Infusion catheter

• US 5,653,689 A
• Filed: 09/30/1995
• Issued: 08/05/1997
• Est. Priority Date: 09/30/1995
• Status: Expired due to Fees

• Current Assignee: Abacus Design & Development, Inc.
• Original Assignee: Abacus Design & Development, Inc.
• Inventors: Lubock, Paul, Noda, Wayne A., Buelna, Terrence J.
• Primary Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US08/531,242
• Time in Patent Office: 675 Days
• Field of Search: 604/96, 604/101, 604/104, 604/265, 606/108, 606/192, 606/194
• US Class Current: 604/103.09
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• 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 25/104 used for angioplasty

Abstract

An infusion catheter, for use in conjunction with a balloon dilatation catheter, comprises an elongate, flexible tube defining an infusion lumen, and an expansible infusion sleeve located near its distal end, the sleeve comprising an expansible network of spacer elements disposed between proximal and distal elastomeric sealing bands. When deployed at a treatment site in a blood vessel or other bodily passage, the elongate tube of the present invention concentrically surrounds the dilatation catheter, the infusion lumen being defined therebetween, with the infusion sleeve concentrically surrounding the balloon. The spacer elements of the expansible network create an axially-elongated, circumferential flow path or interstice between the balloon and the vessel wall when the balloon is inflated, the interstice being in fluid communication with the infusion lumen, through which a therapeutic fluid is delivered to the treatment site. In a first preferred embodiment, the infusion sleeve comprises a network of filaments that define the spacer elements, wherein the network has a substantial degree of shape memory, allowing the sleeve to return to its original shape when the balloon is deflated. The grid is permanently fixed to the proximal and distal sealing bands. In a second preferred embodiment, the sleeve comprises a perforated tube of deformable, biocompatible metal formed as a mesh or latticework that defines a network of spacer elements. The perforated tube is detachably joined to the sealing bands, so that it may be left in place as a stent after the catheter is withdrawn.

Claims

1. An infusion and dilatation device for insertion into a vessel, duct, or passage in the body of a patient, comprising:

a dilatation catheter having an elongate, flexible catheter tube defining an inflation lumen in fluid communication with an inflatable element near the distal end of the catheter tube, and wherein the inflatable element is inflatable from a deflated state to an inflated state by a pressurized inflation fluid received from the inflation lumen;

an elongate, flexible infusion tube internally dimensioned so as to allow the catheter tube to be disposed concentrically therein, and having a distal end; and

an expansible sleeve, on the infusion tube near the distal end thereof, that assumes a contracted position when the inflatable element is in the deflated state and an expanded position when the inflatable element is in the inflated state, the sleeve comprising a perforated tubular element defining a deformable expansible network of spacer elements, wherein the sleeve is permanently deformable to its expanded position;

whereby, when the catheter tube is disposed within the infusion tube, (a) an infusion lumen is defined between the catheter tube and the infusion tube, (b) the infusion lumen has a distal end proximal to the sleeve, and (c) the sleeve concentrically surrounds the inflatable element so as to be deformable into an expanded position by the inflation of the inflatable element; and

whereby the spacer elements create an interstice between the inflatable element and a surrounding interior tissue surface of the vessel, duct, or passage for fluid flow axially from the distal end of the infusion lumen to the interstice and thereby to the interior tissue surface around the inflatable element when the sleeve is in its expanded position.

2. The device of claim 1, wherein the outside diameter of the sleeve is approximately equal to the outside diameter of the infusion tube when the sleeve is in the contracted position.

3. The device of claim 1, wherein the spacing between the spacer elements is at a minimum when the sleeve is in its contracted position, and at a maximum when the sleeve is in its expanded position, the minimum spacing being sufficient to permit the passage of a liquid therapeutic agent therethrough.

4. The device of claim 1, wherein a portion of the catheter tube extends distally through the distal end of the infusion tube, and wherein the sleeve is coaxially attached between the distal end of the infusion tube and the distally extended portion of the catheter tube.

5. The device of claim 4, wherein the sleeve is joined to the distal end of the infusion tube by an elastomeric proximal sealing element and to the distally extended portion of the catheter tube by an elastomeric distal sealing element, the proximal and distal sealing elements being displaceable radially outwardly when the sleeve is moved from its contracted position to its expanded position.

6. The device of claim 5, wherein the sleeve is detachably joined to the proximal and distal sealing elements.

7. An infusion and dilatation device for insertion into a vessel, duct, or passage in the body of a patient, comprising:

a dilatation catheter having an elongate, flexible catheter tube defining an inflation lumen in fluid communication with an inflatable element near the distal end of the catheter tube, and wherein the inflatable element is inflatable from a deflated state to an inflated state by a pressurized inflation fluid received from the inflation lumen;

an elongate, flexible infusion tube internally dimensioned so as to allow the catheter tube to be disposed concentrically therein, and having a distal end; and

an expansible sleeve, on the infusion tube near the distal end thereof, and comprising an expansible network of spacer elements, wherein the sleeve assumes a contracted position when the inflatable element is in the deflated state and an expanded position when the inflatable element is in the inflated state, and wherein the sleeve is connected to the infusion tube by an elastomeric sealing element that is displaceable radially outwardly when the sleeve is moved from its contracted position to its expanded position;

whereby, when the catheter tube is disposed within the infusion tube, (a) an infusion lumen is defined between the catheter tube and the infusion tube, (b) the infusion lumen has a distal end proximal to the sleeve, and (c) the sleeve concentrically surrounds the inflatable element so as to be deformable into an expanded position by the inflation of the inflatable element; and

whereby the spacer elements create an interstice between the inflatable element and a surrounding interior tissue surface of the vessel, duct, or passage for fluid flow axially from the distal end of the infusion lumen to the interstice and thereby to the interior tissue surface around the inflatable element when the sleeve is in its expanded position.

