US20030204188A1 - Tissue separating and localizing catheter assembly - Google Patents

Abstract

A tissue-separating catheter assembly comprises a rotatable shaft, having a distal shaft portion, and a tissue separator device extending along the shaft. The tissue separator device has a distal separator part at the distal shaft portion movable between a retracted state, towards the distal shaft portion, and an outwardly extending, operational state, away from the distal shaft portion. A localization device is movable to a radially expanded state. An expandable tubular element is movable so that its outer end is generally axially aligned with the localization device so to capture a separated tissue section therebetween to aid removal of the separated tissue section from the patient.

Description

CROSS REFERENCE TO OTHER APPLICATIONS
• This application is a continuation-in-part of U.S. patent application Ser. No. 10/045,657 filed Nov. 7, 2001 and entitled Tissue Separator Assembly And Method. This application is related to the following two patent applications filed on the same date as this application: Tissue Separating Catheter Assembly And Method, attorney Docket No. ARTM 1016-1; Tissue Localizing And Separating Assembly, attorney Docket No. 1019-1. See also: (1) U.S. Pat. No. 6,179,860 issued Jan. 30, 2001 and entitled Target Tissue Localization Device And Method, (2) International Publication No. WO 00/10471 published Mar. 2, 2000 and entitled Target Tissue Localization Device And Method, (3) U.S. Pat. No. 6,221,006 issued Apr. 24, 2001 and entitled Entrapping Apparatus And Method For Use, (4) International Publication No. WO 99/39648 published Aug. 12, 1999 and entitled Entrapping Apparatus And Method For Use, (5) U.S. patent application Ser. No. 09/588,278 filed Jun. 5, 2000 and entitled Tissue Removal Methods And Apparatus, (6) International Publication No. WO 00/74561 published Dec. 14, 2000 and entitled Tissue Removal Methods And Apparatus; (7) U.S. patent application Ser. No. 09/844,661 filed Apr. 27, 2001 and entitled Intraoperative Tissue Treatment Methods.[0001]
BACKGROUND OF THE INVENTION
• Cancer presently results in over one thousand five hundred deaths every day in the United States (550,000 deaths every year). Therapy modalities for cancer are plentiful and continued to be researched with vigor. Still, the preferred treatment continues to be physical removal of the cancer. When applicable, surgical removal is preferred (breast, colon, brain, lung, kidney, etc.). Open, excisional, surgical removal is often extremely invasive so that efforts to remove cancerous tissue in less invasive ways continue, but have not yet been perfected.[0002]
• The only cure for cancer continues to be the early diagnosis and subsequent early treatment. As cancer therapies continue at earlier stages of diagnosis, the cancerous tissue being operated on is also smaller. Early removal of the smaller cancers demand new techniques for removal and obliteration of these less invasive cancers.[0003]
• There is a variety of techniques that attempt to accomplish less invasive cancer therapy, but so far without sufficiently improved results. For example, the ABBI system from U.S. Surgical Corporation and the Site Select system from ImaGyn Corporation, attempt to accomplish less invasive cancer therapy. However, conventional techniques, in contrast with Minimally Invasive Surgery (MIS) techniques, require a large core (that is more than about 15 mm diameter) incision. Additionally, the Mammotome system from Johnson and Johnson and MIBB system from U.S. Surgical Corporation also require large core (over about 4 mm diameter) access to accomplish biopsy.[0004]
• A convention held by the American Society of Surgical Oncologists on Mar. 13, 2000 reported that conventional stereotactic core biopsy (SCB) procedures fall short in providing definitive answers to detail precise surgical regimens after this SCB type vacuum assisted biopsy, especially with ductile carcinoma in situ (DCIS). Apparently these percutaneous systems damage “normal” tissue cells so that it is difficult to determine if the cells are “normal damaged” cells or early pre-cancerous (e.g. Atypical Ductal Hyerplasia (ADH)) cells.[0005]
• A study presented by Dr. Ollila et al. from the University of North Carolina, Chapel Hill, demonstrated that histology and pathology is compromised using these conventional techniques because of the damage done to the removed tissue specimens. Hence, for many reasons, including the fact that DCIS is becoming more detectable and hence more prevalent in breast cancer diagnosis in the U.S., there is a growing need to improve upon conventional vacuum assisted core biopsy systems.[0006]
SUMMARY OF THE INVENTION
• A first aspect of the invention is directed to a tissue-separating catheter assembly comprising a rotatable shaft having a distal shaft portion, a tissue separator device extending along the shaft and having an expandable distal separator part at the distal shaft portion, a radially-expandable localization device at the distal shaft portion, and an expandable tubular element movable so its outer end may be generally axially aligned with the localization device. A tissue section separated from surrounding tissue by the tissue separator device may be capturable by the localization device and the tubular element to aid removal of the separated tissue section from a patient.[0007]
• A second aspect of the invention is directed to a method for separating and capturing a tissue section from surrounding tissue of a patient. A localization device is directed along a tissue track to a position distal of a target site. The localization device is changed from a first, radially-contracted state to a second, radially-expanded state. A tissue section at the target site is separated from surrounding tissue. An expandable tubular element is pushed over the separated tissue section until its outer end is generally aligned with the localization device, thereby effectively capturing the separated tissue section.[0008]
• Other features and advantages of the invention will appear from the following description in which the preferred embodiments have been set forth in detail in conjunction with the accompanying drawings.[0009]
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a partially schematic overall view of a tissue separator assembly made according to the invention with portions of the handle removed for clarity;[0010]
• FIG. 1A is a simplified cross-sectional view taken along line[0011]1A-1A of FIG. 1 showing the engagement of a pin within a slot in the lead nut mounted to the lead screw;
• FIG. 2 is schematic view of portions of the drive elements of the assembly of FIG. 1;[0012]
• FIG. 3 is a simplified cross-sectional view of the catheter assembly taken along line[0013]3-3 of FIG. 1;
