Source: http://www.freepatentsonline.com/8100858.html
Timestamp: 2018-10-22 20:18:39
Document Index: 780051306

Matched Legal Cases: ['Application No. 783650', 'Application No. 01', 'Application No. 98', 'Application No. 98', 'Application No. 2006200679', 'application No. 201', 'art 6', 'art 6', 'art 6', 'art 6', 'art 6', 'art 6', 'art 6', 'art 6', 'art 25', 'art 6', 'art 25', 'art 25', 'art 25', 'art 25', 'art 25']

Protective device for an injection needle - B. Braun Melsungen AG
Protective device for an injection needle
United States Patent 8100858
Protective devices for injection needles or infusion needles that include a needle holder at a proximal end of the needle, on whose shaft a protective element for the needle tip can be positioned and moved, are herein disclosed. The protective element is configured to block the needle tip following an injection to prevent accidental contact therewith. The protective element may be positioned on the shaft in a ready to use position inside a grip part or middle retaining portion, which is also used to activate the protective element over the needle following the injection.
Woehr, Kevin (Felsberg, DE)
Fuchs, Juergen (Bad Emstal, DE)
Raines, Kenneth C. (Bethlehem, PA, US)
Bartholomew, Joel M. (Danielsvile, PA, US)
12/574963
B. Braun Melsungen AG (Melsungen, DE)
604/110
604/164.08, 604/198
A61M5/00; A61M5/178; A61M5/32; A61M25/06; A61B17/34; A61M5/158
604/110, 604/192-198, 604/263, 604/163, 604/164
Download PDF 8100858 PDF help
7611487 Protective device for an injection needle 2009-11-03 Woehr et al. 604/110
7214211 Needle assembly with protective element 2007-05-08 Woehr et al. 604/164.08
20040204681 Catheter and introducer needle assembly with needle shield 2004-10-14 Thoresen et al.
20040186434 Catheter and introducer needle assembly with needle shield 2004-09-23 Harding et al.
6749588 Catheter and introducer needle assembly with needle shield 2004-06-15 Howell et al.
6623458 Spring launched needle safety clip 2003-09-23 Woehr et al. 604/192
6616630 Spring clip safety IV catheter 2003-09-09 Woehr et al.
6585704 Method of retaining a tip protector on a needle with a curved tip 2003-07-01 Luther et al.
6443929 Needle tip guard for hypodermic needles 2002-09-03 Kuracina et al.
6379333 Catheter and introducer needle assembly with needle shield 2002-04-30 Brimhall et al.
6287278 Spring dip safety IV catheter 2001-09-11 Woehr et al.
6224569 Compact needle point shield 2001-05-01 Brimhall
6117108 Spring clip safety IV catheter 2000-09-12 Woehr et al.
6004294 Catheter and introducer needle assembly with needle shield 1999-12-21 Brimhall et al.
6001080 Intravenous catheter assembly 1999-12-14 Kuracina et al.
5910130 Shield and actuator for needles 1999-06-08 Caizza et al.
5882337 Tip protection device 1999-03-16 Bogert et al.
5879337 Needle tip guard for hypodermic needles 1999-03-09 Kuracina et al.
5843048 Epidural catheter needle 1998-12-01 Gross
5738665 Shield and actuator for needles 1998-04-14 Caizza et al.
5718688 Catheter placement units 1998-02-17 Wozencroft
5697907 Safety catheter 1997-12-16 Gaba
5662610 Automatic needle guard tip protection 1997-09-02 Sircom
5611781 Catheter with automatic needle guard 1997-03-18 Sircom et al.
5601536 Needle tip cover 1997-02-11 Crawford et al.
5599310 I.V. catheter assembly with automatic cannula tip guard 1997-02-04 Bogert
5584818 Safety hypodermic needle and shielding cap assembly 1996-12-17 Morrison
5584810 Needle point guard assembly 1996-12-17 Brimhall
5584809 Safety catheter 1996-12-17 Gaba
5558651 Apparatus and method for a needle tip cover 1996-09-24 Crawford et al.
5501675 Safety catheter assembly having safety stop push button 1996-03-26 Erskine
5458658 Positive locking needle-mounted needle guard for needle supported catheters 1995-10-17 Sircom
5423766 Safety shield having spring tether 1995-06-13 Di Cesare
5419766 Catheter with stick protection 1995-05-30 Chang et al.
5370623 Catheter with protective cover and method of catheterization 1994-12-06 Kreamer
5348544 Single-handedly actuatable safety shield for needles 1994-09-20 Sweeney et al.
5344408 Break-away safety shield for needle cannula 1994-09-06 Partika
5334158 Automatic needle tip guard for standard hypodermic needles 1994-08-02 McLees
5328482 Catheter with automatic needle guard 1994-07-12 Sircom et al.
5322517 Disposable automatic hypodermic needle guard 1994-06-21 Sircom et al.
5312371 Method of making a needle sleeve assembly 1994-05-17 Dombrowski et al.
5300045 Interventional needle having an automatically capping stylet 1994-04-05 Plassche, Jr.
5279591 Protector for needle catheter 1994-01-18 Simon
5279570 Needle assembly with a movable stylet controlled by a spacer mechanism 1994-01-18 Dombrowski et al.
RE34416 I.V. catheter with self-locating needle guard 1993-10-19 Lemieux
5217438 Needle stop and safety sheath 1993-06-08 Davis et al.
5215528 Catheter introducer assembly including needle tip shield 1993-06-01 Purdy et al. 604/164.08
5215525 Safety casing for intravenous catheter needle 1993-06-01 Sturman
5183468 Snap ring needle guard 1993-02-02 McLees
5171229 Needle tip cover 1992-12-15 McNeil et al.
5147327 Hypodermic needle with protective sheath 1992-09-15 Johnson
5135504 Needle tip guard 1992-08-04 McLees
5126090 Method of forming a catheter with backflow restriction 1992-06-30 Egolf et al.
5120321 Safety disposable needle 1992-06-09 Oksman et al.
5120320 I.V. infusion or blood collection assembly with automatic safety feature 1992-06-09 Fayngold
5085648 Dual diameter needle with a smooth transition 1992-02-04 Purdy et al.
5053107 Ceramic staple fiber and glass fiber paper 1991-10-01 Barber, Jr.
