CA2085912C - Apparatus for the cannulation of blood vessels - Google Patents
Apparatus for the cannulation of blood vessels Download PDFInfo
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- CA2085912C CA2085912C CA002085912A CA2085912A CA2085912C CA 2085912 C CA2085912 C CA 2085912C CA 002085912 A CA002085912 A CA 002085912A CA 2085912 A CA2085912 A CA 2085912A CA 2085912 C CA2085912 C CA 2085912C
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- tubular member
- outer tubular
- tubular members
- longitudinal axis
- lumen
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/06—Measuring blood flow
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
Abstract
An apparatus for use in cannulation of blood vessels which includes an ultrasonic flow sensing assembly. The assembly includes inner and outer elongated electrically conducting tubular members which are separated by an electrical insulator. A
piezoelectric transducer capable of generating and receiving ultrasonic waves is located at the distal ends of the tubular members and is electrically connected to them. A power source is applied to the tubular members and to the piezoelectric transducer such that when a hollow needle containing the ultrasonic flow sensing assembly is advanced through tissue, emitted and detected ultrasonic waves can be employed to locate body vessels which can then be penetrated by the sharpened end of the hollow needle.
piezoelectric transducer capable of generating and receiving ultrasonic waves is located at the distal ends of the tubular members and is electrically connected to them. A power source is applied to the tubular members and to the piezoelectric transducer such that when a hollow needle containing the ultrasonic flow sensing assembly is advanced through tissue, emitted and detected ultrasonic waves can be employed to locate body vessels which can then be penetrated by the sharpened end of the hollow needle.
Description
~'~'TIJS FflR G.Tl<r~T~~I~ t9F lg~~D VESS~L~
Technical Field of the Invention The present invention relates generally to the cannulation of arteries and veins through the use of ultrasonic techniques.
8~~,~o_und of the Invention It is well established that the insertion of ~u~teerial and venous catheters for various purposes such as for angiogzaphy can be responsible for patient discomfort.
Locating and penetrating arteries and veins can be especially difficult when dealing with patients who are obese or present unusual anatomy.
Arterial and venous catheters are particularly useful for cardiac catheterization and other radiologic pr~edures such as cerebral angiograms.
The potential utility of Doppler ultrasound for accurately guiding the needle into a.
vessel has been recognized. Most applications utalize the transmission of ultrasonic waves through the needle and reception of ultrasonic echoes by a separate transducer located on the body of the patient separated from the syringe and needle. Such applications obviously have limited accuracy. For example, U.S. Patent N'o. 3,556,079 dir~ted to a "Method of Puncturing a M~ical Instrument Under Guidance of Ultrasound" discloses in one embodiment the placement of both the transmitting and receiving transducers in the neaile and syringe. Such an embodiment:, however, requires a special catheter construction and can give an erroneous signal when the needle engages the blood vessel before penetrating the vessel.
A major advance was made to this technology by virtue of U.S. Patent No. 4,887,606 directed to "Apparatus For Use in Cannulation of Blood Vessels." This patent teaches the use of a transducer insert positioned within a hollow needle including an ultrasonic transducer at one end for transmitting and receiving ultrasonic waves through the sharpened end of the needle. Upon location and penetration of a blood vessel, the transducer insert is removable from the needle for implementation of the known Seldinger technique for placing a catheter in a blood vessel.
:15 FIG.. 1 depict:, in cross section, a device which is the subject: of U.S. hatent No. 4,887,606. In referring to FIG. 1, needle 10 is shown as having sharpened end 11 and, located therein, ultrasonic flow sensing assembly 12.
The assembly 12 include:; a plastic support member 13 through which a first conductoz:~ 14 extends intc contact with an electrode 15 on the back surface of transducer 16.
Transducer 16 is affixed to support member 13 by means of a low impedance epoxy 17 which is :filled with glass microballoons (not shown). A second conductor 1F3 is formed 2,5 on the exterior surface of suppo=t rod 40 by means of metal deposition and extends into contact with electrode 15 on the front surface of transducer 16. The conductors 14 and 18 form a coaxial cable and the outer shield conductor 18 can be grounded during use.
2a An insulative material. 19 such as an epoxy is formed around the periphery of t:he transducer 16 to electrically isolate electrode 1.4 from conductor 18 which is in turn connected to electrode 15. Transducer 16 is positioned near the distal sharpened end 11 of needle 10 for the transmission and recepta.on c~f energy through the opening in the distal sharpened end of the needle.
Although the device disclosed in U.S. Patent No.
4,887,606 represents a superior apparatus for cannulation of ~~~~~12 blood vessels, such apparatus is difficult to manufacture and at times provides a device whose sensitivity is somewhat low and, ideally, could be improve upon.