8. The device of claim 7, wherein the outside diameter of the sleeve is approximately equal to the outside diameter of the infusion tube when the sleeve is in the contracted position.

9. The device of claim 7, wherein the spacing between the spacer elements is at a minimum when the sleeve is in its contracted position, and at a maximum when the sleeve is in its expanded position, the minimum spacing being sufficient to permit the passage of a liquid therapeutic agent therethrough.

10. An infusion and dilatation device for insertion into a vessel, duct, or passage in the body of a patient, comprising:

a dilatation catheter having an elongate, flexible catheter tube defining an inflation lumen in fluid communication with an inflatable element near the distal end of the catheter tube, and wherein the inflatable element is inflatable from a deflated state to an inflated state by a pressurized inflation fluid received from the inflation lumen;

an elongate, flexible infusion tube internally dimensioned so as to allow the catheter tube to be disposed concentrically therein, and having a main tube portion and a distal end portion; and

an expansible sleeve attached coaxially to the infusion tube between the main tube portion and the distal end portion thereof, and that assumes a contracted position when the inflatable element is in the deflated state and an expanded position when the inflatable element is in the inflated state, the sleeve comprising a resiliently expansible network of spacer elements, whereby the sleeve has sufficient shape memory to return substantially to its contracted position after having been expanded to its expanded position;

wherein the sleeve is joined to the main tube portion by an elastomeric proximal sealing element and to the distal end portion by an elastomeric distal sealing element, the proximal and distal sealing elements being displaceable radially outwardly when the sleeve is moved from its contracted position to its expanded position;

whereby, when the catheter tube is disposed within the infusion tube, (a) an infusion lumen is defined between the catheter tube and the infusion tube, (b) the infusion lumen has a distal end proximal to the sleeve, and (c) the sleeve concentrically surrounds the inflatable element so as to be deformable into an expanded position by the inflation of the inflatable element; and

whereby the spacer elements create an interstice between the inflatable element and a surrounding interior tissue surface of the vessel, duct, or passage for fluid flow axially from the distal end of the infusion lumen to the interstice and thereby to the interior tissue surface around the inflatable element when the sleeve is in its expanded position.

11. The device of claim 10, wherein the outside diameter of the sleeve is approximately equal to the outside diameter of the infusion tube when the sleeve is in the contracted position.

12. The device of claim 10, wherein the spacing between the spacer elements is at a minimum when the sleeve is in its contracted position, and at a maximum when the sleeve is in its expanded position, the minimum spacing being sufficient to permit the passage of a liquid therapeutic agent therethrough.

13. The device of claim 10, wherein the sleeve is permanently fixed to the proximal and distal sealing elements.

14. A dilatation and infusion device for insertion into a vessel, passage, or duct in the body of a patient, comprising:

a first elongate, flexible, hollow tube having a proximal end, a distal end, and an inflation lumen;

an inflatable element near the distal end of the first tube and in fluid communication with the inflation lumen so as to be inflatable from a deflated state to an inflated state by an inflation fluid received from the inflation lumen;

a second elongate, flexible, hollow tube concentrically disposed around the first tube so as to define an infusion lumen between the first and second tubes, the second tube comprising a main tube portion and a distal end portion, the infusion lumen having a distal end terminating in the main tube portion;

an expansible sleeve coaxially connected between the main tube portion and the distal end portion of the second tube, in fluid communication with the distal end of the infusion lumen, and concentrically surrounding the inflatable element so as to be expansible to an expanded position in response to the inflation of the inflatable element, the sleeve comprising an expansible network of spacer elements defining an interstice between the inflatable element and an interior tissue surface of the vessel, passage, or duct when it is in its expanded position, thereby providing an axial fluid flow path from the distal end of the infusion lumen to the interstice and thereby to the interior tissue surface around the exterior of the inflatable element, wherein the sleeve assumes a contracted position, having an outside diameter that is approximately equal to the outside diameter of the main tube portion of the second tube, when the inflatable element is in the deflated state, and an expanded position when the inflatable element is in the inflated state; and

elastomeric proximal and distal sealing elements respectively joining the sleeve to the main tube portion and the distal end tube portion, the proximal and distal sealing elements being displaceable radially outwardly when the sleeve is moved from its contracted position to its expanded position.

