WO2000007654B1 - Inflatable cannula and method of using same - Google Patents

Inflatable cannula and method of using same

Info

Publication number
WO2000007654B1
WO2000007654B1 PCT/US1999/017200 US9917200W WO0007654B1 WO 2000007654 B1 WO2000007654 B1 WO 2000007654B1 US 9917200 W US9917200 W US 9917200W WO 0007654 B1 WO0007654 B1 WO 0007654B1
Authority
WO
WIPO (PCT)
Prior art keywords
cannula
catheter
balloon
hildebrand
tube
Prior art date
Application number
PCT/US1999/017200
Other languages
French (fr)
Other versions
WO2000007654A9 (en
WO2000007654A1 (en
Inventor
Kevin Hahnen
Original Assignee
Embol X Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Embol X Inc filed Critical Embol X Inc
Priority to AU53262/99A priority Critical patent/AU5326299A/en
Publication of WO2000007654A1 publication Critical patent/WO2000007654A1/en
Publication of WO2000007654B1 publication Critical patent/WO2000007654B1/en
Publication of WO2000007654A9 publication Critical patent/WO2000007654A9/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12136—Balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00557—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1052—Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector

Abstract

This invention is an expandable lumen cannula which includes an elongate tube (6) having a proximal region (1), a distal region (3), an intermediate flexible region (2), and a lumen (8) therebetween. The cannula further includes a balloon occluder (13) mounted on the distal end of the tube (6). The intermediate flexible region (2) of the tube (6) further includes an elongate generally cylindrical balloon (10) disposed circumferentially about the intermediate flexible region (2) which, upon inflation, expands the luminal diameter of the intermediate flexible region (2). First, and second inflation ports (4, 6) are in fluid communication with the balloon occluder (13), and the cylindrical balloon (10). The cannula may optionally include a cardioplegia port (11) disposed within the distal region of the tube, proximal the balloon occluder (13), and distal the generally cylindrical balloon (10). Methods of using such a cannula are also disclosed, particularly to provide cannulation through a minimally invasive port incision and thereafter displace the tissues and organs adjacent an intercostal access port upon inflation, and expansion of the generally cylindrical balloon (10).

