US20060144548A1 - Method of manufacturing a needle assembly for use with a biopsy device - Google Patents

Abstract

An improved process for manufacturing a biopsy needle assembly is provided. The process may comprise the steps of forming an aperture for receiving tissue to be sampled in an exterior surface of an elongated tube for receiving a cutter, wherein the elongated tube comprises a proximal portion and a distal portion; forming a hole in the exterior surface of the elongated tube; and applying a coating of material over the elongated tube to form a lumen for receiving vacuum on the exterior surface of the elongated tube, wherein the hole in the exterior surface of the elongated tube provides communication between an interior of the elongated tube and an interior of the lumen. In one version, the elongated tube may be placed in a mold configured to form the vacuum lumen when material is injected into the mold. A proximal hub may advantageously be formed by overmolding.

Description

FIELD OF THE INVENTION
• The present invention is related generally to biopsy devices and, more particularly, to an improved process of manufacturing a needle assembly for use with a biopsy device for acquiring a tissue sample.
BACKGROUND OF THE INVENTION
• The diagnosis and treatment of patients with cancerous tumors, pre-malignant conditions, and other disorders has long been an area of intense investigation. Non-invasive methods for examining tissue include palpation, thermography, PET, SPECT, Nuclear imaging, X-ray, MRI, CT, and ultrasound imaging. When the physician suspects that tissue may contain cancerous cells, a biopsy may be done either in an open procedure or in a percutaneous procedure. For an open procedure, a scalpel is used by the surgeon to create a large incision in the tissue in order to provide direct viewing and access to the tissue mass of interest. Removal of the entire mass (excisional biopsy) or a part of the mass (incisional biopsy) is performed. For a percutaneous biopsy, a needle-like instrument is inserted through a very small incision to access the tissue mass of interest and to obtain a tissue sample for later examination and analysis.
• The advantages of the percutaneous method as compared to the open method are significant: less recovery time for the patient, less pain, less surgical time, lower cost, less risk of injury to adjacent bodily tissues such as nerves, and less disfigurement of the patient's anatomy.
• Generally there are two ways to percutaneously obtain a portion of tissue from within the body: aspiration and core sampling. Aspiration of the tissue through a fine needle requires the tissue to be fragmented into pieces small enough to be withdrawn in a fluid medium. This method is less intrusive than other known sampling techniques, but one may only examine cells in the liquid (cytology) and not the cells and the structure (pathology). In core sampling, a core or fragment of tissue is obtained for histologic examination and/or genetic tests, which may be done via a frozen or paraffin section. The type of biopsy used depends mainly on various factors present in the patient, and no single procedure is ideal for all cases. However, core biopsies seem to be more widely used by physicians.
• The following patent documents are incorporated herein by reference for the purpose of illustrating biopsy devices and methods: U.S. Pat. No. 5,526,822 issued Jun. 18, 1996; U.S. Pat. No. 5,895,401 issued Apr. 20, 1999; U.S. Pat. No. 6,086,544 issued Jul. 11, 2000; U.S. Pat. No. 6,620,111 issued Sep. 16, 2003; U.S. Pat. No. 6,626,849 issued Sep. 30, 2003; U.S. Pat. No. 6,638,235 issued Oct. 28, 2003; US Patent Application 2003/0109803 published Jun. 12, 2003; US Patent Application 2003/0199753 published Oct. 23, 2003; US Patent Application 2003/0199754 published Oct. 23, 2003; US Patent Application 2003/0199785 published Oct. 23, 2003; and U.S. Ser. No. 08/825,899 filed on Apr. 2, 1997.
• It is known in the art to use a double lumen biopsy needle incorporating vacuum suction to obtain a tissue sample. With devices of this type, the needle is inserted into a small incision in a patient and is advanced through tissue until the needle is adjacent the tissue of interest. At that point, a vacuum source may be activated, providing suction inside one of the two lumens. The suction is communicated to the second lumen via a passage between the two lumens. The second lumen may contain an aperture through which suspicious tissue may be drawn when the vacuum source is activated. Once tissue is drawn into the aperture, the surgeon may advance a cutter through the second lumen in order to excise a sample from the tissue of interest.
