WO1999007422A1

WO1999007422A1 - Bloodless guide catheter

Info

Publication number: WO1999007422A1
Application number: PCT/US1998/016667
Authority: WO
Inventors: Jonathan S. Reiner
Original assignee: Intervent, Llc
Priority date: 1997-08-11
Filing date: 1998-08-10
Publication date: 1999-02-18
Also published as: AU8779598A

Abstract

A system for reducing blood loss when placing a guiding catheter into an artery of a human subject. The guiding catheter has a sealing means (40) located on or in its proximal end, or is attached to a proximal end catheter attachment having such a sealing means (40). The sealing means (40) is essentially planar and is adapted to permit passage of a guide wire without loss of blood as the guide wire and guide catheter are advanced through the arterial system and the guide wire is removed, and is further adapted to permit reversible piercing by a blunt object, such as the conical end of a male Luer attachment, and such as in a Y adaptor (100), in such a manner as to avoid residual parts remaining on the guiding catheter lumen (30) that could encumber the passage of contrast, balloons, or other intervention devices. A method for using such a system is also provided, which requires substantially no modification of current techniques.

Description

BLOODLESS GUIDE CATHETER

FIELD OF THE INVENTION

This invention is in the field of guiding catheters that are inserted through a patient's skin in order to facilitate the entry of guide wires, balloon catheters, and other devices, into a coronary, peripheral, or cerebral blood vessel.

BACKGROUND

Guiding catheters are typically inserted via the femoral, brachial or radial arteries with their proximal end remaining outside the patient and their distal end placed in the artery. Guide wires are used to help advance these guiding catheters to an appropriate place in the arterial system. However, during the time it takes to properly advance the guiding catheter's distal end into the ascending aorta or other large artery, there is typically substantial blood leakage out of the guiding catheter's proximal end. This exposes health care workers to the risks associated with blood-borne pathogens.

U.S. Pat. No. 5,413,561 entitled "Guiding Catheter with Sealing Cap System for Reducing Blood Loss When Inserting Guide Catheters" (which issued to Fischell et al.) relates to a sealing cap device which reduces blood loss during insertion and removal of the guide wire. However, after each placement of the catheter and removal of the guide wire the healthcare worker must remove the cap (and usually tries, in practice, to hold a finger, e.g., a thumb over the end of the catheter) while a Tuohy-Borst "Y" adaptor is attached to the female Luer Lock fitting of the guiding catheter. This procedure requires an additional step, compared with standard procedures. Furthermore, blood loss occurs which exposes the operator to the risks associated with blood-borne pathogens. Such loss of blood and exposure of healthcare workers to potential blood-borne pathogens is undesirable.

Accordingly, there is a need for a fixed sealing means in a section of the catheter near its proximal end (or for a device adapted to attach to the proximal end) through which a guide wire may be run which will minimize or eliminate blood loss during the procedure of advancing the guiding catheter over the guide wire and attaching the Y adaptor.

SUMMARY OF THE INVENTION

The purpose of this invention is to overcome the problem of blood loss when a guiding catheter is advanced over a guide wire and thorough the arterial system as well as when a Y adapter is being attached to the guiding catheter. In a preferred aspect such problem is overcome without decreasing the inner luminal diameter of the catheter and thereby permitting the unimpeded insertion of various devices through the Y adapter and on through the catheter.

The invention consists of a guiding catheter having a sealing means located on or in the proximal end of the catheter, or a proximal end catheter attachment having a the sealing means located on or in the proximal end of the catheter attachment, which sealing means is adapted to permit passage of a guide wire through the sealing means without loss of blood as the guide wire is inserted into the guiding catheter and removed, and which sealing means is adapted to permit reversible piercing of a portion of the sealing means with a blunt object, such as the end of the central tubing of a Y adapter (the standard male end of a Luer lock connector) in such a manner as to avoid residual parts remaining within the lumen of the guiding catheter that could prevent the passage of contrast dye or interventional devices through the guiding catheter.

Thus it is an object of this invention to provide a means and method to prevent substantial loss of the patient's blood when a guiding catheter is being advanced into the arterial system as well as when a Y adapter or other device is being attached to the catheter. In a preferred aspect, such is accomplished without requiring any substantial change in the external dimensions of the proximal portions of currently existing guiding catheters. In another preferred aspect, such is accomplished by utilizing a guiding catheter attachment adapted to attach to the proximal portion of an existing guiding catheter, or is adapted to attach to another guiding catheter attachment which may in turn be attached to the proximal portion of an existing guiding catheter.

Another object of this invention is to reduce the exposure of health care workers to the patient's blood during all aspects of insertion, use and removal of a guiding catheter.

Still another object of this invention is to provide a guiding catheter with a sealing means which is a displaceable valve adapted for piercing with a blunt object such as a male Luer lock connector at the guiding catheter's proximal end, or to provide a guiding catheter attachment comprising such a sealing means; the sealing means of the guiding catheter, of a guiding catheter attachment, or of both the catheter and attachment being adapted to allow the passage of a guide wire while preventing the free release of blood, and being adapted to allow piercing with a blunt object to displace the sealing means without any parts remaining on or in the catheter which could encumber the doctor in his or her performance of an interventional procedure using the guiding catheter. In a preferred aspect the proximal end of a guiding catheter comprises the sealing means.