The present invention provides an apparatus for the cannulation of blood vessels S which is not only easier to manufacture but is also of higher sensitivity than the device shown in IJ.S. Patent N~. 4,887,6t3~.
These and other advantages of the invention will biome more apparent when considering the following description of the invention and the accompanying exemplary drawings.
Summary ode Invention The present invention involves an ultrasonic flow sensing assembly for use in an apparatus to be ernployed in the cannulation of blood vessels. The apparatus comprises a hollow needle having a longitudinal axis and sharpened distal end for penetration of tissue and a proximal end having means for detachably connecting a syringe to the needle.
The ultrasonic flow sensing assembly comprises an elongated electrically conducting first tubular member which has a longitudinal axis, a distal end and lumen extending therein. An elongated electrically conducting second tubular member is provided which has a longitudinal axis and lumen preferable coincident with the longitudinal axis and lumen of the first tubular member. 'The second tubular member resides substantially within the first tubular member.
An electrically insulating means such as a polymer tube is bated between the first and second tubular members. A piezoelectric transducer capable of generating or receiving ultrasonic waves is located proximate the distal ends of the first and second tubular members and is electrically connected to these tubular members. Means are further provided for ~0 connecting an electrical power source to the tubular members electrically connected to the piezoelectric transducer for the generation and reception of ultrasonic waves.
_3_ 3a The invention may be summarized as an ultrasonic flow sensing assembly comprising: a. an elongated electrically conducting outer tubular member having a longitudinal. axis, a distal end and a lumen extending therein; b. an elongated electrically c~onducting~ inner tubular member disposed within the outer tubular member having a longitudinal axis and lumen coincident with the longitudinal axis and lumen of said outer tubular member; c.
electrical insulating means located between the inner and outer tubular members; d. a piezoelectric means capable of generating and receiving ultrasonic waves which is located proximate the distal ends of the inner and outer tubular members and being electrically connected to the tubular members, and wherein the piezoelectric means is attached to the distal end of the inner tubular member providing a closure for the lumen thereof; and e. means for connecting an electrical power source to the piezoelectric means far the generation and rece~otion of ultrasonic waves through the tubular members.
According to another aspect the invention may be summarized in an apparatus for cannulation of a blood vessel comprising a hollow needle a longitudinal axis, a sharpened distal end for penetration of tissue and a syringe portion detachably connected to the proximal end of. the needle, the improvement comprising an ultrasonic flow sensing assembly located within the hollow needle which includes: a. an elongated electrically conducting outer tubular rnember having a longitudinal axis, a distal end and an inner lumen extending therein; b. an elongated electrically conducting inner tubular member disposed within the outer tubular member having a longitudinal axis and an inner lumen coincident with the longitudinal axis and the inner lumen of the outer tubular member; c. electrical insulating means 3b located between the inner and outer tubular members; d. a piezoelectric means capable of generating and receiving ultrasonic waves which is located proximate the distal ends of the inner and outer tubular members and bei.na electrically connected to the tubular members; and e. means for connecting an electrical power source to the piezoelectric means for the generation and reception of the ultrasonic waves through the tubular members.
Brief De,~cri 'on f the Drs PIG. 1 represents a cross-sectional view of the prior are device depict~i in U.~.
Patent hTo. 4, 887, f~6.
PIG. 2 is a schematic ration of a needle being inserted into tissue. fw cannulation of a vessel.
FIG. 3 is a plot of Doppler signal intensity versus distance in tissue of a needle in FIG. 2.
FIG. 4 is a perspective view illustrating cannulation apparatus in accordance with the present invention.
FIG. 5 is a longitudinal cross-sectional view of an embodiment of the ultrasonic flow sensing assembly of the present invention.
FIG. 6 is a longitudinal cross-sectional view of an another embodiment of the ultrasonic flow sensing assembly of the present invention.
Detailed Due' txon of t~l ~ Invention With reference to FIG. 2, a schematic illustration of a syringe assembly is shown generally at 20 which includes needle 21 and a cant~~tirter portion or syringe 22 with ultrasonic transducer means 23 within necdie 21 as will be described herein below. i%lire conductozs 24 are el~trically connects with the transducer means 23 for the transnussion and reception of electrical signals. In the illustrated schematic, needle 21 is inser~i through tissue 25 toward blood vessel 26.
As noted in U.S. Patent Ielo. 4,887,606, the insertion of arterial and venous catheters can be a major source of discomfort. According to the teachings of U.S. Patent No. 4,887,606 as well as the present invention, the piezoelectric transducer containing assembly 23 is employs to more accurately dirt the ne~le 21 to vessel 26 and facilitate its penetration. As the needle 21 is passed through tissue 25, the sharpen~i distal tip of the needle is moved transversely, e.g. in a slight arc, for directing ultrasound energy transmitted through the n~dle to the vessel 26. The return or mho signal r~eived by the transducer 23 is use for accu_~ately guiding the ne~le 21 to the vessel 26 and provides an indication of when the needle penetrates vessel.
