The accompanying drawings, which are hereby incorporated into and constitute a part of this specification, illustrate various embodiments of the invention and, together with the description, serve to explain the principles of the invention. In the drawings wherein like reference numerals represent like parts:
a) and 7(b) are enlarged distal end and fragmentary top views, respectively, of the fiber optic assembly illustrated in
Referring now to
Assembly 11 may include an injection needle 13, a light source 15, a spectrometer 17, a computer 19 and an indicator 21.
Injection needle 13 may comprise a hollow outer needle 31. Outer needle 31 may include an elongated, unitary, tubular member of uniform diameter, made of stainless steel or the like, outer needle 13 may be shaped to include a blunt proximal end 33, a beveled distal end 35 and a longitudinal bore 37. Outer needle 31 may be dimensioned to be, for example, a 22 gauge extra thin walled hypodermic needle having a bevel of 18 degrees.
Injection needle 13 may also comprise a hollow inner needle 41. Inner needle 41 may be positioned within bore 37 of outer needle 31. Inner needle 41 may be an elongated, unitary, tubular member of uniform diameter, made of stainless steel or the like. Inner needle 41 may be shaped to include a blunt proximal end 43, a beveled distal end 45 and a longitudinal bore 47. Inner needle 41 may be dimensioned to be, for example, a 25 gauge extra thin walled hypodermic needle having a bevel of 18 degrees. Inner needle 41 may be dimensioned so that blunt proximal end 43 and beveled distal end 45 lie flush with blunt proximal end 33 and beveled distal end 35, respectively, of needle 31. As will be discussed further below, longitudinal bore 47 of inner needle 41 may be used to convey fluids, such as a solution of implant material where injection needle 13 is used to inject such a solution into the LES muscle of a GERD patient. (Alternatively, injection needle 13 may be used to inject therapeutic and diagnostic agents.)
Injection needle 13 may further comprise a pair of optical fibers 49-1 and 49-2, the distal ends (not shown) of optical fibers 49-1 and 49-2 may be inserted into longitudinal bore 37 of needle 31. In the present embodiment, fibers 49-1 and 49-2 may be identical to one another and may be 0.22 NA, step index multimode fibers optimized for the VIS-NIR range, each of fibers 49-1 and 49-2 may include a silica-based core 50 of 100 micron diameter, a silica-based cladding 51 of 110 micron diameter, and a polyimide buffer 52 of 125 micron diameter. The distal ends (not shown) of fibers 49-1 and 49-2 may be beveled and lie flush with distal end 35 of needle 31. The proximal ends 53-1 and 53-2 of fibers 49-1 and 49-2, respectively, may extend proximally beyond proximal end 33 of needle 31 and may be coupled to connectors 55-1 and 55-2, respectively. Examples of connectors suitable for use as connectors 55-1 and 55-2 include SMA 905 connectors.
Injection needle 13 may further comprise a spacer 56, spacer 56 being positioned within bore 37 of outer needle 31. Spacer 56, which may be made of a suitable medical grade plastic or the like, may include an elongated, unitary, solid member that is appropriately dimensioned to keep fibers 49-1 and 49-2 spaced apart at a desired distance. Spacer 56 has a distal end 57 and a proximal end 58. Preferably, distal end 57 is beveled and lies flush with beveled distal end 35 of needle 31. In the present embodiment, proximal end 58 is blunt and lies flush with blunt proximal end 33 of needle 31; however, it should be understood that proximal end 58, if flexible, could extend proximally beyond blunt proximal end 33 of needle 31.
Injection needle 13 may further comprise a bonding material 59, which may comprise an optical bonding material, such as an optical epoxy or like material. Optical bonding material 59 is provided to fill the remaining spaces within bore 37 of outer needle 31 and to bond together the various components positioned within bore 37. The distal end 60 of optical bonding material 59 is shaped to lie flush with beveled distal end 35 of needle 31.
