MULTI-LUMEN CATHETER WITH ATTACHABLE HUB

• US 20080033350A1
• Filed: 09/26/2007
• Published: 02/07/2008
• Est. Priority Date: 01/24/2001
• Status: Active Grant

• Current Assignee: Arrow International, LLC (Teleflex Incorporated)
• Original Assignee: Arrow International Incorporated (Teleflex Incorporated)
• Inventors: Wilson, Jon, Fleming, Carl, Fleming, Gary, Boyd, Ronald, Cassidy, Kenneth
• Granted Patent: US 7,833,214 B2
• Time in Patent Office: Days
• US Class Current: 604/43
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores making of catheters A61M25/0009
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/0098 having a strain relief at the proximal end, e.g. sleeve
• CPC Class Codes: A61M 25/0028 characterized by features relating to at least one lumen located at the proximal part of the catheter, e.g. alterations in lumen shape or valves catheter hubs A61M25/0097
• CPC Class Codes: A61M 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10

Abstract

A method of inserting a multi-lumen catheter assembly. First, an incision is made near the area to be catheterized. The proximal portion of the multi-lumen catheter tube is then inserted into the area to be catheterized. A subcutaneous tunnel is created, and the first end of the tunnel is near the incision. The catheter tube is then routed through the subcutaneous tunnel and pulled tube through a second end of the subcutaneous tunnel. The hub body is then securely attached to the catheter tube by connecting the connection cover to the hub body by threaded engagement. In a preferred embodiment the hub body is attached to the catheter tube by backfitting the connection cover over the catheter tube. A compression sleeve is also backfit over the catheter tube. The cannulae of the hub body are inserted into the lumens of the catheter tube to create fluid communication therebetween. The connection between the cannulae and the first and the catheter tube is compressed by sliding the compression sleeve over the cannulae that have been inserted into the catheter tube.

Claims

1-16. -16. (canceled)

17. A method for inserting a multi-lumen hemodialysis catheter assembly into an area to be catheterized, the multi-lumen hemodialysis catheter assembly having a multi-lumen catheter tube having a distal portion and a proximal portion, the method comprising the steps of:

a. making an insertion incision;

b. inserting the proximal portion of the multi-lumen catheter tube through the incision and into the area to be catheterized;

c. creating a subcutaneous tunnel having a first end and a second end, wherein the first end is closer than the second end to the insertion incision;

d. routing the distal portion of the catheter tube through the subcutaneous tunnel while the proximal portion of the multi-lumen catheter tube remains in the area to be catheterized, the distal portion entering the first end and exiting the second end of the subcutaneous tunnel;

e. attaching the distal portion of the catheter tube to a device which supplies fluid to a first lumen of the multi-lumen catheter and withdraws fluid from a second lumen of the multi-lumen catheter; and

f. conducting hemodialysis through the multi-lumen hemodialysis catheter assembly.

18. The method of claim 17, wherein the multi-lumen hemodialysis catheter assembly further comprising a hub having (i) a hub body with a distal portion and a proximal portion, the hub body being formed about a first cannula and a second cannula, each of the cannula having a proximal portion and a distal portion, and (ii) a compression sleeve, fitting axially about the distal portion of the multi-lumen dialysis catheter tube and the proximal portions of the first and second cannulae, further comprising of the steps of:

a. backfitting the compression sleeve over the distal portion of the multi-lumen dialysis catheter tube; and

b. subsequent to the routing the distal portion of the catheter through the subcutaneous tunnel, inserting the first cannula into the first lumen of the multi-lumen catheter tube and inserting the second cannula into the second lumen of the multi-lumen catheter tube;

c. after the cannula inserting steps, compressing the connection between the first and second cannulae and the first and second lumens of the multi-lumen dialysis catheter tube by sliding the compression sleeve over the proximal portion of the first and second cannulae and the distal portion of the multi-lumen dialysis catheter tube.

19. The method of claim 18, wherein the compression sleeve is malleable.

20. The method of claim 18, the hub further comprising a connection cover having a proximal portion and a distal portion, the connection cover fitting axially about the distal portion of the multi-lumen dialysis catheter tube, further comprising of the step of:

a. backfitting the connection cover over the distal portion of the multi-lumen dialysis catheter tube; and

b. simultaneously with compressing the cannulae and catheter tube connections, connecting the distal portion of the connection cover to the proximal portion of the hub body.

21. The method of claim 20, wherein the distal portion of the connection cover is threaded and the proximal portion of the hub is threaded and the step of connecting the connection cover to the hub body further comprising the step of:

a. turning the connection cover so that the threaded portion of the connection cover engages the threaded portion of the hub body.

22. The method of claim 17, wherein the first lumen is associated with a first lumen indicator, the second lumen is associated with a second lumen indicator and the multi-lumen hemodialysis catheter assembly further comprising a hub having (i) a hub body with a distal portion and a proximal portion, the hub body being formed about a first cannula associated with a first hub indicator and a second cannula associated with a second hub indicator, each of the cannulae having a proximal portion and a distal portion, further comprising of the steps of:

a. matching the first lumen indicator with the first hub indicator;

b. matching the second lumen indicator with the second hub indicator; and

c. inserting the first cannula into the first lumen and the second cannula into the second lumen.

23. The method of claim 22, wherein hub further comprising a first extension tube, including a first connector and a first clamp, the first extension tube in fluid communication with the distal portion of the first cannula;

and a second extension tube, including a second connector and a second clamp, the second extension tube in fluid communication with the distal portion of the second cannula, the first extension tube further including the first hub indicator integral with at least one of the first connector or the first clamp and the second extension tube further including the second hub indicator integral with at least one of the second connector or the second clamp.

