Catheters having separable reusable components

• US 5,549,554 A
• Filed: 02/02/1995
• Issued: 08/27/1996
• Est. Priority Date: 04/01/1994
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Miraki, Manouchehr
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): SMITH, CHALIN A
• Application Number:
  US08/382,768
• Time in Patent Office: 572 Days
• Field of Search: 604/94, 604/96, 604/101, 604/167, 604/283, 604/284, 604/05, 604/161, 604/165, 606/192, 606/195, 606/196, 606/194, 606/199
• US Class Current: 604/101.05
• CPC Class Codes: A61M 2025/0047 the inner layer having a higher lubricity
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/1054 having detachable or disposable balloons
• CPC Class Codes: A61M 2025/1063 having only one lumen used for guide wire and inflation, e.g. to minimise the diameter
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/1025 Connections between catheter tubes and inflation tubes
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Dual headed catheter assemblies are provided with a tubular central instrument body portion connected at each end to an elongate tubular distal body, each of which may be provided with an expansible balloon for dilatation purposes. One or more releasible connectors may be provided for sealingly connecting each of the tubular distal bodies to the central instrument body portion to allow for replacement of the tubular distal body and to simplify potential resterilization and reuse of the central instrument body portion. Alternative embodiments include multiple inflation lumens each provided with an individual inflation port which may be preferentially accessed by a fluid conducting inflation assembly configured to preferentially access individual inflation ports. The dual headed catheter with replaceable components may be utilized in place of multiple single headed catheters to perform medical procedures involving repeat access to vascular target sites.

Claims

1. A dual headed catheter assembly comprising:

a generally tubular elongate central body having generally opposed first and second ends and at least one lumen extending therethrough;

a first elongate tubular distal body having proximal and distal ends, an inflatable member with an inner chamber near the distal end a first longitudinally extending bore in communication with said lumen in said central body and the interior of the inflatable member and being releasable and sealingly connected at its proximal end to said first end of said central body portion;

a second elongate tubular distal body having proximal and distal end and being sealingly connected at its proximal end to said second end of said central body and provided with a second longitudinally extending bore in communication with said lumen in said central body; and

means associated with the central body to selectively engage in fluid communication either the first or second longitudinally extending bore with a source of fluid.

2. The dual headed catheter assembly of claim 1 including a connector member to releasably connect the proximal end of the first elongate tubular distal body to the central body.

3. The dual headed catheter assembly of claim 1 including a connector member to releasably connect the proximal end of the second elongate tubular distal body to the central body.

4. The dual headed catheter assembly of claim 3 further comprising a second releasible connector disposed between said second end of said central body and said proximal end of said second elongate tubular distal body.

5. The dual headed catheter assembly of claim 1 wherein said first elongate tubular distal body is provided with an expansible balloon disposed adjacent the distal end thereof which has an interior in fluid communication with the longitudinally extending bore thereof.

6. The dual headed catheter assembly of claim 5 wherein said central body is provided with a first inflation port in fluid communication with said lumen thereof and said longitudinally extending bore of said first tubular distal body.

7. The dual headed catheter assembly of claim 6 wherein, said second elongate tubular distal body is provided with a second expansible balloon disposed adjacent the distal end thereof and said central body is provided with a second inflation port and a second inflation lumen in fluid communication between said second inflation port and said second expansible balloon.

8. The dual headed catheter assembly of claim 7 wherein the central body is provided with means to deliver inflation fluid to either said first inflation port or said second inflation port.

9. A method for performing a medical procedure within a patient, said method comprising the steps of:

providing the dual headed catheter assembly of claim 1; and

inserting at least one of said first or said second elongate tubular distal bodies into the patient.

10. The method of claim 9 further comprising the additional steps of disconnecting said first elongate tubular body from said first end of said central body portion;

connecting a replacement tubular distal body to said first end of said central body portion; and

inserting at least one of said second elongate tubular distal body or said replacement tubular distal body into the patient.

18. A method for performing an angioplasty procedure to dilate a vascular stenosis within a patient, said method comprising the steps of:

providing the dual headed catheter assembly of claim 7;

inserting said first elongate tubular distal body into the patient and advancing said first expansible balloon to a position crossing the stenosis;

inflating said first expansible balloon;

deflating said first expansible balloon and withdrawing said first elongate tubular distal body from the patient;

inserting said second elongate tubular distal body into the patient and advancing said second expansible balloon into a position across the stenosis; and

deflating said second expansible balloon and withdrawing said second elongate tubular distal body from the patient.

19. The method of claim 18 further comprising the additional steps of disconnecting said first elongate tubular distal body from said first end of said central body portion following withdrawal of said first elongate tubular distal body from the patient;

connecting a replacement tubular distal body to said first end of said central body portion; and

inserting said replacement tubular distal body into the patient.

20. The method of claim 19 further comprising the additional steps of removing said replacement tubular distal body from the patient;

disconnecting said replacement tubular distal body from said first end of said central body portion;

connecting an alternative replacement tubular distal body to said first end of said central body portion; and

inserting said alternative replacement tubular distal body into the patient.