Injection needle 13 further comprises an inner catheter 61. In the present embodiment, inner catheter 61 may include an elongated, unitary, flexible member, for example, made of a suitable medical grade plastic, inner catheter 61 being shaped to include a proximal end 63, a distal end 65 and a longitudinal bore 67. Proximal end 33 of needle 31 may be disposed within bore 67 of inner catheter 61 and may be securely retained therewithin by a tubular band 69 crimped around the outside of catheter 61 against needle 31, with distal end 35 of needle 31 extending distally a short distance from distal end 65 of catheter 61.
Injection needle 13 may further comprise an outer catheter 71. In the present embodiment, outer catheter 71 may include an elongated, unitary, flexible member, for example, made of a suitable medical grade plastic, outer catheter 71 may be shaped to include a proximal end 73, a distal end 75 and a longitudinal bore 77. Outer catheter 71 may be appropriately dimensioned to receive inner catheter 61 coaxially within bore 77, with inner catheter 61 and outer catheter 71 may be slidable relative to one another. In this manner, as will be discussed further below, outer needle 31, as well as the various components housed therewithin, may be alternately extended distally from outer catheter 71, as when making an injection, and retracted into outer catheter 71, as when not making an injection.
Injection needle 13 may further comprise an outer hub 81. In one embodiment, outer hub 81 comprises an elongated, unitary, tubular, rigid member, for example, made of a suitable medical grade plastic, outer hub 81 may be shaped to include a distal stem portion 83, an intermediate shoulder portion 85, and a proximal collar portion 87. Stem portion 83 may have has an outer profile that is generally cylindrical and further may comprise a pair of opposing flattened surfaces 89-1 and 89-2 that extend longitudinally. Shoulder portion 85 may have an outer profile that is generally conical, tapering outwardly from stem portion 83 to collar portion 87. Collar portion 87, which may be generally cylindrical in outer profile, may be shaped to include embossed indicia 91-1 and 91-2, the purpose of which will be discussed further below. A longitudinal bore may be provided in outer hub 81, said longitudinal bore comprising a first portion 93, a second portion 94, a third portion 95, a fourth portion 96, and a fifth portion 97. First portion 93 may extend proximally from distal end 99 of hub 81 to second portion 94. Second portion 94, which may be smaller in diameter than first portion 93, may comprise an internal flange 101 provided in stem portion 83. Flange 101 may be appropriately dimensioned so that proximal end 73 of catheter 71, which is freely received in first portion 93, may be securely retained within outer hub 81. Outer hub 81 may be insert-molded around proximal end 73 of outer catheter 71, with internal flange 101 being sized to frictionally engage catheter 71 in a highly retentive manner. Third portion 95, which may extend between second portion 94 and fourth portion 96, may be greater in diameter than each of first portion 93 and second portion 94. Fourth portion 96, which may be located within shoulder portion 85 and which may extend between third portion 95 and fifth portion 97, may be greater in diameter than each of third portion 95 and fifth portion 97. A washer 103 may be fixedly mounted within fourth portion 97, washer 103 having a generally oval aperture 104, the purpose of which will be described below. If desired, outer hub 81 may be insert-molded around washer 103. Fifth portion 97, which may be smaller in diameter than fourth portion 96 but may be greater in diameter than third portion 95, may extend proximally from fourth portion 96 to proximal end 105 of hub 81.
Injection needle 13 may further comprise an inner hub 111. In the present embodiment, inner hub 111 may include an elongated, unitary, tubular, rigid member, for example, made of a suitable medical grade plastic, inner hub 111 being shaped to include a distal stem portion 113, an intermediate neck portion 115 and a proximal body portion 117. Stem portion 113, which may be generally cylindrical in outer profile, except for a pair of opposing flattened surfaces 118 that may extend longitudinally, may be shaped to include a slotted distal section 119 and a tubular proximal section 120. Distal section 119 may have a bifurcated barb 121 at its distal end. Proximal end 63 of inner catheter 61 may be fixedly mounted within slotted distal section 119 of stem portion 113 by a friction fit. (If desired, slotted distal section 119 may be provided with serrations to help grip inner catheter 61.) Tubular proximal section 120 may be shaped to include a longitudinal bore 122 and a pair of proximal notches 124-1 and 124-2 along its outer surface. Stem portion 113 may be partially inserted into outer hub 81, with barb 121 being appropriately sized relative to aperture 104 of washer 103 so that barb 121 may be inserted through aperture 104 during assembly of injection needle 13 but, thereafter, cannot easily be withdrawn proximally through aperture 104. In addition, tubular proximal section 120 may be dimensioned relative to aperture 104 of washer 103 so that, when stem portion 113 and aperture 104 are properly aligned rotationally, proximal section 120 may be moved back and forth through aperture 104 and so that, when stem portion 113 is fully inserted into outer hub 81 (with notches 124-1 and 124-2 disposed within aperture 104), stem portion 113 may be rotated 90 degrees relative to aperture 104, thereby preventing proximal section 120 from being moved translationally relative to outer hub 81.
