NZ808071A - Expandable Introducer Sheath for Medical Device - Google Patents
Expandable Introducer Sheath for Medical DeviceInfo
- Publication number
- NZ808071A NZ808071A NZ808071A NZ80807119A NZ808071A NZ 808071 A NZ808071 A NZ 808071A NZ 808071 A NZ808071 A NZ 808071A NZ 80807119 A NZ80807119 A NZ 80807119A NZ 808071 A NZ808071 A NZ 808071A
- Authority
- NZ
- New Zealand
- Prior art keywords
- lumen
- proximal
- distal
- expandable sheath
- diameter
- Prior art date
Links
- 210000004204 blood vessel Anatomy 0.000 claims abstract 19
- 239000000463 material Substances 0.000 claims abstract 13
- 230000001154 acute effect Effects 0.000 claims abstract 12
- 229920000642 polymer Polymers 0.000 claims abstract 12
- 238000003780 insertion Methods 0.000 claims abstract 7
- 230000037431 insertion Effects 0.000 claims abstract 7
- 230000023597 hemostasis Effects 0.000 claims 26
- 239000008280 blood Substances 0.000 claims 13
- 210000004369 blood Anatomy 0.000 claims 13
- 239000011248 coating agent Substances 0.000 claims 2
- 238000000576 coating method Methods 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- 230000007704 transition Effects 0.000 claims 1
Abstract
introducer sheath for the insertion of a medical device into a blood vessel, the introducer sheath comprising: an expandable sheath body having a first length, a longitudinal axis, and proximal and distal ends, the expandable sheath body comprising: a braid forming a first lumen, the first lumen extending between the proximal and distal ends of the expandable sheath body, the first lumen having a first diameter in a first elongated state, a second diameter in a second relaxed state, and a third diameter in a third expanded state, wherein the first diameter in the first elongated state is sized to insert the expandable sheath body in the blood vessel, and wherein the third diameter in the third expanded state is sized to accommodate the medical device, the braid formed of at least one strand of a first material extending from the proximal end of the expandable sheath body at an acute angle relative to the longitudinal axis of the expandable sheath body; and a polymer encapsulating at least a distal portion of the braid, wherein the polymer is configured to expand or collapse along with the braid, the acute angle and the first material selected to allow the medical device to pass through the expandable sheath body in the third expanded state.
Claims (17)
1. An introducer sheath for the insertion of a medical device into a blood vessel, the introducer sheath comprising: an expandable sheath body having a first length, a longitudinal axis, and proximal and distal ends, the expandable sheath body comprising: a braid forming a first lumen, the first lumen extending between the proximal and distal ends of the expandable sheath body, the first lumen having a first diameter in a first elongated state, a second diameter in a second relaxed state, and a third diameter in a third expanded state, wherein the first diameter in the first elongated state is sized to insert the expandable sheath body in the blood vessel, and wherein the third diameter in the third expanded state is sized to accommodate the medical device, the braid formed of at least one strand of a first material extending from the proximal end of the expandable sheath body at an acute angle relative to the longitudinal axis of the expandable sheath body; and a polymer encapsulating at least a distal portion of the braid, wherein the polymer is configured to expand or collapse along with the braid, the acute angle and the first material selected to allow the medical device to pass through the expandable sheath body in the third expanded state.
2. An introducer sheath for the insertion of a medical device into a blood vessel, the introducer sheath comprising: an expandable sheath body having a first length, a longitudinal axis, and proximal and distal ends, the expandable sheath body comprising: a braid forming a first lumen, the first lumen extending between the proximal and distal ends of the expandable sheath body, the first lumen having a first diameter in a first relaxed state and a second diameter in a second expanded state, wherein the second diameter in the second expanded state is sized to accommodate the medical device, the braid formed of at least one strand of a first material extending from the proximal end of the expandable sheath body at an acute angle relative to the longitudinal axis of the expandable sheath body; and a polymer encapsulating at least a distal portion of the braid, wherein the polymer can expand or collapse along with the braid, the acute angle and the first material selected to allow the medical device to pass through the expandable sheath body in the second expanded state.
3. A sheath assembly for the insertion of a medical device into a blood vessel, the sheath assembly comprising: an introducer sheath comprising: an expandable sheath body having a first length, a longitudinal axis, and proximal and distal ends, the expandable sheath body comprising: a first lumen extending between the proximal and distal ends of the expandable sheath body, the first lumen having a first diameter in a first elongated state and a second diameter in a second relaxed state, wherein the second diameter in the second relaxed state is sized to accommodate the medical device; a braid forming the first lumen, the braid formed of at least one strand of a first material extending from the proximal end of the expandable sheath body at an acute angle relative to the longitudinal axis of the expandable sheath body; and a polymer encapsulating at least a distal portion of the braid, wherein the polymer can expand or collapse along with the braid, the acute angle and the first material selected to allow the medical device to pass through the expandable sheath body without the expandable sheath body buckling; and a dilator assembly comprising: an inner dilator having a second length and a second lumen between proximal and distal ends of the inner dilator; an outer dilator having a third length and a third lumen between proximal and distal ends of the outer dilator, wherein the outer dilator is axially aligned with the inner dilator and the second length is greater than the third length, wherein the inner dilator and outer dilator are configured to be inserted into the first lumen of the expandable sheath body to adjust a diameter of the expandable sheath; and a hub attachment having a third length and a third lumen between proximal and distal ends of the hub attachment, wherein the hub attachment is axially aligned with the outer dilator and inner dilator and the outer dilator and inner dilator lie within the third lumen, wherein the distal end of the hub attachment is attached to a proximal end of the introducer sheath.
