Adjustable catheter assembly

• US 4,955,863 A
• Filed: 06/12/1989
• Issued: 09/11/1990
• Est. Priority Date: 02/05/1986
• Status: Expired due to Term

• Current Assignee: Menlo Care, Inc. (Johnson & Johnson)
• Original Assignee: Menlo Care, Inc. (Johnson & Johnson)
• Inventors: Sheehan, Neil J., Walker, Jack M.
• Primary Examiner(s): Ostrager, Allen M.
• Application Number:
  US07/366,268
• Time in Patent Office: 456 Days
• Field of Search: 604/158, 604/164, 604/165, 604/240, 604/265, 604/280, 604/283, 604/905, 128/343, 521/905, 528/904
• US Class Current: 604/165.02
• CPC Class Codes: A61M 25/0014 Connecting a tube to a hub
• CPC Class Codes: A61M 25/0111 Aseptic insertion devices
• CPC Class Codes: A61M 25/0637 Butterfly or winged devices, e.g. for facilitating handling or for attachment to the skin

Abstract

The invention relates to a catheter assembly comprising a cannula, needle and catheter inserter wherein the inserter is in slidable relationship to the cannula and wherein the inserter or other device also serves to selectively restrict the cannula and needle from sliding relative to the inserter. The cannula comprises a material which, when inserted into the body of a living subject, softens and/or swells and has a tensile energy to break of at least about 700 N-cm/cm³ and a 2.5% Secant modulus of less than about 7,000 N/cm². The invention also relates to a method of inserting a cannula into a living subject using an inserter which is positioned such that the desired length of cannula for initial insertion extends beyond the inserter. The method also relates to further inserting the cannula into the living subject after initial insertion of the cannula.

Claims

1. A catheter assembly, comprising:

a cannula having a distal end portion, a proximal end portion, and a longitudinal duct therethrough from the distal end portion to the proximal end portion;

a needle having a distal and a proximal end and having a sharpened insertion tip at the distal end, the needle being positioned within the distal end portion of the longitudinal duct of the cannula with the insertion tip extending beyond the distal end of the cannula;

a catheter inserter having inserter distal and proximal ends and having a cannula guide channel extending from the inserter distal end to the inserter proximal end, the cannula being positioned in slidable relationship through the channel such that the distal end portion of the cannula extends beyond the distal end of the channel; and

a means for selectively restricting the cannula and needle from sliding relative to the channel;

material which when inserted into a body of a living subject and maintained therein;

(a)

(i) softens with a softening ratio of at least about 2;

1; and

/or

(ii) swells with a swelling ratio of at least about 1.3;

1;

(b) has a tensile energy to break of at least about 700 N-cm/cm³ ; and

(c) has a 2.5% Secant modulus of less than about 7,000 N/cm².

2. A catheter assembly, according to claim 1, wherein the cannula guide channel comprises a bore extending from the distal end to the proximal end of the inserter.

3. A catheter assembly according to claim 1, wherein the catheter inserter comprises a body having a pair of members extending therefrom, the members being movable to selectively restrict or release the cannula and needle from sliding relative to the channel.

4. A catheter assembly according to claim 1, wherein at least a portion of the cannula is of a material selected such that an inner cross-section of the duct increases to form an enlarged duct cross section when at least a part of the distal end portion of the cannula is inserted into a body of a living subject and maintained therein and/or when the duct is contacted by a liquid, for a period of time sufficient for the enlarged duct cross-section to form.

5. A catheter assembly according to claim 4, wherein the inner cross-section of the duct increases when the duct is contacted by an aqueous liquid.

6. A catheter assembly according to claim 4, wherein the outer circumference of the cannula increases such that the cannula is restricted from sliding relative to the channel and the duct inner cross-section decreases such that the needle is restricted from sliding relative to the cannula.

7. A catheter assembly according to claim 4, wherein the increase in the duct cross-section is from about 25% to about 400%.

8. A catheter assembly according to claim 1, wherein at least a portion of the cannula is of a material selected such that an outer circumference of the duct increases to form an enlarged outer circumference when at least a part of the distal end portion of the cannula is inserted into a body of a living subject and maintained therein and/or when the duct is contacted by a liquid, for a period of time sufficient for the enlarged outer diameter to form.

9. A catheter assembly according to claim 1, which further comprises a cannula hub portion having a passageway therethrough from the proximal end to the distal end of the hub, and having an attaching means for attaching the proximal end portion of the cannula to the distal end of the hub with the passageway in flow communication with the duct in the proximal end portion of the cannula.

10. A catheter assembly according to claim 9, wherein the hub has a penetrable polymeric sealing member positioned to seal the proximal end of the hub.

11. A catheter assembly according to claim 9, wherein the hub has a connection means at the proximal end of the hub for attaching tubings or fitting in flow communication with the hub passageway.

12. A catheter assembly according to claim 9, wherein the needle or an extraction wire that is attached to the proximal end of the needle extends through the longitudinal duct of the cannula distally to the hub passageway and out the proximal end of the hub.

13. A catheter assembly according to claim 12, wherein the hub has a connection means at the proximal end of the hub for attaching tubings or fittings in flow communication with the hub passageway.

14. A catheter assembly according to claim 1, wherein the needle or an extraction wire attached to the proximal end of the needle extends through the longitudinal duct of the cannula and out the proximal end of the cannula.

15. A catheter assembly according to claim 1, wherein the distal end portion of the cannula is of a material which prior to insertion into the body of a living subject has a 2.5% secant modulus greater than about 20,000 N/cm².