11. A dual headed catheter assembly comprising:

a generally tubular elongate central body having generally longitudinally opposed first and second ends, first and second parallel lumens extending therethrough and coextensive at least in part, a first inflation port in fluid communication with said first parallel lumen and a second inflation port in fluid communication with said second parallel lumen;

a first elongate tubular distal body sealingly connected at its proximal end to said first end of said central body and provided with at least one longitudinally extending bore in communication between said first parallel lumen in said central body and a first expansible balloon disposed adjacent the distal end of said first elongate tubular distal body;

a second elongate tubular distal body sealingly connected at its proximal end to said second end of said second end of said central body and provided with at least one longitudinally extending bore in communication between said second parallel lumen in said central body;

a releasable connector disposed between said first end of said central body and said proximal send of said first elongate tubular distal body.

12. The dual headed catheter assembly of claim 11 further comprising a second releasible connector disposed between said second end of said central body portion and said proximal end of said second elongate tubular distal body.

13. The dual headed catheter assembly of claim 11 further comprising a protective sheath for releasably covering one of the first or second tubular distal bodies while the other tubular distal body is in use.

14. The dual headed catheter assembly of claim 11 wherein said first elongate tubular distal body is provided with a guide wire lumen disposed along at least a portion of its longitudinal extent and said second elongate tubular distal body is provided with a guide wire lumen disposed along at least a portion of its longitudinal extent.

15. The dual headed catheter assembly of claim 11 wherein said first and second parallel lumens are coaxially disposed with respect to one another.

16. The dual headed catheter assembly of claim 11 wherein the central body is provided with means to deliver inflation fluid to either said first inflation port or said second inflation port.

17. The dual headed catheter assembly of claim 16 wherein said inflation assembly comprises a fluid conducting generally tubular body sealingly disposed about said central body portion in adjustable sliding relationship between a first position in fluid conducting communication with said first inflation port and a second position in fluid conducting communication with said second inflation port.

21. A catheter assembly comprising:

a) an elongated body which includes

a central section having first and second ends, a first inflation lumen extending to the first end, a second inflation lumen extending to the second end, a first port in fluid communication with the first inflation lumen, and a second port in fluid communication with the second inflation lumen,

a first extremity releasably connected to the first end of the central section and having a third inflation lumen extending therein in fluid communication with the first inflation lumen,

a first balloon on the first extremity having an interior in fluid communication with the third inflation lumen,

a second extremity connected to the second end of the central section and having a fourth inflation lumen extending therein in fluid communication with the second inflation lumen,

a second balloon on the second extremity having an interior in fluid communication with the fourth inflation lumen; and

b) a connector element having first and second ends, a first inner lumen which is configured to slidably receive the central section of the elongated body, means on the first and second ends of the connector element to sealingly engage a first portion of the central section of the elongated body on one side of one of the inflation ports in the central section and a second portion of the central section of the elongated body on the opposite side of said one of the inflation ports to selectively engage in fluid communication either the first or the second inflation lumens and a second inner lumen having one end in communication with the first inner lumen and a second end configured to be connected to a source of inflation fluid.

22. The catheter assembly of claim 21 wherein the second balloon has a larger inflated diameter than the inflated diameter of the first balloon.

23. The catheter assembly of claim 21 wherein the central section comprises an outer tubular member and an inner tubular member disposed within the outer tubular member.

24. The catheter assembly of claim 23 wherein at least one of the inner and outer tubular members is formed of hypotubing.

25. The catheter assembly of claim 23 wherein the second inflation lumen is defined between the inner tubular member and the outer tubular member.

26. The catheter assembly of claim 23 wherein the second inflation port extends through a wall portion of the outer tubular member and is in fluid communication with the second inflation lumen.

27. The catheter assembly of claim 23 wherein the inner tubular member defines the first inflation lumen.

28. The catheter assembly of claim 23 wherein the first inflation port extends through a wall portion of the outer tubular member and a wall portion of the inner tubular member and is in fluid communication only with the first inflation lumen.

29. The catheter assembly of claim 23 wherein the catheter shaft of the first extremity has a distal end, a first guidewire port in the distal end, a second guidewire port spaced proximally from the balloon on the first extremity and a guidewire passageway extending from the first guidewire port to the second guidewire port.

30. The catheter assembly of claim 29 wherein the guidewire passage is defined by an inner tubular sleeve disposed within the catheter shaft of the first extremity.

31. The catheter assembly of claim 29 wherein the catheter shaft of the second extremity has a distal end, a third guidewire port in the distal end, a fourth guidewire port spaced proximally from the balloon on the second extremity and a second guidewire passageway extending from the third guidewire port to the fourth guidewire port.

32. The catheter assembly of claim 31 wherein the second guidewire passage is defined by an inner tubular sleeve disposed within the catheter shaft of the second extremity.