• While biopsy needles of the type described above are useful in obtaining tissue samples, the processes known in the art for manufacturing these needles are often expensive and labor-intensive due to the number of components and steps involved. For instance, certain biopsy needles provide a double lumen structure formed of two separate rigid structures, thus requiring a reliable method of attaching the two structures, such as a weld or adhesive, along the entire length of the lumens. Similarly, many biopsy needles include a sharpened feature on the leading end of the needle that cuts through tissue as the needle is advanced into the body. These sharpened tips often have small components and/or features that require significant time and expense to make and attach to the needle. Further, biopsy needles often include a mounting component that allows the needle to be attached to a handle or other platform. Often, these mounting components are manufactured separately from the body of the needle, and must be joined together after formation, such as by gluing, a process that is heavily reliant on the skill and concentration of a human worker. Even if a more reliable method of attaching the mounting component to the needle is used, such as induction heating or heat staking, such methods still involve the added expense necessitated by the extra assembly equipment as well as the steps of manufacturing the mounting component and attaching it to the needle.
• Accordingly, while double lumen biopsy needles are known in the art, there exists a significant need for a process of manufacturing a biopsy needle that reduces the number of components that must be separately manufactured, as well as the time and labor that must be expended in manufacturing and assembling the components of the biopsy needle, while still maintaining the necessary strength and rigidity for safe and satisfactory performance during surgery.
SUMMARY OF THE INVENTION
• The process of the current invention overcomes the above-noted and other deficiencies of the prior art by providing a process for manufacturing a biopsy needle device that reduces the number of components that must be separately manufactured and assembled, thereby reducing the cost of manufacturing the biopsy needle device while maintaining the necessary biomechanical properties.
• In one aspect consistent with the present invention, a process of manufacturing a biopsy needle may comprise the steps of forming an aperture for receiving tissue to be sampled in an exterior surface of an elongated tube that has a proximal and distal portion, wherein the elongated tube may be configured to receive a cutter; forming a hole in the exterior surface of the elongated tube; and applying a coating of material over the elongated tube to form a lumen for receiving vacuum on the exterior surface of the elongated tube, wherein the hole in the exterior surface of the elongated tube may be adapted to provide communication between an interior of the elongated tube and an interior of the lumen. This process advantageously allows the vacuum lumen to be formed over the elongated tube without requiring separate manufacturing and assembly steps, thus reducing assembly costs.
• In another version, the process of manufacturing the biopsy needle device may comprise the steps of forming an aperture for receiving tissue to be sampled in an exterior surface of an elongated tube, wherein the elongated tube may be adapted to receive a cutter and may further comprise a proximal portion and a distal portion; forming a hole in the exterior surface of the elongated tube; and placing the elongated tube in a mold and injecting the mold with a material, wherein the mold may be configured such that the material forms a lumen for receiving vacuum on the exterior surface of the elongated tube, and wherein further the hole in the exterior surface of the elongated tube may be adapted to provide communication between an interior of the elongated tube and the interior of the lumen. This version advantageously provides for the formation of a vacuum lumen on an elongated tube by overmolding a coating of material onto the elongated tube, avoiding the need to separately manufacture the vacuum lumen and then attach it to the elongated tube. Further, this process may provide for a stronger attachment between the vacuum lumen and the elongated tube than some previously known methods of attachment of the two components.
• In another aspect, the process of manufacturing a biopsy needle device may comprise the steps of placing a cutter tube, which may comprise a port adapted to receive a tissue sample and may further comprise a cutter lumen adapted to receive a cutter, in a mold; injecting a material in a liquid state into the mold; cooling the material in order to convert it to a solid state; wherein the mold may be configured to cause the material to form a lumen for receiving vacuum on an exterior surface of the cutter tube, and wherein further the vacuum lumen is in communication with the cutter lumen.
• The present invention also extends to a biopsy instrument manufactured according to a process that may comprise the steps of forming an aperture for receiving tissue to be sampled in an exterior surface of an elongated tube for receiving a cutter, wherein the elongated tube may have a proximal portion and a distal portion; forming a hole in the exterior surface of the elongated tube; and applying a coating of material over the elongated tube to form a lumen for receiving vacuum on the exterior surface of the elongated tube, and wherein the hole in the exterior surface of the elongated tube may be adapted to provide communication between an interior of the elongated tube and an interior of the lumen.