• FIG. 4 is an oblique view of the housing half of FIG. 1 together with the drive screw, drive nut and an L-shaped actuator connected to and movable with the drive nut;[0014]
• FIGS. 5 and 6 show the handle and catheter assembly of FIG. 1 after the actuator has moved from the position of FIG. 1 and the actuator extension has pushed the separator wire pusher screw in a distal direction causing the separator wire to move radially outwardly;[0015]
• FIG. 7 is a simplified the end view of the block and the pusher screw just after the pusher screw has exited the slot in the block showing the off-vertical orientation of the pusher screw;[0016]
• FIG. 8 illustrates the proximal end of the lead screw, which is visible from outside the housing, and a rotary position indicator marked thereon corresponding to the position of the separator wire in FIG. 10;[0017]
• FIGS. 9 and 10 illustrate the structure of FIGS. 5 and 6 after the drive screw has moved the actuator distally causing the lead nut to rotate the lead screw, catheter shaft and separator wire therewith about 540 degrees to create a separated tissue section;[0018]
• FIGS. 11 and 12 illustrate the manual actuation of tissue section holding elements;[0019]
• FIG. 13 is a simplified view of certain of the components of FIG. 12;[0020]
• FIG. 14 is a cross-sectional view of the catheter taken along line[0021]14-14 of FIG. 13;
• FIGS. 15 and 16 illustrate the manual actuation of a tubular braided element to surround the separated tissue section;[0022]
• FIG. 17 is a simplified view of certain of the components of FIG. 16;[0023]
• FIG. 18 is enlarged side view of the distal end of an alternative embodiment of the catheter assembly of FIG. 1;[0024]
• FIG. 19 is a side view of a modified embodiment of the distal end of the catheter assembly of FIG. 18;[0025]
• FIG. 20 is a schematic illustration showing the difference in size between the separated tissue sections of the embodiments of FIGS. 18 and 19;[0026]
• FIG. 21 is an enlarged top view taken along line[0027]21-21 of FIG. 18;
• FIG. 22 is an enlarged cross-sectional view taken along the line[0028]22-22 of FIG. 21;
• FIG. 23 is a cross-sectional view taken along line[0029]23-23 of FIG. 18;
• FIGS.[0030]24A-24H are simplified side views of different embodiments of the guide element/transition surface of FIG. 18;
• FIG. 25 is an overall view of the distal end of the catheter assembly of FIG. 18 illustrating a hook wire/tissue holding element in a deployed condition;[0031]
• FIG. 26 is a cross-sectional view of a portion of the shaft of FIG. 25;[0032]
• FIG. 27 is a somewhat simplified cross-sectional view of the structure of FIG. 25 with the separator wire portion in a radially retracted state;[0033]
• FIG. 27A is a somewhat simplified cross-sectional view of the structure of FIG. 25 with the separator wire portion in a radially extended state;[0034]
• FIG. 28 illustrates a further embodiment of the invention of FIG. 18 including three separator wire portions, one of which is shown in the operational state; and[0035]
• FIG. 29A is a simplified end view of the structure of FIG. 28 suggesting three equally-spaced separator wire portions, each in their retracted states;[0036]
• FIG. 29B is a view similar to FIG. 29A but with one separator wire portion in an operational state;[0037]
• FIG. 30 is a simplified schematic illustration of a tissue-penetrating assembly;[0038]
• FIG. 31 is an overall view of a tissue localizing and separating assembly made according to the invention including a tissue separator assembly, a coupler and a tissue localization assembly, the localization device of the tissue localization assembly being in an expanded condition at a target site within a patient;[0039]
• FIG. 32 is an enlarged view of a portion of the assembly of FIG. 31 illustrating a loop at the distal end of the coupler being engaged with the proximal end of the tissue localization assembly;[0040]
• FIGS. 33 and 34 illustrate the distal end of the coupler and the proximal end of the tissue localization assembly of FIG. 31 joined to one another;[0041]
• FIG. 35 illustrates the distal movement of the tissue separator assembly causing the joined ends of FIGS. 33 and 34 to be moved into the catheter assembly thereby docking the tissue localization assembly to the tissue separator assembly;[0042]
• FIGS.[0043]35A-35C are simplified drawings showing the movement of an indicator tube, secured to the elongate coupler, through an opening in the proximal end of the handle;
• FIG. 36 is an enlarged view of the distal portion of the assembly of FIG. 35 after the separator wire portion has been radially expanded and rotated and after the hook wire has been deployed to engage the separated tissue section;[0044]
• FIG. 37 illustrates the assembly of FIG. 36 after the catheter assembly sleeve has been moved proximally a short distance to expose the distal end of the tubular braided element;[0045]
• FIG. 38 is a somewhat idealized illustration of the movement of the tubular braided element in a distal direction within a patient with the tubular braided element initially generally following the outline of the separated tissue section and its outer end generally axially aligned with the localization device;[0046]
• FIG. 39 illustrates the assembly of FIG. 38 after having been removed from the patient with the outer end of the tubular braided element returned to its relaxed state;[0047]
• FIG. 40 illustrates the shape of a tubular braided material after it has been stretched over a cylindrical mandrel having an enlarged central portion;[0048]
• FIG. 41 illustrates the structure of FIG. 40 after one end of the mandrel and the tubular braided material has been dipped into a silicone compound;[0049]
• FIG. 42 illustrates the open mesh end of the dipped tubular braided material, after the silicone has been cured and removed from the mandrel, being pulled back into the dipped end to create a tubular braided element;[0050]
• FIG. 43 illustrates the resulting tubular braided element being mounted to the distal end of the actuator tube;[0051]
• FIG. 44 shows the proximal end of the tubular braided element being secured to the distal end of the actuator tube by a length of heat shrink tubing; and[0052]
• FIG. 45 illustrates the tubular braided element secured to the actuator tube.[0053]
DESCRIPTION OF THE SPECIFIC EMBODIMENTS
