US20030014068A1 - Expandable cannula - Google Patents
Expandable cannula Download PDFInfo
- Publication number
- US20030014068A1 US20030014068A1 US10/242,205 US24220502A US2003014068A1 US 20030014068 A1 US20030014068 A1 US 20030014068A1 US 24220502 A US24220502 A US 24220502A US 2003014068 A1 US2003014068 A1 US 2003014068A1
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- US
- United States
- Prior art keywords
- cannula
- sheath
- passage
- tubular member
- arcuate plate
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0662—Guide tubes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
- A61B17/3421—Cannulas
- A61B17/3439—Cannulas with means for changing the inner diameter of the cannula, e.g. expandable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0082—Catheter tip comprising a tool
- A61M25/0084—Catheter tip comprising a tool being one or more injection needles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/02—Holding devices, e.g. on the body
- A61M25/04—Holding devices, e.g. on the body in the body, e.g. expansible
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0409—Instruments for applying suture anchors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0414—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having a suture-receiving opening, e.g. lateral opening
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0417—T-fasteners
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
- A61B2017/06052—Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B2017/348—Means for supporting the trocar against the body or retaining the trocar inside the body
- A61B2017/3482—Means for supporting the trocar against the body or retaining the trocar inside the body inside
- A61B2017/3484—Anchoring means, e.g. spreading-out umbrella-like structure
- A61B2017/3486—Balloon
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M2025/0024—Expandable catheters or sheaths
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0082—Catheter tip comprising a tool
- A61M25/0084—Catheter tip comprising a tool being one or more injection needles
- A61M2025/0089—Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0082—Catheter tip comprising a tool
- A61M2025/0095—Catheter tip comprising a tool being one or more needles protruding from the distal tip and which are not used for injection nor for electro-stimulation, e.g. for fixation purposes
Definitions
- the present invention relates to cannulas for surgical and medical use.
- a typical cannula is a fixed diameter tube which a surgeon uses to maintain an instrument passage through tissue to a subcutaneous working location. The surgeon must first make an incision the full depth of the cannula in order to insert the cannula. This traumatic action damages good tissue in order to get to bad tissue. It would be desirable to provide cannulas which do not require a full depth incision, or at least require only a needle-size entrance opening, and which still allow use of a cannula to maintain an instrument passage.
- cannulas are provided which expand along their length.
- the cannulas are inserted through tissue when in an unexpanded condition and with a small diameter.
- the cannulas are then expanded radially outwardly to give a full-size instrument passage. Expansion of the cannulas occurs against the viscoelastic resistance of the surrounding tissue.
- the cannulas may be expanded by inserting members into the cannulas or by fluid pressure.
- a leading end portion of the cannula is constructed to pierce human body tissue. This enables the cannula to form its own opening in body tissue as the cannula is inserted into the tissue.
- the cannula can be inserted into a blood vessel and expanded.
- a flow of fluid can be conducted through the cannula into the blood vessel.
- the cannula advantageously includes a sheath which encloses a plurality of wires.
- a member may be inserted into the sheath and moved along the wires to expand the cannula.
- Each of the wires may advantageously include a core which is at least partially enclosed by a jacket which is integrally formed as one piece with the sheath. If desired, the cannula may be expanded by fluid pressure rather than inserting a member into the cannula.
- FIG. 1 is a perspective view of a cannula in accordance with a first embodiment of the invention, shown in an unexpanded condition;
- FIG. 2 is an exploded longitudinal sectional view of the cannula of FIG. 1;
- FIG. 3 is an assembled view of the cannula of FIG. 1;
- FIG. 4 is a schematic side view illustrating the cannula of FIG. 1 in an expanded condition
- FIG. 5 is a schematic side view illustrating the cannula of FIG. 1 in a contracted or collapsed condition
- FIG. 6 is a side view similar to FIG. 5 illustrating a trocar inserted in the cannula of FIG. 1;
- FIG. 7 is a sectional view taken along line 7 - 7 of FIG. 5;
- FIG. 8 illustrates the cannula of FIG. 7 in a partially expanded condition with a trocar and a tubular insert therein;
- FIG. 9 illustrates the cannula of FIG. 7 in a fully expanded condition with a larger tubular insert therein;
- FIG. 10 illustrates the cannula of FIG. 1 in use
- FIG. 11 is a view of a cannula in accordance with a second embodiment of the present invention, shown in an unexpanded condition;
- FIG. 12 is an end view of the cannula of FIG. 11 in a fully collapsed condition
- FIG. 13 is a view similar to FIG. 12 with the cannula in a partially expanded condition
- FIG. 14 is a view similar to FIG. 13 with the cannula in a fully expanded condition
- FIG. 15 is a perspective view of the cannula of FIG. 11;
- FIG. 16 illustrates the cannula of FIG. 15 with a trocar therein
- FIG. 17 illustrates the cannula of FIG. 11 in use
- FIG. 18 is a perspective view of a cannula forming another embodiment of the invention.
- FIG. 19 is a sectional view of the cannula of FIG. 18, the cannula being shown in a retracted condition;
- FIG. 20 is a sectional view of the cannula of FIG. 18, the cannula being shown in an expanded condition;
- FIG. 21 is an enlarged fragmentary sectional view of a pointed end portion of another embodiment of the cannula of FIG. 1;
- FIG. 22 is an end view, taken generally along the line 22 - 22 of FIG. 21, illustrating the relationship between a sheath and wires in the pointed end portion of the cannula;
- FIG. 23 is a fragmentary plan view, taken generally along the line 23 - 23 of FIG. 21, further illustrating the construction of the pointed end portion of the cannula;
- FIG. 24 is a schematic sectional view illustrating the manner in which the cannula is expanded from the contracted condition of FIG. 22 by insertion of tubular members into the cannula;
- FIG. 25 is an enlarged fragmentary schematic illustration depicting the relationship between the contracted cannula of FIGS. 21 - 23 and body tissue immediately prior to insertion of the contracted cannula into the body tissue;
- FIG. 26 is a fragmentary schematic illustration depicting the relationship between the contracted cannula and a blood vessel after the cannula has pierced skin and body tissue adjacent to the blood vessel and prior to piercing of a side wall of the blood vessel;
- FIG. 27 is an enlarged fragmentary schematic illustration of a portion of FIG. 26 further illustrating the relationship between the pointed end portion of the cannula and the side wall of the blood vessel;
- FIG. 28 is a fragmentary schematic illustration, generally similar to FIG. 26, illustrating the relationship of the cannula to the blood vessel after the cannula has pierced the side wall of the blood vessel and has been inserted into the blood vessel with the cannula in the contracted condition of FIG. 22;
- FIG. 29 is a fragmentary schematic illustration, taken generally along the line 29 - 29 of FIG. 28, further illustrating the relationship between the cannula and the blood vessel;
- FIG. 30 is a fragmentary schematic illustration, generally similar to FIG. 28, illustrating the relationship between the cannula and the blood vessel when the cannula is in an expanded condition;
- FIG. 31 is a schematic illustration, similar to FIG. 29, and taken generally along the line 31 - 31 of FIG. 30;
- FIG. 32 is an enlarged schematic illustration, generally similar to FIG. 25, illustrating the relationship between another embodiment of the cannula and the skin of a patient immediately prior to piercing of the skin of the patient with the cannula;
- FIG. 33 is a fragmentary schematic illustration, generally similar to FIG. 31, illustrating the relationship between another embodiment of the cannula and a blood vessel after the cannula has been inserted into the blood vessel and expanded by fluid pressure;
- FIG. 34 is a sectional view, taken along the line 34 - 34 of FIG. 33, further illustrating the relationship between the expanded cannula and the blood vessel;
- FIG. 35 is a fragmentary sectional view, generally similar to FIG. 21, illustrating a pointed end portion of another embodiment of the cannula;
- FIG. 36 is a fragmentary sectional view, generally similar to FIG. 21, illustrating a pointed end portion of another embodiment of the cannula;
- FIG. 37 is an enlarged fragmentary sectional view of a portion of FIG. 36 illustrating the construction of an end portion of the cannula which is expandable when the cannula is in the expanded condition of FIG. 24;
- FIG. 38 is a sectional view, taken generally along the line 38 - 38 of FIG. 37, further illustrating the construction of the end portion of the cannula.
- a cannula 10 (FIG. 1) includes an expanding portion 12 and a proximal end portion 14 .
- the expanding portion 12 includes a plurality of longitudinally extending wires 16 .
- the wires 16 are surrounded for most of their length by an overlying elastic sheath 18 .
- the wires 16 define between them a central instrument passage 20 .
- the wires 16 are preferably made of a material which is flexible, does not break, and does not stretch.
- a preferred material is music wire, which is thin gauge steel about 0.015′′ in diameter.
- the use of the term “wire” in this application and its claims does not limit the invention to metal wires.
- the “wires” may also be made of other elongate material such as composites or plastics or other metals.
- the “wires” may also be coated.
- the number of wires may be selected as desired. Applicants have found that 8 to 10 wires will suffice for a cannula expandable up to 7 mm OD, and that 12 wires or more may be necessary for a larger cannula. Ten larger diameter wires (0.025′′) may be used rather a larger number of small diameter wires. A greater number of wires 16 can be used if a greater diameter is needed. If not enough wires 16 are used, an instrument (trocar, insert, scope, etc.) inserted through the passage 20 when the cannula 10 is expanded will contact the elastic sheath 18 rather than the wires 16 , at locations between the wires.
- the wires 16 are self-aligning. When the cannula 10 is in a contracted condition, the wires 16 may overlap. When the cannula 10 is expanded, the wires 16 straighten out as shown.
- the elastic sheath 18 is preferably secured to the wires 16 at both proximal and distal ends, to prevent the sheath from sliding off the wires during insertion and removal of the cannula 10 .
- Rubber cement or cyanoacrylate or a similar adhesive can be used to bond the sheath 18 to the wires 16 as shown schematically at 24 .
- the elastic sheath 18 is preferably made of latex or silicone, or of C-Flex®, a general purpose thermoplastic elastomer sold by Linvatec Corporation of Clearwater, Fla.
- the sheath 18 is of a diameter such that it is stressed even when the cannula 10 is fully contracted. Thus, the sheath 18 constantly biases the wires 16 radially inwardly toward the axis 22 of the cannula 10 .
- the wires 16 are clamped between an inner ring member 30 and an outer ring member 32 .
- the inner ring member 30 has a central opening 34 .
- the inner ring member 30 has a clamping surface 36 including a beveled edge 38 and an annular radially extending surface 40 .
- the outer ring member 32 has a threaded central opening 42 for receiving a standard luer lock 43 .
- the outer ring member 32 has a clamping surface 44 including a beveled edge 46 and an annular radially extending surface 48 .
- the ring members 30 and 32 can be made of metal, in which case they can be brazed or welded together.
- the ring members 30 and 32 can be made of plastic, in which case then they can be UV joined or joined by adhesive.
- Proximal end portions 50 of the wires 16 are trapped between the ring members 30 and 32 .
- the proximal end portions 50 of the wires 16 are trapped between the clamping surface 36 of the inner ring 30 and the clamping surface 44 of the outer ring 32 .
- the proximal end portion 52 of the sheath 18 is preferably also trapped between the rings 30 and 32 , to secure the sheath proximally.
- the proximal end portion 52 of the sheath 18 may be bonded to the wires 16 at a proximal location adjacent the ring members 30 and 32 .
- the proximal end of the cannula expanding portion 12 is secured, having a large diameter generally equal to the expanded diameter of the cannula 10 .
- the sheath 18 has a longitudinally extending circumferential outer surface 54 (FIG. 7) and a longitudinally extending circumferential inner surface 56 .
- the wires 16 engage the circumferential inner surface 56 of the sheath 18 .
- the radially inner surfaces 60 of the wires 16 define an annular periphery 62 within which any item inserted in the cannula 10 is disposed.
- the cannula 10 when contracted, the cannula 10 is about 2 mm diameter, the size of a 14 ga needle.
- the constructed cannula is about 90 mm long.
- Other useful sizes include (i) up to 2.5 mm diameter with a 70 mm length; (ii) up to 7 mm diameter with a 110 mm length; and (iii) up to 11 mm diameter with a 160 mm length.
- the surgeon makes a small incision in the epidermis. He inserts a narrow trocar such as the trocar 70 (FIGS. 6 and 8) into the central passage 20 of the cannula 10 .
- the pointed end portion 72 of the trocar 70 will project distally.
- the shaft portion 74 of the trocar 70 is disposed inside the passage 20 .
- the outer surface 76 of the trocar shaft portion 74 engages the radially inner surfaces 60 of the wires 16 .
- the proximal end portion 78 of the trocar 70 extends proximally from the cannula 10 .
- the end portion 72 of the trocar 70 may be blunt in order to push away internal tissue. In this case, a small incision would need to be made through the epidermis.
- the trocar/cannula assembly is inserted through the incision in the epidermis to the subcutaneous working location. Then, a tubular insert 80 (FIG. 8) is moved distally between the wires 16 of the cannula 10 and the trocar 70 .
- the insert 80 is preferably a hollow metal tube at least as large in ID as the OD of the trocar pointed end portion 72 .
- the trocar 70 can then be removed from the cannula 10 , leaving the cannula and the insert 80 in place in the tissue.
- the cannula 10 is expanded radially outwardly, as seen in a comparison of FIGS. 7 and 8 (which are not necessarily to scale). The tissue around the cannula 10 is also stretched. The surgeon has thus made a larger passage for instruments, along its entire length, without cutting tissue.
- the surgeon removes the insert 80 .
- the cannula 10 collapses radially inwardly because of the elastic sheath and because of the force of the tissue around it. But the tissue opening does not necessarily collapse completely, because of the viscoelastic nature of tissue, which tends to maintain its stretched condition for some time.
- the second insert is a hollow tube larger in diameter than the first insert 80 . Again, the cannula expands radially outwardly, and the tissue stretches.
- the surgeon continues with larger and larger inserts, until the tissue opening is as large as desired.