• These and other objects and advantages of the process of the present invention shall be made apparent from the accompanying drawings and the description thereof.
BRIEF DESCRIPTION OF THE DRAWINGS
• The novel features and steps of the invention are set forth with particularity in the appended claims. The invention itself, however, both as to organization and methods of operation, together with further objects and advantages thereof, may best be understood by reference to the following description, taken in conjunction with the accompanying drawings in which:
• FIG. 1 is an isometric view of a hand-held vacuum-assisted biopsy device including a needle assembly manufactured according to one version of the process.
• FIG. 2 is a side view of a needle assembly manufactured according to one version of the process.
• FIG. 3 is a top view of a needle assembly manufactured according to one version of the process.
• FIG. 4 is a side view of a distal tissue-piercing tip manufactured according to one version of the process.
• FIG. 5 is an isometric view of a distal tissue-piercing tip manufactured according to one version of the process.
• FIG. 6 is a section view of a cutter lumen and cutter stop manufactured according to one version of the process.
• FIG. 7 is a section view of a cutter stop manufactured according to one version of the process.
• FIG. 8 is a partial view of a cutter lumen and axial slide according to one version of the process.
• FIG. 9 is an isometric view of a needle assembly with slides in place for use in injection molding according to one version of the process.
• FIG. 10 is a partial frontal cross-sectional view of a needle assembly manufactured according to one version of the process.
• FIG. 11 is a partial sagittal cross-sectional view of a needle assembly manufactured according to one version of the process.
DETAILED DESCRIPTION OF THE INVENTION
• FIG. 1 shows a hand-held vacuum-assistedbiopsy device10 comprising ahandle20 detachably connected to aneedle assembly30 having aproximal portion32 and adistal portion34 manufactured according to a version of the process of the current invention. Together, they constitute a lightweight, ergonomically-shaped, hand-manipulatedbiopsy device10. In one aspect,needle assembly30 may be part of a disposable probe that may mount onhandle20. In one aspect, hand-heldbiopsy device10 may be used in conjunction with an ultrasound to guideneedle assembly30. Sincehandle20 may be manipulated by the operator's hand, the operator may steerneedle assembly30 with great freedom towards the tissue mass of interest. The surgeon has tactile feedback while doing so and may therefore ascertain to a significant degree the density and hardness of the tissue being encountered. In addition, handle20 may be held approximately parallel to the chest wall of a patient for obtaining tissue portions closer to the chest wall than may be obtained whenneedle assembly30 is attached to another type of device. Alternatively,needle assembly30 may be attached to an electromechanical arm, a platform, a table or other suitable support. Such alternative mountings may be used in conjunction with applications in which the needle assembly is guided by stereotactic (x-ray) or MRI modalities.
• As controls for obtaining a tissue sample, handle20 may include aforward button36 which may be used to move a cutter38 distally through acutter lumen40 to sever a sample of suspicious tissue collected in a tissue-receivingport42.Handle20 may further include areverse button44 which may be used to move cutter38 proximally throughcutter lumen40, thereby moving the tissue sample inport42 to a tissue collection surface46. Avacuum button48 onhandle20 may be used to open or close afirst vacuum line50 for communicating suction to avacuum lumen52 so as to cause tissue to become disposed withinport42 and asecond vacuum line54 for communicating axial suction to cutter38 to aid in withdrawal of a severed tissue sample.
• Referring now toFIGS. 2 and 3, aneedle assembly30 made by one version of the process of the current invention for use with abiopsy device10 is illustrated.Cutter lumen40 may comprise aproximal portion56 and adistal portion58.Cutter lumen40 forms a smooth, uninterrupted passage for receiving cutter38 such that it may be advanced through theproximal portion56 ofcutter lumen40 to thedistal portion58. Tissue-receivingport42 may be formed in anexterior surface60 ofcutter lumen40.Port42 may be located on thedistal portion58 ofcutter lumen40.Cutter lumen40 may also comprise an openproximal end62 and an opendistal end64.
• Vacuum lumen52 may comprise aproximal portion66 and adistal portion68. In one version,cutter lumen40 may be oriented abovevacuum lumen52. A vacuum source (not pictured) may be attached tovacuum lumen52, possibly atproximal portion66 thereof, viafirst vacuum line50.