FIG. 3 is a plot of intensity of the Doppler signal versus depth within tissue 25.
When the needle 21 is first inserted into the tissue 25, the response is small and relatively flat as indicated. Urn directing the needle toward a vein, an increased generally uniform signal is detected. As the n~le is advanced toward the artery or vein, the intensity of the reflected wave increases and upon penetration of the vessel a stepped increase in the intensity of the reflected signal is indicated. Actual penetration of the vessel will be further indicated 1~ by the back flow of blood when the vessel is penetrated by maintaining a negative pressure in the ne~lle by pulling back the syringe plunger while the needle is being advanced. A plot of intensity of the Doppler or reflected signal verses depth within the tissue with respect to the advancement toward an artery and the penetration thereof is similar to FIG. 3 except for the undulations from the heart beat. Once the vessel is penetrated, a brisk back flow of blond in the n~clle indicates safe penetration of the vessel and can cause a stepped increase in neflect~ wave intensity thereby indicating a safe location for injection of medications or for the safe passage of an introducer shaft or a guidewire into the vessel.
FIG. 4 is a perspective view of apparatus for the cannulation of blood vessels in accordance with the present invention. The apparatus includes a needle portion 21, shown in sectioned view to illustrate the ultrasonic assembly 23 therein. The needle 21 and assembly 23 are connected to syringe 27 by means of connector 28. Electrical wires 30 and 31 are interconnected through the assembly with an ultrasonic transducer 23 at one end thereof.
Transducer 23 is positioned at a sharpened distal end 32 of ne~lle 21 for the transmission and reception of ultrasonic energy through the ogee end of the needle.
The present invention employs an ultrasonic flow sensing assembly 34 as shown in FI(i. 5 which includes an elongated electric conducting inner tubular member charactex5zed by having a longitudinal axis 36, a distal end 37 and an inner lumen 3g extending therein.
The ultrasonic flow sensing assembly 34 also includes an elongated electrically conductaaag outer tubular member 40 which has a distal end 41, an inner lumen 43, and a longitudinal saris 42 coincident with the longitudinal axis 36 of the inner tubular member.
Elongate electrically conductive outer tubular member 40 is separated from inner tubular member 35 by the thickness of insulating means 44 which is preferably an insulating tube formed of a polyimide. The inner tubular member 35 can be formed of stainless steel. The outer tubular member 40 of this emb~iiment is a layer of conducive material, such as gold, on the exterior of the insulating golyimide tube 44.
Piezoelectric transducer means 23 is capable of generating and receiving ultrasonic waves, and is located at the distal ends 37 and 43 of inner and outer tubular members 35 and 40, respectively, and is electrically connected to the tubular members as shown. As a preferred embodiment, piezoelectric means 23 can be connect~i to tubular member 35 by an electrical conducting silver epoxy 45.
The inner lumen 3g of the inner tubular member 35 is closed by the transducer which is'secured to the distal end thereof, The closexi inner lumen 3g forms a chambez°
behind the ~ansducer which is filled with air or other gas and which greatly enhances the sensitivity of the transducer 23.
Electrical conductors 30 and 31 are shown in FTG. 5 connected to inner and outer tubular members 35 and 40, respectively. Conductor 30 is joined to the inner conductive tubular member 35 by means of a solder joint 46, whereas conductor 31 is Connects to outer tube 40 via tungsten bands 47 and solder joint 4g. An electrical coating 49, i.e. gold, is provide on the exterior of the transducer 23 to electrically connect the outer tubular member 40 with the transducer.
The entire assembly 34 shown in FIG. 5 can be placed within needle 21 as shown schematir;ally in FIG. 4 for cannulation of blood vessels which can be utilized for the carrying out of a Seldinger t~hnique. After the needle 21 is inserted and guide to a blood vessel, as described in conjunction with the discussion of FIG. 3, the blood vessel ~netradon is indicated by the back flow of blood through the needle past assembly 34.
~nce this is accomplished, assembly 34 can be removed from the needle 21 and a guidewire can be placed through the needle into the blood vessel and the ne~le itself then removed.