- the cannula may then be in the expanded condition shown in FIG. 9, with a full size metal insert 90 within the cannula 80 .
- the insert 90 then functions as a normal cannula, allowing insertion and removal of surgical instruments and the like.
- FIG. 11 An example is illustrated in FIG. 11 showing a probe 94 extending through the central instrument passage 20 of the cannula 10 having an insert 90 therein.
- the cannula 10 has expanded tissue 96 radially outwardly to create a cavity 98 therein.
- the cannula 10 is discarded after use to prevent contamination.
- the wires 16 have outer surface portions 60 disposed radially inwardly in the cannula 10 and forming contact surfaces for surgical instruments and the like inserted through the central instrument passage 20 of the cannula.
- the sheath 18 has an outer circumferential surface 54 engaging tissue when the cannula 10 is in use.
- the wires 16 block engagement of instruments inserted through the central instrument passage 20 of the cannula 16 with the elastic sheath 18 .
- the sheath 18 blocks engagement of tissue with the wires 16 , and the sheath and the wires block engagement of tissue with any instruments inserted through the cannula 10 .
- the cannula 10 expands radially outwardly along substantially its entire length against the bias of the sheath 18 .
- the cannula 10 can accommodate through its central instrument passage 20 a surgical instrument or the like having a diameter along its entire length which is greater than the diameter of the cannula in the contracted condition. This is not possible with cannulas which expand only along a portion of their length.
- FIGS. 11 - 17 A second embodiment of the invention is illustrated in FIGS. 11 - 17 .
- An expandable cannula 100 includes four longitudinally extending members 102 , 104 , 106 , and 108 . Each member includes a longitudinally extending arcuate segment and a widened proximal end portion.
- the members 102 , 104 , 106 , and 108 are made of plastic.
- One suitable material is Delrin® brand plastic.
- the member 102 includes a longitudinally extending arcuate segment 110 and a widened proximal end portion 112 .
- the member 104 includes a longitudinally extending arcuate segment 114 and a widened proximal end portion 116 .
- the member 106 includes a longitudinally extending arcuate segment 118 and a widened proximal end portion 120 .
- the member 108 includes a longitudinally extending arcuate segment 122 and a widened proximal end portion 124 .
- the members 102 , 104 , 106 , and 108 each subtend an angle of 90°.
- their longitudinally extending arcuate segments 110 , 114 , 118 , and 122 form a tubular expandable cannula structure 130 .
- the distal ends 132 of the members 102 , 104 , 106 , and 108 are tapered inwardly for ease of entrance through tissue.
- the widened proximal end portions 112 , 116 , 120 , and 124 together form a handle for the cannula 100 which also allows entry of an instrument therethrough.
- the end portions have angled inner surfaces 134 to guide an instrument into the longitudinally extending central instrument passage 136 of the cannula 100 in the direction indicated by the arrow 138 .
- the handle (proximal end) portion of the cannula 100 can be configured to attach instruments to it, or to have a cap screwed onto the end to close the cannula.
- the arcuate segments 110 , 114 , 118 , and 122 are surrounded for most of their length by an overlying elastic sheath 140 .
- the elastic sheath 140 is secured to the segments 110 , 114 , 118 , and 122 at proximal and distal locations 142 and 144 , to prevent the sheath from sliding off the segments during insertion and removal of the cannula 100 .
- Rubber cement or cyanoacrylate or a similar adhesive can be used to bond the sheath 140 to the segments.
- the elastic sheath 140 is preferably made of latex or silicone, or of the C-Flex® material described above.
- the sheath 140 is of a diameter such that it is stressed even when the cannula 100 is fully contracted. Thus, the sheath 140 constantly biases the segments radially inwardly toward the center of the cannula 100 .
- One cannula that has been constructed is 90 mm in length, and about 5 mm in diameter when aligned in a tube form as shown in FIGS. 12 - 14 .
- the members can collapse (overlap onto themselves as shown in FIG. 12) into a smaller diameter.
- the cannula can expand to about 12+mm OD.
- the surgeon makes a small incision in the epidermis. He inserts a narrow trocar such as the trocar 70 (FIG. 16) into the central passage 136 of the cannula 100 .
- the pointed end portion 72 of the trocar 70 will project distally.
- the shaft portion 74 of the trocar 70 is disposed inside the passage 136 .
- the proximal end portion 78 of the trocar 70 extends proximally from the cannula 100 .
- a trocar should be used with the cannula 100 only when needed.
- the distal end portion of the cannula 100 is preferably used alone to push through internal tissue once an epidermal incision has been made.
- the trocar/cannula assembly is inserted through the incision in the epidermis to the subcutaneous working location. Then, a tubular insert 80 (FIG. 14) is inserted longitudinally between the cannula 100 and the trocar 70 .
- the insert 80 is preferably a hollow metal tube at least as large in ID as the OD of the trocar pointed end portion 72 .
- the trocar 70 can then be removed from the cannula 100 , leaving the cannula and the insert 80 in place in the tissue.
- the outer surface of the insert engages longitudinally extending radially inner edges 148 of the members 102 , 104 , 106 , and 108 .
- the cannula 100 is expanded radially outwardly, as seen in a comparison of FIGS. 13 and 14 (which are not necessarily to scale).
- the four members 102 , 104 , 106 , and 108 move radially outwardly away from each other.
- the passage 136 is enlarged.
- the tissue around the cannula 100 is also stretched. The surgeon has thus made a larger passage for instruments, along its entire length, without cutting tissue.
- the surgeon removes the insert 80 .
- the cannula 100 collapses radially inwardly because of the elastic sheath and because of the force of the tissue around it. But the tissue opening does not necessarily collapse completely, because the tissue is viscoelastic.
- the surgeon then puts a second insert 90 (FIG. 17) inside the cannula 100 .
- the second insert 90 is a hollow tube larger in diameter than the first insert 80 .
- the cannula 100 expands further radially outwardly, and the tissue stretches.
- the surgeon continues with larger and larger inserts, until the tissue opening is as large as desired.
- the cannula may then be in the expanded condition shown in FIG. 17, with the insert 90 within the cannula 100 .
- the cannula 100 can then be removed proximally, leaving the insert in place.
- the insert then functions as a normal cannula, allowing insertion and removal of surgical instruments and the like such as the probe illustrated schematically at 94 .
- the cannula 100 expands radially outwardly along substantially its entire length against the bias of the sheath 130 .
- the cannula 100 can accommodate through its central instrument passage 136 a surgical instrument or the like having a diameter along its entire length which is greater than the diameter of the cannula in the contracted condition. This is not possible with cannulas which expand only along a portion of their length.
- a first, smaller size would extend from an OD of 2.5 mm to an ID of 7 mm, being about 70 mm in length.
- a second, larger size would extend from an OD of 6 mm to an ID of 12 mm, being about 150 mm in length.
- the expandable cannulas of the present invention may be designed to selectively expand at a location at or near the distal end. This is illustrated in FIGS. 18 - 20 .
- An expandable cannula 300 similar to the expandable cannula 10 (FIGS. 1 - 9 ) includes a plurality of longitudinally extending wires 302 .
- the cannula 300 includes an inflatable sheath 304 .
- the sheath 304 includes an inner sheath member 306 and an outer sheath member 308 .
- the inner sheath member 306 is of a double-walled construction, including an inner wall 310 and an outer wall 312 .
- An inflation volume 314 separates the inner wall 310 and the outer wall 312 .
- Fluid under pressure such as air, saline, etc. may be introduced into the inflation volume 314 through a fluid port 316 .
- the inner sheath member 306 overlies the wires 302 .
- the outer wall 312 of the inner sheath member 306 expands radially outwardly, as shown in FIG. 20. Radially outward expansion of the outer wall 312 of the inner sheath member 306 is limited by the outer sheath member 308 .
- the outer sheath member 308 is a single-layer sheath overlying the inner sheath member 306 .
- a notch 320 is cut out of the outer sheath member 308 .
- the outer wall 312 of the inner sheath member 306 can expand radially outwardly only at the location of the notch 320 in the outer sheath member 308 .
- the notch 320 may be placed at or near the distal end of the cannula 300 . This will stabilize the cannula 300 in the tissue, at the closest possible location to the work area off the distal end of the cannula.
- each of the wires includes a core and a coating or jacket which is integrally formed as one piece with the plastic sheath of the cannula. It is contemplated that the embodiment of the cannula illustrated in FIGS. 21 - 31 will be particularly advantageous for use in establishing communication with interior of a vessel, such as a sac, organ, tube, duct or canal. However, the cannula may be used to establish communication with any desired portion of the human body.
- the cannula 400 (FIGS. 21, 22 and 23 ) has the same general construction as the cannula 10 of FIGS. 1 - 10 .
- the cannula 400 includes an elastic sheath 402 which encloses a plurality of longitudinally extending wires 404 .
- the wires define between them a central passage 406 through which instruments may be inserted into a human body or fluid may be conducted into the human body.
- the sheath 402 and wires 404 are clamped between ring members in the same manner illustrated in FIGS. 2 and 3 for the cannula 10 .
- each of the wires 404 includes a core 410 (FIG. 22) which is at least partially enclosed by a coating or jacket 412 .
- the cores 410 and jackets 412 extend between opposite ends of the sheath 402 .
- the cores 410 and jackets 412 extend from a generally circular opening 416 (FIG. 21) at the distal or leading end of the sheath 402 to clamping ring members at the proximal end (not shown) of the sheath.
- each of the jackets 412 is integrally formed as one piece with the sheath 402 .
- each of the jackets 412 is formed of the same elastic material as the sheath 402 .
- the elastic polymeric material of the sheath and the jackets 412 may be molded or extruded around the cores 410 during formation of the cannula 400 .
- Each of the jackets 412 has a longitudinal central axis which extends parallel to a longitudinal central axis 418 of the cannula 400 .
- the jackets 412 extend throughout the entire length of the sheath 402 . Since the jackets 412 are integrally formed as one piece with the sheath 402 , the wires 404 are maintained in a parallel relationship with the longitudinal central axis 418 of the cannula 400 .
- the parallel wires 404 extend from the opening 416 at the distal end of the sheath 402 to the location where the proximal end of the sheath is clamped between ring members in a manner similar to that illustrated in FIGS. 2 and 3. The wires 404 do not intersect.
- Central cores 410 of the wires 404 may be formed of any desired material.
- the cores 410 are formed of metal.
- the cores 410 are formed of music wire, that is a thin gauge steel of about 0.015 inches in diameter.
- the cores 410 could be formed of composite polymeric materials if desired.
- the cores 410 could be formed by a matrix of polymeric material strengthened by longitudinally extending carbon fibers.
- the parallel cores 410 of the wires 404 have a cylindrical configuration.
- each of the cores 410 has a circular cross sectional configuration as viewed in a plane extending perpendicular to a longitudinal central axis of the core.
- the sheath 402 engages longitudinally extending side portions of the cores 410 .
- the longitudinally extending side portions of the cores 410 which are engaged by the sheath 402 face radially outward away from the central axis 418 of the cannula 400 .
- the surface portions of the cores 410 which do not engage the sheath 402 are enclosed by the jackets 412 . Since the jackets 412 are integrally formed as one piece with the sheath 402 , there is no precise line of demarcation between the jackets and the sheath. However, the jackets 412 extend inward from the sheath 402 toward the central axis 418 of the cannula 400 and cooperate with the sheath to enclose each of the cores 410 . If desired, the jackets 412 could extend completely around the cores 410 .
- Circular axial end faces 424 of the cores 410 are exposed at opposite ends of the sheath 402 .
- the circular end faces 424 (FIGS. 22 and 23) of the cores are visible.
- the jackets 412 extend from the end faces 424 of the cores 410 to the opposite end of the sheath 402 .
- the cannula 400 is expandable throughout its length from a contracted condition (FIG. 22) to an expanded condition (FIG. 24) in the same manner as in which the cannula 10 of FIGS. 1 - 10 is expandable.
- a first cylindrical tubular member 430 is axially inserted into the central passage 406 through the proximal end portion of the cannula 400 (FIG. 24).
- a cylindrical outer side surface 432 on the tubular member 430 slides along the wires 404 toward the distal or leading end of the cannula.
- the outer side surface 432 of the tubular member 430 slides on surfaces of the jackets 412 which enclose the cores 410 of the wires 404 .
- the tubular member 430 As the tubular member 430 is axially moved into the cannula 400 from the proximal end portion (not shown) of the cannula to the distal end portion, the wires 404 are forced radially outward away from the longitudinal central axis 418 of the cannula. Thus, the cylindrical outer side surface 432 of the member 430 applies radially outward force against the wires 404 . This radially outward force is transmitted through the wires 404 to the sheath 402 . As this occurs, the elastic material of the sheath 402 is resiliently stretched and the distance between the wires 404 increases.
- the first tubular member 430 has a length which is greater than the length of the sheath 402 and extends axially outward from opposite ends of the sheath.
- the cannula 400 may be used with the tubular member 430 holding the cannula in an expanded condition. However, it is believed that it may be desirable to further expand the cannula 400 . Therefore, a second cylindrical tubular member 436 is inserted into the cannula 400 through the proximal end of the cannula to further expand the cannula.
- the second tubular member 436 has an inside diameter which is larger than the outside diameter of the first cylindrical tubular member 430 .
- the resilient material of the cylindrical sheath 402 is circumferentially stretched, the distance between the parallel wires 404 increases. Sliding of the tubular member 436 from the proximal end to the distal end of the cannula 400 is relatively easy since the tubular member slides along the jackets 412 on the wires 404 and does not engage the inner side surface of the sheath 402 .
- the second cylindrical tubular member 436 extends axially outward from opposite ends of the sheath 402 .
- the first tubular member can be axially withdrawn from the cannula 400 . This results in the cylindrical central passage 406 through the cannula 400 having a diameter equal to the inside diameter of the relatively large second tubular member 436 .
