Title of Invention

AN INTRODUCER NEEDLE FOR PENETRATING A MEMBRANE AND AN INFUSION SET THEREOF

Abstract

ABSTRACT An introducer needle for an infusion set or the like includes a solid tip portion wilh a plurality of intersecting wedge surface that converge a common insertion point. Preferably, the common insertion point is coincident with a central axis of the introducer needle. The tip portion also includes a plurality of cutting edges formed at intersections of the wedge surfaces, fhe cutting edges coverage toward the common insertion point so that insertion of the needle into the membrane causes even cutting and separation of the membrane around the introducer needle. figure 2.

Full Text

This invention relates to medical devices, and more particularly to an introducer needle arranged to (acilitate membrane penetration and installation of a cannula or catheter within the membrane. The delivery of medication or other lluids is often accomplished through a cannula or catlieter that is typically placed either suhcutaneously or intravenously. I'or subcutaneous delivery of lluids, the use of an infusion set or injection port reduces the need to constantly puncture the skin and provides a method ol" temporarily detaching the lluid line for activities such as dressing or bathing. Infusion sets typically include a cannula and an introducer needle that extends through the cannula. A self-adhesive pad is often used to secure the cannula against movement once installed. A manual inserter is ol'len used to install the fusion set. The manual ijiscrlcr typically includes a housing and a spring-loaded sliding mechanism located in the housing to which the infusion set is temporarily connected. In use, the user typically grasps the inserter housing with one hand while pinching a Ibid of skin between the thumb and forefinger of the other hand. I he sliding mechanism is then released to force the introducer needle and the outer end of the cannula into the fold of skin. T'he introducer needle is then removed, leaving the cannula installed in the subcutaneous layer. The cannula can then be secured against movement. A tubing li'om a Huid supply source, such as an insulin pump, can be connected to the cannula housing to deliver insulin or other substances to the subcutaneous layer through the cannula. The introducer needle is typically constructed of a hollow, metallic tube with one end ground at an angle to form a cutting tip that is offset from a central a.xis of the tube. Insertion of the introducer needle into the skin typically requires a relatively high insertion (brce, due at least in part to the offset nature of the cutting tip. 'fhe combination of relatively high insertion force and the offset nature of the tip niay create a bending is av moment about the introducer needle during insertion. When the bending moment relieved, such as when the introducer needle pierces the skin, the surrounding tissue ma) be damaged and discomfort may be increased as the introducer needle attempts to spring back to its original shape. In addition, burr formation is often prevalent during manufacture of the angle ground hollow introducer needle. The removal of such burrs can be time consuming and diflicull. kurlhermorc, during assembly of an infusion set, the offset cutting lip of the introducer needle ean contact and damage the inner side wall of the cannula, fhus, great care is needed to ensure thai the introducer needle and cannula are properly aligned during insertion of the introducer needle through the cannula. 'Ilie some of the documents listed below appears to be close prior art to the instant invention, further, each of the prior art is explained in brief along with the limitations, and disadvantages, (i) IJS5057082, (ii) FJ'0378095, (iii) IJS3742958, (iv) IJS3994287, and (v) IJS4513747 The document (i) U.S. Patent Application IJS5()57082 relates to surgical instruments and, more particularly, to a trocar assembly which may also be useful for endoscopic procedures. This reference discloses a trocar assembly including a trocar tube or cannula having the ■"eonvenlionar" operating head and a trocar actuator or mandrel releasably supported 1 sue e one within the tube. The head may be of conventional fabrication including a valve for the ntroduction of lluid or gaseous material into the cavity being pierced, or other devices h as viewing eye pieces in the event the trocar assembly is to be utilized as an ndoscopic diagnostic insti'ument. 'fhe trocar actuator or mandrel is preferably a unitary, piece structure made of polymeric material, either thermoplastic or thermoset and from a process which results in the final manufacture as a single article of manul'acture. I'xamples of suitable polymeric materials include, without limitation, nylons, polyacetals. and polycarbonates. The piercing and cutting end preferably has a diameter slightly larger than that for the shank 18 and provides clearance space within the cannula. 