1~inally, prothesis can be guided into position in the blood vessel over the guidewire~
Reference is made to FIG. 6 which illustrates another preferred embodiment of an ultrasonic flow sensing assembly 50 in accordance with the invention. The assembly 50 includes an outer, electrically conductive tubular member 51 having a distal end 52-and an inner lumen 53 extending within the outer tubular member, and an inner, electaically conductive tubular member 54 having a distal end 55 and an inner lumen 56 extending within the inner tubular member. A piezoelectric transducer 57 is adjacent proximate and el~trically connected to the distal ends 52 and 55 of the tubular members 51 and 54 resp~tively. An electrically insulating riabular member 5S is disposed between the outer and a inner tubular members 51 and 54. An electrically conductive coating or layer 59 is providers on the exterior of the piezoelectric transducer 57 which extends to and electrically contacts the distal end 52 of the outer tubular member 51. An electrically conductive adhesive 60 bonds and electrically connebts the distal end of the inner tubular member 54 to the backside of the piezoelectric transducer 57. Conductors 61 arid 62 are secured to the proximal ends of the inner and outer tubular members 51 and 54 respectively by suitable means such as solder 63 and 64. 1fie proximal end 65 of the outer conductive tubular member 51 is dispose a short distance from the distal end of tlhe inner conductive tubular member 54 to provide access to the inner tubular member in order to join the conductor 66 to the innez tubular member by means of solder 63.
The operation of the ultrasonic flow sensing assembly 50 of this embodiment is essentially the same as the operation of the previously described assembly as shown in FIGS.
2-5.
_7_ Typical dimensions of the components which form the assembly SO include an outer tubular member 51 with an OD of about 0.038 inch (0.965 mm) and an TAD
of about 0.034 inch (0.864 mm). The insulating tube 58 has an OD of about 0.034 inch (0.804 mm) an Ip of about 0.03 inch (0.76 mm). The inner conducting tubular member 54 has an OD of S about 0.03 inch (0.76 mm) and an ID of about 0.20 inch (0.S1 mm). The overall l~gth of assembly SO is about 3.75 inches (9.53 cm) The inner and outer el~trically condu tubular members 51 and 54 may be made of stainless steel and the iruier insulative tubular member 58 may be formed of polyimide. Other conducting and insulating materials may also be employed. The transverse crossssectional shape of the ultrasonic flow sensing assembly is circular to readily fit within the inner lumen of a needle and is dimensioned to leave a space between the outer surface of the assembly and the inner surface of the needle so that blood may r~dily flow there between. ''JVhen the needle penetrates a blood vessel, blood will flow through the annular area between the assembly and the ne~le when a vacuum is pulp by the syringe (not shown) which is releasably soured to the proximal end of the needle.
The ultrasonic transducer is preferably formed of a lead zirconium titanate ceramic material which is sold by the Vernitrun Company of Bedford, OH. It is sold by the designation 5H. Ceramic material SA is also suitable.
Various modifications and improvements may be made to the invention without departing from the scope thereof.
_8_
Technical Field of the Invention The present invention relates generally to the cannulation of arteries and veins through the use of ultrasonic techniques.
8~~,~o_und of the Invention It is well established that the insertion of ~u~teerial and venous catheters for various purposes such as for angiogzaphy can be responsible for patient discomfort.
Locating and penetrating arteries and veins can be especially difficult when dealing with patients who are obese or present unusual anatomy.
Arterial and venous catheters are particularly useful for cardiac catheterization and other radiologic pr~edures such as cerebral angiograms.
The potential utility of Doppler ultrasound for accurately guiding the needle into a.
vessel has been recognized. Most applications utalize the transmission of ultrasonic waves through the needle and reception of ultrasonic echoes by a separate transducer located on the body of the patient separated from the syringe and needle. Such applications obviously have limited accuracy. For example, U.S. Patent N'o. 3,556,079 dir~ted to a "Method of Puncturing a M~ical Instrument Under Guidance of Ultrasound" discloses in one embodiment the placement of both the transmitting and receiving transducers in the neaile and syringe. Such an embodiment:, however, requires a special catheter construction and can give an erroneous signal when the needle engages the blood vessel before penetrating the vessel.
A major advance was made to this technology by virtue of U.S. Patent No. 4,887,606 directed to "Apparatus For Use in Cannulation of Blood Vessels." This patent teaches the use of a transducer insert positioned within a hollow needle including an ultrasonic transducer at one end for transmitting and receiving ultrasonic waves through the sharpened end of the needle. Upon location and penetration of a blood vessel, the transducer insert is removable from the needle for implementation of the known Seldinger technique for placing a catheter in a blood vessel.
:15 FIG.. 1 depict:, in cross section, a device which is the subject: of U.S. hatent No. 4,887,606. In referring to FIG. 1, needle 10 is shown as having sharpened end 11 and, located therein, ultrasonic flow sensing assembly 12.
The assembly 12 include:; a plastic support member 13 through which a first conductoz:~ 14 extends intc contact with an electrode 15 on the back surface of transducer 16.