- a still larger tubular member may be telescopically inserted into the cannula 400 around the second tubular member 436 to further expand the cannula and increase the size of the central passage 436 through the cannula. It is possible to expand the cannula 400 to any one of many different sizes depending upon the size of the tubular member which is used to apply force against the wires 404 and resiliently stretch the sheath 402 of the cannula. It is believed that it will be preferred to have the extent of expansion of the sheath 402 be less than the elastic limit of the material forming the sheath.
- the cannula 400 has a pointed distal end portion 442 (FIG. 21).
- the pointed distal end portion 442 of the cannula 400 facilitates piercing of body tissue with the cannula.
- the pointed end portion 442 is formed by cutting the materials of the sheath 402 and wires 404 at an acute angle to the longitudinal central axis 418 of the cannula 400 .
- the pointed end portion 442 of the cannula 400 is formed by cutting the material of the sheath 402 and wires 404 at an angle of approximately 30° to the longitudinal central axis 418 of the cannula.
- the pointed end portion 442 could be skewed at a different angle relative to the longitudinal central axis 418 of the cannula 400 if desired.
- the ends of the wires 404 and the end of the sheath 402 cooperate to provide the cannula 400 with an end portion 442 which can cut body tissue when the end portion of the cannula is pressed against the body tissue.
- the sheath 402 may advantageously be cut away adjacent to an apex 446 of the pointed end portion 442 .
- a beveled surface 448 is formed in the material of the sheath 402 adjacent to the apex 446 of the pointed end portion 442 .
- the beveled surface 448 makes the pointed end portion 442 of the cannula sharper to facilitate severing the body tissue.
- the beveled surface 448 extends outward to a leading end of a wire 404 which extends through the central part of the apex 446 of the pointed end portion 442 of the cannula 400 .
- the cylindrical cores 410 of the parallel wires 404 are formed by thin gauge steel wire.
- the leading end of the core 410 of the wire 404 extends through the apex 446 of the pointed end portion 442 of the cannula 400 .
- the leading end of the core 410 of the wire 404 through the apex 446 provides a relatively sharp cutting edge at the axially outer end of the cannula 400 . This sharp cutting edge can readily penetrate relatively tough body tissue.
- the leading end portions of additional wires 404 and leading edges of segments of the sheath 402 disposed between the wires sever the body tissue to increase the size of the opening.
- the sheath 402 and ends of the wires 404 cooperate to form an opening in the body tissue at a location where there was no natural opening.
- the size of the opening formed in the body tissue by the pointed end portion 442 of the cannula 400 increases until the opening is large enough to accept the cylindrical outer side surface of the cannula when it is in the contracted condition of FIG. 22.
- the cannula 400 is expanded from the contracted condition of FIG. 22 to the expanded condition of FIG. 24. As this occurs, the viscoelastic material of the body tissue is resiliently stretched and the size of the small opening formed by the cannula 400 in its contracted condition is increased.
- surgical tools and/or optical instruments can be inserted through the cylindrical passage 406 within the second tubular member 436 and expanded cannula 400 .
- the viscoelastic body tissue also contracts. Therefore, the size of the wound in the body tissue is minimized.
- the cannula 400 will have many different uses, including the establishment of communication with the interior of many different types of vessels in a human body.
- the cannula could be used to establish communication with the interior of a vessel such as a lung, heart, endolymphatic duct or sac, a hernial sac, or a bladder.
- the cannula 400 will be used as a passage through body tissue for many different types of instruments and/or fluids.
- the cannula 400 may be used to facilitate laproscopic or arthroscopic surgery.
- the cannula 400 will be particularly advantageous in establishing communication with the interior of a blood vessel.
- the cannula 400 can be used to establish communication with the interior of a blood vessel in a human body for an intravenous infusion.
- the pointed end portion 442 of the cannula 400 is used to pierce an imperforate surface area on the skin 454 (FIG. 25) of a human body.
- the pointed end portion 446 of the cannula 400 pierces an imperforate surface area on a side wall 456 of a vein or blood vessel 458 (FIGS. 26, 27 and 28 ).
- the cannula 400 is used to initiate the formation of openings in the skin 454 and side wall 456 of the blood vessel 458 at locations where there is no naturally occurring opening and without the necessity of making an incision prior to insertion of the cannula.
- An intravenous infusion of a suitable liquid preparation can then be conducted through the cannula 400 into the vein.
- the apex 446 of the pointed end portion 442 of the contracted cannula 400 is first pressed against an outer side surface 464 of the skin 454 (FIG. 25). Engagement of the end face 424 of the core 410 of the wire 404 which extends through the apex 446 of the pointed end portion 442 (FIGS. 21 and 23) of the cannula 400 punctures the outer side surface 464 of the skin 454 under the influence of force transmitted axially through the cannula 400 .
- the pointed end portion 442 of the cannula 400 could have the sheath 402 configured in such a manner, that is, by elimination of the bevelled surface 448 , so as to have the sheath itself initiate the formation of the opening in the skin 464 .
- the cannula 400 After the cannula 400 has pierced the skin 454 , the cannula is pressed toward the blood vessel 448 and pierces the body tissue 460 (FIG. 26). The cannula 400 is moved through the body tissue 460 until the pointed end portion 446 of the cannula 400 engages the side wall 456 of the blood vessel 458 . The pointed leading end portion 442 of the cannula 400 is then pressed firmly against the side wall 456 of the blood vessel 458 (FIG. 27).
- the axial force transmitted through the contracted cannula 400 causes the axially tapered leading end of the core 410 of the wire 404 which extends through the apex 446 (FIG. 21) of the pointed end portion 442 of the cannula to initiate the formation of an opening at an imperforate outer side surface 472 (FIG. 27) of the side wall 456 of the blood vessel 458 .
- Continued axial movement of the cannula 400 results in the leading end portion 442 of the cannula piercing the side wall 456 of the blood vessel 456 . Since the cannula 400 is in the contracted condition of FIG. 22 when the side wall 456 of the blood vessel 458 is pierced, a relatively small opening 476 is formed in the side wall 456 of the blood vessel 456 by the cannula 400 .
- the cannula 400 is shown in FIG. 25 as being oriented with its longitudinal central axis at an angle of approximately 30° relative to the outer side surface 464 of the skin 454 as the skin is pierced, it is contemplated that it may be desired to have the cannula oriented at an angle of approximately 45° relative to the outer side surface 464 of the skin 454 when the skin is pierced by the cannula.
- the cannula is shown as being oriented relative to the blood vessel 458 with the longitudinal central axis of the cannula extending at an angle of approximately 30° relative to the outer side surface 472 of the blood vessel 458 .
- the cannula oriented at a smaller angle relative to the outer side surface 472 of the blood vessel 458 as the blood vessel is pierced.
- Reducing the angle between the longitudinal central axis of the cannula 400 and the outer side surface 472 of the blood vessel 458 prior to piercing the blood vessel facilitates piercing the side wall 456 of the blood vessel 458 without pushing the cannula 400 clear through the blood vessel.
- the cannula 400 is moved axially along the blood vessel (FIG. 28) to increase the telescopic relationship between the blood vessel and the cannula.
- FIG. 28 the cannula 400 has been shown in FIG. 28 as being inserted for only a relatively a small distance into the blood vessel 458 , it is contemplated that the cannula may be inserted for a substantial distance into the blood vessel.
- the cannula 400 may be moved along the blood vessel 458 to another vessel, such as a sac or organ.
- the cannula 400 Since the cannula 400 is in the contracted condition of FIG. 22, the cannula will have a small outside diameter (FIG. 29) and will be relatively easy to move along the blood vessel 458 .
- the contracted cannula 400 will form a relatively small opening 476 in the side wall 456 of the blood vessel 458 .
- the contracted cannula 400 may have a sufficiently large central passage 406 for some purposes. For example, an intravenous injection of a small dose of medicine could be made through the contracted cannula 400 if desired.
- the cannula 400 will be advantageously used in circumstances requiring a relatively large passage 406 for communication with the interior of the blood vessel 458 and/or a vessel connected with the blood vessel 458 .
- the cannula 400 is expanded from the contracted condition of FIG. 22 to the expanded condition of FIG. 24 by the sequential insertion of members into the cannula.
- the first tubular member 430 (FIG. 24) is inserted into the cannula 400 to increase the diameter of the outer side surface 468 of the cannula and to effect a relatively small radial expansion of the side wall 456 of the blood vessel 458 .
- the outer side surface 468 of the cannula is pressed against edge portions of the opening 476 to increase the size of the opening.
- the outer side surface 468 of the cannula 400 is pressed against the edge portions of the opening in the skin 454 to increase the size of the opening in the skin.
- the outer side surface 468 of the cannula 400 also applies force against the inner side surface of the blood vessel 458 to expand the blood vessel.
- the tubular member 436 (FIGS. 24, 30 and 31 ) is then inserted into the cannula 400 to further expand the cannula and the blood vessel 458 .
- force is transmitted from the outer side surface 468 of the cannula to an inner side surface of the blood vessel 458 to radially expand the blood vessel.
- the openings in both the blood vessel 458 and skin 454 are expanded.
- the diameter of the blood vessel can be substantially increased by expanding the cannula 400 from the contracted condition of FIGS. 28 and 29 to the expanded condition of FIGS. 30 and 31.
- expanding the side wall 456 of the blood vessel 458 enable fluid (liquid) to be conducted at a relatively high flow rate into the blood vessel. The fluid is conducted through the tubular member 436 and the cannula 400 into the blood vessel 458 .
- expansion of the side wall 456 of the blood vessel 458 along with the cannula 400 enables surgical instruments and/or optical instruments to be inserted through the cannula into the blood vessel.
- the contracted cannula 400 is moved along the blood vessel into another vessel, such as a sac or organ, before being expanded, the surgical instruments inserted through the central passage of the expanded cannula can be used within the sac or other body part.
- the core 410 of the wire 404 which extends into the apex 446 of the pointed end portion 442 is co-extensive with the sheath 402 .
- the core of the wire which extends into the apex of the pointed end portion of the cannula extends beyond the sheath of the cannula to facilitate engagement of the core with the wire with body tissue. Since the embodiment of the invention illustrated in FIG. 32 is generally similar to the embodiment of the invention illustrated in FIGS. 21 - 31 , similar numerals will be utilized to designate similar components, the suffix letter “b” being associated with the numerals of FIG. 32 to avoid confusion.
- the cannula 400 b has a cylindrical sheath 402 b which encloses a plurality of longitudinally extending wires 404 b.
- Each of the wires 404 b has a linear core 410 b which is enclosed by a jacket 412 b.
- the jacket 412 b is integrally formed as one piece with the sheath 402 b and cooperates with the sheath to enclose one of the cores 410 b.
- the pointed end portion 442 b has a circular opening 416 b.
- a core 410 b of one of the wires 404 b extends past the beveled outer edge surface 448 b of the sheath 402 b.
- an end portion 482 of the core 410 b of the wire 404 b extends past the opening 416 b to the central passage 406 b through the cannula 400 b.
- the outwardly projecting core 410 b has a pointed end portion 484 which projects axially outwardly from the sheath 402 b.
- the pointed end portion 484 of the wire core 410 b engages the outer side surface 464 b of the skin before the sheath 402 b engages the skin. This results in the sharp outer end portion 484 of the core 410 b piercing the outer side surface 464 b of the skin 454 b before the skin is engaged by the sheath 402 b.
- the pointed end portion 484 of the core 410 b By piercing the outer side surface 464 b of the skin 454 b with the pointed end portion 484 of the core 410 b, the forming of an opening in the skin by the contracted cannula 400 b is facilitated.
- the cannula 400 has a circular cross sectional configuration as viewed in a plane extending perpendicular to a longitudinal central axis 418 of the cannula (FIG. 22). It is contemplated that the cross sectional area of the cannula may be maximized by forming the cannula with an oval cross sectional configuration as viewed in a plane extending perpendicular to a longitudinal central axis of the cannula.
- the cannula is expanded under the influence of fluid pressure rather than by inserting members into the cannula in the manner described in conjunction with FIG. 24.
- members having an oval cross sectional configuration could be inserted into the cannula of FIGS. 33 and 34 to expand the cannula. Since the cannula of FIGS. 33 and 34 have the components of the same construction as the components of the cannula of FIGS. 21 - 31 , similar numerals will be utilized to identify similar components, the suffix letter “c” being associated with the numerals of FIGS. 33 and 34 to avoid confusion.
- the cannula 400 c is inserted into a blood vessel 458 c in the manner illustrated in FIGS. 33 and 34.
- the cannula 400 c includes an elastic sheath 402 c.
- the sheath 402 c encloses longitudinally extending wires 404 c.
- the wires 404 c include cores 410 c and jackets 412 c.
- the jackets 412 c are integrally formed as one piece with the sheath 402 c.
- the cannula 400 c has an oval configuration (FIG. 34) as viewed in across sectional plane extending perpendicular to a longitudinal central axis of the cannula.
- the major axis of the oval cross section of the cannula is aligned with the longitudinal central axis of the blood vessel 458 c at the location where the cannula extends through an opening in the side wall of the blood vessel.
- the longitudinal central axis of the blood vessel 458 c is disposed in the same plane as the major cross sectional axis of the oval cross section (FIG. 34) of the cannula.
- the minor axis of the oval cross section of the cannula extends radially relative to the blood vessel 458 c.
- the major axis of the opening formed in the blood vessel 458 c extends longitudinally along the side wall 456 c of the blood vessel (FIG. 33).
- the opening which is formed in the outer side surface 472 c of the blood vessel 458 c is relatively long in a lengthwise direction along the blood vessel.
- the opening formed in the outer side surface 472 c of the blood vessel 458 c is relatively small in a direction extending circumferentially around the blood vessel.
- the cannula 400 c pierces the side wall 456 c of the blood vessel 458 c, the cannula is in a contracted condition in which it has a substantially smaller cross sectional configuration than is illustrated in FIG. 33.
- the relationship of the contracted cannula 400 c to the blood vessel 458 c when the cannula pierces the side wall 456 c of the blood vessel is similar to the relationship illustrated in FIG. 29 for the cannula 400 to the blood vessel 458 .
- the contracted cannula 400 c will have a major cross sectional axis which is aligned with the longitudinal central axis of the blood vessel 458 c (FIG. 33).