1'hc document (ii) l-uropean Patent Application EP0378095 relates to the instrument set for puncturing a body cavity, in particular for suprapubic bladder drainage. The citation discloses the preferred embodiment which consists of a longitudinall) separable sleeve in which a retractable, cylindrical trocar fits whose end piece projects beyond the distal edge of the sleeve and is provided with a triangularly cut, closed lip. According to the invention, the distal edge of the sleeve is bevelled in downwards towards the cylindrical circumference of the trocar and the cut tip is formed at the distal end of a conical dilation zone of the end piece. The trocar is hollow. Behind the dilation /one and in front of the distal edge of the sleeve, it has a side hole opening into the longitudinal channel of the trocar, and it is provided at the proximal end with an outlet. Such an instrument set is charaeleri/ed by low puncture forces and by a reduced risk of injury to the vessels of the wall of the body cavity during penetration. The document (iii) U.S. Patent Application IJS3742958 relates to improvements in surgical and medical apparatus and more particularly to apparatus for inserting a catheter into a body cavity for establishing a lluid transmission path thereto. This reference discloses the trocar has along its length a reduced diameter between its tip and base. 'J'hc trocar may be formed of a single piece of material, 'fhe tip of the trocar has a four sided point of medium bevel formed on it to case insertion through the abdominal tissues. The particular type point formed is of interest, since it is not intended as truly a cutting edge; rather, it is designed for spreading the tissues wiiereby when the instrument and catheter arc withdrawn from the wound the tissues contract readily without producing a constantly draining llstula. This invention is of particularly beneficial use following a surgical repair on the bladder known as an anterior colporrhaphy, commonly accompanied by posterior colporrhapy and vaginal hysterectomy, before inserting any vaginal packing. I'hc document (iv) U.S. Patent Application IJS3994287 relates to a surgical instrument Cor piercing a body cavity and lor therealtcr providing a means for communicating inside the cavity, e.g., to drain or deliver lluids or to perform other surgical acts. This reference discloses the trocar is particularly intended for use during laparoscopic tubal cauterization. In this type of surgical intervention, the abdominal cavity of a patient is first insufllated with C()2. A trocar is then used to pierce the cavity wall, fhc puncturing clement of the trocar is subsccjuently disassociated with the cannula, a portion of which is retained inside the cavity. fhc trocar comprises, in combination: a sharp-pointed puncturing instrument made of a bio-compatible plastic material; a cannula also made of a bio-compatible plastic material and having a llange at one end thereof; a llcxible insulating member secured in the cannula llange and in constricting engagement with the puncturing instrument; and a collar tightly fitted in the cannula tlange and securing the ficxible member in place allowing, however, a portion of the member to Ilex in the longitucbnal axis of the cannula as the puncturing instrument is introduced in the cannula or disassociated therefrom. 'fhe puncturing instrument ol'the trocar includes an elongated shank portion terminating at one extremity thereof with a sharp pointed end and at the other extremity thereof with a linger knob, lind has a pyramidal shape defining three spaced cutting edges diverging from a tip and defining three smooth surfaces. I'he document (v) U.S. Patent ApplicaUon US45T3747 relates to surgical needles and in particular lo an improved .surgical needle for suturing through calcified tissue, cartilage or bone. 'fhis reference discloses a surgical needle. Needle includes a body portion and a cutting portion has a curved axis which defines a reference plane, 'fhc needle may optionally be curved in a direction opposite lo that of the needle and will have a curved axis which nevertheless lies in the same reference plane as that defined by axis. A main cutting edge is formed in a conventional manner at the bottom of said cutting portion by the intersection of a first substantially planar surface and a second substantially planar surface, fhus it can be seen that main cutting edge lies in the reference plane. Secondary cutting edges arc formed by the inlei-scclion of a third substantially planar surface, with planar surfaces respectively. Culling portion includes an end portion and a lip, the longitudinal a.xis of the needle being designated. Substantially planar sva-faces are formed at the bottom of end portion, thus creating three additional culling edges. It will be noted that cutting edge constitutes an extension of cutting edge and said cutting edge extends to the lip which lies at the interscclion of the reference plane and planar surface. It will also be noted that the angle "a" between cutting edges, is necessarily greater than the angle "b" between culling edges. Whereas the present invention relates to an introducer needle for penetrating a membrane comprises a solid body portion having a central axis and a lip portion extending from the solid body portion. The lip portion includes a plurality of intersecting wedge surfaces that converge toward a common insertion point from the solid body portion. Preferably, the common insertion point is coincident with the central axis of the solid body portion. The tip portion also includes a plurality of culling edges formed at interseclions of the wedge surfaces. The cutting edges converge toward the common insertion point from the solid body portion. With this arrangement, insertion of the introducer needle into the membrane causes even cutting and separation of the membrane aixHind the introducer needle. fhe introducer needle 1 8 includes a body portion 40 and a tip portion 42 that is integrally formed with, and extends from, the body portion 40. Preferably, the body portion 40 and tip portion 42 are of solid construction. 