16. A catheter assembly in accordance with claim 1, wherein the distal end portion of the cannula is of a material which when inserted in the body of a living subject has a 2.5% Secant modulus less than about 5,000 N/cm².

17. A catheter assembly in accordance with claim 1, wherein the distal end portion of the cannula is of a material which when inserted in the body of a living subject has a 2.5% Secant modulus less than about 3,000 N/cm².

18. A catheter assembly according to claim 1, wherein at least a portion of the cannula is selected of a material comprising a thermoplastic composition with an effective glass transition temperature of greater than room temperature but less than about the body temperature of the living subject into which the cannula is to be inserted.

19. A catheter assembly according to claim 18, wherein the thermoplastic composition further has shape memory properties.

20. A catheter assembly according to claim 4 which further comprises a cannula hub portion having a hub passageway therethrough from a first to a second end thereof, wherein the hub passageway has a cross-sectional area throughout at least substantially equal to the enlarged duct cross-section and which further comprises an attaching means for attaching the proximal end portion of the cannula to the first end of the hub with the passageway through the hub in flow communication with the duct in the proximal end portion of the cannula, the attaching being in a manner such that the cross-sectional area of the duct adjacent the proximal end portion, following formation of the enlarged duct cross-section, is throughout at least substantially equal to the enlarged duct cross-section along the remainder of the cannula.

21. A catheter assembly according to claim 1, wherein the cannula comprises a material with hydrophilic properties.

22. A catheter assembly according to claim 2, wherein the cannula comprises a material comprising:

(a) a first phase which comprises a substantially nonhydrophilic polymeric component; and

(b) a second phase which comprises a hydrophilic polymeric component;

said material (i) being capable of absorbing water to an extent that it softens with a softening ratio of at least about 2;

1 and/or swells with a swelling ratio of at least about 1.3;

1; and

(ii) when substantially completely hydrated, having an energy to break of at least about 700 N-cm/cm³ and a 2.5% Secant modulus of less than about 7,000 N/cm².

23. A catheter assembly in accordance with claim 22, wherein said material comprises a physical admixture of a substantially non-hydrophilic polymeric component and a hydrophilic polymeric component.

24. A catheter assembly in accordance with claim 22, wherein the material is cross-linked.

25. A catheter assembly according to claim 21, wherein the cannula comprises a graft or block copolymer with hydrophilic segments with a softening ratio of at least 2:

1.

26. A catheter assembly according to claim 21, wherein the cannula comprises a polyurethane diacrylate composition having from about 90 to about 65 weight percent of a hydrophilic polyurethane resin and from about 10 to about 35 weight percent of a diacrylate.

27. A method of inserting a catheter into a living subject comprising:

(A) selecting a catheter assembly comprising;

a cannula having a distal end portion, a proximal end portion, and a longitudinal duct therethrough from the distal end portion to the proximal end portion;

a needle having a distal and a proximal end and having a sharpened insertion tip at the distal end, the needle being positioned within the distal end portion of the longitudinal duct of the cannula with the insertion tip extending beyond the distal end of the cannula;

a catheter inserter having inserter distal and proximal ends and having a cannula guide channel extending from the inserter distal end to the inserter proximal end the cannula being positioned in slidable relationship through the channel such that the distal end portion of the cannula extends beyond the distal end of the channel; and

means for selectively restricting the cannula and needle from sliding relative to the channel;

wherein at least a portion of the cannula is made of a material which when inserted into a body of a living subject and maintained therein;

(a)

(i) softens with a softening ratio of at least about 2;

1; and

/or

(ii) swells with a swelling ratio of at least about 1.3;

1;

(b) has a tensile energy to break of at least about 700 N-cm/cm³ ; and

(c) has a 2.5% Secant modulus of less than about 7,000 N/cm² ;

(B) positioning the inserter on the cannula such that the desired length of the distal end of the cannula extends beyond the distal end of the channel;

(C) engaging the means such that the cannula and the needle are restricted from sliding relative to the channel; and

(D) inserting the needle and the cannula partially into the living subject.

28. A method according to claim 27, which further comprises the step of disengaging the inserter means.

29. A method according to claim 28, which further comprises the steps of inserting the cannula further into the living subject to the desired length.

30. A method according to claim 27 which further comprises the step withdrawing the needle at least a portion of the way toward the proximal end portion of the cannula.

31. A method according to claim 30, wherein the needle is withdrawn by pulling on an extraction wire attached to the proximal end of the needle.

32. A method according to claim 27, wherein the inserter comprises a body having a pair of members extending therefrom, the inserter means being movable to selectively restrict or release the cannula and needle from sliding relative to the channel.

33. A method according to claim 27, wherein the cannula is of a material selected such that the outer circumference increases when at least a part of the distal end portion of the cannula is inserted into a body of a living subject and maintained therein and/or when the duct is contacted by a liquid, for a period of time sufficient for the enlarged outer circumference to form such that it selectively restricts the cannula from sliding relative to the channel.

34. A method according to claim 27, wherein the cannula and the needle are inserted into a blood vessel of a living subject.

35. A method according to claim 27, wherein the cannula and the needle are inserted into a cavity of a living subject.

36. A method according to claim 27, including the added steps of:

(e) attaching the mechanical means to the living subject adjacent the point of insertion of the cannula; and

(f) maintaining the distal end portion of the cannula partially in the living subject for a desired period of time.