• Theneedle assembly30 may also include one or more passages, also called interlumen vacuum holes70, betweencutter lumen40 andvacuum lumen52. When the vacuum source is activated, thereby providing suction invacuum lumen52, interlumen vacuum holes70 allow that suction to be communicated intocutter lumen40. As best illustrated inFIGS. 3 and 11, the interlumen vacuum holes70 may be located betweencutter lumen40 andvacuum lumen52 opposite the tissue-receivingport42. As illustrated inFIG. 6, acutter stop72 may also be located incutter lumen40 distally of tissue-receivingport42. Aface74 ofcutter stop72 may provide a cutting surface for severing a tissue sample.Face74 ofcutter stop72 may be designed to match the leading profile of cutter38 (FIGS. 6 and 7). Depending on the means used to advance cutter38,cutter stop72 may also provide tactile feedback to a surgeon once cutter38 comes into contact withcutter stop72 after a sample has been severed. However, if, as known in the art, a computer software program is used to control advancement of cutter38, the surgeon will not be provided with tactile feedback by contact between cutter38 andcutter stop72.
• As illustrated inFIG. 2, ahub76 having aproximal portion78 and adistal portion80 may be located onproximal portion32 ofneedle assembly30.Hub76 assists in mountingneedle assembly30 to handle20 or other any other suitable support.Hub76 may detachably mount onhandle20 in order to allowdisposable needle assembly30 to be removed from the multiple-use handle20 after surgery.Hub76 may also include a flange82 (not pictured) on itsproximal portion301.Flange82 may snap into a rib or similar retaining element ofhandle20 or another suitable support.Hub76 may also include avacuum manifold84 that provides a connection between the vacuum source andvacuum lumen52.Hub76 may also allowsecond vacuum line54 to connect with cutter38 so that axial suction may be communicated to cutter38.
• In one aspect consistent with the process of the current invention, a distal tissue-piercingtip86 having aproximal portion88 and adistal portion90 may be disposed ondistal portion34 ofneedle assembly30. As best pictured inFIGS. 4 and 5,distal portion90 of distal tissue-piercingtip86 may include acutting edge92 of sufficient sharpness to cut through human tissue and thereby aid in movingneedle assembly30 adjacent the tissue of interest. The junction of piercingtip86 andcutter lumen40 may include a tapered profile94 therebetween that further assistsneedle assembly30 in moving smoothly through a patient's tissue.
• Piercingtip86 may comprise a substantially flat blade formed of any suitable material. Piercingtip86 may also includetabs96,98 onproximal portion88 thereof to aid in the attachment of piercingtip86 tocutter lumen40.Tab96 may be located abovetab98. In one version,tab98 extends further towardproximal end62 ofcutter lumen40 than doestab96 for reasons addressed below. Piercingtip86 may also include anopening100, to aid in formation of tapered profile94, which is also discussed in more detail below.
• In operation,needle assembly30 may be inserted into a small incision in the body. When utilized, tissue-piercingtip86 helpsneedle assembly30 penetrate through tissue untildistal portion34 ofneedle assembly30 is located adjacent the tissue of interest. Piercingtip86, along with tapered profile94, may help to minimize tissue drag experienced during insertion and extraction ofneedle assembly30. Onceneedle assembly30 is properly positioned relative to the tissue of interest, vacuum suction may be applied tovacuum lumen52 viafirst vacuum line50.
• Suction may be communicated fromvacuum lumen52 tocutter lumen40 via the interlumen vacuum holes70. The suction insidecutter lumen40 actively pulls suspicious tissue into tissue-receivingport42. Once the suspicious tissue has been drawn intocutter lumen40 throughport42, the surgeon may advance cutter38 in the distal direction until a sample is severed from the suspicious tissue.Cutter stop72 may be located incutter lumen40 distally of tissue-receivingport42 to provide a cutting surface to aid cutter38 in severing a sample of suspicious tissue. Once the sample has been severed, cutter38 may contactcutter stop72. As mentioned above, depending on the means used to advance cutter38 throughcutter lumen40, contact between cutter38 and cutter stop72 may provide tactile feedback to the surgeon, indicating that a sample has been obtained and that cutter38 may be withdrawn towardproximal end62 ofcutter lumen40. Once cutter38contacts cutter stop72,needle assembly30 may be repositioned in the patient's body (e.g., rotated, longitudinally translated) in order to obtain another sample.
• As mentioned above, cutter38 may be attached tosecond vacuum line54, thereby providing cutter38 with axial suction. After a sample has been obtained, and before a second sample is drawn intoport42, axial suction, if utilized, may assist cutter38 in pulling the sample throughcutter lumen40 as cutter38 is withdrawn. Once cutter38 has been withdrawn fromcutter lumen40, the sample may be cleared from cutter38 onto a tissue collection site46 located onhandle20 or platform. At that point, another sample may be obtained by applying vacuum to draw a sample intoport42 and advancing cutter38 to sever the sample. This procedure may be repeated until the desired number of samples has been acquired.