'flic cutting edges 60, 62 and 64 preferably converge toward the common insertion poinl 52 from the solid body portion 40 and are preferably circumfercntially spaced about the central axis 54 al an angle B of approximately 120 degrees. Since the culling edges extend along the intersection of the wedge faces, they also extend or slope from the solid body portion 40 to the conmion insertion poinl or central axis 54 at an angle A in ihe rangc of approximately 5-30 degrees, and more preferably al an angle A ol~ approximately 15 degrees. In this manner, the length of each cutting edge 60,62 and 64 can be less than a cutting length of the prior art angle ground hollow needle to thereby reduce material costs. The introducer needle IS is preferably constructed from a solid rod or bar of material, such as stainless steel, by cutting the rod or bar to a predetermined length, then grinding or otherwise forming one end of the rod or bar to form the lip portion 42. fhe concentric location of the insertion point 52 together with the symmetrically spaced cutting edges 60, 62 and 64 facilitate insertion of the introducer needle 18 into the skin with a concentric coaxial force, 'fhis coaxial force has substantially no bending component, as in the prior art angle ground hollow needles. The three culling edges 60. 62 and 64 cooperate with (he concentric insertion point 52 and the wedge faces 46, 48 and 50 to minimize skin displacement during needle inserlion while assuring a clean cut ihrough the tissue. In addition, Ihe solid construction of the introducer needle 18 gives added strength over prior arl hollow body constructions. Based on the above explanation, herein the present invention provides the inserter needle with wedge surfaces which allow the needle to pierce the body and move smoothly inlo the membrane during needle insertion which helps in clean cut and minimize skin displacement and accidental damages lo the tissue. As in the case of prior arts, which requires the combination of relatively high insertion force and the olTsel nature of Ihe cutting tip may create a bending moment about the introducer needle during inserlion, when the bending moment is relieved such as when the introducer needle pierces he skin, the surrounding tissue may be damaged and discomfort may be increased as the introducer needle attempts to spring back to its original shape. Thus, by creating wedge surfaces in the insertion needle can generally avoid the discomfort and inadvertent damages lo the tissues. Secondly, the wedge faces of cutting edge are equally distributed and the common insertion point is preferably coincide with central axis of the introducer needle which facilitate insertion of Ihe introducer needle 18 into the skin with a concentric coaxial force. This coaxial force has substantially no bending component, as in the prior art angle ground hollow needles. And llnally, the length ol'the each cutting edge is less than the prior arts which provides us to cut pierces the skin to required length which is not in the case of prior art. In particular, documents (1) to (v) fails to disclose anything related to wedge surfaces, the common insertion point is preferably coincide with central axis of the introducer needle and length of the needle which is less than prior art length. Thus none of the prior arts alone or in combination disclose the needle and the infusion set of the instant invention. Hence, the instant invention is developed to overcome the potcntitil limitations of the prior arts and provide belter and efficient needle. OH.rK.C IS OF TIIK INVENTION The main object of the present invention is to develop an introducer needle (18) for penetrating a membrane, the needle comprising: a solid body portion (40) having a central axis; and a solid lip portion (42) extending from the solid body portion (40), the solid tip portion comprising; a common insertion point (52) that is coincident with the central axis (54); a plurality of wedge surfaces (46, 48 and 50) extending from the solid body portion (40) and converging toward the common insertion point (52), each wedge surface forming an intersection with an adjacent wedge surface; and a plurality of cutting edges (60, 62 and 64) formed at the intersections of the wedge surfaces, the cutting edges (60, 62 and 64) )convcrging toward the common insertion point (52); wherein insertion of the introducer needle (1 8) into the membrane causes even cutting