IPC분류정보
국가/구분 |
United States(US) Patent
등록
|
국제특허분류(IPC7판) |
|
출원번호 |
UP-0338768
(2003-01-06)
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등록번호 |
US-7628784
(2009-12-16)
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발명자
/ 주소 |
- Diaz, Joseph Robert
- Capstick, Ian
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출원인 / 주소 |
|
대리인 / 주소 |
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인용정보 |
피인용 횟수 :
15 인용 특허 :
15 |
초록
▼
Balloon catheters are disclosed that comprise a material that confers improved resistance to non-deflation. Balloon catheters are also disclosed that comprise a reduced drainage lumen diameter. In some embodiments the catheters achieve these characteristics without rendering the catheters undesirabl
Balloon catheters are disclosed that comprise a material that confers improved resistance to non-deflation. Balloon catheters are also disclosed that comprise a reduced drainage lumen diameter. In some embodiments the catheters achieve these characteristics without rendering the catheters undesirably stiff.
대표청구항
▼
What is claimed is: 1. A balloon catheter, comprising: a catheter shaft including: a generally tubular first layer defining a drainage lumen along substantially the entire length of the shaft from a proximal end of the shaft to a distal end thereof, the first layer consisting essentially of a non-m
What is claimed is: 1. A balloon catheter, comprising: a catheter shaft including: a generally tubular first layer defining a drainage lumen along substantially the entire length of the shaft from a proximal end of the shaft to a distal end thereof, the first layer consisting essentially of a non-metallic material with a first wet Young's Modulus; a generally tubular second layer bonded to an outer surface of the first layer, the second layer material having a second wet Young's Modulus less than the first wet Young's Modulus, an inflation lumen extending along the length of the shaft through the second layer from the proximal end of the shaft to a distal portion thereof, the inflation lumen positioned adjacent the first layer outer surface and terminating in an inflation eye extending through an outer surface of the second layer proximate to the distal end of the catheter shaft; and a generally tubular third layer, comprising a finish layer, bonded to the second layer outer surface from the proximal end of the shaft to the distal end thereof, the finish layer including a section applied over a pre-formed balloon that is unattached to the second layer outer surface at a circumferential location overlying the inflation eye, the unattached section of the balloon displaceable from the second layer outer surface in response to an inflation medium infused through the inflation eye. 2. The balloon catheter of claim 1, wherein the first wet Young's Modulus is about 1.5 times greater than the second wet Young's Modulus. 3. The balloon catheter of claim 1, wherein the first wet Young's Modulus is about 3 times greater than the second wet Young's Modulus. 4. The balloon catheter of claim 1, wherein the first wet Young's Modulus is greater than or equal to about 50 psi. 5. The balloon catheter of claim 4, wherein the first wet Young's Modulus is greater than or equal to about 80 psi. 6. The balloon catheter of claim 1, wherein the first wet Young's Modulus is in the range of about 70 psi to about 120 psi, and wherein the second wet Young's Modulus is in the range of about 20 psi to about 40 psi. 7. The balloon catheter of claim 1, wherein the first wet Young's Modulus is in the range of about 80 psi to about 90 psi, and wherein the second wet Young's Modulus is in the range of about 20 psi to about 30 psi. 8. The balloon catheter of claim 1, wherein the first wet Young's Modulus is greater than or equal to about 100 psi. 9. The balloon catheter of claim 1, wherein the first wet Young's Modulus is greater than or equal to about 200 psi. 10. The balloon catheter of claim 1, wherein the first wet Young's Modulus is greater than or equal to about 250 psi. 11. The balloon catheter of claim 1, wherein said first layer, said second layer, and said third layer are comprised of silicone. 12. The balloon catheter of claim 1, wherein said first layer, said second layer, and said third layer are comprised of latex. 13. A balloon catheter, comprising: a catheter shaft including: a tubular first layer defining a drainage lumen along substantially the entire length of the shaft from a proximal end of the shaft to a distal end thereof; a tubular second layer bonded to an outer surface of said first layer, the tubular second layer defining an inflation lumen through the second layer along the length of the shaft from the proximal end of the shaft to a distal portion thereof adjacent to said first layer outer surface, the inflation lumen terminating in an inflation eye that extends radially outward through said outer surface of said second layer; and a tubular third layer bonded to an outer surface of said second layer from the proximal end of the shaft to the distal end thereof except for a distal portion overlying said inflation eye of said inflation lumen such that a pre-formed balloon and a circumferential portion of said tubular third layer applied over the pre-formed balloon are displaceable away from said underlying portion of said second layer in response to an inflation medium infused through said inflation lumen, through said inflation eye, and into an interstice between said second layer and said third layer; wherein a substantially horizontal length of the distal end of the catheter is about 13 centimeters or less in a hand test; wherein said catheter lacks any type of tip reinforcement other than said first layer, said second layer, and said third layer; and wherein a distal tip of the catheter resists tip penetration of a pin inserted through the drainage lumen when the force applied against the distal tip by the pin is at least about 2.2 pounds. 