5053017 Hypodermic needle safety clip 1991-10-01 Chamuel
5051109 Protector for catheter needle 1991-09-24 Simon
5049136 Hypodermic needle with protective sheath 1991-09-17 Johnson
4994041 Needle and catheter assembly 1991-02-19 Dombrowski et al.
4978344 Needle and catheter assembly 1990-12-18 Dombrowski et al.
4964854 Intravascular catheter assembly incorporating needle tip shielding cap 1990-10-23 Luther
4952207 I.V. catheter with self-locating needle guard 1990-08-28 Lemieux
4944725 Safety needle apparatus 1990-07-31 McDonald
4929241 Medical needle puncture guard 1990-05-29 Kulli
4846809 Needle tip protective device 1989-07-11 Sims
4795432 Shield assembly for hypodermic injection devices 1989-01-03 Karczmer
4790828 Self-capping needle assembly 1988-12-13 Dombrowski et al.
4747831 Cannula insertion set with safety retracting needle 1988-05-31 Kulli
4735618 Protective enclosure for hypodermic syringe 1988-04-05 Hagen
4725267 Post-injection needle sheath 1988-02-16 Vaillancourt
4250881 Catheter insertion device 1981-02-17 Smith
4160450 Outside-the-needle catheter device with needle housing 1979-07-10 Doherty
3904033 Pick-guard 1975-09-09 Haerr
3610240 INTRAVENOUS CATHETER APPARATUS WITH CATHETER TELESCOPED INSIDE PUNCTURING CANNULA 1971-10-05 Harautuneian
EP0352928 1992-12-30 I.V. catheter with self-locating needle guard
EP0554841 1993-08-11 Catheter introducer assembly including needle tip shield
EP0588470 1994-03-23 Needle stop and safety sheath
EP0750915 1997-01-02 Tip protection device
EP0750916 1997-01-02 Protective needle cover containment
EP0747085 2003-04-02 I.V. catheter assembly with automatic cannula tip guard
EP1003588 2004-11-17 SPRING CLIP AS NEEDLE TIP PROTECTION FOR A SAFETY IV CATHETER
EP1180381 2005-12-28 Intravenous catheter with needle guard
JP0999068 April, 1997
JP0999073 April, 1997
MX209311A October, 1997
WO1990008564A1 1990-08-09 DISPOSABLE AUTOMATIC HYPODERMIC NEEDLE GUARD
WO1997042989A1 1997-11-20 CATHERER PLACEMENT DEVICE
WO1999008742A1 1999-02-25 SPRING CLIP AS NEEDLE TIP PROTECTION FOR A SAFETY IV CATHETER
WO2000069501A1 2000-11-23 CATHETER AND INTRODUCER NEEDLE ASSEMBLY WITH NEEDLE SHIELD
JPH0999073A 1997-04-15
JPH0999068A 1997-04-15
Office Action mailed Sep. 29. 2008 from related U.S. Appl. No. 11/609,772.
Notice of Allowance mailed Aug. 28. 2009 from related U.S. Appl. No. 11/537,368.
Final Office Action mailed Mar. 18, 2009 from related U.S. Appl. No. 11/537,368.
Office Action mailed Sep. 26, 2008 from related U.S. Appl. No. 11/537,368.
Office Action mailed Dec. 26, 2008 from related U.S. Appl. No. 11/678,565.
Office Action mailed Jan. 25, 2006 from related United States Patent No. 7,125,397.
Notice of Allowance mailed Jun. 28, 2006 from related United States Patent No. 7,125,397.
Corrected Notice of Allowability mailed Oct. 4, 2006 from related United States Patent No. 7,125,397.
Response to 312 Amendment mailed Jan. 3, 2007 from related United States Patent No. 7,214,211.
Notice of Allowance mailed Sep. 19, 2006 from related United States Patent No. 7,214,211.
Advisory Action mailed May 5, 2006 from related United States Patent No. 7,214,211.
Final Office Action mailed Apr. 4, 2006 from related United States Patent No. 7,214,211.
Office Action mailed Jul. 28, 2005 from related United States Patent No. 7,214,211.
Office Action mailed May 18, 2005 from related United States Patent No. 7,214,211.
Office Action mailed Nov. 16, 2006 from related United States Patent No. 7,214,211.
Office Action mailed Jan. 3, 2007 from related United States Patent No. 7,214,211.
Office Action mailed Dec. 5, 2008 from related U.S. Appl. No. 11/326,780.
Office Action mailed Oct. 23, 2007 from related U.S. Appl. No. 10/734,931.
Final Office Action mailed Apr. 8, 2008 from related U.S. Appl. No. 10/734,931.
Examiner's Answer mailed Dec. 30, 2008 from related U.S. Appl. No. 10/734,931.
Office Action mailed Aug. 13, 2004 from related United States Patent No. 7,264,613.
Office Action mailed Dec. 1, 2004 from related United States Patent No. 7,264,613.
Final Office Action mailed May 13, 2005 from related United States Patent No. 7,264,613.
Office Action mailed Feb. 10, 2006 from related United States Patent No. 7,264,613.
Final Office Action mailed Nov. 17, 2006 from related United States Patent No. 7,264,613.
Advisory Action mailed Dec. 27, 2006 from related United States Patent No. 7,264,613.
Notice of Allowance mailed Feb. 7, 2007 from related United States Patent No. 7,264,613.
Office Action mailed Sep. 18. 2002 from related United States Patent No. 6,616,630.
Office Action mailed Dec. 31, 2002 from related United States Patent No. 6,616,630.
Notice of Allowance mailed Apr. 28, 2003 from related United States Patent No. 6,616,630.
Office Action mailed Sep. 10, 1999 from related United States Patent No. 6,287,278.
Office Action mailed Nov. 22, 1999 from related United States Patent No. 6,287,278.
Final Office Action mailed Dec. 11, 2000 from related United States Patent No. 6,287,278.
Final Office Action mailed Feb. 14, 2001 from related United States Patent No. 6,287,278.
Notice of Allowance mailed Jun. 14, 2001 from related United States Patent No. 6,287,278.
Office Action mailed Apr. 22, 1999 from related United States Patent No. 6,117,108.
Final Office Action mailed Sep. 14, 1999 from related United States Patent No. 6,117,108.
Notice of Allowance mailed Feb. 8, 2000 from related United States Patent No. 6,117,108.
Office Action mailed Apr. 30, 1998 from related U.S. Appl. No. 08/915,148.
Office Action mailed Jul. 20, 1998 from related U.S. Appl. No. 08/915,148.
Complaint for Case No. 09 CV 00347, filed May 13, 2009, District of Delaware, United States District Court (40 pages).