and separation of the membrane around the introducer needle (18). STATEMENT OF TFIE INVENTION According to one aspect of the invention, an introducer needle for penetrating a membrane comprises a solid body portion having a central axis and a tip portion extending from the solid body portion. The tip portion includes a plurality of intersecting wedge surlaces that converge toward a common insertion point from the solid body portion. Preferably, the common insertion point is coincident with the central axis of the solid body portion. The tip portion also includes a plurality of cutting edges Ibrmed at intersections of the wedge surfaces. I'he cutting edges converge toward the common insertion point Irom the solid body portion. With this arrangement, insertion of the introducer needle into the membrane causes even cutting and separation of the membrane around the introducer needle. BklF.F DESCRIPTION OF IIIF SFVKRAL VIEWS OF THE DRAWINGS fhe foregoing summary, as well as the following detailed description of preferred embodiments ol'the invention, will be better understood when read in conjunction with the appended drawings, for the purpose of illustrating the invention, there is shown in the drawings embodiments which are presently preferred. It should be understood, however. that the invention is not limited to the precise arrangements and instrumentalities shown. In the drawings: V\G. I is a front perspective view of an inserter assembly incorporating an infusion set with an introducer needle in accordance with the present invention; MCi.2 is an enlarged perspective view of a portion of the introducer needle and cannula; blCi. 3 is a side eievational view of a portion of the introducer needle; f'Ki. 4 is a front eievational view of the introducer needle; and I'ICi. 5 is a front eievational view of an introducer needle in accordance with a further embodiment of the invention. It is noted that the drawings are intended to represent only typical embodiments of the invention and therefore should not be construed as limiting the scope thereof. The invention will now be described in greater detail with reference to the drawings, wherein like parts throughout tlie drawing llgurcs are represented by like numerals. DF/I AIEED DESCRirnON OF HIE INVENTION Certain terminology may be used in the following description for convenience only and is not limiting. The words "left," "right," "upper," and "lower" designate directions in the drawings to which reference is made, 'fhe words "inwardly" and "outwardly" rel'er to directions toward and away from, respectively, the geometric center of the needle and designated parts thereof. I'he terminology includes the words above spceilleally mentioned, derivatives thereof, and words of similar import. Referring now to the drawings and to FlCi. 1 in particular, an mtusion sci lu ui accordance with the present invention is shown temporarily positioned on an inserter assembly 12 for installation in the subcutaneous skin layer of a user. fhe infusion set 10 inchides a cannula 14 extending from a generally hollow cannula housing 16 and an introducer needle 18 extending through the cannula 14 and into the cannula housing 16. The cannula 14 is preferably constructed of a lluoropolymer material, such as Tellon, or other inert material. An adhesive-backed pad 20 is preferably attached to the cannula housing 16 with the adhesive layer (not shown) facing away from the cannula housing 16. A portion of the pad 20 is shown broken away in klCi. I to more clearly illustrate the introducer needle 18 and cannula 14 extending underneath the housing. It will be understood that the infusion set 10 is not limited to the low-protlle type, but may be arranged to insert the introducer needle 18 and cannula 14 at different angles, including perpendicular, to the skin surface. 'fhe inserter 12 includes an inserter housing 22 with an angled alignment guide 24 formed therewith so that the infusion set 10 can be inserted into the skin at a predetermined angle, 'fhe inserter 12 also includes a spring-loaded slide assembly 26 that is biased toward a forward position as shown, and is retractable to a rearward or cocked position. A locking mechanism 28 is adapted to hold the slide assembly 26 in the cocked position, and an actuating button 30 is operatively associated with the locking mechanism 28 for releasing the slide assembly 26. A locking lever 32 can also be provided for preventing inadvertent depression ol'the actuating button 30, and thus inadvertent release ol'lhe slide assembly 26. luirlher details of the inserter assembly can be foimd in copending IJ. S. Patent Application Publication No. 2002/0077599 filed on December 18, 2001, the disclosure of which is hereby incorporated by reference. It will be understood that the infusion set 10 can be used with inserters of different configurations, or can be used without an inserter. With reference now to fKiS. 2-4, the introducer needle 18 includes a body portion 40 and a tip portion 42 that is integrally formed with, and extends from, the body portion 40. Preferably, the body portion 40 and tip portion 42 are of solid construction, .