- the minor cross sectional axis of the contracted cannula 400 c will have an extent which is equal to the diameter of the contracted cannula 400 of FIGS. 21 - 31 .
- the cannula 400 c is expanded throughout its length under the influence of fluid pressure.
- a pump 490 is connected with the central passage 406 c in the cannula 400 c through a valve 492 and a conduit 494 .
- Relatively high pressure fluid is discharged from the pump 490 through the valve 492 and conduit 494 into the central passage 406 c in the contracted cannula 400 c.
- This fluid pressure is applied against an inner side surface of the sheath 402 c and the wires 404 c.
- the fluid pressure inside the cannula 400 c is effective to cause the elastic material of the sheath 402 c to expand from a contracted condition to an expanded condition. As this occurs, the size of the opening formed in the viscoelastic material of the blood vessel 458 c is enlarged. In addition, the outer side surface of the cannula 400 c presses against the inner side surface of the side wall 456 c to expand the blood vessel 458 c downstream from the location where the cannula enters the blood vessel.
- the fluid from the pump 490 forms an intravenous infusion of a liquid solution to the blood vessel 458 c.
- the cannula 400 c could be expanded by using tubular members having an oval cross sectional configuration in the manner described in conjunction with FIG. 24. It should be understood that fluid pressure may be used to expand the cannula 400 of FIGS. 21 - 31 if desired.
- the end face or surfaces 424 on the core 410 of the wires 404 are exposed (FIGS. 22 and 23).
- the jackets 412 enclose the cores 410 throughout the length of the cores.
- the jackets 412 do not cover the end surfaces 424 of the cores 410 . Therefore, the end surfaces 424 of the cores 410 are exposed at the pointed end portion 442 of the cannula 400 .
- the jackets around the cores cover the end surfaces of the cores. Since the embodiment of the invention illustrated in FIG. 35 is generally similar to the embodiment of the invention illustrated in FIGS. 21 - 31 , similar components will be identified with similar numerals, the suffix letter “d” being associated with the numerals of FIG. 35 to avoid confusion.
- a cannula 400 d includes an elastic sheath 402 d.
- the sheath 402 d encloses a plurality of longitudinally extending wires 404 d.
- the cannula 400 d has a longitudinally extending central passage 406 d.
- Each of the wires 404 d includes a core 410 d and a jacket 412 d which extends around the core 410 d.
- Each of the jackets 412 d is integrally formed as one piece with the sheath 402 d.
- Each of the jackets 412 d extends between opposite ends of the sheath 402 d.
- the jacket 412 d around each of the cores 410 d extends across an axially outer end face 424 d of a core 410 d.
- the cores 410 d of the wires 404 d are completely enclosed by cooperation between the jackets 412 d and the sheath 402 d.
- the jackets 412 d include end sections 502 which extend across the end surfaces 424 d of the cores 410 d of the wires 404 d. This results in the cannula 400 d having a pointed end portion 442 d with an apex 446 d which is formed by the sheath 402 d.
- the pointed apex 446 d of the end portion 442 d of the cannula engages the body tissue.
- the apex 446 d of the pointed end portion 442 d is formed by the elastic material of the sheath 402 d and jackets 412 d.
- the cores 410 d do not engage the body tissue as the cannula hood is inserted into the body tissue.
- the pointed end of the sheath 402 d initiates the formation of the opening in the body tissue.
- the wires 404 d stiffen the elastic material of the sheath 402 d to enable force to be transmitted through the cannula 400 d to the axially outer end of the sheath.
- an end portion of the cannula 300 is expandable outward of the outer sheath 308 and the inner wall 310 .
- the cannula also has an end portion which is expandable outward of an outer side surface of a sheath to engage body tissue. Since the embodiment of the invention illustrated in FIGS. 36, 37 and 38 is generally similar to the embodiment of the invention illustrated in FIGS. 21 - 31 , similar numerals will be utilized to designate similar components, the suffix letter “e” being associated with the numerals of FIGS. 36, 37 and 38 to avoid confusion.
- a cannula 400 e has an elastic sheath 402 e.
- the sheath 402 e encloses a plurality of longitudinally extending wires 404 e.
- the cannula 400 e has a longitudinally extending central passage 406 e.
- Each of the wires 404 e includes a core 410 e and a jacket 412 e (FIG. 38).
- Each of the jackets 412 e is integrally formed as one piece with the sheath 402 e.
- Each of the jackets 412 e extends between opposite ends of the sheath 402 e.
- the pointed end portion 442 e (FIG. 36) of the cannula 400 e engages the body tissue.
- the apex 446 e of the pointed end portion 442 e penetrates the body tissue and initiates the formation of an opening in the body tissue at an imperforate surface area on the body tissue.
- the initiating of the opening in the body tissue is facilitated by having an exposed relatively sharp end portion of a core 410 e of a wire 404 e which extends through the apex 446 e of the pointed end portion 442 e of the contracted cannula 400 e engage the body tissue to initially cut the imperforate surface area of the body tissue.
- leading edge portions of the sheath 402 e disposed adjacent to opposite sides of the wire 404 e through the apex 446 e of the cannula 400 e are then effective to sever body tissue to increase the size of the opening in the body tissue.
- the leading end portions of additional wires 404 e and leading edges of segments of the sheath 402 e disposed between the wires sever the body tissue to increase the size of the opening.
- the size of the opening is increased until it is large enough to accept the cylindrical outer side surface 468 e of the cannula 400 e when the cannula is in the contracted condition.
- the cannula 400 e is expanded by inserting a tubular cylindrical member 430 e (FIG. 38) into the contracted cannula 400 e.
- a tubular cylindrical member 430 e FIG. 38
- the sheath 402 e is resiliently expanded and the cross sectional size of the longitudinally extending array of wires 404 e is increased.
- the cannula 400 e could be further expanded by the insertion of a second tubular member, corresponding to the tubular member 436 of FIG. 24.
- a portion 600 of the pointed end portion 442 e of the cannula is expandable outward of an outer side surface 468 e of the sheath 402 e.
- the portion 600 is expandable from the configuration shown in solid lines in FIGS. 37 and 38 to the configuration shown in dashed lines in FIGS. 37 and 38. This enables the portion 600 of the cannula 400 e to engage body tissue and hold the cannula in place in the body tissue.
- both the cannula sheath 402 e and the portion 600 of the cannula are contracted.
- the cannula sheath 402 e is expanded by either fluid pressure or by insertion of the tubular member 430 e.
- the portion 600 of the cannula 400 e is then expanded radially outward from the cylindrical sheath 402 e to grip the inner side surface of the vein. It is contemplated that in certain circumstances it may not be necessary to expand the sheath 402 e and the portion 600 will be expanded while the sheath is contracted.
- the portion 600 of the cannula 400 e includes a resilient panel 604 (FIGS. 37 and 38) which is disposed in a rectangular recess 606 formed in the sheath 402 e.
- a resilient panel 604 FIGS. 37 and 38
- an arcuate outer side surface 608 of the panel 604 is aligned with the outer side surface 468 e of the sheath 402 e.
- the panel 604 cooperates with the sheath 402 e to form a variable volume chamber 610 in the side wall of the sheath.
- the panel 604 is formed of a polymeric material having a substantially greater elasticity than the material of the sheath 402 e. The elasticity of the material of the panel 604 enables the panel to be resiliently expanded from the position shown in solid lines in FIGS. 37 and 38 to the position shown in dashed lines and subsequently retracted.
- the chamber 610 is connected in fluid communication, through an opening 612 in the sheath 402 e with a conduit 614 .
- the conduit 614 has a side wall 616 which is integrally formed with the sheath 402 e.
- the side wall 616 of the conduit 614 and the sheath 402 e cooperate to form a cylindrical passage 620 which extends between opposite ends of the sheath 402 e.
- An axially outer or distal end portion of the conduit 620 is blocked by a pointed segment 622 of a metal core 410 e (FIG. 37) of a wire.
- the core 410 e is fixedly secured, by adhesive, in the passage 620 to block fluid flow through the outer end of the passage.
- the passage 620 extends to the opposite or proximal end of the cannula 400 e.
- the proximal end of the passage 620 is connected with a pump 626 (FIG. 37) through a valve 628 . Since the segment 622 of a wire core 410 e blocks the axially outer or distal end of the passage 620 , any fluid which flows through the valve 628 into the passage 620 must flow into the chamber 610 .
- the side wall 616 of the conduit 614 is formed in the same manner and has the same size as the jackets 412 e of the wires 404 e.
- a removable core is provided at the location where the passage 620 is to be formed.
- conduit 614 being disposed in the longitudinal array of wires 404 e and having the same size as one of the wires.
- the outer side surface of the tubular member slides along the side wall 616 of the conduit 614 in the same manner as in which the tubular member slides along the jackets 412 e of the wires 404 e. Therefore, force is transmitted from the tubular member 430 e through the conduit 614 to the sheath 402 e to expand the sheath when the tubular member is inserted into the cannula 400 e.
- the recess 606 is formed in the side wall of the sheath 402 e. After the opening 612 between the passage 620 and the recess 606 in the sheath 402 e has been formed, the panel 604 is electron beam welded or otherwise secured to the sheath.
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Abstract
Description
- The present invention relates to cannulas for surgical and medical use. A typical cannula is a fixed diameter tube which a surgeon uses to maintain an instrument passage through tissue to a subcutaneous working location. The surgeon must first make an incision the full depth of the cannula in order to insert the cannula. This traumatic action damages good tissue in order to get to bad tissue. It would be desirable to provide cannulas which do not require a full depth incision, or at least require only a needle-size entrance opening, and which still allow use of a cannula to maintain an instrument passage.
- In accordance with one of the features of the invention, cannulas are provided which expand along their length. The cannulas are inserted through tissue when in an unexpanded condition and with a small diameter. The cannulas are then expanded radially outwardly to give a full-size instrument passage. Expansion of the cannulas occurs against the viscoelastic resistance of the surrounding tissue. The cannulas may be expanded by inserting members into the cannulas or by fluid pressure.
- In accordance with another feature of the invention, a leading end portion of the cannula is constructed to pierce human body tissue. This enables the cannula to form its own opening in body tissue as the cannula is inserted into the tissue.
- In accordance with still another feature of the invention, the cannula can be inserted into a blood vessel and expanded. A flow of fluid can be conducted through the cannula into the blood vessel.
- The cannula advantageously includes a sheath which encloses a plurality of wires. A member may be inserted into the sheath and moved along the wires to expand the cannula. Each of the wires may advantageously include a core which is at least partially enclosed by a jacket which is integrally formed as one piece with the sheath. If desired, the cannula may be expanded by fluid pressure rather than inserting a member into the cannula.
- The foregoing and other features of the present invention will become apparent to one skilled in the art to which the present invention relates upon consideration of the following description of the invention with reference to the accompanying drawings, wherein:
- FIG. 1 is a perspective view of a cannula in accordance with a first embodiment of the invention, shown in an unexpanded condition;
- FIG. 2 is an exploded longitudinal sectional view of the cannula of FIG. 1;
- FIG. 3 is an assembled view of the cannula of FIG. 1;
- FIG. 4 is a schematic side view illustrating the cannula of FIG. 1 in an expanded condition;
- FIG. 5 is a schematic side view illustrating the cannula of FIG. 1 in a contracted or collapsed condition;
- FIG. 6 is a side view similar to FIG. 5 illustrating a trocar inserted in the cannula of FIG. 1;
- FIG. 7 is a sectional view taken along line7-7 of FIG. 5;
- FIG. 8 illustrates the cannula of FIG. 7 in a partially expanded condition with a trocar and a tubular insert therein;
- FIG. 9 illustrates the cannula of FIG. 7 in a fully expanded condition with a larger tubular insert therein;
- FIG. 10 illustrates the cannula of FIG. 1 in use;
- FIG. 11 is a view of a cannula in accordance with a second embodiment of the present invention, shown in an unexpanded condition;
- FIG. 12 is an end view of the cannula of FIG. 11 in a fully collapsed condition;
- FIG. 13 is a view similar to FIG. 12 with the cannula in a partially expanded condition;
- FIG. 14 is a view similar to FIG. 13 with the cannula in a fully expanded condition;
- FIG. 15 is a perspective view of the cannula of FIG. 11;
- FIG. 16 illustrates the cannula of FIG. 15 with a trocar therein;
- FIG. 17 illustrates the cannula of FIG. 11 in use;
- FIG. 18 is a perspective view of a cannula forming another embodiment of the invention;
- FIG. 19 is a sectional view of the cannula of FIG. 18, the cannula being shown in a retracted condition;
- FIG. 20 is a sectional view of the cannula of FIG. 18, the cannula being shown in an expanded condition;
- FIG. 21 is an enlarged fragmentary sectional view of a pointed end portion of another embodiment of the cannula of FIG. 1;
- FIG. 22 is an end view, taken generally along the line22-22 of FIG. 21, illustrating the relationship between a sheath and wires in the pointed end portion of the cannula;
- FIG. 23 is a fragmentary plan view, taken generally along the line23-23 of FIG. 21, further illustrating the construction of the pointed end portion of the cannula;
- FIG. 24 is a schematic sectional view illustrating the manner in which the cannula is expanded from the contracted condition of FIG. 22 by insertion of tubular members into the cannula;
- FIG. 25 is an enlarged fragmentary schematic illustration depicting the relationship between the contracted cannula of FIGS.21-23 and body tissue immediately prior to insertion of the contracted cannula into the body tissue;
- FIG. 26 is a fragmentary schematic illustration depicting the relationship between the contracted cannula and a blood vessel after the cannula has pierced skin and body tissue adjacent to the blood vessel and prior to piercing of a side wall of the blood vessel;
- FIG. 27 is an enlarged fragmentary schematic illustration of a portion of FIG. 26 further illustrating the relationship between the pointed end portion of the cannula and the side wall of the blood vessel;
- FIG. 28 is a fragmentary schematic illustration, generally similar to FIG. 26, illustrating the relationship of the cannula to the blood vessel after the cannula has pierced the side wall of the blood vessel and has been inserted into the blood vessel with the cannula in the contracted condition of FIG. 22;
- FIG. 29 is a fragmentary schematic illustration, taken generally along the line29-29 of FIG. 28, further illustrating the relationship between the cannula and the blood vessel;
- FIG. 30 is a fragmentary schematic illustration, generally similar to FIG. 28, illustrating the relationship between the cannula and the blood vessel when the cannula is in an expanded condition;
- FIG. 31 is a schematic illustration, similar to FIG. 29, and taken generally along the line31-31 of FIG. 30;
- FIG. 32 is an enlarged schematic illustration, generally similar to FIG. 25, illustrating the relationship between another embodiment of the cannula and the skin of a patient immediately prior to piercing of the skin of the patient with the cannula;
- FIG. 33 is a fragmentary schematic illustration, generally similar to FIG. 31, illustrating the relationship between another embodiment of the cannula and a blood vessel after the cannula has been inserted into the blood vessel and expanded by fluid pressure;
- FIG. 34 is a sectional view, taken along the line34-34 of FIG. 33, further illustrating the relationship between the expanded cannula and the blood vessel;
- FIG. 35 is a fragmentary sectional view, generally similar to FIG. 21, illustrating a pointed end portion of another embodiment of the cannula;
- FIG. 36 is a fragmentary sectional view, generally similar to FIG. 21, illustrating a pointed end portion of another embodiment of the cannula;
- FIG. 37 is an enlarged fragmentary sectional view of a portion of FIG. 36 illustrating the construction of an end portion of the cannula which is expandable when the cannula is in the expanded condition of FIG. 24; and
- FIG. 38 is a sectional view, taken generally along the line38-38 of FIG. 37, further illustrating the construction of the end portion of the cannula.