These and other objects and advantages of this invention will become clear to persons of ordinary skill in this art upon reading of the detailed description of the invention presented herein in conjunction with the related drawings and the state of the art.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a longitudinal cross-sectional view of the proximal end of a guiding catheter with a sealing means which is a displaceable valve adapted for piercing with a blunt object shown in the closed (sealed) state.

FIG. 2 is a longitudinal cross-sectional view of another embodiment of the invention, which is a side view of a guiding catheter attachment adapted for attaching to the proximal end of a guiding catheter (of for attaching to another guiding catheter attachment which may in turn be attached to the proximal end of a guiding catheter) with a sealing means which is a displaceable valve adapted for being pierced with a blunt object shown in the closed (sealed) state.

FIG. 3 is an enlarged perspective view of a preferred elastomeric partition member which may be utilized as a member of the sealing means for either of the devices shown in FIGS. 1 or 2, which view shows a preferred slit pattern for the elastomeric partition member.

FIG. 4 is a transverse sectional view taken along a diagonal of the elastomeric partition member shown in FIG. 3.

FIG. 5 is a side view of a Tuohy-Borst "Y" adaptor, which may be utilized with the present invention.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 is a longitudinal cross-sectional view of the proximal end of a guiding catheter with a sealing means 40 which is a displaceable valve adapted for being pierced with a blunt object such as the distal end of a Tuohy-Borst "Y" adaptor, which is located in the proximal end portion 20 of the guiding catheter's main body. The proximal end portion 20 consists of an elongated flexible tube 22 having a central lumen 30, which elongated flexible tube 22 continues on to the distal end (not shown) of the guiding catheter, and a proximal end having a grasping portion 36 which is preferably hollow and is open to the central lumen 30 and a female Luer lock fitting 38 with at least one thread member 32. The Luer lock fitting 38 has a tapered Luer entry lumen 34 which is designed to mate with a male Luer lock fitting of a Tuohy-Borst "Y" adaptor such as the one shown in FIG. 5 or any device with a standard male Luer lock fitting. FIG. 2 is a longitudinal cross-sectional view of another embodiment of the invention which is a side view of a guided catheter attachment, having a proximal end portion 58 (which includes a female Luer lock member 56) joined to a male Luer end 51 via a tube member 50 which has a central lumen 54 (which male Luer end 51 is adapted with a male member 53 and thread grooves 52 for attaching to the female Luer end of a guiding catheter or to the female Luer end of another guiding catheter attachment) the proximal end portion 58 of the guided catheter attachment includes a sealing means 60 which is a displaceable valve adapted for being pierced with a blunt object such as the distal end of a Tuohy-Borst "Y" adaptor. The proximal end portion 58 comprises a female Luer lock fitting 56 with at least one thread member 57. The Luer lock fitting 56 has a tapered Luer entry lumen 55 which is designed to mate with a male Luer lock fitting of a Tuohy-Borst "Y" adaptor such as the one shown in FIG. 5 or any device with a standard male Luer lock fitting.

As shown in FIG. 3, a preferred sealing means corresponding to the sealing means 40 of FIG.l or the sealing means 60 of FIG.2 may include an elastomeric partition member 74 with an outer portion 80 and an inner portion 71 and a preferred slit pattern 70. Specifically, the cross-sectional shape of slit pattern 70 may be in the shape of three intersecting, substantially equangualarly spaced slits 73, 79 and 82 (having radii 72, 76 and 83 at a first surface 75 and radii 81, 84 and 85 at second surface 88) .

FIG. 4 is a transverse sectional view 93 of the sealing means of FIG. 3, taken along a diagonal origin line 95 the elastomeric partition member 74 of FIG. 3, having: a peripheral section 99 with an outermost surface 92, a first major face 91 and a second major face 92; a first conical portion 94; a second conical portion 98; a first helical cuts 90; and a second helical cut 96.

FIG. 5 shows a Tuohy-Borst "Y" adaptor 100 having at its distal end a male Luer cone 101 which mates with the female entry lumen of a guiding catheter as known in the art (not shown) . Also, the nut 102 is adapted to engage a female Luer thread member of a guiding wire catheter or of a proximal end attachment of a guiding wire catheter (such as thread member 32 of FIG. 1 or thread member 57 of FIG.2) . A first branch 104 of the "Y" adaptor has a Luer thread 105 at its open, female Luer fitting end. A second branch 106 leads to a Tuohy-Borst fitting 107.

Examples of elastomeric substances and dimensions for an elastomeric partition member as shown in FIGS. 3 and 4 may be found in EP patent application 308,815 published March 9, 1989 or U.S. Patent 4,626,245 and the documents cited therein, all of which are incorporated herein by reference. Such designs, elastomeric compositions and slit patterns are not critical to the present invention but may be utilized herein.