14. The balloon catheter of claim 13, wherein the distal tip of the catheter resists tip penetration of a pin inserted through the drainage lumen when the force applied against the distal tip by the pin is at least about 10 pounds. 15. The balloon catheter of claim 13, wherein the distal tip of the catheter resists tip penetration of a pin inserted through the drainage lumen when the force applied against the distal tip by the pin is at least about 20 pounds. 16. The balloon catheter of claim 13, wherein a substantially horizontal length of the distal end of the catheter is about 11 centimeters in a hand test. 17. A balloon catheter, comprising: a catheter shaft including: a tubular first layer defining a drainage lumen along substantially the entire length of the shaft from a proximal end of the shaft to a distal end thereof; a tubular second layer bonded to an outer surface of said first layer, the tubular second layer defining an inflation lumen through the second layer along the length of the shaft from the proximal end of the shaft to a distal portion thereof adjacent to said first layer outer surface, the inflation lumen terminating in an inflation eye that extends radially outward through said outer surface of said second layer; and a tubular third layer bonded to an outer surface of said second layer from the proximal end of the shaft to the distal end thereof except for a distal portion applied over a balloon that is overlying said inflation eye of said inflation lumen such that a portion of the balloon and a circumferential portion of said tubular third layer are displaceable away from said underlying portion of said second layer in response to an inflation medium being infused through said inflation lumen, through said inflation eye, and into an interstice between said second layer and said third layer; wherein a substantially horizontal length of the distal end of the catheter is about 13 centimeters or less in a hand test; and wherein the catheter shaft is configured to prevent collapse of the inflation lumen and inflation eye at an inward radial pressure of about 25 psi or less when the drainage lumen is at about atmospheric pressure. 18. The balloon catheter of claim 17, wherein the catheter shaft is configured to prevent collapse of the inflation lumen and inflation eye at an inward radial pressure of up to about 35 psi when the drainage lumen is at about atmospheric pressure. 19. The balloon catheter of claim 17, wherein the catheter shaft is configured to prevent collapse of the inflation lumen and inflation eye at an inward radial pressure of up to about 40 psi when the drainage lumen is at about atmospheric pressure. 20. A balloon catheter, comprising: a catheter shaft including: a first layer defining a drainage lumen along substantially the entire length of the shaft from a proximal end of the shaft to a distal end thereof; and a second layer disposed about the first layer, including an inflation lumen extending along the length of the shaft from the proximal end of the shaft to a distal portion thereof, the inflation lumen terminating in an inflation eye extending radially through an outer surface of the second layer, the first layer comprising a non-metallic material having a first wet Young's Modulus, the second layer comprising a material having a second wet Young's Modulus less than the first wet Young's Modulus; a third layer bonded to the second layer outer surface from the proximal end of the shaft to the distal end thereof, the third layer including a section applied over a pre-formed balloon that is unattached to the second layer outer surface at a circumferential location overlying the inflation eye, the unattached section of the balloon displaceable from the second layer outer surface in response to an inflation medium infused through the inflation eye. 21. The balloon catheter of claim 20, wherein the first wet Young's Modulus is about 1.5 times greater than the second wet Young's Modulus. 22. The balloon catheter of claim 20, wherein the first wet Young's Modulus is about 3 times greater than the second wet Young's Modulus. 23. The balloon catheter of claim 20, wherein the first wet Young's Modulus is greater than or equal to about 50 psi. 24. The balloon catheter of claim 23, wherein the first wet Young's Modulus is greater than or equal to about 80 psi. 25. The balloon catheter of claim 20, wherein the first wet Young's Modulus is in the range of about 70 psi to about 120 psi, and wherein the second wet Young's Modulus is in the range of about 20 psi to about 40 psi. 26. The balloon catheter of claim 20, wherein the first wet Young's Modulus is in the range of about 80 psi to about 90 psi, and wherein the second wet Young's Modulus is in the range of about 20 psi to about 30 psi. 27. The balloon catheter of claim 20, wherein the first wet Young's Modulus is greater than or equal to about 100 psi. 28. The balloon catheter of claim 20, wherein the first wet Young's Modulus is greater than or equal to about 200 psi. 29. The balloon catheter of claim 20, wherein the first wet Young's Modulus is greater than or equal to about 250 psi. 30. The balloon catheter of claim 20, wherein the first and second layers are comprised of silicone. 