- In a first embodiment of the invention, a cannula10 (FIG. 1) includes an expanding
portion 12 and aproximal end portion 14. The expandingportion 12 includes a plurality of longitudinally extendingwires 16. Thewires 16 are surrounded for most of their length by an overlyingelastic sheath 18. Thewires 16 define between them acentral instrument passage 20. - The
wires 16 are preferably made of a material which is flexible, does not break, and does not stretch. A preferred material is music wire, which is thin gauge steel about 0.015″ in diameter. The use of the term “wire” in this application and its claims does not limit the invention to metal wires. The “wires” may also be made of other elongate material such as composites or plastics or other metals. The “wires” may also be coated. - The number of wires may be selected as desired. Applicants have found that 8 to 10 wires will suffice for a cannula expandable up to 7 mm OD, and that 12 wires or more may be necessary for a larger cannula. Ten larger diameter wires (0.025″) may be used rather a larger number of small diameter wires. A greater number of
wires 16 can be used if a greater diameter is needed. If notenough wires 16 are used, an instrument (trocar, insert, scope, etc.) inserted through thepassage 20 when thecannula 10 is expanded will contact theelastic sheath 18 rather than thewires 16, at locations between the wires. - The
wires 16 are self-aligning. When thecannula 10 is in a contracted condition, thewires 16 may overlap. When thecannula 10 is expanded, thewires 16 straighten out as shown. - The
elastic sheath 18 is preferably secured to thewires 16 at both proximal and distal ends, to prevent the sheath from sliding off the wires during insertion and removal of thecannula 10. Rubber cement or cyanoacrylate or a similar adhesive can be used to bond thesheath 18 to thewires 16 as shown schematically at 24. - The
elastic sheath 18 is preferably made of latex or silicone, or of C-Flex®, a general purpose thermoplastic elastomer sold by Linvatec Corporation of Clearwater, Fla. Thesheath 18 is of a diameter such that it is stressed even when thecannula 10 is fully contracted. Thus, thesheath 18 constantly biases thewires 16 radially inwardly toward theaxis 22 of thecannula 10. - At the
proximal end portion 14 of thecannula 10, thewires 16 are clamped between aninner ring member 30 and anouter ring member 32. Theinner ring member 30 has acentral opening 34. Theinner ring member 30 has a clampingsurface 36 including abeveled edge 38 and an annularradially extending surface 40. Theouter ring member 32 has a threadedcentral opening 42 for receiving astandard luer lock 43. Theouter ring member 32 has a clampingsurface 44 including abeveled edge 46 and an annularradially extending surface 48. - The
ring members ring members -
Proximal end portions 50 of thewires 16 are trapped between thering members ring members proximal end portions 50 of thewires 16 are trapped between the clampingsurface 36 of theinner ring 30 and the clampingsurface 44 of theouter ring 32. Theproximal end portion 52 of thesheath 18 is preferably also trapped between therings proximal end portion 52 of thesheath 18 may be bonded to thewires 16 at a proximal location adjacent thering members cannula expanding portion 12 is secured, having a large diameter generally equal to the expanded diameter of thecannula 10. - The
sheath 18 has a longitudinally extending circumferential outer surface 54 (FIG. 7) and a longitudinally extending circumferentialinner surface 56. Thewires 16 engage the circumferentialinner surface 56 of thesheath 18. The radiallyinner surfaces 60 of thewires 16 define anannular periphery 62 within which any item inserted in thecannula 10 is disposed. In one embodiment which has been constructed, when contracted, thecannula 10 is about 2 mm diameter, the size of a 14 ga needle. Thus, thecannula 10 can possibly be inserted as a needle, clearing its own path, and not needing a trocar first. The constructed cannula is about 90 mm long. Other useful sizes include (i) up to 2.5 mm diameter with a 70 mm length; (ii) up to 7 mm diameter with a 110 mm length; and (iii) up to 11 mm diameter with a 160 mm length. - In use of the
cannula 10, the surgeon makes a small incision in the epidermis. He inserts a narrow trocar such as the trocar 70 (FIGS. 6 and 8) into thecentral passage 20 of thecannula 10. Thepointed end portion 72 of thetrocar 70 will project distally. Theshaft portion 74 of thetrocar 70 is disposed inside thepassage 20. Theouter surface 76 of thetrocar shaft portion 74 engages the radiallyinner surfaces 60 of thewires 16. Theproximal end portion 78 of thetrocar 70 extends proximally from thecannula 10. - The
end portion 72 of thetrocar 70 may be blunt in order to push away internal tissue. In this case, a small incision would need to be made through the epidermis. - The trocar/cannula assembly is inserted through the incision in the epidermis to the subcutaneous working location. Then, a tubular insert80 (FIG. 8) is moved distally between the
wires 16 of thecannula 10 and thetrocar 70. Theinsert 80 is preferably a hollow metal tube at least as large in ID as the OD of the trocar pointedend portion 72. Thetrocar 70 can then be removed from thecannula 10, leaving the cannula and theinsert 80 in place in the tissue. - Because the
insert 80 is larger in diameter than thetrocar 70, during insertion of theinsert 80, thecannula 10 is expanded radially outwardly, as seen in a comparison of FIGS. 7 and 8 (which are not necessarily to scale). The tissue around thecannula 10 is also stretched. The surgeon has thus made a larger passage for instruments, along its entire length, without cutting tissue. - After the tissue is allowed to relax, the surgeon removes the
insert 80. Thecannula 10 collapses radially inwardly because of the elastic sheath and because of the force of the tissue around it. But the tissue opening does not necessarily collapse completely, because of the viscoelastic nature of tissue, which tends to maintain its stretched condition for some time. - The surgeon then puts a second insert inside the
cannula 10. The second insert is a hollow tube larger in diameter than thefirst insert 80. Again, the cannula expands radially outwardly, and the tissue stretches. - In this manner, the surgeon continues with larger and larger inserts, until the tissue opening is as large as desired. The cannula may then be in the expanded condition shown in FIG. 9, with a full
size metal insert 90 within thecannula 80. Theinsert 90 then functions as a normal cannula, allowing insertion and removal of surgical instruments and the like. - Items inserted through the
central passage 20 of thecannula 10 always contact the innercylindrical surface 92 of theinsert 90. This provides a non-wearing, slippery engagement, which is desirable for insertion and removal of the instruments. An example is illustrated in FIG. 11 showing aprobe 94 extending through thecentral instrument passage 20 of thecannula 10 having aninsert 90 therein. Thecannula 10 has expandedtissue 96 radially outwardly to create acavity 98 therein. - Items inserted through the
central passage 20 of thecannula 10, such as theinserts inner surfaces 60 of thewires 16. This also provides a non-wearing, slippery engagement, which is desirable for insertion and removal of the inserts. - The
cannula 10 is discarded after use to prevent contamination. - Thus, it is seen that the
wires 16 haveouter surface portions 60 disposed radially inwardly in thecannula 10 and forming contact surfaces for surgical instruments and the like inserted through thecentral instrument passage 20 of the cannula. Thesheath 18 has an outercircumferential surface 54 engaging tissue when thecannula 10 is in use. Thewires 16 block engagement of instruments inserted through thecentral instrument passage 20 of thecannula 16 with theelastic sheath 18. Thesheath 18 blocks engagement of tissue with thewires 16, and the sheath and the wires block engagement of tissue with any instruments inserted through thecannula 10. - The
cannula 10 expands radially outwardly along substantially its entire length against the bias of thesheath 18. Thus, thecannula 10 can accommodate through its central instrument passage 20 a surgical instrument or the like having a diameter along its entire length which is greater than the diameter of the cannula in the contracted condition. This is not possible with cannulas which expand only along a portion of their length. - A second embodiment of the invention is illustrated in FIGS.11-17. An
expandable cannula 100 includes four longitudinally extendingmembers members - Specifically, the
member 102 includes a longitudinally extendingarcuate segment 110 and a widenedproximal end portion 112. Themember 104 includes a longitudinally extendingarcuate segment 114 and a widenedproximal end portion 116. Themember 106 includes a longitudinally extendingarcuate segment 118 and a widenedproximal end portion 120. Themember 108 includes a longitudinally extendingarcuate segment 122 and a widenedproximal end portion 124. - The
members members arcuate segments expandable cannula structure 130. - The distal ends132 of the
members proximal end portions cannula 100 which also allows entry of an instrument therethrough. The end portions have angledinner surfaces 134 to guide an instrument into the longitudinally extendingcentral instrument passage 136 of thecannula 100 in the direction indicated by thearrow 138. The handle (proximal end) portion of thecannula 100 can be configured to attach instruments to it, or to have a cap screwed onto the end to close the cannula. - The
arcuate segments elastic sheath 140. Theelastic sheath 140 is secured to thesegments distal locations 142 and 144, to prevent the sheath from sliding off the segments during insertion and removal of thecannula 100. Rubber cement or cyanoacrylate or a similar adhesive can be used to bond thesheath 140 to the segments. Theelastic sheath 140 is preferably made of latex or silicone, or of the C-Flex® material described above. Thesheath 140 is of a diameter such that it is stressed even when thecannula 100 is fully contracted. Thus, thesheath 140 constantly biases the segments radially inwardly toward the center of thecannula 100. - One cannula that has been constructed is 90 mm in length, and about 5 mm in diameter when aligned in a tube form as shown in FIGS.12-14. The members can collapse (overlap onto themselves as shown in FIG. 12) into a smaller diameter. The cannula can expand to about 12+mm OD.
- In use of the
cannula 100, the surgeon makes a small incision in the epidermis. He inserts a narrow trocar such as the trocar 70 (FIG. 16) into thecentral passage 136 of thecannula 100. Thepointed end portion 72 of thetrocar 70 will project distally. Theshaft portion 74 of thetrocar 70 is disposed inside thepassage 136. Theproximal end portion 78 of thetrocar 70 extends proximally from thecannula 100. - A trocar should be used with the
cannula 100 only when needed. The distal end portion of thecannula 100 is preferably used alone to push through internal tissue once an epidermal incision has been made. - The trocar/cannula assembly is inserted through the incision in the epidermis to the subcutaneous working location. Then, a tubular insert80 (FIG. 14) is inserted longitudinally between the
cannula 100 and thetrocar 70. Theinsert 80 is preferably a hollow metal tube at least as large in ID as the OD of the trocar pointedend portion 72. Thetrocar 70 can then be removed from thecannula 100, leaving the cannula and theinsert 80 in place in the tissue. - As the
insert 80 is inserted in thecannula 100, the outer surface of the insert engages longitudinally extending radiallyinner edges 148 of themembers insert 80 is larger in diameter than thetrocar 70, during insertion of the insert, thecannula 100 is expanded radially outwardly, as seen in a comparison of FIGS. 13 and 14 (which are not necessarily to scale). The fourmembers passage 136 is enlarged. The tissue around thecannula 100 is also stretched. The surgeon has thus made a larger passage for instruments, along its entire length, without cutting tissue. - After the tissue is allowed to relax, the surgeon removes the
insert 80. Thecannula 100 collapses radially inwardly because of the elastic sheath and because of the force of the tissue around it. But the tissue opening does not necessarily collapse completely, because the tissue is viscoelastic. - The surgeon then puts a second insert90 (FIG. 17) inside the
cannula 100. Thesecond insert 90 is a hollow tube larger in diameter than thefirst insert 80. Again, thecannula 100 expands further radially outwardly, and the tissue stretches. The surgeon continues with larger and larger inserts, until the tissue opening is as large as desired. The cannula may then be in the expanded condition shown in FIG. 17, with theinsert 90 within thecannula 100. Thecannula 100 can then be removed proximally, leaving the insert in place. The insert then functions as a normal cannula, allowing insertion and removal of surgical instruments and the like such as the probe illustrated schematically at 94. - The
cannula 100 expands radially outwardly along substantially its entire length against the bias of thesheath 130. Thus, thecannula 100 can accommodate through its central instrument passage 136 a surgical instrument or the like having a diameter along its entire length which is greater than the diameter of the cannula in the contracted condition. This is not possible with cannulas which expand only along a portion of their length. - It is contemplated that one would use two
different size cannulas 100 to obtain a desired range of expansion. A first, smaller size, would extend from an OD of 2.5 mm to an ID of 7 mm, being about 70 mm in length. A second, larger size, would extend from an OD of 6 mm to an ID of 12 mm, being about 150 mm in length. - The expandable cannulas of the present invention may be designed to selectively expand at a location at or near the distal end. This is illustrated in FIGS.18-20. An
expandable cannula 300 similar to the expandable cannula 10 (FIGS. 1-9) includes a plurality of longitudinally extendingwires 302. Instead of an elastic sheath like the sheath 18 (FIGS. 1-9), thecannula 300 includes aninflatable sheath 304. Thesheath 304 includes aninner sheath member 306 and anouter sheath member 308. - The
inner sheath member 306 is of a double-walled construction, including aninner wall 310 and anouter wall 312. Aninflation volume 314 separates theinner wall 310 and theouter wall 312. Fluid under pressure such as air, saline, etc. may be introduced into theinflation volume 314 through afluid port 316. Theinner sheath member 306 overlies thewires 302. - When fluid under pressure is introduced into the
inflation volume 314 through thefluid port 316, theouter wall 312 of theinner sheath member 306 expands radially outwardly, as shown in FIG. 20. Radially outward expansion of theouter wall 312 of theinner sheath member 306 is limited by theouter sheath member 308. Theouter sheath member 308 is a single-layer sheath overlying theinner sheath member 306. Anotch 320 is cut out of theouter sheath member 308. Theouter wall 312 of theinner sheath member 306 can expand radially outwardly only at the location of thenotch 320 in theouter sheath member 308. - The
notch 320, or any similar opening in theouter sheath member 308, may be placed at or near the distal end of thecannula 300. This will stabilize thecannula 300 in the tissue, at the closest possible location to the work area off the distal end of the cannula. - In the embodiment of the invention illustrated in FIGS.21-31, the cannula of FIGS. 1-10 has been provided with a pointed distal or leading end portion to facilitate the piercing of human body tissue with the end portion of the cannula. In addition, each of the wires includes a core and a coating or jacket which is integrally formed as one piece with the plastic sheath of the cannula. It is contemplated that the embodiment of the cannula illustrated in FIGS. 21-31 will be particularly advantageous for use in establishing communication with interior of a vessel, such as a sac, organ, tube, duct or canal. However, the cannula may be used to establish communication with any desired portion of the human body.