24. The method of claim 23 wherein the first hub indicator is the color red and the second hub indicator is the color blue.

25. The method of claim 17, wherein the multi-lumen dialysis catheter assembly further comprises (a) an attachable hub assembly, the hub assembly having (i) a hub body with a distal portion and a proximal portion, the hub body being formed about a first cannula and a second cannula, each of the cannula having a proximal portion and a distal portion, (ii) a connection cover having a proximal portion and a distal portion, the connection cover fitting axially about the distal portion of the multi-lumen dialysis catheter tube, the method further comprising the steps of:

a. backfitting the connection cover over the distal portion of the multi-lumen dialysis catheter tube;

b. inserting the proximal portion of the first cannula into the first lumen of the distal portion of the multi-lumen dialysis catheter tube, and inserting the proximal portion of the second cannula into the second lumen of the distal portion of the multi-lumen dialysis catheter tube, to create fluid communication between the first cannula and the first lumen and the second cannula and the second lumen;

c. connecting the distal portion of the connection cover to the proximal portion of the hub body, such that the multi-lumen dialysis catheter tube is securely attached to the hub body.

26. The method of claim 25, wherein the connection cover further comprising threads at the distal portion thereof and the hub body further comprising threads at the proximal portion thereof, wherein the step of connecting the distal portion of the connection cover to the proximal portion of the hub body further comprising:

a. turning the connection cover so that the threads thereof engage the hub body threads.

27. The method of claim 17, wherein the multi-lumen dialysis catheter assembly further comprises (a) an attachable hub assembly, the hub assembly having a (i) a hub body with a distal portion and a proximal portion, the hub body being formed about a first cannula and a second cannula, each of the cannula having a proximal portion and a distal portion, (ii) a connection cover having a proximal portion and a distal portion, the connection cover fitting axially about the distal portion of the multi-lumen dialysis catheter tube, and (iii) a compression sleeve, the compression sleeve fitting axially about the distal portion of the multi-lumen dialysis catheter tube, the first lumen having a first lumen indicator associated therewith, the first cannula having a first cannula indicator associated therewith, the second lumen having a second lumen indicator associated therewith and the second cannula having a second cannula indicator associated therewith, the method comprising the steps of:

a. backfitting the connection cover over the distal portion of the multi-lumen dialysis catheter tube;

b. backfitting the compression sleeve over the distal portion of the multi-lumen dialysis catheter tube;

c. matching the first cannula indicator and the first lumen indicator and inserting the proximal portion of the first cannula into the first lumen of the distal portion of the multi-lumen dialysis catheter tube to create fluid communication between the first cannula and the first lumen; and

d. matching the second cannula indicator and the second lumen indicator and inserting the proximal portion of the second cannula into the second lumen of the distal portion of the multi-lumen dialysis catheter tube to create fluid communication between the second cannula and the second lumen;

e. compressing the connection between the first and second cannulae and the first and second lumens of the multi-lumen dialysis catheter tube by sliding the compression sleeve over the proximal portion of the first and second cannulae that have been inserted into the first and second lumens of the distal portion of the multi-lumen dialysis catheter tube; and

f. connecting the distal portion of the connection cover to the proximal portion of the hub body, such that the multi-lumen dialysis catheter tube is securely attached to the hub body.

28. The method of claim 27, wherein the hub further comprising a first extension tube including a first connector and a first clamp, the first extension tube in fluid communication with the distal portion of the first cannula;

and a second extension tube including a second connector and a second clamp, the second extension tube in fluid communication with the distal portion of the second cannula, the first extension tube further including the first cannula indicator integral with at least one of the first connector or the first clamp and the second extension tube further including the second cannula indicator integral with at least one of the second connector or the second clamp.

29. The method of claim 28 wherein the first hub indicator is the color red and the second hub indicator is the color blue.

30. A method for inserting a hemodialysis catheter into a vein, the hemodialysis catheter assembly comprising a multi-lumen catheter tube having a distal portion and a proximal portion, the method comprising the steps of:

a. making an insertion incision extending from a skin portion of a patient into the vein;

b. inserting the proximal portion of the multi-lumen catheter tube through the incision and into the vein;

c. creating a subcutaneous tunnel having a first end and a second end, the first end near the insertion incision;

d. attaching a trocar to the distal portion of the catheter tube;

e. routing the trocar and the attached distal portion of the catheter tube through the subcutaneous tunnel;

f. disconnecting the trocar from the catheter tube;

g. attaching the distal portion of the catheter tube to a device which supplies fluid to a first lumen of the multi-lumen catheter and withdraws fluid from a second lumen of the multi-lumen catheter; and

h. conducting hemodialysis through the hemodialysis catheter.

31. The method of claim 30 further wherein the step of attaching the distal portion of the catheter tube to a device which supplies fluid to a first lumen of the multi-lumen catheter and withdraws fluid from a second lumen of the multi-lumen catheter further includes the step of:

a. utilizing a matching means for assuring that the second lumen is attached to the device such that fluid is withdrawn through the second lumen and that the first lumen is attached to the device such that fluid is supplied to the first lumen.

32. The method of claim 31 wherein the matching means includes the colors blue and red associated with portions of the hemodialysis catheter.

33. The method of claim 30 further comprising the step of:

a. confirming placement of a tip of the proximal portion of the catheter tube at the opening of the patient'"'"'s right atrium.

34. The method of claim 33 wherein the step of confirming placement of the tip of the proximal portion of the catheter tube is performed using fluoroscopy.