• In one aspect consistent with the process of the current invention,cutter lumen40 may comprise a preformed tube open at each end and cut to the desired length ofneedle assembly30. The preformed tube may be advantageously straight and round for receiving cutter38. The material of the preformed tube may be rigid to allow insertion ofneedle assembly30 through tissue with minimal deflection. In one version,cutter lumen40 may be made of metal. More particularly,cutter lumen40 may be made of stainless steel.Cutter lumen40 may also be made from other suitable materials, including but not limited to titanium, titanium alloy, aluminum, or aluminum alloy. Alternatively,cutter lumen40 may be made from nonmetallic materials having structural characteristics sufficient to allow a coating of material to be applied overcutter lumen40 and having the strength and rigidity characteristics sufficient to withstand the force experienced bycutter lumen40 when it is pressed through human tissue.
• Tissue-receivingport42 and interlumen vacuum holes70 may be cut into the preformed tube comprisingcutter lumen40. As shown inFIG. 3, the distal and proximal edges ofport42 may be cut on an angle relative to the longitudinal edges ofport42. The angling of these edges can produce a scissoring effect asneedle assembly30 is pushed through tissue, aiding in positioning thedevice10. In addition, a pair of notches (not pictured) may be cut intodistal end64 of the preformed tube comprisingcutter lumen40 to provide points of attachment for piercingtip86.
• Piercingtip86 may be formed of a material providing sufficient strength and rigidity to allow it to move through tissue with minimal deflection. In one version,tip86, including the above-described features included thereon, may be stamped from metal sheet stock. More particularly, the metal may be 440A stainless steel. However, other suitable materials may be used, including but not limited to titanium, titanium alloy, aluminum, or aluminum alloy. Non-metallic materials, such as MRI compatible resins, including but not limited to Ultem and Vectra, may be used to formtip86. Likewise,tip86 may also be formed from ceramics or glass. By stamping piercingtip86 out of metal sheet stock, cuttingedge92 may be sharpened prior to attachment oftip86 tocutter lumen40. Cuttingedge92 may be sharpened after formation oftip86 by grinding perpendicular to cuttingedge92, which is sometimes thought to be advantageous in producing a sharp cutting surface. Alternatively, cuttingedge92 may be sharpened by any other suitable method known in the art.
• Piercingtip86 may be attached tocutter lumen40. In one version, piercingtip86 may be welded tocutter lumen40. More particularly, piercingtip86 may be laser welded tocutter lumen40. In one version, piercingtip86 may be welded tocutter lumen40 at two preformed locations.Tabs96,98 of piercingtip86 may each be welded inside a notch ofcutter lumen40. Alternatively, piercingtip86 may be attached tocutter lumen40 through any suitable method known in the art that provides satisfactory strength of attachment betweentip86 andcutter lumen40, including but not limited to adhesive, press-fit, or screws.
• Other features ofneedle assembly30 may be formed by applying a coating of material overcutter lumen40. The coating of material may be applied tocutter lumen40 as a liquid, and then hardened to the necessary rigidity for use in the human body after formation of the desired features thereon. In one version, the coating of material may be applied tocutter lumen40 by injection molding. In this version, the mold (not pictured) is designed such that the injected material may flow into predetermined cavities and form the desired features overcutter lumen40, including but not limited tovacuum lumen52 andhub76. The gates (not pictured) through which the material is injected into the mold may be located along the mold part line, shown as P_LinFIG. 9. Further, the gates may be located in the mold underneathcutter lumen40.
• In this version, when the material is injected into the mold, it may form anouter sheath106 overcutter lumen40, as well as tapered profile94 between piercingtip86 andcutter lumen40. To assist in formation of tapered profile94, piercingtip86 may include opening100 (FIG. 4) through which the injected material may flow. Flow of injected material through opening100 from each side oftip86 may strengthen attachment of the injected material to piercingtip86.
• The mold may also be shaped so that the appliedmaterial forms hub76,flange82, andvacuum manifold84 overproximal portion56 ofcutter lumen40. The mold may also be designed so thathub76 extends pastproximal end62 ofcutter lumen40 in order to facilitate the mounting ofneedle assembly30 to handle20 or another suitable support. Alternatively,hub76, includingflange82 andvacuum manifold84 may be formed separately from the remainder ofneedle assembly30 and be attached by gluing, press-fitting or any other suitable method known in the art.