B. Braun Melsungen AG's Response to Opposition of Communication dated Sep. 26, 2005 and two (2) Notices of Opposition of Termuno; Response to Opposition dated Mar. 24, 2006, filed by Klingseisen of Zumstein & Klingseisen, including supporting documents (39 pages).
Australian Patent No. 783650, Published Feb. 21, 2002, Applicant's B. Braun Melsungen AG, entitled “Intravenous Catheter Device” (23 pages).
Statutory Declaration of Joseph J. Chang, Executed and Notarized on Jan. 9, 2007, In the matter of Australian Patent Acceptance No. 783650 and In the Matter of Opposition thereto by Smiths Medical ASD, Inc. (16 pages).
Australian Statement of Grounds and Particulars of Opposition from Medex, Inc., Spruson & Ferguson dated May 17, 2006 regarding Patent Application No. 783650 (2 pages).
Notice of Opposition to a European Patent; Opponents Smiths Medical ASD, Inc.; to B. Braun Melsungen AG for Opposed Patent No. 1 180 381; Application No. 01 109 231.9; dated Sep. 27, 2006 (25 pages).
Notice of Opposition to a European Patent; Opponent Terumo Corporation; to B. Braun Melsungen AG for Opposed Patent No. EP 1 003 588 Bl; Application No. 98 948 843.2; dated Aug. 16, 2005 (17 pages).
Notice of Opposition to a European Patent; Opponent Medex, Inc.: to B. Braun Melsungen AG for Opposed Patent No. 1 003 588: Application No. 98 948843.2; dated Aug. 17, 2005 (26 pages).
Affidavit of Joseph J. Chang; In the Court of the Commissioner of Patents for the Republic of South Africa; Case No. Patent 2001/3937; In the matter between: B. Braun Melsungen AG (First Applicant), B. Braun Medical (Proprietary) Limited (Second Applicant) and Specialised Systems Electro Medical (Proprietary) Limited (Respondent dated May 6, 2004 (84 pages).
Supplementary Answering Affidavit of Dennis Bialecki; In the Court of the Commissioner of Patents for the Republic of South Africa; Case No. Patent 2001/3937; In the matter between: B. Braun Melsungen AG (First Applicant), B. Braun Medical (Proprietary) Limited (Second Applicant) and Specialised Systems Electro Medical (Proprietary) Limited (Respondent) dated Sep. 15, 2005 (35 pages).
Replying Affidavit of Kevin Woehr; In the Court of the Commissioner of Patents for the Republic of South Africa; Case No. Patent 2001/3937; In the matter between: B. Braun Melsungen AG (First Applicant), B. Braun Medical (Proprietary) Limited (Second Applicant) and Specialised Systems Electro Medical (Proprietary) Limited (First Respondent) dated Oct. 19, 2005 (34 pages).
Affidavit of Kevin Woehr; In the Court of the Commissioner of Patents for the Republic of South Africa; Case No. Patent 2001/3937; In the matter between: B. Braun Melsungen AG (First Applicant), B. Braun Medical (Proprietary) Limited (Second Applicant) and Specialised Systems Electro Medical (Proprietary) Limited (First Respondent) and The Registrar of Patents (Second Respondent) dated Jun. 4, 2004 (16 pages).
Amended Sheet of Claims for South African Serial No. 2001/3937; filed Oct. 22, 2003; Claims 1-12 (8 sheets) and Figures 1-10 (3 sheets) (11 sheets total).
Affidavit of Dennis Bialecki; In the Court of the Commissioner of Patents for the Republic of South Africa; Case No. Patent 2001/3937; In the matter between: B. Braun Melsungen AG (First Applicant), B. Braun Medical (Proprietary) Limited (Second Applicant) and Specialised Systems Electro Medical (Proprietary) Limited (First Respondent), The Registrar of Patents (Second Respondent) and Medex Inc. (Third Respondent) dated Oct. 13, 2004 (33 pages).
Affidavit of Kevin Woehr; In the Court of the Commissioner of Patents for the Republic of South Africa; Case No. Patent 2001/3937; In the matter between: B. Braun Melsungen AG (First Applicant), B. Braun Medical (Proprietary) Limited (Second Applicant) and Specialised Systems Electro Medical (Proprietary) Limited (First Respondent), The Registrar of Patents (Second Respondent) and Medex Inc. (Third Respondent) dated Nov. 22, 2004 (38 pages).
In the Court of the Commissioner of Patent for the Republic of South Africa, entitled “Supplemental Answering Affidavit,” Case No. Patent 2001/3937, B. Braun Melsungen AG (First Applicant) and B. Braun Medical (Proprietary) Limited (Second Applicant) and Specialised Systems Electro Medical (Proprietary) Limited (Respondent), in regards patent of addition 2001/3937 and an application for infringement thereof, Affidavit of Dennis Bialecki, dated an signed Sep. 1, 2005 (36 pages).
Letter to Commissioner, dated Aug. 18, 2006, U.S. Appl. No. 10/445,166, filed May 23, 2003, entitled “Spring Clip Safety IV Catheter,” Confirmation No. 1659, executed by Tom H. Dao, Registration No. 44,641 (3 pages).
Administrative Declaration of Nullity requested by a Counterclaim against Patent No. 218,845, entitled “Spring Clip as Needle Tip Protection for an IV Safety Catheter,” B. Braun Melsungen AG vs. Medex De Mexico, S.A. De C.V. (58 pages).
Mexican Institute of Industrial Property Division Direction for the Protection of Intellectual Property Divisional Subdirection of Industrial Property Processes Department Coordination of Cancellation and Lapsing, N-2 Response to the Petition for the Administrative Declaration of Nullity of Patent 218,845, entitled “Spring Clip as Needle Tip Protection for an IV Safety Catheter,” Case No. P.C. 664/2004 (n-358) 9767 (33 pages).
Nullity of the Patent of invention PI9812128-6, filed on Aug. 18, 1998 and issued on Mar. 30, 2004, In the name of B. Braun Melsungen AG under the Title “IV Catheter and Catheter Device,” Signed by Antonio M.P. Arnaud, Sao Paulo, Sep. 29, 2004 (21 pages).
Response to the Request of Administration Nullity of the Patent P19812128-6, dated Mar. 30, 2004, Patentee: B. Braun Melsungen AG, entitled “Catheter and Catheter Device,” Rio de Janeiro, Feb. 28, 2005, Momsen, Leonardos& CIA (8 pages).
