Catheter insert devices

Patent metadata

Field	Value
Publication number	US-12409254-B2
Application number	US-202017617507-A
Country	US
Kind code	B2
Filing date	Jun 9, 2020
Priority date	Jun 10, 2019
Publication date	Sep 9, 2025
Grant date	Sep 9, 2025

Abstract

A catheter insert device includes a powder composition, and a housing. The powder composition includes a solid phase S-nitrosothiol (RSNO). The housing includes a polymeric wall that is i) permeable to nitric oxide, ii) non-porous, and iii) permeable to water vapor, and an inner lumen defined at least in part by the polymeric wall. The powder composition is completely sealed within the inner lumen of the housing.

First claim

What is claimed is:

1. A catheter insert device, comprising:
a powder composition including a solid phase S-nitrosothiol (RSNO);
a housing, including:
a polymeric wall that is i) permeable to nitric oxide, ii) non-porous, and iii) permeable to water vapor; and
an inner lumen defined at least in part by the polymeric wall;

wherein the powder composition is completely sealed within the inner lumen of the housing; and
a solid phase additive completely sealed within the inner lumen of the housing, wherein the solid phase additive is a metal wire.

2. The catheter insert device as defined in claim 1 wherein the powder composition further comprises a water uptake material selected from the group consisting of poly(ethylene glycol), poly(vinyl alcohol), a polypeptide, a polyionic species, a monosaccharide, a polysaccharide, silica particles, and a salt.

3. The catheter insert device as defined in claim 2 wherein a weight ratio of the solid phase RSNO to the water uptake material ranges from 1:1 to 10:1.

4. The catheter insert device as defined in claim 3 , wherein the powder composition further comprises an additional solid phase additive to accelerate a rate of release of nitric oxide from the solid phase RSNO after exposure to water vapor.

5. The catheter insert device as defined in claim 4 wherein
the powder composition includes from about 40 wt % to about 85.5 wt % of the solid phase RSNO, from about 5 wt % to about 20 wt % of the additional solid phase additive, and from about 8 wt % to about 47.5 wt % of the water uptake material.

6. The catheter insert device as defined in claim 1 wherein:
the powder composition further comprises an additional solid phase additive to accelerate a rate of release of nitric oxide from the solid phase RSNO after exposure to water vapor; and
the additional solid phase additive is selected from the group consisting of zinc oxide nanoparticles, a copper (II/I)-ligand complex, copper nanoparticles, ascorbic acid, a thiol, a hydrogen ion precursor, a selenium species, an organo-selenium molecule, an organo-tellurium molecule, stainless steel nanoparticles, gold nanoparticles, silica or polymeric particles coated with or possessing immobilized forms of an organic accelerant species, and combinations thereof.

7. The catheter insert device as defined in claim 6 wherein the powder composition consists of from about 15 wt % to about 95 wt % of the solid phase RSNO and from about 5 wt % to about 85 wt % of the additional solid phase additive.

8. The catheter insert device as defined in claim 1 wherein the polymeric wall is selected from the group consisting of silicone rubber, polyurethane, polyethylene, plasticized poly(vinyl chloride) (PVC), siloxane-based polyurethane elastomers, and thermoplastic silicone-polycarbonate-polyurethane.

9. The catheter insert device as defined in claim 1 wherein the polymeric wall is a tube, and wherein the housing further comprises respective sealing members attached to opposed ends of the tube.

10. A kit, comprising:
a catheter insert device, including:
a powder composition including a solid phase S-nitrosothiol (RSNO);
an insert housing, including:
a polymeric wall that is i) permeable to nitric oxide, ii) non-porous, and iii) permeable to water vapor; and
an inner lumen defined at least in part by the polymeric wall;

wherein the powder composition is completely sealed within the inner lumen of the housing; and

a catheter, including:
a catheter tubing that is permeable to nitric oxide and has at least one lumen; and
an adapter attached to a proximal end of the catheter tubing and having an opening that is operatively connected to the at least one lumen of the catheter tubing; and

a mechanism to lock the catheter insert device in place within the at least one lumen or within the adapter.