^s shown the body portion 40 is circular in cross section, but may be configured with other cross sectional shapes, such as triangular, square, oval, and so on. fhc lip portion 42 preferably includes a plurality of substantially planar wedge faces, such as first wedge face 46; seeond wedge face 48 and third wedge face 50 that convei-ge toward a common insertion point 52 from the body portion 40. The common insertion point 52 is preferably coincident with a central axis 54 of the introducer needle 18. Preferably, the wedge faces extend from the solid body portion 40 to the central axis 54 at an angle A in the range of approximately 5-30 degrees, and more preferably at an angle A of approximately 15 degrees. As shown, the llrst and second wedge faces 46 and 48 intersect to form a fu'st cutting edge 60, the first and third wedge faces 46 and 50 intersect to form a second cutting edge 62, and the second and third wedge laces 48 and 50 intersect to form a third cutting edge 64. 'I'he cutting edges 60, 62 and 64 preferably converge toward the common insertion point 52 from the solid body portion 40 and are preibrably circumferentially spaced about the central axis 54 at an angle B of approximately 120 degrees. Since the cutting edges extend along the intersection of the wedge faces, they also extend or slope from the solid body portion 40 to the common insertion point or central axis 54 at an angle A in the range of approximately 5-30 degrees, and more preferably at an angle A of approximately 15 degrees. In this manner, the length of each cutting edge 60,62 and 64 can be less than a cutting length of the prior art angle ground hollow needle (o thereby reduce material costs. I'he introducer needle 18 is preferably constructed from a solid rod or bar of material, such as stainless steel, by cutting the rod or bar to a predetermined length, then grinding or otherwise forming one end of the rod or bar to ibrm the tip portion 42. Referring again to f'Ki. 1, in use, and by way of example, the infusion set 10 is loaded onto the slide assembly 26 of the inserter assembly 12. I'he slide assetnbly 26 is then retracted to the cocked position and held in place by the locking mechanism 28. The inserter assembly 12 is then positioned against the skin of a user and the button 30 is depressed to release the slide assembly 26. The infusion set 10 moves together with the slide assembly under spring bias toward the skin until the introducer needle 18 and cannula 14 are positioned in the subcutaneous layer. The concentric location of the insertion point .52 together with the symmetrically spaced cutting edges 60. 62 and 64 facilitale insertion of the introducer needle 18 into the skin with a concentric coaxial force. This coaxial force has no bending component, as in the prior art angle ground hollow needles, 'fhc three cutting edges 60, 62 and 64 cooperate with the concentric insertion point52 and the wedge feces 46, 48 and 50 to minimize skin displacement during needle insertion while assuring a clean cut through the tissue. In addition, the solid construction of the introducer needle 18 gives added strength over prior art hollow body constructions. Still another advantage of the above-described introducer needle 1 8 is less burr formation and easier burr removal during manufacturing than in the prior art angle grinding of hollow needles. .Still further, the introducer needlel8 facilitates assembly of the infusion set 10. When inserted through the cannula 14 during assembly, the introducer needle 18 glides through wilhcHit touching or damaging the cannula 14 since the insertion point 52 is spaced awav from the wall of the cannula. Referring now to 14(i. 5, a front elevational view ol' an introducer needle 18a in accordance with a further embodiment of the invention is illustrated. 'I'he introducer needle 18a has a tip portion 42a with a plurality of substantially planar wedge faces, such as llrsl wedge face 70, second wedge face72, third wedge face 74, and fourth wedge face 76 that converge toward a common insertion point78 from the body portion 40. The insertion point 78 is preferably coincident with a central axis of the introducer needle 18A. Preferably, the wedge faces extend from the solid body portion 40 to the central axis 78 at an angle A in the range of approximately 5-30 degrees, and more preferably at an angle A of approximately 15 degrees. As shown, the llrst and second wedge faces 70 and 72 intersect to form a lirst cutting edge 80, the second and third wedge laccs72 and 74 intersect to form a second cutting cdgc82, the third and fourth wedge faces 74 and 76 intersect to Ibrm a third cutting edge K4, and the fourth and first wedge faces 76 and 70 intersect to form a fourth cutting edge 86. The cutting cdges80-86 preferably converge toward the insertion point 78 from the solid body portion 40 and are preferably circumfcrcntially spaced about the central axis 54 at an angle C of approximately 90 degrees. Since the cutting edges extend along the intersection of the wedge faces, Ihey also extend or slope from the solid body porlion40 lo ihc central axis 78 al an angle A that is preferably in the range of approximately5-30 degrees, and more