31. The balloon catheter of claim 20, wherein the first and second layers are comprised of latex. 32. A balloon catheter, comprising: a catheter shaft including: a tubular first layer defining a drainage lumen along substantially the entire length of the shaft from a proximal end of the shaft to a distal end thereof; and a tubular second layer bonded to an outer surface of said first layer, the tubular second layer defining an inflation lumen through the second layer along the length of the shaft from the proximal end of the shaft to a distal portion thereof adjacent to said first layer outer surface, the inflation lumen terminating in an inflation eye that extends radially outward through said outer surface of said second layer; a generally tubular third layer, comprising a finish layer, bonded to the second layer outer surface from the proximal end of the shaft to the distal end thereof, the third layer including a section applied over a pre-formed balloon that is unattached to the second layer outer surface at a circumferential location overlying the inflation eye, the unattached section of the balloon displaceable from the second layer outer surface in response to an inflation medium infused through the inflation eye; wherein a substantially horizontal length of the distal end of the catheter is about 13 centimeters or less in a hand test; wherein said catheter lacks any type of tip reinforcement other than said first layer, and said second layer, and wherein a distal tip of the catheter resists tip penetration of a pin inserted through the drainage lumen when the force applied against the distal tip by the pin is at least about 2.2 pounds. 33. The balloon catheter of claim 32, wherein the distal tip of the catheter resists tip penetration of a pin inserted through the drainage lumen when the force applied against the distal tip by the pin is at least about 10 pounds. 34. The balloon catheter of claim 32, wherein the distal tip of the catheter resists tip penetration of a pin inserted through the drainage lumen when the force applied against the distal tip by the pin is at least about 20 pounds. 35. The balloon catheter of claim 32, wherein a substantially horizontal length of the distal end of the catheter is about 11 centimeters in a hand test. 36. A balloon catheter, comprising: a catheter shaft including: a generally tubular first layer defining a drainage lumen along substantially the entire length of the shaft from a proximal end of the shaft to a distal end thereof, the first layer consisting essentially of a non-metallic material with a first wet Young's Modulus; and a generally tubular second layer disposed about the first layer, the second layer material having a second wet Young's Modulus less than the first wet Young's Modulus, an inflation lumen extending through the second layer along the length of the shaft from the proximal end of the shaft to a distal portion thereof and terminating in an inflation eye extending radially through the second layer proximate the distal end of the catheter shaft, the catheter shaft configured to prevent collapse of the inflation lumen and inflation eye at inward radial pressures of about 25 psi or less when the drainage lumen is at about atmospheric pressure; a generally tubular third layer, comprising a finish layer, bonded to the second layer outer surface from the proximal end of the shaft to the distal end thereof, the third layer including a section applied over a pre-formed balloon that is unattached to the second layer outer surface at a circumferential location overlying the inflation eye, the unattached section of the balloon displaceable from the second layer outer surface in response to an inflation medium infused through the inflation eye. 37. The balloon catheter of claim 36, the catheter shaft configured to prevent collapse of the inflation lumen and inflation eye at inward radial pressures of about 35 psi or less when the drainage lumen is at about atmospheric pressure. 38. The balloon catheter of claim 36, the catheter shaft configured to prevent collapse of the inflation lumen and inflation eye at inward radial pressures of about 40 psi or less when the drainage lumen is at about atmospheric pressure. 39. A catheter, comprising a catheter shaft, a distal catheter tip, and at least one drainage eye proximal of the tip in fluid communication with a drainage lumen extending along substantially the entire length of the shaft from a distal end of the catheter shaft to a proximal end thereof, the catheter shaft including a first layer of latex material having a first wet Young's Modulus of at least about 200 psi, a second layer of latex material having a second wet Young's Modulus less than the first wet Young's Modulus disposed coaxially over the first layer of material, and a third layer of material disposed coaxially over the second layer of material, the second layer including an inflation lumen extending from the proximal end of the shaft to a distal portion thereof and terminating in an inflation eye proximal of the drainage eye, a section of the third layer applied over a balloon that is disposed over the inflation eye displaceable away from the second layer. 40. The balloon catheter according to claim 39, wherein the drainage lumen includes a diameter less than about 50% of an outer diameter of the catheter shaft. 41. The balloon catheter according to claim 39, wherein the drainage lumen includes a diameter in the range of about 40% of an outer diameter of the catheter shaft to about 50% of the catheter shaft outer diameter.
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