Transducer 16 is affixed to support member 13 by means of a low impedance epoxy 17 which is :filled with glass microballoons (not shown). A second conductor 1F3 is formed 2,5 on the exterior surface of suppo=t rod 40 by means of metal deposition and extends into contact with electrode 15 on the front surface of transducer 16. The conductors 14 and 18 form a coaxial cable and the outer shield conductor 18 can be grounded during use.
2a An insulative material. 19 such as an epoxy is formed around the periphery of t:he transducer 16 to electrically isolate electrode 1.4 from conductor 18 which is in turn connected to electrode 15. Transducer 16 is positioned near the distal sharpened end 11 of needle 10 for the transmission and recepta.on c~f energy through the opening in the distal sharpened end of the needle.
Although the device disclosed in U.S. Patent No.
4,887,606 represents a superior apparatus for cannulation of ~~~~~12 blood vessels, such apparatus is difficult to manufacture and at times provides a device whose sensitivity is somewhat low and, ideally, could be improve upon.
The present invention provides an apparatus for the cannulation of blood vessels S which is not only easier to manufacture but is also of higher sensitivity than the device shown in IJ.S. Patent N~. 4,887,6t3~.
These and other advantages of the invention will biome more apparent when considering the following description of the invention and the accompanying exemplary drawings.
Summary ode Invention The present invention involves an ultrasonic flow sensing assembly for use in an apparatus to be ernployed in the cannulation of blood vessels. The apparatus comprises a hollow needle having a longitudinal axis and sharpened distal end for penetration of tissue and a proximal end having means for detachably connecting a syringe to the needle.
The ultrasonic flow sensing assembly comprises an elongated electrically conducting first tubular member which has a longitudinal axis, a distal end and lumen extending therein. An elongated electrically conducting second tubular member is provided which has a longitudinal axis and lumen preferable coincident with the longitudinal axis and lumen of the first tubular member. 'The second tubular member resides substantially within the first tubular member.
An electrically insulating means such as a polymer tube is bated between the first and second tubular members. A piezoelectric transducer capable of generating or receiving ultrasonic waves is located proximate the distal ends of the first and second tubular members and is electrically connected to these tubular members. Means are further provided for ~0 connecting an electrical power source to the tubular members electrically connected to the piezoelectric transducer for the generation and reception of ultrasonic waves.
_3_ 3a The invention may be summarized as an ultrasonic flow sensing assembly comprising: a. an elongated electrically conducting outer tubular member having a longitudinal. axis, a distal end and a lumen extending therein; b. an elongated electrically c~onducting~ inner tubular member disposed within the outer tubular member having a longitudinal axis and lumen coincident with the longitudinal axis and lumen of said outer tubular member; c.
electrical insulating means located between the inner and outer tubular members; d. a piezoelectric means capable of generating and receiving ultrasonic waves which is located proximate the distal ends of the inner and outer tubular members and being electrically connected to the tubular members, and wherein the piezoelectric means is attached to the distal end of the inner tubular member providing a closure for the lumen thereof; and e. means for connecting an electrical power source to the piezoelectric means far the generation and rece~otion of ultrasonic waves through the tubular members.
According to another aspect the invention may be summarized in an apparatus for cannulation of a blood vessel comprising a hollow needle a longitudinal axis, a sharpened distal end for penetration of tissue and a syringe portion detachably connected to the proximal end of. the needle, the improvement comprising an ultrasonic flow sensing assembly located within the hollow needle which includes: a. an elongated electrically conducting outer tubular rnember having a longitudinal axis, a distal end and an inner lumen extending therein; b. an elongated electrically conducting inner tubular member disposed within the outer tubular member having a longitudinal axis and an inner lumen coincident with the longitudinal axis and the inner lumen of the outer tubular member; c. electrical insulating means 3b located between the inner and outer tubular members; d. a piezoelectric means capable of generating and receiving ultrasonic waves which is located proximate the distal ends of the inner and outer tubular members and bei.na electrically connected to the tubular members; and e. means for connecting an electrical power source to the piezoelectric means for the generation and reception of the ultrasonic waves through the tubular members.
Brief De,~cri 'on f the Drs PIG. 1 represents a cross-sectional view of the prior are device depict~i in U.~.
Patent hTo. 4, 887, f~6.
PIG. 2 is a schematic ration of a needle being inserted into tissue. fw cannulation of a vessel.
FIG. 3 is a plot of Doppler signal intensity versus distance in tissue of a needle in FIG. 2.
FIG. 4 is a perspective view illustrating cannulation apparatus in accordance with the present invention.
FIG. 5 is a longitudinal cross-sectional view of an embodiment of the ultrasonic flow sensing assembly of the present invention.
FIG. 6 is a longitudinal cross-sectional view of an another embodiment of the ultrasonic flow sensing assembly of the present invention.