Technical Report Published on Jul. 26, 2005, Brazilian Patent No. PI9812128-6, PCT/EP98/05231, filed Aug. 18, 1998, Applicant: B. Braun Melsungen AG, Classification: A61M 25/06; A61M 5/32, Granting Date: Mar. 30, 2004, entitled “IV Catheter and Catheter Device,” dated Jun. 29, 2005, signed by Vania Gouvea Geraidina, Andriana Briggs de Aguiar, Patent Examiners. In agreement, signed by Leila Freire Falcone, Coordinator of the Appeal and Administrative Nullity Section (4 pages).
Response to the Technical Report Regarding the Request for Administrative Nullity of the Patent PI9812128-6, dated Mar. 30, 2004, Patentee: B. Braun Melsungen AG, entitled “IV Catheter and Catheter Device,” Rio de Janeiro, Sep. 26, 2005, Momsen, Leonardos & CIA (9 pages).
Lawsuit: Your Honot the Feder Judge of the Federal Court of the Rio de Janeiro District Court, B. Braun Melsungen AG vs. National Institute of Industrial Property—INPI (1st Defendant) and Johnson & Johnson Produtos Profissionais LTDA (2nd Defendant) (23 pages).
Description of Claims 27 and 28 in regards to Claim 27 vs. US Patent No. 5,135,504, Claim 27 vs. EP554841 and the novelty of PI9812128-6 over US Patent No. 6,652,486, INPI comments regarding the Federal Court action in Brazil (4 pages).
Amended Passages in the Specification, Claims as presented on Jan. 19, 2003, showing the pending claims at issue in the Brazilian nullity action (5 pages).
Stipulated Protective Order for Case No. 09 CV 00347-JJF-LPS, Document 67, filed Dec. 7, 2009, District of Delaware, United States District Court (17 pages).
Declaration of Michael A. Pearson, Jr. in Support of Braun's Response to Terumo's Counter-Statement in Response to Braun's Motion for Partial Summary Judgment on Terumo's Anticipation and Obviousness Invalidity Defenses and Counterclaims for Certain Claims of the '613 Patent, including Appendixes 15-22; Case No. 09 CV 00347-JJF-LPS, Document 252, filed Aug. 17, 2010; District of Delaware, United States District Court; Redacted—Public Version (82 pages).
Braun's Response to Terumo's Counter-Statements in Response to Braun's Motion for Partial Summary Judgment on Terumo's Anticipation and Obviousness Invalidity Defenses and Counterclaims for Certain Claims of the '613 Patent; Case No. 09 CV 00347-JJF-LPS, Document 251, filed Aug. 17, 2010, District cf Delaware, United States District Court; Redacted—Public Version (15 pages).
Declaration of Douglas E. McCann in Support of Terumo's Counter-Statements of Genuine Issues of Material Fact in Response to Braun's Motions for Summary Judgment; Case No. 09 CV 00347-JJF-LPS, Document 234, filed Jul. 29, 2010, District of Delaware, United States District Court; Redacted (22 pages).
Declaration of Dr. John C. Kulli in Support of Terumo's Counter-Statements of Genuine Issues of Material Fact in Response to Braun's Motions for Summary Judgment; Case No. 09 CV 00347-JJF-LPS, Document 233, filed Jul. 29, 2010, District of Delaware, United States District Court; Redacted (75 pages).
Terumo's Counter-Statement of Genuine Issues of Material Fact in Response to Braun's Motion for Partial Summary Judgment on Terumo's Anticipation and Obviousness Invalidity Defenses and Counterclaims for Certain Claims of the '613 Patent; Case No. 09 CV 00347-JJF-LPS, Document 232, filed Jul. 29, 2010, District of Delaware, United States District Court; Redacted (24 pages).
Declaration of Michael A. Pearson, Jr. in Support of Braun's Motion for Partial Summary Judgment on Terumo's Anticipation and Obviousness Invalidity Defenses and Counterclaims for Certain Claims of the '613 Patent; Case No. 09 CV 00347-JJF-LPS, dated Jun. 25, 2010, District of Delaware, United States District Court; Redacted—Public Version (161 pages).
Braun's Opening Brief in Support of its Motion for Partial Summary Judgment on Terumo's Anticipation and Obviousness Invalidity Defenses and Counterclaims for Certain Claims of the '613 Patent; Case No. 09 347 JJF-LPS, dated Jun. 25, 2010, redacted version Jul. 2, 2010, District of Delaware, United States District Court; Redacted—Public Version (22 pages).
Braun's Motion for Partial Summary Judgment on Terumo's Anticipation and Obviousness Invalidity Defenses and Counterclaims for Certain Claims of the '613 Patent; Case No. 09 CV 00347-JJF-LPS, Document 200, filed Jun. 25, 2010, District of Delaware, United States District Court (2 pages).
Opening Expert Report of Dr. John C. Kulli Regarding Certain Claims of U.S. Patent No. 7,264,613, including Appendixes A-J; B. Braun Melsungen AG & B. Braun Medical Inc. v. Terumo Medical Corporation & Terumo Corporation, dated Apr. 9, 2010 (874 pages).
Terumo Medical Corporation & Terumo Corporation's First Supplemental Responses to B. Braun Melsungen AG & B. Braun Medical Inc.'s First Set of Interrogatories (No. 3), with Attachments A and B and Appendixes 2-11; Case No. 09-347-JJF, dated Sep. 22, 2009, District of Delaware, United States District Court (1506 pages).
Terumo Medical Corporation & Terumo Corporation's Supplemental Answers to B. Braun Melsungen AG & B. Braun Medical Inc.'s First Set of Interrogatories (Nos. 1-6); Case No. 09 347 JJF, dated Dec. 30, 2009, District of Delaware, United States District Court; Redacted (36 pages).
Terumo Medical Corporation & Terumo Corporation's Third Supplemental Answers to B. Braun Melsungen AG & B. Braun Medical Inc.'s First Set of Interrogatories (Nos. 2 and 3); Case No. 09-347-JJF, dated Feb. 26, 2010, District of Delaware, United States District Court; Redactd (23 pages).
Terumo Medical Corporation & Terumo Corporation's Fourth Supplemental Answers to B. Braun Melsungen AG & B. Braun Medical Inc.'s First Set of Interrogatories (No. 3), Case No. 09 347 JJF-LPS, dated Mar. 11, 2010, District of Delaware, United States District Court; Redacted (22 pages).
Decision on Opposition by Terumo Corporation; In the Court of the Commissioner of Patents for the Australian Patent Office; Patent Application No. 2006200679 in the name of B. Braun Melsungen AG; Terumo Corporation v. B. Braun Melsungen AG [2011] APO 71 dated Sep. 16, 2011 (17 pages).