• FIGS. 1 and 2 illustrate a[0054]tissue separator assembly10 used to separate target tissue from surrounding tissue, typically within a patient's breast. The removal of target tissue may be for diagnostic or therapeutic purposes. Theassembly10 includes acatheter assembly12 extending from ahandle14. Introduction ofcatheter assembly12 into the patient, typically through the skin, is preferably aided by the use of, for example, a trocar or an RF tip to provide a suitable path through the tissue. Astepper motor16 is connected to handle14 by adrive cable18 and adrive cable connector20 mounted to thehandle housing22. Note that in the Figs. only one-half ofhandle housing22 is shown; the other housing half is substantially similar. RF energy is supplied tocatheter assembly12 from anRF source24, alongdrive cable18 and to the interior ofhandle14. Acontroller26 controls the operation ofstepper motor16 as well asRF source24, such as speed of operation and energy level.Controller26 also receives appropriate feedback signals fromhandle14 andcatheter assembly12, such as tissue temperature, resistance force signals, tissue impedance, rotary orientation, and so forth.
• [0055]Drive cable18 is connected to and rotates adrive screw28 rotatably mounted withinhandle14 at a fixed axial location by drive screw supports30,32. Adrive nut34 is threadably mounted to drivescrew28. An L-shapedactuator36 is secured to drivenut34.Actuator36, see FIG. 4, includes a generallyhorizontal base portion38 and a generallyvertical upright portion40 sized and configured to move withinhandle14 parallel to the axis ofdrive screw28. Therefore, rotation ofdrive screw28 bystepper motor16 causes actuator36 to slide withinhousing22 from the initial position of FIG. 1 to the position of FIG. 10. Reverse and reciprocating movement is also possible.
• [0056]Catheter assembly12 includes inintroducer sheath42 mounted to and extending fromhousing22.Catheter assembly12 also includes anactuator tube43, discussed below with reference to FIGS.14-17, passing throughsheath42 and ashaft44 passing throughtube43. See FIG. 3.Shaft44 has adistal portion46 extending distally of thedistal end48 ofsheath42 and aproximal portion50 extending into the interior ofhandle14.Proximal portion50 is secured to and rotates with alead screw52. Accordingly,shaft44 rotates withlead screw52. Leadscrew52 is mounted withinhousing22 in a manner so that it can rotate but not move axially withinhousing22. Atissue separator device54 extends alongshaft44 and has aseparator wire portion56 secured to the distal end58 ofshaft44. Theseparator wire56 is positioned externally ofdistal portion46. The majority oftissue separator device54 is in the form of a wire and extends through anaxial bore60 formed inshaft44. Theseparator device54 has a radially extendingpusher screw62 at its proximal end. The proximal end ofshaft44 has an axially extendingslot64, see FIG. 2, through which pusher screw62 extends. Accordingly, pushingpusher screw62 distally, that is to the left in the Figs., causestissue separator wire56 to move outwardly from its radially contracted condition of FIG. 1 to its radially extended condition of FIGS. 5 and 6. This radially outwardly movement is typically accomplished at the target site within the patient, typically a patient's breast. To aid movement of separator wire through the tissue,wire56 is supplied with RF energy fromRF source24. Other applications of energy, such as mechanical reciprocation or mechanical vibration, can also be used.
• The axial movement of[0057]pusher screw62 is caused by the axial movement ofactuator36.Actuator36 has anextension66 extending distally fromupright portion40.Extension66 has a downwardly formeddistal end68 aligned withpusher screw62. The initial axial movement ofactuator40, caused by the rotation ofdrive screw28 bystepper motor16, closes a small gap70 (see FIG. 2) betweendistal end68 andpusher screw62. This small gap permits the initiation of an electrosurgical arc prior to the outwardly radial movement ofseparator wire56. Continued distal movement ofactuator36 moves pusher screw62 distally causingseparator wire56 to bow outwardly to the position of FIGS. 5 and 6. FIGS. 5 and 6 (but not FIG. 1) show the use of asupport block72, which is a part ofhousing22, to support the distal end oflead screw52 and the proximal end ofshaft44.Support block72 has an axially extendingslot74, see FIGS. 5 and 7, which initially housespusher screw62. At thetime separator wire56 is fully extended,pusher screw62exits slot74 and thedistal end68 ofextension66, which has a chamfered face, causespusher screw62, along withshaft44, to begin rotating to the off-vertical position of FIG. 7. At the same timeupright portion40 ofactuator36 closes gap73 (see FIG. 2) and contacts alead nut75 threadably mounted onlead screw52. Ananti-rotation pin76 extends fromupright portion40 ofactuator36 and is housed within aU-shaped slot78 formed inlead nut74, see FIG. 1A, to preventlead nut74 from rotating aroundlead screw52 aslead nut74 it is moved axially byactuator36. Instead, the axial movement ofactuator36 causes leadscrew52 to rotate thus rotatingshaft44.Assembly10 is configured so thatshaft44 rotates about 540 degrees to ensure atissue section80 is completely separated from the surrounding tissue by the passage ofseparator wire56 through the tissue. The radial position ofseparator wire56 can be easily determined by looking at theproximal end82 oflead screw52, which is exposed throughhousing22. See FIG. 8.Proximal end82 has arotary position indicator84 formed thereon corresponding to the rotary position ofseparator wire56.
• The above-described sequence of events, according to this disclosed embodiment, proceeds automatically once initiated by a user. Of course operation of the device, including one or more of extension of[0058]separator wire56, rotation ofshaft44 and energizingwire56, can be terminated manually or automatically based on, for example, an unexpected resistance to the rotation ofshaft44.
• [0059]Assembly10 also includes a T-pusher device86 having a pair ofpusher tabs88 extending laterally outwardly from slots formed inhousing22. See FIGS.11-13. Aftershaft44 has completed its rotation, the user begins pushingtabs88 distally. This causes anextension90 ofdevice86 to rotate aflipper cam92 about apivot pin94;flipper cam92 is connected to the proximal ends of a pair of tissuesection holding elements96. Holdingelements96 are in the form of wires passing throughaxial bores98 formed inshaft44 as shown in FIG. 3. The distal ends of holdingelements96 are preformedhook wires100, preferably made of a shape memory material such as Nitinol, which pass through openings formed indistal portion46 ofshaft44 and engage separatedtissue section80 to helpsecure tissue section80 todistal portion46 ofshaft44.