Detailed Due' txon of t~l ~ Invention With reference to FIG. 2, a schematic illustration of a syringe assembly is shown generally at 20 which includes needle 21 and a cant~~tirter portion or syringe 22 with ultrasonic transducer means 23 within necdie 21 as will be described herein below. i%lire conductozs 24 are el~trically connects with the transducer means 23 for the transnussion and reception of electrical signals. In the illustrated schematic, needle 21 is inser~i through tissue 25 toward blood vessel 26.
As noted in U.S. Patent Ielo. 4,887,606, the insertion of arterial and venous catheters can be a major source of discomfort. According to the teachings of U.S. Patent No. 4,887,606 as well as the present invention, the piezoelectric transducer containing assembly 23 is employs to more accurately dirt the ne~le 21 to vessel 26 and facilitate its penetration. As the needle 21 is passed through tissue 25, the sharpen~i distal tip of the needle is moved transversely, e.g. in a slight arc, for directing ultrasound energy transmitted through the n~dle to the vessel 26. The return or mho signal r~eived by the transducer 23 is use for accu_~ately guiding the ne~le 21 to the vessel 26 and provides an indication of when the needle penetrates vessel.
FIG. 3 is a plot of intensity of the Doppler signal versus depth within tissue 25.
When the needle 21 is first inserted into the tissue 25, the response is small and relatively flat as indicated. Urn directing the needle toward a vein, an increased generally uniform signal is detected. As the n~le is advanced toward the artery or vein, the intensity of the reflected wave increases and upon penetration of the vessel a stepped increase in the intensity of the reflected signal is indicated. Actual penetration of the vessel will be further indicated 1~ by the back flow of blood when the vessel is penetrated by maintaining a negative pressure in the ne~lle by pulling back the syringe plunger while the needle is being advanced. A plot of intensity of the Doppler or reflected signal verses depth within the tissue with respect to the advancement toward an artery and the penetration thereof is similar to FIG. 3 except for the undulations from the heart beat. Once the vessel is penetrated, a brisk back flow of blond in the n~clle indicates safe penetration of the vessel and can cause a stepped increase in neflect~ wave intensity thereby indicating a safe location for injection of medications or for the safe passage of an introducer shaft or a guidewire into the vessel.
FIG. 4 is a perspective view of apparatus for the cannulation of blood vessels in accordance with the present invention. The apparatus includes a needle portion 21, shown in sectioned view to illustrate the ultrasonic assembly 23 therein. The needle 21 and assembly 23 are connected to syringe 27 by means of connector 28. Electrical wires 30 and 31 are interconnected through the assembly with an ultrasonic transducer 23 at one end thereof.
Transducer 23 is positioned at a sharpened distal end 32 of ne~lle 21 for the transmission and reception of ultrasonic energy through the ogee end of the needle.
The present invention employs an ultrasonic flow sensing assembly 34 as shown in FI(i. 5 which includes an elongated electric conducting inner tubular member charactex5zed by having a longitudinal axis 36, a distal end 37 and an inner lumen 3g extending therein.
The ultrasonic flow sensing assembly 34 also includes an elongated electrically conductaaag outer tubular member 40 which has a distal end 41, an inner lumen 43, and a longitudinal saris 42 coincident with the longitudinal axis 36 of the inner tubular member.
Elongate electrically conductive outer tubular member 40 is separated from inner tubular member 35 by the thickness of insulating means 44 which is preferably an insulating tube formed of a polyimide. The inner tubular member 35 can be formed of stainless steel. The outer tubular member 40 of this emb~iiment is a layer of conducive material, such as gold, on the exterior of the insulating golyimide tube 44.
Piezoelectric transducer means 23 is capable of generating and receiving ultrasonic waves, and is located at the distal ends 37 and 43 of inner and outer tubular members 35 and 40, respectively, and is electrically connected to the tubular members as shown. As a preferred embodiment, piezoelectric means 23 can be connect~i to tubular member 35 by an electrical conducting silver epoxy 45.
The inner lumen 3g of the inner tubular member 35 is closed by the transducer which is'secured to the distal end thereof, The closexi inner lumen 3g forms a chambez°
behind the ~ansducer which is filled with air or other gas and which greatly enhances the sensitivity of the transducer 23.
Electrical conductors 30 and 31 are shown in FTG. 5 connected to inner and outer tubular members 35 and 40, respectively. Conductor 30 is joined to the inner conductive tubular member 35 by means of a solder joint 46, whereas conductor 31 is Connects to outer tube 40 via tungsten bands 47 and solder joint 4g. An electrical coating 49, i.e. gold, is provide on the exterior of the transducer 23 to electrically connect the outer tubular member 40 with the transducer.
