Miniature balloon catheter method and apparatus

Claim 2

A miniaturized balloon catheter assembly for use in small vessels comprising: a cannula having proximal and distal ends including an attaching means at the proximal end thereof for attaching to a source of pressurized fluid and having a small outer diameter for insertion into small vessels; an inflatable balloon including a means forming a mouth at a proximal end thereof mounted on an external surface of the cannula at the distal end of the cannula to be in fluid communication therewith, the cannula and balloon together adapted to be carried by the fluid in a vessel to desired locations therein, whereupon attachment of the cannula fluid source of pressurized fluid and intro-duction of amounts of pressurized fluid flow inflate the balloon to fix it in position against the wall of said vessel at a desired location; and, a balloon-retaining means responsive to a predetermined further amount of pressure to initiate a desired procedure within the small vessels, said balloon-retaining means including a resilient contracting member surrounding said means forming said mouth for holding said means forming said mouth on said external surface of said cannula, said resilient contracting member being constructed to have a specific predetermined internal size when in a contracted state for: contracting with a uniform prede-termined tension about said means forming said mouth when said means forming said mouth is mounted on said cannula to hold said balloon on said cannula upon said balloon being inflated to fix it in position against the wall of said vessel at said desired location, expanding in response to said predetermined further amount of pressure in said balloon to release said cannula from said mouth, and there-after contracting toward said specific predetermined internal size to close said balloon mouth and thereby retain said inflated balloon fixed in position against said wall.

Claim 3

A miniaturized balloon catheter as in claim 1 wherein said resilient contracting member does not wrap about said means forming said mouth more than once.

Claim 4

A miniaturized balloon catheter as in claim 1 wherein said balloon is of an elastomeric silastic material.

Claim 5

A miniaturized balloon catheter assembly as in claim 1 wherein said cannula and said balloon are normally of approx-imately the same diameter and attachment of the inflatable portion of the cannula is achieved by expanding the means forming a mouth, and extending it over the adjacent end of the cannula.

Claim 6

A miniaturized balloon catheter as in claim 4 wherein said resilient contracting member is a C-shaped spring.

Claim 7

A miniaturized balloon catheter as in claim 5 wherein the inner diameter of said balloon is approximately 0.011 inches and its outer diameter is approximately 0.024 inches while said C-shaped spring has an inner diameter of approxi-mately 0.018 inches when it is in a non-expanded condition.

Claim 8

A miniaturized balloon catheter assembly adapted for use in diagnostic and therapeutic procedures in connection with small vessels comprising; a cannula having means at a proximal end for attachment to a source of pressurized fluid and having a small outer diameter for insertion into small vessels, an inflatable tubular balloon having a mouth portion and mounted at the distal end of the cannula in fluid communi-cation therewith, the cannula and balloon adapted to be carried by the fluid in the vessel to a desired location therein, whereupon introduction of an amount of pressurized fluid flow from the source of pressurized fluid will inflate the balloon to fix it in position, activation means responsive to a further amount of pressure to initiate a desired pro-cedure within the small vessel at the desired location, said balloon being detachably mounted at the distal end of said cannula and having a sealing means thereon so that when the cannula and balloon are positioned in the desired location in the human vessel the cannula can be detached from the balloon whereupon the sealing means will seal the mouth portion of the balloon, said sealing means including elastomeric self-sealing plug material positioned in the mouth of the inflatable balloon adjacent to the end of the cannula, a circumferential expandable band on the outer surface of the inflatable balloon in concentric position with respect to the plug material therein, said assembly further comprising a pin having a passageway therethrough and one end mounted at the distal end of the cannula with the passageway therein in communication with the passageway through the cannula and the other end of the pin positioned through a small opening in the self sealing plug material into fluid communication with the inflatable balloon on the side of the plug material distal from the cannula and when in that position expanding the circumfer-ential band, so that when sufficient pressurized fluid has passed through the cannula and pin into the inflatable balloon to inflate the balloon to the desired amount, further fluid will inflate the mouth portion thereby freeing the cannula and attached pin from the balloon for removal whereupon the elastomeric self-sealing plug material will close the open-ing in the plug material and the mouth portion of the balloon to retain the balloon in inflated condition.