Hoffer, Erik K. et al., “Peripherally Inserted Central Catheters with Distal versus Proximal Valves: Prospective Randomized Trial”, Journal of Vascular and Interventional Radiology, Oct. 2001, pp. 1173-1177, vol. 12 No. 10 (5 pages).
Image™ II Angiographic Catheter, product information. Boston Scientific Online www.bostonscientific.com (3 sheets).
Information Sheet on Multilumen CVPs. www.icufaqs.org/CentralLines and www.cc.nih.gov/vads/lines.html (1 sheet).
Desanto, Matthew F.
This application is a continuation of application of Ser. No. 11/537,368; filed Sep. 29, 2006, now U.S. Pat. No. 7,611,487 which is a divisional application of Ser. No. 10/856,315, filed May 27, 2004, now U.S. Pat. No. 7,125,397, which is a continuation-in-part of an application entitled PROTECTIVE DEVICE FOR AN INJECTION NEEDLE, application Ser. No. 10/468,923 filed Feb. 2, 2004, now U.S. Pat. No. 7,214,211, which claims priority to international application No. PCT/EP02/02042, entitled PROTECTIVE DEVICE FOR AN INJECTION NEEDLE, filed Feb. 26, 2002, which claims the benefit of German application No. 201 03 363, filed Feb. 26, 2001, and also a continuation-in-part of an application entitled SPRING CLIP SAFETY IV CATHETER, application Ser. No. 10/445,166, filed May 23, 2003, now U.S. Pat. No. 7,264,613, which is a continuation of application Ser. No. 09/638,641, filed Aug. 14, 2000, now U.S. Pat. No. 6,616,630, which is a continuation-in-part of application Ser. No. 09/183,697, filed Oct. 30, 1998, now U.S. Pat. No. 6,287,278, which is a continuation-in-part of application Ser. No. 09/097,170, filed Jun. 12, 1998, now U.S. Pat. No. 6,117,108, which is a continuation-in-part of application Ser. No. 08/915,148, filed Aug. 20, 1997, now abandoned, the contents of which are expressly incorporated herein by reference.
1. A protective device of an injection needle or infusion needle characterized in that: a needle holder holds a portion of the needle on an end spaced apart from a needle tip; a needle protective element comprises a wall portion having a sleeve which said needle penetrates and two resilient arms extending from said wall on both sides of the needle, each said resilient arm having a distal end portion that offsets with respect to one another, press-contacts with the needle shaft in a standby position and covers the needle tip in a protection position; a grip part comprises an interior surface defining an interior cavity which accepts said needle protective element therein and an exterior surface defining a gripping portion; the grip part and the needle holder have portions that overlap when the protective element is in the standby position; the grip part is configured to be gripped and slide distally, which separates the grip part from the needle holder, which grip part then moves the protective element to the protection position where said two resilient arms disengage from the needle to protect the needle tip; and an enlarged diameter part disposed on the needle shaft in the proximity of the needle tip is blocked by the sleeve of the wall portion of said needle protective element to prevent the needle protective element from being displaced further.
2. The protective device of claim 1, wherein the two resilient arms are of dissimilar lengths.
3. The protective device of claim 1, wherein the two resilient arms each has sections of different widths.
4. The protective device of claim 1, wherein the protective element is made from a metal material.
5. The protective device of claim 1, wherein the grip part is delimited by the needle protective element from displacing distally of the needle tip.
6. The protective device of claim 1, wherein the needle tip comprises a curve tip.
7. A protective device for an injection needle or infusion needle comprising a needle, a needle shaft, a needle tip, and a needle holder at the proximal end of the needle, a protective element for the needle tip located on the needle shaft and movable relative to the needle shaft, said protective element comprising a sleeve having a generally cylindrical element to interact with the needle shaft to prevent the protective element from being removed from the needle shaft; a grip part provided between the protective element and the needle holder for containing and moving the protective element, the grip part in use being held in a hand, and as a result of relative movement between the needle and the grip part, the protective element is moved into its protection position on the needle tip without the protective element being touched; wherein the protective element includes two arms extending from a proximal wall portion, the proximal wall portion having a hole for passage of the needle from a starting position to the protection position, the two arms having at a distal end, an end portion which lies on an outer circumference of the needle and, on reaching the needle tip, is moved by spring action over the needle tip into the protection position.
8. The protective device of claim 7, whereby the grip part is prevented from being removed from the needle.
9. The protective device of claim 7, whereby the needle shaft includes an enlarged diameter which interacts with the sleeve to prevent the protective element from being removed from the needle.
10. The protective device of claim 7, wherein the two arms are of dissimilar lengths.
11. The protective device of claim 7, wherein the two arms each has sections of different widths.
12. The protective device of claim 7, wherein the protective element is made from a metal material.
13. The protective device of claim 7, wherein the needle tip comprises a curve tip.
Protective devices for covering needle tips are well known, for example from U.S. Pat. No. 4,929,241, wherein a relatively small protective element is arranged on a needle and can be moved by a spring from a retracted or ready position to a protected position on the needle tip. The elastic arms of the protective element engage over the needle tip while an engagement device on the protective element holds the latter on the needle shaft. Because of the relatively small size of the protective element, it is difficult to move it by hand on the needle, in addition, the securing spring can only be released when the needle tip lies free so that a risk of injury cannot be ruled out.
Accordingly, there is a need for a needle assembly that has an easy use grip part for moving the protective element, which is positioned between the protective element and the needle holder or hub.
The present invention may be implemented by providing a needle assembly comprising a needle holder comprising a body comprising a channel extending at least a portion of the body, an interior cavity in communication with the channel; a needle holding sleeve, and a Huber needle comprising a needle shaft attached to the needle holding sleeve; said Huber needle comprising a bent section along a portion of the needle shaft; a middle retaining portion removably received in the interior cavity of the needle holder, the middle retaining portion comprising a flange, a tubular projection, and a bore extending through the tubular projection and the flange having the Huber needle extending through the bore; said bore comprising a first section comprising a first dimension and a second section comprising a second dimension; and a protective element coaxially disposed with the needle shaft and positioned inside the bore; said protective element comprising a distal portion comprising a third dimension when positioned inside the bore and a fourth dimension when separated from the bore. In one exemplary embodiment, the first dimension is larger than the third dimension, which is larger than the second dimension, which is larger than the fourth dimension.