15. The device of claim 14, wherein the sleeve is permanently fixed to the proximal and distal sealing elements.

16. A dilatation and infusion device, comprising:

a first elongate, flexible, hollow tube having a proximal end and a distal end and having an inflation lumen;

an inflatable element near the distal end of the first tube and in fluid communication with the inflation lumen so as to be inflatable from a deflated state to an inflated state by a pressurized inflation fluid received from the inflation lumen;

a second, elongate, flexible, hollow tube concentrically disposed around the first tube so as to define an infusion lumen between the first and second tubes, and having a distal end through which a portion of the first tube extends distally; and

an expansible sleeve, coaxially connected between the distal end of the second tube and the distally extended portion of the first tube, in fluid communication with the infusion lumen, and located so as to concentrically surround the inflatable element, the sleeve comprising an expansible network of spacer elements defining a flow path from the infusion lumen around the exterior of the inflatable element.

17. The device of claim 16, wherein the sleeve assumes a contracted position, having an outside diameter that is approximately equal to the outside diameter of the main tube portion of the second tube, when the inflatable element is in the deflated state, and an expanded position when the inflatable element is in the inflated state.

18. The device of claim 17, wherein the spacing between the spacer elements is at a minimum when the sleeve is in its contracted position, and at a maximum when the sleeve is in its expanded position, the minimum spacing being sufficient to permit the passage of a liquid therapeutic agent therethrough.

19. The device of claim 17, wherein the sleeve comprises a perforated tubular element defining a deformably expansible network of spacer elements, wherein the sleeve is permanently deformable to its expanded position.

20. The device of claim 19, wherein the sleeve is joined to the distal end of the second tube by an elastomeric proximal sealing element and to the distally extended portion of the first tube by an elastomeric distal sealing element, the proximal and distal sealing elements being displaceable radially outwardly when the sleeve is moved from its contracted position to its expanded position.

21. The device of claim 20, wherein the sleeve is detachably joined to the proximal and distal sealing elements.

22. A method of delivering a liquid therapeutic agent to a treatment site in the tissue surrounding a bodily passage, vessel, or duct, comprising the steps of:

providing a catheter assembly having an inflation lumen communicating with an inflatable element near its distal end, and an infusion lumen having a distal end communicating with an expansible infusion member located distally from the distal end of the infusion lumen, defining an expansible network of spacer elements, concentrically surrounding the inflatable element;

positioning the catheter assembly within the bodily passage, vessel, or duct so that the inflatable element and the infusion member are located at the treatment site;

inflating the inflatable element from a deflated state to an inflated state with an inflation fluid introduced through the inflation lumen to expand the infusion member radially from a contracted position to an expanded position in which the spacer elements are brought into contact with the treatment site, thereby creating an interstice between the inflatable element and the treatment site;

infusing the liquid agent into the treatment site while the inflatable element is inflated by expressing the liquid agent from the distal end of the infusion lumen into the interstice created by the spacer elements between the inflatable element and the treatment site;

deflating the inflatable element after the infusion step without restoring the infusion member to its contracted position;

detaching the infusion member from the catheter assembly while the spacer elements are in contact with the treatment site; and

withdrawing the catheter assembly from the vessel, passage, or duct, leaving the infusion member in place at the treatment site as a stent.

23. The method of claim 22, wherein the spacing between the spacer elements is at a minimum when the infusion member is in its contracted position, and at a maximum when the infusion member is in its expanded position, the minimum spacing being sufficient to permit the passage of a liquid therapeutic agent therethrough.

24. The method of claim 22, wherein the step of infusing is performed at a pressure sufficient to allow the liquid agent to penetrate the surface of the tissue.

25. A method of delivering a liquid therapeutic agent to a treatment site in the tissue surrounding a bodily passage, vessel, or duct, comprising the steps of:

providing a catheter assembly having an inflation lumen fluidly communicating with an inflatable element near its distal end, and an infusion lumen having a distal end fluidly communicating with an expansible infusion member, located distally from the distal end of the infusion lumen, that defines an expansible network of spacer elements, concentrically surrounding the inflatable element;

positioning the catheter assembly within the bodily passage, vessel, or duct so that the inflatable element and the infusion member are located at the treatment site;

inflating the inflatable element from a deflated state to an inflated state with an inflation fluid delivered through the inflation lumen to expand the infusion member radially from a contracted position to an expanded position in which the spacer elements are brought into contact the treatment site and create an interstice between the inflatable element and the treatment site;

while the inflatable element is inflated and the spacer elements are in contact with the treatment site, delivering a liquid therapeutic agent from the distal end of the infusion lumen to the treatment site through the interstice;

deflating the inflatable element after the infusion step without restoring the infusion member to its contracted position;

detaching the infusion member from the catheter assembly while the spacer elements are in contact with the treatment site; and

withdrawing the catheter assembly from the vessel, passage, or duct, leaving the infusion member in place at the treatment site as a stent.

26. The method of claim 25, wherein the spacing between the spacer elements is at a minimum when the infusion member is in its contracted position, and at a maximum when the infusion member is in its expanded position, the minimum spacing being sufficient to permit the passage of a liquid therapeutic agent therethrough.

27. The method of claim 25, wherein the step of infusing is performed at a pressure sufficient to allow the liquid agent to penetrate the surface of the tissue.