preferably at an angle A of approximately 15 degrees. While the two embodiments of the invention shown in blGS. 4 and 5 illustrate inserter needles with 3 and 4 edge faces, il should be understood that the invention is not so limited and thai 5 or more faces can be used. While the invention has been taught with specific reference to the above-described embodiments, those skilled in the art will recognize that changes can be made in form and detail without departing from the spirit aud the scope of the invention. By way of exaniple, it will be understood that the invention is not limited to the particular number of wedge faces and culling edges illustrated, but may have more or less faces and culling edges. In addition, ihe angles between the cutting edges and/or their slopes can be asymmetrical. Moreover, although the introducer needle has been taught for use with an inserter assembly, il will be understood that the introducer needle is not so limited, but may be used in other devices andA^- methods lor positioning a cannula or catheter in a membrane or tissue andA)r for creating a passage or opening in a membrane or tissue, fhus, the described embodiments are lo be considered in all respects only as illuslrati\e and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes that come within ihe meaning and range of equivalency of the claims are lo be embraced within Iheir scope. Wc claim: 1. An introducer needle (1 8) for penetrating a membrane, the needle comprising; a solid body portion (40) having a central axis; and a solid tip portion (42) extending from the solid body portion (40), the solid tip portion comprising; a common insertion point (52) that is coincident with the central axis (54): a plurality of wedge surfaces (46, 48 and 50) extending Irom the solid body portion (40) and convei-ging toward the common insertion point (52), eacJi wedge surface forming an intersection with an adjacent wedge surface; and a plurality of cutting edges (60, 62 and 64) formed at the intersections of the wedge surfaces, the cutting edges (60, 62 and 64) )convcrging toward the common insertion point (52); wherein insertion of the introducer needle (18) into the membrane causes even cutting and separation of the membi'ane around the introducer needle (18). 2. I'he introducer needle as claimed in claim 1, wherein the plurality of wedge surfaces comprises lirsl (46), second (48) and third (50) wedge surfaces, with the llrst (46) and second wedge surfaces (4K) intersecting at a llrst intersection, the llrst (46) and third wedge surfaces (50) intersecting at a second intersection, and the second (48) and third wedge surfaces (50) intersecting at a third intersection. 3. The introducer needle as claimed in claim 2, wherein a ilrst angle is formed between the llrst (46) and second (48) wedge surfaces, a second angle is formed between the llrst (46) and third (50) wedge surlaccs, and a third angle is formed between the third (50) and llrst (46) wedge surfaces. 4. The introducer needle as claimed in claim 2, wherein the plurality of cutting edges (60, 62 and 64) comprises a llrst cutting edge (60) located at the first intersection, a second cutting edge (62) located at the second intersection, and a third cutting edge (64) located at the third intersection. 5. The introducer needle as claimed in claim 4, wherein the ilrst, second and third angles are each approximately! 20 degrees. 6. The introducer needle as claimed in claim 5, wherein the llrsl (60), second (62) and third (64) cutting edges have a slope in the range of about 5 degrees to abt)ut 30 degrees with respect to the central axis. 7. The introducer needle as claimed in claim 6, wherein the llrsl (60), second (62) and third (64) cutting edges have a slope of about 15 degrees with respect to the central axis, 8. I'he introducer needle as claimed in claim 4, wherein the llrst (60), second (62) and third (64) cutting edges have a slope in the range of about 5 degrees to about 30 degrees with respect to the central axis. 9. The introducer needle as claimed in claim 1, wherein each wedge surface extends at an angle in the range of about 5 degrees to about 30 degrees with respect to the central axis. 10. The introducer needle as claimed in claim 9, wherein each wedge surface extends at an angle of about 15 degrees with respect to the central axis. 1 I. fhe introducer needle as claimed in claim I, wherein each wedge surface is planar. 12. An inlroduccr needle (or penelraling a membrane substantially as herein described with reference to the accompanying drawings.

Documents:

1716-chenp-2005 abstract-duplicate.pdf

1716-chenp-2005 abstract.jpg

1716-chenp-2005 abstract.pdf

1716-chenp-2005 claims-duplicate.pdf

1716-chenp-2005 claims.pdf

1716-chenp-2005 correspondence-others.pdf

1716-chenp-2005 correspondence-po.pdf

1716-chenp-2005 description(complete) -duplicate.pdf

1716-chenp-2005 description(complete).pdf

1716-chenp-2005 drawings-duplicate.pdf

1716-chenp-2005 drawings.pdf

1716-chenp-2005 form-1.pdf

1716-chenp-2005 form-13.pdf

1716-chenp-2005 form-18.pdf

1716-chenp-2005 form-26.pdf

1716-chenp-2005 form-3.pdf

1716-chenp-2005 form-5.pdf

1716-chenp-2005 pct.pdf