The entire assembly 34 shown in FIG. 5 can be placed within needle 21 as shown schematir;ally in FIG. 4 for cannulation of blood vessels which can be utilized for the carrying out of a Seldinger t~hnique. After the needle 21 is inserted and guide to a blood vessel, as described in conjunction with the discussion of FIG. 3, the blood vessel ~netradon is indicated by the back flow of blood through the needle past assembly 34.
~nce this is accomplished, assembly 34 can be removed from the needle 21 and a guidewire can be placed through the needle into the blood vessel and the ne~le itself then removed.
1~inally, prothesis can be guided into position in the blood vessel over the guidewire~
Reference is made to FIG. 6 which illustrates another preferred embodiment of an ultrasonic flow sensing assembly 50 in accordance with the invention. The assembly 50 includes an outer, electrically conductive tubular member 51 having a distal end 52-and an inner lumen 53 extending within the outer tubular member, and an inner, electaically conductive tubular member 54 having a distal end 55 and an inner lumen 56 extending within the inner tubular member. A piezoelectric transducer 57 is adjacent proximate and el~trically connected to the distal ends 52 and 55 of the tubular members 51 and 54 resp~tively. An electrically insulating riabular member 5S is disposed between the outer and a inner tubular members 51 and 54. An electrically conductive coating or layer 59 is providers on the exterior of the piezoelectric transducer 57 which extends to and electrically contacts the distal end 52 of the outer tubular member 51. An electrically conductive adhesive 60 bonds and electrically connebts the distal end of the inner tubular member 54 to the backside of the piezoelectric transducer 57. Conductors 61 arid 62 are secured to the proximal ends of the inner and outer tubular members 51 and 54 respectively by suitable means such as solder 63 and 64. 1fie proximal end 65 of the outer conductive tubular member 51 is dispose a short distance from the distal end of tlhe inner conductive tubular member 54 to provide access to the inner tubular member in order to join the conductor 66 to the innez tubular member by means of solder 63.
The operation of the ultrasonic flow sensing assembly 50 of this embodiment is essentially the same as the operation of the previously described assembly as shown in FIGS.
2-5.
_7_ Typical dimensions of the components which form the assembly SO include an outer tubular member 51 with an OD of about 0.038 inch (0.965 mm) and an TAD
of about 0.034 inch (0.864 mm). The insulating tube 58 has an OD of about 0.034 inch (0.804 mm) an Ip of about 0.03 inch (0.76 mm). The inner conducting tubular member 54 has an OD of S about 0.03 inch (0.76 mm) and an ID of about 0.20 inch (0.S1 mm). The overall l~gth of assembly SO is about 3.75 inches (9.53 cm) The inner and outer el~trically condu tubular members 51 and 54 may be made of stainless steel and the iruier insulative tubular member 58 may be formed of polyimide. Other conducting and insulating materials may also be employed. The transverse crossssectional shape of the ultrasonic flow sensing assembly is circular to readily fit within the inner lumen of a needle and is dimensioned to leave a space between the outer surface of the assembly and the inner surface of the needle so that blood may r~dily flow there between. ''JVhen the needle penetrates a blood vessel, blood will flow through the annular area between the assembly and the ne~le when a vacuum is pulp by the syringe (not shown) which is releasably soured to the proximal end of the needle.
The ultrasonic transducer is preferably formed of a lead zirconium titanate ceramic material which is sold by the Vernitrun Company of Bedford, OH. It is sold by the designation 5H. Ceramic material SA is also suitable.
Various modifications and improvements may be made to the invention without departing from the scope thereof.
_8_
Claims (10)
1. An ultrasonic flow sensing assembly comprising:
a. an elongated electrically conducting outer tubular member having a longitudinal axis, a distal end and a lumen extending therein;
b. an elongated electrically conducting inner tubular member disposed within the outer tubular member having a longitudinal axis and lumen coincident with the longitudinal axis and lumen of said outer tubular member;
c. electrical insulating means located between the inner and outer tubular members;
d. a piezoelectric means capable of generating and receiving ultrasonic waves which is located proximate the distal ends of the inner and outer tubular members and being electrically connected to the tubular members, and wherein the piezoelectric means is attached to the distal end of the inner tubular member providing a closure for the lumen thereof; and e. means for connecting an electrical power source to the piezoelectric means for the generation and reception of ultrasonic waves through the tubular members.
a. an elongated electrically conducting outer tubular member having a longitudinal axis, a distal end and a lumen extending therein;
b. an elongated electrically conducting inner tubular member disposed within the outer tubular member having a longitudinal axis and lumen coincident with the longitudinal axis and lumen of said outer tubular member;
c. electrical insulating means located between the inner and outer tubular members;
d. a piezoelectric means capable of generating and receiving ultrasonic waves which is located proximate the distal ends of the inner and outer tubular members and being electrically connected to the tubular members, and wherein the piezoelectric means is attached to the distal end of the inner tubular member providing a closure for the lumen thereof; and e. means for connecting an electrical power source to the piezoelectric means for the generation and reception of ultrasonic waves through the tubular members.