• Referring toFIG. 9, prior to application of the coating of material, aslide108 may be placed alongexterior surface60 ofcutter lumen40, substantially parallel to the longitudinal axis thereof. More particularly, slide108 may be placed on the underside ofexterior surface60. The material then coatscutter lumen40 andslide108, formingvacuum lumen52 substantially parallel to the longitudinal axis ofcutter lumen40.Slide108 also serves to prevent the applied material from blocking interlumen vacuum holes70. The mold may also be designed so thatslide108 may be placed in alternate locations in order to orientvacuum lumen52 above or to either side ofcutter lumen40, so long as at least oneinterlumen vacuum hole70 is present betweenvacuum lumen52 andcutter lumen40 to allow suction to be communicated therebetween.
• While use ofslide108 is one process for formingvacuum lumen52 in the coating of material applied overcutter lumen40, it is recognized that other methods of formingvacuum lumen52 in the coating of material are also possible. For example,vacuum lumen52 could be drilled out of the coating of material after the material reaches sufficient hardness.
• As shown inFIG. 10, in one version consistent with the invention, the coating of material provides the combinedcutter lumen40 andvacuum lumen52 with an egg-shapedfrontal cross-section110. During surgery,cross-section110 promotes efficient motion of theneedle assembly30 through tissue. However, it is recognized that the application of a coating of material tocutter lumen40 may provideneedle assembly30 with cross-sections of various shapes that are consistent with the process of the current invention. Further, as illustrated inFIGS. 9 and 10,slide108 may comprise a scoop-shaped cross-section111 that providesvacuum lumen52 with a generally scoop-shapedfrontal cross-section112. While this is helpful in providing the combinedcutter lumen40 andvacuum lumen52 with the egg-shapedfrontal cross-section110 described above,vacuum lumen52 and slide108 could comprise various frontal cross-sections that are consistent with the process of the current invention. For instance, slide108 could have a circular frontal cross-section, thus providingvacuum lumen52 with a circular frontal cross-section.
• As shown inFIGS. 4 and 5,tab98 on piercingtip86 may be elongated and slope downward in the proximal direction. In addition to serving as a point of attachment for welding piercingtip86 tocutter lumen40,tab98 may also align and help holdslide108 in place during molding.
• Prior to application of the material to cutter lumen, a slide112 (FIG. 9) may be inserted into tissue-receivingport42.Slide112 prevents any of the applied material from enteringport42.
• Referring now toFIGS. 8 and 9, anaxial slide114 having aproximal end116 and adistal end118 may be inserted into openproximal end62 ofcutter lumen40 prior to application of the coating of material.Axial slide114 prevents the applied material from enteringproximal end62 ofcutter lumen40. Further,axial slide114 may be of a predetermined length such thatdistal end118 extends intocutter lumen40 distally of tissue-receivingport42 but does not reach opendistal end62 ofcutter lumen40.Distal end118 ofslide114 may further comprise anindentation120. Piercingtip86 may be attached todistal end64 ofcutter lumen40 in a manner that does not prevent material from flowing into opendistal end64 during application of the material overcutter lumen40. Accordingly, during the application process, material flows into opendistal end64 ofcutter lumen40 and intoindentation120 inaxial slide114, thereby formingcutter stop72 incutter lumen40 distally of tissue-receivingport42.
• Additionally, in one version of the present invention, one or more slides may be placed againstexterior surface60 ofcutter lumen40 in order to holdcutter lumen40 in position while the material is applied overcutter lumen40 and prevent deformation due to the pressure of the applied material againstexterior surface60. As a result,outer sheath106 may include windows122 (FIG. 3) through whichcutter lumen40 is exposed.
• The injected material may be selected from materials including, but not limited to, plastics, thermoplastics, thermoresins, and polymers. For instance, the molded features may be formed of a liquid crystal polymer or a glass reinforced polymer. One suitable material is a glass reinforced liquid crystal polymer such as VECTRA A130 available from Ticona Corp. In one version, the injected material may have a melt flow index of at least about 10 grams/minute, more particularly at least about 15 grams/minute. Without being limited by theory, such a mold flow index is thought to be beneficial for molding relatively long, thin-walled cross-sections.
• While various versions of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such alternatives are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the present invention. Additionally, each component or element may be described in terms of a means for performing the component's function. Accordingly, it is intended that the invention be limited only by the spirit and scope of the appended claims.