• [0060]Device86 includes adistal end102 connected to the proximal end ofactuator tube43. Thus, the movement ofdevice86 causestube43 to move distally withinintroducer sheath42. At this point, that is withhook wires100 deployed as an FIGS.11-13, atubular braided element104, see FIGS.14-17, secured to the distal end ofactuator tube43, is still fully housed withinsheath42. Further distal movement ofdevice86 causes tubular braidedelement104 to extend outwardly pastdistal end48 ofsheath42 to the position of FIGS.15-17. The purpose oftubular braided element104 is to surround separatedtissue section80 by passing along the dissection plane between the separated tissue section and the surrounding tissue. The openouter end106 ofelement104 naturally expands radially as it is pushed axially through the tissue. To aid the proper initial radial expansion ofelement104,shaft44 has an outwardlytapered guide surface108, formed on aguide element110, positioned adjacent todistal end48 ofintroducer shaft42. The proper radial expansion ofelement104 may also be aided by the shape thatelement104 takes when in its relaxed state. See, for example, the discussion oftubular braided element104 with regard to FIGS.40-45.Guide element110 has a slot in its proximal surface into which the proximal end ofseparator wire56 passes when in the radially expanded condition of FIG. 9; this helps to keepseparator wire56 from folding over during rotation. If desired,outer end106 oftubular braided element104 could include a drawstring or other type of closure element. The separatedtissue section80, now substantially enclosed withintubular braided element104 and secured todistal portion46 ofshaft44 byhook wires100, may be removed from the patient.
• With the present invention separated[0061]tissue section80 retains most if not all of its physical integrity once removed from the patient. Also, the use oftubular braided element104, especially when it is sealed or otherwise impermeable to the passage of material, helps to reduce the possibility of seeding diseased tissue along the tissue track during removal of separatedtissue section80.
• FIGS.[0062]18-29B illustrate further embodiments of the invention with like reference numerals referring to like elements. FIG. 18 is an enlarged side view of the distal end120 of alternative embodiment of thecatheter assembly12 of FIG. 1. Referring now also to FIGS. 21, 22 and27,separator wire portion56 is seen to include adistal end122.Distal end122 terminates at a ball-type element124 (see FIG. 22) housed within acavity126 defined withindistal portion46 ofshaft44 at thetip136 of the distal portion to form apivot joint128. The provision of pivot joint128 permitsdistal end122 to effectively pivot freely asseparator wire portion56 is moved between the operational and retracted states. In addition to reducing stresses and improving the fatigue characteristics ofdistal end122 ofseparator wire portion56, the use of pivot joint128 helps to increase the volume of the separated tissue section removed from the patient for the same distance of travel oftissue separator device54. This increase in volume may be appreciated by comparing the embodiments of FIGS. 18 and 19. In the FIG. 19 embodiment, thedistal end122 ofseparator wire portion56 is rigidly or otherwise non-pivotally secured todistal portion46 ofshaft44. FIG. 20 illustrates the increased volume of separatedtissue section80A resulting from the embodiment of FIG. 18 to the reduced volume, separatedtissue section80B from the embodiment of FIG. 19. In this example the volume of separatedtissue section80A has been calculated to be about 50 percent greater than the volume of separatedtissue section80B for the same distance of travel oftissue separator device54.
• [0063]Distal portion46 ofshaft44 includesguide element110 which acts as atransition surface110.Transition surface110 is a distally-facing surface extending radially outwardly and proximally, that is longitudinally away from thetip136 ofdistal portion46. A series of spaced-apart, first, proximal energizabletissue separator elements130 are positioned alongtransition surface110. FIG. 23 is a cross-sectional view taken along line23-23 of FIG. 18 and illustrates the electrical connection ofelements130 tometallic tube132.
• FIGS.[0064]24A-24H illustrate alternative embodiments offirst elements130.Elements130A have extended longitudinal lengths, as compared with the essentiallycircular elements130 of FIGS. 18 and 23. It is believed that the extended lengths ofelement130A may be useful for reducing the penetration force needed for placement at the target site. The FIG. 24A embodiment is the presently preferred embodiment. Element130B comprises a circumferentially continuous or substantially circumferentially continuous element. The circumferentially extending element130B may also be useful for reducing the required penetration force.Elements130C are similar toelements130 but are located atperipheral region140 oftransition surface110. Elements130D and130E, shown in FIGS. 24D and 24E, are generally V-shaped and serpentine-shaped variations.Elements130F and130G, shown in FIGS. 24F and 24G, extend along substantially the entire lengths ofdistal portion46 in straight and spiral configurations, respectively. FIG. 24H illustrates a further embodiment of elements130H with elements130H extending radially outwardly fromdistal portion46; elements130H may be retractable and may have shapes other than the pointed, triangular shape illustrated. Whileelements130 are typically formed from metal wires or similar structure,elements130 may also be painted, plated or otherwise deposited on the surface ofdistal portion46. A combination of two or more of the arrangements ofelement130 may be useful in appropriate circumstances. While presently all ofelements130 are supplied with equal energy levels, different energy levels may be supplied. Also, the energy levels supplied may be varied over time or according to the resistance to the passage ofseparator wire portion56 through the tissue. Also, energy toelements130 may be turned on as needed at the discretion of the user.
• [0065]Distal portion46 is hollow and contains an electrically conductive,metallic tube132 defining anopening134 at thetip136 ofdistal portion46. The outer, annular edge oftube132 acts as a second, distal energizabletissue separator element138. Bothfirst element130 andsecond element138 are selectively coupleable to one or more appropriate energy sources to aid movement ofdistal portion46 through tissue to the target site.
• FIGS. 25 and 26 illustrate the[0066]hook wires100, which act as tissue holding elements, extending throughopenings142 formed withindistal portion46 ofshaft44.Hook wires100 are preferably sized, positioned and shaped to engage separatedtissue section80 at about its center of mass. While twohook wires100 are shown in this embodiment, a greater or lesser number may also be used. Also, hookwires100 having different sizes and shapes may be used.Hook wires100 may also be located at different axial positions and may be energizable to aid movement through tissue.