A typical procedure which utilizes a guiding catheter with a sealing means (such as illustrated in FIG. 1) is described below. The procedure would be the same for an existing guiding catheter to which the guiding catheter proximal end attachment with a sealing means (such as illustrated in FIG. 2) has been attached except that a step of removing the sterile attachment comprising the sealing means is removed from its package and attached to the existing catheter. The procedure would be as follows utilizing the numbering of FIG. 1: (1) The guiding catheter system having a sealing means according to the invention is removed from its sterile package and, using a syringe, is flushed out with normal saline or a heparin solution.

(2) The distal end of a guide wire is placed through the sealing means which is essentially planar to pierce the sealing means and placed through the lumen 30 of the guiding catheter proximal end 20 and continuing on to the distal end of the guiding catheter (not shown) .

(3) The guide wire and guiding catheter are then advanced together through a percutaneous sheath into the arterial system until the distal end of the guiding catheter is placed in a desired position in the ostium of an artery such as a coronary artery.

(4) When the guiding catheter is advanced to the desired position, the guide wire is then removed, and the sealing means reversibly seals the proximal end portion 20 of the guiding catheter preventing back leak of blood.

(5) A Tuohy-Borst "Y" adaptor (such as shown in FIG. 5) is then connected to the female Luer fitting 38 of the guiding catheter proximal end portion 20, and the blunt male Luer distal end 101 reversibly pierces the sealing means to push the sealing means out of the way and clears the central lumen 30 of the proximal end portion 20 of the guiding catheter. Should the Y adaptor be removed, the sealing means is preferably adapted to reseal the proximal end portion 20 of the guiding catheter without loss of blood. With the design of the present catheter with sealing means, a system is provided which leaves no residual parts or materials remaining in the lumen of the guiding catheter that would encumber the passage of contrast, balloons, or other interventional device, through the guiding catheter and which requires no modification of current techniques .

The Figures and above description of the invention are merely meant to exemplify the invention and to convey important aspects. Various other modifications, adaptations, and alternative designs are of course possible in light of the above teachings. In particular, other sealing means than the illustrated or preferred embodiments may be utilized. Therefore, it should be understood at this time that within the scope of the appended claims, the invention may be practiced otherwise than as specifically described herein.

Claims

CLAIMSHaving thus described my invention, what I claim as new and desire to secure by Letters Patent is as follows:

1. A guiding catheter having a sealing means located on or in the proximal end of the catheter, which sealing means is essentially planar and is adapted to permit passage of a guide wire through the sealing means without loss of blood as the guide wire and guide catheter are advanced through the arterial system and the guide wire removed, and which sealing means is adapted to permit reversible piercing of a portion of the sealing means with a blunt object, such as the male cone at the center of a male Luer end or a catheter guide wire, in such a manner as to avoid residual parts remaining on the guiding catheter lumen that could encumber the passage of contrast, balloons, or other interventional devices, and which requires substantially no modification to current techniques, and wherein said guiding catheter is adapted for percutaneous insertion of the guiding catheter into an introducer sheath in one of the femoral, brachial or radial arteries of a human subject and comprises a guiding catheter having a proximal end and a distal end and an elongated, generally cylindrical main body, the guiding catheter having a female Luer lumen situated at its proximal end and the distal end being adapted for placement within the ostium of an artery.

2. A catheter according to claim 1, wherein the sealing means comprises at least one slit.

3. A catheter according to claim 2, wherein the at least one slit is helical in shape.

4. A catheter according to claim 1, wherein the sealing means is an elastomeric partition member recessed within the proximal end of the guiding catheter.

5. A guiding catheter proximal end attachment comprising a female Luer end, a male Luer end and a sealing means which is essentially planar and is adapted to permit passage of a guide wire through the sealing means without loss of blood as the guide wire is inserted into the guiding catheter and removed, and which sealing means is adapted to permit reversible piercing of a portion of the sealing means with a blunt object, such as the male cone at the center of a male Luer end or a catheter guide wire, in such a manner as to avoid residual parts remaining on the guiding catheter that could encumber the doctor in his or her performance of an interventional procedure using the guiding catheter.

6. The catheter attachment according to claim 5, wherein the sealing means comprises at least one slit.

7. The catheter attachment according to claim 5, wherein the at least one slit is helical in shape.

8. The catheter attachment according to claim 5, wherein the sealing means is an elastomeric partition member recessed within the proximal end of the attachment which comprises the female Luer member.

9. A method of using a catheter system to treat a patient wherein the catheter system includes a catheter according to claim 1.

10. A method according to claim 1, wherein the system includes a guide wire.

11. A method of using a catheter system to treat a patient wherein the catheter system includes the use of a catheter attachment according to claim 5.

12. A method of using a catheter system to treat a patient wherein the catheter system includes the use of a catheter attachment according to claim 6.

13. A method of using a catheter system to treat a patient wherein the catheter system includes the use of a catheter attachment according to claim 7.

14. A method of using a catheter system to treat a patient wherein the catheter system includes the use of a catheter attachment according to claim 8.