11. The kit as defined in claim 10 wherein the powder composition further comprises a water uptake material selected from the group consisting of poly(ethylene glycol), poly(vinyl alcohol), a polypeptide, a polyionic species, a monosaccharide, a polysaccharide, silica particles, and a salt.

12. The kit as defined in claim 11 wherein a weight ratio of the solid phase RSNO to the water uptake material ranges from 1:1 to 10:1.

13. The kit as defined in claim 12 wherein the device further comprises a solid phase additive to accelerate a rate of release of nitric oxide from the solid phase RSNO after exposure to water vapor, and wherein the solid phase additive is also completely sealed within the inner lumen of the housing.

14. The kit as defined in claim 13 wherein:
the solid phase additive is a component of the powder composition; and
the powder composition includes from about 40 wt % to about 85.5 wt % of the solid phase RSNO, from about 5 wt % to about 20 wt % of the solid phase additive, and from about 8 wt % to about 47.5 wt % of the water uptake material.

15. The kit as defined in claim 10 wherein:
the powder composition further comprises a solid phase additive to accelerate a rate of release of nitric oxide from the solid phase RSNO after exposure to water vapor; and
the solid phase additive is selected from the group consisting of zinc oxide nanoparticles, a copper (II/I) complex, copper nanoparticles, ascorbic acid, a thiol, a hydrogen ion precursor, a selenium species, an organo-selenium molecule, an organo-tellurium species, stainless steel nanoparticles, gold nanoparticles, silica or polymeric particles coated with or possessing immobilized forms of an organic accelerant species, and combinations thereof.

16. The kit as defined in claim 15 wherein the powder composition consists of from about 15 wt % to about 95 wt % of the solid phase RSNO and from about 5 wt % to about 85 wt % of the solid phase additive.

17. The kit as defined in claim 10 , further comprising a solid phase additive completely sealed within the inner lumen of the housing, wherein the solid phase additive is a metal wire.

18. The kit as defined in claim 10 wherein the polymeric wall is selected from the group consisting of silicone rubber, polyurethane, polyethylene, plasticized poly(vinyl chloride) (PVC), siloxane-based polyurethane elastomers, and thermoplastic silicone-polycarbonate-polyurethane.

19. The kit as defined in claim 10 wherein the catheter is an acute catheter or a chronic catheter.

20. The kit as defined in claim 19 wherein:
the acute catheter is selected from the group consisting of an intravascular catheter and a urinary catheter; or
the chronic catheter is selected from the group consisting of a tunneled dialysis catheter, a parenteral nutrition catheter, and a drug infusion catheter.

21. The kit as defined in claim 10 wherein the polymeric wall is an insert tube, and wherein the housing further comprises respective sealing mechanisms attached to opposed ends of the insert tube.

22. The kit as defined in claim 10 wherein an outer diameter of the catheter insert device ranges from about 0.5 mm to about 3 mm.

23. The kit as defined in claim 10 wherein:
a length of the insert housing is shorter than a length of the catheter;
a diameter of the insert housing is smaller than an inner diameter of the at least one lumen of the catheter tubing;
the length of the insert housing ranges from about 2 cm to about 20 cm; and
an outer diameter of the catheter insert device ranges from about 0.5 mm to about 3 mm.

24. The kit as defined in claim 10 wherein:

Assignees

• Univ Michigan Regents

Inventors

• Kim Maria
• Brisbois Elizabeth J
• Doverspike Joshua C
• Mack Shale J
• Lautner-Csorba Orsolya I
• Konopinska Kamila Katarzyna
• Meyerhoff Mark E

Classifications

• A61M25/0043

  characterised by structural features · CPC title

• A61L29/06

  obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds · CPC title

• A61M2202/0275

  Nitric oxide [NO] · CPC title

• A61L29/02

  Inorganic materials · CPC title

• A61M2025/0057

  Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings · CPC title