• FIGS. 25, 27 and[0067]27A illustrate the passage ofseparator wire portion56 through proximal anddistal channels146,148 formed indistal shaft portion46.Distal portion46 defines abase surface150 extending along the bottoms ofchannels146 and148 and extending betweenchannels146 and148.Separator wire portion56 lies againstbase surface150 when in a retracted state. As shown best in FIGS. 27 and 27A, thecentral portion152 ofbase surface150 is convex so that whenseparator wire portion56 is in the retracted state, a central portion ofwire portion56 lies along a convex line, that is a line that bows slightly outwardly. Therefore whentissue separator device54 is moved distally,separator wire portion56 is predisposed to move radially outwardly in the desired manner. The amount of force needed to be applied todevice54 may also be reduced by the use of convexcentral portion152.
• FIG. 28 illustrates a further alternative embodiment to the embodiment of FIG. 18 comprising three[0068]separator wire portions56, as opposed to one in FIG. 18, onewire portion56 being shown in an operational state and the other twowire portions56 in retracted states and adjacent base surfaces150. This is suggested in FIG. 29B. Another difference from the embodiment of FIG. 18 is that the function of first, proximal energizabletissue separator elements130 has been replaced by energizing the threeseparator wire portions56 when the device is directed through tissue to a target site withwire portions56 in retracted states. This is suggested in FIG. 29A. Once at the target site the physician may decide to move one, two or all three ofseparator wire portions56 from the retracted state to the operational state depending on various factors, such as the characteristics of the tissue and the number ofpieces tissue section80 is to be divided into.
• [0069]Distal portion46, in the embodiment of FIGS.18-29B, comprises aproximal element154, a body portion156 andtip136,tip136 acting as an end cap. FIG. 27 illustrates the interengagement ofelements154,156 and136.Elements154,156 and136 are configured to promote simple assembly. Assembly may take place by simply stacking each element in order overcentral tube132, the parts being held in place distally by the flaredend138 of the tube.Elements154,156 and136 are preferably electrically non-conductive.Elements154 and156 are typically made from the medical grade ceramic material, such as Al₂O₃or zirconia, whiletip136 is typically made from a medical grade polymer, such as PEEK or polyimide.
• The amount of force required for the passage of a needle, or other tissue-penetrating element, such as[0070]distal portion46 ofshaft44, through tissue often changes because the tissue characteristics often changes between the point of entry and the target site. If the tissue-penetrating element must pass through a hard or otherwise difficult-to-penetrate tissue region, the amount of force needed to penetrate the hard tissue region may be sufficiently great to, for example, cause the tissue-penetrating element to buckle. Even if the tissue-penetrating element has sufficient columnar strength to resist buckling, the amount of force required may be sufficient to cause the tissue to be deformed making it difficult to position the tip of the tissue-penetrating element at the target site. Also, once the tip has passed through the difficult-to-penetrate tissue region, the amount of force needed to do so may tend to cause the tip of the tissue-penetrating element to be inserted much farther than desired causing unintended tissue trauma and possibly injuring adjacent organs.
• FIG. 30 illustrates, in schematic form, a tissue-penetrating[0071]assembly160 comprising broadly a tissue-penetratingsubassembly162 coupled to a tissue-energizing circuit164 and a force-sensitive switch166 operably coupled to the tissue-penetrating subassembly. Thesubassembly162 comprises ahandle assembly168, or other support assembly, including ahandle170, ahandle extension172 extending rigidly fromhandle170, and aneedle clamp172 mounted to handle170 at apivot176. Subassembly162 also includes aneedle178, or other tissue-penetrating device, secured to and extending from needle clamp174.Needle178 includes aneedle shaft180 covered byelectrical installation182 along most of its length.Electrical installation182 helps to concentrate the tissue-penetrating energy at thetip184 ofneedle178,tip184 having a tissue-separatingsurface185.
• Force-sensitive switch[0072]166 includes acompression spring186 captured between needle clamp174 and handleextension172.Assembly160 also includes an armingswitch188 mounted to handle170, switch188 including anarm190 mounted to handle170 at apivot192. Switch188 also includes an armingcompression spring194 captured betweenarm190 and handleextension172. The use of armingswitch188 helps to enhance the safety ofassembly160 by helping to prevent the inadvertent connection ofneedle178 toRF generator200. Circuit164 includes a pair ofleads196,198 electrically connected to needle clamp174, and thusneedle tip184, and toarm190 throughpivots176,192, respectively. Circuit164 also comprises anRF generator200, from which leads196,198 extend, and areturn cable202coupling generator200 to a return pad204. An electrical conductor206 is mounted to handleextension172 and has electrical contact surfaces208,210 positioned opposite the corresponding surfaces ofneedle shaft180 andarm190. Anarming button212 is mounted toarm190 to permit the user to arm assembly116 by pressing onarming button212 to causearm190 to contactsurface210. With the device now armed,needle178 is directed into tissue, exemplified by three layers of tissue, including soft tissue layers214 and218 and hard or otherwise difficult-to-penetrate tissue layer216. Upon encountering hard tissue layer216, the force needed to penetrate tissue layer216 is sufficient to compressspring186 and causeneedle shaft180 to contactelectrical contact surface208 thus completing the circuit toRF generator200. At thispoint RF generator200 can supply energy to surface185 attip184 permittingneedle178 to pass through hard tissue216 without excessive force. Oncetip184 has passed through hard tissue layer216, the force onneedle178 decreases to permitspring186 toseparate needle shaft180 fromcontact surface208 so to stop supplying RF energy totissue separator surface185.
• Tissue-penetrating[0073]assembly160 can be used to aid the insertion of a simple needle into tissue. However, the tissue-penetrating invention also can be incorporated into other devices including tissue-penetrating elements, such as the embodiments discussed above includingshaft44 and a target tissue localization device disclosed in U.S. Pat. No. 6,179,860.
• FIGS.[0074]31-39 illustrate further aspects of the invention in whichtissue separator assembly10 is combined with anelongated coupler220 and atissue localization assembly222 to arrive at a tissue localizing and separatingassembly224.Tissue localization assembly222 may be of the type disclosed in U.S. Pat. No. 6,179,860.Assembly222 is shown deployed within apatient226 with localization device to112 in a radially expanded, deployed condition.Assembly222 includes a sheath228 (see FIG. 32) within which apull wire230 is slidably housed. The relative axial movement ofsheath228 and pullwire230 causeslocalization device112 to radially expand and radially contract. Theproximal end232 ofpull wire230 is a recurved end232 (see FIGS. 32, 34) for engagement bycoupler220 as discussed below.