Neck portion 115, which may be generally cylindrical in outer profile, may be shaped to include a longitudinal bore 127, bore 127 being aligned with bore 122 of proximal section 120. Neck portion 115 may be appropriately dimensioned to serve as a stop to limit insertion of inner hub 111 into outer hub 81.
Proximal body portion 117, which may be generally rectangular in outer profile, may be shaped to include an unbranched distal portion, i.e., a first arm 131, and a branched proximal portion, i.e., second and third arms 133 and 135, respectively. First arm 131 may be shaped to include a bore 137, bore 137 being aligned with bore 127 of neck portion 115. Embossed indicia 139-1 and 139-2 may be provided on opposing surfaces of first arm 131, indicia 139-1 and 139-2 being provided to be alignable with indicia 91-1 and 91-2, respectively, to indicate the rotational alignment of inner hub 111 to outer hub 81, such as when one wishes to prevent longitudinal movement of inner hub 111 relative to outer hub 81. Second arm 133, which is substantially coaxial with first arm 131, may be shaped to include a bore 141, bore 141 being aligned with bore 137 of first arm 131. The proximal end of second arm 133 may be shaped to include an externally threaded connector 143 adapted for use with a needle-less syringe or the like. Third arm 135, which may lie off-axis with first arm 131, may be shaped to include a bore 145, bore 145 communicating with bore 137. A flexible strain relief 150 is coaxially mounted over the free end of third arm 135.
Injection needle 13 may further comprise a sheath 151. Sheath 151 may be an elongated, unitary, flexible, tubular member, for example, a length of furcation tubing. Sheath 151 may be shaped to include a proximal end 153 and a distal end 155, proximal end 153 being bifurcated into arms 154-1 and 154-2 to hold the proximal ends of optical fibers 49-1 and 49-2, respectively. Distal end 155 of sheath 151 may be fixedly mounted within strain relief 150.
Light source 15, which may be a conventional, variable-wavelength light source (e.g., tunable laser, lamp with filters, etc.) of the type used to illuminate objects with one or more of ultraviolet, visible and infrared light for purposes of performing optical spectroscopy, may be coupled to connector 55-2 to provide light to optical fiber 49-2.
Spectrometer 17, which may be a conventional spectrometer, may be coupled to connector 55-1 to detect the light from optical fiber 49-1. Spectrometer 17 may also be electrically coupled to computer 19, which, in one embodiment, compares the detected spectrum to standards from objects whose composition is known (e.g., fat tissue, muscle tissue, blood, etc.). The results of the comparison from computer 19 may then be transmitted to indicator 21. Indicator 21 may take the form of a computer monitor, a printer, one or more light signals (e.g., a green light turned on for targeted objects, a red light turned on for other objects), one or more audio signals (e.g., a bell rung for targeted objects, a buzzer actuated for other objects), or the like.