Claims (38)

1. A process of manufacturing a biopsy needle assembly comprising:

forming an aperture for receiving tissue to be sampled in an exterior surface of an elongated tube for receiving a cutter and having a proximal portion and a distal portion;

forming a hole in said exterior surface of said elongated tube; and

applying a coating of material over said elongated tube to form a lumen for receiving vacuum on said exterior surface of said elongated tube, wherein said hole in said exterior surface of said elongated tube provides communication between an interior of said elongated tube and an interior of said lumen.

2. The process ofclaim 1, further comprising attaching a tissue-piercing tip to said distal portion of said elongated tube.

3. The process ofclaim 2, further comprising stamping said tissue-piercing tip out of metal sheet stock prior to attaching said tissue-piercing tip to said elongated tube.

4. The process ofclaim 2, further comprising stamping said tissue-piercing tip out of stainless steel sheet stock prior to attaching said tissue-piercing tip to said elongated tube.

5. The process ofclaim 2, further comprising grinding a cutting blade on said tissue-piercing tip prior to attaching said tissue-piercing tip to said elongated tube.

6. The process ofclaim 3, wherein said tissue-piercing tip is attached to said elongated tube by welding.

7. The process ofclaim 3, wherein said tissue-piercing tip is attached to said elongated tube by laser welding.

8. The process ofclaim 6, wherein said tissue-piercing includes a plurality of attachment points for welding said tissue-piercing tip to said elongated tube.

9. The process ofclaim 2, wherein said tissue-piercing tip comprises an opening through which said coating of material may flow.

10. The process ofclaim 1, further comprising placing said elongated tube in a mold, wherein said coating of material is applied to said elongated tube by injection molding.

11. The process ofclaim 1, wherein said coating of material comprises a liquid crystal polymer.

12. The process ofclaim 1, wherein said coating of material has a melt flow index of at least 15 grams/minute.

13. The process ofclaim 10, further comprising placing a lumen slide against said exterior surface of said elongated tube before said coating of material is injected into said mold, wherein said coating of material flows over said elongated tube and said lumen slide to form said vacuum lumen.

14. The process ofclaim 11, wherein said lumen slide covers said hole in said exterior surface of elongated tube so that said coating of material does not block said hole.

15. The process ofclaim 10, further comprising inserting an aperture slide into said aperture in said elongated tube before said coating of material is injected into said mold to prevent said coating of material from entering said aperture.

16. The process ofclaim 10, further comprising inserting an elongated tube slide comprising a distal end and a proximal end through a proximal end of said elongated tube before said coating of material is injected into said mold.