Claim 9

A miniaturized balloon catheter assembly adapted for use in diagnostic and therapeutic procedures in connection with small vessels comprising; a cannula having means at a proximal end for attachment to a source of pressurized fluid and having a small outer diameter for insertion into small vessels, an inflatable tubular balloon having a mouth portion and mounted at the distal end of the cannula in fluid communi-cation therewith, the cannula and balloon adapted to be carried by the fluid in the vessel to a desired location therein, whereupon introduction of an amount of pressurized fluid flow from the source of pressurized fluid will inflate the balloon to fix it in position, activation means responsive to a further amount of pressure to initiate a desired pro-cedure within the small vessel at the desired location, said balloon being detachably mounted at the distal end of said cannula and having a sealing means thereon so that when the cannula and balloon are positioned in the desired location in the human vessel the cannula can be detached from the balloon whereupon the sealing means will seal the mouth portion of the balloon, said sealing means including elastomeric self-sealing plug material positioned in the mouth of the inflatable balloon adjacent to the end of the cannula, a circumferential expandable band on the outer surface of the inflatable balloon in concentric position with respect to the plug material therein, said assembly further comprising a pin having a passageway therethrough and one end mounted at the distal end of the cannula with the passageway therein in communication with the passageway through the cannula and the other end of the pin positioned through a small opening in the self sealing plug material into fluid communication with the inflatable balloon on the side of the plug material distal from the cannula and when in that position expanding the circumfer-ential band, so that when sufficient pressurized fluid has passed through the cannula and pin into the inflatable balloon to inflate the balloon to the desired amount, further fluid will inflate the mouth portion thereby freeing the cannula and attached pin from the balloon for removal whereupon the elastomeric self-sealing plug material will close the open-ing in the plug material and the mouth portion of the balloon to retain the balloon in inflated condition.

Claim 10

A miniaturized balloon catheter assembly as in claim 7 wherein the distal end of the pin has a beveled configuration.

Claim 11

A miniaturized balloon catheter assembly as in claim 7 wherein said elastomeric self-sealing plug material cooperates with the circumferential band to close the open-ing in the plug material.

Claim 12

10, In a miniaturized balloon catheter assembly adapted for use in diagnostic and therapeutic procedures in connection with small vessels comprising; a cannula having means at a proximal end for attachment to a source of pressurized fluid and having a small outer diameter for insertion into small vessels, an inflatable tubular balloon having a mouth portion and mounted at the distal end of the cannula in fluid communi-cation therewith, the cannula and balloon adapted to be carried by the fluid in the vessel to a desired location therein, whereupon introduction of an amount or pressurized fluid flow from the source of pressurized fluid will inflate the balloon to fix it in position, activation means respons-ive to a further amount of pressure to initiate a desired procedure within the small vessel at the desired location, said balloon being detachably mounted at the distal end of said cannula; the subassembly of a sealing means which, when the cannula and balloon are positioned at the desired location in the human vessel, seals the mouth portion of the balloon, said sealing means including elastomeric self-seallng plug material positioned in the mouth of the inflatable balloon adj-acent to the end of the cannula, an expandable circumferential band on the outer surface of the inflatable balloon in concentric position with respect to the plug material therein, said sub-assembly further comprising a pin having a passageway therethrough and one end mounted at the distal end of the cannula with the passageway therein in communication with the passageway through the cannula and the other end of the pin positioned through a small opening in the self-sealing plug material into fluid communication with the inflatable balloon on the side of the plug material distal from the cannula and when in that position expanding the cir-cumferential band, so that when the balloon is detached from the distal end of the cannula the pin is removed from the plug material, whereupon the elastomeric self-sealing plug material and the expand-able circumferential band will close the opening in the plug material and the mouth portion of the balloon to retain the balloon in inflated condition.