In another aspect of the present invention, there is provided a needle assembly comprising a needle holder comprising a body comprising a channel extending at least a portion of the body, an interior cavity in communication with the channel, a needle holding sleeve, and a Huber needle comprising a needle shaft attached to the needle holding sleeve; said Huber needle comprising a bent section along a portion of the needle shaft and a needle tip; a middle retaining portion removably received in the interior cavity of the needle holder comprising a flange, a tubular projection, a bore extending through the tubular projection and the flange, and the Huber needle extending through the bore; said bore comprising a wall surface comprising a wall engagement structure; and a protective element coaxially disposed with the needle shaft and positioned inside the bore; said protective element engaging the will engagement structure of the bore when the Huber needle is moved relative to the middle retaining portion. In one exemplary embodiment, the protective element is disengaged from the wall engagement structure of the bore when the needle tip moves from a position distal of a finger portion of the protective element to a position proximal of the finger portion of the protective element.
In yet another aspect of the present invention, there is provided a needle assembly comprising a needle hub comprising abuse section, a nose section, an exterior surface, and a interior surface defining an interior cavity; a needle comprising a needle shaft, a distal end comprising a needle tip, and a proximal end attached to the nose section of the needle hub; a middle retaining portion telescopically disposed over at least a portion of the nose section of the needle hub comprising a body structure comprising an exterior surface and an interior surface defining a bore; said bore comprising a wall surface comprising a wall engagement structure; and a protective element coaxially disposed with the needle shaft and positioned at least partially inside the bore of the middle retaining portion; said protective element engaging the wall engagement structure of the bore when the needle is moved relative to the middle retaining portion. In one exemplary embodiment, the protective element is disengaged from the wall engagement structure of the bore when the needle tip moves from a position distal of a finger portion of the protective element to a position proximal of the finger portion of the protective element.
These and other features and advantages of the present invention will become appreciated as the same become better understood with reference to the specification, claims and appended drawings wherein:
The detailed description set forth below in connection with the appended drawings is intended as a description of the presently preferred embodiments of protective devices for injection needles provided in accordance with practice of the present invention and is not intended to represent the only forms in which the present invention may be constructed or utilized. The description sets forth the features and the steps for constructing and using the protective devices of the present invention in connection with the illustrated embodiments. It is to be understood, however, that the same or equivalent functions and structures be accomplished by different embodiments that are also intended to be encompassed within the spirit and scope of the invention. Also, as denoted elsewhere herein, like element numbers are intended to indicate like or similar elements or features.
Arranged between needle holder 1 and protective element 3 there is a grip part 6 which, at the proximal end, has a hollow cylindrical portion 7 on which a radially protruding shield 8 is formed. On the front face of the shield 8 there is a cylindrical portion 9 whose distal end is hollow. In the standby position according to FIG. 1, the protective element 3 is arranged in the cavity 10 and, by displacement of the grip part 6, can be moved forward to the needle tip 5, while the needle holder 1 is held with the other hand. The angled ends of the intersecting arms of the protective element 3 engage over the needle tip 5, on that injury to operating personnel by the needle tip is prevented.
These ribs 11 protruding over the outer circumference of the cylindrical portion 9 of the grip part 6 serve for attachment of a needle cap 13, which is shown in FIG. 4. This needle cap 13 is used for storing and handling the device. It can be removed from the needle holder 1 immediately before use of the injection needle, in order to expose the needle, without the grip part 6 and the protective element 3 being moved, because the needle cap 13 is held by the ribs 11 at a radial distance from the portion 9 of the grip part 6.
FIG. 4 shows a preferred embodiment of the grip part 6, the hollow cylindrical portion at the distal end of the grip part 6 being omitted, so that the solid cylindrical portion 14 forms the distal end of the grip part 6. After removal of the needle cap 13 from the ribs 11, the protective element 3 lies free in FIG. 4.
FIG. 6a shows, in a perspective view, a needle cap 50 which is formed by injection-molding and whose distal end can be closed, while the proximal end has, on the inner circumference, flutes or grooves 51 which correspond to the number of ribs 11 and which engage with the ribs 11 when the needle cap is placed on the needle holder 17, so that, by turning the attached needle cap 50, the needle holder 17 can also be turned. A threaded engagement is usually provided between needle holder 17 and syringe 16, so that, by turning the needle cap 50, the needle holder 17 can be screwed onto the syringe 16.
It is customary to draw liquid into the syringe by means of a needle of relatively large diameter and then to replace this needle with a needle haying a relatively small diameter, in order to perform an infusion on the patient. In the embodiment according to FIGS. 5 and 6, the needle can be changed without difficulty.
FIG. 7 shows a plan view of a needle holder 1 which is provided with laterally protruding wings 23 and to which a connection tube 24 is attached. Arranged between the protective element 3 arranged on the needle shaft and the needle holder 1 there is a grip pan 6 with a hub-shaped portion 26 which, because of the flat injection angle (FIG. 8), expediently has a surface part 25 for bearing on the patient's skin which, on the bearing side, can be provided for example with an adhesive layer for better retention on the skin. A foam material 25′ is preferably provided on the bearing side. The hub portion 26 of the grip part 6 protruding from the front end of the surface part 25 at least partially covers the protective element 3. The surface part 25 or the soft bearing part 25′ also serves as spacer for keeping the protective element 3 from the patient's skin. In the illustrative embodiment according to FIG. 8, the soft bearing part 25′ extends across the surface part 25 under the hub portion 26, so that the protective element 3 does not lie on the patient's skin.
FIG. 16 shows an embodiment with a Huber needle 2 according to FIG. 15, where a needle cap 13 of smaller internal diameter is pushed onto the needle 2. The needle cap corresponds substantially to that of FIG. 14, the needle cap 13 being held on the needle by means of friction at the angled front end. This needle cap 13 in FIG. 16 can be provided with radially protruding and diametrically opposite surface portions 52 through which handling is improved and the tubular needle cap 13 is made more rigid. FIG. 16a shows a perspective view of such a needle cap 13 with diametrically opposite surface portions 52.