To use assembly 11, for example, to inject implant material into the lower esophageal sphincter of a patient, one may first insert the distal end of an endoscope through the mouth of the patient and then into the esophagus of the patient in the vicinity of the lower esophageal sphincter. Placement of the distal end of the endoscope in the vicinity of the lower esophageal sphincter may be aided by real-time observation equipment loaded into a viewing channel of the endoscope. Then, one may attach a solution-containing syringe to connector 143 of injection needle 13 and may load the distal end of injection needle 13 into the working channel of the endoscope, with needle 31 being placed in a retracted position within outer catheter 71. Next, one may extend needle 31 distally from outer catheter 71 by sliding inner hub 111 into outer hub 81 until neck portion 115 of inner hub 111 abuts washer 103. One then may rotate inner hub 111 relative to outer hub 81 by 90 degrees (i.e., so that indicia 91-1 and 91-2 are aligned with indicia 139-1 and 139-2, respectively) to keep inner hub 111 and outer hub 81 from sliding relative to one another. With needle 31 thus extended distally from outer catheter 71, one may begin to insert needle 31 into a targeted area of the patient. (Visual identification of the targeted area is preferably aided by the real-time observation equipment of the endoscope.) As needle 31 is inserted into the targeted area, light from light source 15 may be transmitted to the penetrated depth of the targeted area using optical fiber 49-2. The light reflected from the illuminated area may then be collected by optical fiber 49-1, may be detected by spectrometer 17, and may be analyzed by computer 19. The results of the comparison may then be transmitted to indicator 21, which may provide an indication (e.g., visual, aural, etc.) as to whether needle 31 has been inserted into the area to an appropriate depth (e.g., to the depth at which muscle tissue is located). As can be appreciated, the aforementioned spectroscopic testing of the illuminated area may be conducted continuously so that, as one inserts needle 31 into the area to changing depths, one may obtain virtually instantaneous feedback as to whether needle 31 is positioned at the appropriate depth for the desired tissue type within the targeted area. Once an indication has been made that needle 31 has been inserted into the desired tissue type, one may dispense the solution from the syringe into the tissue using injection needle 13, the solution being conducted successively through bores 141, 137, 127, 122, 67 and 47, respectively. After the injection is complete, one may retract needle 31 into catheter 71 by rotating inner hub 111 relative to outer hub 81 by another 90 degrees (i.e., so that indicia 91-1 and 91-2 are 90 degrees out of alignment with indicia 139-1 and 139-2) and by sliding inner hub 111 proximally away from outer hub 81 until barb 121 of distal portion 113 abuts washer 103. One then may remove injection needle 13 and the endoscope from the patient.
Referring now to
Assembly 201 is similar in many respects to the needle assembly of injection needle 13, assembly 201 including (i) an outer needle 203 that is similar to outer needle 31, (ii) an inner needle 205 that is similar to inner needle 41, and (iii) an optical bonding material 207 that is similar to optical bonding material 59. However, assembly 201 differs from the needle assembly of injection needle 13 in that, instead of including spacer 56 and optical fibers 49-1 and 49-2, assembly may include fiber optic assembly 211. Assembly 211, which is shown separately in
In another embodiment (not shown), the light source and/or the light detector may be positioned at or near the distal end of the injection needle. For example, an LED or other light source may be positioned at or near the distal end of the hollow needle, and a light sensor may be located on the outside of the hollow needle or integrated into the wall of the hollow needle. Alternatively, the needle itself could be an optical light guide, either to deliver light or to receive light.
It should be noted that, although the endoscopic injection needle assembly of the present invention has been described above as being used to inject implant material into LES tissue, this assembly is not limited to injecting implant materials nor is it limited to injecting materials into LES tissue. For example, it may include use as a needle to inject therapeutic and/or diagnostic agents and implants.
The embodiments of the present invention described above are intended to be merely exemplary and those skilled in the art shall be able to make numerous variations and modifications to it without departing from the spirit of the present invention. For example, it should be understood that, instead of using one optical fiber to illuminate an object and another optical fiber to collect the light reflected from the object, one could use an arrangement that includes a single optical fiber for both illumination and collection. All such variations and modifications are intended to be within the scope of the present invention as defined in the appended claims.
The present application claims the benefit under 35 U.S.C. 119(e) of U.S. Provisional Patent Application Ser. No. 60/819,586, filed Jul. 10, 2006, the disclosure of which is incorporated herein by reference.
Number | Date | Country | |
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60819586 | Jul 2006 | US |