- The cannula400 (FIGS. 21, 22 and 23) has the same general construction as the
cannula 10 of FIGS. 1-10. Thus, thecannula 400 includes anelastic sheath 402 which encloses a plurality of longitudinally extendingwires 404. The wires define between them acentral passage 406 through which instruments may be inserted into a human body or fluid may be conducted into the human body. At a proximal end portion (not shown) of thecannula 400, thesheath 402 andwires 404 are clamped between ring members in the same manner illustrated in FIGS. 2 and 3 for thecannula 10. - In accordance with one of the features of the embodiment of the invention illustrated in FIGS.21-23, each of the
wires 404 includes a core 410 (FIG. 22) which is at least partially enclosed by a coating orjacket 412. Thecores 410 andjackets 412 extend between opposite ends of thesheath 402. Thus, thecores 410 andjackets 412 extend from a generally circular opening 416 (FIG. 21) at the distal or leading end of thesheath 402 to clamping ring members at the proximal end (not shown) of the sheath. - The
jacket 412 around thecore 410 of each of thewires 404 is integrally formed as one piece with thesheath 402. Thus, each of thejackets 412 is formed of the same elastic material as thesheath 402. The elastic polymeric material of the sheath and thejackets 412 may be molded or extruded around thecores 410 during formation of thecannula 400. - Each of the
jackets 412 has a longitudinal central axis which extends parallel to a longitudinalcentral axis 418 of thecannula 400. Thejackets 412 extend throughout the entire length of thesheath 402. Since thejackets 412 are integrally formed as one piece with thesheath 402, thewires 404 are maintained in a parallel relationship with the longitudinalcentral axis 418 of thecannula 400. Theparallel wires 404 extend from theopening 416 at the distal end of thesheath 402 to the location where the proximal end of the sheath is clamped between ring members in a manner similar to that illustrated in FIGS. 2 and 3. Thewires 404 do not intersect. -
Central cores 410 of thewires 404 may be formed of any desired material. In the embodiment of the invention illustrated in FIGS. 21-31, thecores 410 are formed of metal. Thus, thecores 410 are formed of music wire, that is a thin gauge steel of about 0.015 inches in diameter. However, thecores 410 could be formed of composite polymeric materials if desired. For example, thecores 410 could be formed by a matrix of polymeric material strengthened by longitudinally extending carbon fibers. - In the illustrated embodiment of the invention, the
parallel cores 410 of thewires 404 have a cylindrical configuration. Thus, each of thecores 410 has a circular cross sectional configuration as viewed in a plane extending perpendicular to a longitudinal central axis of the core. In the embodiment of the invention illustrated in FIGS. 21-23, thesheath 402 engages longitudinally extending side portions of thecores 410. The longitudinally extending side portions of thecores 410 which are engaged by thesheath 402 face radially outward away from thecentral axis 418 of thecannula 400. - The surface portions of the
cores 410 which do not engage thesheath 402 are enclosed by thejackets 412. Since thejackets 412 are integrally formed as one piece with thesheath 402, there is no precise line of demarcation between the jackets and the sheath. However, thejackets 412 extend inward from thesheath 402 toward thecentral axis 418 of thecannula 400 and cooperate with the sheath to enclose each of thecores 410. If desired, thejackets 412 could extend completely around thecores 410. - Circular axial end faces424 of the
cores 410 are exposed at opposite ends of thesheath 402. Thus, at the distal end of thecannula 400, the circular end faces 424 (FIGS. 22 and 23) of the cores are visible. Thejackets 412 extend from the end faces 424 of thecores 410 to the opposite end of thesheath 402. - The
cannula 400 is expandable throughout its length from a contracted condition (FIG. 22) to an expanded condition (FIG. 24) in the same manner as in which thecannula 10 of FIGS. 1-10 is expandable. When thecannula 400 is to be expanded from the contracted condition of FIG. 22, a firstcylindrical tubular member 430 is axially inserted into thecentral passage 406 through the proximal end portion of the cannula 400 (FIG. 24). As the firsttubular member 430 is inserted into thecannula 400, a cylindricalouter side surface 432 on thetubular member 430 slides along thewires 404 toward the distal or leading end of the cannula. Thus, theouter side surface 432 of thetubular member 430 slides on surfaces of thejackets 412 which enclose thecores 410 of thewires 404. - As the
tubular member 430 is axially moved into thecannula 400 from the proximal end portion (not shown) of the cannula to the distal end portion, thewires 404 are forced radially outward away from the longitudinalcentral axis 418 of the cannula. Thus, the cylindricalouter side surface 432 of themember 430 applies radially outward force against thewires 404. This radially outward force is transmitted through thewires 404 to thesheath 402. As this occurs, the elastic material of thesheath 402 is resiliently stretched and the distance between thewires 404 increases. - There is minimal resistance to axial sliding movement of the
tubular member 430 into thecannula 400. This is because thetubular member 430 is engaged by only thejackets 412 on thewires 404 along very thin linear areas. Theouter side surface 432 of thetubular member 430 is maintained in a spaced apart relationship with the inner side surface of thesheath 402 by thewires 404. Once thetubular member 430 has been inserted into thecannula 400, thesheath 402 presses thejackets 412 on thewires 404 against theouter side surface 432 of thetubular member 430. The firsttubular member 430 has a length which is greater than the length of thesheath 402 and extends axially outward from opposite ends of the sheath. - If the central passage through the
tubular member 430 has sufficient cross sectional area, thecannula 400 may be used with thetubular member 430 holding the cannula in an expanded condition. However, it is believed that it may be desirable to further expand thecannula 400. Therefore, a second cylindricaltubular member 436 is inserted into thecannula 400 through the proximal end of the cannula to further expand the cannula. The secondtubular member 436 has an inside diameter which is larger than the outside diameter of the firstcylindrical tubular member 430. - As the second
tubular member 436 is inserted into the proximal end of thecannula 400, a cylindricalouter side surface 438 on the secondtubular member 436 slides along thewires 404. The secondtubular member 436 forces thewires 404 radially outward away from the cylindricalouter side surface 432 of the firsttubular member 430. As this occurs, the elastic material of thesheath 402 is further resiliently stretched by the force applied against thewires 404 by thetubular member 436. - As the resilient material of the
cylindrical sheath 402 is circumferentially stretched, the distance between theparallel wires 404 increases. Sliding of thetubular member 436 from the proximal end to the distal end of thecannula 400 is relatively easy since the tubular member slides along thejackets 412 on thewires 404 and does not engage the inner side surface of thesheath 402. The second cylindricaltubular member 436 extends axially outward from opposite ends of thesheath 402. - Once the second cylindrical
tubular member 436 has been telescopically inserted into thecannula 400 around the first or innertubular member 430, the first tubular member can be axially withdrawn from thecannula 400. This results in the cylindricalcentral passage 406 through thecannula 400 having a diameter equal to the inside diameter of the relatively large secondtubular member 436. - If desired, a still larger tubular member may be telescopically inserted into the
cannula 400 around the secondtubular member 436 to further expand the cannula and increase the size of thecentral passage 436 through the cannula. It is possible to expand thecannula 400 to any one of many different sizes depending upon the size of the tubular member which is used to apply force against thewires 404 and resiliently stretch thesheath 402 of the cannula. It is believed that it will be preferred to have the extent of expansion of thesheath 402 be less than the elastic limit of the material forming the sheath. - Since the elastic limit of the material forming the
sheath 402 is not exceeded by expanding thecannula 400 by insertion of themembers cannula 400 back to its original size, it is merely necessary to axially pull thetubular member 436 out of the proximal end of the cannula. The elastic material of thesheath 402 will move thewires 404 radially inward toward the longitudinalcentral axis 418 of the cannula and return the cannula back to the retracted condition shown in FIG. 22. - In accordance with one of the features of this embodiment of the invention, the
cannula 400 has a pointed distal end portion 442 (FIG. 21). The pointeddistal end portion 442 of thecannula 400 facilitates piercing of body tissue with the cannula. Thepointed end portion 442 is formed by cutting the materials of thesheath 402 andwires 404 at an acute angle to the longitudinalcentral axis 418 of thecannula 400. In the embodiment of the invention illustrated in FIGS. 21 and 23, thepointed end portion 442 of thecannula 400 is formed by cutting the material of thesheath 402 andwires 404 at an angle of approximately 30° to the longitudinalcentral axis 418 of the cannula. Of course, thepointed end portion 442 could be skewed at a different angle relative to the longitudinalcentral axis 418 of thecannula 400 if desired. - The ends of the
wires 404 and the end of thesheath 402 cooperate to provide thecannula 400 with anend portion 442 which can cut body tissue when the end portion of the cannula is pressed against the body tissue. Thesheath 402 may advantageously be cut away adjacent to an apex 446 of thepointed end portion 442. Thus, abeveled surface 448 is formed in the material of thesheath 402 adjacent to the apex 446 of thepointed end portion 442. Thebeveled surface 448 makes thepointed end portion 442 of the cannula sharper to facilitate severing the body tissue. Thebeveled surface 448 extends outward to a leading end of awire 404 which extends through the central part of the apex 446 of thepointed end portion 442 of thecannula 400. - In the illustrated embodiment of the invention, the
cylindrical cores 410 of theparallel wires 404 are formed by thin gauge steel wire. The leading end of thecore 410 of thewire 404 extends through the apex 446 of thepointed end portion 442 of thecannula 400. The leading end of thecore 410 of thewire 404 through the apex 446 provides a relatively sharp cutting edge at the axially outer end of thecannula 400. This sharp cutting edge can readily penetrate relatively tough body tissue. - When the
pointed end portion 442 of the contractedcannula 400 is pressed against an imperforate surface area on body tissue, force is transmitted axially through thewires 404 and through thesheath 402 to the body tissue. The apex 446 of the pointed end portion penetrates the body tissue and initiates the formation of an opening in the body tissue. The initiating of the opening in the body tissue is facilitated by having the exposed relatively sharp end of thecore 410 of thewire 404 which extends through the apex 446 of thepointed end portion 442 of the contractedcannula 400 engage the body tissue to initially cut the imperforate surface area of the body tissue. The leading edge portions of the sheath disposed adjacent to opposite sides of thewire 404 through the apex 446 of thecannula 400 are then effective to sever body tissue to increase the size of the opening in the body tissue. - As the contracted
cannula 400 is further inserted into the body tissue, the leading end portions ofadditional wires 404 and leading edges of segments of thesheath 402 disposed between the wires sever the body tissue to increase the size of the opening. Thus, thesheath 402 and ends of thewires 404 cooperate to form an opening in the body tissue at a location where there was no natural opening. The size of the opening formed in the body tissue by thepointed end portion 442 of thecannula 400 increases until the opening is large enough to accept the cylindrical outer side surface of the cannula when it is in the contracted condition of FIG. 22. - Once the contracted
cannula 400 has been inserted for a desired distance into the body tissue, the cannula is expanded from the contracted condition of FIG. 22 to the expanded condition of FIG. 24. As this occurs, the viscoelastic material of the body tissue is resiliently stretched and the size of the small opening formed by thecannula 400 in its contracted condition is increased. When thecannula 400 is in the expanded condition of FIG. 24 and the first orinner member 430 has been removed, surgical tools and/or optical instruments can be inserted through thecylindrical passage 406 within the secondtubular member 436 and expandedcannula 400. When the expandedcannula 400 is subsequently contracted and removed from the body tissue, the viscoelastic body tissue also contracts. Therefore, the size of the wound in the body tissue is minimized. - It is contemplated that the
cannula 400 will have many different uses, including the establishment of communication with the interior of many different types of vessels in a human body. For example, the cannula could be used to establish communication with the interior of a vessel such as a lung, heart, endolymphatic duct or sac, a hernial sac, or a bladder. It is also contemplated that thecannula 400 will be used as a passage through body tissue for many different types of instruments and/or fluids. For example, thecannula 400 may be used to facilitate laproscopic or arthroscopic surgery. However, it is believed that thecannula 400 will be particularly advantageous in establishing communication with the interior of a blood vessel. - The
cannula 400 can be used to establish communication with the interior of a blood vessel in a human body for an intravenous infusion. When this is to be done, thepointed end portion 442 of thecannula 400 is used to pierce an imperforate surface area on the skin 454 (FIG. 25) of a human body. After penetratingbody tissue 460 beneath the skin, thepointed end portion 446 of thecannula 400 pierces an imperforate surface area on aside wall 456 of a vein or blood vessel 458 (FIGS. 26, 27 and 28). Thus, thecannula 400 is used to initiate the formation of openings in theskin 454 andside wall 456 of theblood vessel 458 at locations where there is no naturally occurring opening and without the necessity of making an incision prior to insertion of the cannula. An intravenous infusion of a suitable liquid preparation can then be conducted through thecannula 400 into the vein. - When the
cannula 400 is to be inserted into theblood vessel 458 for an intravenous infusion or other purpose, theapex 446 of thepointed end portion 442 of the contractedcannula 400 is first pressed against anouter side surface 464 of the skin 454 (FIG. 25). Engagement of theend face 424 of thecore 410 of thewire 404 which extends through the apex 446 of the pointed end portion 442 (FIGS. 21 and 23) of thecannula 400 punctures theouter side surface 464 of theskin 454 under the influence of force transmitted axially through thecannula 400. If desired, thepointed end portion 442 of thecannula 400 could have thesheath 402 configured in such a manner, that is, by elimination of thebevelled surface 448, so as to have the sheath itself initiate the formation of the opening in theskin 464. However, it is preferred to use the relatively sharp leading end portion of thecore 410 of thewire 404 which extends through the apex 446 of the pointed end portion 442 (FIGS. 21 and 23) of the contractedcannula 400 to initiate the formation of the opening in theskin 454. - As the axially tapered pointed
