissue, the catheter buckles and locks within the tube, causing the filament and needle to advance as one. When the needle reaches the target tissue or fluid-filled cavity, the filament unlocks and slides freely into the target region while the needle remains stationary. A similar locking phenomenon has long been observed in drill strings inside drill shafts used by the oil-drilling industry, and oil industry models were adapted to describe the motion of this clutch system. A predictive analytical model was generated and validated with empirical data and used to develop prototypes of a complete device then tested in vitro on muscle tissue and in vivo on a porcine laparoscopic model with promising results.

SUBMITTER: Bassett EK

PROVIDER: S-EPMC2667015 | biostudies-literature | 2009 Apr

REPOSITORIES: biostudies-literature

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Design of a mechanical clutch-based needle-insertion device.

Bassett Erik K EK Slocum Alexander H AH Masiakos Peter T PT Pryor Howard I HI Farokhzad Omid C OC Karp Jeffery M JM

Proceedings of the National Academy of Sciences of the United States of America 20090323 14

Insertion of trocars, needles, and catheters into unintended tissues or tissue compartments results in hundreds of thousands of complications annually. Current methods for blood vessel cannulation or epidural, chest tube, and initial trocar placement often involve the blind pass of a needle through several layers of tissue and generally rely on distinguishable anatomic landmarks and a high degree of clinical skill. To address this simply and without the use of electronics, a purely mechanical cl ...[more]

PMID: 19307560

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Project description:BACKGROUND:When using ultrasound guidance to place a perineural catheter for a continuous peripheral nerve block, keeping the needle in plane and nerve in short axis results in a perpendicular needle-to-nerve orientation. Many have opined that when placing a perineural catheter via the needle, the acute angle may result in the catheter bypassing the target nerve when advanced beyond the needle tip. Theoretically, greater catheter tip-to-nerve distances result in less local anesthetic-to-nerve contact during the subsequent perineural infusion, leading to inferior analgesia. Although a potential solution may appear obvious-advancing the catheter tip only to the tip of the needle, leaving the catheter tip at the target nerve-this technique has not been prospectively evaluated. We therefore hypothesized that during needle in-plane ultrasound-guided perineural catheter placement, inserting the catheter a minimum distance (0-1 cm) past the needle tip is associated with improved postoperative analgesia compared with inserting the catheter a more traditional 5 to 6 cm past the needle tip. METHODS:Preoperatively, subjects received a popliteal-sciatic perineural catheter for foot or ankle surgery using ultrasound guidance exclusively. Subjects were randomly assigned to have a single-orifice, flexible catheter inserted either 0 to 1 cm (n = 50) or 5 to 6 cm (n = 50) past the needle tip. All subjects received a single-injection mepivacaine (40 mL of 1.5% with epinephrine) nerve block via the needle, followed by catheter insertion and a ropivacaine 0.2% infusion (basal 6 mL/hr, bolus 4 mL, 30-min lockout), through at least the day after surgery. The primary end point was the average surgical pain as measured with a 0- to 10-point numeric rating scale the day after surgery. Secondary end points included time for catheter insertion, incidence of catheter dislodgement, maximum ("worst") pain scores, opioid requirements, fluid leakage at the catheter site, and the subjective degree of an insensate extremity. RESULTS:Average pain scores the day after surgery for subjects of the 0- to 1-cm group were a median of 2.5 (interquartile range, 0.0-5.0), compared with 2.0 (interquartile range, 0.0-4.0) for subjects of the 5- to 6-cm group (P = 0.42). Similarly, among the secondary end points, no statistically significant differences were found between the 2 treatment groups. There was a trend of more catheter dislodgements in the minimum-insertion group (5 vs 1; P = 0.20). CONCLUSIONS:This study did not find evidence to support the hypothesis that, for popliteal-sciatic perineural catheters placed using ultrasound guidance and a needle-in-plane technique, inserting the catheter a minimum distance (0-1 cm) past the needle tip improves (or worsens) postoperative analgesia compared with inserting the catheter a more traditional distance (5-6 cm). Caution is warranted if extrapolating these results to other catheter designs, ultrasound approaches, or anatomic insertion sites.

Dataset Information

Design of a mechanical clutch-based needle-insertion device.

Publications

Design of a mechanical clutch-based needle-insertion device.

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