Bumped dilator tip
a dilator tip and tip technology, applied in the field of dilators and sheaths, can solve the problems of deformation (damage), trauma to patients, damage to the sheath, etc., and achieve the effect of preventing the tip deformation
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example 1
[0113]The following example involved thin film testing. Comparative testing of three different sheath tips was conducted, where the tests were conducted with a thin polymer film (FIGS. 5 and 6). The thin polymer film was 0.015 inch thick natural polyurethane from Stevens Urethane P / N ST-1880 (Easthampton, Mass.). Insertion force was measured with an MTS Universal Testing Machine with a 50 Newton (N) load cell. The test stand advances the sheath-dilator assembly through the film at a controlled rate. The film was perforated with a needle prior to insertion. The needle was a 21 GA introducer needle. Testing was with an assembled dilator-sheath. The three tips that were tested were as follows:
[0114](1) A preferred embodiment sheath tip (45 degree chamfer) (gmf) (squares),
[0115](2) Predicate sheath tip (gmf) (diamonds), and
[0116](3) Competitor sheath tip (gmf) (solid dots) (FIG. 5).
[0117]The insertion force is shown in units of gmf. The sheaths were identical for the preferred embodimen...
example 2
[0124]The following example used porcine skin testing. The potential for sheath tip deformation upon insertion through porcine tissue was measured. What was compared was insertion of the standard sheath and dilator and the standard sheath with a non-limiting preferred embodiment (45 degree chamfer) dilator and the predicate dilator. The non-limiting preferred embodiment (45 degree chamfer) dilator allowed for 29 / 31 sheaths to be inserted through the porcine tissue without any damage. But with the standard dilator, the standard dilator only allowed 6 / 32 sheaths to be inserted without any damage. This represents a 75% improvement in performance, or a 59%-91% improvement with 95% confidence.
Test Medium
[0125]Porcine skin collected from pig feet was used for testing. Animals aged about 2 years yield usable skin. The skin was from Animal Technologies, Inc. (Tyler, Tex. 75702). Skin is delivered either fresh, on ice, or frozen. Porcine skin from other areas on the body as well as other ani...
example 3
[0137]A 3-dimensional diagram of a generic embodiment is disclosed in FIG. 7. Starting from the distal end, (71) is the sheath tip, (72) is the sheath body, (73) is the sheath housing (also called sheath hub), (74) indicates the general position of the sheath aperture (not visible in this view, but visible when viewed from the proximal end), (75) is the dilator tip, (76) is the dilator bump (also called radially enlarged dilation member), (77) is the dilator shaft (also called elongate dilator shaft), and (78) is the dilator hub or coupler. The fin in the dilator hub and the groove in the sheath hub is a non-limiting coupling mechanism.
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