17. The process ofclaim 16, further comprising placing said elongated tube slide into said elongated tube distally of said aperture before said coating of material is injected into said mold, wherein said distal end of said elongated tube slide further comprises a cutter stop mold such that said coating of material forms a cutter stop in said elongated tube located distally of said aperture.

18. The process ofclaim 1, wherein application of said coating of material forms a mounting component having a proximal end and a distal end on said proximal portion of said elongated tube.

19. The process ofclaim 18, wherein said distal end of said mounting component includes a flange.

20. The process ofclaim 1, wherein application of said coating of material forms a vacuum manifold on said needle, said vacuum manifold having a first opening in communication with said lumen and a second opening for communication with a vacuum source.

21. The process ofclaim 1, wherein said mounting component is adapted to allow communication between a cutter and a vacuum source.

22. The process ofclaim 2, wherein application of said coating of material forms a tapered profile between said tissue-piercing tip and said elongated tube.

23. The process ofclaim 1, wherein said coating of material forms a substantially egg-shaped frontal cross-section for a distal portion of said needle assembly.

24. The process ofclaim 1, further comprising placing a support against said exterior surface of said elongated tube before application of said coating of material to minimize deflection of said elongated tube during application of said coating of material.

25. The process ofclaim 1, wherein said coating of material is approximately 0.020″ thick.

26. A process of manufacturing a biopsy needle assembly comprising:

forming an aperture for receiving tissue to be sampled in an exterior surface of an elongated tube for receiving a cutter and having a proximal portion and a distal portion;

forming a hole in said exterior surface of said elongated tube; and

placing said elongated tube in a mold and injecting said mold with a material, wherein said mold is configured such that said material forms a lumen for receiving vacuum on said exterior surface of said elongated tube, wherein said hole in said exterior surface of said elongated tube provides communication between an interior of said elongated tube and an interior of said lumen.

27. A process of manufacturing a biopsy needle assembly comprising:

placing a cutter tube comprising a port adapted to receive a tissue sample, and further comprising a cutter lumen adapted to receive a cutter, in a mold;

injecting a material in a liquid state into said mold;

cooling said material in order to convert it to a solid state;

wherein said mold is configured to cause said material to form a lumen for receiving vacuum on an exterior surface of said cutter tube;

wherein further said lumen for receiving vacuum is in communication with said cutter lumen.

28. A biopsy needle assembly comprising:

an elongated tube for receiving a cutter and having a proximal portion and a distal portion, the elongate tube including an aperture for receiving tissue to be sampled and a hole in an exterior surface of said elongated tube; and

a lumen formed by a coating of material molded over said elongated tube, wherein said lumen includes an interior in communication with said hole in said elongated tube.

29. The biopsy needle assembly ofclaim 28, further comprising a tissue-piercing tip attached to said distal portion of said elongated tube.

30. The biopsy needle assembly ofclaim 29, wherein said tissue-piercing tip is formed by stamping a tip out of metal sheet stock prior to attaching said tissue-piercing tip to said elongated tube.

31. The biopsy needle assembly ofclaim 29, wherein said tissue-piercing tip further comprises a cutting blade formed by grinding prior to attaching said tissue-piercing tip to said elongated tube.

32. The biopsy needle assembly ofclaim 29, wherein said tissue-piercing tip is attached by a selected one of a group of processes consisting of welding and laser welding.

33. The biopsy needle assembly ofclaim 32, wherein said tissue-piercing tip includes a plurality of attachment points for welding said tissue-piercing tip to said elongated tube.

34. The biopsy needle assembly ofclaim 29, wherein said tissue-piercing tip includes an opening through which said lumen of coating of material is attached.

35. The biopsy needle assembly ofclaim 28, wherein said lumen of coating of material forms a mounting component having a proximal end and a distal end on said proximal portion of said elongated tube.

36. The biopsy needle assembly ofclaim 37, wherein said distal end of said mounting component includes a flange.

37. The biopsy needle assembly ofclaim 28, wherein said lumen of coating of material comprises a vacuum manifold on said needle, said vacuum manifold having a first distal opening in communication with said aperture of said elongate tube and having a second proximal opening operably configured to communicate with a vacuum source.

38. The biopsy needle assembly ofclaim 28, wherein said lumen of coating of material comprises an approximately 0.020″ thickness.

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