end portion 442 of the contractedcannula 400 pierces theskin 454, the size of the opening in the skin is increased. A cylindricalouter side surface 468 of the sheath 402 (FIGS. 25 and 26) enters the opening in the skin. At this time, thecannula 400 is in the contracted condition of FIG. 22. Therefore, a relatively small opening in theskin 454 can accommodate thecannula 400. - After the
cannula 400 has pierced theskin 454, the cannula is pressed toward theblood vessel 448 and pierces the body tissue 460 (FIG. 26). Thecannula 400 is moved through thebody tissue 460 until thepointed end portion 446 of thecannula 400 engages theside wall 456 of theblood vessel 458. The pointedleading end portion 442 of thecannula 400 is then pressed firmly against theside wall 456 of the blood vessel 458 (FIG. 27). - The axial force transmitted through the contracted
cannula 400 causes the axially tapered leading end of thecore 410 of thewire 404 which extends through the apex 446 (FIG. 21) of thepointed end portion 442 of the cannula to initiate the formation of an opening at an imperforate outer side surface 472 (FIG. 27) of theside wall 456 of theblood vessel 458. Continued axial movement of thecannula 400 results in theleading end portion 442 of the cannula piercing theside wall 456 of theblood vessel 456. Since thecannula 400 is in the contracted condition of FIG. 22 when theside wall 456 of theblood vessel 458 is pierced, a relativelysmall opening 476 is formed in theside wall 456 of theblood vessel 456 by thecannula 400. - Although the
cannula 400 is shown in FIG. 25 as being oriented with its longitudinal central axis at an angle of approximately 30° relative to theouter side surface 464 of theskin 454 as the skin is pierced, it is contemplated that it may be desired to have the cannula oriented at an angle of approximately 45° relative to theouter side surface 464 of theskin 454 when the skin is pierced by the cannula. In addition, in FIG. 26, the cannula is shown as being oriented relative to theblood vessel 458 with the longitudinal central axis of the cannula extending at an angle of approximately 30° relative to theouter side surface 472 of theblood vessel 458. It is contemplated that it may be desired to have the cannula oriented at a smaller angle relative to theouter side surface 472 of theblood vessel 458 as the blood vessel is pierced. Thus, there may be an angle of only 15° between the longitudinal central axis of thecannula 400 and thesurface 472 of theblood vessel 458 as the blood vessel is pierced by thecannula 400. Reducing the angle between the longitudinal central axis of thecannula 400 and theouter side surface 472 of theblood vessel 458 prior to piercing the blood vessel facilitates piercing theside wall 456 of theblood vessel 458 without pushing thecannula 400 clear through the blood vessel. - Once the contracted
cannula 400 has been inserted into theblood vessel 458, the cannula is moved axially along the blood vessel (FIG. 28) to increase the telescopic relationship between the blood vessel and the cannula. Although thecannula 400 has been shown in FIG. 28 as being inserted for only a relatively a small distance into theblood vessel 458, it is contemplated that the cannula may be inserted for a substantial distance into the blood vessel. Thus, thecannula 400 may be moved along theblood vessel 458 to another vessel, such as a sac or organ. - Since the
cannula 400 is in the contracted condition of FIG. 22, the cannula will have a small outside diameter (FIG. 29) and will be relatively easy to move along theblood vessel 458. The contractedcannula 400 will form a relativelysmall opening 476 in theside wall 456 of theblood vessel 458. It is contemplated that the contractedcannula 400 may have a sufficiently largecentral passage 406 for some purposes. For example, an intravenous injection of a small dose of medicine could be made through the contractedcannula 400 if desired. However, it is believed that thecannula 400 will be advantageously used in circumstances requiring a relativelylarge passage 406 for communication with the interior of theblood vessel 458 and/or a vessel connected with theblood vessel 458. - When a relatively
large passage 406 is required through thecannula 400 to communicate with the interior of theblood vessel 458, thecannula 400 is expanded from the contracted condition of FIG. 22 to the expanded condition of FIG. 24 by the sequential insertion of members into the cannula. Thus, the first tubular member 430 (FIG. 24) is inserted into thecannula 400 to increase the diameter of theouter side surface 468 of the cannula and to effect a relatively small radial expansion of theside wall 456 of theblood vessel 458. - As the
cannula 400 is expanded, theouter side surface 468 of the cannula is pressed against edge portions of theopening 476 to increase the size of the opening. In addition, theouter side surface 468 of thecannula 400 is pressed against the edge portions of the opening in theskin 454 to increase the size of the opening in the skin. Of course, theouter side surface 468 of thecannula 400 also applies force against the inner side surface of theblood vessel 458 to expand the blood vessel. - The tubular member436 (FIGS. 24, 30 and 31) is then inserted into the
cannula 400 to further expand the cannula and theblood vessel 458. As thecannula 400 is expanded, force is transmitted from theouter side surface 468 of the cannula to an inner side surface of theblood vessel 458 to radially expand the blood vessel. In addition, the openings in both theblood vessel 458 andskin 454 are expanded. - Due to the viscoelastic characteristics of the
side wall 456 of theblood vessel 458, the diameter of the blood vessel can be substantially increased by expanding thecannula 400 from the contracted condition of FIGS. 28 and 29 to the expanded condition of FIGS. 30 and 31. Of course, expanding theside wall 456 of theblood vessel 458 enable fluid (liquid) to be conducted at a relatively high flow rate into the blood vessel. The fluid is conducted through thetubular member 436 and thecannula 400 into theblood vessel 458. In addition, expansion of theside wall 456 of theblood vessel 458 along with thecannula 400 enables surgical instruments and/or optical instruments to be inserted through the cannula into the blood vessel. Of course, if the contractedcannula 400 is moved along the blood vessel into another vessel, such as a sac or organ, before being expanded, the surgical instruments inserted through the central passage of the expanded cannula can be used within the sac or other body part. - In the embodiment of the invention illustrated in FIGS.21-31, the
core 410 of thewire 404 which extends into the apex 446 of thepointed end portion 442 is co-extensive with thesheath 402. In the embodiment of the invention illustrated in FIG. 32, the core of the wire which extends into the apex of the pointed end portion of the cannula extends beyond the sheath of the cannula to facilitate engagement of the core with the wire with body tissue. Since the embodiment of the invention illustrated in FIG. 32 is generally similar to the embodiment of the invention illustrated in FIGS. 21-31, similar numerals will be utilized to designate similar components, the suffix letter “b” being associated with the numerals of FIG. 32 to avoid confusion. - In the embodiment of the invention illustrated in FIG. 32, the
cannula 400 b has acylindrical sheath 402 b which encloses a plurality of longitudinally extendingwires 404 b. Each of thewires 404 b has alinear core 410 b which is enclosed by ajacket 412 b. Thejacket 412 b is integrally formed as one piece with thesheath 402 b and cooperates with the sheath to enclose one of thecores 410 b. Thepointed end portion 442 b has acircular opening 416 b. - At an apex446 b of the
pointed end portion 442 b, acore 410 b of one of thewires 404 b extends past the beveledouter edge surface 448 b of thesheath 402 b. Thus, anend portion 482 of the core 410 b of thewire 404 b extends past theopening 416 b to thecentral passage 406 b through thecannula 400 b. The outwardly projectingcore 410 b has apointed end portion 484 which projects axially outwardly from thesheath 402 b. - When the contracted
cannula 400 b is to be used to form an opening inskin 454 b, thepointed end portion 484 of thewire core 410 b engages theouter side surface 464 b of the skin before thesheath 402 b engages the skin. This results in the sharpouter end portion 484 of the core 410 b piercing theouter side surface 464 b of theskin 454 b before the skin is engaged by thesheath 402 b. By piercing theouter side surface 464 b of theskin 454 b with thepointed end portion 484 of the core 410 b, the forming of an opening in the skin by the contractedcannula 400 b is facilitated. - In the embodiment of the invention illustrated in FIGS.21-31, the
cannula 400 has a circular cross sectional configuration as viewed in a plane extending perpendicular to a longitudinalcentral axis 418 of the cannula (FIG. 22). It is contemplated that the cross sectional area of the cannula may be maximized by forming the cannula with an oval cross sectional configuration as viewed in a plane extending perpendicular to a longitudinal central axis of the cannula. - In addition, in the embodiment of the invention illustrated in FIGS. 33 and 34, the cannula is expanded under the influence of fluid pressure rather than by inserting members into the cannula in the manner described in conjunction with FIG. 24. Of course, if desired, members having an oval cross sectional configuration could be inserted into the cannula of FIGS. 33 and 34 to expand the cannula. Since the cannula of FIGS. 33 and 34 have the components of the same construction as the components of the cannula of FIGS.21-31, similar numerals will be utilized to identify similar components, the suffix letter “c” being associated with the numerals of FIGS. 33 and 34 to avoid confusion.
- The
cannula 400 c is inserted into ablood vessel 458 c in the manner illustrated in FIGS. 33 and 34. Thecannula 400 c includes anelastic sheath 402 c. Thesheath 402 c encloses longitudinally extendingwires 404 c. Thewires 404 c includecores 410 c andjackets 412 c. Thejackets 412 c are integrally formed as one piece with thesheath 402 c. - In accordance with one of the features of the embodiment of the invention illustrated in FIGS. 33 and 34, the
cannula 400 c has an oval configuration (FIG. 34) as viewed in across sectional plane extending perpendicular to a longitudinal central axis of the cannula. By forming thecannula 400 c with an oval configuration, the area of acentral passage 406 c through the cannula tends to be maximized. - When the
cannula 400 c is inserted into ablood vessel 458 c (FIG. 33), the major axis of the oval cross section of the cannula is aligned with the longitudinal central axis of theblood vessel 458 c at the location where the cannula extends through an opening in the side wall of the blood vessel. Thus, the longitudinal central axis of theblood vessel 458 c is disposed in the same plane as the major cross sectional axis of the oval cross section (FIG. 34) of the cannula. The minor axis of the oval cross section of the cannula extends radially relative to theblood vessel 458 c. - By aligning the major axis of the oval cross section of the
cannula 400 c with the longitudinal central axis of theblood vessel 458 c, the major axis of the opening formed in theblood vessel 458 c extends longitudinally along theside wall 456 c of the blood vessel (FIG. 33). Thus, when thecannula 400 c pierces theouter side surface 472 c of theblood vessel 458 c, the opening which is formed in theouter side surface 472 c of theblood vessel 458 c is relatively long in a lengthwise direction along the blood vessel. However, the opening formed in theouter side surface 472 c of theblood vessel 458 c is relatively small in a direction extending circumferentially around the blood vessel. - It should be understood that when the
cannula 400 c pierces theside wall 456 c of theblood vessel 458 c, the cannula is in a contracted condition in which it has a substantially smaller cross sectional configuration than is illustrated in FIG. 33. Thus, the relationship of the contractedcannula 400 c to theblood vessel 458 c when the cannula pierces theside wall 456 c of the blood vessel is similar to the relationship illustrated in FIG. 29 for thecannula 400 to theblood vessel 458. However, the contractedcannula 400 c will have a major cross sectional axis which is aligned with the longitudinal central axis of theblood vessel 458 c (FIG. 33). The minor cross sectional axis of the contractedcannula 400 c will have an extent which is equal to the diameter of the contractedcannula 400 of FIGS. 21-31. - In accordance with another feature of the present invention, the
cannula 400 c is expanded throughout its length under the influence of fluid pressure. Apump 490 is connected with thecentral passage 406 c in thecannula 400 c through avalve 492 and aconduit 494. Relatively high pressure fluid is discharged from thepump 490 through thevalve 492 andconduit 494 into thecentral passage 406 c in the contractedcannula 400 c. This fluid pressure is applied against an inner side surface of thesheath 402 c and thewires 404 c. - The fluid pressure inside the
cannula 400 c is effective to cause the elastic material of thesheath 402 c to expand from a contracted condition to an expanded condition. As this occurs, the size of the opening formed in the viscoelastic material of theblood vessel 458 c is enlarged. In addition, the outer side surface of thecannula 400 c presses against the inner side surface of theside wall 456 c to expand theblood vessel 458 c downstream from the location where the cannula enters the blood vessel. - The fluid from the
pump 490 forms an intravenous infusion of a liquid solution to theblood vessel 458 c. Of course, if thecannula 400 c is to be used to provide access for surgical tools and/or optical instruments to the interior of theblood vessel 458 c or with a part of the body connected with the blood vessel, thecannula 400 c could be expanded by using tubular members having an oval cross sectional configuration in the manner described in conjunction with FIG. 24. It should be understood that fluid pressure may be used to expand thecannula 400 of FIGS. 21-31 if desired. - In the embodiment of the invention illustrated in FIGS.21-31, the end face or surfaces 424 on the
core 410 of thewires 404 are exposed (FIGS. 22 and 23). Thus, thejackets 412 enclose thecores 410 throughout the length of the cores. However, in the embodiment of the invention illustrated in FIGS. 21-31, thejackets 412 do not cover the end surfaces 424 of thecores 410. Therefore, the end surfaces 424 of thecores 410 are exposed at thepointed end portion 442 of thecannula 400. - In the embodiment of the invention illustrated in FIG. 35, the jackets around the cores cover the end surfaces of the cores. Since the embodiment of the invention illustrated in FIG. 35 is generally similar to the embodiment of the invention illustrated in FIGS.21-31, similar components will be identified with similar numerals, the suffix letter “d” being associated with the numerals of FIG. 35 to avoid confusion.