4. A sheath assembly for the insertion of a medical device into a blood vessel, the sheath assembly comprising: an introducer sheath comprising: an expandable sheath body having a first length, a longitudinal axis, and proximal and distal ends, the expandable sheath body comprising: a first lumen extending between the proximal and distal ends of the expandable sheath body, the first lumen having a first diameter in a first elongated state and a second diameter in a second relaxed state, wherein the second diameter in the second relaxed state is sized to accommodate the medical device; a braid forming the first lumen, the braid formed of at least one strand of a first material extending from the proximal end of the expandable sheath body at an acute angle relative to the longitudinal axis of the expandable sheath body; and a polymer encapsulating at least a distal portion of the braid, wherein the polymer can expand or collapse along with the braid, the acute angle and the first material selected to allow the medical device to pass through the expandable sheath body without the expandable sheath body buckling; and a hemostasis stylet assembly comprising: a locking hub having distal and proximal ends, the distal end configured to attach to a proximal end of the introducer sheath; a hemostasis stylet having distal and proximal ends, the hemostasis stylet comprising: a hemostasis stylet body having distal and proximal ends, wherein the distal end of the hemostasis stylet body is configured to be inserted into an expandable sheath of the introducer assembly in order to control hemostasis between the expandable sheath and an opening of a blood vessel; and a first sterile layer having a first length and a first lumen between distal and proximal ends of the first sterile layer, wherein the proximal end of the first sterile layer is attached to the distal end of the locking hub of the hemostasis stylet; and a second sterile layer having a second length and a second lumen between distal and proximal ends of the second sterile layer, wherein the distal end of the second sterile layer is attached to the proximal end of the locking hub of the hemostasis stylet.
5. The introducer sheath of claim 4, wherein the sheath assembly further comprises: a hub having a lumen between distal and proximal ends of the hub, wherein the hemostasis stylet body is attached to the proximal end of the hemostasis stylet hub.
6. A sheath assembly for the insertion of a medical device into a blood vessel, the sheath assembly comprising: an introducer sheath comprising: an expandable sheath body having a first length, a longitudinal axis, and proximal and distal ends, the expandable sheath body comprising: a first lumen extending between the proximal and distal ends of the expandable sheath body, the first lumen having a first diameter in a first elongated state and a second diameter in a second relaxed state, wherein the second diameter in the second relaxed state is sized to accommodate the medical device; a braid forming the first lumen, the braid formed of at least one strand of a first material extending from the proximal end of the expandable sheath body at an acute angle relative to the longitudinal axis of the expandable sheath body; and a polymer encapsulating at least a distal portion of the braid, wherein the polymer can expand or collapse along with the braid, the acute angle and the first material selected to allow the medical device to pass through the expandable sheath body without the expandable sheath body buckling; and a dilator assembly comprising: an inner dilator having a second length and a second lumen between proximal and distal ends of the inner dilator; an outer dilator having a third length and a third lumen between proximal and distal ends of the outer dilator, wherein the outer dilator is axially aligned with the inner dilator and the second length is greater than the third length, wherein the inner dilator and outer dilator are configured to be inserted into the first lumen of the expandable sheath body to adjust a diameter of the expandable sheath; and a hub attachment having a third length and a third lumen between proximal and distal ends of the hub attachment, wherein the hub attachment is axially aligned with the outer dilator and the outer dilator lies within the third lumen, wherein the distal end of the hub attachment is attached to a proximal end of the introducer sheath; and a hemostasis stylet assembly comprising: a locking hub having distal and proximal ends, the distal end configured to attach to a proximal end of the introducer sheath; a hemostasis stylet having distal and proximal ends, the hemostasis stylet comprising: a hemostasis stylet hub having a lumen between distal and proximal ends of the hemostasis stylet hub, wherein a first sterile layer and a hemostasis stylet body are attached to the distal end of the hemostasis stylet hub and a second sterile layer is attached to the proximal end of the hemostasis stylet hub; and the hemostasis stylet body having distal and proximal ends, wherein the distal end of the hemostasis stylet body is configured to be inserted into an expandable sheath of the introducer assembly in order to control hemostasis between the expandable sheath and an opening of a blood vessel; and the first sterile layer having a first length and a first lumen between distal and proximal ends of the first sterile layer, wherein the distal end of the first sterile layer is attached to the locking hub; and a second sterile layer having a second length and a second lumen between distal and proximal ends of the second sterile layer.