• [0075]Coupler220 is a flexible wire having acoupler loop234 at its distal end and an enlargedproximal end236.Coupler220 passes through shaft44 (see FIGS. 2, 32) ofcatheter assembly12.Coupler loop234 is used to joincoupler220 to therecurved end232 ofpull wire230; this is shown in FIGS.31-34. After being so joined,tissue separator assembly10 is moved distally alongcoupler220, while the user graspsend236 to maintain tension on thetissue localization assembly220, causing the joined ends232,234 to pass intoshaft44 thus dockingtissue localization assembly222 totissue separator assembly10. Continued distal movement ofassembly10 causescatheter assembly12 to enterpatient226 and pass along the tissue track created bytissue localization assembly222 untiltip136 ofdistal portion46 ofshaft44 is properly positioned relative tolocalization device112. Proper positioning is visually indicated to the user by a length oftube233, typically colored red and affixed tocoupler220, becoming exposed after exiting the proximal end opening235 ofhandle14 as shown in FIGS.35A-35C. When properly positioned, see FIG. 35C, alocking spring clip237, located onhandle14 adjacent toproximal end opening235, springs back from its biased position of FIG. 35B to its unbiased position of FIGS. 35A and 35C to preventtube237 from inadvertently reenteringhandle14. When so positioned,tissue localization assembly222 becomes at least temporarily locked or fixed totissue separator assembly10 to prevent the inadvertent relative axial movement betweenlocalization device112 andassembly10. Of course other locking mechanisms, such as a spring finger carried byassembly220 and engageable withhandle14, can also be used to lockassemblies10,222 to one another.
• FIG. 36 is an enlarged view of the distal portion of[0076]assembly224 of FIG. 35 afterseparator wire portion56 has been radially expanded and rotated, to create a separatedtissue section80, and afterhook wire100 has been deployed to engage the separatedtissue section80. It has been found to be desirable to leave a space, indicated generally asdistance238, betweenlocalization device112 and separatedtissue section80. FIG. 37 illustrates the assembly of FIG. 36 afterintroducer sheath42 has been moved proximally a short distance to exposeouter end106 oftubular braided element104. FIG. 38 is a somewhat generalized illustration of the movement oftubular braided element104 in a distal direction withinpatient226 with the tubular braided element initially generally following the outline of separatedtissue section80 andouter end106 generally axially aligned withlocalization device112. It should be noted that the movement ofouter end106 oftubular braided element104 will generally following the path indicated until it reachesposition240. Followingposition240, the pathouter end106 takes will largely depend on the physical characteristics of the tissue through which is passing. However, the path illustrated is typical.Separated tissue section80 is then removed frompatient226 by simultaneously pulling the entire assembly shown in FIG. 38, including separatedtissue section80 captured bytubular braided element104 andlocalization device112, secured bycoupler220, back along the tissue track. During this movementtubular braided element104 has a tendency to elongate axially to a reduced diameter, more cylindrical form thus reducing potential tissue trauma along the tissue track and through the access opening at the beginning of the tissue track.
• FIG. 39 illustrates the assembly of FIG. 38 after having been removed from[0077]patient226 withouter end106 oftubular braided element104 returned to its relaxed state andtissue specimen80 retained bytubular braided element104 andlocalization device112. As suggested in FIG. 39,tubular braided element104, when in a relaxed state, has a generally trumpet shape withouter end106 flaring outwardly. It has been found that this trumpet shape helps to guidetubular braided element104 around separatedtissue section80, especially during its initial movement fromintroducer sheath42.
• FIGS.[0078]40-45 illustrate a preferred method of makingtubular braided element104.Tubular braided element104 is sized according to the size of the tissue specimen being removed so that the number of elements, sizes and other specifications discussed below may be varied according to a particular circumstance. FIG. 40 illustrates the shape of a length of tubularbraided material244 after it has been stretched over a cylindrical mandrel (not shown) having an enlarged (20.5 mm diameter by 50 mm long) central portion in this embodiment.Material244, prior to being stretched over the mandrel, is supplied in a continuous length and cut to size for the mandrel and a starting diameter of {fraction (5/16)}″ or ˜8 mm.Material244 is made of monofilament polyester fibers having a diameter of 0.10 inch (0.25 mm) The braid consists of 56 monofilaments and is made on 56 carrier braider. The braid, when formed in continuous lengths, maintains an approximate {fraction (5/16)}″ (8 mm) internal diameter. The braid angle is held fixed during the braiding operation, and was chosen for this application because a small shortening in axial length results in a rapid change in diameter. The enlarged central portion of the mandrel corresponds to the shape of tubularbraided material244, that is it is cylindrical with generally hemispherical ends. FIG. 41 illustrates the structure of FIG. 40 after one end of the mandrel and tubularbraided material244 has been dipped into a silicone compound. The dipped structure is then cured, typically in an oven, to create a silicone film orweb246 covering one end of tubularbraided material244. After curing, the dipped, curedstructure248 is removed from the mandrel by being pulled over the mandrel from left to right in FIG. 41. FIG. 42 illustrates theopen mesh end250 of the dipped, curedstructure248 being pulled back into the dipped end to create the dual-wall tubular braidedelement104 shown in FIG. 43. FIG. 43 illustratestubular braided element104 being mounted to the distal end ofactuator tube43. FIGS. 44 and 45 show the proximal end oftubular braided element104 being secured to the distal end ofactuator tube43 by a length ofheat shrink tubing252 and an adhesive to create a tissue-surroundingassembly254. Dual-wall tubular braidedelement104 has anouter wall256 substantially completely covered withsilicone web246, andinner wall258 at least substantially free of the silicone web material, an an openouter end106 covered withsilicone web246.