In all the embodiments, the protective element 3 is preferably a needle which is made of metal and whose intersecting arms issue from opposite sides of a proximal wall portion having a hole for the passage of the needle, the hole diameter being smaller than the maximum transverse dimension of the needle at the pinch 18, so that the needle clip is held in the protection position on the needle tip by means of the portion 18 of increased diameter. The intersecting arms extending on both sides of the needle 2, as FIG. 14a shows, have, at the distal end, an end portion which is widened to approximately the width of the rear wall and which, in the starting position, lies with elastic pretensioning on the outer circumference of the needle and, on reaching the needle tip, is moved by spring action into the protection position in which the two widened end portions engage over the needle tip. For this purpose, the distal ends of the arms, as the side views show, are slightly offset with respect to one another in the longitudinal direction or the arms are of different lengths, so that it is thus ensured that the two angled end portions of the arms engage over the needle tip. At least on the longer arm, the end portion is curved inward at the free edge in order to ensure that the needle tip is covered even if an attempt is made to push the needle clip back from the protection position on the needle, the inwardly curved end portion hooking onto the needle tip. The needle clip as a whole can be made very compact and only about 7 mm long.
Referring now to FIG. 21, a semi-schematic side view of an alternative safety Huber needle assembly 50 is shown comprising a needle holder 52 and a middle retaining portion 54 received by the needle holder. The middle retaining portion 54 comprises a flange 31, which has a bore for receiving a Huber needle 2. An optional safety sleeve or Huber guard 36 made from a plastic material, such as a polyurethane material, is positioned over the Huber needle 2 to cover the needle tip 58 of the Huber needle. The Huber guard 56 comprises a central cylindrical section 60 and a pair of fins 62a, 62b extending from the central cylindrical section in opposing configuration.
As further discussed below, the Huber needle 2 is attached to a needle holding sleeve 64 of the needle holder 52, which has a lumen in fluid communication with the lumen of the Huber needle. In one exemplary embodiment, a medical grade plastic tubing 65 made from DEHP free PVC is attached at its first end 66 to an outlet end 103 (FIG. 22) of the needle holding sleeve 64 and at its second end 68 to a female Luer lock adapter 70. A screw cap 72 is threadedly engaged to the female Luer lock adapter 70 to preserve sterility until use. A tubing clamp 74, such as those offered by Halkey-Roberts of St. Petersburg, Fla. is disposed on the tubing 65 for isolating or clamping the tubing when desired.
FIG. 22 is a semi-schematic cross-sectional side view of the Huber needle assembly 50 of FIG. 21 from a reverse angle without the tubing 65 for clarity. As show n, the Huber needle 2 is attached to the needle holder 52 by means of a section of the needle proximal of a bent section 76 inserted into the inlet end 78 of the needle holding sleeve 64 and, in one embodiment, fixed in place by adhesive or glue. In the Huber needle ready to use position (FIGS. 21 and 22), at least a portion of the middle retaining portion 54 is received in the interior cavity 80 of the needle holder 52. In one exemplary embodiment, a tubular extension 82 of the middle retaining portion 54 extending from the base or flange 31 comprising an exterior surface 84 and an interior surface 86 extends into the interior cavity 80 of the needle holder 52. As further discussed below, the exterior surface 84 of the tubular extension 82 engages the surface of the interior cavity 80 of the needle holder 52 to maintain the two in removable engagement when in the ready to use position.
The interior surface 86 of the middle retaining portion 54 defines a retaining bore 88 adapted to pass the Huber needle 2 therethrough and to retain the protective element 3 therein. In one exemplary embodiment, this retaining configuration is implemented by incorporating a bump 85 comprising a reduced diameter section Dr that is nominally smaller than an inside diameter dimension Did of the retaining bore 88, at either end or opening of the retaining bore. With reference to FIGS. 22 and 23, when the protective element 3 is in the ready to use position (FIGS. 22 and 23, top), the arms 92a, 92b (FIG. 23) are biased radially apart by the curved tips 94a, 94b abutting the side of the Huber needle 3. In this position, the dimension D2 measured from one intersecting joint 96a to another intersecting joint 96b is larger than the same measurement D1 measured when the arms 92a, 92b are in a relaxed state (i.e., not abutting the side of the needle) and the fingers 98a, 98b overlapped (FIG. 23, bottom). In one exemplary embodiment, the reduced diameter section Dr is larger than D1 but is smaller than D2, which is smaller than Did. Expressed mathematically, the diameters have the following relationship: D1<Dr<D2<Did. Alternatively, D2 can be equal to Did or slightly larger than Did as the fingers 98a, 98b are able to flex when positioned inside the retaining bore 88 and slide past the bump 85.
The Huber needle assembly 50 may be placed in the ready to use position by first positioning the protective clip 3 over the Huber needle 2 and then sliding the Huber needle through the retaining bore 88 of the middle retaining portion 54. The Huber needle 2 may include a bulge or a crimp 91 for stopping the forward movement of the protective clip 3 when the opening 93 of the clip, which is smaller than the crimp 91, abuts the crimp. As the tubular extension 82 of the middle retaining portion 54 moves into the interior cavity 80 of the needle holder 52, the portions adjacent the interconnecting joints 96a, 96b of the protective clip 3 abuts the reduced diameter section Dr of the retaining bore 88. Further downward movement of the needle holder 52 relative to the middle retaining portion 54 causes the protective clip 3 to flex and the fingers 98a, 98b move past the reduced diameter portion Dr into the ready to use position. The relative movement stops when the upper end surface 100 of the middle retaining portion 54 abuts the interior surface of the interior cavity 80 of the needle holder 52.
A gap or channel 116 is provided intermediate the two shrouds 100. The channel 116 runs or extends a portion of the top surface of the needle holder 52 and the entire length of the front side opposite the central needle base structure 102. For assembling or making the needle holder 52, the channel 116 facilitates insertion of the blunt end of the Huber needle 2 into the inlet end 78 of the needle holding member 64 as the gap defined by the channel provides access into the interior cavity 80 of the needle holder 52. Alternatively, the channel 116 can extend a portion of the length of the front side opposite the central needle base structure 102 and a portion of the top surface of the needle holder 52 and still provide for access to the interior cavity 80 for mounting the Huber needle 2.
FIG. 26 is a semi-schematic bottom view of the needle holder 52 of FIG. 24. In the configuration shown, the main interior section 118 of the interior cavity 80 is semi-frustoconical in shape, in view of the gaps 120, 122, with the interior surface 130 of the main interior section 118 having a slight taper that tapers inwardly from about the base 104 towards the top 105. However, a straight wall surface without a slight taper may be incorporated. Side wall portions 132 of the central needle base structure 102 extend at an angle from the back wall 134 of the central needle base structure 102 to create a generally rectangular secondary interior section 120 of the interior cavity 80. However, this secondary interior section 120 may incorporate other configurations by changing the contour or shape of the side a portions, such as a square or a curved structure.