2. The ultrasonic flow sensing assembly of claim 1 wherein the electrical insulating means is a polymer tube.
3. The ultrasonic flow sensing assembly of claim 2 wherein the polymer tube is formed of a polyimide.
4. The ultrasonic flow sensing assembly of claim 1 wherein at least one of the inner or outer tubular members is connected to the piezoelectric means by means of an electrically conductive coating applied to the piezoelectric means.
5. In an apparatus for cannulation of a blood vessel comprising a hollow needle a longitudinal axis, a sharpened distal end for penetration of tissue and a syringe portion detachably connected to the proximal end of the needle, the improvement comprising an ultrasonic flow sensing assembly located within the hollow needle which includes:
a. an elongated electrically conducting outer tubular member having a longitudinal axis, a distal end and an inner lumen extending therein;
b. an elongated electrically conducting inner tubular member disposed within the outer tubular member having a longitudinal axis and an inner lumen coincident with the longitudinal axis and the inner lumen of the outer tubular member;
c. electrical insulating means located between the inner and outer tubular members;
d. a piezoelectric means capable of generating and receiving ultrasonic waves which is located proximate the distal ends of the inner and outer tubular members and being electrically connected to the tubular members; and e. means for connecting an electrical power source to the piezoelectric means for the generation and reception of the ultrasonic waves through the tubular members.
a. an elongated electrically conducting outer tubular member having a longitudinal axis, a distal end and an inner lumen extending therein;
b. an elongated electrically conducting inner tubular member disposed within the outer tubular member having a longitudinal axis and an inner lumen coincident with the longitudinal axis and the inner lumen of the outer tubular member;
c. electrical insulating means located between the inner and outer tubular members;
d. a piezoelectric means capable of generating and receiving ultrasonic waves which is located proximate the distal ends of the inner and outer tubular members and being electrically connected to the tubular members; and e. means for connecting an electrical power source to the piezoelectric means for the generation and reception of the ultrasonic waves through the tubular members.
6. The apparatus of claim 5 wherein the inner tubular member is spaced from the hollow needle to facilitate back flow of blood when a blood vessel is penetrated.
7. The apparatus of claim 5 wherein the piezoelectric means is securely attached to the distal ends of the inner and outer tubular members providing a closure of the inner lumens thereof.
8. The apparatus of claim 5 wherein the electrical insulating means comprises a polymer tube.
9. The apparatus of claim 8 wherein the polymer tube is formed of a polyimide.
10. The apparatus of claim 5 wherein at least one of the inner or outer tubular members is connected to the piezoelectric means by means of an electrically conductive coating applied to the piezoelectric means.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US813,123 | 1991-12-23 | ||
| US07/813,123 US5259385A (en) | 1991-12-23 | 1991-12-23 | Apparatus for the cannulation of blood vessels |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2085912A1 CA2085912A1 (en) | 1993-06-24 |
| CA2085912C true CA2085912C (en) | 2004-02-24 |
Family
ID=25211509
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002085912A Expired - Fee Related CA2085912C (en) | 1991-12-23 | 1992-12-21 | Apparatus for the cannulation of blood vessels |
Country Status (5)
| Country | Link |
|---|---|
| US (1) | US5259385A (en) |
| EP (1) | EP0548872B1 (en) |
| JP (1) | JP3732527B2 (en) |
| CA (1) | CA2085912C (en) |
| DE (1) | DE69220560T2 (en) |
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-
1991
- 1991-12-23 US US07/813,123 patent/US5259385A/en not_active Expired - Lifetime
-
1992
- 1992-12-21 CA CA002085912A patent/CA2085912C/en not_active Expired - Fee Related
- 1992-12-21 DE DE69220560T patent/DE69220560T2/en not_active Expired - Lifetime
- 1992-12-21 EP EP92121687A patent/EP0548872B1/en not_active Expired - Lifetime
- 1992-12-22 JP JP34259492A patent/JP3732527B2/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| CA2085912A1 (en) | 1993-06-24 |
| EP0548872A1 (en) | 1993-06-30 |
| DE69220560T2 (en) | 1997-12-18 |
| JP3732527B2 (en) | 2006-01-05 |
| US5259385A (en) | 1993-11-09 |
| EP0548872B1 (en) | 1997-06-25 |
| DE69220560D1 (en) | 1997-07-31 |
| JPH07184998A (en) | 1995-07-25 |
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