• [0079]Silicone web246 serves at least two functions. It helps maintain the trumpet shape oftubular braided element104 in its relaxed state while permitting the tubular braided element to radially expand and radially contract from the trumpet shape. It also helps to prevent passage of tissue throughtubular braided element104 during removal of separatedtissue section80. This helps to prevent contamination along the tissue track during tissue removal procedures. Whiletubular braided element104 could be made as a single layer, that is withoutopen mesh end250 being pulled back into the structure, it has been found that doing so helps to maintain a softer leading edge atouter end106 oftubular braided element104. The general trumpet shape shown in FIGS.43-45 occurs as a natural result of the forming process illustrated and described.
• The following discussion of the development of the current embodiment of[0080]braided element104 may be useful in appreciating its various features and advantages. The presently preferred embodiment ofbraided element104 comprises a tubular sleeve of braided polyester (PET—polyethylene terephthalate) monofilament folded over itself to form a smooth end. The open weave construction allows it to enlarge to several times its original diameter. The outer braided layer is coated with silicone.
• Early braided element prototypes consisted of Nitinol braided tubing. The wire diameter, braid angle and number of wires that comprise the braid were explored. These properties affect the strength of the braided element. The braided element must have enough stiffness and columnar strength to overcome the forces acting against it as it is deployed in the tissue. However, if it is too rigid, it may push the separated tissue section further into the cut cavity. Non-braided forms were also considered, such as Nitinol wire placed axially along the lengths of the axis, supported by coating or other rigid members. The combination of wire diameter, braid angle, and number of wires also affects the retracted properties of the braided element. In its undeployed state, the braided element was designed to fit inside a 6 mm sheath. Some of the Nitinol prototypes that were fabricated seemed to have adequate strength and stiffness, and fit within a 6 mm sheath. However, because of other factors discussed below, a PET braid presently preferred over a Nitinol braid.[0081]
• There are several factors that interact to effect columnar strength. Braid angle, number of filaments, and filament material stiffness and diameter are the main determinants. Axial orientation, greater number and stiffer filaments all combine for greater columnar strength. The presently preferred material for[0082]braided element104 is 0.010″ (0.25 mm) diameter monofilament. The number of monofilaments in the braid was chosen to optimize the mechanical properties ofbraided element104. Increasing the number of filaments will create the opposite effect—the columnar strength will be reduced thus increasing the chance of buckling. Fewer filaments creates an increase in spacing between the filaments as the braided element expands from retracted to deployed. If the spacing becomes too large, the coating may tear. Also, a braided element constructed with a more axially oriented braid angle will take up much more length in the retracted state and therefore require a greater amount of travel to deploy. The number of filaments was chosen to optimize braided element strength, spacing between filaments, and amount of deployment travel.
• It is presently preferred that the distal end of the braided element, that is the end that first comes into contact with the tissue, be smooth. It was discovered at a braided element with jagged or sharp edge may get caught in the tissue and fail to slide into the cut tissue interface around the separated tissue section. For the Nitinol braid, various methods of terminating the lose wires were explored, such as soldering, brazing, or bonding balls at the wire ends, or folding each single wire over. These methods were not very successful. For the balls to be atraumatic, they need to be of considerable size. The balls or folded-over ends increase the diameter of the retracted braided element, making it difficult to fit inside a sheath. This led to concepts of ‘roll-over’ and ‘double layer’ braided elements. For both concepts, the tubular braid is folded over itself to form a two-layered braided element with folded-over, smooth ends. For a ‘double layer’ braided element, the two layers are bonded together at the proximal end. The two-layered Nitinol braided elements that were prototyped showed promising characteristics. However the folded-over ends provided too much bulge and made it difficult or impossible to retract into a 6 mm diameter sheath. The PET braid, on the other hand, forms a nice crease when the braid is folded over, and is easily retracted into the sheath. For deployment, the outer layer is pushed forward and allowed to slide over the inner layer. This embodiment has potential but is not the presently preferred embodiment.[0083]
• The shape of the braided element also affects its functionality. Braided element prototypes of many different shapes were tested, such as “bullet”, “cone”, and “bell” or “trumpet” profiles of varying diameters. A desirable characteristic of[0084]braided element104 is that the braided element flares open as it is initially deployed, so that it is predisposed to expand around the biopsy sample rather than push the sample further into the cavity. The shape ofbraided element104 has been optimized to maximize the amount that it flares open during deployment.
• The braided element is currently coated with a two-component silicone elastomer. Some polyurethane coatings were investigated also, but did not perform as well as silicone coatings during preliminary testing. The silicone coating was chosen because of its high tear strength and elasticity. From the retracted state to the fully deployed state, the diameter of braided[0085]element104 may expand as much as 300%. The braided element may have a snare at the distal end to aid in capturing the sample.
• Modification and variation can be made to the disclosed embodiments without departing from the subject of the invention as defined in the following claims. For example,[0086]lead screw52 could be hollow to permitactuator shaft114, or other medical devices, to pass therethrough and into a lumen withinshaft44. Whilebase surface150 is shown to have a smoothly curving shape,surface150 may have other shapes, such as a discontinuous surface shape, a flat surface shape with one or more projections providing the desired bow in theseparator wire portion56, or a combination thereof.Braided element104 may be made of other materials and by other processes than those disclosed.
• Any and all patents, patent applications and printed publications referred to above are hereby incorporated by reference.[0087]