7. A method of inserting a pump into a blood vessel, the method comprising: attaching an introducer assembly to a dilator assembly, the introducer assembly comprising an expandable sheath having a first diameter and a first length; moving the dilator assembly with respect to the introducer assembly in the proximal direction, wherein the expandable sheath of the introducer assembly transitions to a second diameter and a second length, wherein the second diameter is smaller than the first diameter and the second length is greater than the first length; inserting the introducer assembly and the dilator assembly into a desired location in a blood vessel, wherein an opening of the blood vessel expands to accommodate the second diameter of the expandable sheath; moving the dilator assembly with respect to the introducer assembly in the distal direction, wherein the expandable sheath of the introducer assembly expands to a third diameter and a third length, wherein the third diameter is greater than the second diameter and the third length is smaller than the second length, wherein the opening of the blood vessel expands to accommodate the third diameter of the expandable sheath; detaching the dilator assembly from the introducer assembly and removing the dilator assembly from the desired location in the blood vessel; inserting a pump through the introducer assembly, wherein the expandable sheath expands to a fourth diameter to accommodate the pump as the pump traverses within the introducer assembly, wherein the fourth diameter is greater than the third diameter and the opening of the blood vessel expands to accommodate the fourth diameter of the expandable sheath; and inserting a hemostasis stylet through the introducer assembly, wherein the expandable sheath expands to the fourth diameter sized to accommodate the hemostasis stylet as the hemostasis stylet traverses within the introducer assembly, wherein the fifth diameter is selected to facilitate hemostasis between the opening of the blood vessel and the expandable sheath.
8. A blood pump system, the blood pump system comprising: a blood pump coupled to a catheter having proximal and distal ends; an introducer sheath, wherein the introducer sheath is sized to accommodate the blood pump during insertion into the blood vessel; and a repositioning sheath assembly comprising: a repositioning sheath; a first sterile sleeve having a first length and a first lumen between distal and proximal ends of the first sterile sleeve, wherein the distal end of the first sterile sleeve is attached to the proximal end of the repositioning sheath; the repositioning sheath having distal and proximal ends, wherein the distal end of the repositioning sheath is configured to be inserted into the introducer sheath in order to control hemostasis between the introducer sheath and an opening of the blood vessel; a second sterile sleeve having a second length and a second lumen between distal and proximal ends of the second sterile sleeve, wherein the proximal end of the second sterile sleeve is attached to the proximal end of the repositioning sheath, and the distal end of the second sterile sleeve is attached to a proximal end of the introducer sheath.
9. The blood pump system of claim 8 further comprising an introducer sheath comprising: an expandable sheath frame having a length, a first thickness, a proximal end and a distal end; the frame comprising a plurality of strands extending longitudinally between the proximal end and the distal end, and having an exterior surface and an interior surface that form an interior lumen along the length of the frame; the frame being configured to achieve an expanded state and a contracted state, the expanded state forming an expanded cross-section in the lumen for passing a medical device therethrough; and the frame having a smooth coating about the exterior surface and protrusions extending into the lumen along the interior surface.
10. The blood pump system of any of claims 8 and 9, wherein the first sterile sleeve and the second sterile sleeve are flexible.
11. The blood pump system of any of claims 8-10, wherein the first sterile sleeve comprises a first plurality of flexible layers and the second sterile sleeve comprises a second plurality of flexible layers.
12. The blood pump system of claims 8-11, wherein the first and second plurality of flexible layers comprises a flexible material.
13. The blood pump system of any of claims 8-12, wherein the catheter extends through: the first sterile sleeve, the repositioning sheath, the second sterile sleeve, and the introducer sheath.
14. The blood pump system of claim 13, wherein the catheter extends slideably through the first sterile sleeve and the second sterile sleeve.
15. The blood pump system of any of claims 13 and 14, wherein the repositioning sheath is configured to move relative to the catheter.
16. The blood pump system of claim 15, wherein at least one of the first and second sterile sleeves is configured to be reduced in length when the repositioning sheath is configured to move relative to the catheter.
17. The blood pump system of any of claims 8-16, wherein the introducer sheath comprises: an expandable sheath frame having a length, a first thickness, a proximal end and a distal end; the frame comprising a plurality of strands extending longitudinally between the proximal end and the distal end, and having an exterior surface and an interior surface that form an interior lumen along the length of the frame; the frame being configured to achieve an expanded state and a contracted state, the expanded state forming an expanded cross-section in the lumen for passing a medical device therethrough; and the frame having a smooth coating about the exterior surface and protrusions extending into the lumen along the interior surface
Publications (1)
| Publication Number | Publication Date |
|---|---|
| NZ808071A true NZ808071A (en) |
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