Claim 13

10, In a miniaturized balloon catheter assembly adapted for use in diagnostic and therapeutic procedures in connection with small vessels comprising; a cannula having means at a proximal end for attachment to a source of pressurized fluid and having a small outer diameter for insertion into small vessels, an inflatable tubular balloon having a mouth portion and mounted at the distal end of the cannula in fluid communi-cation therewith, the cannula and balloon adapted to be carried by the fluid in the vessel to a desired location therein, whereupon introduction of an amount or pressurized fluid flow from the source of pressurized fluid will inflate the balloon to fix it in position, activation means respons-ive to a further amount of pressure to initiate a desired procedure within the small vessel at the desired location, said balloon being detachably mounted at the distal end of said cannula; the subassembly of a sealing means which, when the cannula and balloon are positioned at the desired location in the human vessel, seals the mouth portion of the balloon, said sealing means including elastomeric self-seallng plug material positioned in the mouth of the inflatable balloon adj-acent to the end of the cannula, an expandable circumferential band on the outer surface of the inflatable balloon in concentric position with respect to the plug material therein, said sub-assembly further comprising a pin having a passageway therethrough and one end mounted at the distal end of the cannula with the passageway therein in communication with the passageway through the cannula and the other end of the pin positioned through a small opening in the self-sealing plug material into fluid communication with the inflatable balloon on the side of the plug material distal from the cannula and when in that position expanding the cir-cumferential band, so that when the balloon is detached from the distal end of the cannula the pin is removed from the plug material, whereupon the elastomeric self-sealing plug material and the expand-able circumferential band will close the opening in the plug material and the mouth portion of the balloon to retain the balloon in inflated condition.

Claim 14

The subassembly of claim 10 wherein said expandable circumferential band comprises a single strand element which does not extend about said plug material a plurality of times.

Claim 15

A miniaturized balloon catheter assembly adapted for use in diagnostic and therapeutic procedures in connection with small vessels comprising; a cannula having means at a proximal end for attachment to a source of pressurized fluid and having a small outer diameter for insertion into small vessels, an inflatable tubular balloon having a mouth means constructed of self-sealing material for forming an opening into said balloon through which said balloon can be inflated, but which can be closed to maintain said balloon in an in-flated state, said balloon being mounted at the distal end of the cannula in fluid communication therewith, said cannula extending into the mouth means of said balloon so that said balloon can be inflated and deflated via said cannula, the cannula and balloon adapted to be carried by the fluid in the vessel to a desired location therein, whereupon introduction of an amount of pressurized fluid flow from the source of pressurized fluid will inflate the balloon to fix it in posi-tion and a further amount of pressure will initiate a desired procedure within the small vessel at the desired location, said balloon having a sealing means thereon so that when the cannula and balloon are positioned in the desired location in the human vessel the cannula can be detached from the balloon whereupon the sealing means will seal the mouth portion of the balloon, said sealing means including a circumferential expandable-band means on the outer surface of the mouth means of said inflatable balloon tending to hold the balloon mouth means onto said cannula, said expandable-band means compris-ing a single strand element which does not extend about said mouth means a plurality of times, said expandable-band means and said mouth means having the joint function of responding to a sufficient amount of pressurized fluid passing through the cannula into the inflatable balloon to inflate the balloon to a desired amount by detaching the cannula from the balloon for removal of the cannula from the balloon mouth means, and responding to a decreased pressure in said balloon after said cannula has been removed by closing the opening in said mouth means of the balloon to retain the balloon in an inflated condition.

Claim 16

A miniaturized balloon catheter assembly adapted for use in diagnostic and therapeutic procedures in connection with small vessels comprising; a cannula having means at a proximal end for attachment to a source of pressurized fluid and having a small outer diameter for insertion into small vessels, an inflatable tubular balloon having a mouth means constructed of self-sealing material for forming an opening into said balloon through which said balloon can be inflated, but which can be closed to maintain said balloon in an in-flated state, said balloon being mounted at the distal end of the cannula in fluid communication therewith, said cannula extending into the mouth means of said balloon so that said balloon can be inflated and deflated via said cannula, the cannula and balloon adapted to be carried by the fluid in the vessel to a desired location therein, whereupon introduction of an amount of pressurized fluid flow from the source of pressurized fluid will inflate the balloon to fix it in posi-tion and a further amount of pressure will initiate a desired procedure within the small vessel at the desired location, said balloon having a sealing means thereon so that when the cannula and balloon are positioned in the desired location in the human vessel the cannula can be detached from the balloon whereupon the sealing means will seal the mouth portion of the balloon, said sealing means including a circumferential expandable-band means on the outer surface of the mouth means of said inflatable balloon tending to hold the balloon mouth means onto said cannula, said expandable-band means compris-ing a single strand element which does not extend about said mouth means a plurality of times, said expandable-band means and said mouth means having the joint function of responding to a sufficient amount of pressurized fluid passing through the cannula into the inflatable balloon to inflate the balloon to a desired amount by detaching the cannula from the balloon for removal of the cannula from the balloon mouth means, and responding to a decreased pressure in said balloon after said cannula has been removed by closing the opening in said mouth means of the balloon to retain the balloon in an inflated condition.