Claims (5)

What is claimed is:

1. A tissue-separating catheter assembly comprising:

a rotatable shaft having a distal shaft portion;

a tissue separator device extending along the shaft and having a distal separator part at the distal shaft portion movable between a retracted state, towards the distal shaft portion, and an outwardly extending, operational state, away from the distal shaft portion;

a localization device at the distal shaft portion movable from a first, radially-contracted state to a second, radially-expanded state; and

an expandable tubular element, having an outer end, said tubular element being movable between a first position, with the outer end proximal of the tissue separator device, and a second position, with the outer end generally axially aligned with the localization device;

whereby a tissue section separated from surrounding tissue by the tissue separator device is capturable by the localization device in the second state and the tubular element in the second position to aid removal of the separated tissue section from a patient.

2. The assembly according toclaim 1 wherein the expandable tubular element comprises a radially-expandable tubular braided element.

3. A method for separating and capturing a tissue section from surrounding tissue of a patient comprising:

directing a localization device along a tissue track to a position distal of a target site;

changing the localization device from a first, radially-contracted state to a second, radially-expanded state;

separating a tissue section at the target site from surrounding tissue; and

pushing an expandable tubular element, having an outer end, over the separated tissue section until the outer end is generally aligned with the localization device, thereby effectively capturing the separated tissue section.

4. The method according toclaim 3 wherein the pushing step is carried out using a radially-expandable tubular braided element as the expandable tubular element.

5. The method according toclaim 3 further comprising removing the separated tissue section, together with the localization device and the tubular element, along the tissue track.

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