Porous protheses and methods for making the same wherein the protheses are formed by spraying water soluble and water insoluble fibers onto a rotating mandrel

• US 6,056,993 A
• Filed: 04/17/1998
• Issued: 05/02/2000
• Est. Priority Date: 05/30/1997
• Status: Expired due to Fees

• Current Assignee: Lifeshield Sciences LLC (Acacia Research Corporation)
• Original Assignee: Schneider Electric SE
• Inventors: Leidner, Jacob, Amellal, Karim
• Primary Examiner(s): DUDASH, DIANA L
• Application Number:
  US09/062,129
• Time in Patent Office: 746 Days
• Field of Search: 427/2.25, 427/2.28, 427/2.3, 427/2.31, 427/425, 427/426, 427/462, 427/470, 427/481, 427/352, 427/353, 427/407.1, 427/243, 427/273, 427/184, 427/200, 427/201 , 427/202, 427/206, 427/299, 427/336, 427/479
• US Class Current: 427/2.25
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/062 Apparatus for the production of blood vessels made from natural tissue or with layers of living cells prostheses made from natural tissue or living cells A61L27/507
• CPC Class Codes: B29C 41/085 by rotating the former around its axis of symmetry
• CPC Class Codes: B29K 2105/04 cellular or porous
• CPC Class Codes: B29K 2995/0059 Degradable
• CPC Class Codes: B29L 2031/7534 Cardiovascular protheses

Abstract

A porous, tubular synthetic prosthesis, prosthesis precursor, and methods of producing the same are provided. Specifically the method involves co-spraying both a water soluble and water insoluble fibrous component onto a mold to form the prosthesis precursor. The water soluble fibrous component may then be at least partially removed so as to provide a porous, tubular synthetic prosthesis.

Claims

1. A method of making a porous, tubular, synthetic prosthesis, comprising the steps of:

(a) electrostatically co-spraying ingredients comprising a water soluble fibrous component and a water insoluble fibrous component onto a mold to form a prosthesis precursor, wherein the water soluble fibrous component functions as a spacer to inhibit coalescence of the water insoluble fibrous component on the mold; and

(b) removing at least a portion of the water soluble fibrous component from the precursor to form the prosthesis, said prosthesis comprising fibrous-shaped voids.

3. The method of claim 1, wherein the mold is a rotating mandrel.

4. The method of claim 1, wherein step (b) comprises eluting the water soluble fibrous component by washing the tubular prosthesis precursor with an eluent.

5. The method of claim 4, wherein the eluent is water.

6. The method of claim 1, wherein the prosthesis precursor is tubular and wherein step (b) comprises removing a sufficient amount of the water soluble, fibrous component from the precursor such that the prosthesis has an inner wall surface with a sufficient amount of porosity to promote the ingrowth of tissue when the prosthesis is therapeutically implanted in a host.

7. The method of claim 1, wherein the prosthesis has a porosity in the range from about 5% to about 95%.

8. The method of claim 7, wherein the prosthesis has a porosity of from about 60% to about 95%.

9. The method of claim 8, wherein the prosthesis has a porosity of from about 70% to about 80%.

10. The method of claim 1, wherein the prosthesis mold is a rotating mandrel, and said co-spraying step comprises electrostatically co-spraying the water insoluble and water soluble fibrous components onto the rotating mandrel from first and second orifices, respectively, and wherein the first and second orifices are caused to translate axially back and forth relative to the mandrel such that the fibrous components coat the mandrel to form said precursor.

11. The method of claim 10, wherein the co-spraying step comprises the steps of:

(i) extruding a first composition comprising a water insoluble silicone resin through the first orifice to form the water insoluble fibrous component; and

(ii) extruding a second composition comprising a water soluble polyethylene glycol through the second orifice to form the water soluble fiber component.

12. The method of claim 11, wherein the polyethylene glycol has a weight average molecular weight of at least 1000.

13. The method of claim 12, wherein the polyethylene glycol has a weight average molecular weight in the range from about 1000 to about 15,000.

14. The method of claim 11, wherein the first composition further comprises a solvent in which the silicone resin is substantially completely soluble, said solvent comprising first and second solvent components, wherein the first solvent component has a boiling point at least 10°

C. greater than that of the second solvent component.

15. The method of claim 14, wherein the first solvent component has a boiling point at least 25°

C. greater than that of the second solvent component.

16. The method of claim 14, wherein the weight ratio of the second solvent component to the first solvent component is in the range of from about 2:

1 to about 10;

1.

17. The method of claim 14, wherein the solvent comprises a halogenated alkane solvent selected from a trihaloethane, a dihaloethane, a trihalomethane, a dihalomethane, or combinations of these.

18. The method of claim 17, wherein the solvent comprises 1 to 20 parts by weight dichloromethane and 1 to 20 parts by weight of trichloroethane.

19. The method of claim 1, wherein the weight ratio of the water insoluble fibrous component to the water soluble fibrous component is in the range of from about 1:

10 to about 5;

1.

20. The method of claim 19, wherein the weight ratio of the water insoluble fibrous component to the water soluble fibrous component is in the range of from about 1:

3 to about 1;

2.

21. The method of claim 1, wherein the co-spraying step comprises co-spraying both the water insoluble and water soluble fibrous components onto the mold to build up an inner portion of the tubular prosthesis precursor, and wherein the method further comprises the steps of:

(i) ceasing to spray the water soluble fibrous component onto the mold when said inner portion is formed, and

(ii) after ceasing to spray the water soluble fibrous component onto the mold, continuing to spray the water insoluble fibrous component onto the mold until said tubular prosthesis precursor body is formed.

22. The method of claim 1, further comprising the step of, prior to co-spraying said fibrous components onto the mold, coating the mold with a coating comprising polyethylene glycol.

2. A method of making a tubular prosthesis precursor, comprising the step of co-spraying a water insoluble, fibrous component and a water soluble fibrous component onto a mold to form the tubular prosthesis precursor comprising a water soluble fibrous component and a water insoluble fibrous component.