Thin-Walled Delivery System
A system for tissue augmentation using a thin-walled needle. The system includes a thin-walled needle and a syringe. The system further includes a plurality of particles for injection into a desired tissue to be augmented. The thin-walled needle has an inner diameter sufficient to allow for passage of the particles and an outer diameter designed to minimize the puncture wound in the skin when the needle is inserted. The particles may be suspended in a carrier.
1 . A system for augmenting tissue comprising:
needle assembly having:
a hub and a needle, the hub having a first end for engaging a syringe and a second end for engaging the needle;
the needle comprising a hollow shaft with a first end and a second end, each end having an opening respectively into an interior volume of the hollow shaft, the first end engaging the second end of the hub and a second end having a lancet;
the hollow shaft having an outer surface and an inner surface, with a thickness of material there between, the outer surface having a nominal diameter of about 0.353 mm to about 0.367 mm and the inner surface having a nominal diameter of about 0.198 mm to about 0.244 mm, with the nominal thickness of material being about 0.062 to about 0.078 mm, and
a tissue augmentation material;
wherein the tissue augmentation material is capable of passing through the needle.
2 . The system of claim 1 , further comprising a syringe.
3 . The system of claim 1 , wherein the tissue augmentation material is stored in the syringe prior to injection through the needle.
4 . The system of claim 1 , wherein the tissue augmentation material comprises particles of about 15 microns to about 65 microns.
5 . The system of claim 4 , wherein the tissue augmentation material comprises particles of about 15 microns to about 55 microns.
6 . The system of claim 4 , wherein the tissue augmentation material comprises particles of about 25 microns to about 45 microns.
7 . The system of claim 4 , wherein concentration of the particles ranges from about 30% to about 45%.
8 . A kit for augmenting tissue comprising:
a needle assembly comprising a hub and a needle, the hub engaging the needle;
the needle comprising a hollow shaft with a first end and a second end, each end having an opening respectively into an interior volume of the hollow shaft, the first end engaging the second end of the hub and a second end having a pointed tip;
the hollow shaft having an outer diameter and an inner diameter, with a thickness of material there between, the nominal outer diameter being about 0.353 mm to about 0.367 mm and the inner surface having a nominal diameter of about 0.198 mm to about 0.244 mm, with the nominal thickness of material being about 0.062 to about 0.078 mm;
an enclosure containing a tissue augmentation material, the tissue augmentation material storable in the enclosure and injectable into a tissue to be augmented through the needle.
9 . The kit of claim 8 , wherein the enclosure is a syringe, the syringe engageable with a first end of the hub and a second end of the hub engageable with the needle.
10 . The kit of claim 8 , further comprising a syringe engageable with a first end of the hub and a second end of the hub engageable with the needle.
11 . The kit of claim 10 , further comprising a plurality of syringes.
12 . The kit of claim 8 , wherein each of the needles in the plurality of needle assemblies has a different nominal inner diameter and a nominal outer diameter, providing a range of needle sizes for use.
13 . The kit of claim 8 , wherein the enclosure comprises a plurality of containers.
14 . The kit of claim 8 , further comprising a plurality of needle assemblies.
15 . The kit of claim 8 , wherein the needle has a nominal outer diameter of about 0.353 mm and a nominal inner diameter of about 0.198 mm.
16 . The kit of claim 8 , wherein the needle has a nominal outer diameter of about 0.305 mm and a nominal inner diameter of about 0.198 mm.
17 . The kit of claim 8 , wherein the needle has a nominal outer diameter of about 0.406 mm and a nominal inner diameter of about 0.254 mm.
18 . A system for augmenting tissue comprising:
a syringe;
a needle assembly having:
a hub and a needle, the hub having a first end for engaging the syringe and a second end for engaging the needle;
the needle comprising a hollow shaft with a first end and a second end, each end having an opening respectively into an interior volume of the hollow shaft, the first end engaging the second end of the hub and a second end having a lancet;
the hollow shaft having an outer diameter and an inner diameter, with a thickness of material there between, the nominal outer diameter being about 0.367 mm and the nominal inner diameter of about 0.244 mm, with the nominal thickness of material being about 0.078 mm.
a plurality of injectable particles suspended in a carrier and disposed in the syringe, the plurality of particles having a size distribution within the range of 15 microns to about 65 microns.
19 . The system of claim 18 , wherein the tissue augmentation material comprises particles of about 15 microns to about 65 microns.
20 . The system of claim 18 , wherein concentration of the particles ranges from about 30% to about 45%.