Claim 17

A miniaturized balloon catheter assembly for use in small vessels comprising: a cannula including an attaching means at one end thereof for attaching to a source of pressurized fluid and having a small outer diameter for insertion into small vessels; an inflatable balloon mounted on the opposite end of the cannula and in fluid communication therewith, the cannula and balloon adapted to be carried by the fluid in a vessel to desired locations therein, whereupon attachment of the cannula fluid source of pressurized fluid and introduction of amounts of pressurized fluid flow inflate the balloon; said balloon including an activation means responsive to further amounts of pressures to initiate a de-sired procedure within the small vessels, said activation means comprising a reinforced portion of said balloon having a passageway therethrough, said passageway normally being so small that it effectively does not allow the passage of fluid from said balloon through said passageway, but said reinforced portion allowing the opening of said passageway in response to a predetermined amount of pressure within said balloon to allow passage of said fluid from said balloon into said vessels, said reinforced portion of said balloon being thicker than the remainder of said balloon.

Claim 18

A miniaturized balloon catheter assembly for use in small vessels comprising: a cannula including an attaching means at one end thereof for attaching to a source of pressurized fluid and having a small outer diameter for insertion into small vessels; an inflatable balloon mounted on the opposite end of the cannula and in fluid communication therewith, the cannula and balloon adapted to be carried by the fluid in a vessel to desired locations therein, whereupon attachment of the cannula fluid source of pressurized fluid and introduction of amounts of pressurized fluid flow inflate the balloon; said balloon including an activation means responsive to further amounts of pressures to initiate a de-sired procedure within the small vessels, said activation means comprising a reinforced portion of said balloon having a passageway therethrough, said passageway normally being so small that it effectively does not allow the passage of fluid from said balloon through said passageway, but said reinforced portion allowing the opening of said passageway in response to a predetermined amount of pressure within said balloon to allow passage of said fluid from said balloon into said vessels, said reinforced portion of said balloon being thicker than the remainder of said balloon.

Claim 19

A miniaturized balloon catheter assembly as in claim 13 wherein said passageway has a round cross-section with a diameter of approximately 0.001 inch.

Claim 20

A miniaturized balloon catheter as in claim 13 wherein said reinforced portion of said balloon forms plug material which extends inwardly into the interior of said balloon.

Claim 21

A miniaturized balloon catheter as in claim 15 wherein said passageway has a round cross-section with a diameter of approximately 0.001 inch.

Claim 22

A miniaturized balloon catheter as in claim 13 wherein said balloon having said passageway is formed by a molding process.

Claim 23

A miniaturized balloon catheter as in claim 17, wherein said balloon is formed by the process of: covering a mandril with liquified resilient material of which said balloon is to be constructed, said mandril having the general shape of said balloon but includ-ing a pin protruding therefrom at the desired position of said passageway to form said passageway; hardening the liquified material on said mandril; removing said hardened material from said man-dril, said hardened material forming said balloon having a passageway therethrough.

Claim 24

A miniaturized balloon catheter assembly as in claim 18 wherein said pin has a round cross-section with a diameter of approximately 0.001 inch.

Claim 27

A method of constructing a balloon catheter as in claim 20 wherein said mandril includes an indentation therein, and said pin protrudes from said mandril at said indentation.

Claim 28

A method of constructing a balloon catheter as in claim 21 wherein said pin has a round cross-section with a diameter of approximately 0.001 inch.

Claim 29

A method of constructing a balloon catheter as in claim 22 wherein said mandril is constructed of steel.

Claim 30

A method as in claim 20 wherein said pin has a round cross-section with a diameter of 0.001 inch.

Claim 31

A method of constructing a balloon catheter as in claim 20 wherein said mandril is constructed of steel.