FIG. 27 is a semi-schematic cross-sectional side view of the middle retaining portion 54 provided in accordance with aspects of the present invention. In the figure shown, the orientation marker 124 is attached to the tubular extension 82 is a webbing 136, which is similar to a rib and, in one embodiment, is integrally molded with the flange 31, the orientation marker 124, and the tubular extension 82. The orientation marker 124 is configured to fit into the secondary interior section 120 of the interior cavity 80 or the secondary slot 122 when the middle retaining portion 54 is removably mated to the needle holder 52. The middle retaining portion 54 may be made from polyethylene or similar plastics and may be enhanced with color, such as a light green or other desired colors. A plurality of openings (not shown) may be incorporated in the base 31 of the middle retaining portion 54 to facilitate taping the base to the patient. The openings can vary in shapes, sizes, and numbers and can also be eliminated.
Referring now to FIG. 28 in addition to FIG. 22, the alternative needle assembly 50 may be used by first removing the safety sleeve 56 from the Huber needle 2. The needle 2 is then inserted into a subject until the flange 31 abuts the subject. When the injection is completed, the needle 2 may be withdrawn from the subject and the needle tip shielded by the protective clip 3 by holding onto the flange 31 while concurrently retracting the needle 2 proximally or away from the subject. During this proximal needle motion, the intersecting joints 96a, 96b of the needle clip 3 abut the reduced diameter section Dr of the main internal section 118 of the interior cavity 80 of the middle retaining portion 54 to permit the needle to move relative to the protective clip 3. As previously discussed, this relative movement is provided due to the larger clip dimension D2 (FIG. 23) when the curved lips 94a, 94b of the needle clip 3 abut the side of the needle 2 as compared to the reduced diameter section Dr of the interior cavity 80.
When the needle tip moves proximal of the curved lips 94a, 94b of the needle clip 3 so that the needle clip 3 is no longer biased by the needle (FIGS. 23, bottom, and 28), the resilient arms 92a, 92b are unrestrained and flex radially inwardly over the needle tip. This radial movement causes the measurement of the two intersecting joints 96a, 96b (FIG. 23) to decrease from D2 to D1 while at the same time allows the fingers 98a, 98b to overlap over the needle tip to shield the needle tip. As the measurement D1 between the two intersecting joints 96a, 96b is now smaller than the reduced diameter section Dr of the interior cavity 80, the needle clip 3 is able to slip past the reduced diameter section Dr of the bore 88 when the needle 2 is further moved proximally (FIG. 28). The needle clip 3 is now attached to the needle 2 and separates from the middle retaining portion 54 (FIG. 28).
FIGS. 29-31 show another alternative needle assembly 140 provided in accordance with aspects of the present invention in various views and state of assembly. Referring initially to FIG. 29, the needle assembly 140 comprises a needle hub 142, a needle 144 having a protective clip 3 positioned thereon attached at its proximal end to the distal end 146 of the needle hub 142, a middle retaining portion 148, and a needle cover 150. The needle hub 142 comprises abase section 152 having a Luer lock 154 and a transition section 156 that connects to a nose section 158 having a nose flange 160 positioned thereon. A plurality of spaced apart ribs 162 are formed along the exterior surface of the hub, which in one exemplary embodiment comprises four ribs evenly spaced along the exterior surface although no ribs, fewer ribs, or more ribs may be included without deviating from the spirit and scope of the present invention.
The needle cover 150 comprises a base section 176 and a protective section 178. The base section 176 is configured to removably engage with the nose flange 160 on the needle hub 142 while the protective section 178 is configured to shield the needle and needle tip prior to usage of the needle. In one exemplary embodiment, the base section 170 comprises an opened lower section 180 and a pair of grooves or detents on an inside interior surface (not shown) of the base section 176. The pair of grooves or detents are configured to latch with the nose flange 160 in a detent-type configuration. In one exemplary embodiment, the needle cover 150 is semi-opaque to permit visual inspection of the needle prior to use.
FIG. 31 is a cross-sectional side view of the needle assembly of from a different viewing angle. As shown, the middle retaining portion 142 comprises a bow 186 having an interior surface that includes bump or a reduced diameter section Dr, similar in configuration as the middle retaining portion 54 of FIGS. 27 and 28. The bump or reduced diameter section Dr of FIG. 31 cooperates with the protective clip 3 in the same way as the middle retaining portion 54 and needle clip 3 of FIGS. 23-28 to provide the same retaining and relative movement functions. Also shown is a needle hub bore 185, which is configured to receive a Luer tip of a syringe (not shown) or other medical implements.
The protective clip 3 may be moved to a ready to use position by pushing the middle retaining portion 148 over the nose tip section 182 of the needle hub 142. To ensure that the distal portion of the protective clip 3 (See, e.g., the portions comprising the intersecting joints 96a, 96b of FIG. 23) slides past the bump or reduced diameter section Dr of the middle retaining portion 148, the distance between the reduced diameter section Dr and the distal end surface 188 of the nose section 158 of the needle hub 142 should be less than the distance between the proximal end wall 190 of the protective clip 3 and the intersection joints 96a, 96b of the protective clip 3 (See, e.g., FIG. 23). Once mounted in the position shown (FIG. 31), the protective clip 3 moves with the middle retaining portion 148 and relative to the needle 3 until the clip is no longer urged by the needle, as further described below and as described above with reference to FIGS. 22 and 28.
The needle assembly 140 may be used by first mounting the needle hub 142 over a syringe or other medical implement and then removing the needle cover 150. A fluid may be aspirated into the syringe via the needle or the needle may be inserted into a subject if a fluid sample from the subject is to be taken. Following the injection, the needle 144 is retracted or withdrawn from the subject (either by pulling on the syringe (not shown) or grapping the needle hub 142 and pulling on the needle hub away from the subject) with one hand while holding or grabbing onto the middle retaining portion 148 with the other hand.
As the needle is retracted, the protective clip 3 is held by the reduced diameter section Dr of the middle retaining portion 148 and moves relative to the needle 144 until the needle tip moves proximal of the curved lips 94a, 94b (See, FIG. 23, bottom), at which point the protective clip moves radially inwardly such that the fingers 98a, 98b overlap over the needle tip to shield the needle tip. Approximately simultaneously therewith, the cross-sectional dimension of the protective clip 3 at its distal end collapses or reduces in size so that said section of the protective clip is now smaller than the reduced diameter section Dr of the middle retaining portion 148, which then allows the protective clip 3 to separate from the middle retaining portion. The needle and needle hub may then be disposed of pursuant to standard protocols.
<- Previous Patent (Method and apparatus...) | Next Patent (Bent obturator) ->