Claims

AMENDED CLAIMS
[received by the International Bureau on 2 February 2000 (02.02.00); original claims 1-21 replaced by amended claims 1-20 (3 pages)]
1. An expandable lumen cannula, comprising: an elongate tube having a proximal end adapted for attachment to a cardiopulmonary bypass machine, a distal end, an intermediate flexible region, and a lumen therebetween; an elongate generally cylindrical balloon disposed circumferentially about the flexible intermediate region of the tube; a first inflation port communicating with the cylindrical balloon; and a balloon occluder mounted on the distal end of the tube and a second inflation port communicating with the balloon occluder.
2. The cannula of claim 1, wherein the elongate tube further comprises a cardioplegia lumen extending distally from the proximal end and communicating with a cardioplegia port proximal the balloon occluder.
3. The cannula of claim 1, wherein the elongate tube further comprises a helical thread disposed about the distal end of the tube proximal the balloon occluder and distal the cylindrical balloon.
4. The cannula of claim 1 , wherein the elongate tube extends distally beyond the balloon occluder.
5. The cannula of claim 1, wherein the distal end of the tube is angulated relative to the proximal end and intermediate region of the tube.
6. The cannula of claim 5, wherein the angulation is approximately ninety degrees.
7. The cannula of claim 1, wherein the lumen is sized to permit flow of oxygenated blood from a cardiopulmonary bypass machine.
8. The cannula of claim 1, wherein the distal end of the tube further includes a flow diffuser.
9. The cannula of claim 1, wherein the balloon occluder comprises an elastomeric balloon.
10. A method of minimally invasive aortic cannulation, comprising the steps of: providing an expandable lumen cannula comprising an elongate tube having a proximal end, a distal end, an intermediate flexible region, and a lumen therebetween, the elongate tube further including an elongate generally cylindrical balloon disposed circumferentially about the flexible intermediate region of the tube; inserting the expandable lumen cannula through a port access, and advancing the distal end of the cannula into the ascending aorta; inflating the cylindrical balloon; and infusing fluid through the lumen of the cannula into the aorta.
11. The method of claim 10, wherein the elongate tube further comprises a balloon occluder mounted on the distal end, and wherein the method further comprises the step of inflating the balloon occluder.
12. The method of claim 10, wherein the step of inflating the cylindrical balloon increases the luminal diameter of the cannula.
13. The method of claim 11, wherein the fluid is oxygenated blood.
14. The method of claim 13, wherein the oxygenated blood is infused into the aorta distal the balloon occluder.
15. The method of claim 10, further comprising the step of performing cardiopulmonary bypass.
16. The method of claim 10, further comprising the step of performing coronary artery bypass graft.
17. The method of claim 10, further comprising the step of performing a valve replacement.
19. The method of claim 10, further comprising the step of performing thoracic aortic aneurysm repair.
20. The method of claim 10, further comprising the step of performing septal defect repair.
14
STATEMENT UNDER ARTICLE 19 (1)
The limitations previously described in claims 2 and 8 have been added to claim 1 as amended. Thus, claim 1 as amended describes the proximal end of the elongate tube as being adapted for attachment to a cardiopulmonary bypass machine, and further recites a balloon occluder mounted on the distal end of the tube and a second inflation port communicating with it. In accordance with the amendment made to claim 1, claims 2 and 8 have been deleted without prejudice.
Hildebrand, Randolph et al., Leone et al., and Maahs were all cited as references allegedly precluding the novelty of claim 1 as originally filed. Applicant respectfully asserts, however, that claim 1 as amended is not anticipated by any of those references.
Neither Hildebrand nor Leone et al. either teach or suggest a cannula having a proximal end adapted for attachment to a cardiopulmonary bypass machine. In fact, Hildebrand does not teach a catheter for use in blood vessels at all, and Leone teaches away from cardiopulmonary bypass.
The catheter disclosed in Hildebrand is specifically designed for introduction into the body through the urethra of a patient to access the prostate gland. Thus, not only is there no teaching of adapting the proximal end of the catheter for attachment to a cardiopulmonary bypass machine, but there is no need, motivation, or suggestion in Hildebrand to do so. Therefore, claim 1 as amended is patentably distinct from Hildebrand, and claims 2-9, which depend from claim 1, are also patentably distinct from Hildebrand for at least the same reasons.
Leone et al. makes no mention of using the catheter in connection with cardiopulmonary bypass. And, there are no structures disclosed in Leone et al. that could be adapted for attachment to a cardiopulmonary bypass machine. Furthermore, Leone et al. actually teaches away from attaching the catheter to a cardiopulmonary bypass machine, because the catheter includes blood perfusion ports 23 leading to a blood perfusion outlet opening 24. Cardiopulmonary bypass would preclude the need for those structures because there would be no blood upstream of the balloon 16. Therefore, claim 1 as amended is patentably distinct from Leone et al., and claims 2-9, which depend from claim 1, are also patentably distinct from Leone et al. for at least the same reasons.
Randolph et al. and Maahs, as indicated by the International Search Report, do not anticipate claim 2 as originally filed. Therefore, claim 1 as amended is patentably distinct from both Randolph et al. and Maahs, and claims 2-9, which depend from claim 1, are also patentably distinct from Randolph et al. and Maahs for at least the same reasons. 15
Randolph et al. and Hildebrand were cited in the International Search Report as references allegedly precluding the novelty of method claim 12, which has been renumbered as claim 10 by this Amendment. Claim 10 recites a method of minimally invasive aortic cannulation. and describes the steps of providing a cannula, inserting the cannula through a port access and advancing the distal end of the cannula into the ascending aorta, and infusing fluid through the lumen of the cannula into the aorta.
Randolph et al. teaches a guiding catheter for the coronary sinus. The catheter of Randolph et al. is thread through the right atrium and into the coronary sinus to deliver intravascular devices thereto. There is no teaching, motivation, or suggestion to advance any part of the catheter into the ascending aorta or to infuse fluid through the catheter into the aorta. In fact, it would be impossible to thread any catheter either to the coronary sinus by way of the aorta or to the aorta by way of the coronary sinus. Thus, Randolph et al. actually teaches away from using the catheter in the aorta. Therefore, claim 10 is patentably distinct from Randolph et al., and claims 11-20, which depend from claim 10, are also patentably distinct from Randolph et al. for at least the same reasons.
As described above, Hildebrand teaches a prostatic drug-delivery catheter. There is no teaching, motivation, or suggestion to introduce the catheter of Hildebrand into the aorta or the aortic arch. In fact, there is no teaching, motivation, or suggestion to introduce the catheter of Hildebrand into any blood vessel. Therefore, claim 10 is patentably distinct from Hildebrand, and claims 11-20, which depend from claim 10, are also patentably distinct from Hildebrand for at least the same reasons.
PCT/US1999/017200 1998-08-07 1999-07-29 Inflatable cannula and method of using same WO2000007654A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU53262/99A AU5326299A (en) 1998-08-07 1999-07-29 Inflatable cannula and method of using same

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US09/130,585 US6168586B1 (en) 1998-08-07 1998-08-07 Inflatable cannula and method of using same
US09/130,585 1998-08-07

Publications (3)

Publication Number Publication Date
WO2000007654A1 WO2000007654A1 (en) 2000-02-17
WO2000007654B1 true WO2000007654B1 (en) 2000-03-23
WO2000007654A9 WO2000007654A9 (en) 2000-10-05

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1999/017200 WO2000007654A1 (en) 1998-08-07 1999-07-29 Inflatable cannula and method of using same

Country Status (3)

Country Link
US (3) US6168586B1 (en)
AU (1) AU5326299A (en)
WO (1) WO2000007654A1 (en)

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US6679871B2 (en) 2004-01-20
WO2000007654A9 (en) 2000-10-05
US20010023332A1 (en) 2001-09-20
US20040138614A1 (en) 2004-07-15
WO2000007654A1 (en) 2000-02-17
US6168586B1 (en) 2001-01-02
AU5326299A (en) 2000-02-28

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