- In the embodiment of the invention illustrated in FIG. 35, a
cannula 400 d includes anelastic sheath 402 d. Thesheath 402 d encloses a plurality of longitudinally extendingwires 404 d. Thecannula 400 d has a longitudinally extendingcentral passage 406 d. - Each of the
wires 404 d includes a core 410 d and ajacket 412 d which extends around thecore 410 d. Each of thejackets 412 d is integrally formed as one piece with thesheath 402 d. Each of thejackets 412 d extends between opposite ends of thesheath 402 d. - In accordance with a feature of the embodiment of the invention illustrated in FIG. 35, the
jacket 412 d around each of thecores 410 d extends across an axiallyouter end face 424 d of a core 410 d. Thus, at apointed end portion 442 d of thecannula 400 d, thecores 410 d of thewires 404 d are completely enclosed by cooperation between thejackets 412 d and thesheath 402 d. Thejackets 412 d includeend sections 502 which extend across the end surfaces 424 d of thecores 410 d of thewires 404 d. This results in thecannula 400 d having apointed end portion 442 d with an apex 446 d which is formed by thesheath 402 d. - When the
cannula 404 d is to pierce body tissue, thepointed apex 446 d of theend portion 442 d of the cannula engages the body tissue. In the embodiment of the invention illustrated in FIG. 35, the apex 446 d of thepointed end portion 442 d is formed by the elastic material of thesheath 402 d andjackets 412 d. Thus, thecores 410 d do not engage the body tissue as the cannula hood is inserted into the body tissue. - When the
cannula 400 d is to be inserted into body tissue, the pointed end of thesheath 402 d initiates the formation of the opening in the body tissue. Thewires 404 d stiffen the elastic material of thesheath 402 d to enable force to be transmitted through thecannula 400 d to the axially outer end of the sheath. - In the embodiment of the invention illustrated in FIGS.18-20, an end portion of the
cannula 300 is expandable outward of theouter sheath 308 and theinner wall 310. In the embodiment of the invention illustrated in FIGS. 36, 37 and 38, the cannula also has an end portion which is expandable outward of an outer side surface of a sheath to engage body tissue. Since the embodiment of the invention illustrated in FIGS. 36, 37 and 38 is generally similar to the embodiment of the invention illustrated in FIGS. 21-31, similar numerals will be utilized to designate similar components, the suffix letter “e” being associated with the numerals of FIGS. 36, 37 and 38 to avoid confusion. - In the embodiment of the invention illustrated in FIGS.36-38, a
cannula 400 e has anelastic sheath 402 e. Thesheath 402 e encloses a plurality of longitudinally extendingwires 404 e. Thecannula 400 e has a longitudinally extendingcentral passage 406 e. - Each of the
wires 404 e includes a core 410 e and ajacket 412 e (FIG. 38). Each of thejackets 412 e is integrally formed as one piece with thesheath 402 e. Each of thejackets 412 e extends between opposite ends of thesheath 402 e. - When the contracted
cannula 400 e is to be used for form an opening in body tissue, thepointed end portion 442 e (FIG. 36) of thecannula 400 e engages the body tissue. The apex 446 e of thepointed end portion 442 e penetrates the body tissue and initiates the formation of an opening in the body tissue at an imperforate surface area on the body tissue. The initiating of the opening in the body tissue is facilitated by having an exposed relatively sharp end portion of a core 410 e of awire 404 e which extends through the apex 446 e of thepointed end portion 442 e of the contractedcannula 400 e engage the body tissue to initially cut the imperforate surface area of the body tissue. The leading edge portions of thesheath 402 e disposed adjacent to opposite sides of thewire 404 e through the apex 446 e of thecannula 400 e are then effective to sever body tissue to increase the size of the opening in the body tissue. - As the contracted
cannula 400 e is further inserted into the body tissue, the leading end portions ofadditional wires 404 e and leading edges of segments of thesheath 402 e disposed between the wires sever the body tissue to increase the size of the opening. The size of the opening is increased until it is large enough to accept the cylindricalouter side surface 468 e of thecannula 400 e when the cannula is in the contracted condition. - Once the
cannula 400 e has been inserted for a desired distance into the body tissue, the cannula is expanded by inserting a tubularcylindrical member 430 e (FIG. 38) into the contractedcannula 400 e. As thetubular member 430 e is inserted into the contracted cannula, thesheath 402 e is resiliently expanded and the cross sectional size of the longitudinally extending array ofwires 404 e is increased. Of course, thecannula 400 e could be further expanded by the insertion of a second tubular member, corresponding to thetubular member 436 of FIG. 24. - In accordance with a feature of this embodiment of the invention, once the
cannula 400 e has been positioned in body tissue, aportion 600 of thepointed end portion 442 e of the cannula is expandable outward of anouter side surface 468 e of thesheath 402 e. Thus, theportion 600 is expandable from the configuration shown in solid lines in FIGS. 37 and 38 to the configuration shown in dashed lines in FIGS. 37 and 38. This enables theportion 600 of thecannula 400 e to engage body tissue and hold the cannula in place in the body tissue. - When the
pointed end portion 442 e of thecannula 400 e is inserted into body tissue, for example, into a vein, both thecannula sheath 402 e and theportion 600 of the cannula are contracted. When thecannula 400 e has been inserted a desired distance into the vein, thecannula sheath 402 e is expanded by either fluid pressure or by insertion of thetubular member 430 e. Theportion 600 of thecannula 400 e is then expanded radially outward from thecylindrical sheath 402 e to grip the inner side surface of the vein. It is contemplated that in certain circumstances it may not be necessary to expand thesheath 402 e and theportion 600 will be expanded while the sheath is contracted. - The
portion 600 of thecannula 400 e includes a resilient panel 604 (FIGS. 37 and 38) which is disposed in arectangular recess 606 formed in thesheath 402 e. When theportion 600 is in the contracted condition shown in solid lines in FIGS. 37 and 38, an arcuateouter side surface 608 of thepanel 604 is aligned with theouter side surface 468 e of thesheath 402 e. - The
panel 604 cooperates with thesheath 402 e to form avariable volume chamber 610 in the side wall of the sheath. Thepanel 604 is formed of a polymeric material having a substantially greater elasticity than the material of thesheath 402 e. The elasticity of the material of thepanel 604 enables the panel to be resiliently expanded from the position shown in solid lines in FIGS. 37 and 38 to the position shown in dashed lines and subsequently retracted. - The
chamber 610 is connected in fluid communication, through anopening 612 in thesheath 402 e with aconduit 614. Theconduit 614 has aside wall 616 which is integrally formed with thesheath 402 e. Theside wall 616 of theconduit 614 and thesheath 402 e cooperate to form acylindrical passage 620 which extends between opposite ends of thesheath 402 e. An axially outer or distal end portion of theconduit 620 is blocked by apointed segment 622 of ametal core 410 e (FIG. 37) of a wire. The core 410 e is fixedly secured, by adhesive, in thepassage 620 to block fluid flow through the outer end of the passage. - The
passage 620 extends to the opposite or proximal end of thecannula 400 e. The proximal end of thepassage 620 is connected with a pump 626 (FIG. 37) through avalve 628. Since thesegment 622 of awire core 410 e blocks the axially outer or distal end of thepassage 620, any fluid which flows through thevalve 628 into thepassage 620 must flow into thechamber 610. - Once the
sheath 402 e of thecannula 400 e has been expanded (FIG. 38) by the insertion of atubular member 430 e or by fluid pressure, fluid pressure is conducted through thepassage 620 to thechamber 610 to expand thechamber 610. Thus, the valve 628 (FIG. 37) is actuated to connect thepump 626 in fluid communication with thepassage 620. Fluid flows from thepump 626 through thepassage 620 andopening 612 to thechamber 610. The fluid pressure in thechamber 610 moves thepanel 604 outwardly from the position shown in solid lines in FIGS. 37 and 38 to the position shown in dashed lines. As this occurs, thepanel 604 grips body tissue to retain thecannula 400 e against movement relative to the body tissue. - In the embodiment of the invention illustrated in FIG. 38, the
side wall 616 of theconduit 614 is formed in the same manner and has the same size as thejackets 412 e of thewires 404 e. Thus, when thesheath 402 e is formed with thewires 404 e, a removable core is provided at the location where thepassage 620 is to be formed. Once the material of thejackets 412 e and theside wall 616 of theconduit 614 has solidified, the core in theside wall 616 of theconduit 614 is removed to leave thepassage 620. The end segment 662 (FIG. 37) of one of thecores 410 e is then inserted into thepassage 620 to block the axially outer end of the passage. - This results in the
conduit 614 being disposed in the longitudinal array ofwires 404 e and having the same size as one of the wires. When thetubular member 430 e (FIG. 38) is inserted into the cannula, the outer side surface of the tubular member slides along theside wall 616 of theconduit 614 in the same manner as in which the tubular member slides along thejackets 412 e of thewires 404 e. Therefore, force is transmitted from thetubular member 430 e through theconduit 614 to thesheath 402 e to expand the sheath when the tubular member is inserted into thecannula 400 e. - During construction of the
cannula 400 e, therecess 606 is formed in the side wall of thesheath 402 e. After theopening 612 between thepassage 620 and therecess 606 in thesheath 402 e has been formed, thepanel 604 is electron beam welded or otherwise secured to the sheath. - While various descriptions of the present invention are described above, it should be understood that the various features can be used singly or in any combination thereof. Therefore, this invention is not to be limited to only the specifically preferred embodiments depicted herein.
- Further, it should be understood that variations and modifications within the spirit and scope of the invention may occur to those skilled in the art to which the invention pertains. Accordingly, all expedient modifications readily attainable by one versed in the art from the disclosure set forth herein that are within the scope and spirit of the present invention are to be included as further embodiments of the present invention. The scope of the present invention is accordingly defined as set forth in the appended claims.
Claims (23)
Priority Applications (2)
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US10/242,205 US20030014068A1 (en) | 1993-02-04 | 2002-09-12 | Expandable cannula |
US11/930,332 US20080051734A1 (en) | 1993-02-04 | 2007-10-31 | Expandable cannula |
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US08/013,942 US5320611A (en) | 1993-02-04 | 1993-02-04 | Expandable cannula having longitudinal wire and method of use |
US08/254,368 US5573517A (en) | 1993-02-04 | 1994-06-06 | Expandable cannulas |
US08/470,142 US6338730B1 (en) | 1993-02-04 | 1995-06-06 | Method of using expandable cannula |
US09/992,211 US6814715B2 (en) | 1993-02-04 | 2001-11-16 | Expandable cannula |
US10/242,205 US20030014068A1 (en) | 1993-02-04 | 2002-09-12 | Expandable cannula |
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US11/930,332 Continuation US20080051734A1 (en) | 1993-02-04 | 2007-10-31 | Expandable cannula |
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US08/470,142 Expired - Lifetime US6338730B1 (en) | 1993-02-04 | 1995-06-06 | Method of using expandable cannula |
US09/992,209 Expired - Fee Related US6613038B2 (en) | 1993-02-04 | 2001-11-16 | Method of using expandable cannula |
US09/992,211 Expired - Fee Related US6814715B2 (en) | 1993-02-04 | 2001-11-16 | Expandable cannula |
US10/242,205 Abandoned US20030014068A1 (en) | 1993-02-04 | 2002-09-12 | Expandable cannula |
US11/930,332 Abandoned US20080051734A1 (en) | 1993-02-04 | 2007-10-31 | Expandable cannula |
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US08/470,142 Expired - Lifetime US6338730B1 (en) | 1993-02-04 | 1995-06-06 | Method of using expandable cannula |
US09/992,209 Expired - Fee Related US6613038B2 (en) | 1993-02-04 | 2001-11-16 | Method of using expandable cannula |
US09/992,211 Expired - Fee Related US6814715B2 (en) | 1993-02-04 | 2001-11-16 | Expandable cannula |
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US11/930,332 Abandoned US20080051734A1 (en) | 1993-02-04 | 2007-10-31 | Expandable cannula |
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Cited By (54)
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US20030073998A1 (en) * | 2000-08-01 | 2003-04-17 | Endius Incorporated | Method of securing vertebrae |
US20030153927A1 (en) * | 2001-05-15 | 2003-08-14 | Endius Incorporated | Structure for receiving surgical instruments |
US20030195550A1 (en) * | 1998-08-20 | 2003-10-16 | Davison Thomas W. | Cannula for receiving surgical instruments |
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US6613038B2 (en) | 2003-09-02 |
US20020052624A1 (en) | 2002-05-02 |
US6814715B2 (en) | 2004-11-09 |
US20080051734A1 (en) | 2008-02-28 |
US20020052625A1 (en) | 2002-05-02 |
US6338730B1 (en) | 2002-01-15 |
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